Latest from EBN

What can qualitative research do for randomised controlled trials? A systematic mapping review [RESEARCH]

Mon, 17 Jun 2013 00:00:00 +0000

ObjectiveTo develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. DesignSystematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sourcesMEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteriaArticles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. ConclusionsA large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit within their articles about the learning for trials and evidence-based practice.

Selective reporting of outcomes in randomised controlled trials in systematic reviews of cystic fibrosis [RESEARCH]

Mon, 17 Jun 2013 00:00:00 +0000

BackgroundOutcome reporting bias (ORB) in randomised trials has been identified as a threat to the validity of systematic reviews. Previous work highlighting this problem is limited to considering a single primary review outcome. The aim of this study was to assess ORB across all efficacy outcomes in the Cochrane systematic reviews of cystic fibrosis. MethodsSystematic reviews of interventions for cystic fibrosis published on the Cochrane Library by the Cochrane Cystic Fibrosis and Genetic Disorders Group before 2010 were assessed for discrepancies in outcomes between review protocol and full review. ORB in eligible trials was also assessed for all efficacy review outcomes. Two authors independently classified each outcome using a nine-point classification system developed by the Outcome Reporting Bias In Trials study. These classifications were used to inform the assessment of the risk of bias for selective outcome reporting for each trial. Results-46 Cochrane cystic fibrosis systematic reviews were included. The median number of primary outcomes, number of trials and participants per trial in the reviews were 3 (IQR 2, 3), 4 (IQR 2, 8) and 21 (IQR 14, 41), respectively. 18 reviews (39%, 18/46) had a discrepancy in outcomes between protocol and full review. 37 reviews were eligible to be included in the ORB assessment. When considering review primary outcomes and all review outcomes, ORB was suspected in at least one trial in 86% and 100%, respectively. ConclusionsAssessment of ORB within a systematic review of a single primary outcome underestimates the risk of ORB in comparison to the assessment of multiple primary and secondary outcomes. ORB in trials is highly prevalent within systematic reviews of cystic fibrosis when assessed across all outcomes. This could be reduced by the development of a core outcome set for trials and systematic reviews in cystic fibrosis.

Are there sleep-specific phenotypes in patients with chronic fatigue syndrome? A cross-sectional polysomnography analysis [RESEARCH]

Mon, 17 Jun 2013 00:00:00 +0000

ObjectivesDespite sleep disturbances being a central complaint in patients with chronic fatigue syndrome (CFS), evidence of objective sleep abnormalities from over 30 studies is inconsistent. The present study aimed to identify whether sleep-specific phenotypes exist in CFS and explore objective characteristics that could differentiate phenotypes, while also being relevant to routine clinical practice. DesignA cross-sectional, single-site study. SettingA fatigue clinic in the Netherlands. ParticipantsA consecutive series of 343 patients meeting the criteria for CFS, according to the Fukuda definition. MeasuresPatients underwent a single night of polysomnography (all-night recording of EEG, electromyography, electrooculography, ECG and respiration) that was hand-scored by a researcher blind to diagnosis and patient history. ResultsOf the 343 patients, 104 (30.3%) were identified with a Primary Sleep Disorder explaining their diagnosis. A hierarchical cluster analysis on the remaining 239 patients resulted in four sleep phenotypes being identified at saturation. Of the 239 patients, 89.1% met quantitative criteria for at least one objective sleep problem. A one-way analysis of variance confirmed distinct sleep profiles for each sleep phenotype. Relatively longer sleep onset latencies, longer Rapid Eye Movement (REM) latencies and smaller percentages of both stage 2 and REM characterised the first phenotype. The second phenotype was characterised by more frequent arousals per hour. The third phenotype was characterised by a longer Total Sleep Time, shorter REM Latencies, and a higher percentage of REM and lower percentage of wake time. The final phenotype had the shortest Total Sleep Time and the highest percentage of wake time and wake after sleep onset. ConclusionsThe results highlight the need to routinely screen for Primary Sleep Disorders in clinical practice and tailor sleep interventions, based on phenotype, to patients presenting with CFS. The results are discussed in terms of matching patients' self-reported sleep to these phenotypes in clinical practice.

The use of glucosamine for chronic low back pain: a systematic review of randomised control trials [RESEARCH]

Mon, 17 Jun 2013 00:00:00 +0000

ObjectivesTo ascertain whether the use of oral glucosamine influences symptoms or functional outcomes in patients with chronic low back pain (LBP) thought to be related to spinal osteoarthritis (OA). DesignSystematic review of randomised control trials. Searches were performed up to March 2011 on Medline, AMED, CINHAL, Cochrane and EMBASE with subsequent reference screening of retrieved studies. In addition, the grey literature was searched via opensigle. Included studies were required to incorporate at least one of the Cochrane Back Pain Review Group's outcome measures as part of their design. Trials with participants over 18 years with a minimum of 12 weeks of back pain, in combination with radiographic changes of OA in the spine, were included. Studies were rated for risk-of-bias and graded for quality. Results148 studies were identified after screening and meeting eligibility requirements, and three randomised controlled trials (n=309) were included in the quantitative synthesis. The review found that there was low quality but generally no evidence of an effect from glucosamine on function, with no change in the Roland-Morris Disability Questionnaire score in all studies. Conflicting evidence was demonstrated with pain scores with two studies showing no difference and one study with a high risk-of-bias showing both a statistically and clinically significant improvement from taking glucosamine. ConclusionsOn the basis of the current research, any clinical benefit of oral glucosamine for patients with chronic LBP and radiographic changes of spinal OA can neither be demonstrated nor excluded based on insufficient data and the low quality of existing studies.

Endoscopic retrograde cholangiopancreatography: utilisation and outcomes in a 10-year population-based cohort [RESEARCH]

Fri, 31 May 2013 00:00:00 +0000

ObjectiveTo determine utilisation of endoscopic retrograde cholangiopancreatography (ERCP); incidence of inpatient admissions for complications occurring within 30 days of ERCP and risk factors for procedural-related complications, in a population-based study. DesignRetrospective cohort study. SettingOlmsted County, Minnesota. ParticipantsAll adult residents of Olmsted County, Minnesota, who underwent ERCP from 1997 to 2006. InterventionsDiagnostic and therapeutic ERCPs were assessed. Primary and secondary outcome measuresPatient and procedural characteristics and complications within 30 days; and rates of ERCP utilisation and unplanned admissions and risk factors for admissions. ResultsIn 10 years, 1072 ERCPs were performed on 827 individual patients. Average utilisation of ERCP was 83.1 ERCPs/100 000 persons/year, with an increase from 58 to 104.8 ERCPs/100 000 persons/year over time, driven by increases in therapeutic procedures. Within 30 days after 236 procedures, 62 admissions were definitely related to the index ERCP. The complication rate was 5.3%, including pancreatitis (26, 2.4%), infection/cholangitis (16, 1.5%), bleeding (15, 1.4%) and perforation (4, 0.37%). 30-day mortality was 2.4%, none of which was directly related to the ERCP or complications thereof. Risk factors identified through multivariate analysis to be associated with adverse events included: age <45 years (p=0.0498); body mass index [≥]35 (p=0.0024); pancreatic duct cannulation (p=0.0026); outpatient procedure (p<0.0001); intraprocedure sphincterotomy bleeding (p<0.0001); difficulty grade (p=0.115) and patient's first ERCP (p=0.0394). LimitationsRetrospective study. ConclusionsPopulation utilisation of ERCP rose during the study period, specifically in therapeutic procedures. Admissions within 30 days of ERCP are common but often unrelated. Complications of ERCP remain infrequent and deaths quite unusual.

Clinical implementation of a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectivesThis study was undertaken to test the extent to which a new antibiotic prophylaxis regimen for percutaneous endoscopic gastrostomy (PEG), identified as a justified and simpler alternative to conventional regimen in a randomised clinical trial, has been adopted in clinical practice. DesignA Swedish nationwide implementation survey, conducted in February 2013, assessed the level of clinical implementation of a 20 ml dose of oral solution of sulfamethoxazole and trimethoprim deposited in the PEG catheter immediately after insertion. All hospitals inserting at least five PEGs annually were identified from the Swedish Patient Registry. A clinician involved in the PEG insertions at each hospital participated in a structured telephone interview addressing their routine use of antibiotic prophylaxis. SettingAll Swedish hospitals inserting PEGs (n=60). ParticipantsRepresentatives of PEG insertions at each of the 60 eligible hospitals participated (100% participation). Main outcome measuresUse of routine antibiotic prophylaxis for PEG. ResultsA total of 32 (53%) of the 60 hospitals had adopted the new regimen. It was more frequently adopted in university hospitals (67%) than in community hospitals (41%). An annual total of 1813 (70%) of 2573 patients received the new regimen. Higher annual hospital volume was associated with a higher level of adoption of the new regimen (80% in the highest vs 31% in the lowest). ConclusionsThe clinical implementation of the new antibiotic prophylaxis regimen for PEG was high and rapid (70% of all patients within 3 years), particularly in large hospitals.

On the time spent preparing grant proposals: an observational study of Australian researchers [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectiveTo estimate the time spent by the researchers for preparing grant proposals, and to examine whether spending more time increase the chances of success. DesignObservational study. SettingThe National Health and Medical Research Council (NHMRC) of Australia. ParticipantsResearchers who submitted one or more NHMRC Project Grant proposals in March 2012. Main outcome measuresTotal researcher time spent preparing proposals; funding success as predicted by the time spent. ResultsThe NHMRC received 3727 proposals of which 3570 were reviewed and 731 (21%) were funded. Among our 285 participants who submitted 632 proposals, 21% were successful. Preparing a new proposal took an average of 38 working days of researcher time and a resubmitted proposal took 28 working days, an overall average of 34 days per proposal. An estimated 550 working years of researchers' time (95% CI 513 to 589) was spent preparing the 3727 proposals, which translates into annual salary costs of AU$66 million. More time spent preparing a proposal did not increase the chances of success for the lead researcher (prevalence ratio (PR) of success for 10 day increase=0.91, 95% credible interval 0.78 to 1.04) or other researchers (PR=0.89, 95% CI 0.67 to 1.17). ConclusionsConsiderable time is spent preparing NHMRC Project Grant proposals. As success rates are historically 20-25%, much of this time has no immediate benefit to either the researcher or society, and there are large opportunity costs in lost research output. The application process could be shortened so that only information relevant for peer review, not administration, is collected. This would have little impact on the quality of peer review and the time saved could be reinvested into research.

Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectiveThis study describes the 5 years' results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. DesignA randomised controlled trial. SettingNine Dutch hospitals. ParticipantsFive years' follow-up data from 231 of 283 patients (82%) were collected. InterventionEarly surgery or an intended 6 months of conservative treatment. Main outcome measuresScores from Roland disability questionnaire, visual analogue scale (VAS) for leg and back pain and a Likert self-rating scale of global perceived recovery were analysed. ResultsThere were no significant differences between groups on the 5 years' primary outcome scores. Despite at least 6 months of conservative treatment 46% of the conservatively allocated patients were treated surgically because of severe leg pain and disability. Forty-nine (21%) patients had an unsatisfactory recovery at 5 years and the recovery pattern showed that there was a variable group of 66 patients (31%) with at least one unsatisfactory outcome at 1, 2 or 5 years of follow-up. Multivariate logistic regression showed that age (>40; OR 2.42 (95% CI 1.16 to 5.02)), severity of leg pain (VAS >70; OR 3.32 (95% CI 1.69 to 6.54)) and the Mc Gill affective score (score >3; OR 6.23 (95% CI 2.23 to 17.38)) were the only significant predictors for an unsatisfactory outcome at 5 years. ConclusionsIn the long term, 8% of the patients with sciatica never showed any recovery and in at least 23%, sciatica appears to result in ongoing complaints, which fluctuate over time, irrespective of treatment. Prolonged conservative care might give patients a fair chance for pain and disability to resolve without surgery, but with the risk to receive delayed surgery after prolonged suffering of sciatica. Age above 40 years, severe leg pain at baseline and a higher affective Mc Gill pain score were predictors for unsatisfactory recovery. Trial Registry ISRCT No 26872154.

Pulmonary metastasectomy in colorectal cancer: a prospective study of demography and clinical characteristics of 543 patients in the Spanish colorectal metastasectomy registry (GECMP-CCR) [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectivesTo capture an accurate contemporary description of the practice of pulmonary metastasectomy for colorectal carcinoma in one national healthcare system. DesignA national registry set up in Spain by Grupo Espanol de Cirugia Metastasis Pulmonares de Carcinoma Colo-Rectal (GECMP-CCR). Setting32 Spanish thoracic units. ParticipantsAll patients with one or more histologically proven lung metastasis removed by surgery between March 2008 and February 2010. InterventionsPulmonary metastasectomy for one or more pulmonary nodules proven to be metastatic colorectal carcinoma. Primary and secondary outcome measuresThe age and sex of the patients having this surgery were recorded with the number of metastases removed, the interval between the primary colorectal cancer operation and the pulmonary metastasectomy, and the carcinoembryonic antigen level. Also recorded were the practices with respect to mediastinal lymphadenopathy and coexisting liver metastases. ResultsData were available on 543 patients from 32 units (6-43/unit). They were aged 32-88 (mean 65) years, and 65% were men. In 55% of patients, there was a solitary metastasis. The median interval between the primary cancer resection and metastasectomy was 28 months and the serum carcinoembryonic antigen was low/normal in the majority. Liver metastatic disease was present in 29% of patients at some point prior to pulmonary metastasectomy. Mediastinal lymphadenectomy varied from 9% to 100% of patients. ConclusionsThe data represent a prospective comprehensive national data collection on pulmonary metastasectomy. The practice is more conservative than the impression gained when members of the European Society of Thoracic Surgeons were surveyed in 2006/2007 but is more inclusive than would be recommended on the basis of recent outcome analyses. Further analyses on the morbidity associated with this surgery and the correlation between imaging studies and pathological findings are being published separately by GECMP-CCR.

Evidence-based commissioning in the English NHS: who uses which sources of evidence? A survey 2010/2011 [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectivesTo investigate types of evidence used by healthcare commissioners when making decisions and whether decisions were influenced by commissioners' experience, personal characteristics or role at work. DesignCross-sectional survey of 345 National Health Service (NHS) staff members. SettingThe study was conducted across 11 English Primary Care Trusts between 2010 and 2011. ParticipantsA total of 440 staff involved in commissioning decisions and employed at NHS band 7 or above were invited to participate in the study. Of those, 345 (78%) completed all or a part of the survey. Main outcome measuresParticipants were asked to rate how important different sources of evidence (empirical or practical) were in a recent decision that had been made. Backwards stepwise logistic regression analyses were undertaken to assess the contributions of age, gender and professional background, as well as the years of experience in NHS commissioning, pay grade and work role. ResultsThe extent to which empirical evidence was used for commissioning decisions in the NHS varied according to the professional background. Only 50% of respondents stated that clinical guidelines and cost-effectiveness evidence were important for healthcare decisions. Respondents were more likely to report use of empirical evidence if they worked in Public Health in comparison to other departments (p<0.0005, commissioning and contracts OR 0.32, 95%CI 0.18 to 0.57, finance OR 0.19, 95%CI 0.05 to 0.78, other departments OR 0.35, 95%CI 0.17 to 0.71) or if they were female (OR 1.8 95% CI 1.01 to 3.1) rather than male. Respondents were more likely to report use of practical evidence if they were more senior within the organisation (pay grade 8b or higher OR 2.7, 95%CI 1.4 to 5.3, p=0.004 in comparison to lower pay grades). ConclusionsThose trained in Public Health appeared more likely to use external empirical evidence while those at higher pay scales were more likely to use practical evidence when making commissioning decisions. Clearly, National Institute for Clinical Excellence (NICE) guidance and government publications (eg, National Service Frameworks) are important for decision-making, but practical sources of evidence such as local intelligence, benchmarking data and expert advice are also influential. New Clinical Commissioning Groups will need a variety of different evidence sources and expert involvement to ensure that effective decisions are made for their populations.

A brief intervention for drug use, sexual risk behaviours and violence prevention with vulnerable women in South Africa: a randomised trial of the Women's Health CoOp [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectiveTo assess the impact of the Women's Health CoOp (WHC) on drug abstinence among vulnerable women having HIV counselling and testing (HCT). DesignRandomised trial conducted with multiple follow-ups. Setting15 communities in Cape Town, South Africa. Participants720 drug-using women aged 18-33, randomised to an intervention (360) or one of two control arms (181 and 179) with 91.9% retained at follow-up. InterventionsThe WHC brief peer-facilitated intervention consisted of four modules (two sessions), 2 h addressing knowledge and skills to reduce drug use, sex risk and violence; and included role-playing and rehearsal, an equal attention nutrition intervention, and an HCT-only control. Primary outcome measuresBiologically confirmed drug abstinence measured at 12-month follow-up, sober at last sex act, condom use with main and casual sex partners, and intimate partner violence. ResultsAt the 12-month endpoint, 26.9% (n=83/309) of the women in the WHC arm were abstinent from drugs, compared with 16.9% (n=27/160) in the Nutrition arm and 20% (n=31/155) in the HCT-only control arm. In the random effects model, this translated to an effect size on the log odds scale with an OR of 1.54 (95% CI 1.07 to 2.22) comparing the WHC arm with the combined control arms. Other 12-month comparison measures between arms were non-significant for sex risk and victimisation outcomes. At 6-month follow-up, women in the WHC arm (65.9%, 197/299) were more likely to be sober at the last sex act (OR1.32 (95% CI 1.02 to 1.84)) than women in the Nutrition arm (54.3%, n=82/152). ConclusionsThis is the first trial among drug-using women in South Africa showing that a brief intervention added to HCT results in greater abstinence from drug use at 12 months and a larger percentage of sexual activity not under the influence of substances. Trial registration numberNCT00729391 ClinicalTrials.gov

Exploring adaptations to the modified shuttle walking test [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectiveThe 10 m modified shuttle walking test (MSWT) is recommended to determine the functional capacity in older individuals and for patients entering cardiac rehabilitation. Participants are required to negotiate around cones set 1 m from the end markers. However, consistent comments indicate that for some individuals manoeuvring around the cones can be quite difficult. Therefore, the objective of this study was to explore differences within and between non-cardiac and postmyocardial infarction (MI) males during MSWT with and without the cones. DesignComparative study. Participants20 post-MI (64.8{+/-}6.6, range 51-74 years) and 20 non-cardiac male controls (64.1{+/-}5.7, range 52-74 years) participated. MethodsParticipants performed MSWT with and without cones. Throughout, the participants expired air, and the heart rate (bpm) (HR) and ratings of perceived exertion (RPE) were measured. Participant protocol preference was recorded verbatim. ResultsOne-way analysis of variance found no significant difference in VO2 peak (cones 20.4{+/-}5.1 vs no-cones 21.9{+/-}4.8 ml/kg/min, p=0.197) or distance ambulated (cones 631.8{+/-}132.9 m vs no-cones 662.4{+/-}164.1 m, p=0.371) between protocols or groups. Analysis comparing lines of regression showed a significant trajectory difference in VO2 (ml/kg/min) (p<0.01) between protocols with higher HR (p<0.01) and respiratory exchange ratio (RER, p<0.001) values during cones. RPEs were higher for post-MIs versus controls during both protocols (p<0.05). Post-MIs taking {beta}-blockers produce significantly lower HR values. The {chi}2 analysis found no significant difference in protocol preference (no-cones: all n=25, 63%; post-MIs n=13, 65%; and controls n=12, 60%). ConclusionsPost-MIs found both protocols subjectively harder than controls with no significant difference in the VO2 peak. However, both groups worked at a lesser percentage of their anaerobic threshold during no-cones protocol as indicated by lower RER values. Importantly, for the post-MIs, this would reduce their risk of functional impairment. Therefore, though more research is required, indicators at present are more favourable for the use of the no-cones with post-MIs.

Bed sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies [RESEARCH]

Tue, 28 May 2013 00:00:00 +0000

ObjectiveTo resolve uncertainty as to the risk of Sudden Infant Death Syndrome (SIDS) associated with sleeping in bed with your baby if neither parent smokes and the baby is breastfed. DesignBed sharing was defined as sleeping with a baby in the parents' bed; room sharing as baby sleeping in the parents' room. Frequency of bed sharing during last sleep was compared between babies who died of SIDS and living control infants. Five large SIDS case-control datasets were combined. Missing data were imputed. Random effects logistic regression controlled for confounding factors. SettingHome sleeping arrangements of infants in 19 studies across the UK, Europe and Australasia. Participants1472 SIDS cases, and 4679 controls. Each study effectively included all cases, by standard criteria. Controls were randomly selected normal infants of similar age, time and place. ResultsIn the combined dataset, 22.2% of cases and 9.6% of controls were bed sharing, adjusted OR (AOR) for all ages 2.7; 95% CI (1.4 to 5.3). Bed sharing risk decreased with increasing infant age. When neither parent smoked, and the baby was less than 3 months, breastfed and had no other risk factors, the AOR for bed sharing versus room sharing was 5.1 (2.3 to 11.4) and estimated absolute risk for these room sharing infants was very low (0.08 (0.05 to 0.14)/1000 live-births). This increased to 0.23 (0.11 to 0.43)/1000 when bed sharing. Smoking and alcohol use greatly increased bed sharing risk. ConclusionsBed sharing for sleep when the parents do not smoke or take alcohol or drugs increases the risk of SIDS. Risks associated with bed sharing are greatly increased when combined with parental smoking, maternal alcohol consumption and/or drug use. A substantial reduction of SIDS rates could be achieved if parents avoided bed sharing.

Placing clinical variables on a common linear scale of empirically based risk as a step towards construction of a general patient acuity score from the electronic health record: a modelling study [RESEARCH]

Tue, 14 May 2013 00:00:00 +0000

ObjectiveTo explore the hypothesis that placing clinical variables of differing metrics on a common linear scale of all-cause postdischarge mortality provides risk functions that are directly correlated with in-hospital mortality risk. DesignModelling study. SettingAn 805-bed community hospital in the southeastern USA. Participants42302 inpatients admitted for any reason, excluding obstetrics, paediatric and psychiatric patients. Outcome measuresAll-cause in-hospital and postdischarge mortalities, and associated correlations. ResultsPearson correlation coefficients comparing in-hospital risks with postdischarge risks for creatinine, heart rate and a set of 12 nursing assessments are 0.920, 0.922 and 0.892, respectively. Correlation between postdischarge risk heart rate and the Modified Early Warning System (MEWS) component for heart rate is 0.855. The minimal excess risk values for creatinine and heart rate roughly correspond to the normal reference ranges. We also provide the risks for values outside that range, independent of expert opinion or a regression model. By summing risk functions, a first-approximation patient risk score is created, which correctly ranks 6 discharge categories by average mortality with p<0.001 for differences in category means, and Tukey's Honestly Significant Difference Test confirmed that the means were all different at the 95% confidence level. ConclusionsQuantitative or categorical clinical variables can be transformed into risk functions that correlate well with in-hospital risk. This methodology provides an empirical way to assess inpatient risk from data available in the Electronic Health Record. With just the variables in this paper, we achieve a risk score that correlates with discharge disposition. This is the first step towards creation of a universal measure of patient condition that reflects a generally applicable set of health-related risks. More importantly, we believe that our approach opens the door to a way of exploring and resolving many issues in patient assessment.

Individual empowerment in overweight and obese patients: a study protocol [PROTOCOL]

Tue, 14 May 2013 00:00:00 +0000

IntroductionObesity is a growing health problem in Europe and it causes many diseases. Many weight-reducing methods are reported in medical literature, but none of them proved to be effective in maintaining the results achieved over time. Self-empowerment can be an important innovative method, but an effectiveness study is necessary. In order to standardise the procedures for a randomised controlled study, a pilot study will be run to observe, measure and evaluate the effects of a period of self-empowerment group treatment on overweight/obese patients. Methodsand analysis Non-controlled, experimental, pilot study. A selected group of patients with body mass index >25, with no severe psychiatric disorders, with no aesthetic or therapeutic motivation will be included in the study. A set of quantitative and qualitative measures will be utilised to evaluate the effects of a self-empowerment course in a 12 month time. Group therapy and medical examinations will also complete this observational phase. At the end of this pilot study, a set of appropriate measures and procedures to determine the effectiveness of individual empowerment will be identified and agreed among the different professional figures. Results will be recorded and analysed to start a randomised controlled trial to evaluate the effectiveness of the proposed methodology. Ethics and disseminationThis protocol was approved by the local Ethics Committee of Udine in March 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Trial Registrationhttp://www.clinicalstrials.gov identifier NCT01644708.

Sustainability of knowledge translation interventions in healthcare decision-making: protocol for a scoping review [PROTOCOL]

Tue, 14 May 2013 00:00:00 +0000

IntroductionKnowledge translation (KT also known as research utilisation, translational medicine and implementation science) is a dynamic and iterative process that includes the synthesis, dissemination, exchange and ethically sound application of knowledge to improve health. After the implementation of KT interventions, their impact on relevant outcomes should be monitored. The objectives of this scoping review are to: (1) conduct a systematic search of the literature to identify the impact on healthcare outcomes beyond 1 year, or beyond the termination of funding of the initiative of KT interventions targeting chronic disease management for end-users including patients, clinicians, public health officials, health services managers and policy-makers; (2) identify factors that influence sustainability of effective KT interventions; (3) identify how sustained change from KT interventions should be measured; and (4) develop a framework for assessing sustainability of KT interventions. Methods and analysisComprehensive searches of relevant electronic databases (eg, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), websites of funding agencies and websites of healthcare provider organisations will be conducted to identify relevant material. We will include experimental, quasi-experimental and observational studies providing information on the sustainability of KT interventions targeting chronic disease management in adults and focusing on end-users including patients, clinicians, public health officials, health services managers and policy-makers. Two reviewers will pilot-test the screening criteria and data abstraction form. They will then screen all citations, full articles and abstract data in duplicate independently. The results of the scoping review will be synthesised descriptively and used to develop a framework to assess the sustainability of KT interventions. Discussion and disseminationOur results will help inform end-users (ie, patients, clinicians, public health officials, health services managers and policy-makers) regarding the sustainability of KT interventions. Our dissemination plan includes publications, presentations, website posting and a stakeholder meeting.

Does contact with a podiatrist prevent the occurrence of a lower extremity amputation in people with diabetes? A systematic review and meta-analysis [RESEARCH]

Wed, 8 May 2013 00:00:00 +0000

ObjectiveTo determine the effect of contact with a podiatrist on the occurrence of Lower Extremity Amputation (LEA) in people with diabetes. Design and data sourcesWe conducted a systematic review of available literature on the effect of contact with a podiatrist on the risk of LEA in people with diabetes. Eligible studies, published in English, were identified through searches of PubMed, CINAHL, EMBASE and Cochrane databases. The key terms, podiatry', amputation' and diabetes', were searched as Medical Subject Heading terms. Reference lists of selected papers were hand-searched for additional articles. No date restrictions were imposed. Study selectionPublished randomised and analytical observational studies of the effect of contact with a podiatrist on the risk of LEA in people with diabetes were included. Cross-sectional studies, review articles, chart reviews and case series were excluded. Two reviewers independently assessed titles, abstracts and full articles to identify eligible studies and extracted data related to the study design, characteristics of participants, interventions, outcomes, control for confounding factors and risk estimates. AnalysisMeta-analysis was performed separately for randomised and non-randomised studies. Relative risks (RRs) with 95% CIs were estimated with fixed and random effects models as appropriate. ResultsSix studies met the inclusion criteria and five provided data included in meta-analysis. The identified studies were heterogenous in design and included people with diabetes at both low and high risk of amputation. Contact with a podiatrist did not significantly affect the RR of LEA in a meta-analysis of available data from randomised controlled trials (RCTs); (1.41, 95% CI 0.20 to 9.78, 2 RCTs) or from cohort studies; (0.73, 95% CI 0.39 to 1.33, 3 Cohort studies with four substudies in one cohort). ConclusionsThere are very limited data available on the effect of contact with a podiatrist on the risk of LEA in people with diabetes.

Access to medicines in Latin America and the Caribbean (LAC): a scoping study [RESEARCH]

Fri, 3 May 2013 00:00:00 +0000

ObjectiveTo assess scientific publication and map research gaps on access to medicines (ATM) in Latin American and the Caribbean low-income and middle-income countries (LMIC). DesignScoping review. Two independent reviewers assessed studies for inclusion and extracted data from each study. Information sourcesSearch strategies were developed and the following databases were searched: MEDLINE, ISI, SCOPUS and Lilacs, from 2000 to 2010. Eligibility criteriaResearch articles and reviews published in English, Spanish and Portuguese were included. Studies including only high-income countries were excluded, as well as those carried out in very limited settings and discussion papers. ResultsThe 77 articles retained were categorised through consensus among the research team according to the level of the health system addressed, ATM domain and research issues covered. Publications on ATM have increased over time during the study period (r 0.93, p=0.00; R2 0.85). The top five countries covered were Brazil (68.8%), Mexico (15.6%), Colombia (11.7%), Argentina (10.4%) and Peru (10.4%). Health services delivery' and patients, household and communities' were the health system levels most frequently covered. The ATM domains leadership and governance', sustainable financing, affordability and price of medicines', medicines selection and use' and availability of medicines' were the top four explored. There are research gaps in important areas such as human resources for health', global policies and human rights', production of medicines' and traditional medicine'. ConclusionsThe upward trend on scientific publication reflects a growing research capacity in the region, which is concentrated on research teams in selected countries. The gaps on research capacity could be overcome through research collaboration among countries. It is important to strengthen these collaborations, assuring that interests and needs from the LMIC are addressed and local capacity building is promoted.

A systematic review of the effect of red blood cell transfusion on mortality: evidence from large-scale observational studies published between 2006 and 2010 [RESEARCH]

Thu, 2 May 2013 00:00:00 +0000

ObjectiveTo carry out a systematic review of recently published large-scale observational studies assessing the effects of red blood cell transfusion (RBCT) on mortality, with particular emphasis on the statistical methods used to adjust for confounding. Given the limited number of randomised trials of the efficacy of RBCT, clinicians often use evidence from observational studies. However, confounding factors, for example, individuals receiving blood generally being sicker than those who do not, make their interpretation challenging. DesignSystematic review. Information sourcesWe searched MEDLINE and EMBASE for studies published from 1 January 2006 to 31 December 2010. Eligibility criteria for included studiesWe included prospective cohort, case-control studies or retrospective analyses of databases or disease registers where the effect of risk factors for mortality or survival was examined. Studies must have included more than 1000 participants receiving RBCT for any cause. We assessed the effects of RBCT versus no RBCT and different volumes and age of RBCT. Results-32 studies were included in the review; 23 assessed the effects of RBCT versus no RBCT; 5 assessed different volumes and 4 older versus newer RBCT. There was a considerable variability in the patient populations, study designs and level of statistical adjustment. Overall, most studies showed a higher rate of mortality when comparing patients who received RBCT with those who did not, even when these rates were adjusted for confounding; the majority of these increases were statistically significant. The same pattern was observed in studies where protection from bias was likely to be greater, such as prospective studies. ConclusionsRecent observational studies do show a consistently adverse effect of RBCT on mortality. Whether this is a true effect remains uncertain as it is possible that even the best conducted adjustments cannot completely eliminate the impact of confounding.

Publication rate for funded studies from a major UK health research funder: a cohort study [RESEARCH]

Thu, 2 May 2013 00:00:00 +0000

ObjectivesThis study aimed to investigate what percentage of National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme-funded projects have published their final reports in the programme's journal HTA and to explore reasons for non-publication. DesignRetrospective cohort study. SettingFailure to publish findings from research is a significant area of research waste. It has previously been suggested that potentially over 50% of studies funded are never published. ParticipantsAll NIHR HTA projects with a planned submission date for their final report for publication in the journal series on or before 9 December 2011 were included. Primary and secondary outcome measuresThe projects were classified according to the type of research, whether they had been published or not; if not yet published, whether they would be published in the future or not. The reasons for non-publication were investigated. Results628 projects were included: 582 (92.7%) had published a monograph; 19 (3%) were expected to publish a monograph; 13 (2.1%) were discontinued studies and would not publish; 12 (1.9%) submitted a report which did not lead to a publication as a monograph; and two (0.3%) did not submit a report. Overall, 95.7% of HTA studies either have published or will publish a monograph: 94% for those commissioned in 2002 or before and 98% for those commissioned after 2002. Of the 27 projects for which there will be no report, the majority (21) were commissioned in 2002 or before. Reasons why projects failed to complete included failure to recruit; issues concerning the organisation where the research was taking place; drug licensing issues; staffing issues; and access to data. ConclusionsThe percentage of HTA projects for which a monograph is published is high. The advantages of funding organisations requiring publication in their own journal include avoidance of publication bias and research waste.

Influence of societal and practice contexts on health professionals' clinical reasoning: a scoping study protocol [PROTOCOL]

Mon, 29 Apr 2013 00:00:00 +0000

IntroductionIn a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals' CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals' CR. Methods and analysisA scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. DiscussionThis scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals' societal and practice contexts that impact their CR and (2) how these aspects influence health professionals' CR. Through the synergy of a multidisciplinary research team from a wide range of expertise, clinical pertinence and an exhaustive dissemination of results to knowledge-users will be ensured.

Effectiveness of nurse home-visiting for disadvantaged families: results of a natural experiment [RESEARCH]

Wed, 24 Apr 2013 00:00:00 +0000

ObjectiveTo evaluate the effects of a postnatal home-visiting programme delivered by community health nurses to socially disadvantaged mothers in South Australia. DesignThe intervention group of 428 mothers lived in metropolitan Adelaide and the comparison group of 239 mothers lived in regional towns where the programme was not yet available. All participating mothers met health service eligibility criteria for enrolment in the home-visiting programme. Participants in both groups were assessed at baseline (mean child age=14.4 weeks SD=2.3), prior to programme enrolment, and again when the children were aged 9, 18 and 24 months. SettingState-wide community child health service. Participants667 socially disadvantaged mothers enrolled consecutively. 487 mothers (73%) completed the 24-month assessment. InterventionTwo-year postnatal home-visiting programme based on the Family Partnership Model. Primary outcome measuresParent Stress Index (PSI), Kessler Psychological Distress Scale and the Ages and Stages Questionnaire. ResultsMixed models adjusting for baseline differences were used to compare outcomes in the two groups. The mothers in the home-visiting group reported greater improvement on the PSI subscales assessing a mother's perceptions on the quality of their relationship with their child (1.10, 95% CI 0.06 to 2.14) and satisfaction with their role as parents (0.46, 95% CI -0.15 to 1.07) than mothers in the comparison group. With the exception of childhood sleeping problems, there were no other significant differences in the outcomes across the two groups. ConclusionsThe findings suggest that home-visiting programmes delivered by community health nurses as part of routine clinical practice have the potential to improve maternal-child relationships and help mothers adjust to their role as parents. Clinical Trial RegistrationAustralian and New Zealand Clinical Trials Registry ACTRN12608000275369.

Cost-effectiveness and quality of life in surgeon versus general practitioner-organised colon cancer surveillance: a randomised controlled trial [RESEARCH]

Thu, 18 Apr 2013 00:00:00 +0000

ObjectiveTo assess whether colon cancer follow-up can be organised by general practitioners (GPs) without a decline in the patient's quality of life (QoL) and increase in cost or time to cancer diagnoses, compared to hospital follow-up. DesignRandomised controlled trial. SettingNorthern Norway Health Authority Trust, 4 trusts, 11 hospitals and 88 local communities. ParticipantsPatients surgically treated for colon cancer, hospital surgeons and community GPs. Intervention24-month follow-up according to national guidelines at the community GP office. To ensure a high follow-up guideline adherence, a decision support tool for patients and GPs were used. Main outcome measuresPrimary outcomes were QoL, measured by the global health scales of the European Organisation for Research and Treatment of Cancer QoL Questionnaire (EORTC QLQ C-30) and EuroQol-5D (EQ-5D). Secondary outcomes were cost-effectiveness and time to cancer diagnoses. Results110 patients were randomised to intervention (n=55) or control (n=55), and followed by 78 GPs (942 follow-up months) and 70 surgeons (942 follow-up months), respectively. Compared to baseline, there was a significant improvement in postoperative QoL (p=0.003), but no differences between groups were revealed (mean difference at 1, 3, 6, 9, 12, 15, 18, 21 and 24-month follow-up appointments): Global Health; {Delta}-2.23, p=0.20; EQ-5D index; {Delta}-0.10, p=0.48, EQ-5D VAS; {Delta}-1.1, p=0.44. There were no differences in time to recurrent cancer diagnosis (GP 35 days vs surgeon 45 days, p=0.46); 14 recurrences were detected (GP 6 vs surgeon 8) and 7 metastases surgeries performed (GP 3 vs surgeon 4). The follow-up programme initiated 1186 healthcare contacts (GP 678 vs surgeon 508), 1105 diagnostic tests (GP 592 vs surgeon 513) and 778 hospital travels (GP 250 vs surgeon 528). GP organised follow-up was associated with societal cost savings ({pound}8233 vs {pound}9889, p<0.001). ConclusionsGP-organised follow-up was associated with no decline in QoL, no increase in time to recurrent cancer diagnosis and cost savings. Trial registrationClinicalTrials.gov identifier NCT00572143.

Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators [RESEARCH]

Thu, 11 Apr 2013 00:00:00 +0000

ObjectivesMany randomised trials in surgery suffer from recruitment rates that lag behind projected targets. We aim to identify perceived barriers to recruitment among these pioneering trials in the field of head and neck cancer surgery. DesignRecruiting centres to all three trials (Selective Elective Neck Dissection (SEND), Positron Emission Tomography (PET)-Neck and Hyperbaric Oxygen in the Prevention of Osteoradionecrosis (HOPON)) were contacted by email by the chief investigators. Responders were asked to complete a web-based survey in order to identify the barriers to recruitment in their centre and grade each by severity. SettingSecondary care: 44 head and neck oncology regional referral centres. ParticipantsAnalysis was based on 85 responses evenly distributed between the three trials. ResultsThe most commonly identified perceived barriers to recruitment (more than 50% of responders identified the item as a barrier in all the three trials) in the order of frequency were: patients consent refusal because of expressed treatment preference, patients consent refusal owing to aversion to randomisation, excess complexity/amount of information provided to patients and lack of time in clinic to accommodate research. The most severely rated of these problems was consent refusal because of the expressed treatment preference and lack of time in the clinic. ConclusionsOur findings confirm others' work in surgery that the most significant barrier to trial recruitment in head and neck cancer surgery is the patient's preference for one arm of the trial. It may be that additional training for those taking consent may be helpful in this regard. It is also important to adequately resource busy surgical clinics to support clinical trial recruitment.

The influence of time pressure on adherence to guidelines in primary care: an experimental study [RESEARCH]

Thu, 11 Apr 2013 00:00:00 +0000

ObjectivesEvidence from cognitive sciences has systematically shown that time pressure influences decision-making processes. However, very few studies have examined the role of time pressure on adherence to guidelines in clinical practice. The aim of this study was to examine the influence of time pressure on adherence to guidelines in primary care concerning: history taking, clinical examination and advice giving. DesignA within-subjects experimental design was used. SettingAcademic. Participants34 general practitioners (GPs) were assigned to two experimental conditions (time pressure vs no time pressure) consecutively, and presented with two scenarios involving virus respiratory tract infections. Primary and secondary outcome measuresOutcome measures included adherence to guidelines on history taking, clinical examination and advice giving. ResultsUnder time pressure, GPs asked significantly less questions concerning presenting symptoms, than the ones indicated by the guidelines, (p=0.019), conducted a less-thorough clinical examination (p=0.028), while they gave less advice on lifestyle (p=0.05). ConclusionsAs time pressure increases as a result of high workload, there is a need to examine how adherence to guidelines is affected to safeguard patient's safety.

Quality improvement needed in quality improvement randomised trials: systematic review of interventions to improve care in diabetes [RESEARCH]

Tue, 9 Apr 2013 00:00:00 +0000

ObjectiveDespite the increasing numbers of published trials of quality improvement (QI) interventions in diabetes, little is known about the risk of bias in this literature. DesignSecondary analysis of a systematic review. Data sourcesMedline, the Cochrane Effective Practice and Organisation of Care (EPOC) database (from inception to July 2010) and references of included studies. Eligibility criteriaRandomised trials assessing 11 predefined QI strategies or financial incentives targeting health systems, healthcare professionals or patients to improve the management of adult outpatients with diabetes. AnalysisRisk of bias (low, unclear or high) was assessed for the 142 trials in the review across nine domains using the EPOC version of the Cochrane Risk of Bias Tool. We used Cochran-Armitage tests for trends to evaluate the improvement over time. ResultsThere was no significant improvement over time in any of the risk of bias domains. Attrition bias (loss to follow-up) was the most common source of bias, with 24 trials (17%) having high risk of bias due to incomplete outcome data. Overall, 69 trials (49%) had at least one domain with high risk of bias. Inadequate reporting frequently hampered the risk of bias assessment: allocation sequence was unclear in 82 trials (58%) and allocation concealment was unclear in 78 trials (55%). There were significant reductions neither in the proportions of studies at high risk of bias over time nor in the adequacy of reporting of risk of bias domains. ConclusionsNearly half of the included QI trials in this review were judged to have high risk of bias. Such trials have serious limitations that put the findings in question and therefore inhibit evidence-based QI. There is a need to limit the potential for bias when conducting QI trials and improve the quality of reporting of QI trials so that stakeholders have adequate evidence for implementation.

Comparison of handheld rebound tonometry with Goldmann applanation tonometry in children with glaucoma: a cohort study [RESEARCH]

Tue, 2 Apr 2013 00:00:00 +0000

ObjectiveTo test agreement of two methods to measure intraocular pressure (IOP): rebound tonometry (RBT) and gold standard Goldmann applanation tonometry (GAT) in children with glaucoma. DesignObservational prospective cohort study. SettingTertiary paediatric glaucoma clinic at a single centre. Participants102 individuals attending a paediatric glaucoma clinic, mean (SD) age 11.85 (3.17), of whom 53 were male. Primary and secondary outcome measuresIntraocular pressure, central corneal thickness, child preference for measurement method. ResultsLimits of agreement for intraobserver and interobserver were, respectively, (-2.71, 2.98) mm Hg and (-5.75, 5.97) mm Hg. RBT frequently gave higher readings than GAT and the magnitude of disagreement depend on the level of IOP being assessed. Differences of 10 mm Hg were not uncommon. RBT was the preferred method for 70% of children. ConclusionsThere is poor agreement between RBT and GAT in children with glaucoma. RBT frequently and significantly overestimates IOP. However, normal' RBT readings are likely to be accurate and may spare children an examination under anaesthesia (EUA). High RBT readings should prompt the practitioner to use another standard method of IOP measurement if possible, or consider the RBT measurement in the context of clinical findings before referring the child to a specialist clinic or considering EUA.

Study protocol for a randomised controlled double-blinded trial of the dose-dependent efficacy and safety of primaquine for clearance of gametocytes in children with uncomplicated falciparum malaria in Uganda [PROTOCOL]

Tue, 26 Mar 2013 00:00:00 +0000

ObjectivesFor the purpose of blocking transmission of Plasmodium falciparum malaria from humans to mosquitoes, a single dose of primaquine is recommended by the WHO as an addition to artemisinin combination therapy. Primaquine clears gametocytes but causes dose-dependent haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Evidence is needed to inform the optimal dosing of primaquine for malaria elimination programmes and for the purpose of interrupting the spread of artemisinin-resistant malaria. This study investigates the efficacy and safety of reducing doses of primaquine for clearance of gametocytes in participants with normal G6PD status. Methods and analysisIn this prospective, four-armed randomised placebo-controlled double-blinded trial, children aged 1-10 years, weighing over 10 kg, with haemoglobin [≥]8 g/dl and uncomplicated P falciparum malaria are treated with artemether lumefantrine and randomised to receive a dose of primaquine (0.1, 0.4 or 0.75 mg base/kg) or placebo on the third day of treatment. Participants are followed up for 28 days. Gametocytaemia is measured by quantitative nucleic acid sequence-based analysis on days 0, 2, 3, 7, 10 and 14 with a primary endpoint of the number of days to gametocyte clearance in each treatment arm and secondarily the area under the curve of gametocyte density over time. Analysis is for non-inferiority of efficacy compared to the reference dose, 0.75 mg base/kg. Safety is assessed by pair-wise comparisons of the arithmetic mean ({+/-}SD) change in haemoglobin concentration per treatment arm and analysed for superiority to placebo and incidence of adverse events. Ethics and dissemination Approval was obtained from the ethical committees of Makerere University School of Medicine, the Ugandan National Council of Science and Technology and the London School of Hygiene and Tropical Medicine. ResultsThese will be disseminated to inform malaria elimination policy, through peer-reviewed publication and academic presentations.

Cross-sectional study of sociodemographic patterning of risk factors for cardiovascular disease in three isolated-based subgroups of the Uyghur population in Xinjiang, China [RESEARCH]

Fri, 15 Mar 2013 00:00:00 +0000

ObjectiveTo explore the sociodemographic patterning of risk factors for cardiovascular disease (CVD) in three isolated-based subgroups of the Uyghur population in Xinjiang, China. DesignA cross-sectional study. Between 2005 and 2008, a non-probability sampling design method was used to select three specific groups of the Uyghur rural populations based on their potential socioeconomic status (ie, isolated, semi-isolated and open-environment status). SettingThree communities (named Desert, Turpan and Yuli Rob) in Southern Xinjiang autonomous region, China. Participants1656 people were included in this study. The inclusion criteria were that all participants were 18 years or older, they were descendants of at least three generations living in the same region, and there was no history of intermarriage. Main outcome measuresThe prevalence of CVD risk factors (ie, tobacco use, alcohol use, obesity, dyslipidemia, hypertension, diabetes, etc) was assessed. ResultsCompared with the Desert and Turpan communities, Yuli Rob had the highest levels of obesity, dyslipidemia and hypertension, and the Desert had the lowest levels of CVD risk factors. Age standardisation slightly altered the estimates, though the patterns remained unchanged. Some unique characteristics were also found. For example, the Desert group displayed significantly lower high-density lipoprotein cholesterol (HDLC) level compared with Yuli Rob and Turpan groups. The mean values were 0.63, 1.06 and 1.45 mmol/l for men and 0.64, 1.22 and 1.51 mmol/l for women (p<0.0001). The HDLC levels in the Desert group increased with increase in body mass index and fasting glucose levels, which was inconsistent with previous studies. ConclusionsIdentifying the unique CVD risk factors of the ethnic-specific populations is very important in development of tailored strategies for the prevention of CVD.

Long-acting versus short-acting methylphenidate for paediatric ADHD: a systematic review and meta-analysis of comparative efficacy [RESEARCH]

Fri, 15 Mar 2013 00:00:00 +0000

ObjectiveTo synthesise existing knowledge of the efficacy and safety of long-acting versus short-acting methylphenidate for paediatric attention deficit hyperactivity disorder (ADHD). DesignSystematic review and meta-analysis. Data sourcesElectronic literature search of CENTRAL, MEDLINE, PreMEDLINE, CINAHL, EMBASE, PsychINFO, Scopus and Web of Science for articles published in the English language between 1950 and 2012. Reference lists of included studies were checked for additional studies. Study selectionRandomised controlled trials of paediatric ADHD patients (<18 years), comparing a long-acting methylphenidate form to a short-acting methylphenidate form. Data extractionTwo authors independently selected trials, extracted data and assessed risk of bias. Continuous outcomes were compared using standardised mean differences (SMDs) between treatment groups. Adverse events were compared using risk differences between treatment groups. Heterogeneity was explored by subgroup analysis based on the type of long-acting formulation used. ResultsThirteen RCTs were included; data from 882 participants contributed to the analysis. Meta-analysis of three studies which used parent ratings to report on hyperactivity/impulsivity had an SMD of -0.30 (95% CI -0.51 to -0.08) favouring the long-acting forms. In contrast, three studies used teacher ratings to report on hyperactivity and had an SMD of 0.29 (95% CI 0.05 to 0.52) favouring the short-acting methylphenidate. In addition, subgroup analysis of three studies which used parent ratings to report on inattention/overactivity indicate that the osmotic release oral system generation long-acting formulation was favoured with an SMD of -0.35 (95% CI -0.52 to -0.17), while the second generation showed less efficacy than the short-acting formulation with an SMD of 0.42 (95% CI 0.17 to 0.68). The long-acting formulations presented with slightly more total reported adverse events (n=578) as compared with the short-acting formulation (n=566). ConclusionsThe findings from this systematic review indicate that the long-acting forms have a modest effect on the severity of inattention/overactivity and hyperactivity/impulsivity according to parent reports, whereas the short-acting methylphenidate was preferred according to teacher reports for hyperactivity.

Assessing fracture risk in people with MS: a service development study comparing three fracture risk scoring systems [RESEARCH]

Fri, 15 Mar 2013 00:00:00 +0000

ObjectivesSuboptimal bone health is increasingly recognised as an important cause of morbidity. Multiple sclerosis (MS) has been consistently associated with an increased risk of osteoporosis and fracture. Various fracture risk screening tools have been developed, two of which are in routine use and a further one is MS-specific. We set out to compare the results obtained by these in the MS clinic population. DesignThis was a service development study. The 10-year risk estimates of any fracture and hip fracture generated by each of the algorithms were compared. SettingThe MS clinic at the Royal London Hospital. Participants88 patients with a confirmed diagnosis of MS. Outcome measuresMean 10-year overall fracture risk and hip fracture risk were calculated using each of the three fracture risk calculators. The number of interventions that would be required as a result of using each of these tools was also compared. ResultsMean 10-year fracture risk was 4.7%, 2.3% and 7.6% using FRAX, QFracture and the MS-specific calculator, respectively (p<0.0001 for difference). The agreement between risk scoring tools was poor at all levels of fracture risk. ConclusionsThe agreement between these three fracture risk scoring tools is poor in the MS population. Further work is required to develop and validate an accurate fracture risk scoring system for use in MS. Trial registrationThis service development study was approved by the Clinical Effectiveness Department at Barts Health NHS Trust (project registration number 156/12).

The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study [RESEARCH]

Tue, 12 Mar 2013 00:00:00 +0000

ObjectiveTo determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD). DesignCohort study. SettingSingle centre orthopaedic unit. ParticipantsFollowing the identification of complications potentially related to metal wear debris, a blood metal ion screening programme was instigated at our unit in 2007 for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip resurfacings. Patients were followed annually unless symptoms presented earlier. Symptomatic patients were investigated with ultrasound scan and joint aspiration. The clinical course of all 278 patients with no pain' or slight/occasional' pain and a Harris Hip Score greater than or equal to 95 at the time of venesection were documented. A retrospective analysis was subsequently conducted using mixed effect modelling to investigate the temporal pattern of blood Co levels in the patients and survival analysis to investigate the potential role of case demographics and blood Co levels as risk factors for subsequent failure secondary to ARMD. ResultsBlood Co concentration was a positive and significant risk factor (z=8.44, p=2x10-16) for joint failure, as was the device, where the Birmingham Hip Resurfacing posed a significantly reduced risk for revision by 89% (z=-3.445, p=0.00005 (95% CI on risk 62 to 97)). Analysis using Cox-proportional hazards models indicated that men had a 66% lower risk of joint failure than women (z=-2.29419, p=0.0218, (95% CI on risk reduction 23 to 89)). ConclusionsThe results suggest that elevated blood metal ion concentrations are associated with early failure of MoM devices secondary to adverse reactions to metal debris. Co concentrations greater than 20 {micro}g/l are frequently associated with metal staining of tissues and the development of osteolysis. Development of soft tissue damage appears to be more complex with females and patients with ASR devices seemingly more at risk when exposed to equivalent doses of metal debris.

The role of organisational and cultural factors in the implementation of system-wide interventions in acute hospitals to improve patient outcomes: protocol for a systematic literature review [PROTOCOL]

Sat, 9 Mar 2013 00:00:00 +0000

IntroductionLittle is known about the role of the organisational culture in the success and sustainability of the hospital-wide interventions, and how local culture affects patient outcomes in acute hospitals. Methods and analysisA systematic literature review will be conducted to identify organisational factors influencing hospital-wide interventions and patient outcomes. A search of English language articles will be performed in MEDLINE, CINAHL, EMBASE, Web of Science, PsychInfo and Global Health databases using Medical Subject Headings and keywords. Randomised controlled trials, quasi-randomised trials, controlled before and after design studies and interrupted time-series analysis studies will be included. Grey literature' will be excluded, however peer-reviewed journals that are likely to publish relevant studies (JAMA, BMJ, BMJ Quality and Safety, Lancet and New England Journal of Medicine and Implementation Science) will be hand searched for the last 5 years. Two reviewers will independently undertake a title and abstract review using inclusion and exclusion criteria. Studies will be excluded only after discussion between at least two reviewers, who will assess and agree on the inclusion, risk of bias and quality rating of the studies. One author will extract summary descriptive data from these studies; the other author will review this documentation for accuracy and completeness. ResultsIt is likely that the studies will be heterogeneous in nature, therefore a narrative synthesis of the findings will be conducted. ConclusionsWe will discuss characteristics of the studies and stratify the results according to the type of hospital-wide interventions, organisational factors associated with them and outcomes measured.

Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design [PROTOCOL]

Sat, 9 Mar 2013 00:00:00 +0000

IntroductionArthroscopic partial meniscectomy (APM) to treat degenerative meniscus injury is the most common orthopaedic procedure. However, valid evidence of the efficacy of APM is lacking. Controlling for the placebo effect of any medical intervention is important, but seems particularly pertinent for the assessment of APM, as the symptoms commonly attributed to a degenerative meniscal injury (medial joint line symptoms and perceived disability) are subjective and display considerable fluctuation, and accordingly difficult to gauge objectively. Methods and analysisA multicentre, parallel randomised, placebo surgery controlled trial is being carried out to assess the efficacy of APM for patients from 35 to 65 years of age with a degenerative meniscus injury. Patients with degenerative medial meniscus tear and medial joint line symptoms, without clinical or radiographic osteoarthritis of the index knee, were enrolled and then randomly assigned (1 : 1) to either APM or diagnostic arthroscopy (placebo surgery). Patients are followed up for 12 months. According to the prior power calculation, 140 patients were randomised. The two randomised patient groups will be compared at 12 months with intention-to-treat analysis. To safeguard against bias, patients, healthcare providers, data collectors, data analysts, outcome adjudicators and the researchers interpreting the findings will be blind to the patients' interventions (APM/placebo). Primary outcomes are Lysholm knee score (a generic knee instrument), knee pain (using a numerical rating scale), and WOMET score (a disease-specific, health-related quality of life index). The secondary outcome is 15D (a generic quality of life instrument). Further, in one of the five centres recruiting patients for the randomised controlled trial (RCT), all patients scheduled for knee arthroscopy due to a degenerative meniscus injury are prospectively followed up using the same protocol as in the RCT to provide an external validation cohort. In this article, we present and discuss our study design, focusing particularly on the internal and external validity of our trial and the ethics of carrying out a placebo surgery controlled trial. Ethics and disseminationThe protocol has been approved by the institutional review board of the Pirkanmaa Hospital District and the trial has been duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. Trial registrationClinicalTrials.gov, number NCT00549172.

An evaluation of the performance of the NHS Health Check programme in identifying people at high risk of developing type 2 diabetes [RESEARCH]

Tue, 5 Mar 2013 00:00:00 +0000

ObjectiveTo evaluate the performance of the National Health Service (NHS) Health Check in identifying people at high risk of having or developing type 2 diabetes. DesignRetrospective evaluation of the performance of the NHS Health Check diabetes filter (based on ethnicity, body mass index and blood pressure) in identifying people at risk for type 2 diabetes (glycated haemoglobin (HbA1c) [≥]42 mmol/mol recorded within 3 months of their NHS Health Check). SettingHeart of Birmingham Primary Care Trust (HoB PCT). Subjects34 022 patients with a Read code in the general practitioners' (GP) clinical record indicating that they had attended an NHS Health Check over the period April 2009 - February 2012. Outcome measuresPrimary outcome measure: proportion (%) of patients at risk of diabetes or non-diabetes hyperglycaemia not identified by a simple application of the NHS Health Check diabetes filter. Secondary outcome measures included sensitivity, positive predictive value (PPV) and specificity of the NHS Health Check diabetes filter. ResultsIn HoB PCT, the simple application of the NHS Health Check diabetes filter led to a failure to identify 1990/5968 (33.3% (95% CI, 31.2% to 35.4%)) of patients of known ethnicity at risk of having or developing diabetes (HbA1c[≥]42 mmol/mol). The NHS Health Check diabetes filter has a sensitivity of 66.8% (95% CI 65.7% to 68.0%), and the PPV was 41.1% (95% CI 40.1% to 42.1%). Specificity was 34.7% (95%CI 33.9% to 35.6%). Sensitivity and PPV of the NHS Health Check diabetes filter in the HoB PCT population are significantly greater for patients of Asian ethnic origin than for those of other ethnic backgrounds. ConclusionsThis evaluation, which was based on a large population sample, demonstrates that the NHS Health Check programme diabetes filter failed to identify a third of people at high risk of having or developing diabetes.

The interactions of ethical notions and moral values of immediate stakeholders of immunisation services in two Indian states: a qualitative study [RESEARCH]

Fri, 1 Mar 2013 00:00:00 +0000

ObjectivesThis study examines the existing norms regarding immunisation within the communities and the ethical notions that govern the actions of different health professionals and their collective synergistic or conflicting effects on the governance of the programme. DesignWe used descriptive and analytical qualitative methods as it suited the research question. SettingThe data were collected from areas under 16 primary health centres in Kerala and Tamil Nadu identified through a three-step sampling process. ParticipantsThis involved in-depth interviews with stakeholders including providers, beneficiaries and other stakeholders, focus group discussions with mothers of under-five children and participant and non-participant observations of vaccination-related activities. ResultsUnlike most other ethical analyses that look at the ethics of vaccination policies, the interactions of normative principles and notions are analysed in this article. Moral obligation of parents towards their children, beneficence of healthcare providers and the utilitarian aspirations of the state are the key normative principles involved. Our analysis points to the interplay of both synergy and conflict in ethical notions and moral values in the context of immunisation services. Paternalistic interventions like special immunisation campaigns against polio and Japanese encephalitis are a case in point: they generate conflict at the normative level and create mistrust. ConclusionsAnalysis of vaccination policies and programmes needs to go beyond factors that assess monetary benefits or herd immunity. Understanding the interactions of normative notions that shape the social organisation of the providers and the users of vaccination is important in creating a sustainable environment for the programme.

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports [RESEARCH]

Tue, 26 Feb 2013 00:00:00 +0000

ObjectiveTo explore the structure and content of a non-random sample of clinical study reports (CSRs) to guide clinicians and systematic reviewers. Search strategyWe searched public sources and lodged Freedom of Information requests for previously confidential CSRs primarily written by the industry for regulators. Selection criteriaCSRs reporting sufficient information for extraction ( adequate'). Primary outcome measuresPresence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). Data extractionData were extracted on standard forms and crosschecked for accuracy. ResultsWe assembled a population of 78 CSRs (covering 90 randomised controlled trials; 144 610 pages total) dated 1991-2011 of 14 pharmaceuticals. Report synopses had a median length of 5 pages, efficacy evaluation 13.5 pages, safety evaluation 17 pages, attached tables 337 pages, trial protocol 62 pages, statistical analysis plan 15 pages and individual efficacy and safety listings had a median length of 447 and 109.5 pages, respectively. While 16 (21%) of CSRs contained completed case report forms, these were accessible to us in only one case (765 pages representing 16 individuals). Compression factors ranged between 1 and 8805. ConclusionsClinical study reports represent a hitherto mostly hidden and untapped source of detailed and exhaustive data on each trial. They should be consulted by independent parties interested in a detailed record of a clinical trial, and should form the basic unit for evidence synthesis as their use is likely to minimise the problem of reporting bias. We cannot say whether our sample is representative and whether our conclusions are generalisable to an undefined and undefinable population of CSRs.

What intervention is best practice for vestibular schwannomas? A systematic review of controlled studies [RESEARCH]

Fri, 22 Feb 2013 00:00:00 +0000

ObjectiveLargely, watchful waiting is the initial policy for patients with small-sized or medium-sized vestibular schwannoma, because of slow growth and relatively minor complaints, that do not improve by an intervention. If intervention (microsurgery, radiosurgery or fractionated radiotherapy) becomes necessary, the choice of intervention appears to be driven by the patient's or clinician's preference rather than by evidence based. This study addresses the existing evidence based on controlled studies of these interventions. DesignA systematic Boolean search was performed focused on controlled intervention studies. The quality of the retrieved studies was assessed based on the Sign-50 criteria on cohort studies. Data sourcesPubmed/Medline, Embase, Cochrane Central Register of Controlled Trials and reference lists. Study selectionSix eligibility criteria included a controlled intervention study on a newly diagnosed solitary, vestibular schwannoma reporting on clinical outcomes. Two prospective and four retrospective observational, controlled studies published before November 2011 were selected. Data analysisTwo reviewers independently assessed the methodological quality of the studies and extracted the outcome data using predefined formats. ResultsNeither randomised studies, nor controlled studies on fractionated radiotherapy were retrieved. Six studies compared radiosurgery and microsurgery in a controlled way. All but one were confined to solitary tumours less than 30 mm in diameter and had no earlier interventions. Four studies qualified for trustworthy conclusions. Among all four, radiosurgery showed the best outcomes: there were no direct mortality, no surgical or anaesthesiological complications, but better facial nerve outcome, better preservation of useful hearing and better quality of life. ConclusionsThe available evidence indicates radiosurgery to be the best practice for solitary vestibular schwannomas up to 30 mm in cisternal diameter.

Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial [PROTOCOL]

Wed, 20 Feb 2013 00:00:00 +0000

IntroductionNeonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns' length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). Methods and analysis690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. Ethics and disseminationWritten informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n{degrees}22/int./CEI/27239) and it is under review by the other regional ethics committees. ResultsDissemination of results from this trial will be through scientific medical journals and conferences. Trial registrationThis trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137).

Thirty-day complications after laparoscopic or open cholecystectomy: a population-based cohort study in Italy [RESEARCH]

Wed, 13 Feb 2013 00:00:00 +0000

ObjectiveThe objective of the study is to evaluate short-term complications after laparoscopic (LC) or open cholecystectomy (OC) in patients with gallstones by using linked hospital discharge data. DesignPopulation-based cohort study. SettingData were obtained from the Regional Hospital Discharge Registry Lazio Region in Central Italy (around 5 million inhabitants) in 2007-2008. ParticipantsAll patients admitted to hospitals of Lazio with symptomatic gallstones (International Classification of disease, 9th Revision, Clinical Modification (ICD-9-CM)=574) who underwent LC (ICD-9-CM 51.23) or OC (ICD-9-CM 51.22). Outcome measures(1) 30-day surgical-related complications' defined as any complication of the biliary tract (including postoperative infection, haemorrhage or haematoma or seroma complicating a procedure, persistent postoperative fistula, perforation of bile duct and disruption of wound). (2) 30-day systemic complications' defined as any complications of other organs (including sepsis, infections from other organs, major cardiovascular events and selected adverse events). Results13 651 patients were included; 86.1% had LC, 13.9% OC. 2.0% experienced surgical-related complications (SRC), 2.1% systemic complications (SC). The OR of complications after LC versus OC was 0.60 (p<0.001) for SRC and 0.52 (p<0.001) for SC. In relation to SRC, the advantage of LC was consistent across age categories, severity of gallstones and previous upper abdominal surgery, whereas there was no advantage among people with emergency admission (OR=0.94, p=0.764). For SC, no significant advantage of LC was seen among very old people (OR=0.99, p=0.975) and among those with previous upper abdominal surgery (OR=0.86, p=0.905). ConclusionsThis large observational study confirms that LC is more effective than OC with respect to 30-day complications. Population-based linkage of administrative datasets can enlarge evidence of treatment benefits in clinical practice.

Strategy for treating selective serotonin reuptake inhibitor-resistant social anxiety disorder in the clinical setting: a randomised controlled trial protocol of cognitive behavioural therapy in combination with conventional treatment [PROTOCOL]

Wed, 13 Feb 2013 00:00:00 +0000

IntroductionPharmacotherapy and cognitive behavioural therapy (CBT) are consistently effective as first-line treatments for social anxiety disorders (SADs). Nevertheless, pharmacotherapy is often the first choice in clinical practice. In many countries, the first line of pharmacotherapy involves the administration of a selective serotonin reuptake inhibitor (SSRI). Although a significant proportion of patients with SAD fail to respond to the initial SSRI administration, there is no standard approach to the management of SSRI-resistant SAD. This paper describes the study protocol for a randomised controlled trial to evaluate the clinical effectiveness of CBT as a next-step strategy, concomitant with conventional treatment, for patients with SSRI-resistant SAD. Methods and analysisThis Prospective Randomized Open Blinded End-point study is designed with two parallel groups, with dynamic allocation at the individual level. The interventions for the two groups are conventional treatment, alone, and CBT combined with conventional treatment, for 16 weeks. The primary end-point of SAD severity will be assessed by an independent assessor using the Liebowitz Social Anxiety Scale, and secondary end-points include severity of other social anxieties, depressive severity and functional impairment. All measures will be assessed at weeks 0 (baseline), 8 (halfway point) and 16 (postintervention) and the outcomes will be analysed based on the intent-to-treat. Statistical analyses are planned for the study design stage so that field materials can be appropriately designed. Ethics and disseminationThis study will be conducted at the academic outpatient clinic of Chiba University Hospital. Ethics approval was granted by the Institutional Review Board of Chiba University Hospital. All participants will be required to provide written informed consent. The trial will be implemented and reported in accordance with the recommendations of CONSORT. Clinical Trial Registration NumberUMIN000007552.

A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR-FVG): the study protocol [PROTOCOL]

Tue, 12 Feb 2013 00:00:00 +0000

IntroductionThere is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective. Methods and analysisA randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with standard face-to-face brief intervention to be conducted in primary care settings in the Region of Friuli Giulia Venezia, Italy. Adult patients will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Screen positives will be requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming a reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis. Ethics and disseminationThe protocol was approved by the Isontina Independent Local Ethics Committee on 14 June 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Registration detailsTrial registration number NCT: 01638338.

A population-level prediction tool for the incidence of first-episode psychosis: translational epidemiology based on cross-sectional data [RESEARCH]

Mon, 11 Feb 2013 00:00:00 +0000

ObjectivesSpecialist early intervention services (EIS) for people aged 14-35 years with first episodes of psychosis (FEP) have been commissioned throughout England since 2001. A single estimate of population need was used everywhere, but true incidence varies enormously according to sociodemographic factors. We sought to develop a realistically complex, population-based prediction tool for FEP, based on precise estimates of epidemiological risk. Design and participantsData from 1037 participants in two cross-sectional population-based FEP studies were fitted to several negative binomial regression models to estimate risk coefficients across combinations of different sociodemographic and socioenvironmental factors. We applied these coefficients to the population at-risk of a third, socioeconomically different region to predict expected caseload over 2.5 years, where the observed rates of ICD-10 F10-39 FEP had been concurrently ascertained via EIS. SettingEmpirical population-based epidemiological data from London, Nottingham and Bristol predicted counts in the population at-risk in the East Anglia region of England. Main outcome measuresObserved counts were compared with predicted counts (with 95% prediction intervals (PI)) at EIS and local authority district (LAD) levels in East Anglia to establish the predictive validity of each model. ResultsA model with age, sex, ethnicity and population density performed most strongly, predicting 508 FEP participants in EIS in East Anglia (95% PI 459, 559), compared with 522 observed participants. This model predicted correctly in 5/6 EIS and 19/21 LADs. All models performed better than the current gold standard for EIS commissioning in England (716 cases; 95% PI 664-769). ConclusionsWe have developed a prediction tool for the incidence of psychotic disorders in England and Wales, made freely available online (http://www.psymaptic.org), to provide healthcare commissioners with accurate forecasts of FEP based on robust epidemiology and anticipated local population need. The initial assessment of some people who do not require subsequent EIS care means additional service resources, not addressed here, will be required.

Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis [RESEARCH]

Thu, 7 Feb 2013 00:00:00 +0000

This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. ObjectiveTo identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. DesignSystematic review. Data sourcesThe Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Study selectionRandomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. Results45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters. ConclusionsThere are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study [RESEARCH]

Wed, 30 Jan 2013 00:00:00 +0000

ObjectivesAn initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DesignThe design was an observational prospective study of risk factors embedded in a randomised controlled study. SettingAcute whiplash patients from units, general practitioners in four Danish counties were referred to two research centres. ParticipantsDuring a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. ResultsThe risk score and number of sick-listing days were related (Kruskal-Wallis, p<0.0001). In stratum 1, less than 4%, but in stratum 7, 68% were work-disabled after 1 year. Early work assessment (p<0.0001), impact of the event questionnaire (p<0.0006), psychophysical pain measures being McGill pain questionnaire parameters (p<0.0001), pressure pain algometry (p<0.0001) and palpation (p<0.0001) showed a significant relationship with risk stratification. AnalysisFindings confirm previous studies reporting intense neck pain/headache and distress as predictors for work disability after whiplash. Neck-mobility was a strong predictor in this study; however, it was a more inconsistent predictor in other studies. ConclusionsApplication of the risk assessment score and use of the risk strata system may be beneficial in future studies and may be considered as a valuable tool to assess return-to-work following injuries; however, further studies are needed.

Framework of policy recommendations for implementation of evidence-based practice: a systematic scoping review [RESEARCH]

Thu, 24 Jan 2013 00:00:00 +0000

ObjectivesEvidence-based practice (EBP) may help improve healthcare quality. However, not all healthcare professionals and managers use EBP in their daily practice. We systematically reviewed the literature to summarise self-reported appreciation of EBP and organisational infrastructure solutions proposed to promote EBP. DesignSystematic review. Two investigators independently performed the systematic reviewing process. Information sourcesMEDLINE, EMBASE and Cochrane Library were searched for publications between 2000 and 2011. Eligibility criteria for included studiesReviews and surveys of EBP attitude, knowledge, awareness, skills, barriers and facilitators among managers, doctors and nurses in clinical settings. ResultsWe found 31 surveys of fairly good quality. General attitude towards EBP was welcoming. Respondents perceived several barriers, but also many facilitators for EBP implementation. Solutions were proposed at various organisational levels, including (inter)national associations and hospital management promoting EBP, pregraduate and postgraduate education, as well as individual support by EBP mentors on the wards to move EBP from the classroom to the bedside. ConclusionsMore than 20 years after its introduction, the EBP paradigm has been embraced by healthcare professionals as an important means to improve quality of patient care, but its implementation is still deficient. Policy exerted at microlevel , middlelevel and macrolevel, and supported by professional, educational and managerial role models, may further facilitate EBP.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study [RESEARCH]

Fri, 18 Jan 2013 00:00:00 +0000

ContextA participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. ObjectiveTo examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. DesignRegistry-based study of clinical trial results reporting. SettingClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteriaA random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measureClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. ResultsIn 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). ConclusionsDeaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications.

How long has NICE taken to produce Technology Appraisal guidance? A retrospective study to estimate predictors of time to guidance [RESEARCH]

Fri, 11 Jan 2013 00:00:00 +0000

ObjectivesTo assess how long the UK's National Institute for Health and Clinical Excellence's (NICE) Technology Appraisal Programme has taken to produce guidance and to determine independent predictors of time to guidance. DesignRetrospective time to event (survival) analysis. SettingTechnology Appraisal guidance produced by NICE. DatasourceAll appraisals referred to NICE by February 2010 were included, except those referred prior to 2001 and a number that were suspended. Outcome measureDuration from the start of an appraisal (when the scope document was released) until publication of guidance. ResultsSingle Technology Appraisals (STAs) were published significantly faster than Multiple Technology Appraisals (MTAs) with median durations of 48.0 (IQR; 44.3-75.4) and 74.0 (IQR; 60.9-114.0) weeks, respectively (p <0.0001). Median time to publication exceeded published process timelines, even after adjusting for appeals. Results from the modelling suggest that STAs published guidance significantly faster than MTAs after adjusting for other covariates (by 36.2 weeks (95% CI -46.05 to -26.42 weeks)) and that appeals against provisional guidance significantly increased the time to publication (by 42.83 weeks (95% CI 35.50 to 50.17 weeks)). There was no evidence that STAs of cancer-related technologies took longer to complete compared with STAs of other technologies after adjusting for potentially confounding variables and only weak evidence suggesting that the time to produce guidance is increasing each year (by 1.40 weeks (95% CI -0.35 to 2.94 weeks)). ConclusionsThe results from this study suggest that the STA process has resulted in significantly faster guidance compared with the MTA process irrespective of the topic, but that these gains are lost if appeals are made against provisional guidance. While NICE processes continue to evolve over time, a trade-off might be that decisions take longer but at present there is no evidence of a significant increase in duration.

Occurrence of refeeding syndrome in adults started on artificial nutrition support: prospective cohort study [RESEARCH]

Fri, 11 Jan 2013 00:00:00 +0000

BackgroundRefeeding syndrome is a potentially life-threatening condition characterised by severe intracellular electrolyte shifts, acute circulatory fluid overload and organ failure. The initial symptoms are non-specific but early clinical features are severely low-serum electrolyte concentrations of potassium, phosphate or magnesium. Risk factors for the syndrome include starvation, chronic alcoholism, anorexia nervosa and surgical interventions that require lengthy periods of fasting. The causes of the refeeding syndrome are excess or unbalanced enteral, parenteral or oral nutritional intake. Prevention of the syndrome includes identification of individuals at risk, controlled hypocaloric nutritional intake and supplementary electrolyte replacement. ObjectiveTo determine the occurrence of refeeding syndrome in adults commenced on artificial nutrition support. DesignProspective cohort study. SettingLarge, single site university teaching hospital. Recruitment period 2007-2009. Participants243 adults started on artificial nutrition support for the first time during that admission recruited from wards and intensive care. Main outcome measuresPrimary outcome: occurrence of the refeeding syndrome. Secondary outcome: analysis of the risk factors which predict the refeeding syndrome. Tertiary outcome: mortality due to refeeding syndrome and all-cause mortality. Results133 participants had one or more of the following risk factors: body mass index <16-18.5[≥](kg/m2), unintentional weight loss >15% in the preceding 3-6 months, very little or no nutritional intake >10 days, history of alcohol or drug abuse and low baseline levels of serum potassium, phosphate or magnesium prior to recruitment. Poor nutritional intake for more than 10 days, weight loss >15% prior to recruitment and low-serum magnesium level at baseline predicted the refeeding syndrome with a sensitivity of 66.7%: specificity was >80% apart from weight loss of >15% which was 59.1%. Baseline low-serum magnesium was an independent predictor of the refeeding syndrome (p=0.021). Three participants (2% 3/243) developed severe electrolyte shifts, acute circulatory fluid overload and disturbance to organ function following artificial nutrition support and were diagnosed with refeeding syndrome. There were no deaths attributable to the refeeding syndrome, but (5.3% 13/243) participants died during the feeding period and (28% 68/243) died during hospital admission. Death of these participants was due to cerebrovascular accident, traumatic injury, respiratory failure, organ failure or end-of-life causes. ConclusionsRefeeding syndrome was a rare, survivable phenomenon that occurred during hypocaloric nutrition support in participants identified at risk. Independent predictors for refeeding syndrome were starvation and baseline low-serum magnesium concentration. Intravenous carbohydrate infusion prior to artificial nutrition support may have precipitated the onset of the syndrome.

The Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) study: cluster randomised trial of humour therapy in nursing homes [RESEARCH]

Fri, 11 Jan 2013 00:00:00 +0000

ObjectivesTo determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents. DesignThe Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy. Setting35 Sydney nursing homes. ParticipantsAll eligible residents within geographically defined areas within each nursing home were invited to participate. InterventionProfessional ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff LaughterBosses'. Controls received usual care. MeasurementsDepression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment. RandomisationSites were stratified by size and level of care then assigned to group using a random number generator. ResultsSeventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045). ConclusionsHumour therapy did not significantly reduce depression but significantly reduced agitation. Trial registrationAustralian New Zealand Clinical Trials Registry -ACTRN12611000462987.

Early and intermediate survival after transcatheter aortic valve implantation: systematic review and meta-analysis of 14 studies [RESEARCH]

Fri, 11 Jan 2013 00:00:00 +0000

BackgroundTranscatheter aortic valve implants (TAVIs) is indicated as an alternative to surgical valve replacement for patients unfit for surgery. No systematic review has studied survival after 2 years and limited information is available on between-study heterogeneity. ObjectivesA systematic review and meta-analysis on intermediate survival after TAVI. Data sourcesPubMed, EMBASE, Scopus and references of selected articles. Study eligibility criteriaClinical studies evaluating TAVI, published between 2010 and 2012, reporting survival at 2 or more years. ParticipantsAbout 3500 patients from 14 studies. Study appraisal and synthesis methodsProportion meta-analysis with 95% CI and heterogeneity assessment (I2 and Cochran's Q). Meta-regression analysis was performed as well. ResultsPooled immediate postoperative death rate was 7.8% (95% CI 6.2% to 9.8%, I2=40.8%; Cochran's Q=97.7 with 92.9 df, p<0.0001) and stroke rate was 3.8% (95% CI 2.8% to 5.0%, I2=34.3%; Cochran's Q=96.5 with 92.9 df, p<0.0001). Pooled death rates at 1, 2 and 3 years were 23.2%, 31.0% and 38.6%, respectively. Among studies reporting on concomitant percutaneous coronary intervention, pooled death rates at 30 days, 1 year and 2 years were 6.3%, 17.8% and 25.8%, respectively. LimitationsAlthough our analysis examined a total of about 3500 patients, only a minority of these were actually followed up after 2 years. ConclusionsPooled survival rates after TAVI (at 2 years: 69.0%; at 3 years: 61.4%) can be considered excellent, particularly in the light of the high-risk profile of this patient population. Implications of key findingsThe favourable intermediate outcome in patients subjected to TAVI seems to justify its use in patients unfit for surgery. Such pooled results indicate that TAVI is a valid alternative to surgical valve replacement, but lack of data on late durability after TAVI prevents its use in low-risk patients with long expectancy of life.

Health economic evaluation of the Lund Integrated Medicines Management Model (LIMM) in elderly patients admitted to hospital [RESEARCH]

Thu, 10 Jan 2013 00:00:00 +0000

ObjectiveTo evaluate the cost effectiveness of a multidisciplinary team including a pharmacist for systematic medication review and reconciliation from admission to discharge at hospital among elderly patients (the Lund Integrated Medicines Management (LIMM)) in order to reduce drug-related readmissions and outpatient visits. MethodPublished data from the LIMM project group were used to design a probabilistic decision tree model for evaluating tools for (1) a systematic medication reconciliation and review process at initial hospital admission and during stay (admission part) and (2) a medication report for patients discharged from hospital to primary care (discharge part). The comparator was standard care. Inpatient, outpatient and staff time costs (Euros, 2009) were calculated during a 3-month period. Dis-utilities for hospital readmissions and outpatient visits due to medication errors were taken from the literature. ResultsThe total cost for the LIMM model was {euro}290 compared to {euro}630 for standard care, in spite of a {euro}39 intervention cost. The main cost offset arose from avoided drug-related readmissions in the Admission part ({euro}262) whereas only {euro}66 was offset in the Discharge part as a result of fewer outpatient visits and correction time. The reduced disutility was estimated to 0.005 quality-adjusted life-years (QALY), indicating that LIMM was a dominant alternative. The probability that the intervention would be cost-effective at a zero willingness to pay for a gained QALY compared to standard care was estimated to 98%. ConclusionsThe LIMM medication reconciliation (at admission and discharge) and medication review was both cost-saving and generated greater utility compared to standard care, foremost owing to avoided drug-related hospital readmissions. When implementing such a review process with a multidisciplinary team, it may be important to consider a learning curve in order to capture the full advantage.

Can the London 2012 Olympics 'inspire a generation' to do more physical or sporting activities? An overview of systematic reviews [RESEARCH]

Mon, 7 Jan 2013 00:00:00 +0000

ObjectiveTo examine if there is an increased participation in physical or sporting activities following an Olympic or Paralympic games. DesignOverview of systematic reviews. MethodsWe searched the Medline, Embase, Cochrane, DARE, SportDISCUS and Web of Knowledge databases. In addition, we searched for grey literature' in Google, Google scholar and on the International Olympic Committee websites. We restricted our search to those reviews published in English. We used the AMSTAR tool to assess the methodological quality of those systematic reviews included. Primary and secondary outcome measuresThe primary outcome was evidence for an increased participation in physical or sporting activities. Secondary outcomes included public perceptions of sport during and after an Olympic games, barriers to increased sports participation and any other non-sporting health benefits. ResultsOur systematic search revealed 844 citations, of which only two matched our inclusion criteria. The quality of these two reviews was assessed by three independent reviewers as good' using the AMSTAR tool for quality appraisal. Both reviews reported little evidence of an increased uptake of sporting activity following an Olympic Games event. Other effects on health, for example, changes in hospital admissions, suicide rates and drug use, were cited although there was insufficient evidence to see an overall effect. ConclusionThere is a paucity of evidence to support the notion that hosting an Olympic games leads to an increased participation in physical or sporting activities for host countries. We also found little evidence to suggest other health benefits. We conclude that the true success of these and future games should be evaluated by high-quality, evidence-based studies that have been commissioned before, during and following the completion of the event. Only then can the true success and legacy of the games be established.

Transdiagnostic, affect-focused, psychodynamic, guided self-help for depression and anxiety through the internet: study protocol for a randomised controlled trial [PROTOCOL]

Wed, 19 Dec 2012 00:00:00 +0000

IntroductionCognitive behaviour therapy delivered in the format of guided self-help via the internet has been found to be effective for a range of conditions, including depression and anxiety disorders. Recent results indicate that guided self-help via the internet is a promising treatment format also for psychodynamic therapy. However, to date and to our knowledge, no study has evaluated internet-delivered psychodynamic therapy as a transdiagnostic treatment. The affect-phobia model of psychopathology by McCullough et al provides a psychodynamic conceptualisation of a range of psychiatric disorders. The aim of this study will be to test the effects of a transdiagnostic guided self-help treatment based on the affect-phobia model in a sample of clients with depression and anxiety. Methods and analysisThis study will be a randomised controlled trial with a total sample size of 100 participants. The treatment group receives a 10-week, psychodynamic, guided self-help treatment based on the transdiagnostic affect-phobia model of psychopathology. The treatment consists of eight text-based treatment modules and includes therapist contact in a secure online environment. Participants in the control group receive similar online therapist support without any treatment modules. Outcome measures are the 9-item Patient Health Questionnaire Depression Scale and the 7-item Generalised Anxiety Disorder Scale (GAD-7). Process measures that concerns emotional processing and mindfulness are included. All outcome and process measures will be administered weekly via the internet and at 6-month follow-up. DiscussionThis trial will add to the body of knowledge on internet-delivered psychological treatments in general and to psychodynamic treatments in particular. We also hope to provide new insights in the effectiveness and working mechanisms of psychodynamic therapy based on the affect-phobia model.

Effectiveness of involving the private medical sector in the National TB Control Programme in Bangladesh: evidence from mixed methods [RESEARCH]

Tue, 18 Dec 2012 00:00:00 +0000

ObjectivesIn Bangladesh, private healthcare is common and popular, regardless of income or area of residence, making the private sector an important player in health service provision. Although the private sector offers a good range of health services, tuberculosis (TB) care in the private sector is poor. We conducted research in Dhaka, between 2004 and 2008, to develop and evaluate a public-private partnership (PPP) model to involve private medical practitioners (PMPs) within the National TB Control Programme (NTP)'s activities. Since 2008, this PPP model has been scaled up in two other big cities, Chittagong and Sylhet. This paper reports the results of this development, evaluation and scale-up. DesignMixed method, observational study design. We used NTP service statistics to compare the TB control outcomes between intervention and control areas. To capture detailed insights of PMPs and TB managers about the process and outcomes of the study, we conducted in-depth interviews, focus group discussions and workshops. SettingUrban setting, piloted in four areas in Dhaka city; later scaled up in other areas of Dhaka and in two major cities. FindingsThe partnership with PMPs yielded significantly increased case finding of sputum smear-positive TB cases. Between 2004 and 2010, 703 participating PMPs referred 3959 sputum smear-positive TB cases to the designated Directly Observed Treatment, Short-course (DOTS) centres, contributing about 36% of all TB cases in the project areas. There was a steady increase in case notification rates in the project areas following implementation of the partnership. ConclusionsThe PPP model was highly effective in improving access and quality of TB care in urban settings.

Impact of prior probabilities of MRSA as an infectious agent on the accuracy of the emerging molecular diagnostic tests: a model simulation [RESEARCH]

Tue, 18 Dec 2012 00:00:00 +0000

ObjectivesTraditional microbiology identification takes 48-72 h to complete. This lag forces clinicians to rely on broad-spectrum empiric coverage. To address this gap, manufacturers are developing rapid molecular diagnostics (RMD). We hypothesised that RMD's accuracy is more dependent upon population risk of harbouring the culprit pathogen than to their sensitivity and specificity. DesignA mathematical model. Setting and participantsWe used the range of risks (5-50%) for methicillin-resistant Staphylococcus aureus (MRSA) among patients hospitalised with complicated skin and skin structure infections (cSSSI), pneumonia or sepsis. Main outcome measuresWe modelled the impact of changing a test's characteristics on its positive (PPV) and negative (NPV) predictive values, and hence the risk of overtreatment or undertreatment, within strata of an organism's population prevalence. MRSA diagnostics provided assumptions for the test sensitivity and specificity (95-99%). Scenarios with low sensitivity and specificity (90%), and best-case and worst-case scenarios normalised to the annual universe of populations of interest, were examined. ResultsWith a low prevalence (5%) and high test specificity, the PPV was 84%. Conversely, with 50% prevalence and 95% test specificity the PPV rose to [≥]95%. Even when the test's specificity and sensitivity were both 90%, in a high-risk population both PPV and NPV were [~]90%. In the worst-case scenario, 150 000 patients with cSSSI, pneumonia and sepsis annually were at risk for inappropriate treatment, 91% of these at risk for over-treatment. In the best-case scenario, 81% of 18 000 patients at risk for inappropriate coverage were subject to overtreatment. ConclusionsAlthough promising for limiting exposure to excessive antimicrobial coverage, RMDs alone will not solve the issue of inappropriate, and particularly overtreatment. Increasing pretest probability as a strategy to minimise antibiotic abuse results in more accurate patient classification than does developing a test with near-perfect characteristics. The healthcare community must build robust evidence and information technology infrastructure to guide appropriate use of such testing.

The older the better: are elderly study participants more non-representative? A cross-sectional analysis of clinical trial and observational study samples [RESEARCH]

Fri, 14 Dec 2012 00:00:00 +0000

ObjectiveStudy participants can differ from the target population they are taken to represent. We sought to investigate whether older age magnifies such differences, examining age-trends, among study participants, in self-rated level of activity compared to others of the same age. DesignCross-sectional examination of the relation of participant age to reported relative activity' (ie, compared to others of the same age), a bidirectionally correlated proxy for relative vitality, in exemplars of randomised and observational studies. SettingUniversity of California, San Diego (UCSD) Participants2404 adults aged 40-79 including employees of UCSD, and their partners (San Diego Population Study, observational study). 1016 adults (aged 20-85) not on lipid medications and without known heart disease, diabetes, cancer or HIV (UCSD Statin Study, randomised trial). MeasurementsSelf-rated activity relative to others' age, 5-point Likert Scale, was evaluated by age decade, and related via correlation and regression to a suite of health-relevant subjective and objective outcomes. ResultsSuccessively older participants reported successively greater activity relative to others of their age (greater departure from the norm for their age), p<0.001 in both studies. Relative activity significantly predicted (in regression adjusted for age) actual activity (times/week exercised), and numerous self-rated and objective health-predictors. These included general self-rated health, CES-D (depression score), sleep, tiredness, energy; body mass index, waist circumference, serum glucose, high-density lipoprotein-cholesterol, triglycerides and white cell count. Indeed, some health-predictor associations with age in participants were paradoxical,' consistent with greater apparent health in older age--for study participants. ConclusionsStudy participants may not be representative of the population they are intended to reflect. Our results suggest that departures from representativeness may be amplified with increasing age. Consequently, the older the age, the greater the disparity may be between what is recommended based on evidence, ' and what is best for the patient. Trial RegistrationUCSD Statin Study--Clinicaltrials.gov # NCT00330980 (http://ClinicalTrials.gov)

Carbidopa/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design [RESEARCH]

Tue, 11 Dec 2012 00:00:00 +0000

ObjectiveSinemet, a combination drug containing carbidopa and levodopa is considered the gold standard therapy for the treatment of Parkinson's disease (PD). When approved by the Food and Drug Administration (FDA) in 1988, a maximum daily dosage limit of 800 mg (eight tablets) of the 25/100 carbidopa/levodopa formulation was introduced. Overall, the FDA approval was a historic success; however, the pill limit has been hardcoded into many online medical record systems. This study investigates the 800 mg threshold by using a prospectively collected database of patient information. DesignA retrospective cohort study: (Part I) cross-sectional, (Part II) longitudinal. Setting and participantsPD patients at a Movement Disorders Center in a large academic, tertiary medical setting. Outcome measuresAn analysis was performed using carbidopa/levodopa at dosages below and above the 800 mg threshold. A secondary analysis was then performed using two consecutive clinic visits to determine the effects of crossing the 800 mg threshold. Comparisons were made on standardised scales. ResultsThere was no significant difference in motor, mood and quality-of-life scores in patients consuming below and above the 800 mg carbidopa/levodopa threshold, though a mild worsening in dyskinesia duration was noted without worsening in dyskinesia pain and disability. In PD patients who crossed the 800 mg threshold between two consecutive clinic visits, a significant improvement in depressive symptoms and quality-of-life measures was demonstrated, and in these patients there was no worsening of motor fluctuations or dyskinesia. ConclusionsThe data suggest that PD patients have the potential for enhanced clinical benefits when eclipsing the 800 mg carbidopa/levodopa threshold. Many patients will likely need to eclipse the 800 mg threshold and pharmacies and insurance companies should be aware of the requirements that may extend beyond approval limits.

What is a disease? Perspectives of the public, health professionals and legislators [RESEARCH]

Sun, 2 Dec 2012 00:00:00 +0000

ObjectiveTo assess the perception of diseases and the willingness to use public-tax revenue for their treatment among relevant stakeholders. DesignA population-based, cross-sectional mailed survey. SettingFinland. Participants3000 laypeople, 1500 doctors, 1500 nurses (randomly identified from the databases of the Finnish Population Register, the Finnish Medical Association and the Finnish Nurses Association) and all 200 parliament members. Main outcome measuresRespondents' perspectives on a five-point Likert scale on two claims on 60 states of being: (This state of being) is a disease'; and (This state of being) should be treated with public tax revenue'. ResultsOf the 6200 individuals approached, 3280 (53%) responded. Of the 60 states of being, [≥]80% of respondents considered 12 to be diseases (Likert scale responses of 4' and 5') and five not to be diseases (Likert scale responses of 1' and 2'). There was considerable variability in most states, and great variability in 10 ([≥]20% of respondents of all groups considered it a disease and [≥]20% rejected as a disease). Doctors were more inclined to consider states of being as diseases than laypeople; nurses and members were intermediate (p<0.001), but all groups showed large variability. Responses to the two claims were very strongly correlated (r=0.96 (95% CI 0.94 to 0.98); p<0.001). ConclusionsThere is large disagreement among the public, health professionals and legislators regarding the classification of states of being as diseases and whether their management should be publicly funded. Understanding attitudinal differences can help to enlighten social discourse on a number of contentious public policy issues.

Cause of death in MS: long-term follow-up of a randomised cohort, 21 years after the start of the pivotal IFN{beta}-1b study [RESEARCH]

Fri, 30 Nov 2012 00:00:00 +0000

ObjectivesCompared with controls, multiple sclerosis (MS) patients die, on average, 7-14 years prematurely. Previously, we reported that, 21 years after their participation in the pivotal randomised, controlled trial (RCT) of interferon {beta}-1b, mortality was reduced by 46-47% in the two groups who received active therapy during the RCT. To determine whether the excessive deaths observed in placebo-treated patients was due to MS-related causes, we analysed the causes-of-death (CODs) in these three, randomised, patient cohorts. DesignLong-term follow-up (LTF) of the pivotal RCT of interferon {beta}-1b. SettingEleven North American MS-centres participated. ParticipantsIn the original RCT, 372 patients participated, of whom 366 (98.4%) were identified after a median of 21.1 years from RCT enrolment. InterventionsUsing multiple information sources, we attempted to establish COD and its relationship to MS in deceased patients. Primary outcomeAn independent adjudication committee, masked to treatment assignment and using prespecified criteria, determined the likely CODs and their MS relationships. ResultsAmong the 366 MS patients included in this LTF study, 81 deaths were recorded. Mean age-at-death was 51.7 ({+/-}8.7) years. COD, MS relationship, or both were determined for 88% of deaths (71/81). Patients were assigned to one of nine COD categories: cardiovascular disease/stroke; cancer; pulmonary infections; sepsis; accidents; suicide; death due to MS; other known CODs; and unknown COD. Of the 69 patients for whom information on the relationship of death to MS was available, 78.3% (54/69) were adjudicated to be MS related. Patients randomised to receive placebo during the RCT (compared with patients receiving active treatment) experienced an excessive number of MS-related deaths. ConclusionsIn this long-term, randomised, cohort study, MS patients receiving placebo during the RCT experienced greater all-cause mortality compared to those on active treatment. The excessive mortality in the original placebo group was largely from MS-related causes, especially, MS-related pulmonary infections.

Why do clinicians not refer patients to online decision support tools? Interviews with front line clinics in the NHS [RESEARCH]

Fri, 30 Nov 2012 00:00:00 +0000

ObjectiveTo assess whether clinical teams would direct patients to use web-based patient decision support interventions (DESIs) and whether patients would use them. DesignRetrospective semistructured interviews and web server log analysis. Participants and settings57 NHS professionals (nurses, doctors and others) in orthopaedic, antenatal, breast, urology clinics and in primary care practices across 22 NHS sites given access to DESIs hosted on the NHS Direct website. ResultsFewer than expected patients were directed to use the web tools. The most significant obstacles to referral to the tools were the attitudes of clinicians and clinical teams. Technical problems contributed to the problems but the low uptake was mainly explained by clinicians' limited understanding of how patient DESIs could be helpful in clinical pathways, their perception that shared decision-making' was already commonplace and that, in their view, some patients are resistant to being involved in treatment decisions. External factors, such as efficiency targets and best practice' recommendations were also cited being significant barriers. Clinicians did not feel the need to refer patients to use decision support tools, web-based or not, and, as a result, felt no requirement to change existing practice routines. Uptake is highest when clinicians set expectations that these tools are integral to practice and embed their use into clinical pathways. ConclusionsExisting evidence of patient benefit and the free availability of patient DESIs via the web are not sufficient drivers to achieve routine use. Health professionals were not motivated to refer patients to these interventions. Clinicians will not use these interventions simply because they are made available, despite good evidence of benefit to patients. These attitudes are deep seated and will not be modified by solely developing web-based interventions: a broader strategy will be required to embed DESIs into routine practice.

Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study [PROTOCOL]

Wed, 28 Nov 2012 00:00:00 +0000

IntroductionLimb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysisThis is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibiotic-related adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at =0.05. Ethics and disseminationThis study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.

Quality of descriptions of treatments: a review of published randomised controlled trials [RESEARCH]

Thu, 22 Nov 2012 00:00:00 +0000

ObjectivesTo be useable in clinical practise, treatments studied in trials must provide sufficient information to enable clinicians and researchers to replicate. We sought to assess the completeness of treatment descriptions in published randomised controlled trials (RCTs) using a checklist and to determine the extent to which peer reviewers and editors comment on the quality of reporting of treatments. DesignA cross-sectional study. SettingTrials published in the BMJ, a general medical journal. ParticipantsFifty-one trials published in the BMJ were independently evaluated by two raters using a checklist. Reviewers' and editors' comments were also assessed for statements on treatment descriptions. Primary and secondary outcome measuresProportion of trials rated as replicable (primary outcome). ResultsFor 57% (29/51) of the papers, published treatment descriptions were not considered sufficient to allow replication. Most poorly described aspects were the actual procedures involved including the sequencing of the technique (what happened and when) and the physical or informational materials used (eg, training materials): 53% and 43% not clear, respectively. For a third of treatments, the dose/duration of individual sessions was not clear and for a quarter the schedule (interval, frequency, duration or timing) was not clear. Although the majority of problems were not picked up by reviewers and editors, when they were detected only about two-thirds were fixed before publication. ConclusionsJournals wanting to publish the research of use to practising healthcare professionals need to pay more attention to descriptions of treatments. Our checklist, may be useful for reviewers, and editors and could help ensure that important details of treatments are provided before papers are in the public domain.

Support and assessment for fall emergency referrals (SAFER 2) research protocol: cluster randomised trial of the clinical and cost effectiveness of new protocols for emergency ambulance paramedics to assess and refer to appropriate community-based care [PROTOCOL]

Mon, 12 Nov 2012 00:00:00 +0000

IntroductionEmergency calls to ambulance services are frequent for older people who have fallen, but ambulance crews often leave patients at the scene without ongoing care. Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances. SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen, and do not need hospital care, to community-based falls services. In this protocol paper, we report methods and progress during trial implementation. SAFER 2 is recruiting patients through three ambulance services. A successful trial will provide robust evidence about the value of this new model of care, and enable ambulance services to use resources efficiently. DesignPragmatic cluster randomised trial. Methods and analysisWe randomly allocated 25 participating ambulance stations (clusters) in three services to intervention or control group. Intervention paramedics received training and clinical protocols for assessing and referring older people who have fallen to community-based falls services when appropriate, while control paramedics deliver care as usual. Patients are eligible for the trial if they are aged 65 or over; resident in a participating falls service catchment area; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms. The principal outcome is the rate of further emergency contacts (or death), for any cause and for falls. Secondary outcomes include further falls, health-related quality of life, fear of falling', patient satisfaction reported by participants through postal questionnaires at 1 and 6 months, and quality and pathways of care at the index incident. We shall compare National Health Service (NHS) and patient/carer costs between intervention and control groups and estimate quality-adjusted life years (QALYs) gained from the intervention and thus incremental cost per QALY. We shall estimate wider system effects on key-performance indicators. We shall interview 60 intervention patients, and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service. We shall analyse quantitative trial data by treatment allocated'; and qualitative data using content analysis. Ethics and disseminationThe Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval. We shall disseminate study findings through peer-reviewed publications and conference presentations. Trial Registration: ISRCTN 60481756

Challenges in implementing government-directed VTE guidance for medical patients: a mixed methods study [RESEARCH]

Tue, 6 Nov 2012 00:00:00 +0000

BackgroundImplementing venous thromboembolism (VTE) risk assessment guidance on admission to hospital has proved difficult worldwide. In 2010, VTE risk assessment in English hospitals was linked to financial sanctions. This study investigated possible barriers and facilitators for VTE risk assessment in medical patients and evaluated the impact of local and national initiatives. SettingAcute Medical Unit in one English National Health Service university teaching hospital. MethodsThis was a mixed methods study; National Research Ethics Service approval was granted. Data were collected over four 1-week periods; November 2009 (1), January 2010 (2), April 2010 (3) and April 2011 (4). Case notes for all medical patients admitted during these periods were reviewed. Thirty-six staff were observed admitting 71 of these patients; 24 observed staff participated in a structured interview. Results876 case notes were reviewed. In total, 82.1% of patients had one or more VTE risk factors and 25.3% one or more bleeding risks. VTE risk assessment rose from a baseline of 6.9-19.6%, following local initiatives, and to 98.7% following financially sanctioned government targets. A similar increase in appropriate prescribing of prophylaxis was seen, but inappropriate prescribing also rose. No staff observed in period 1 conducted VTE risk assessment, risk-assessment forms were largely ignored or discarded during period 2; and electronic recording systems available during period 3 were not accessed. Few patients were asked any VTE-related questions in periods 1, 2 or 3. Interviewees' actual knowledge of VTE risk was not related to perceived knowledge level. Eight of the 24 staff interviewed were aware of national policies or guidance: none had seen them. Principal barriers identified to risk assessment were: involvement of multiple staff in individual admissions; interruptions; lack of policy awareness; time pressure and complexity of tools. ConclusionsNational financial sanctions appear effective in implementing guidance, where other local measures have failed.

Medication intensification in diabetes in rural primary care: a cluster-randomised effectiveness trial [RESEARCH]

Sun, 4 Nov 2012 00:00:00 +0000

ObjectiveTo determine the effectiveness of a provider-based intervention to improve medication intensification among patients with diabetes. DesignEffectiveness cluster-randomised trial. Baseline and follow-up cross-sections of diabetes physicians' patients. SettingEleven U.S. Southeastern states, 2006-2008. Participants205 Rural primary care physicians, 95 completed the study. InterventionMulticomponent interactive intervention including web-based continuing medical education (CME), performance feedback and quality improvement tools. Primary outcome measuresMedication intensification, a dose increase of an existing medication or the addition of a new class of medication for glucose, blood pressure and lipids control on any of the three most recent office visits. ResultsOf 364 physicians attempting to register, 102 were randomised to the intervention and 103 to the control arms; 95 physicians (intervention, n=48; control, n=47) provided data on their 1182 of their patients at baseline (intervention, n=715; control, n=467) and 945 patients at follow-up (intervention, n=479; control, n=466). For A1c control, medication intensification increased in both groups (intervention, pre 26.4% vs post 32.6%, p=0.022; control, pre 24.8% vs post 31.1%, p=0.033) (intervention, adjusted OR (AOR) 1.37; 95% CI 1.06 to 1.76; control, AOR 1.41 (95% CI 1.06 to 1.89)); however, we observed no incremental benefit solely due to the intervention (group-by-time interaction, p=0.948). Among patients with the worst glucose control (A1c >9%), intensification increased in both groups (intervention, pre 34.8% vs post 62.5%, p=0.002; control, pre 35.7% vs post 61.4%, p=0.008). ConclusionsA wide-reach, low-intensity, web-based interactive multicomponent intervention had no significant incremental effect on medication intensification for control of glucose, blood pressure or lipids for patients with diabetes of physicians practising in the rural Southeastern USA. Trial registrationNCT00403091.

Systematic review of SGLT2 receptor inhibitors in dual or triple therapy in type 2 diabetes [RESEARCH]

Thu, 18 Oct 2012 00:00:00 +0000

BackgroundDespite the number of medications for type 2 diabetes, many people with the condition do not achieve good glycaemic control. Some existing glucose-lowering agents have adverse effects such as weight gain or hypoglycaemia. Type 2 diabetes tends to be a progressive disease, and most patients require treatment with combinations of glucose-lowering agents. The sodium glucose co-transporter 2 (SGLT2) receptor inhibitors are a new class of glucose-lowering agents. ObjectiveTo assess the clinical effectiveness and safety of the SGLT2 receptor inhibitors in dual or triple therapy in type 2 diabetes. Data sourcesMEDLINE, Embase, Cochrane Library (all sections); Science Citation Index; trial registries; conference abstracts; drug regulatory authorities; bibliographies of retrieved papers. Inclusion criteriaRandomised controlled trials of SGLT2 receptor inhibitors compared with placebo or active comparator in type 2 diabetes in dual or combination therapy. MethodsSystematic review. Quality assessment used the Cochrane risk of bias score. ResultsSeven trials, published in full, assessed dapagliflozin and one assessed canagliflozin. Trial quality appeared good. Dapagliflozin 10 mg reduced HbA1c by -0.54% (weighted mean differences (WMD), 95% CI -0.67 to -0.40) compared to placebo, but there was no difference compared to glipizide. Canagliflozin reduced HbA1c slightly more than sitagliptin (up to -0.21% vs sitagliptin). Both dapagliflozin and canagliflozin led to weight loss (dapagliflozin WMD -1.81 kg (95% CI -2.04 to -1.57), canagliflozin up to -2.3 kg compared to placebo). LimitationsLong-term trial extensions suggested that effects were maintained over time. Data on canagliflozin are currently available from only one paper. Costs of the drugs are not known so cost-effectiveness cannot be assessed. More data on safety are needed, with the Food and Drug Administration having concerns about breast and bladder cancers. ConclusionsDapagliflozin appears effective in reducing HbA1c and weight in type 2 diabetes, although more safety data are needed.

Pulmonary metastasectomy for sarcoma: a systematic review of reported outcomes in the context of Thames Cancer Registry data [RESEARCH]

Mon, 8 Oct 2012 00:00:00 +0000

ObjectivesSarcoma has a predilection to metastasis to the lungs. Surgical excision of these metastases (pulmonary metastasectomy) when possible has become standard practice. We reviewed the published selection and outcome data. DesignSystematic review of published reports that include survival rates or any other outcome data. Survival data were put in the context of those in a cancer registry. SettingSpecialist thoracic surgical centres reporting the selection and outcome for pulmonary metastasectomy in 18 follow-up studies published 1991-2010. ParticipantsPatients having one or more of 1357 pulmonary metastasectomy operations performed between 1980 and 2006. InterventionsAll patients had surgical pulmonary metastasectomy. A first operation was reported in 1196 patients. Of 1357 patients, 43% had subsequent metastasectomy, some having 10 or more thoracotomies. Three studies were confined to patients having repeated pulmonary metastasectomy. Primary and secondary outcome measuresSurvival data to various time points usually 5 years and sometimes 3 or 10 years. No symptomatic or quality of life data were reported. ResultsAbout 34% and 25% of patients were alive 5 years after a first metastasectomy operation for bone or soft tissues sarcoma respectively. Better survival was reported with fewer metastases and longer intervals between diagnosis and the appearance of metastases. In the Thames Cancer Registry for 1985-1994 and 1995-2004 5 year survival rates for all patients with metastatic sarcoma were 20% and 25% for bone, and for soft tissue sarcoma 13% and 15%. ConclusionsThe 5 year survival rate among sarcoma patients who are selected to have pulmonary metastasectomy is higher than that observed among unselected registry data for patients with any metastatic disease at diagnosis. There is no evidence that survival difference is attributable to metastasectomy. No data were found on respiratory or any other symptomatic benefit. Given the certain harm associated with thoracotomy, often repeated, better evidence is required.

A clinical audit of changes in suicide ideas with internet treatment for depression [RESEARCH]

Sun, 7 Oct 2012 00:00:00 +0000

ObjectivesTo examine reductions in suicidal ideation among a sample of patients who were prescribed an internet cognitive behavior therapy (iCBT) course for depression. DesignEffectiveness study within a quality assurance framework. SettingPrimary care. Participants299 patients who were prescribed an iCBT course for depression by primary care clinicians. InterventionSix lesson, fully automated cognitive behaviour therapy course delivered over the internet. Primary outcome: suicidal ideation as measured by question 9 on the Patient Health Questionnaire (PHQ-9). ResultsSuicidal ideation was common (54%) among primary care patients prescribed iCBT treatment for depression but dropped to 30% post-treatment despite minimal clinician contact and the absence of an intervention focused on suicidal ideation. This reduction in suicidal ideation was evident regardless of sex and age. ConclusionsThe findings do not support the exclusion of patients with significant suicidal ideation.

Monitoring fitness levels and detecting implications for health in a French population: an observational study [RESEARCH]

Sat, 29 Sep 2012 00:00:00 +0000

ObjectiveTo analyse the physical fitness of a large sample of the French population across different ages. DesignObservational cross-sectional study. SettingData were collected from the Athletic Track and Field Federation, which organised events dedicated to measuring physical fitness. The events took place in 22 regions between 2006 and 2010. ParticipantsFrench volunteer citizens (N=31 349) aged between 4 and 80 years old who participated in events dedicated to measuring physical fitness. Primary and secondary outcome measuresWe assessed the results of the following fitness tests: 20 m shuttle run, standing broad jump, repeated squat jump, 4x10 m shuttle run, speed, flexibility and push-ups in relation to age and body mass index (BMI) using Spearman's rho, a one-way analysis of variance. A bi-exponential model was used to represent the performance with age. ResultsOur major results showed higher performances for men and for subjects with normal BMI at all age groups except for the flexibility test. BMI was strongly correlated across all ages with physical fitness p<0.0001. Furthermore, through bi-exponential model, a mean peak performance was identified at 26.32 years of age for men and 22.18 years of age for women. ConclusionsPhysical fitness assessment using a simple series of tests on the general population offers an important indicator of health status. The possibility of observing the evolution of fitness levels with time provides an important monitoring method from a public health perspective. Further research is needed to reinforce and evaluate the approach.

Assessing community health workers' performance motivation: a mixed-methods approach on India's Accredited Social Health Activists (ASHA) programme [RESEARCH]

Thu, 27 Sep 2012 00:00:00 +0000

ObjectiveThis study examined the performance motivation of community health workers (CHWs) and its determinants on India's Accredited Social Health Activist (ASHA) programme. DesignCross-sectional study employing mixed-methods approach involved survey and focus group discussions. SettingThe state of Orissa. Participants386 CHWs representing 10% of the total CHWs in the chosen districts and from settings selected through a multi-stage stratified sampling. Primary and secondary outcome measuresThe level of performance motivation among the CHWs, its determinants and their current status as per the perceptions of the CHWs. ResultsThe level of performance motivation was the highest for the individual and the community level factors (mean score 5.94-4.06), while the health system factors scored the least (2.70-3.279). Those ASHAs who felt having more community and system-level recognition also had higher levels of earning as CHWs (p=0.040, 95% CI 0.06 to 0.12), a sense of social responsibility (p=0.0005, 95% CI 0.12 to 0.25) and a feeling of self-efficacy (p=0.000, 95% CI 0.38 to 0.54) on their responsibilities. There was no association established between their level of dissatisfaction on the incentives (p=0.385) and the extent of motivation. The inadequate healthcare delivery status and certain working modalities reduced their motivation. Gender mainstreaming in the community health approach, especially on the demand-side and community participation were the positive externalities of the CHW programme. ConclusionsThe CHW programme could motivate and empower local lay women on community health largely. The desire to gain social recognition, a sense of social responsibility and self-efficacy motivated them to perform. The healthcare delivery system improvements might further motivate and enable them to gain the community trust. The CHW management needs amendments to ensure adequate supportive supervision, skill and knowledge enhancement and enabling working modalities.

Barriers to the uptake of evidence from systematic reviews and meta-analyses: a systematic review of decision makers' perceptions [RESEARCH]

Fri, 21 Sep 2012 00:00:00 +0000

ObjectiveTo review the barriers to the uptake of research evidence from systematic reviews by decision makers. Search strategyWe searched 19 databases covering the full range of publication years, utilised three search engines and also personally contacted investigators. Reference lists of primary studies and related reviews were also consulted. Selection criteriaStudies were included if they reported on the views and perceptions of decision makers on the uptake of evidence from systematic reviews, meta-analyses and the databases associated with them. All study designs, settings and decision makers were included. One investigator screened titles to identify candidate articles then two reviewers independently assessed the quality and the relevance of retrieved reports. Data extractionTwo reviewers described the methods of included studies and extracted data that were summarised in tables and then analysed. Using a pre-established taxonomy, the barriers were organised into a framework according to their effect on knowledge, attitudes or behaviour. ResultsOf 1726 articles initially identified, we selected 27 unique published studies describing at least one barrier to the uptake of evidence from systematic reviews. These studies included a total of 25 surveys and 2 qualitative studies. Overall, the majority of participants (n=10 218) were physicians (64%). The most commonly investigated barriers were lack of use (14/25), lack of awareness (12/25), lack of access (11/25), lack of familiarity (7/25), lack of usefulness (7/25), lack of motivation (4/25) and external barriers (5/25). ConclusionsThis systematic review reveals that strategies to improve the uptake of evidence from reviews and meta-analyses will need to overcome a wide variety of obstacles. Our review describes the reasons why knowledge users, especially physicians, do not call on systematic reviews. This study can inform future approaches to enhancing systematic review uptake and also suggests potential avenues for future investigation.

Identifying early warning signs for diagnostic errors in primary care: a qualitative study [RESEARCH]

Mon, 17 Sep 2012 00:00:00 +0000

ObjectiveWe investigate the mechanisms of diagnostic error in primary care consultations to detect warning signs for possible error. We aim to identify places in the diagnostic reasoning process associated with major risk indicators. DesignA qualitative study using semistructured interviews with open-ended questions. SettingA 2-month study in primary care conducted in Oxfordshire, UK. ParticipantsWe approached about 25 experienced general practitioners by email or word of mouth, 15 volunteered for the interviews and were available at a convenient time. InterventionInterview transcripts provided 45 cases of error. Three researchers searched these independently for underlying themes in relation to our conceptual framework. Outcome measuresLocating steps in the diagnostic reasoning process associated with major risk of error and detecting warning signs that can alert clinicians to increased risk of error. ResultsInitiation and closure of the cognitive process are most exposed to risk of error. Cognitive biases developed early in the process lead to errors at the end. These warning signs can be used to alert clinicians to the increased risk of diagnostic error. Ignoring red flags or critical cues was related to processes being biased through the initial frame, but equally well, it could be explained by knowledge gaps. ConclusionsCognitive biases developed at the initial framing of the problem relate to errors at the end of the process. We refer to these biases as warning signs that can alert clinicians to the increased risk of diagnostic error. We conclude that lack of knowledge is likely to be an important factor in diagnostic error. Reducing diagnostic errors in primary care should focus on early and systematic recognition of errors including near misses, and a continuing professional development environment that promotes reflection in action to highlight possible causes of process bias and of knowledge gaps.

Validation of prescribing appropriateness criteria for older Australians using the RAND/UCLA appropriateness method [RESEARCH]

Fri, 14 Sep 2012 00:00:00 +0000

ObjectiveTo further develop and validate previously published national prescribing appropriateness criteria to assist in identifying drug-related problems (DRPs) for commonly occurring medications and medical conditions in older ([≥]65 years old) Australians. DesignRAND/UCLA appropriateness method. ParticipantsA panel of medication management experts were identified consisting of geriatricians/pharmacologists, clinical pharmacists and disease management advisors to organisations that produce Australian evidence-based therapeutic publications. This resulted in a round-one panel of 15 members, and a round-two panel of 12 members. Main outcome measureAgreement on all criteria. ResultsForty-eight prescribing criteria were rated. In the first rating round via email, there was disagreement regarding 17 of the criteria according to median panel ratings. During a face-to-face second round meeting, discussion resulted in retention of 25 criteria after amendments, agreement for 14 criteria with no changes required and deletion of 9 criteria. Two new criteria were added, resulting in a final validated list of 41 prescribing appropriateness criteria. Agreement after round two was reached for all 41 criteria, measured by median panel ratings and the amount of dispersion of panel ratings, based on the interpercentile range. ConclusionsA set of 41 Australian prescribing appropriateness criteria were validated by an expert panel. Use of these criteria, together with clinical judgement and other medication review processes such as patient interview, is intended to assist in improving patient care by efficiently detecting potential DRPs related to commonly occurring medicines and medical conditions in older Australians. These criteria may also contribute to the medication management education of healthcare professionals.

How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the Clinicaltrials.gov database [RESEARCH]

Wed, 29 Aug 2012 00:00:00 +0000

ContextThe Food and Drug Administration Modernization Act of 1997 (FDAMA) and the FDA Amendment Act of 2007 (FDAAA), respectively, established mandates for registration of interventional human research studies on the website clinicaltrials.gov (CTG) and for posting of results of completed studies. ObjectiveTo characterise, contrast and explain rates of compliance with ontime registration of new studies and posting of results for completed studies on CTG. DesignStatistical analysis of publically available data downloaded from the CTG website. ParticipantsUS studies registered on CTG since 1 November 1999, the date when the CTG website became operational, through 24 June 2011, the date the data set was downloaded for analysis. Main outcome measuresOntime registration (within 21 days of study start); average delay from study start to registration; proportion of studies posting their results from within the group of studies listed as completed on CTG. ResultsAs of 24 June 2011, CTG contained 54 890 studies registered in the USA. Prior to 2005, an estimated 80% of US studies were not being registered. Among registered studies, only 55.7% registered within the 21-day reporting window. The average delay on CTG was 322 days. Between 28 September 2007 and June 23 2010, 28% of intervention studies at Phase II or beyond posted their study results on CTG, compared with 8.4% for studies without industry funding (RR 4.2, 95% CI 3.7 to 4.8). Factors associated with posting of results included exclusively paediatric studies (adjusted OR (AOR) 2.9, 95% CI 2.1 to 4.0), and later phase clinical trials (relative to Phase II studies, AOR for Phase III was 3.4, 95% CI 2.8 to 4.1; AOR for Phase IV was 6.0, 95% CI 4.8 to 7.6). ConclusionsNon-compliance with FDAMA and FDAAA appears to be very common, although compliance is higher for studies sponsored by industry. Further oversight may be required to improve compliance.

Six months fixed duration multidrug therapy in paucibacillary leprosy: risk of relapse and disability in Agra PB cohort study [RESEARCH]

Thu, 16 Aug 2012 00:00:00 +0000

BackgroundMany studies have focused on multidrug therapy (MDT) for multibacillary (MB) leprosy and rarely on long-term outcome of paucibacillary (PB) leprosy having recommendation of therapy for 6 months fixed duration therapy for PB patients. Studies on measuring risk of disability are rare. The present study is to assess the cure; default, relapse and disability in a prospective cohort of PB leprosy during follow-up of >4 years after treatment. DesignProspective. SettingPrimary in our field area of Agra District. Participants920 PB leprosy patients entered the study, 621 completed treatment, 599 followed finally including 271 males, no ethnic differentiation, patients of all age groups except for children below 5 years and old persons above 70 years were not included. Treatment6 months fixed duration MDT as recommended by WHO. Primary and secondary outcomesTreatment completion, cure, relapse and development of disability based on clinical assessment by well-experienced doctors. Statistical methodsData have been analysed using SPSS software, risk is computed as incidence per 100 person-years (PY) and test of significance used. ResultsStudy reports 91% cure rate. Incidence of relapse was 1.3/100 PY with no significant variation by age, sex, delay in detection, patches and nerves. Crude incidence of disability was 2.2% and varied significantly by age and nerve thickening but not by sex, number of patches, nerves and delay in treatment. Incidence of disability was 0.50/100 PY in treatment completed and 0.43 among defaulters. ConclusionThe study concludes that relapses do occur after MDT treatment but at the level of 1-2%, incidence of disability remains low (<1/100 PY) in PB leprosy. Low incidence of relapse and disability suggests that 6 months therapy is quite effective. However, further improvement may help to improve its efficacy. Longer follow-up may add to efficacy measures.

Covert checks by standardised patients of general practitioners' delivery of new periodic health examinations: clustered cross-sectional study from a consumer organisation [RESEARCH]

Tue, 7 Aug 2012 00:00:00 +0000

ObjectiveTo assess if data collected by a consumer organisation are valid for a health service research study on physicians' performance in preventive care. To report first results of the analysis of physicians performance like consultation time and guideline adherence in history taking. DesignSecondary data analysis of a clustered cross-sectional direct observation survey. SettingGeneral practitioners (GPs) in Vienna, Austria, visited unannounced by mystery shoppers (incognito standardised patients (ISPs)). Participants21 randomly selected GPs were visited by two different ISPs each. 40 observation protocols were realised. Main outcome measuresRobustness of sampling and data collection by the consumer organisation. GPs consultation and waiting times, guideline adherence in history taking. ResultsThe double stratified random sampling method was robust and representative for the private and contracted GPs mix of Vienna. The clinical scenarios presented by the ISPs were valid and believable, and no GP realised the ISPs were not genuine patients. The average consultation time was 46 min (95% CI 37 to 54 min). Waiting times differed more than consultation times between private and contracted GPs. No differences between private and contracted GPs in terms of adherence to the evidence-based guidelines regarding history taking including questions regarding alcohol use were found. According to the analysis, 20% of the GPs took a perfect history (95% CI 9% to 39%). ConclusionsThe analysis of secondary data collected by a consumer organisation was a valid method for drawing conclusions about GPs preventive practice. Initial results, like consultation times longer than anticipated, and the moderate quality of history taking encourage continuing the analysis on available clinical data.

Inter-rater and test-retest reliability of quality assessments by novice student raters using the Jadad and Newcastle-Ottawa Scales [RESEARCH]

Tue, 31 Jul 2012 00:00:00 +0000

IntroductionQuality assessment of included studies is an important component of systematic reviews. ObjectiveThe authors investigated inter-rater and test-retest reliability for quality assessments conducted by inexperienced student raters. DesignStudent raters received a training session on quality assessment using the Jadad Scale for randomised controlled trials and the Newcastle-Ottawa Scale (NOS) for observational studies. Raters were randomly assigned into five pairs and they each independently rated the quality of 13-20 articles. These articles were drawn from a pool of 78 papers examining cognitive impairment following electroconvulsive therapy to treat major depressive disorder. The articles were randomly distributed to the raters. Two months later, each rater re-assessed the quality of half of their assigned articles. SettingMcMaster Integrative Neuroscience Discovery and Study Program. Participants10 students taking McMaster Integrative Neuroscience Discovery and Study Program courses. Main outcome measuresThe authors measured inter-rater reliability using {kappa} and the intraclass correlation coefficient type 2,1 or ICC(2,1). The authors measured test-retest reliability using ICC(2,1). ResultsInter-rater reliability varied by scale question. For the six-item Jadad Scale, question-specific {kappa}s ranged from 0.13 (95% CI -0.11 to 0.37) to 0.56 (95% CI 0.29 to 0.83). The ranges were -0.14 (95% CI -0.28 to 0.00) to 0.39 (95% CI -0.02 to 0.81) for the NOS cohort and -0.20 (95% CI -0.49 to 0.09) to 1.00 (95% CI 1.00 to 1.00) for the NOS case-control. For overall scores on the six-item Jadad Scale, ICC(2,1)s for inter-rater and test-retest reliability (accounting for systematic differences between raters) were 0.32 (95% CI 0.08 to 0.52) and 0.55 (95% CI 0.41 to 0.67), respectively. Corresponding ICC(2,1)s for the NOS cohort were -0.19 (95% CI -0.67 to 0.35) and 0.62 (95% CI 0.25 to 0.83), and for the NOS case-control, the ICC(2,1)s were 0.46 (95% CI -0.13 to 0.92) and 0.83 (95% CI 0.48 to 0.95). ConclusionsInter-rater reliability was generally poor to fair and test-retest reliability was fair to excellent. A pilot rating phase following rater training may be one way to improve agreement.

Physiotherapy rehabilitation following lumbar spinal fusion: a systematic review and meta-analysis of randomised controlled trials [RESEARCH]

Tue, 24 Jul 2012 00:00:00 +0000

ObjectiveTo evaluate the effectiveness of physiotherapy intervention following lumbar spinal fusion. DesignSystematic review and meta-analysis. 2 independent reviewers searched information sources, assessed studies for inclusion and evaluated risk of bias. Quantitative synthesis using standardised mean differences was conducted on comparable outcomes across trials with similar interventions. Information sourcesPredefined terms were employed to search electronic databases. Additional studies were identified from key journals, reference lists, authors and experts. Eligibility criteria for included studiesRandomised control trials published in English prior to 30 September 2011 investigating physiotherapy outpatient management of patients (>16 years), following lumbar spinal fusion, with measurements reported on one or more outcome of disability, function and health were included. Results2 Randomised control trials (188 participants) from two countries were included. Both trials included a behavioural and an exercise intervention. 1 trial was evaluated as high risk of bias and one as unclear. 159 participants were incorporated in the meta-analysis. Although evidence from both trials suggested that intervention might reduce back pain short term (6 months) and long term (12 months and 2 years), and a behavioural intervention might be more beneficial than an exercise intervention, the pooled effects (0.72, 95% CI -0.25 to 1.69 at 6 months; 0.52, 95% CI -0.45 to 1.49 at 12 months and 0.75, 95% CI -0.46 to 1.96 at 2 years) did not demonstrate statistically significant effects. There was no evidence that intervention changes pain in the short (6 months) or long term (12 months and 2 years). The wide CI for pooled effects indicated that intervention could be potentially beneficial or harmful. Considerable heterogeneity was evident. ConclusionsInconclusive, very low-quality evidence exists for the effectiveness of physiotherapy management following lumbar spinal fusion. Best practice remains unclear. Limited comparability of outcomes and retrieval of only two trials reflect a lack of research in this area that requires urgent consideration.

Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial [PROTOCOL]

Tue, 24 Jul 2012 00:00:00 +0000

BackgroundEach year, approximately 350 000 women in the UK experience perineal suturing following childbirth. For those women whose perineal wound dehisces, the management will vary according to individual practitioner's preferences. For most women, the wound will be managed expectantly (healing by secondary intention), whereas others may be offered resuturing. However, there is limited scientific evidence and no clear guidelines to inform best practice. PREVIEW is a two-part study aiming to identify the best management strategy for dehisced perineal wounds, in terms of clinical effectiveness and women's preferences. Methods/designThe main part of this study is a pilot and feasibility randomised controlled trial designed to provide preliminary evidence of the effectiveness of resuturing versus expectant management for dehisced perineal wounds following childbirth and to feed into the design and feasibility of a larger definitive trial. 144 participants will be randomly allocated to either intervention. The primary outcome is the proportion of women with a healed perineal wound at 6-8 weeks from the trial entry. Secondary outcomes include perineal pain, breast feeding rates, dyspareunia and women's satisfaction with the aesthetic results of the wound healing at 6 weeks, 3 months and 6 months post randomisation. Information will be collected using validated questionnaires. The second part of this study will be to conduct semistructured interviews with 12 study participants, aiming to capture information relating to their physical and psychological experiences following perineal wound dehiscence, assess the acceptability of the research plan and ensure that all outcomes relevant to women are included in the definitive trial. DisseminationThe results of this study will inform a definitive randomised controlled trial that will provide conclusive evidence of what is the best management of perineal wound dehiscence. This will potentially lead to significant improvements in perineal care and will help to reduce the short- and long-term morbidity experienced by women. Clinical trials registrationPREVIEW is registered with the International Standard Research for Clinical Trials (no: ISRCTN05754020) and adopted as a National Institute for Health Research (NIHR) Reproductive Health and Childbirth specialty group portfolio study UKCRN ID 9098.

Feasibility and potential effectiveness of a non-pharmacological multidisciplinary care programme for persons with generalised osteoarthritis: a randomised, multiple-baseline single-case study [RESEARCH]

Thu, 19 Jul 2012 00:00:00 +0000

ObjectivesTo evaluate the feasibility and potential effectiveness of a 12-week, non-pharmacological multidisciplinary intervention in patients with generalised osteoarthritis (GOA). DesignA randomised, concurrent, multiple-baseline single-case design. During the baseline period, the intervention period and the postintervention period, all participants completed several health outcomes twice a week on Visual Analogue Scales. SettingRheumatology outpatient department of a specialised hospital in the Netherlands. Participants1 man and four women (aged 51-76 years) diagnosed with GOA. Primary outcome measuresTo assess feasibility, the authors assessed the number of dropouts and adverse events, adherence rates and patients' satisfaction. Secondary outcome measuresTo assess the potential effectiveness, the authors assessed pain and self-efficacy using visual data inspection and randomisation tests. ResultsThe intervention was feasible in terms of adverse events (none) and adherence rate but not in terms of participants' satisfaction with the intervention. Visual inspection of the data and randomisation testing demonstrated no effects on pain (p=0.93) or self-efficacy (p=0.85). ConclusionsThe results of the present study indicate that the proposed intervention for patients with GOA was insufficiently feasible and effective. The data obtained through this multiple-baseline study have highlighted several areas in which the therapy programme can be optimised.

{beta}-Blocker treatment during pregnancy and adverse pregnancy outcomes: a nationwide population-based cohort study [RESEARCH]

Thu, 19 Jul 2012 00:00:00 +0000

ObjectiveTo investigate the association between exposure to {beta}-blockers during pregnancy and the risk of being born small for gestational age (SGA), preterm birth and perinatal mortality in a nationwide cohort. DesignA population-based retrospective cohort study, using the Danish Fertility Database. The authors identified all pregnant women redeeming a prescription for {beta}-blockers using the National Prescription Registry. Multivariate logistic regression models were used to assess the association between exposure and our outcomes. SettingRegister-based survey. Participants911'685 births between 1995 and 2008 obtained from the Danish Fertility Database. Outcome measuresBeing born SGA was defined as having a birth weight below the 10th percentile for the corresponding gestational week. Preterm birth was defined as birth before the 37th gestational week. Perinatal mortality was defined as either death occurring within the first 28 days of life or stillbirth. Before 2004, fetal deaths were recorded as stillbirths if they occurred after 28 weeks of gestation, but since then stillbirth is recorded for deaths after 22 gestational weeks. ResultsThe authors identified 2459 pregnancies exposed to {beta}-blockers. {beta}-Blocker exposure during pregnancy was found to be associated with increased risk of SGA (adjusted OR 1.97, 95% CI 1.75 to 2.23), preterm birth (adjusted OR 2.26, 95% CI 2.03 to 2.52) and perinatal mortality (adjusted OR 1.89, 95% CI 1.25 to 2.84). Analyses were adjusted for socioeconomic and maternal variables. The authors found similar risk profiles for pregnancies exposed to labetalol and for pregnancies exposed to other {beta}-blockers. ConclusionsThe authors found that exposure to {beta}-blockers during pregnancy was associated with being born SGA, preterm birth and perinatal mortality. Our findings show that labetalol is not safer than other {beta}-blockers during pregnancy.

The evidence underpinning sports performance products: a systematic assessment [RESEARCH]

Wed, 18 Jul 2012 00:00:00 +0000

BackgroundTo assess the extent and nature of claims regarding improved sports performance made by advertisers for a broad range of sports-related products, and the quality of the evidence on which these claims are based. MethodsThe authors analysed magazine adverts and associated websites of a broad range of sports products. The authors searched for references supporting the performance and/or recovery claims of these products. The authors critically appraised the methods in the retrieved references by assessing the level of evidence and the risk of bias. The authors also collected information on the included participants, adverse events, study limitations, the primary outcome of interest and whether the intervention had been retested. ResultsThe authors viewed 1035 web pages and identified 431 performance-enhancing claims for 104 different products. The authors found 146 references that underpinned these claims. More than half (52.8%) of the websites that made performance claims did not provide any references, and the authors were unable to perform critical appraisal for approximately half (72/146) of the identified references. None of the references referred to systematic reviews (level 1 evidence). Of the critically appraised studies, 84% were judged to be at high risk of bias. Randomisation was used in just over half of the studies (58.1%), allocation concealment was only clear in five (6.8%) studies; and blinding of the investigators, outcome assessors or participants was only clearly reported as used in 20 (27.0%) studies. Only three of the 74 (2.7%) studies were judged to be of high quality and at low risk of bias. ConclusionsThe current evidence is not of sufficient quality to inform the public about the benefits and harms of sports products. There is a need to improve the quality and reporting of research, a move towards using systematic review evidence to inform decisions.

Long-term prophylaxis in hereditary angio-oedema: a systematic review [RESEARCH]

Wed, 11 Jul 2012 00:00:00 +0000

ObjectiveTo systematically review the evidence regarding long-term prophylaxis in the prevention or reduction of attacks in hereditary angio-oedema (HAE). DesignSystematic review and meta-analysis. Data sourcesElectronic databases were searched up to April 2011. Two reviewers selected the studies and extracted the study data, patient characteristics and outcomes of interest. Eligibility criteria for selected studiesControlled trials for HAE prophylaxis. Results7 studies were included, for a total of 73 patients and 587 HAE attacks. Due to the paucity of studies, a meta-analysis was not possible. Since two studies did not report the number of HAE attacks, five studies (52 patients) were finally included in the summary analysis. Four classes of drugs with at least one controlled trial have been proposed for HAE prophylaxis. All those drugs, except heparin, were found to be more effective than placebo. In the absence of direct comparisons, the relative efficacies of these drugs were determined by calculating a RR of attacks (drug vs placebo). The results were as follows: danazol (RR=0.023, 95% CI 0.003 to 0.162), methyltestosterone (RR=0.054, 95% CI 0.013 to 0.163), {varepsilon}-aminocaproic acid (RR=0.095, 95% CI 0.025 to 0.356), tranexamic acid (RR=0.308, 95% CI 0.195 to 0.479) and C1-INH 0.491 (95% CI 0.395 to 0.607). ConclusionsFew trials have evaluated the benefits of HAE prophylaxis, and all drugs but heparin seem to be effective in this setting. Since there are no direct comparisons of HAE drugs, it was not possible to draw definitive conclusions on the most effective one. Thus, to accumulate evidence for HAE prophylaxis, further studies are needed that consider the dose-efficacy relationship and include a head-to-head comparison between drugs, with the active group, rather than placebo, as the control.

Touch screen computer health assessment in Australian general practice patients: a cross-sectional study protocol [PROTOCOL]

Mon, 2 Jul 2012 00:00:00 +0000

IntroductionCardiovascular disease (CVD) and cancer are leading causes of death globally. Early detection of cancer and risk factors for CVD may improve health outcomes and reduce mortality. General practitioners (GPs) are accessed by the majority of the population and play a key role in the prevention and early detection of chronic disease risk factors. This cross-sectional study aims to assess the acceptability of an electronic method of data collection in general practice patients. The study will describe the proportion screened in line with guidelines for CVD risk factors and cancer as well as report the prevalence of depression, lifestyle risk factors, level of provision of preconception care, cervical cancer vaccination and bone density testing. Lastly, the study will assess the level of agreement between GPs and patients perception regarding presence of risk factors and screening. Methods and analysisThe study has been designed to maximise recruitment of GPs by including practitioners in the research team, minimising participation burden on GPs and offering remuneration for participation. Patient recruitment will be carried out by a research assistant located in general practice waiting rooms. Participants will be asked regarding the acceptability of the touch screen computer and to report on a range of health risk and preventive behaviours using the touch screen computer. GPs will complete a one-page survey indicating their perception of the presence of risk behaviours in their patients. Descriptive statistics will be generated to describe the acceptability of the touch screen and prevalence of health risk behaviours. Cohen's {kappa} will be used to assess agreement between GP and patient perception of presence of health risk behaviours. Ethics and disseminationThis study has been approved by the human research committees in participating universities. Findings will be disseminated via peer-reviewed publications, conference presentations as well as practice summaries provided to participating practices.

Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance [RESEARCH]

Mon, 25 Jun 2012 00:00:00 +0000

ObjectivesThe cancer multidisciplinary team (MDT) meeting (MDM) is regarded as the best platform to reduce unwarranted variation in cancer care through evidence-compliant management. However, MDMs are often overburdened with many different agendas and hence struggle to achieve their full potential. The authors developed an interactive clinical decision support system called MATE (Multidisciplinary meeting Assistant and Treatment sElector) to facilitate explicit evidence-based decision making in the breast MDMs. DesignAudit study and a questionnaire survey. SettingBreast multidisciplinary unit in a large secondary care teaching hospital. ParticipantsAll members of the breast MDT at the Royal Free Hospital, London, were consulted during the process of MATE development and implementation. The emphasis was on acknowledging the clinical needs and practical constraints of the MDT and fitting the system around the team's workflow rather than the other way around. Delegates, who attended MATE workshop at the England Cancer Networks' Development Programme conference in March 2010, participated in the questionnaire survey. Outcome measuresThe measures included evidence-compliant care, measured by adherence to clinical practice guidelines, and promoting research, measured by the patient identification rate for ongoing clinical trials. ResultsMATE identified 61% more patients who were potentially eligible for recruitment into clinical trials than the MDT, and MATE recommendations demonstrated better concordance with clinical practice guideline than MDT recommendations (97% of MATE vs 93.2% of MDT; N=984). MATE is in routine use in breast MDMs at the Royal Free Hospital, London, and wider evaluations are being considered. ConclusionsSophisticated decision support systems can enhance the conduct of MDMs in a way that is acceptable to and valued by the clinical team. Further rigorous evaluations are required to examine cost-effectiveness and measure the impact on patient outcomes. The decision support technology used in MATE is generic and if found useful can be applied across medicine.

Social inequality and infant health in the UK: systematic review and meta-analyses [RESEARCH]

Thu, 14 Jun 2012 00:00:00 +0000

ObjectivesTo determine the association between area and individual measures of social disadvantage and infant health in the UK. DesignSystematic review and meta-analyses. Data sources26 databases and websites, reference lists, experts in the field and hand-searching. Study selection36 prospective and retrospective observational studies with socioeconomic data and health outcomes for infants in the UK, published from 1994 to May 2011. Data extraction and synthesis2 independent reviewers assessed the methodological quality of the studies and abstracted data. Where possible, study outcomes were reported as ORs for the highest versus the lowest deprivation quintile. ResultsIn relation to the highest versus lowest area deprivation quintiles, the odds of adverse birth outcomes were 1.81 (95% CI 1.71 to 1.92) for low birth weight, 1.67 (95% CI 1.42 to 1.96) for premature birth and 1.54 (95% CI 1.39 to 1.72) for stillbirth. For infant mortality rates, the ORs were 1.72 (95% CI 1.37 to 2.15) overall, 1.61 (95% CI 1.08 to 2.39) for neonatal and 2.31 (95% CI 2.03 to 2.64) for post-neonatal mortality. For lowest versus highest social class, the odds were 1.79 (95% CI 1.43 to 2.24) for low birth weight, 1.52 (95% CI 1.44 to 1.61) for overall infant mortality, 1.42 (95% CI 1.33 to1.51) for neonatal and 1.69 (95% CI 1.53 to 1.87) for post-neonatal mortality. There are similar patterns for other infant health outcomes with the possible exception of failure to thrive, where there is no clear association. ConclusionsThis review quantifies the influence of social disadvantage on infant outcomes in the UK. The magnitude of effect is similar across a range of area and individual deprivation measures and birth and mortality outcomes. Further research should explore the factors that are more proximal to mothers and infants, to help throw light on the most appropriate times to provide support and the form(s) that this support should take.

The best of the UK? A report on the value and future of UK databases in the health and social care fields: a systematic map protocol [PROTOCOL]

Thu, 31 May 2012 00:00:00 +0000

IntroductionThis protocol covers the first part of a two-part project funded by the Health Libraries Group and the University Health and Medical Librarians Group. It details the proposed methodology for a systematic map of the literature relating to UK bibliographic databases in the fields of health and social care. The aim of this mapping exercise is to consider ways in which UK bibliographic databases are described, considered and discussed in the published and unpublished literature. In doing so, we hope to gain a clearer sense of the ways in which UK bibliographic databases are used and viewed by the research community. It also enables the identification of any gaps in the literature for further research and discussion. This topic is important because UK databases are generally underused by researchers in the UK context and some databases are at risk of closure. A lack of access to UK databases means that researchers may miss relevant UK evidence when identifying an evidence base. MethodSystematic Map. AnalysisThe authors will present a narrative description of the literature relating to UK bibliographic databases in the fields of health and social care. They will use tables to present descriptive information about the literature (eg, frequency tables) and use cross-tabulations to demonstrate intersecting themes. Separately, guidance on how to use the resources (eg, areas of unique content, updating frequencies, unique truncation symbols) will be sought from stakeholders and reported alongside the report narrative as a guide to usage.

Focused sonographic examination of the heart, lungs and deep veins in an unselected population of acute admitted patients with respiratory symptoms: a protocol for a prospective, blinded, randomised controlled trial [PROTOCOL]

Wed, 30 May 2012 00:00:00 +0000

IntroductionPatients admitted to hospital with acute respiratory symptoms remain a diagnostic challenge for the emergency physician. The use of focused sonography may improve the initial diagnostics, as most of the diseases, commonly seen and misdiagnosed in patients with acute respiratory symptoms, can be diagnosed with sonography. The protocol describes a prospective, blinded, randomised controlled trial that aims to assess the diagnostic impact of a pragmatic implementation of focused sonography of the heart, lungs and deep veins as a diagnostic modality in acute admitted patients with respiratory symptoms. Methods and analysisThe primary outcome of the study is the number of patients with a correct presumptive diagnosis within 4 h of admission to the emergency department. The patient is randomised to either an intervention or a control group. In the intervention group, the usual initial diagnostic work up is supplemented by focused sonographic examination of the heart, lungs and deep veins of the legs. In the control group, usual diagnostic work up is performed. The {chi}2 test, alternatively the Fischer exact test will be used, to establish whether there is a difference in the distribution of the total number of patients with a correct/incorrect 4 h' presumptive diagnosis in the control group and in the intervention group. Ethics and disseminationThis clinical trial is performed according to the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee for Southern Denmark and the Danish Data Protection Agency. The results of the trial will be published according to the CONSORT statement with the extension for pragmatic trials. The results of the trial will be published in a peer-reviewed scientific journal regardless of the outcome. Trial registration numberThis study is registered at http://clinicaltrials.gov, registration number NCT01486394.

Mindfulness online: a preliminary evaluation of the feasibility of a web-based mindfulness course and the impact on stress [RESEARCH]

Mon, 21 May 2012 00:00:00 +0000

ObjectivesStress has been shown to have a number of negative effects on health over time. Mindfulness interventions have been shown to decrease perceived stress but access to interventions is limited. Therefore, the effectiveness of an online mindfulness course for perceived stress was investigated. DesignA preliminary evaluation of an online mindfulness course. ParticipantsThis sample consisted of 100 self-referrals to the online course. The average age of participants was 48 years and 74% were women. InterventionsThe online programme consisted of modules taken from Mindfulness Based Stress Reduction and Mindfulness Based Cognitive Therapy and lasted for approximately 6 weeks. Primary and secondary outcome measuresParticipants completed the Perceived Stress Scale (PSS) before the course, after the course and at 1-month follow-up. Completion of formal (eg, body scan, mindful movement) and informal (eg, mindful meal, noticing) mindfulness activities was self-reported each week. ResultsParticipation in the online mindfulness course significantly reduced perceived stress upon completion and remained stable at follow-up. The pre-post effect size was equivalent to levels found in other class-based mindfulness programmes. Furthermore, people who had higher PSS scores before the course reported engaging in significantly more mindfulness practice, which was in turn associated with greater decreases in PSS. ConclusionsBecause perceived stress significantly decreased with such limited exposure to mindfulness, there are implications for the accessibility of mindfulness therapies online. Future research needs to evaluate other health outcomes for which face-to-face mindfulness therapies have been shown to help, such as anxiety and depressive symptoms.

A four-country survey of public attitudes towards restricting healthcare costs by limiting the use of high-cost medical interventions [RESEARCH]

Mon, 14 May 2012 00:00:00 +0000

ObjectiveTo discern how the public in four countries, each with unique health systems and cultures, feels about efforts to restrain healthcare costs by limiting the use of high-cost prescription drugs and medical/surgical treatments. DesignCross-sectional survey. SettingAdult populations in Germany, Italy, the UK and the USA. Participants2517 adults in the four countries. A questionnaire survey conducted by telephone (landline and cell) with randomly selected adults in each of the four countries. Main outcome measuresSupport for different rationales for not providing/paying for high-cost prescription drugs/medical or surgical treatments, measured in the aggregate and using four case examples derived from actual decisions. Measures of public attitudes about specific policies involving comparative effectiveness and cost-benefit decision making. ResultsThe survey finds support among publics in four countries for decisions that limit the use of high-cost prescription drugs/treatments when some other drug/treatment is available that works equally well but costs less. The survey finds little public support, either in individual case examples or when asked in the aggregate, for decisions in which prescription drugs/treatments are denied on the basis of cost or various definitions of benefits. The main results are based on majorities of the public in each country supporting or opposing each measure. ConclusionsThe survey findings indicate that the public distinguishes in practice between the concepts of comparative effectiveness and cost-effectiveness analysis. This suggests that public authorities engaged in decision-making activities will find much more public support if they are dealing with the first type of decision than with the second.

Strategies to increase influenza vaccination rates: outcomes of a nationwide cross-sectional survey of UK general practice [RESEARCH]

Fri, 11 May 2012 00:00:00 +0000

ObjectiveTo identify practice strategies associated with higher flu vaccination rates in primary care. DesignLogistic regression analysis of data from a cross-sectional online questionnaire. Setting795 general practices across England. Participants569 practice managers, 335 nursing staff and 107 general practitioners. Primary outcome measuresFlu vaccination rates achieved by each practice in different groups of at-risk patients. Results7 independent factors associated with higher vaccine uptake were identified. Having a lead staff member for planning the flu campaign and producing a written report of practice performance predicted an 8% higher vaccination rate for at-risk patients aged <65 years (OR 1.37, 95% CI 1.10 to 1.71). These strategies, plus sending a personal invitation to all eligible patients and only stopping vaccination when Quality and Outcomes Framework targets are reached, predicted a 7% higher vaccination rate (OR 1.45, 95% CI 1.10 to 1.92) in patients aged [≥]65 years. Using a lead member of staff for identifying eligible patients, with either a modified manufacturer's or in-house search programme for interrogating the practice IT system, independently predicted a 4% higher vaccination rate in patients aged [≥]65 years (OR 1.22, 95% CI 1.06 to 1.41/OR 1.20, 95% CI 1.03 to 1.40). The provision of flu vaccine by midwives was associated with a 4% higher vaccination rate in pregnant women (OR 1.19, 95% CI 1.02 to 1.40). ConclusionsClear leadership, effective communication about performance and methods used to identify and contact eligible patients were independently associated with significantly higher rates of flu vaccination. Financial targets appear to incentivise practices to work harder to maximise seasonal influenza vaccine uptake. The strategies identified here could help primary care providers to substantially increase their seasonal flu vaccination rates towards or even above the Chief Medical Officer's targets.

A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme [RESEARCH]

Tue, 8 May 2012 00:00:00 +0000

ObjectivesTo evaluate effectiveness of a structured one-to-one behaviour change programme on weight loss in obese and overweight individuals. DesignRandomised controlled trial. Setting23 general practices in Camden, London. Participants381 adults with body mass index [≥]25 kg/m2 randomly assigned to intervention (n=191) or control (n=190) group. InterventionsA structured one-to-one programme, delivered over 14 visits during 12 months by trained advisors in three primary care centres compared with usual care in general practice. Outcome measuresChanges in weight, per cent body fat, waist circumference, blood pressure and heart rate between baseline and 12 months. Results217/381 (57.0%) participants were assessed at 12 months: missing values were imputed. The difference in mean weight change between the intervention and control groups was not statistically significant (0.70 kg (0.67 to 2.17, p=0.35)), although a higher proportion of the intervention group (32.7%) than the control group (20.4%) lost 5% or more of their baseline weight (OR: 1.80 (1.02 to 3.18, p=0.04)). The intervention group achieved a lower mean heart rate (mean difference 3.68 beats per minute (0.31 to 7.04, p=0.03)) than the control group. Participants in the intervention group reported higher satisfaction and more positive experiences of their care compared with the control group. ConclusionsAlthough there is no significant difference in mean weight loss between the intervention and control groups, trained non-specialist advisors can deliver a structured programme and achieve clinically beneficial weight loss in some patients in primary care. The intervention group also reported a higher level of satisfaction with the support received. Primary care interventions are unlikely to be sufficient to tackle the obesity epidemic and effective population-wide measures are also necessary. Clinical trial registration numberTrial registrationClincaltrials.gov NCT00891943.

Risk Factors for Alloimmunisation after red blood Cell Transfusions (R-FACT): a case cohort study [PROTOCOL]

Fri, 4 May 2012 00:00:00 +0000

IntroductionIndividuals exposed to red blood cell alloantigens through transfusion, pregnancy or transplantation may produce antibodies against the alloantigens. Alloantibodies can pose serious clinical problems such as delayed haemolytic reactions and logistic problems, for example, to obtain timely and properly matched transfusion blood for patients in which new alloantibodies are detected. ObjectiveThe authors hypothesise that the particular clinical conditions (eg, used medication, concomitant infection, cellular immunity) during which transfusions are given may contribute to the risk of immunisation. The aim of this research was to examine the association between clinical, environmental and genetic characteristics of the recipient of erythrocyte transfusions and the risk against erythrocyte alloimmunisation during that transfusion episode. Methods and analysis Study designIncident case-cohort study. SettingSecondary care, nationwide study (within the Netherlands) including seven hospitals, from January 2005 to December 2011. Study populationConsecutive red cell transfused patients at the study centres. InclusionThe study cohort comprises of consecutive red blood cell transfused patients at the study centre. ExclusionPatients with transfusions before the study period and/or pre-existing alloantibodies.Cases defined as first time alloantibody formers; Controls defined as transfused individuals matched (on number of transfusions) to cases and have not formed an alloantibody. Statistical analysisLogistic regression models will be used to assess the association between the risk to develop antibodies and potential risk factors, adjusted for other risk factors. Ethics and disseminationApproval at each local ethics regulatory committee will be obtained. Data will be coded for privacy reasons. Patients will be sent a letter and an information brochure explaining the purpose of the study. A consent form in presence of the study coordinator will be signed before the blood taking commences. Investigators will submit progress summary of the study to study sponsor regularly. Investigators will notify the accredited ethics board of the end of the study within a period of 8 weeks.

Effects of the Great East Japan Earthquake and huge tsunami on glycaemic control and blood pressure in patients with diabetes mellitus [RESEARCH]

Fri, 13 Apr 2012 00:00:00 +0000

ObjectiveTo examine the effects of a huge tsunami resulting from the Great East Japan Earthquake on blood pressure (BP) control and glycaemic control in diabetic patients. DesignA retrospective study. SettingTohoku University, Japan. Participants63 patients were visiting Rikuzentakata Hospital for diabetic treatment before the earthquake and returned to the clinic in July after the earthquake, and they were analysed in the present study. The subjects were divided into two groups: those who were hit by the tsunami, the Tsunami (+) group (n=28), and those who were not, the Tsunami (-) group (n=35), and the groups' parameters and their changes were compared. Primary outcome measureChanges of HbA1c. Secondary outcome measuresChanges of BP, body mass index. ResultsHbA1c and both BP increased, while the numbers of most drugs taken decreased in both groups. Parameter changes were significantly greater in the Tsunami (+) group. All medical data stored at the hospital was lost in the tsunami. The Tsunami (+) patients also had their own records of treatment washed away, so it was difficult to replicate their pre-earthquake drug prescriptions afterwards. In comparison, the Tsunami (-) patients kept their treatment information, making it possible to resume the treatment they had been receiving before the earthquake. The BP rose only slightly in men, whereas it rose sharply in women, even though they had not been directly affected by the tsunami. BP rose markedly in both genders affected by the tsunami. ConclusionsAll medical information was lost in the tsunami, and glycaemic and BP controls of the tsunami-affected patients worsened more than those of patients who had been affected by the earthquake alone. Women may be more sensitive to changes in the living environment that result from a major earthquake than are men.

Observational cohort study of the safety of digoxin use in women with heart failure [RESEARCH]

Fri, 13 Apr 2012 00:00:00 +0000

ObjectivesThis study aims to assess whether digoxin has a different effect on mortality risk for women than it does for men in patients with heart failure (HF). DesignThis study uses the UK-based The Health Information Network population database in a cohort study of the impact of digoxin exposure on mortality for men and women who carry the diagnosis of HF. Digoxin exposure was assessed based on prescribing data. Multivariable Cox proportional hazards models were used to assess whether there was an interaction between sex and digoxin affecting mortality hazard. SettingThe setting was primary care outpatient practices. ParticipantsThe study cohort consisted of 17 707 men and 19 227 women with the diagnosis of HF who contributed only time without digoxin exposure and 9487 men and 10 808 women with the diagnosis of HF who contributed time with digoxin exposure. Main outcome measuresThe main outcome measure was all-cause mortality. ResultsThe primary outcome of this study was the absence of a large interaction between digoxin use and sex affecting mortality. For men, digoxin use was associated with a HR for mortality of 1.00, while for women, the HR was also 1.00 (p value for interaction 0.65). The results of sensitivity analyses were consistent with those of the primary analysis. ConclusionObservational data do not support the concern that there is a substantial increased risk of mortality due to the use of digoxin in women. This finding is consistent with previous observational studies but discordant with results from a post hoc analysis of a randomised controlled trial of digoxin versus placebo.

Technology adoption and implementation in organisations: comparative case studies of 12 English NHS Trusts [RESEARCH]

Wed, 4 Apr 2012 00:00:00 +0000

ObjectivesTo understand organisational technology adoption (initiation, adoption decision, implementation) by looking at the different types of innovation knowledge used during this process. DesignQualitative, multisite, comparative case study design. SettingOne primary care and 11 acute care organisations (trusts) across all health regions in England in the context of infection prevention and control. Participants and data analysis121 semistructured individual and group interviews with 109 informants, involving clinical and non-clinical staff from all organisational levels and various professional groups. Documentary evidence and field notes were also used. 38 technology adoption processes were analysed using an integrated approach combining inductive and deductive reasoning. Main findingsThose involved in the process variably accessed three types of innovation knowledge: awareness' (information that an innovation exists), principles' (information about an innovation's functioning principles) and how-to' (information required to use an innovation properly at individual and organisational levels). Centralised (national, government-led) and local sources were used to obtain this knowledge. Localised professional networks were preferred sources for all three types of knowledge. Professional backgrounds influenced an asymmetric attention to different types of innovation knowledge. When less attention was given to how-to' compared with principles' knowledge at the early stages of the process, this contributed to 12 cases of incomplete implementation or discontinuance after initial adoption. ConclusionsPotential adopters and change agents often overlooked or undervalued how-to' knowledge. Balancing principles' and how-to' knowledge early in the innovation process enhanced successful technology adoption and implementation by considering efficacy as well as strategic, structural and cultural fit with the organisation's context. This learning is critical given the policy emphasis for health organisations to be innovation-ready.

Tracking the impact of research on policy and practice: investigating the feasibility of using citations in clinical guidelines for research evaluation [RESEARCH]

Fri, 30 Mar 2012 00:00:00 +0000

ObjectivesTo investigate the feasibility of using research papers cited in clinical guidelines as a way to track the impact of particular funding streams or sources. SettingIn recent years, medical research funders have made efforts to enhance the understanding of the impact of their funded research and to provide evidence of the value' of investments in particular areas of research. One of the most challenging areas of research evaluation is around impact on policy and practice. In the UK, the National Institute of Health and Clinical Excellence (NICE) provide clinical guidelines, which bring together current high-quality evidence on the diagnosis and treatment of clinical problems. Research referenced in these guidelines is an indication of its potential to have real impact on health policy and practice. DesignThis study is based on analysis of the authorship and funding attribution of research cited in two NICE clinical guidelines: dementia and chronic obstructive pulmonary disease. ResultsAnalysis identified that around a third of papers cited in the two NICE guidelines had at least one author based in the UK. In both cases, about half of these UK attributed papers contained acknowledgements which allowed the source of funding for the research to be identified. The research cited in these guidelines was found to have been supported by a diverse set of funders from different sectors. The study also investigated the contribution of research groups based in universities, industry and the public sector. ConclusionsThe study found that there is great potential for guidelines to be used as sources of information on the quality of the research used in their development and that it is possible to track the source of the funding of the research. The challenge is in harnessing the relevant information to track this in an efficient way.

Risk of developing disability in pre and post-multidrug therapy treatment among multibacillary leprosy: Agra MB Cohort study [RESEARCH]

Mon, 26 Mar 2012 00:00:00 +0000

ObjectivesIf leprosy is a public health problem, it is due to the disabilities it causes. Surprisingly little is known about the risk of disabilities. Even now, mainly cross-sectional studies report disability prevalence. The present study aims to report the risk of disability in pre and post-WHO multidrug therapy (MDT) in multibacillary leprosy patients and to assess the extent of the incidence of disability. MethodsThe study design is prospective and the setting is an institutional field area. Patients were detected during 2001-6 field surveys. Of the 289 multibacillary patients, 146 completed the study. Both sexes were involved. The primary outcome planned was to study cure of disease, relapses and disability in patients receiving MDT. The secondary outcome was to measure reaction and default. Assessment was done clinically. Data have been analysed using SPSS software, logistic, survival analysis was performed and the {chi}2 test of significance was used. ResultsAn important risk factor was found to be three or more nerves involved with odds of 3.73 (1.24-11.2), and delay in treatment; 2.27 (1.04-4.96) at the pre-MDT stage and three or more nerves involved with odds of 2.81 (1.0-7.9) at the post-MDT stage. The incidence of disability was found to be 2.74/100 person-years; 2.69 in the MDT arm and 2.84 in defaulters, with slightly higher disability among early defaulters (3.08) than among late defaulters (2.30). The study suggests that the incidence of disability could be slightly higher if treatment is not completed. ConclusionEarly treatment for leprosy is a must for reducing the risk of disability, and treatment delay would increase the risk of disability. It is important to note that the incidence of disability between defaulters and those completing treatment was not found to be significantly different.

Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults [PROTOCOL]

Mon, 26 Mar 2012 00:00:00 +0000

ObjectiveHispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics. Methods and analysisThe Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35-70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity. Ethics and disseminationAll participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-a-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects. Clinical trial registration numberNCT00787475 at clinicaltrials.gov.