Latest from JME

Might stimulant drugs support moral agency in ADHD children? [COMMENTARY]

Sat, 1 Jun 2013 00:00:00 +0000

Stimulants have been shown to be safe and effective for reduction of the symptoms of attention deficit hyperactivity disorder. Despite much debate, however, there has been little empirical evidence as to whether stimulants affect authenticity and moral agency in children. Singh presents evidence that stimulants do not undercut children's' sense of self and increase their experience of agency. These findings are consistent with laboratory evidence that stimulant drugs in therapeutic doses improve cognitive control over thought and behavior.

Not robots: children's perspectives on authenticity, moral agency and stimulant drug treatments [FEATURE ARTICLE]

Sat, 1 Jun 2013 00:00:00 +0000

In this article, I examine children's reported experiences with stimulant drug treatments for attention deficit hyperactivity disorder in light of bioethical arguments about the potential threats of psychotropic drugs to authenticity and moral agency. Drawing on a study that involved over 150 families in the USA and the UK, I show that children are able to report threats to authenticity, but that the majority of children are not concerned with such threats. On balance, children report that stimulants improve their capacity for moral agency, and they associate this capacity with an ability to meet normative expectations. I argue that although under certain conditions stimulant drug treatment may increase the risk of a threat to authenticity, there are ways to minimise this risk and to maximise the benefits of stimulant drug treatment. Medical professionals in particular should help children to flourish with stimulant drug treatments, in good and in bad conditions.

Doctors' willingness to give honest answers about end-of-life practices: a cross-sectional study [RESEARCH]

Thu, 23 May 2013 00:00:00 +0000

ObjectivesWe aimed to (1) evaluate the extent to which doctors in New Zealand would be willing to answer honestly questions about their care of patients at the end of their lives and (2) identify the assurances that would encourage this. Results were compared with findings from a previous pilot study from the UK. DesignSurvey study involving a mailed questionnaire. SettingNew Zealand hospital and community-based medical care settings. ParticipantsThe questionnaire was mailed to a random sample of 800 doctors in New Zealand who were vocationally registered with the Medical Council of New Zealand in disciplines involving caring for patients at the end of their lives. Primary and secondary outcome measuresWillingness to provide honest answers about various aspects of end-of-life care; assurances that might increase willingness to provide honest answers to questions about end-of-life practices. ResultsCompleted questionnaires were returned by 436 doctors. The majority of respondents (59.9-91.5%) indicated willingness to provide honest answers to such questions. However, more than a third of doctors were unwilling to give honest answers to certain questions regarding euthanasia. These results are comparable with the UK data. Complete anonymity was the assurance most likely to encourage honest answering, with most of the respondents preferring the use of anonymous written replies. Respondents were less reassured by survey endorsements from regulatory bodies. Themes in free comments included the deterrent effect of medicolegal consequences, fear of censure from society, peers and the media and concerns about the motivations and potential uses of such research. ConclusionsMany New Zealand doctors were willing to give honest answers to questions about end-of-life practices, particularly if anonymity was guaranteed; others, however, expressed doubts or indicated that they would not be willing to provide honest answers to questions of this sort.

Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study [RESEARCH]

Thu, 23 May 2013 00:00:00 +0000

ObjectivesTo analyse the parental understanding of informed consent information in first-line randomised clinical trials (RCTs) including children with malignant solid tumours and to assess parents' needs for decision-making. DesignObservational prospective study. Setting3 paediatric oncology centres in the Parisian region in France. Participants53 parents were approached to participate in a RCT for their child with malignant solid tumour, over a 1-year period. 40 parents have been interviewed in our study. Primary and secondary outcome measuresParental understanding of information in RCTs, parents' needs for decision-making. Parents were questioned by a psychologist, independent of the paediatric oncology teams, using a semidirected interview, 1 (M1) and 6 months (M6) after the consent was sought. Results18 parents (45%) did not understand the concept of randomisation. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit to their child of inclusion. 35 parents (87.5%) expressed very few specific risks related to the trial. Being mostly French-speaking (p=0.03) and the reading of the information sheet by the parents (p=0.0025) improved their understanding. The parental comprehension did not differ between M1 and M6. The principal factors underlying their decision were confidence in the medical team (39%), wish to access to the best treatment (37%) and the best quality of life (37%). ConclusionsDespite medical explanations, parents have limited knowledge in some areas in first-line RCTs and improvements of information process are required. The risks specific to the randomised trial are underestimated by parents and the unproven nature of the treatment is not well-known or understood.

Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare [EDITORIAL]

Sun, 5 May 2013 00:00:00 +0000

Infanticide: a reply to Giubilini and Minerva [RESPONSE]

Wed, 1 May 2013 00:00:00 +0000

Alberto Giubilini and Francesco Minerva's recent infanticide proposal is predicated on their personism and actualism. According to these related ideas, human beings achieve their moral status in virtue of the degree to which they are capable of laying value upon their lives or exhibiting certain qualities or being desirable to third-party family members. This article challenges these criteria, suggesting that these and related ideas are rely on arbitrary and discriminatory notions of human moral status. Our propensity to sleep, fall unconscious, pass out and so on, demonstrates that we often exhibit our status as potential persons' who are not in the condition of attributing any value to their own existence. Our abilities, age and desirability can and do fluctuate. The equal dignity principle, distinguished in turn from both the excesses of vitalism and consequentialism, is analysed and defended in the context of human rights logic and law. The normalisation of non- and involuntary euthanasia, via such emerging practices as the self-styled Groningen Protocol, is considered. Substituted consent to the euthanasia of babies and others is scrutinised and the implications of institutionalising non-voluntary euthanasia in the context of financial, research and political interests are considered. The impact on the medical and legal professions, carers, families and societies, as well as public attitudes more generally, is discussed. It is suggested that eroding the value of human life carries with it significant destructive long-term implications. To elevate some, often short-term, implications while ignoring others demonstrates the irrational nature of the effort to institutionalise euthanasia.

Significance of past statements: speech act theory [RESPONSE]

Tue, 30 Apr 2013 00:00:00 +0000

Altruism in organ donation: an unnecessary requirement? [CURRENT CONTROVERSY]

Thu, 28 Mar 2013 00:00:00 +0000

Electroconvulsive therapy (ECT) from the patient's perspective [CLINICAL ETHICS]

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

This is a response to Dr Charlotte Rosalind Blease's paper Electroconvulsive Therapy (ECT), the Placebo Effect and Informed Consent', written by Julie K. Hersh who has had ECT. Hersh argues that placebo effect is impossible to prove without endangering the lives of participants in the study. In addition, informing potential ECT patients of unproven placebo effect could discourage patients from using a procedure that from experience has proven highly effective.

Institution animal care and use committees need greater ethical diversity [BRIEF REPORT]

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

In response to public outrage stemming from exposes of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of animal pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare.

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.

Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of prehospital cardiac arrest (REVIVE-Airways): a feasibility study research protocol [PROTOCOL]

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

IntroductionEffective cardiopulmonary resuscitation with appropriate airway management improves outcomes following out-of-hospital cardiac arrest (OHCA). Historically, tracheal intubation has been accepted as the optimal form of OHCA airway management in the UK. The Joint Royal Colleges Ambulance Liaison Committee recently concluded that newer supraglottic airway devices (SADs) are safe and effective devices for hospital procedures and that their use in OHCA should be investigated. This study will address an identified gap in current knowledge by assessing whether it is feasible to use a cluster randomised design to compare SADs with current practice, and also to each other, during OHCA. Methods and analysisThe primary objective of this study is to assess the feasibility of a cluster randomised trial to compare the ventilation success of two newer SADs: the i-gel and the laryngeal mask airway supreme to usual practice during the initial airway management of OHCA. The secondary objectives are to collect data on ventilation success, further airway interventions required, loss of a previously established airway during transport, airway management on arrival at hospital (or termination of the resuscitation attempt), initial resuscitation success, survival to intensive care admission, survival to hospital discharge and patient outcome at 3 months. Ambulance paramedics will be randomly allocated to one of the three methods of airway management. Adults in medical OHCA attended by a trial paramedic will be eligible for the study. Ethics and disseminationApproval for the study has been obtained from a National Health Service Research Ethics Committee with authority to review proposals for trials of a medical device in incapacitated adults. The results will be made publicly available on an open access website, and we will publish the findings in appropriate journals and present them at national and international conferences relevant to the subject field. Trial registrationISRCTN: 18528625.

Moral responsibility for (un)healthy behaviour [PUBLIC HEALTH ETHICS]

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

A public opinion survey: is presumed consent the answer to kidney shortage in Hong Kong? [RESEARCH]

Thu, 3 Jan 2013 00:00:00 +0000

ObjectiveTo project the impact of an opt-out system (presuming consent) in Hong Kong on the likelihood that a potential donor donates his or her kidneys after death and the likelihood of violating a potential donor's autonomy. SettingCross-sectional population-based anonymous telephone survey. ParticipantsRandom sample of 802 adults aged between 18 and 64. Main outcome measureWillingness to donate their own kidneys after death and their willingness to donate the kidneys of a deceased family member in different hypothetical situations under the current opt-in system and under our proposed soft version of an opt-out system. ResultsWhen the wish of the deceased is unknown, 72.6% (n=583) of the respondents said that under the proposed opt-out system, they would definitely or likely consent to donating the kidneys of a deceased family member, significantly more than under the current opt-in system (OR 2.53, 95% CI 2.06 to 3.11). An opt-out system could significantly improve the projected overall donation potential from 0.631 to 0.771 (OR 1.97, 95% CI 1.58-2.45) and reduce the projected overall chance of violating the autonomy of a potential donor from 0.292 to 0.127 (OR 0.35, 95% CI 0.27 to 0.45). ConclusionsA switch to an opt-out system in Hong Kong would likely result in the wishes of more people being followed and raise the overall cadaveric kidney donation rate.

The ethics of unlinked anonymous testing of blood: views from in-depth interviews with key informants in four countries [RESEARCH]

Thu, 20 Dec 2012 00:00:00 +0000

ObjectivesIn this study we explore the ethical issues around unlinked anonymous testing (UAT) of blood, a method of seroprevalence surveillance for infectious diseases. Our study focused on UAT for HIV, although UAT can be used for other infectious diseases. The objectives of the research were to gain a better understanding of the views of key informants in countries adopting different UAT testing strategies, and to use the findings of the research to inform health policy. DesignQualitative study using in-depth interviews and ethical analysis. SettingFour countries using different strategies around UAT of blood for HIV (the UK, the USA, the Netherlands and Norway). ParticipantsTwenty-three key informants in the four countries. ResultsParticipants from the four countries have different views on UAT of blood, and the approaches and policies on UAT adopted by different countries have been historically and culturally determined. We use our findings to explore the relationship between public health policy and ethics, framing our discussion in relation to two important contemporary debates: informed consent for participation in medical and public health research; and the balance between the individual good and the public good. ConclusionsQualitative research and ethical analysis of UAT of blood in different countries has yielded important findings for consideration by policy makers. The policy of UAT of blood for HIV and other diseases in the UK needs reconsideration in the light of these findings.

The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent [RESEARCH ETHICS]

Thu, 13 Dec 2012 00:00:00 +0000

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.

Patients' silence towards the healthcare system after ethical transgressions by staff: associations with patient characteristics in a cross-sectional study among Swedish female patients [RESEARCH]

Thu, 29 Nov 2012 00:00:00 +0000

ObjectivesTo identify which patient characteristics are associated with silence towards the healthcare system after experiences of abusive or ethically wrongful transgressive behaviour by healthcare staff. DesignCross-sectional questionnaire study using the Transgressions of Ethical Principles in Health Care Questionnaire. SettingA women's clinic in the south of Sweden. ParticipantsSelection criteria were: consecutive female patients coming for an outpatient appointment, [≥]18-year-old, with the ability to speak and understand the Swedish language, and a known address. Questionnaires were answered by 534 women (60%) who had visited the clinic, of which 293 were included in the present study sample. Primary outcome measureHow many times the respondent remained silent towards the healthcare system relative to the number of times the respondent spoke up. ResultsAssociations were found between patients' silence towards the healthcare system and young age as well as lower self-rated knowledge of patient rights. Both variables showed independent effects on patients' silence in a multivariate model. No associations were found with social status, country of birth, health or other abuse. ConclusionsThe results offer opportunities for designing interventions to stimulate patients to speak up and open up the clinical climate, for which the responsibility lies in the hands of staff; but more research is needed.

Staff's perception of abuse in healthcare: a Swedish qualitative study [RESEARCH]

Tue, 25 Sep 2012 00:00:00 +0000

ObjectiveThe study aim was to apprehend staff's perception of abuse in healthcare (AHC) after an intervention based on Forum Play', and make comparisons to preintervention interviews and interviews with male and female patients. AHC can be described as a failing encounter from the patient's perspective. DesignQualitative interview follow-up study. SettingA Swedish Women's Clinic. ParticipantsIn a preintervention study 21 staff members were interviewed. Eligible for the follow-up study were 14 informants who had participated in the intervention. Four declined participation leaving ten informants for this study. InterventionDuring January 2008-January 2009, all staff members (N=136) were invited to participate in Forum Play workshops. Seventy-four participants took part in at least 1 of the 17 half-day workshops. Primary outcome measuresStaffs perception of AHC. ResultsThe core category, a summoning stone in the shoe', was constructed of five categories: Dehumanising the patient', Unacceptable: you are bound to act!', Ubiquitous', Unintentional' and Relative'. Forum Play had demonstrated possibilities to act even in seemingly impossible' situations, and that the taboo status of AHC was altered at the clinic. When our results were compared to those in the preintervention study, we found an increased awareness about AHC, more concrete examples of AHC, a stronger empathy for patients, and fewer explanations, justifications and trivialisations of AHC. ConclusionIn this follow-up study staff's perception of AHC was closer to the patient's perspective. Compared to the preintervention interviews staff showed a greater willingness not only to acknowledge AHC, but also to take on a responsibility to act in order to stop or prevent AHC. Explanations for this stance could be that Forum Play had showed staff that there were possibilities to act, and that the taboo status of AHC had been broken at the clinic.

Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population [RESEARCH]

Mon, 24 Sep 2012 00:00:00 +0000

ObjectiveTo identify the most appropriate format for results dissemination to maximise understanding of trial results. DesignQualitative. SettingOf the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. ParticipantsAll participants from these centres were eligible. All 343 participants were sent questionnaires. Primary and secondary outcome measuresThe low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. ResultsAll 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. ConclusionsThe low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

Case stories in general practice: a focus group study [RESEARCH]

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

ObjectivesTo explore the interactive process of sharing case stories in small-group activity in general practice. DesignQualitative focus group study. SettingPeer-group meetings of doctors attending specialist training or continuous medical education in general practice. ParticipantsTwenty female and 30 male doctors working in general practice in Norway. ResultsThe storyline of case presentations included detailed stories with emotional engagement, co-authored by other group members. The stories initiated discussions and reflections concerning patients' and doctors' perspectives, medical ethics as well as clinical problems. The safe atmosphere allowed testing out boundaries of socially shared knowledge. ConclusionsSharing case stories in small groups in general practice initiated interaction that facilitated meaning-making, reflection and peer support.

What potential research participants want to know about research: a systematic review [RESEARCH]

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

ObjectiveTo establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES). Data sourcesMedline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis index's, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors. Study selectionOriginal research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included. Study appraisal and synthesis methodsStudies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet. Results14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items. ConclusionsThere is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and a more tailored evidence-based approach may be necessary.

The tip of an iceberg? A cross-sectional study of the general public's experiences of reporting healthcare complaints in Stockholm, Sweden [RESEARCH]

Wed, 15 Feb 2012 00:00:00 +0000

ObjectivesTo investigate the hypothesis that complaints of adverse events related to encounters with healthcare personnel are underreported and to identify barriers to filing such complaints. DesignA cross-sectional study, where a questionnaire was sent to the respondents asking whether or not they have filed complaints of adverse events. Respondents were also asked whether they have had reasons for doing so but abstained, and if so their reasons for not complaining. The authors also asked about participants' general experience of and trust in healthcare. SettingThe County of Stockholm, Sweden. ParticipantsA random sample of 1500 individuals of the general population registered by the Swedish National Tax Board as living in the County of Stockholm in April 2008. Of the selected group, aged 18-99 years, 50% were women and 50% men. Response rate was 62.1%, of which 58% were women and 42% were men; the median age was 49 years. Primary and secondary outcome measuresPrimary outcome measures were whether the participants have filed a formal complaint with the Patients' Advisory Committee and whether they have had reason to file a complaint but have refrained from doing so. Secondary outcome measures were the participants' general experience of and trust in healthcare. ResultsOfficial complaints have been filed by 23 respondents (2.7%, 95% CI 1.7% to 3.7%), while 159 (18.5%, 95% CI 15.9% to 21.1%) stated that they have had legitimate reasons to file a complaint but have abstained (p<0.001). The degree of under-reporting was greater among patients with a general negative experience of healthcare (37.3%, 95% CI 31.9% to 42.7%) compared with those with a general positive experience (4.8%, 95% CI 2.4% to 7.2%). The reasons given for abstaining were, among others, I did not have the strength', I did not know where to turn' and It makes no difference anyway'. Respondents with a general negative experience also had lower trust in healthcare. ConclusionsThe authors found a considerable discrepancy between the actual complaint rate and the number of respondents stating that they have had reasons to complain but have abstained. This indicates that in official reports of complaints, the authors only see the tip of an iceberg'.

Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis [RESEARCH]

Sun, 27 Nov 2011 00:00:00 +0000

ObjectivesTo evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials. MethodsRandomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http://ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. ConclusionThe quality of registration of randomised controlled trials still needs improvement.

Respectful encounters and return to work: empirical study of long-term sick-listed patients' experiences of Swedish healthcare [RESEARCH]

Sun, 27 Nov 2011 00:00:00 +0000

AimsTo study long-term sick-listed patients' self-estimated ability to return to work after experiences of healthcare encounters that made them feel either respected or wronged. MethodsA cross-sectional and questionnaire-based survey was used to study a sample of long-term sick-listed patients (n=5802 respondents). The survey included questions about positive and negative encounters as well as reactions to these encounters, such as feeling respected' and feeling wronged'. The questionnaire also included questions about the effects of these encounters on the patients' ability to return to work. ResultsAmong patients who had experienced positive encounters, those who also felt respected (n=3327) demonstrated significantly improved self-estimated ability to return to work compared to those who did not feel respected (n=79) (62% (95% CI 60% to 64%) vs 34% (95% CI 28% to 40%)). Among patients with experiences of negative encounters, those who in addition felt wronged (n=993) claimed to be significantly more impeded from returning to work compared to those who did not feel wronged (n=410) (50% (95% CI 47% to 53%) vs 31% (95% CI 27% to 35%)). ConclusionsThe study indicates that positive encounters in healthcare combined with feeling respected significantly facilitate sickness absentees' self-estimated ability to return to work, while negative encounters combined with feeling wronged significantly impair it.

A survey on self-assessed well-being in a cohort of chronic locked-in syndrome patients: happy majority, miserable minority [RESEARCH]

Fri, 2 Sep 2011 00:00:00 +0000

ObjectivesLocked-in syndrome (LIS) consists of anarthria and quadriplegia while consciousness is preserved. Classically, vertical eye movements or blinking allow coded communication. Given appropriate medical care, patients can survive for decades. We studied the self-reported quality of life in chronic LIS patients. Design168 LIS members of the French Association for LIS were invited to answer a questionnaire on medical history, current status and end-of-life issues. They self-assessed their global subjective well-being with the Anamnestic Comparative Self-Assessment (ACSA) scale, whose +5 and -5 anchors were their memories of the best period in their life before LIS and their worst period ever, respectively. Results91 patients (54%) responded and 26 were excluded because of missing data on quality of life. 47 patients professed happiness (median ACSA +3) and 18 unhappiness (median ACSA -4). Variables associated with unhappiness included anxiety and dissatisfaction with mobility in the community, recreational activities and recovery of speech production. A longer time in LIS was correlated with happiness. 58% declared they did not wish to be resuscitated in case of cardiac arrest and 7% expressed a wish for euthanasia. ConclusionsOur data stress the need for extra palliative efforts directed at mobility and recreational activities in LIS and the importance of anxiolytic therapy. Recently affected LIS patients who wish to die should be assured that there is a high chance they will regain a happy meaningful life. End-of-life decisions, including euthanasia, should not be avoided, but a moratorium to allow a steady state to be reached should be proposed.

Factors influencing the inclusion of complementary and alternative medicine (CAM) in undergraduate medical education [RESEARCH]

Fri, 2 Sep 2011 00:00:00 +0000

ObjectiveTo investigate the views and practices of UK medical schools regarding the inclusion (or exclusion) of complementary and alternative medicine (CAM) in undergraduate medical curricula. DesignSurvey (by email) of UK medical schools offering MBBS (or equivalent) degrees. ResultsThe overall response rate was 58.1% (18/31). All respondents indicated that their curricula included CAM elements. However, the quantity of CAM within curricula varied widely between medical schools, as did the methods by which CAM education was delivered. General Medical Council requirements were the strongest factor influencing the inclusion of CAM, although medical student preferences were also important. Respondents were generally satisfied with the extent of CAM provision within their curricula, while a wide range of views on the appropriateness of CAM in the medical curriculum were held by faculty members. ConclusionsIt may be useful for the General Medical Council to clarify the extent to which CAM should be incorporated into the curriculum. Current CAM education appears to exist primarily as a means of educating future doctors on the modalities that their patients may use or request. However, some forms of pedagogy arguably risk students assimilating CAM advocacy in an uncritical fashion.

Fate of manuscripts rejected by a non-English-language general medical journal: a retrospective cohort study [RESEARCH]

Fri, 2 Sep 2011 00:00:00 +0000

ObjectiveThe objective of this study was to determine whether, where and when manuscripts were published following rejection by the Journal of the Danish Medical Association, a general medical journal published in Danish. Similar previous studies have focused on specialty/subspecialty journals published in English. DesignManuscripts rejected during a 4-year period were searched for in PubMed and Embase in order to assess the percentage of manuscripts subsequently published in other journals. In addition, characteristics of both the published manuscripts and the journals in which they were evaluated. ResultsOf 198 rejected manuscripts, 21 (10.6%) were eventually published after a median of 685 days (range 209-1463). The majority of these were original research, published in English-language specialty/subspecialty journals. The median number of citations per article was 2-3 (IQR 0.5-9.5, depending on the database searched). Conclusions10.6% of the rejected manuscripts were eventually published in other journals, mainly English-language specialty journals. This proportion was considerably lower than that for other journals that have studied the fate of rejected manuscripts. Manuscript translation could be a barrier for resubmitting to English-language journals with larger readerships, thus hindering the dissemination of knowledge to the international community.