Biobank-based research is growing in importance. A major controversy exists about the return of aggregate and individual research results.
The authors used a mixed-method approach in order to study parents' attitudes towards the return of research results regarding themselves and their children. Participants attended four 2-h, deliberative-engagement sessions held on two consecutive Saturdays. Each session consisted of an educational presentation followed by focus-group discussions with structured questions and prompts. This manuscript examines discussions from the second Saturday which focused on the benefits and risks of returning aggregate and individual research results regarding both adults (morning session) and children (afternoon session). Attitudes were assessed in pre-engagement and post-engagement surveys.
The authors recruited 45 African-American adults whose children received medical care at two healthcare facilities on the South Side of Chicago that serve different socioeconomic communities. Three dominant themes were identified. First, most participants stated that they would enrol themselves and their children in a biobank, although there was a vocal minority opposed to enrolling children, particularly children unable to participate in the consent process. Second, participants did not distinguish between the results they wanted to receive regarding themselves and their children. Supplemental survey data found no attitudinal changes pre-engagement and post-engagement. Third, participants believed that children should be allowed access to their health information, but they wanted to be involved in deciding when and how the information was shared.
Participant attitudes are in tension with current biobank policies. An intensive educational effort had no effect on their attitudes.
US data reveal a Caesarean rate discrepancy between insured and uninsured patients, with the C-section rate highest among the privately insured. The data have prompted concern that financial incentives associated with insurance status might influence American physicians' decisions to perform Caesarean deliveries.
To determine whether differences in medical risk factors account for the apparent Caesarean rate discrepancy between Medicaid and privately insured patients in Michigan, USA.
A retrospective review was performed of 617 269 live birth deliveries in Michigan hospitals during 2004–8. All live birth records that were able to be linked to their mothers' hospital discharge records were utilised. Diagnosis-related group codes from the hospitalisation records were used to identify Caesarean deliveries. Regression models determined Caesarean probability for the time period under study, adjusted for insurance type, maternal age, race, maternal medical conditions, multiple births, prematurity and birth weight.
From 2004 to 2008, Caesarean rates were 33% for privately insured patients and 29% for Medicaid patients. The probability of Caesarean delivery was significantly greater for privately insured than Medicaid patients on univariate analysis (OR 1.2, 95% CI 1.19 to 1.22) but not on multivariate analysis (adjusted OR 1.01, 95% CI 0.99 to 1.02).
No significant disparity was found in the odds of Caesarean delivery between privately insured and Medicaid patients in Michigan after adjusting for other Caesarean risk factors. A positive disparity would have provided de facto evidence that financial incentives play a role in physician decision-making regarding Caesarean delivery.
Medical futility at the end of life is a growing challenge to medicine. The goals of the authors were to elucidate how clinicians define futility, when they perceive life-sustaining treatment (LST) to be futile, how they communicate this situation and why LST is sometimes continued despite being recognised as futile.
The authors reviewed ethics case consultation protocols and conducted semi-structured interviews with 18 physicians and 11 nurses from adult intensive and palliative care units at a tertiary hospital in Germany. The transcripts were subjected to qualitative content analysis.
Futility was identified in the majority of case consultations. Interviewees associated futility with the failure to achieve goals of care that offer a benefit to the patient's quality of life and are proportionate to the risks, harms and costs. Prototypic examples mentioned are situations of irreversible dependence on LST, advanced metastatic malignancies and extensive brain injury. Participants agreed that futility should be assessed by physicians after consultation with the care team. Intensivists favoured an indirect and stepwise disclosure of the prognosis. Palliative care clinicians focused on a candid and empathetic information strategy. The reasons for continuing futile LST are primarily emotional, such as guilt, grief, fear of legal consequences and concerns about the family's reaction. Other obstacles are organisational routines, insufficient legal and palliative knowledge and treatment requests by patients or families.
Managing futility could be improved by communication training, knowledge transfer, organisational improvements and emotional and ethical support systems. The authors propose an algorithm for end-of-life decision making focusing on goals of treatment.
There has been significant discussion about the need to manage conflict of interest (COI) in medical journals. This has lead many journals to implement policies to manage COI for authors and reviewers; however, surprisingly little attention has been focused on the COI of journal editors.
The goal of this exploratory study was to determine whether the policies were accessible to the public and to researchers, and to discuss the potential impact on public transparency.
The authors conducted an internet search of editor COI policy instruments that have been developed, implemented and communicated by the top 10 peer-reviewed medical journals (2010 ISI Web of Knowledge Impact Factor), and assessed their general accessibility by gauging the level of difficulty in navigating the journal's website (number of clicks to find the policy instruments).
Only four of the 10 medical journals (40%) in this study have accessible COI policy directives that include editors (JIM, PLoS Medicine, AIM, CMAJ). One journal (NEJM) had an editorial on the subject, and another (The Lancet) mentioned editor COI in their general guidelines. These documents are not readily accessible; starting from the journal's main website at least four clicks are needed to access these documents.
These results suggest that there is a general lack of accessible editor COI policy instruments among leading medical journals, something that may consequently have a negative impact on the trust accorded to these journals.
Obtaining informed consent in the clinical setting is an important yet challenging aspect of providing safe and collaborative care to patients. While the medical profession has defined best practices for obtaining informed consent, it is unclear whether these standards meet the expressed needs of patients, their families as well as healthcare providers. The authors sought to address this gap by comparing the responses of these three groups with a standardised informed consent paradigm.
Piloting a web-based ‘reverse’ simulation paradigm, participants viewed a video showing a standardised doctor engaging in an informed consent discussion. The scenario depicted a simulated patient with psychotic symptoms who is prescribed an atypical antipsychotic medication. 107 participants accessed the simulation online and completed a web-based debriefing survey.
Survey responses from patients, family members and healthcare providers indicated disparities in information retention, perception of the doctor's performance and priorities for required elements of the consent process.
To enhance existing informed consent best practices, steps should be taken to improve patient retention of critical information. Adverse events should be described in the short-term and long-term along with preventative measures, and alternative psychosocial and pharmacological treatment options should be reviewed. Information about treatment should include when the medication takes therapeutic effect and how to safely maintain the treatment. The reverse simulation design is a model that can discern gaps in clinical practice, which can be used to improve patient care.
No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent.
A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm.
The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions.
The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians.
Australian New Zealand Clinical Trials Registry ACTRN12610000332022.
Although medical students all over the world conduct research and write papers, the level of knowledge and attitudes of undergraduate and graduate medical students in developing countries towards the importance and consequences of plagiarism remain unclear.
In this study conducted between August and October 2011, we assessed the attitude of the students of Tehran University of Medical Sciences towards plagiarism.
Seventy undergraduate students (by simple random selection) were selected for a pilot phase of the study. Twenty participants were asked to re-answer the questionnaire after 2 weeks. Two hundred and thirty cases were selected by stratified random sampling method regarding different strata (clerkship: 3rd to 6th...]]>
Doctors generally do not discuss the way drugs are manufactured, the source of raw materials and the process of labelling, packing and transport of the drugs for the use of consumers.
A close scrutiny of the process of manufacturing medicinal drugs and chemicals reveals that a significant number of drugs contain animal ingredients (either directly or indirectly).
This research was designed to address the following questions: Current level of physician knowledge about animal ingredients in medicine and the existing rules and regulations about the same. The assumptions and attitudes held by physicians about animal ingredients in medicines. Current practices with respect to the use of medicines containing animal ingredients.
We conducted a cross-sectional survey using self-administered questionnaires distributed to 250 medical professionals.
Of 250 participants, 185 (74%) completed the questionnaire.
Regarding the presence of animal ingredients in medicines, 77% were aware of their presence, while 23% were unaware. Seventy-four per cent thought it was important...]]>
In France, a new payment for performance (P4P) scheme for primary care physicians was introduced in 2009 through the ‘Contract for Improving Individual Practice’ programme. Its objective was to reduce healthcare expenditures while enhancing improvement in guidelines' observance. Nevertheless, in all countries where the scheme was implemented, it raised several concerns in the domain of professional ethics.
To draw out in France the ethical tensions arising in the general practitioner's (GP) profession linked to the introduction of P4P.
Qualitative research using two focus groups: first one with a sample of GPs who joined P4P and second one with those who did not. All collective interviews were recorded and fully transcribed. An inductive analysis of thematic content with construction of categories was conducted. All the data were triangulated.
All participants agreed that conflicts of interest were a real issue, leading to the resurgence of doctor's dirigisme, which could be detrimental for patient's autonomy. GPs who did not join P4P believed that the scheme would lead to patient's selection while those who joined P4P did not. The level of the maximal bonus of the P4P was considered low by all GPs. This was considered as an offense by non-participating GPs, whereas for participating ones, this low level minimised the risk of patient's selection.
This work identified several areas of ethical tension, some being different from those previously described in other countries. The authors discuss the potential impact of institutional contexts and variability of implementation processes on shaping these differences.
Record linkage is a useful tool for health research. Potential benefits aside, its use raises discussions on privacy issues, such as whether a written informed consent for access to health records and linkage should be obtained. The authors aim to systematically review studies that assess consent proportions to record linkage.
8 databases were searched up to June 2011 to find articles which presented consent proportions to record linkage. The screening, eligibility and inclusion of articles were conducted by two independent reviewers. The authors carried out meta-regression, subgroup and sensitivity analyses to assess heterogeneity.
Of the 141 studies identified, only 11 presented empirical consent proportions and were included in the systematic review. The consent proportion varied widely from 39% to 97%. Seven studies presented consent proportions of 88% or higher, one of 72%, and only three presented consented proportion equal to or lower than 53%. None of the studies' characteristics evaluated explained heterogeneity.
The results of this review show that, in general, individuals tend to consent to the use of their data for record linkage, with exceptions in specific populations or minorities. The authors believe that this, as well as the cited literature, lends support to policies that, while keeping relevant ethical controls in place, do not require individual informed consent for each and every study that relies on secondary data.
Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond.
To explore publicly accessible IRB websites for guidance in this area, using summative content analysis.
Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of ‘significant new findings’ (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.
IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.
Decisions on limiting life-sustaining treatment for patients in the vegetative state (VS) are emotionally and morally challenging. In Germany, doctors have to discuss, together with the legal surrogate (often a family member), whether the proposed treatment is in accordance with the patient's will. However, it is unknown whether family members of the patient in the VS actually base their decisions on the patient's wishes.
To examine the role of advance directives, orally expressed wishes, or the presumed will of patients in a VS for family caregivers' decisions on life-sustaining treatment.
A qualitative interview study with 14 next of kin of patients in a VS in a long-term care setting was conducted; 13 participants were the patient's legal surrogates. Interviews were analysed according to qualitative content analysis.
The majority of family caregivers said that they were aware of aforementioned wishes of the patient that could be applied to the VS condition, but did not base their decisions primarily on these wishes. They gave three reasons for this: (a) the expectation of clinical improvement, (b) the caregivers' definition of life-sustaining treatments and (c) the moral obligation not to harm the patient. If the patient's wishes were not known or not revealed, the caregivers interpreted a will to live into the patient's survival and non-verbal behaviour.
Whether or not prior treatment wishes of patients in a VS are respected depends on their applicability, and also on the medical assumptions and moral attitudes of the surrogates. We recommend repeated communication, support for the caregivers and advance care planning.
Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings.
We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data.
This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal.
Standards of care regarding obstetric management of life-threatening anomalies are not defined. It is hypothesised that physicians' management of these pregnancies is variable and influenced by demographic factors.
A questionnaire was mailed to members of the Society of Maternal–Fetal Medicine with valid US addresses assessing obstetric management of both ‘uniformly lethal’ (eg, anencephaly, renal agenesis) and ‘uniformly severe, commonly lethal’ (eg, trisomy 13 and 18) anomalies. Respondents were asked to answer as if not limited by state/institutional restrictions. Fisher's exact or 2 tests were used as appropriate and correction made for multiple comparisons in analyses that were not prespecified.
The response rate was 36% (732/2038). Nearly 100% of respondents discuss termination for both uniformly and commonly lethal anomalies. In continuing pregnancies, with patient request for obstetric non-intervention 99% of providers would comply for either uniformly or commonly lethal anomalies. The majority ‘encourage’ such management, but some were non-directive or discouraged this management. In continuing pregnancies, with patient request for full obstetric intervention the majority of respondents was willing to comply for both uniformly (71%) and commonly (82%) lethal anomalies. While most practitioners ‘discouraged’ full intervention, some were non-directive or encouraged this management. Demographics and severity of anomaly influenced counselling.
Discrepancies exist regarding the management of life-threatening fetal anomalies. Patients may be offered different options based on practitioner demographics. The majority of physicians comply with patient wishes. Differences were noted when comparing the management of lethal with that of severe commonly lethal anomalies, suggesting that practitioners make a distinction when counselling patients.
To provide insights into the students' attitude towards academic integrity and their perspective of academic honesty at Croatian medical schools.
A cross-sectional study using an anonymous questionnaire containing 29 questions on frequency of cheating, perceived seriousness of cheating, perceptions on integrity atmosphere, cheating behaviour of peers and on willingness to report misconduct. Participants were third-year (preclinical) and fifth-year (clinical) students from all four Croatian Schools of Medicine. Outcome measures were descriptive statistical correlates and differences in students' self-reported educational dishonesty, perceptions of cheating behaviour and medical school integrity atmosphere.
Of the 1074 students enrolled in the third and fifth year, 662 (62%) completed the questionnaire. A large proportion of the students (97%) admitted using some method of cheating and 78% admitted engaging in at least one form of misconduct. About 50% had a lenient attitude towards six acts of academic dishonesty. Only 2% reported another student for cheating. Risk factors for cheating were strongly correlated with students' perceptions of peer cheating behaviour, peer approval of cheating, low perception of seriousness of cheating and inappropriate severity level of exams and teaching materials.
Cheating is prevalent in Croatian medical schools and academic dishonesty is seen as acceptable behaviour among numerous future Croatian doctors.