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Diana Elbourne

Publications and source records attributed to Diana Elbourne.

At least 19 recordsLinked to original sources
PubMed2006

CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure.

BACKGROUND: An estimated 350 adults develop severe, but potentially reversible respiratory failure in the UK annually. Current management uses intermittent positive pressure ventilation, but barotrauma, volutrauma and oxygen toxicity can prevent lung recovery. An alternative treatment, extracorporeal membrane oxygenation, uses cardio-pulmonary bypass technology to temporarily provide gas exchange, allowing ventilator settings to be reduced. While extracorporeal membrane oxygenation is proven to result in improved outcome when compared to conventional ventilation in neonates with severe respiratory failure, there is currently no good evidence from randomised controlled trials to compare these managements for important clinical outcomes in adults, although evidence from case series is promising. METHODS/DESIGN: The aim of the randomised controlled trial of Conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR) is to assess whether, for patients with severe, but potentially reversible, respiratory failure, extracorporeal membrane oxygenation will increase the rate of survival without severe disability ('confined to bed' and 'unable to wash or dress') by six months post-randomisation, and be cost effective from the viewpoints of the NHS and society, compared to conventional ventilatory support. Following assent from a relative, adults (18-65 years) with severe, but potentially reversible, respiratory failure (Murray score >/= 3.0 or hypercapnea with pH < 7.2) will be randomised for consideration of extracorporeal membrane oxygenation at Glenfield Hospital, Leicester or continuing conventional care in a centre providing a high standard of conventional treatment. The central randomisation service will minimise by type of conventional treatment centre, age, duration of high pressure ventilation, hypoxia/hypercapnea, diagnosis and number of organs failed, to ensure balance in key prognostic variables. Extracorporeal membrane oxygenation will not be available for patients meeting entry criteria outside the trial. 180 patients will be recruited to have 80% power to be able to detect a one third reduction in the primary outcome from 65% at 5% level of statistical significance (2-sided test). Secondary outcomes include patient morbidity and health status at 6 months. DISCUSSION: Analysis will be based on intention to treat. A concurrent economic evaluation will also be performed to compare the costs and outcomes of both treatments.

Adolescent↗
PubMed2006

Comparison of the effectiveness of trauma services provided by secondary and tertiary hospitals in Malaysia.

STUDY OBJECTIVE: The trauma services provided by 6 hospitals operating at 2 levels of care (4 secondary or district general hospitals and 2 tertiary care hospitals) in Malaysia are compared in terms of mortality and disability for direct admissions to emergency departments to test the hypothesis that care at a tertiary care hospital is better than at a district general hospital. METHODS: All cases were recruited prospectively for 1 year. The hospitals were purposefully selected as typical for Malaysia. There are 3 primary outcome measures: death, musculoskeletal impairment, and disability at discharge. Adjustment was made for potential covariates and within-hospital clustering by using multivariable random-effects logistic regression analysis. RESULTS: For direct admissions, logistic-regression-identified odds of dying were associated with older age (>55 years), odds ratio (OR) 1.9 (95% confidence interval [CI] 1.3 to 2.8); head injury, OR 2.7 (95% CI 1.9 to 3.9); arrival by means other than ambulance, OR 0.6 (95% CI 0.4 to 0.8); severe injuries (Injury Severity Score >15) at a district general hospital, OR 45.2 (95% CI 27.0 to 75.7); severe injuries at a tertiary care hospital, OR 11.2 (95% CI 7.3 to 17.3); and admission to a tertiary care hospital compared to a district general hospital if severely injured (Injury Severity Score >15), OR 0.2 (95% CI 0.1 to 0.4). Admission to a tertiary care hospital was associated with increased odds of disability (OR 1.9; 95% CI 1.5 to 2.3) and musculoskeletal impairment (OR 3.5; 95% CI 2.7 to 4.4) at discharge. CONCLUSION: Care at a tertiary care hospital was associated with reduced mortality (by 83% in severe injuries), but with a higher likelihood of disability and impairment, which has implications for improving access to trauma services for the severely injured in Malaysia and other low- and middle-income settings.

Adult↗
PubMed2006

Informed consent in clinical trials in critical care: experience from the PAC-Man Study.

OBJECTIVES: To identify the proportion of critically ill patients able to consent to participation in a randomised controlled trial (RCT) and to assess to what extent patient consent and relative assent processes could be conducted according to ethics committee permission. DESIGN: Descriptive study nested in an RCT. SETTING: Fifty-six UK intensive care units participating in the PAC-Man trial. PATIENTS AND PARTICIPANTS: First 500 patients consecutively enrolled into PAC-Man. MEASUREMENT AND RESULTS: The outcome measures were patient consent and/or relative assent. Of the 498 patients included, 13 (2.6%) provided consent before randomisation. Of the remaining 485 patients, relative assent was obtained for 394 patients (81.2%), and refused post-randomisation for 3 patients (0.6%). No relatives were available for 15 patients (3.1%), and it was unclear from documentation whether relative assent had been obtained for 73 patients (15.1%). Of the 482 patients who did not provide consent prior to randomisation, 188 (39%) survived. Of these, 175 (93.1%) gave retrospective informed consent, six (3.2%) refused, and seven (3.7%) did not regain mental competency. CONCLUSIONS: A very small proportion of patients were able to give consent before randomisation. Due to the high in-hospital mortality (60.6%), only around one third of the remaining patients could provide consent retrospectively. This study demonstrates difficulties experienced in obtaining consent from critically ill patients to participate in medical research and raises important issues about the ethical basis of the consent process in critical care.

Critical Care↗
PubMed2006

A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People And n-3 Long-chain polyunsaturated fatty acids (OPAL) study protocol [ISRCTN72331636].

The number of individuals with age-related cognitive impairment is rising dramatically in the UK and globally. There is considerable interest in the general hypothesis that improving the diet of older people may slow the progression of cognitive decline. To date, there has been little attention given to the possible protective role of n-3 long-chain polyunsaturated fatty acids (n-3 LCPs) most commonly found in oily fish, in age-related loss of cognitive function. The main research hypothesis of this study is that an increased dietary intake of n-3 LCPs will have a positive effect on cognitive performance in older people in the UK. To test this hypothesis, a double-blind randomised placebo-controlled trial will be carried out among adults aged 70-79 years in which the intervention arm will receive daily capsules containing n-3 LCP (0.5 g/day docosahexaenoic acid and 0.2 g/day eicosapentaenoic acid) while the placebo arm will receive daily capsules containing olive oil. The main outcome variable assessed at 24 months will be cognitive performance and a second major outcome variable will be retinal function. Retinal function tests are included as the retina is a specifically differentiated neural tissue and therefore represents an accessible window into the functioning of the brain. The overall purpose of this public-health research is to help define a simple and effective dietary intervention aimed at maintaining cognitive and retinal function in later life. This will be the first trial of its kind aiming to slow the decline of cognitive and retinal function in older people by increasing daily dietary intake of n-3 LCPs. The link between cognitive ability, visual function and quality of life among older people suggests that this novel line of research may have considerable public health importance.

Aged↗
PubMed2006

United Kingdom collaborative randomized trial of neonatal extracorporeal membrane oxygenation: follow-up to age 7 years.

OBJECTIVE: The UK Collaborative ECMO trial provided an opportunity to describe mortality and morbidity associated with a neonatal ECMO policy compared with conventional management. The improved survival in the ECMO group was not offset by an increase in disability at 4 years, but the children were too young to assess educational and other longer-term impacts. The objective of this study was to assess the longer-term impact of these policies at age 7 years. METHODS: A psychologist assessed 90 of the 100 children available for follow-up without prior knowledge of treatment allocation. The assessments took place at the children's schools within 3 months of their 7th birthdays. RESULTS: Sixty-eight of 89 (76%) children recorded a cognitive level within the normal range. Learning problems were similar in the 2 groups, and there were notable difficulties with spatial and processing tasks. A higher respiratory morbidity and increased risk of behavioral problems among children treated conventionally persisted. Progressive sensorineural hearing loss was found in both groups. CONCLUSIONS: The underlying disease processes appear to be the major influence on morbidity at 7 years. The beneficial influence of an ECMO policy is still present at 7 years.

Child↗
PubMed2006

A brief measure of perceived understanding of informed consent in a clinical trial was validated.

BACKGROUND AND OBJECTIVE: To develop and evaluate an Informed Consent Questionnaire (ICQ) for measuring self-reported perceived understanding of informed consent in a randomized clinical trial. METHODS: The study was embedded in a Department of Veterans Affairs randomized clinical trial of Gulf War veterans' illnesses (CSP#470). The trial was initiated in May 1999 at 20 hospitals and concluded in September 2001; 1,092 participants were enrolled and followed for 12 months. The reliability and validity sample included 1,086 participants evaluated at baseline, 906 at 3 months, 929 at 6 months, and 910 at 12 months. The psychometric evaluations included tests of acceptability (based on missing data, endorsement frequencies, and floor/ceiling effects), item reduction, internal consistency, and construct validity (based on Cronbach's alpha coefficients, item-total correlations, and principal components analysis). RESULTS: The ICQ had >5% missing information on some questions at baseline, indicating poor acceptability prior to the initiation of the trial; however, the scale had good acceptability at each of the follow-up visits. Psychometric evaluation following standard item reduction techniques confirmed the reliability and validity of a four-item subscale of the ICQ (ICQ-4). CONCLUSIONS: The ICQ-4 is a simple and psychometrically sound self-report measure of perceived understanding of informed consent.

Adult↗
PubMed2006

Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: the way forward.

OBJECTIVE: To evaluate the quality of reporting of randomized controlled trials in cardiothoracic surgery, to identify factors associated with good reporting quality, and to assess the awareness of the Consolidated Standards for Reporting of Trials statement and ascertain the views of authors reporting randomized controlled trials on the difficulties in conducting randomized controlled trials and the possible ways to further improve the reporting quality of randomized controlled trials in cardiothoracic surgery. METHODS: Randomized controlled trials of cardiothoracic surgery published in principal cardiothoracic and 4 general medical journals in 2003 were included. The quality of reporting of randomized controlled trials was assessed by using allocation concealment, the Jadad score, and a Consolidated Standards for Reporting of Trials checklist devised for the purpose. A questionnaire survey of authors reporting randomized controlled trials in principal cardiothoracic journals in 2003 was conducted. RESULTS: The overall reporting quality of the 64 randomized controlled trials included in the analysis was suboptimal as assessed by the 3 methods adopted. Most of the authors (63.5%) were not aware of the Consolidated Standards for Reporting of Trials statement; however, awareness was not associated with reporting quality. More than 65% of the authors responded that conducting randomized controlled trials in surgical specialties was difficult, and the main difficulties were blinding and obtaining a large-enough sample size to detect statistically significant differences. Fifty-four percent of the authors responded that endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the reporting quality. CONCLUSIONS: The quality of reporting randomized controlled trials in cardiothoracic surgery is suboptimal. Endorsement of the Consolidated Standards for Reporting of Trials statement by the cardiothoracic journals may improve the quality of reporting.

Humans↗
PubMed2006

Standards of reporting of randomized controlled trials in general surgery: can we do better?

OBJECTIVE: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. SUMMARY BACKGROUND DATA: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. METHODS: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. RESULTS: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of > or =3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). CONCLUSION: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology.

General Surgery↗
PubMed2006

Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding.

BACKGROUND: Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation. METHODS: The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a 'parent' randomized controlled trial of 1092 participants with Gulf War veterans' illnesses recruited in 1999-2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol. RESULTS: There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from +0.020 (-0.015, 0.055) (better understanding) at entry to -0.021 (-0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial. LIMITATIONS: The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation. CONCLUSIONS: Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study.

Adult↗
PubMed2006

Cost-effectiveness of neonatal extracorporeal membrane oxygenation based on 7-year results from the United Kingdom Collaborative ECMO Trial.

OBJECTIVE: To assess the long-term cost-effectiveness of extracorporeal membrane oxygenation (ECMO) for mature newborn infants with severe respiratory failure. METHODS: A prospective economic evaluation was conducted alongside a pragmatic randomized, controlled trial in which 185 infants were randomly allocated to ECMO (n = 93) or conventional management (n = 92) and then followed up to 7 years of age. Information about their use of health services during the follow-up period was combined with unit costs (pound sterling, 2002-2003 prices) to obtain a net cost per child. The cost-effectiveness of neonatal ECMO was expressed in terms of incremental cost per additional life year gained and incremental cost per additional disability-free life year gained. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics at alternative willingness-to-pay thresholds held by decision-makers for an additional life year and for an additional disability-free life year. RESULTS: Over 7 years, neonatal ECMO was effective at reducing known death or severe disability. Mean health service costs during the first 7 years of life were 30,270 pound sterling in the ECMO group and 10,229 pound sterling in the conventional management group, generating a mean cost difference of 20,041 pound sterling that was statistically significant. The incremental cost per life year gained was estimated at 13,385 pound sterling. The incremental cost per disability-free life year gained was estimated at 23,566 pound sterling. At the notional willingness-to-pay threshold of 30,000 pound sterling for an additional life year, the probability that neonatal ECMO is cost-effective at 7 years was estimated at 0.98. This translated into a mean net benefit of 24,362 pound sterling for each adoption of neonatal ECMO rather than conventional management. CONCLUSIONS: This study provides rigorous evidence of the cost-effectiveness of neonatal ECMO during childhood.

Child↗
PubMed2005

"It was a snap decision": parental and professional perspectives on the speed of decisions about participation in perinatal randomised controlled trials.

For some perinatal trials, parents can be asked to make important decisions about trial participation within limited timeframes in highly stressful circumstances. This qualitative study explores the pace of decision-making for 78 parents associated with one or more of four such trials in the UK. The themes associated with rapid decisions were concern for their baby, reactions to staff, and perceptions of the benefits and risks associated with the trial. Those who took longer to decide whether or not to participate often described similar emotions to those who made rapid decisions, but their slower decisions were because more time was available, they wanted further discussion or they found the decision particularly difficult. The majority of those who made rapid decisions felt that there were no risks associated with the trial in question, in contrast to the majority of those who made slower decisions who felt there were risks. The parents did not appear to view rapid decisions as problematic. Although there was evidence of parental vulnerability in each trial context, they largely felt that they acted swiftly and responsibly in the best interests of their child in accordance with the timeframes that were set for them.

Decision Making↗
PubMed2005

Assessing subgroup effects with binary data: can the use of different effect measures lead to different conclusions?

BACKGROUND: In order to use the results of a randomised trial, it is necessary to understand whether the overall observed benefit or harm applies to all individuals, or whether some subgroups receive more benefit or harm than others. This decision is commonly guided by a statistical test for interaction. However, with binary outcomes, different effect measures yield different interaction tests. For example, the UK Hip trial explored the impact of ultrasound of infants with suspected hip dysplasia on the occurrence of subsequent hip treatment. Risk ratios were similar between subgroups defined by level of clinical suspicion (P = 0.14), but odds ratios and risk differences differed strongly between subgroups (P < 0.001). DISCUSSION: Interaction tests on different effect measures differ because they test different null hypotheses. A graphical technique demonstrates that the difference arises when the subgroup risks differ markedly. We consider that the test of interaction acts as a check on the applicability of the trial results to all included subgroups. The test of interaction should therefore be applied to the effect measure which is least likely a priori to exhibit an interaction. We give examples of how this might be done. SUMMARY: The choice of interaction test is especially important when the risk of a binary outcome varies widely between subgroups. The interaction test should be pre-specified and should be guided by clinical knowledge.

Data Interpretation, Statistical↗
PubMed2005

Data monitoring in randomized controlled trials: surveys of recent practice and policies.

BACKGROUND: Data Monitoring Committees (DMCs) are increasingly involved in the conduct of randomized controlled trials, but there is little documented evidence of what they do. Three interlinked surveys were carried out as part of the DAMOCLES project to explore recent and current DMC practice and policy. METHODS: 1) A questionnaire about DMC practice was sent to sample of 45 authors of trials published in selected journals in 2000. The sample was stratified by centre (single/multiple), disease area, and presence of DMC. 2) A sample of investigators in trials ongoing in the United Kingdom in 2001-02 was also sent a questionnaire about DMC practice. The sample was drawn from trials funded by the Medical Research Council, the United Kingdom Department of Health's Health Technology Assessment Programme, and a local and a multicentre research ethics committee. The sample was additionally stratified by funder (public/industry), centre (single/ multiple), and disease area. 3) A sample of major organisations involved in randomised controlled trials was sent a questionnaire about DMC policies. RESULTS: Information about DMC practice from the first survey was obtained from 31 trials (69%), of which four had a DMC. Information about DMC practice from the second survey was obtained about 36 trials (90%), of which 20 had a DMC. Information about DMC policy from the third survey was obtained from 25 out of 25 organisations. There was general agreement about the sorts of trials particularly needing independent DMCs, but there were few uniform approaches to their modes of functioning, and few of the organisations surveyed had developed formal policies. CONCLUSIONS: The roles of existing DMCs and policies governing DMC functioning vary widely across trials and organisations that sponsor or oversee trials, both within the UK and internationally. These findings reinforce previous calls for development of such policies across a wider range of organisations, better means to monitor their implementation within trials, and wider use of structured "charters", which set out DMC modus operandi in advance. Clinical Trials 2005; 2: 22-33. www.SCTjournal.com

Clinical Trials Data Monitoring Committees↗
PubMed2005

Project 27/28: inquiry into quality of neonatal care and its effect on the survival of infants who were born at 27 and 28 weeks in England, Wales, and Northern Ireland.

OBJECTIVE: To identify variations in standards of neonatal care in the first week of life that might have contributed to deaths in infants who were born at 27 and 28 weeks' gestation. METHODS: A case-control study was conducted of infants who were born at 27 and 28 weeks' gestation in England, Wales, and Northern Ireland during a 2-year period. Cases were neonatal deaths; control subjects were randomly selected survivors at day 28. Main outcome measures were failures of prespecified standards of care or deficiencies in care reported by regional panels assessing anonymized medical records. RESULTS: Failures of standards of care relating to ventilatory support (adjusted odds ratio [OR]: 3.29; 95% confidence interval [CI]: 1.97-5.49), cardiovascular support (OR: 2.37; 95% CI :1.36-4.13), and thermal care (OR: 1.71; 95% CI: 1.21-2.43) were associated with neonatal death. Frequencies of unmet resuscitation standards (range: 3%-46%) and of delays in surfactant administration (range: 38%-40%) were similar in cases and control subjects. Panels identified significantly more deficiencies in all aspects of neonatal care in cases with the exception of the management of infection. Stratification by clinical condition of infants at birth showed a stronger association between overall standard of care and death when infants were in a good condition at birth. CONCLUSIONS: Our findings suggest an association between quality of neonatal care and neonatal deaths, most marked for early thermal care and ventilatory and cardiovascular support. Poor overall quality of care was more strongly associated with deaths when the infant was in a good condition at birth.

Case-Control Studies↗
PubMed2005

Economic evaluation of ultrasonography in the diagnosis and management of developmental hip dysplasia in the United Kingdom and Ireland.

BACKGROUND: Clinical neonatal hip screening is performed to identify hip instability and the increased risk of later hip subluxation and dislocation. However, there is minimal information regarding the costs of such screening to parents and health services. The aim of this study was to assess these costs in association with the use of ultrasonography for the diagnosis and management of neonatal hip instability. METHODS: We conducted a prospective economic analysis in conjunction with a randomized clinical trial (the Hip Trial), for which 629 patients were recruited from thirty-three centers in the United Kingdom and Ireland to be randomized to undergo either ultrasonographic hip examination (314 patients) or clinical assessment alone (315 patients). Information on clinical outcomes was obtained from hospital records and records from the Hip Trial. Resource information was obtained from hospital records and from repeated periodic cross-sectional surveys of the families. Typical unit costs were applied to resource information to obtain a cost per patient, and the mean costs in the two study groups were calculated and compared. RESULTS: The average overall health-service cost per patient (and standard deviation) was $1298 +/- $2168 in the ultrasonography group and $1488 +/- $2912 in the group that underwent clinical assessment alone, a net difference of -$190 (95% confidence interval, -$630 to $250). Families in which the infant was examined with ultrasonography had significantly lower costs associated with splinting: $92 compared with $118 in the group that underwent clinical assessment alone, a mean difference of -$26 (95% confidence interval, -$46 to -$6). Costs associated with surgery and total costs to the family were also slightly, but not significantly, lower in the ultrasonography group. CONCLUSIONS: Our results suggest that use of ultrasonography in the management of neonates with clinical hip instability is unlikely to impose an increased cost burden and may reduce costs to health services and families.

Health Care Costs↗
PubMed2004

Equipoise: a case study of the views of clinicians involved in two neonatal trials.

BACKGROUND: It is considered to be a fundamental ethical premise of human experimentation, that it should be carried out only where the effects of an intervention are unclear. The point at which it is considered that there is insufficient scientific and medical evidence to clearly state the superiority of an intervention has been termed equipoise. This concept has been the subject of much recent impassioned debate but little empirical research about the views of people involved in recruitment to randomized controlled trials (RCTs), and none in the particularly emotive area of neonatal intensive care. METHODS: Thirty neonatologists recruiting into one or both of two neonatal RCTs in five centres in England were interviewed using a semi-structured schedule to explore their involvement in randomised trials. The interviews were tape-recorded and transcribed. Equipoise was one among a range of topics covered. Concepts relating to equipoise were identified by close reading of the entire interviews. Themes emerging from the data were noted in their contexts then discussed between the co-authors. Interviewees also completed a brief questionnaire about their demographic background, and their experience of research and RCTs. RESULTS: Almost all the neonatologists used the concept of equipoise [using words and phrases such as uncertainty, lack of knowledge (or ignorance), strengths of views, and balancing of pros and cons] in their interview and, for most of them, equipoise seemed to be a useful term. They explored ideas about equipoise at the individual and community levels, and some linked equipoise with notions of the responsibility that should be exercised by the scientific and professional communities. They differed in the importance they gave to individual equipoise, and in how they reacted to threats to equipoise. Feelings of doubt about a trial and disturbed equipoise were more often expressed by more junior doctors. CONCLUSIONS: Our findings suggest that the concept of equipoise goes beyond the idea of uncertainty. In part this is because it includes the balancing of benefit and harm; this balancing is part of a professional obligation and requires engagement with 'expert' knowledge. Equipoise could therefore be seen as 'active' or 'responsible' uncertainty. Elucidation of this difficult concept may help to facilitate recruitment for both clinicians and parents in future trials and thereby help to find answers to important clinical questions.

Adult↗
PubMed2003

The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial.

BACKGROUND: The aim of this article is to explore ways in which selection bias and ascertainment bias can be reduced and investigated in trials, by using the example of a drug trial carried out in both developed and developing countries in hospital delivery wards. METHODS: We describe an innovative and practical design for the boxes for packing the drugs as a way of increasing the security of allocation concealment and blinding. We also assess ascertainment bias using sensitivity analyses, as some unblinding could have occurred due to a potential side effect of one of the drugs. RESULTS: The sensitivity analyses indicated that the conclusions about the relative effects of the treatments could be maintained even in the unlikely worst-case scenarios. CONCLUSIONS: Detailed description of the procedures protecting against common biases and of the assessment of ascertainment bias in this trial should allow readers to confidently appraise and interpret the results obtained. In addition, our experiences will assist others in planning trials in the future.

Developed Countries↗