Jamie C. Brehaut

Validation of a Decision Regret Scale

Background. As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions. Methods. A5- item scale was administered to 4 patient groups making different health care decisions. Convergent validity was deter- mined by examining the scales correlation with satisfaction measures, decisional conflict, and health outcome measures. Results. The scale showed good internal consistency (Cronbachs = 0.81 to 0.92). It correlated strongly with decision satisfaction (r = -0.40 to -0.60), decisional conflict (r = 0.31 to 0.52), and overall rated quality of life (r = -0.25 to - 0.27). Groups differing on feelings about a decision also differed on rated regret: F(2, 190) = 31.1, P < 0.001. Regret was greater among those who changed their decisions than those who did not, t(175) = 16.11, P < 0.001. Conclusions. The scale is a useful indicator of health care decision regret at a given point in time.

Reporting Guidelines for Survey Research: An Analysis of Published Guidance and Reporting Practices

Carol Bennett and colleagues review the evidence and find that there is limited guidance and no consensus on the optimal reporting of survey research.

The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials

The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.

Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial

Objective To evaluate the effectiveness of an active strategy to implement the validated Canadian C-Spine Rule into multiple emergency departments. Design Matched pair cluster randomised trial. Setting University and community emergency departments in Canada. Participants 11 824 alert and stable adults presenting with blunt trauma to the head or neck at one of 12 hospitals. Interventions Six hospitals were randomly allocated to the intervention and six to the control. At the intervention sites, active strategies were used to implement the Canadian C-Spine Rule, including education, policy, and real time reminders on radiology requisitions. No specific intervention was introduced to alter the behaviour of doctors requesting cervical spine imaging at the control sites. Main outcome measure Diagnostic imaging rate of the cervical spine during two 12 month before and after periods. Results Patients were balanced between control and intervention sites. From the before to the after periods, the intervention group showed a relative reduction in cervical spine imaging of 12.8% (95% confidence interval 9% to 16%; 61.7% v 53.3%; P=0.01) and the control group a relative increase of 12.5% (7% to 18%; 52.8% v 58.9%; P=0.03). These changes were significant when both groups were compared (P<0.001). No fractures were missed and no adverse outcomes occurred. Conclusions Implementation of the Canadian C-Spine Rule led to a significant decrease in imaging without injuries being missed or patient morbidity. Final imaging rates were much lower at intervention sites than at most US hospitals. Widespread implementation of this rule could lead to reduced healthcare costs and more efficient patient flow in busy emergency departments worldwide. Trial registration Clinical trials NCT00290875.

The health and psychosocial functioning of caregivers of children with neurodevelopmental disorders

Purpose. Children with neurodevelopmental disorders (Neuro) pose complex parenting challenges, particularly if the condition co-occurs with behaviour problems. Such challenges are likely to impact caregiver health and well-being. This study explores the extent to which caregivers of children with both Neuro and behaviour problems differ in their physical and psychosocial outcomes from caregivers of children with either condition or neither condition. Method. The first wave of data collected in the National Longitudinal Survey of Children and Youth in Canada (1994) was used to identify four groups of caregivers of 4-to 11-year-old children: caregivers of children with a Neuro disorder and externalising behaviour problems (Both; n = 414), caregivers of children with a Neuro disorder only (Neuro Only; n = 750), caregivers of children with an externalising behaviour problem only (Ext Only; n = 1067), and caregivers of children with neither health condition (Neither; n = 7236). Results. Caregivers in the Both group were least likely to report excellent or very good health, and more frequently reported chronic conditions such as asthma, arthritis, back problems, migraine headaches, and limitations in activities as compared to the Neither group. This group also exhibited higher depression scores, experienced more problematic family functioning and reported lower social support than the Neither group. Scores for caregivers in the Ext Only and Neuro Only groups tended to lie between the Both and Neither group scores and often did not differ from one another. Conclusions. Caregivers of children with both neurovelopmental disorders and behaviour problems exhibited a greater number of health and psychosocial problems. While addressing childrens behaviour problems, health care professionals should also consider caregiver physical and psychosocial health, as this may also have an impact on childrens well-being.

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

A cross-country comparison of intensive care physicians' beliefs about their transfusion behaviour: A qualitative study using the theoretical domains framework

BackgroundEvidence of variations in red blood cell transfusion practices have been reported in a wide range of clinical settings. Parallel studies in Canada and the United Kingdom were designed to explore transfusion behaviour in intensive care physicians. The aim of this paper is three-fold: first, to explore beliefs that influence Canadian intensive care physicians’ transfusion behaviour; second, to systematically select relevant theories and models using the Theoretical Domains Framework (TDF) to inform a future predictive study; and third, to compare its results with the UK study.MethodsTen intensive care unit (ICU) physicians throughout Canada were interviewed. Physicians’ responses were coded into theoretical domains, and specific beliefs were generated for each response. Theoretical domains relevant to behaviour change were identified, and specific constructs from the relevant domains were used to select psychological theories. The results from Canada and the United Kingdom were compared.ResultsSeven theoretical domains populated by 31 specific beliefs were identified as relevant to the target behaviour. The domains Beliefs about capabilities (confident to not transfuse if patients’ clinical condition is stable), Beliefs about consequences (positive beliefs of reducing infection and saving resources and negative beliefs about risking patients’ clinical outcome and potentially more work), Social influences (transfusion decision is influenced by team members and patients’ relatives), and Behavioural regulation (wide range of approaches to encourage restrictive transfusion) that were identified in the UK study were also relevant in the Canadian context. Three additional domains, Knowledge (it requires more evidence to support restrictive transfusion), Social/professional role and identity (conflicting beliefs about not adhering to guidelines, referring to evidence, believing restrictive transfusion as professional standard, and believing that guideline is important for other professionals), and Motivation and goals (opposing beliefs about the importance of restrictive transfusion and compatibility with other goals), were also identified in this study. Similar to the UK study, the Theory of Planned Behaviour, Social Cognitive Theory, Operant Learning Theory, Action Planning, and Knowledge-Attitude-Behaviour model were identified as potentially relevant theories and models for further study. Personal project analysis was added to the Canadian study to explore the Motivation and goals domain in further detail.ConclusionsA wide range of beliefs was identified by the Canadian ICU physicians as likely to influence their transfusion behaviour. We were able to demonstrate similar though not identical results in a cross-country comparison. Designing targeted behaviour-change interventions based on unique beliefs identified by physicians from two countries are more likely to encourage restrictive transfusion in ICU physicians in respective countries. This needs to be tested in future prospective clinical trials.

A systematic review of the use of theory in randomized controlled trials of audit and feedback

BackgroundAudit and feedback is one of the most widely used and promising interventions in implementation research, yet also one of the most variably effective. Understanding this variability has been limited in part by lack of attention to the theoretical and conceptual basis underlying audit and feedback. Examining the extent of theory use in studies of audit and feedback will yield better understanding of the causal pathways of audit and feedback effectiveness and inform efforts to optimize this important intervention.MethodsA total of 140 studies in the 2012 Cochrane update on audit and feedback interventions were independently reviewed by two investigators. Variables were extracted related to theory use in the study design, measurement, implementation or interpretation. Theory name, associated reference, and the location of theory use as reported in the study were extracted. Theories were organized by type (e.g., education, diffusion, organization, psychology), and theory utilization was classified into seven categories (justification, intervention design, pilot testing, evaluation, predictions, post hoc, other).ResultsA total of 20 studies (14%) reported use of theory in any aspect of the study design, measurement, implementation or interpretation. In only 13 studies (9%) was a theory reportedly used to inform development of the intervention. A total of 18 different theories across educational, psychological, organizational and diffusion of innovation perspectives were identified. Rogers’ Diffusion of Innovations and Bandura’s Social Cognitive Theory were the most widely used (3.6% and 3%, respectively).ConclusionsThe explicit use of theory in studies of audit and feedback was rare. A range of theories was found, but not consistency of theory use. Advancing our understanding of audit and feedback will require more attention to theoretically informed studies and intervention design.

When is informed consent required in cluster randomized trials in health research

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.

Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: cross-sectional study

OBJECTIVES To determine which factors predict favorable results and positive conclusions in systematic reviews (SRs) and to assess the level of agreement between SR results and conclusions. STUDY DESIGN AND SETTING A sample of 296 English SRs indexed in MEDLINE (November, 2004) was obtained. Two investigators independently categorized SR characteristics, results, and conclusions. Descriptive analyses and logistic regression predicting favorable results (nonstatistically significant and statistically significant positive) and positive conclusions were conducted. The level of concordance between results and conclusions was assessed using a weighted-kappa statistic. RESULTS Overall, 36.5% of the SRs had favorable results, increasing to 57.7% for Cochrane and 64.3% for non-Cochrane reviews with a meta-analysis of the primary outcome. Non-Cochrane reviews with a meta-analysis of the primary outcome were twice as likely to have positive conclusions as Cochrane reviews with such an analysis (P-value<0.05). The weighted kappa for agreement between SR results and conclusions was 0.55. It was lower for Cochrane (0.41) vs. non-Cochrane (0.67) reviews. CONCLUSION SRs including a meta-analysis of the primary outcome may be affected by indirect publication bias in our sample. Differences between the results and conclusions of Cochrane and non-Cochrane reviews were apparent. Further research on publication-related issues of SRs is warranted.