Choosing which in-hospital laboratory tests to target for intervention: a scoping review.

INTRODUCTION: Some laboratory testing practices may be of low value, leading to wasted resources and potential patient harm. Our scoping review investigated factors and processes that developers report using to inform decisions about what tests to target for practice improvement. METHODS: We searched Medline on May 30th, 2019 and June 28th, 2021 and included guidelines, recommendation statements, or empirical studies related to test ordering practices. Studies were included if they were conducted in a tertiary care setting, reported making a choice about a specific test requiring intervention, and reported at least one factor informing that choice. We extracted descriptive details, tests chosen, processes used to make the choice, and factors guiding test choice. RESULTS: From 114 eligible studies, we identified 30 factors related to test choice including clinical value, cost, prevalence of test, quality of test, and actionability of test results. We identified nine different processes used to inform decisions regarding where to spend intervention resources. CONCLUSIONS: Intervention developers face difficult choices when deciding where to put scarce resources intended to improve test utilization. Factors and processes identified here can be used to inform a framework to help intervention developers make choices relevant to improving testing practices.

Accommodating quality and service improvement research within existing ethical principles.

BACKGROUND: Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The lack of consensus on answers to these questions highlights the need for ethical guidance. MAIN BODY: Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. CONCLUSION: While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research.

Effectiveness and safety of short-stay units in the emergency department: a systematic review.

OBJECTIVES: Overcrowding is a serious and ongoing challenge in Canadian hospital emergency departments (EDs) that has been shown to have negative consequences for patient outcomes. The American College of Emergency Physicians recommends observation/short-stay units as a possible solution to alleviate this problem. However, the most recent systematic review assessing short-stay units shows that there is limited synthesized evidence to support this recommendation; it is over a decade old and has important methodologic limitations. The aim of this study was to conduct a more methodologically rigorous systematic review to update the evidence on the effectiveness and safety of short-stay units, compared with usual care, on hospital and patient outcomes. METHODS: A literature search was conducted using MEDLINE, the Cochrane Library, Embase, ABI/INFOM, and EconLit databases and gray literature sources. Randomized controlled trials of ED short-stay units (stay of 72 hours or less) were compared with usual care (i.e., not provided in a short-stay unit), for adult patients. Risk-of-bias assessments were conducted. Important decision-making (gradable) outcomes were patient outcomes, quality of care, utilization of and access to services, resource use, health system-related outcomes, economic outcomes, and adverse events. RESULTS: Ten reports of five studies were included, all of which compared short-stay units with inpatient care. Studies had small sample sizes and were collectively at a moderate risk of bias. Most outcomes were only reported by one study and the remaining outcomes were reported by two to four studies. No deaths were reported. Three of the four included studies reporting length of stay found a significant reduction among short-stay unit patients, and one of the two studies reporting readmission rates found a significantly lower rate for short-stay unit patients. All four economic evaluations indicated that short-stay units were a cost-saving intervention compared to inpatient care from both hospital and health care system perspectives. Results were mixed for outcomes related to quality of care and patient satisfaction. CONCLUSIONS: Insufficient evidence exists to make conclusions regarding the effectiveness and safety of short-stay units, compared with inpatient care.

A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

BACKGROUND: To date there is no established consensus of assessment criteria for evaluating research ethics review. METHODS: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. RESULTS: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. DISCUSSION: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study.

BACKGROUND: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders. METHODS: We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.

Conceptualizing childhood health problems using survey data: a comparison of key indicators.

BACKGROUND: Many definitions are being used to conceptualize child health problems. With survey data, commonly used indicators for identifying children with health problems have included chronic condition checklists, measures of activity limitations, elevated service use, and health utility thresholds. This study compares these different indicators in terms of the prevalence rates elicited, and in terms of how the subgroups identified differ. METHODS: Secondary data analyses used data from the National Longitudinal Survey of Children and Youth, which surveyed a nationally representative sample of Canadian children (n = 13,790). Descriptive analyses compared healthy children to those with health problems, as classified by any of the key indicators. Additional analyses examined differences between subgroups of children captured by a single indicator and those described as having health problems by multiple indicators. RESULTS: This study demonstrates that children captured by any of the indicators had poorer health than healthy children, despite the fact that over half the sample (52.2%) was characterized as having a health problem by at least one indicator. Rates of child ill health differed by indicator; 5.6% had an activity limitation, 9.2% exhibited a severe health difficulty, 31.7% reported a chronic condition, and 36.6% had elevated service use. Further, the four key indicators captured different types of children. Indicator groupings differed on child and socio-demographic factors. Compared to children identified by more than one indicator, those identified only by the severe health difficulty indicator displayed more cognitive problems (p < 0.0001), those identified only by the chronic condition checklist had a greater likelihood of reporting allergies or asthma (p < 0.0001), and those identified as having elevated service use only were more affluent (p = 0.01) and showed better overall health (p < 0.0001). Children identified by only a single indicator were less likely to have serious health problems than those identified by two or more indicators. CONCLUSION: We provide information useful to researchers when selecting indicators from survey data to identify children with health problems. Researchers and policy makers need to be aware of the impact of such definitions on prevalence rates as well as on the composition of children classified as being in poor health.

Cognitive and social issues in emergency medicine knowledge translation: a research agenda.

The individual practitioner is a linchpin in the process of translating new knowledge into practice, particularly in the emergency department, where physician autonomy is high, resources are limited, and decision-making situations are complex. An understanding of the cognitive and social processes that affect knowledge translation (KT) in emergency medicine (EM) is crucial and at present understudied. As part of the 2007 Academic Emergency Medicine Consensus Conference on KT in EM, our group sought to identify key research areas that would inform our understanding of these cognitive and social processes. We combined an online discussion group of interdisciplinary stakeholders, an extensive review of the existing literature, and a "public hearing" of the recommendations at the Consensus Conference to establish relative preference for the recommendations, as well as their relevance and clarity to attendees. We identified five key research areas as follows. 1) What provider-specific barriers/facilitators to the use of new knowledge are relevant in the EM setting? 2) Can social psychological theories of behavior change be used to develop better KT interventions for EM? 3) Can the study of "distributed cognition" suggest new vehicles for KT in the emergency department? 4) Can the concept of dual-process reasoning inform our understanding of the KT process? 5) Can patient-specific, immediate feedback serve as a vehicle for KT in EM? We believe that exploring these key research questions will directly lead to improved KT interventions and to further discussion of the cognitive and social factors impacting KT in EM.

The influence of display and statistical factors on the interpretation of metaanalysis results by physicians.

OBJECTIVE: The objective of this study was to determine the extent to which various factors affect the interpretation of metaanalytic results by physicians. STUDY DESIGN: A sample of 120 physicians, selected from The Royal College of Physicians and Surgeons of Canada (RCPSC), was randomly assigned to 1 of 6 groups (n = 20) created from a combination of 3 summary measures and 2 levels of disease severity. The intervention consisted of a written scenario and 4 individual displays of metaanalyses (M-A), each followed by questions related to the interpretation of results of M-A. Two final questions examined statistical familiarity/proficiency with the summary measures used. DATA ANALYSIS: Analyses of variance examined main effects and interactions among 4 factors: summary measure, disease severity, effect size, and statistical consistency of the studies comprising the metaanalysis. Two outcomes were examined: interpretation of the treatment effect and confidence in the interpretation of the treatment effect. PRINCIPAL FINDINGS: Physicians were more likely to favor treatment when the results of the primary randomized, controlled trials (RCTs) were statistically homogeneous (P = 0.001) and when the overall effect size was large (P = 0.001). Also, physicians were more likely to be confident when the results were homogeneous (P = 0.001) and when effect size was large (P = 0.000). Interactions also revealed that the effect of statistical consistency of contributing to RCTs was greatest when data were presented as risk difference for treatment outcome (P = 0.026) and when effect size was small (P = 0.000). CONCLUSIONS: The interpretation of metaanalytic displays is influenced by the overall effect size of M-A, the statistical consistency of the contributing RCTs, and interactions of these factors with display factors.