Background

The Canadian CT Head Rule was prospectively derived and validated to assist clinicians with diagnostic decision-making regarding the use of computed tomography (CT) in adult patients with minor head injury. A recent intervention trial failed to demonstrate a decrease in the rate of head CTs following implementation of the rule in Canadian emergency departments. Yet, the same intervention, which included a one-hour educational session and reminders at the point of requisition, was successful in reducing cervical spine imaging rates in the same emergency departments. The reason for the varied effect of the intervention across these two behaviours is unclear. There is an increasing appreciation for the use of theory to conduct process evaluations to better understand how strategies are linked with outcomes in implementation trials. The Theoretical Domains Framework (TDF) has been used to explore health professional behaviour and to design behaviour change interventions but, to date, has not been used to guide a theory-based process evaluation. In this proof of concept study, we explored whether the TDF could be used to guide a retrospective process evaluation to better understand emergency physicians’ responses to the interventions employed in the Canadian CT Head Rule trial.

Methods

A semi-structured interview guide, based on the 12 domains from the TDF, was used to conduct telephone interviews with project leads and physician participants from the intervention sites in the Canadian CT Head Rule trial. Two reviewers independently coded the anonymised interview transcripts using the TDF as a coding framework. Relevant domains were identified by: the presence of conflicting beliefs within a domain; the frequency of beliefs; and the likely strength of the impact of a belief on the behaviour.

Results

Eight physicians from four of the intervention sites in the Canadian CT Head Rule trial participated in the interviews. Barriers likely to assist with understanding physicians’ responses to the intervention in the trial were identified in six of the theoretical domains: beliefs about consequences; beliefs about capabilities; behavioural regulation; memory, attention and decision processes; environmental context and resources; and social influences. Despite knowledge that the Canadian CT Head Rule was highly sensitive and reliable for identifying clinically important brain injuries and strong beliefs about the benefits for using the rule, a number of barriers were identified that may have prevented physicians from consistently applying the rule.

Conclusion

This proof of concept study demonstrates the use of the TDF as a guiding framework to design a retrospective theory-based process evaluation. There is a need for further development and testing of methods for using the TDF to guide theory-based process evaluations running alongside behaviour change intervention trials.

Background

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Methods

Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.

Results

Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.

Conclusions

Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

Background

In the ongoing effort to develop and advance the science of knowledge translation (KT), an important question has emerged around how theory should inform the development of KT interventions.

Discussion

Efforts to employ theory to better understand and improve KT interventions have until recently mostly involved examining whether existing theories can be usefully applied to the KT context in question. In contrast to this general theory application approach, we propose a ‘menu of constructs’ approach, where individual constructs from any number of theories may be used to construct a new theory. By considering the entire menu of available constructs, rather than limiting choice to the broader level of theories, we can leverage knowledge from theories that would never on their own provide a complete picture of a KT intervention, but that nevertheless describe components or mechanisms relevant to it. We can also avoid being forced to adopt every construct from a particular theory in a one-size-fits-all manner, and instead tailor theory application efforts to the specifics of the situation. Using audit and feedback as an example KT intervention strategy, we describe a variety of constructs (two modes of reasoning, cognitive dissonance, feed forward, desirable difficulties and cognitive load, communities of practice, and adaptive expertise) from cognitive and educational psychology that make concrete suggestions about ways to improve this class of intervention.

Summary

The ‘menu of constructs’ notion suggests an approach whereby a wider range of theoretical constructs, including constructs from cognitive theories with scope that makes the immediate application to the new context challenging, may be employed to facilitate development of more effective KT interventions.

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

Background

Evidence 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.

Methods

Ten 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.

Results

Seven 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.

Conclusions

A 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.

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 CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers.

Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.

Introduction:

The effectiveness of pandemic vaccine campaigns such as the H1N1 vaccine rollout is dependent on both the vaccines’ effectiveness and the general public’s willingness to be vaccinated. It is therefore critical to understand the factors that influence the decision of members of the public whether to get vaccinated with new, emergently released vaccines.

Methods:

A systematic review of English language quantitative surveys was conducted to identify consistent predictors of the decision to accept or decline any (pre)pandemic vaccine, including the H1N1 influenza A vaccine. A total of ten studies were included in this review and all pertained to the 2009 H1N1 influenza A pandemic. Respondents’ willingness to receive a pandemic vaccine ranged from 8%–67% across the ten studies. The factors reported to be consistent predictors of the intention to vaccinate were: risk of infection, proximity or severity of the public health event, severity of personal consequences resulting from the illness, harm or adverse events from the vaccine, acceptance of previous vaccination, and ethnicity. Age and sex were the demographic variables examined most frequently across the ten studies and there was no consistent association between these variables and the intention to accept or reject a pandemic vaccine.

Conclusion:

Some predictors of the intention to accept or decline a (pre)pandemic vaccine or the H1N1 influenza A vaccine are consistently identified by surveys. Understanding the important factors influencing the acceptance of a pandemic vaccine by individual members of the public may help inform strategies to improve vaccine uptake during future pandemics.

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.

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

Background

Research needs to be reported transparently so readers can critically assess the strengths and weaknesses of the design, conduct, and analysis of studies. Reporting guidelines have been developed to inform reporting for a variety of study designs. The objective of this study was to identify whether there is a need to develop a reporting guideline for survey research.

Methods and Findings

We conducted a three-part project: (1) a systematic review of the literature (including “Instructions to Authors” from the top five journals of 33 medical specialties and top 15 general and internal medicine journals) to identify guidance for reporting survey research; (2) a systematic review of evidence on the quality of reporting of surveys; and (3) a review of reporting of key quality criteria for survey research in 117 recently published reports of self-administered surveys. Fewer than 7% of medical journals (n = 165) provided guidance to authors on survey research despite a majority having published survey-based studies in recent years. We identified four published checklists for conducting or reporting survey research, none of which were validated. We identified eight previous reviews of survey reporting quality, which focused on issues of non-response and accessibility of questionnaires. Our own review of 117 published survey studies revealed that many items were poorly reported: few studies provided the survey or core questions (35%), reported the validity or reliability of the instrument (19%), defined the response rate (25%), discussed the representativeness of the sample (11%), or identified how missing data were handled (11%).

Conclusions

There is limited guidance and no consensus regarding the optimal reporting of survey research. The majority of key reporting criteria are poorly reported in peer-reviewed survey research articles. Our findings highlight the need for clear and consistent reporting guidelines specific to survey research.

Please see later in the article for the Editors' Summary

Editors' Summary

Background

Surveys, or questionnaires, are an essential component of many types of research, including health, and usually gather information by asking a sample of people questions on a specific topic and then generalizing the results to a larger population. Surveys are especially important when addressing topics that are difficult to assess using other approaches and usually rely on self reporting, for example self-reported behaviors, such as eating habits, satisfaction, beliefs, knowledge, attitudes, opinions. However, the methods used in conducting survey research can significantly affect the reliability, validity, and generalizability of study results, and without clear reporting of the methods used in surveys, it is difficult or impossible to assess these characteristics and therefore to have confidence in the findings.

Why Was This Study Done?

This uncertainty in other forms of research has given rise to Reporting Guidelines—evidence-based, validated tools that aim to improve the reporting quality of health research. The STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement includes cross-sectional studies, which often involve surveys. But not all surveys are epidemiological, and STROBE does not include methods' and results' reporting characteristics that are unique to surveys. Therefore, the researchers conducted this study to help determine whether there is a need for a reporting guideline for health survey research.

What Did the Researchers Do and Find?

The researchers identified any previous relevant guidance for survey research, and any evidence on the quality of reporting of survey research, by: reviewing current guidance for reporting survey research in the “Instructions to Authors” of leading medical journals and in published literature; conducting a systematic review of evidence on the quality of reporting of surveys; identifying key quality criteria for the conduct of survey research; and finally, reviewing how these criteria are currently reported by conducting a review of recently published reports of self-administered surveys.

The researchers found that 154 of the 165 journals searched (93.3%) did not provide any guidance on survey reporting, even though the majority (81.8%) have published survey research. Only three of the 11 journals that provided some guidance gave more than one directive or statement. Five papers and one Internet site provided guidance on the reporting of survey research, but none used validated measures or explicit methods for development. The researchers identified eight papers that addressed the quality of reporting of some aspect of survey research: the reporting of response rates; the reporting of non-response analyses in survey research; and the degree to which authors make their survey instrument available to readers. In their review of 117 published survey studies, the researchers found that many items were poorly reported: few studies provided the survey or core questions (35%), reported the validity or reliability of the instrument (19%), discussed the representativeness of the sample (11%), or identified how missing data were handled (11%). Furthermore, (88 [75%]) did not include any information on consent procedures for research participants, and one-third (40 [34%]) of papers did not report whether the study had received research ethics board review.

What Do These Findings Mean?

Overall, these results show that guidance is limited and consensus lacking about the optimal reporting of survey research, and they highlight the need for a well-developed reporting guideline specifically for survey research—possibly an extension of the guideline for observational studies in epidemiology (STROBE)—that will provide the structure to ensure more complete reporting and allow clearer review and interpretation of the results from surveys.

Additional Information

Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001069.

More than 100 reporting guidelines covering a broad spectrum of research types are indexed on the EQUATOR Networks web site

More information about STROBE is available on the STROBE Statement web site

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 CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently.

We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.

Design Review of a random sample of published cluster randomised trials from an electronic search in Medline.

Setting Cluster randomised trials in health research published in English language journals from 2000 to 2008.

Study sample 300 cluster randomised trials published in 150 journals.

Results 77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).

Conclusions Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.

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, Weijer and colleagues 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 third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act?

In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research.

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation:

1. Who is a research subject?

2. From whom, how, and when must informed consent be obtained?

3. Does clinical equipoise apply to CRTs?

4. How do we determine if the benefits outweigh the risks of CRTs?

5. How ought vulnerable groups be protected in CRTs?

6. Who are gatekeepers and what are their responsibilities?

Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

Background

The Internet has the potential to be an effective medium for delivering health care knowledge to consumers. While computer usability research makes recommendations about how to present Web-based information generally, there remains no clear guidance on how to present specific forms of health care research evidence online in a way that facilitates understanding and good health care decision making.

Objective

The two goals of this study were to describe the Cochrane Musculoskeletal Group’s (CMSG’s) process for developing online patient-focused summaries of systematic reviews and to evaluate the impressions of these summaries formed by users.

Methods

A process for summarizing the results of systematic reviews via consumer summaries has evolved over 15 years. An evaluation of this approach took the form of Internet surveys on the Arthritis Society of Canada website and surveys of members of the Canadian Arthritis Patient Alliance (CAPA). Respondents provided information on background, relationship to the decision, their satisfaction with and preparation for decision making, and suggestions for improvements to the summaries. Survey data were collected between August 1, 2005, and February 28, 2006.

Results

A total of 261 respondents completed the survey. The majority (226/261 or 87%) of respondents reported having an arthritis-related condition. The consumer summary approach was generally reviewed favorably by respondents, with most agreeing that the summary provided appropriate information (177/261 or 68%), would be useful to others (160/261 or 61%), was well laid out (159/261 or 61%), was easy to learn from (157/261 or 60%), and was useful to the reader (153/261 or 59%). Areas of potential improvement were indicated by relatively fewer respondents agreeing that they could easily find all the information they wanted (118/261 or 45%), by a substantial proportion being unable to judge whether the providers of the information are reliable (80/261 or 31%), and by a similar proportion being unable to determine whether the information presented was the best available (68/261 or 26%).

Conclusions

The CMSG has developed an approach to summarizing the results of often-technical systematic reviews into public-friendly consumer summaries. Our online survey showed that this approach was generally well liked but identified specific areas for improvement. Feedback from this survey will help to reshape and improve the current template for consumer summaries used by the CMSG.

Background

The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments.

Methods

We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head.

Results

Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the “before” period (62.8%) to the “after” period (76.2%) (difference +13.3%, 95% CI 9.7%–17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%–10.8%). The change in mean imaging rates from the “before” period to the “after” period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes.

Interpretation

Our knowledge–translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. (ClinicalTrials.gov trial register no. NCT00993252)

Background

Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time.

Methods

We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews.

Results

The existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has increased from 28% between the years 2000-2003, to 60% between 2004-2007 (absolute increase 32%, 95% CI 17 to 47%).

Conclusions

CRTs should include the phrase "cluster randomized trial" in titles or abstracts; this will facilitate more accurate indexing of the publication type by reviewers at the National Library of Medicine, and efficient textword retrieval of the subset employing cluster randomization.

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.

Background

Blood transfusion is an essential part of healthcare and can improve patient outcomes. However, like most therapies, it is also associated with significant clinical risks. In addition, there is some evidence of overuse. Understanding the potential barriers and enablers to reduced prescribing of blood products will facilitate the selection of intervention components likely to be effective, thereby reducing the number of costly trials evaluating different implementation strategies. Using a theoretical basis to understand behaviours targeted for change will contribute to a 'basic science' relating to determinants of professional behaviour and how these inform the selection of techniques for changing behaviour. However, it is not clear which theories of behaviour are relevant to clinicians' transfusing behaviour. The aim of this study is to use a theoretical domains framework to identify relevant theories, and to use these theories to identify factors that predict the decision to transfuse.

Methods

The study involves two steps: interview study and questionnaire study. Using a previously identified framework, we will conduct semi-structured interviews with clinicians to elicit their views about which factors are associated with waiting and further monitoring the patient rather than transfusing red blood cells. Interviews will cover the following theoretical domains: knowledge; skills; social/professional role and identity; beliefs about capabilities; beliefs about consequences; motivation and goals; memory, attention, and decision processes; environmental context and resources; social influences; emotion; behavioural regulation; nature of the behaviour. The interviews will take place independently in Canada and the UK and involve two groups of physicians in each country (UK: adult and neonatal intensive care physicians; Canada: intensive care physicians and orthopaedic surgeons). We will: analyse interview transcript content to select relevant theoretical domains; use consensus processes to map these domains on to theories of behaviour; develop questionnaires based on these theories; and mail them to each group of physicians in the two countries. From our previous work, it is likely that the theories will include: theory of planned behaviour, social cognitive theory and the evidence-based strategy, implementation intention. The questionnaire data will measure predictor variables (theoretical constructs) and outcome variables (intention and clinical decision), and will be analysed using multiple regression analysis. We aim to achieve 150 respondents in each of the four groups for each postal survey.

Approximately one-quarter of all Canadian children will seek emergency care in any given year, with the two most common medical problems affecting children in the emergency department (ED) being acute respiratory illness and injury. Treatment for some medical conditions in the ED remains controversial due to a lack of strong supporting evidence.

The purpose of this paper is to describe a multi-centre team grant in pediatric emergency medicine (PEM) that has been recently funded by the Canadian Institutes of Health Research (CIHR). This program of research integrates clinical research (in the areas of acute respiratory illness and injury) and knowledge translation (KT). This initiative includes seven distinct projects that address the objective to generate new evidence for clinical care and KT in the pediatric ED. Five of the seven research projects in this team grant make significant contributions to knowledge development in KT science, and these contributions are the focus of this paper.

The research designs employed in this program include: cross-sectional surveys, randomized controlled trials (RCTs), quasi-experimental designs with interrupted time-series analysis and staggered implementation strategies, and qualitative designs.

This team grant provides unique opportunities for making important KT methodological developments, with a particular focus on developing a better theoretical understanding of the causal mechanisms and effect modifiers of different KT interventions.

Background

Cardiac arrest victims most often collapse at home, where only a modest proportion receives life-saving bystander cardiopulmonary resuscitation. As many as 40% of all sudden cardiac arrest victims have agonal or abnormal breathing in the first minutes following cardiac arrest. 9-1-1 call takers may wrongly interpret agonal breathing as a sign of life, and not initiate telephone cardiopulmonary resuscitation instructions. Improving 9-1-1 call takers' ability to recognize agonal breathing as a sign of cardiac arrest could result in improved bystander cardiopulmonary resuscitation and survival rates for out-of-hospital cardiac arrest victims.

Methods/Design

The overall goal of this study is to design and conduct a survey of 9-1-1 call takers in the province of Ontario to better understand the factors associated with the successful identification of cardiac arrest (including patients with agonal breathing) over the phone, and subsequent administration of cardiopulmonary resuscitation instructions to callers. This study will be conducted in three phases using the Theory of Planned Behaviour. In Phase One, we will conduct semi-structured qualitative interviews with a purposeful selection of 9-1-1 call takers from Ontario, and identify common themes and belief categories. In Phase Two, we will use the qualitative interview results to design and pilot a quantitative survey. In Phase Three, a final version of the quantitative survey will be administered via an electronic medium to all registered call takers in the province of Ontario. We will perform qualitative thematic analysis (Phase One) and regression modelling (Phases Two and Three), to determine direct and indirect relationship of behavioural constructs with intentions to provide cardiopulmonary resuscitation instructions.

Discussion

The results of this study will provide valuable insight into the factors associated with the successful recognition of agonal breathing and cardiac arrest by 9-1-1 call takers. This will guide future interventional studies, which may include continuing education and protocol changes, in order to help increase the number of callers appropriately receiving cardiopulmonary resuscitation instructions, and save the lives of more cardiac arrest victims.

Trial registration

Clinicaltrials.gov NCT00848588

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.

Background

Cochrane reviews are regarded as being scientifically rigorous and are increasingly used by a variety of stakeholders. However, factors predicting the publication of Cochrane reviews have never been reported. This is important because if a higher proportion of Cochrane protocols with certain characteristics (e.g., funding) are being published, this may lead to inaccurate decisions. We examined the frequency of published and unpublished Cochrane reviews and protocol factors that predict the publication of Cochrane reviews.

Methodology/Principal Findings

Retrospective cohort study of Cochrane protocols published in 2000 (Issues 2 to 4) and 2001 (Issue 1). The publication status of these reviews was followed up to Issue 1, 2008 in The Cochrane Library. Survival analysis of the time from protocol publication to the first review publication and protocol factors predicting the time to publication was conducted. There were 411 new Cochrane protocols in the cohort. After excluding 39; 71/372 (19.1%) were unpublished and 301/372 (80.9%) were published as full Cochrane reviews at the time of study analysis (January 2008). The median time to publication was 2.4 years (range: 0.15 to 8.96). Multivariate analyses revealed that shorter time to publication was associated with the review subsequently being updated (hazard ratio, HR: 1.80 [95% confidence interval, CI: 1.39 to 2.33 years]) and longer time to publication was associated with the review having two published protocols, indicating changes to the review plan (HR: 0.33 [95% CI: 0.12 to 0.90 years]).

Conclusions/Significance

Only about 80% Cochrane protocols were published as full reviews after over 8 years of follow-up. The median time to publication was 2.4 years and some reviews took much longer. Strategies to decrease time to publication should be considered, such as streamlining the review process, increased support for authors when protocol amendments occur, and better infrastructure for updating Cochrane reviews.

Background

Overall survival rates for out-of-hospital cardiac arrest rarely exceed 5%. While bystander cardiopulmonary resuscitation (CPR) can increase survival for cardiac arrest victims by up to four times, bystander CPR rates remain low in Canada (15%). Most cardiac arrest victims are men in their sixties, they usually collapse in their own home (85%) and the event is witnessed 50% of the time. These statistics would appear to support a strategy of targeted CPR training for an older population that is most likely to witness a cardiac arrest event. However, interest in CPR training appears to decrease with advancing age. Behaviour surrounding CPR training and performance has never been studied using well validated behavioural theories.

Methods/Design

The overall goal of this study is to conduct a survey to better understand the behavioural factors influencing CPR training and performance in men and women 55 years of age and older. The study will proceed in three phases. In phase one, semi-structured qualitative interviews will be conducted and recorded to identify common categories and themes regarding seeking CPR training and providing CPR to a cardiac arrest victim. The themes identified in the first phase will be used in phase two to develop, pilot-test, and refine a survey instrument based upon the Theory of Planned Behaviour. In the third phase of the project, the final survey will be administered to a sample of the study population over the telephone. Analyses will include measures of sampling bias, reliability of the measures, construct validity, as well as multiple regression analyses to identify constructs and beliefs most salient to seniors' decisions about whether to attend CPR classes or perform CPR on a cardiac arrest victim.

Discussion

The results of this survey will provide valuable insight into factors influencing the interest in CPR training and performance among a targeted group of individuals most susceptible to witnessing a victim in cardiac arrest. The findings can then be applied to the design of trials of various interventions designed to promote attendance at CPR classes and improve CPR performance.

Trial registration

ClinicalTrials.gov NCT00665288

Background

Evidence shows that the standard process for obtaining informed consent in clinical trials can be inadequate, with study participants frequently not understanding even basic information fundamental to giving informed consent. Patient decision aids are effective decision support tools originally designed to help patients make difficult treatment or screening decisions. We propose that incorporating decision aids into the informed consent process will improve the extent to which participants make decisions that are informed and consistent with their preferences. A mixed methods study will test this proposal.

Methods

Phase one of this project will involve assessment of a stratified random sample of 50 consent documents from recently completed investigator-initiated clinical trials, according to existing standards for supporting good decision making. Phase two will involve interviews of a purposive sample of 50 trial participants (10 participants from each of five different clinical areas) about their experience of the informed consent process, and how it could be improved. In phase three, we will convert consent forms for two completed clinical trials into decision aids and pilot test these new tools using a user-centered design approach, an iterative development process commonly employed in computer usability literature. In phase four, we will conduct a pilot observational study comparing the new tools to standard consent forms, with potential recruits to two hypothetical clinical trials. Outcomes will include knowledge of key aspects of the decision, knowledge of the probabilities of different outcomes, decisional conflict, the hypothetical participation decision, and qualitative impressions of the experience.

Discussion

This work will provide initial evidence about whether a patient decision aid can improve the informed consent process. The larger goal of this work is to examine whether study recruitment can be improved from (barely) informed consent based on disclosure-oriented documents, towards a process of high-quality participant decision-making.

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.