PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (26)
 

Clipboard (0)
None

Select a Filter Below

Journals
more »
Year of Publication
1.  Computer-supported feedback message tailoring: theory-informed adaptation of clinical audit and feedback for learning and behavior change 
Background
Evidence shows that clinical audit and feedback can significantly improve compliance with desired practice, but it is unclear when and how it is effective. Audit and feedback is likely to be more effective when feedback messages can influence barriers to behavior change, but barriers to change differ across individual health-care providers, stemming from differences in providers’ individual characteristics.
Discussion
The purpose of this article is to invite debate and direct research attention towards a novel audit and feedback component that could enable interventions to adapt to barriers to behavior change for individual health-care providers: computer-supported tailoring of feedback messages. We argue that, by leveraging available clinical data, theory-informed knowledge about behavior change, and the knowledge of clinical supervisors or peers who deliver feedback messages, a software application that supports feedback message tailoring could improve feedback message relevance for barriers to behavior change, thereby increasing the effectiveness of audit and feedback interventions. We describe a prototype system that supports the provision of tailored feedback messages by generating a menu of graphical and textual messages with associated descriptions of targeted barriers to behavior change. Supervisors could use the menu to select messages based on their awareness of each feedback recipient’s specific barriers to behavior change. We anticipate that such a system, if designed appropriately, could guide supervisors towards giving more effective feedback for health-care providers.
Summary
A foundation of evidence and knowledge in related health research domains supports the development of feedback message tailoring systems for clinical audit and feedback. Creating and evaluating computer-supported feedback tailoring tools is a promising approach to improving the effectiveness of clinical audit and feedback.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0203-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0203-z
PMCID: PMC4320482  PMID: 25603806
2.  The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials 
PLoS Medicine  2012;9(11):e1001346.
The Ottawa Ethics of Cluster Trials Consensus Group sets out 15 recommendations for the ethical design and conduct of cluster randomized trials.
doi:10.1371/journal.pmed.1001346
PMCID: PMC3502500  PMID: 23185138
3.  Presenting Evidence to Patients Online: What Do Web Users Think of Consumer Summaries of Cochrane Musculoskeletal Reviews? 
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.
doi:10.2196/jmir.1532
PMCID: PMC3221355  PMID: 21247863
Decision support techniques; health care surveys; Internet; patient education; patient satisfaction; patient-centered care; musculoskeletal diseases
4.  Theory of planned behaviour can help understand processes underlying the use of two emergency medicine diagnostic imaging rules 
Background
Clinical decision rules (CDRs) can be an effective tool for knowledge translation in emergency medicine, but their implementation is often a challenge. This study examined whether the Theory of Planned Behaviour (TPB) could help explain the inconsistent results between the successful Canadian C-Spine Rule (CCR) implementation study and unsuccessful Canadian CT Head Rule (CCHR) implementation study. Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time. The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability. The rules subsequently underwent parallel implementations at 12 Canadian hospitals, yet only the CCR was observed to significantly reduce radiography ordering rates, while the CCHR failed to have any significant impact at all. The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules.
Methods
Physicians at the 12 participating Canadian hospitals were randomized to CCR or CCHR TPB surveys that were administered during the baseline phases of the implementation studies, before any intervention had taken place. The collected baseline survey data were linked to concurrent baseline physician and patient-specific imaging data, and subsequently analyzed using mixed effects linear and logistic models.
Results
A total of 223 of the 378 eligible physicians randomized to a TPB survey completed their assigned baseline survey (CCR: 122 of 181; CCHR: 101 of 197). Attitudes were significantly associated with intention in both settings (CCR: ß = 0.40; CCHR: ß = 0.30), as were subjective norms (CCR: ß = 0.26; CCHR: ß = 0.73). Intention was significantly associated with actual image ordering for CCR (OR = 1.79), but not CCHR.
Conclusions
The TPB can be used to better understand processes underlying use of CDRs. TPB constructs were significantly associated with intention to perform both imaging behaviours, but intention was only associated with actual behaviour for CCR, suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0088-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0088-x
PMCID: PMC4243777  PMID: 25099167
Clinical decision rules; Canadian C-Spine Rule; Canadian CT-Head Rule; Theory of planned behaviour; Emergency physicians; Implementation study
5.  Impact of stated barriers on proposed warfarin prescription for atrial fibrillation: a survey of Canadian physicians 
Thrombosis Journal  2014;12:13.
Background
Atrial fibrillation (AF) is a common cardiac arrhythmia, and leading cause of ischemic stroke. Despite proven effectiveness, warfarin remains an under-used treatment in atrial fibrillation patients. We sought to study, across three physician specialties, a range of factors that have been argued to have a disproportionate effect on treatment decisions.
Methods
Cross-sectional survey of Canadian Family Doctors (FD: n = 500), Geriatricians (G: n = 149), and Internal Medicine specialists (IMS: n = 500). Of these, 1032 physicians were contactable, and 335 completed and usable responses were received. Survey questions and clinical vignettes asked about the frequency with which they see patients with atrial fibrillation, treatment practices, and barriers to the prescription of anticoagulants.
Results
Stated prescribing practices did not significantly differ between physician groups. Falls risk, bleeding risk and poor patient adherence were all highly cited barriers to prescribing warfarin. Fewer geriatricians indicated that history of patient falls would be a reason for not treating with warfarin (G: 47%; FD: 71%; IMS: 72%), and significantly fewer changed reported practice in the presence of falls risk (χ2 (6) = 45.446, p < 0.01). Experience of a patient having a stroke whilst not on warfarin had a significant impact on vignette decisions; physicians who had had patients who experienced a stroke were more likely to prescribe warfarin (χ2 (3) =10.7, p = 0.013).
Conclusions
Barriers to treatment of atrial fibrillation with warfarin affect physician specialties to different extents. Prior experience of a patient suffering a stroke when not prescribed warfarin is positively associated with intention to prescribe warfarin, even in the presence of falls risk.
doi:10.1186/1477-9560-12-13
PMCID: PMC4144316  PMID: 25161388
6.  Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries 
Trials  2014;15:48.
Background
Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently.
Methods
A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels.
Results
A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement.
Conclusions
Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.
doi:10.1186/1745-6215-15-48
PMCID: PMC3925119  PMID: 24495542
Cluster randomized trials; Informed consent; Research ethics guidelines; Research ethics review; Web-based survey
7.  A systematic review of the use of theory in randomized controlled trials of audit and feedback 
Background
Audit 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.
Methods
A 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).
Results
A 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).
Conclusions
The 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.
doi:10.1186/1748-5908-8-66
PMCID: PMC3702512  PMID: 23759034
Audit and feedback; Systematic review; Theory; Intervention design
8.  Building theories of knowledge translation interventions: Use the entire menu of constructs 
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.
doi:10.1186/1748-5908-7-114
PMCID: PMC3520870  PMID: 23173596
Theory; Audit and feedback; Knowledge translation; Constructs; Domains; Cognitive psychology; Education
9.  A cross-country comparison of intensive care physicians’ beliefs about their transfusion behaviour: A qualitative study using the theoretical domains framework 
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.
doi:10.1186/1748-5908-7-93
PMCID: PMC3527303  PMID: 22999460
10.  What is the role and authority of gatekeepers in cluster randomized trials in health research? 
Trials  2012;13:116.
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.
doi:10.1186/1745-6215-13-116
PMCID: PMC3443001  PMID: 22834691
11.  Acceptance of a pandemic influenza vaccine: a systematic review of surveys of the general public 
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.
doi:10.2147/IDR.S23174
PMCID: PMC3215344  PMID: 22114512
pandemic; H1N1 influenza A; emergent vaccine; personal risk; demographic
12.  When is informed consent required in cluster randomized trials in health research? 
Trials  2011;12:202.
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.
doi:10.1186/1745-6215-12-202
PMCID: PMC3184061  PMID: 21906277
13.  Reporting Guidelines for Survey Research: An Analysis of Published Guidance and Reporting Practices 
PLoS Medicine  2011;8(8):e1001069.
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
doi:10.1371/journal.pmed.1001069
PMCID: PMC3149080  PMID: 21829330
14.  Who is the research subject in cluster randomized trials in health research? 
Trials  2011;12:183.
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.
doi:10.1186/1745-6215-12-183
PMCID: PMC3162904  PMID: 21791064
15.  Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials 
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.
doi:10.1136/bmj.d2496
PMCID: PMC3092521  PMID: 21562003
16.  Does clinical equipoise apply to cluster randomized trials in health research? 
Trials  2011;12:118.
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.
doi:10.1186/1745-6215-12-118
PMCID: PMC3113987  PMID: 21569349
17.  Ethical issues posed by cluster randomized trials in health research 
Trials  2011;12:100.
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.
doi:10.1186/1745-6215-12-100
PMCID: PMC3107798  PMID: 21507237
18.  Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards 
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.
doi:10.1186/1471-2288-10-15
PMCID: PMC2833170  PMID: 20158899
19.  Using theories of behaviour to understand transfusion prescribing in three clinical contexts in two countries: Development work for an implementation trial 
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.
doi:10.1186/1748-5908-4-70
PMCID: PMC2777847  PMID: 19852832
20.  Improving outcomes for ill and injured children in emergency departments: protocol for a program in pediatric emergency medicine and knowledge translation science 
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.
doi:10.1186/1748-5908-4-60
PMCID: PMC2754977  PMID: 19772665
21.  A survey of factors associated with the successful recognition of agonal breathing and cardiac arrest by 9-1-1 call takers: design and methodology 
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
doi:10.1186/1471-227X-9-14
PMCID: PMC2727488  PMID: 19646269
22.  Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study 
Trials  2009;10:61.
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.
doi:10.1186/1745-6215-10-61
PMCID: PMC2725043  PMID: 19638233
23.  A survey of attitudes and factors associated with successful cardiopulmonary resuscitation (CPR) knowledge transfer in an older population most likely to witness cardiac arrest: design and methodology 
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
doi:10.1186/1471-227X-8-13
PMCID: PMC2585573  PMID: 18986547
24.  Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol 
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.
doi:10.1186/1748-5908-3-38
PMCID: PMC2517068  PMID: 18651981
25.  Conceptualizing childhood health problems using survey data: a comparison of key indicators 
BMC Pediatrics  2007;7:40.
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.
doi:10.1186/1471-2431-7-40
PMCID: PMC2248574  PMID: 18053253

Results 1-25 (26)