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.

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

Background

In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change.

Methods

These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior.

Results

Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior.

Conclusions

We operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.

Background

The Theoretical Domains Framework (TDF) was developed to investigate determinants of specific clinical behaviors and inform the design of interventions to change professional behavior. This framework was used to explore the beliefs of chiropractors in an American Provider Network and two Canadian provinces about their adherence to evidence-based recommendations for spine radiography for uncomplicated back pain. The primary objective of the study was to identify chiropractors’ beliefs about managing uncomplicated back pain without x-rays and to explore barriers and facilitators to implementing evidence-based recommendations on lumbar spine x-rays. A secondary objective was to compare chiropractors in the United States and Canada on their beliefs regarding the use of spine x-rays.

Methods

Six focus groups exploring beliefs about managing back pain without x-rays were conducted with a purposive sample. The interview guide was based upon the TDF. Focus groups were digitally recorded, transcribed verbatim, and analyzed by two independent assessors using thematic content analysis based on the TDF.

Results

Five domains were identified as likely relevant. Key beliefs within these domains included the following: conflicting comments about the potential consequences of not ordering x-rays (risk of missing a pathology, avoiding adverse treatment effects, risks of litigation, determining the treatment plan, and using x-ray-driven techniques contrasted with perceived benefits of minimizing patient radiation exposure and reducing costs; beliefs about consequences); beliefs regarding professional autonomy, professional credibility, lack of standardization, and agreement with guidelines widely varied ( social/professional role & identity); the influence of formal training, colleagues, and patients also appeared to be important factors ( social influences); conflicting comments regarding levels of confidence and comfort in managing patients without x-rays ( belief about capabilities); and guideline awareness and agreements ( knowledge).

Conclusions

Chiropractors’ use of diagnostic imaging appears to be influenced by a number of factors. Five key domains may be important considering the presence of conflicting beliefs, evidence of strong beliefs likely to impact the behavior of interest, and high frequency of beliefs. The results will inform the development of a theory-based survey to help identify potential targets for behavioral-change strategies.

Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.

Background

Although most people with Type 2 diabetes receive their diabetes care in primary care, only a limited amount is known about the quality of diabetes care in this setting. We investigated the provision and receipt of diabetes care delivered in UK primary care.

Methods

Postal surveys with all healthcare professionals and a random sample of 100 patients with Type 2 diabetes from 99 UK primary care practices.

Results

326/361 (90.3%) doctors, 163/186 (87.6%) nurses and 3591 patients (41.8%) returned a questionnaire. Clinicians reported giving advice about lifestyle behaviours (e.g. 88% would routinely advise about calorie restriction; 99.6% about increasing exercise) more often than patients reported having received it (43% and 42%) and correlations between clinician and patient report were low. Patients’ reported levels of confidence about managing their diabetes were moderately high; a median (range) of 21% (3% to 39%) of patients reporting being not confident about various areas of diabetes self-management.

Conclusions

Primary care practices have organisational structures in place and are, as judged by routine quality indicators, delivering high quality care. There remain evidence-practice gaps in the care provided and in the self confidence that patients have for key aspects of self management and further research is needed to address these issues. Future research should use robust designs and appropriately designed studies to investigate how best to improve this situation.

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.

Clinical practice guidelines are one of the foundations of efforts to improve healthcare. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearinghouses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this second paper, we discuss issues of identifying and synthesizing evidence: deciding what type of evidence and outcomes to include in guidelines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, and presentation of evidence; and moving from evidence to recommendations.

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions.

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Background

Routine pre-operative tests for anesthesia management are often ordered by both anesthesiologists and surgeons for healthy patients undergoing low-risk surgery. The Theoretical Domains Framework (TDF) was developed to investigate determinants of behaviour and identify potential behaviour change interventions. In this study, the TDF is used to explore anaesthesiologists’ and surgeons’ perceptions of ordering routine tests for healthy patients undergoing low-risk surgery.

Methods

Sixteen clinicians (eleven anesthesiologists and five surgeons) throughout Ontario were recruited. An interview guide based on the TDF was developed to identify beliefs about pre-operative testing practices. Content analysis of physicians’ statements into the relevant theoretical domains was performed. Specific beliefs were identified by grouping similar utterances of the interview participants. Relevant domains were identified by noting the frequencies of the beliefs reported, presence of conflicting beliefs, and perceived influence on the performance of the behaviour under investigation.

Results

Seven of the twelve domains were identified as likely relevant to changing clinicians’ behaviour about pre-operative test ordering for anesthesia management. Key beliefs were identified within these domains including: conflicting comments about who was responsible for the test-ordering (Social/professional role and identity); inability to cancel tests ordered by fellow physicians (Beliefs about capabilities and social influences); and the problem with tests being completed before the anesthesiologists see the patient (Beliefs about capabilities and Environmental context and resources). Often, tests were ordered by an anesthesiologist based on who may be the attending anesthesiologist on the day of surgery while surgeons ordered tests they thought anesthesiologists may need (Social influences). There were also conflicting comments about the potential consequences associated with reducing testing, from negative (delay or cancel patients’ surgeries), to indifference (little or no change in patient outcomes), to positive (save money, avoid unnecessary investigations) (Beliefs about consequences). Further, while most agreed that they are motivated to reduce ordering unnecessary tests (Motivation and goals), there was still a report of a gap between their motivation and practice (Behavioural regulation).

Conclusion

We identified key factors that anesthesiologists and surgeons believe influence whether they order pre-operative tests routinely for anesthesia management for a healthy adults undergoing low-risk surgery. These beliefs identify potential individual, team, and organisation targets for behaviour change interventions to reduce unnecessary routine test ordering.

Background

Despite evidence-based recommendations supporting long-term use of cardiac medications in patients post ST-elevation myocardial infarction, adherence is known to decline over time. Discontinuation of cardiac medications in such patients is associated with increased mortality.

Methods/design

This is a pragmatic, cluster-randomized controlled trial with blinded outcome assessment and embedded qualitative process evaluation. Patients from one health region in Ontario, Canada who undergo a coronary angiogram during their admission for ST-elevation myocardial infarction and who survive their initial hospitalization will be included. Allocation of eligible patients to intervention or usual care will take place within one week after the angiogram using a computer-generated random sequence. To avoid treatment contamination, patients treated by the same family physician will be allocated to the same study arm. The intervention consists of recurrent, personalized, paper-based educational messages and reminders sent via post on behalf of the interventional cardiologist to the patient, family physician, and pharmacist urging long-term adherence to secondary prevention medications. The primary outcome is the proportion of patients who report in a phone interview taking all relevant classes of cardiac medications at twelve months. Secondary outcomes to be measured at three and twelve months include proportions of patients who report: actively taking each cardiac medication class of interest (item-by-item); stopping medications due to side effects; taking one or two or three medication classes concurrently; a perfect Morisky Medication Adherence Score for cardiac medication compliance; and having a discussion with their family physician about long-term adherence to cardiac medications. Self-reported measures of adherence will be validated using administrative data for prescriptions filled.

Discussion

This intervention is designed to be easily generalizable. If effective, it could be implemented broadly. If it does not change medication utilization, the process evaluation will offer insights regarding how such an intervention could be optimized in future.

Trial registration

Clinicaltrials.gov NCT01325116

Background

One of the most consistent findings from clinical and health services research is the failure to translate research into practice and policy. As a result of these evidence-practice and policy gaps, patients fail to benefit optimally from advances in healthcare and are exposed to unnecessary risks of iatrogenic harms, and healthcare systems are exposed to unnecessary expenditure resulting in significant opportunity costs. Over the last decade, there has been increasing international policy and research attention on how to reduce the evidence-practice and policy gap. In this paper, we summarise the current concepts and evidence to guide knowledge translation activities, defined as T2 research (the translation of new clinical knowledge into improved health). We structure the article around five key questions: what should be transferred; to whom should research knowledge be transferred; by whom should research knowledge be transferred; how should research knowledge be transferred; and, with what effect should research knowledge be transferred?

Discussion

We suggest that the basic unit of knowledge translation should usually be up-to-date systematic reviews or other syntheses of research findings. Knowledge translators need to identify the key messages for different target audiences and to fashion these in language and knowledge translation products that are easily assimilated by different audiences. The relative importance of knowledge translation to different target audiences will vary by the type of research and appropriate endpoints of knowledge translation may vary across different stakeholder groups. There are a large number of planned knowledge translation models, derived from different disciplinary, contextual (i.e., setting), and target audience viewpoints. Most of these suggest that planned knowledge translation for healthcare professionals and consumers is more likely to be successful if the choice of knowledge translation strategy is informed by an assessment of the likely barriers and facilitators. Although our evidence on the likely effectiveness of different strategies to overcome specific barriers remains incomplete, there is a range of informative systematic reviews of interventions aimed at healthcare professionals and consumers (i.e., patients, family members, and informal carers) and of factors important to research use by policy makers.

Summary

There is a substantial (if incomplete) evidence base to guide choice of knowledge translation activities targeting healthcare professionals and consumers. The evidence base on the effects of different knowledge translation approaches targeting healthcare policy makers and senior managers is much weaker but there are a profusion of innovative approaches that warrant further evaluation.

The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice.The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality.Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction.A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines.These recommendations aim to enhance the transparency, quality and completeness of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis.

In this editorial, we reflect on the arguments for starting a scientific society focused on research on how to improve healthcare. This society would take an inclusive approach to what constitutes healthcare. For instance, it should include mental health healthcare, treatment for substance abuse, the work of allied health professions, and preventive healthcare. The society would be open to researchers from all traditions. Thus, we take an inclusive approach to what constitutes scientific research, as long as it uses rigorous methods, is focused on improving healthcare, and aims at knowledge that can be transferred across settings. The society would primarily target scientific researchers but would invite others with an interest in this area of research, regardless of their discipline, position, field of application, or group affiliation (e.g., improvement science, behavioral medicine, knowledge translation). A society would need fruitful collaboration with related societies and organizations, which may include having combined meetings. Special links may be developed with one or more journals. A website to provide information on relevant resources, events, and training opportunities is another key activity. It would also provide a voice for the field at funding agencies, political arenas, and similar institutions. An organizational structure and financial resources are required to develop and run these activities. Our aim is to start an international debate, to discover if we can establish a shared vision across academics and stakeholders engaged with creating scientific knowledge on how to improve healthcare. We invite readers to express their views in the online questionnaire accessed by following the URL link provided at the end of the editorial.

This editorial marks the launch of a special collection of articles highlighting 'Five years of Trials' (http://www.trialsjournal.com/series/5years). The journal's achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonstrated progress on its objectives. These include the publication of raw data, extended versions of previously published trial-related articles, descriptions of 'lessons learned', negative results, and educational articles regarding ethics and reporting bias.

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.

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.

Background

Psychological models predict behaviour in a wide range of settings. The aim of this study was to explore the usefulness of a range of psychological models to predict the health professional behaviour 'referral for lumbar spine x-ray in patients presenting with low back pain' by UK primary care physicians.

Methods

Psychological measures were collected by postal questionnaire survey from a random sample of primary care physicians in Scotland and north England. The outcome measures were clinical behaviour (referral rates for lumbar spine x-rays), behavioural simulation (lumbar spine x-ray referral decisions based upon scenarios), and behavioural intention (general intention to refer for lumbar spine x-rays in patients with low back pain). Explanatory variables were the constructs within the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-Regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Weinstein's Stage Model termed the Precaution Adoption Process (PAP), and knowledge. For each of the outcome measures, a generalised linear model was used to examine the predictive value of each theory individually. Linear regression was used for the intention and simulation outcomes, and negative binomial regression was used for the behaviour outcome. Following this 'theory level' analysis, a 'cross-theoretical construct' analysis was conducted to investigate the combined predictive value of all individual constructs across theories.

Results

Constructs from TPB, SCT, CS-SRM, and OLT predicted behaviour; however, the theoretical models did not fit the data well. When predicting behavioural simulation, the proportion of variance explained by individual theories was TPB 11.6%, SCT 12.1%, OLT 8.1%, and II 1.5% of the variance, and in the cross-theory analysis constructs from TPB, CS-SRM and II explained 16.5% of the variance in simulated behaviours. When predicting intention, the proportion of variance explained by individual theories was TPB 25.0%, SCT 21.5%, CS-SRM 11.3%, OLT 26.3%, PAP 2.6%, and knowledge 2.3%, and in the cross-theory analysis constructs from TPB, SCT, CS-SRM, and OLT explained 33.5% variance in intention. Together these results suggest that physicians' beliefs about consequences and beliefs about capabilities are likely determinants of lumbar spine x-ray referrals.

Conclusions

The study provides evidence that taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour. However, a number of conceptual and methodological challenges remain.

Background

Health-system policy makers need timely access to synthesised research evidence to inform the policy-making process. No efforts to address this need have been evaluated using an experimental quantitative design. We developed an evidence service that draws inputs from Health Systems Evidence, which is a database of policy-relevant systematic reviews. The reviews have been (a) categorised by topic and type of review; (b) coded by the last year searches for studies were conducted and by the countries in which included studies were conducted; (c) rated for quality; and (d) linked to available user-friendly summaries, scientific abstracts, and full-text reports. Our goal is to evaluate whether a "full-serve" evidence service increases the use of synthesized research evidence by policy analysts and advisors in the Ontario Ministry of Health and Long-Term Care (MOHLTC) as compared to a "self-serve" evidence service.

Methods/design

We will conduct a two-arm randomized controlled trial (RCT), along with a follow-up qualitative process study in order to explore the findings in greater depth. For the RCT, all policy analysts and policy advisors (n = 168) in a single division of the MOHLTC will be invited to participate. Using a stratified randomized design, participants will be randomized to receive either the "full-serve" evidence service (database access, monthly e-mail alerts, and full-text article availability) or the "self-serve" evidence service (database access only). The trial duration will be ten months (two-month baseline period, six-month intervention period, and two month cross-over period). The primary outcome will be the mean number of site visits/month/user between baseline and the end of the intervention period. The secondary outcome will be participants' intention to use research evidence. For the qualitative study, 15 participants from each trial arm (n = 30) will be purposively sampled. One-on-one semi-structured interviews will be conducted by telephone on their views about and their experiences with the evidence service they received, how helpful it was in their work, why it was helpful (or not helpful), what aspects were most and least helpful and why, and recommendations for next steps.

Discussion

To our knowledge, this will be the first RCT to evaluate the effects of an evidence service specifically designed to support health-system policy makers in finding and using research evidence.

Trial registration

ClinicalTrials.gov: NCT01307228

Background

To support the use of research evidence by community-based organizations (CBOs) we have developed 'Synthesized HIV/AIDS Research Evidence' (SHARE), which is an evidence service for those working in the HIV sector. SHARE consists of several components: an online searchable database of HIV-relevant systematic reviews (retrievable based on a taxonomy of topics related to HIV/AIDS and open text search); periodic email updates; access to user-friendly summaries; and peer relevance assessments. Our objective is to evaluate whether this 'full serve' evidence service increases the use of research evidence by CBOs as compared to a 'self-serve' evidence service.

Methods/design

We will conduct a two-arm randomized controlled trial (RCT), along with a follow-up qualitative process study to explore the findings in greater depth. All CBOs affiliated with Canadian AIDS Society (n = 120) will be invited to participate and will be randomized to receive either the 'full-serve' version of SHARE or the 'self-serve' version (a listing of relevant systematic reviews with links to records on PubMed and worksheets that help CBOs find and use research evidence) using a simple randomized design. All management and staff from each organization will be provided access to the version of SHARE that their organization is allocated to. The trial duration will be 10 months (two-month baseline period, six-month intervention period, and two month crossover period), the primary outcome measure will be the mean number of logins/month/organization (averaged across the number of users from each organization) between baseline and the end of the intervention period. The secondary outcome will be intention to use research evidence as measured by a survey administered to one key decision maker from each organization. For the qualitative study, one key organizational decision maker from 15 organizations in each trial arm (n = 30) will be purposively sampled. One-on-one semi-structured interviews will be conducted by telephone on their views about and their experiences with the evidence service they received, how helpful it was in their work, why it was helpful (or not helpful), what aspects were most and least helpful and why, and recommendations for next steps.

Discussion

To our knowledge, this will be the first RCT to evaluate the effects of an evidence service specifically designed to support CBOs in finding and using research evidence.

Trial registration

ClinicalTrials.gov: NCT01257724

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 rapid and continuing progress in gene discovery for complex diseases is fueling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by previous reporting guidelines. These recommendations aim to enhance the transparency, quality and completeness of study reporting, and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis.

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.