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.

Background

Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders.

Methods

We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.

Background

Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set.

Methods

A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries.

Results

Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005–February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% – 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% – 33.5%) completed the key clinical and methodological data fields.

Conclusion

While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.

Complex behaviour change interventions are not well described; when they are described, the terminology used is inconsistent. This constrains scientific replication, and limits the subsequent introduction of successful interventions. Implementation Science is introducing a policy of initially encouraging and subsequently requiring the scientific reporting of complex behaviour change interventions.

Background

Practice guidelines can improve health care delivery and outcomes but several issues challenge guideline adoption, including their intrinsic attributes, and whether and how they are implemented. It appears that guideline format may influence accessibility and ease of use, which may overcome attitudinal barriers of guideline adoption, and appear to be important to all stakeholders. Guideline content may facilitate various forms of decision making about guideline adoption relevant to different stakeholders. Knowledge and attitudes about, and incentives and capacity for implementation on the part of guideline sponsors may influence whether and how they develop guidelines containing these features, and undertake implementation. Examination of these issues may yield opportunities to improve guideline adoption.

Methods

The attributes hypothesized to facilitate adoption will be expanded by thematic analysis, and quantitative and qualitative summary of the content of international guidelines for two primary care (diabetes, hypertension) and institutional care (chronic ulcer, chronic heart failure) topics. Factors that influence whether and how guidelines are implemented will be explored by qualitative analysis of interviews with individuals affiliated with guideline sponsoring agencies.

Discussion

Previous research examined guideline implementation by measuring rates of compliance with recommendations or associated outcomes, but this produced little insight on how the products themselves, or their implementation, could be improved. This research will establish a theoretical basis upon which to conduct experimental studies to compare the cost-effectiveness of interventions that enhance guideline development and implementation capacity. Such studies could first examine short-term outcomes predictive of guideline utilization, such as recall, attitude toward, confidence in, and adoption intention. If successful, then long-term objective outcomes reflecting the adoption of processes and associated patient care outcomes could be evaluated.

Background

Since being identified as a concept for understanding knowledge sharing, management, and creation, communities of practice (CoPs) have become increasingly popular within the health sector. The CoP concept has been used in the business sector for over 20 years, but the use of CoPs in the health sector has been limited in comparison.

Objectives

First, we examined how CoPs were defined and used in these two sectors. Second, we evaluated the evidence of effectiveness on the health sector CoPs for improving the uptake of best practices and mentoring new practitioners.

Methods

We conducted a search of electronic databases in the business, health, and education sectors, and a hand search of key journals for primary studies on CoP groups. Our research synthesis for the first objective focused on three areas: the authors' interpretations of the CoP concept, the key characteristics of CoP groups, and the common elements of CoP groups. To examine the evidence on the effectiveness of CoPs in the health sector, we identified articles that evaluated CoPs for improving health professional performance, health care organizational performance, professional mentoring, and/or patient outcome; and used experimental, quasi-experimental, or observational designs.

Results

The structure of CoP groups varied greatly, ranging from voluntary informal networks to work-supported formal education sessions, and from apprentice training to multidisciplinary, multi-site project teams. Four characteristics were identified from CoP groups: social interaction among members, knowledge sharing, knowledge creation, and identity building; however, these were not consistently present in all CoPs. There was also a lack of clarity in the responsibilities of CoP facilitators and how power dynamics should be handled within a CoP group. We did not find any paper in the health sector that met the eligibility criteria for the quantitative analysis, and so the effectiveness of CoP in this sector remained unclear.

Conclusion

There is no dominant trend in how the CoP concept is operationalized in the business and health sectors; hence, it is challenging to define the parameters of CoP groups. This may be one of the reasons for the lack of studies on the effectiveness of CoPs in the health sector. In order to improve the usefulness of the CoP concept in the development of groups and teams, further research will be needed to clarify the extent to which the four characteristics of CoPs are present in the mature and emergent groups, the expectations of facilitators and other participants, and the power relationship within CoPs.

Background

In the experience of health professionals, it appears that interacting with peers in the workplace fosters learning and information sharing. Informal groups and networks present good opportunities for information exchange. Communities of practice (CoPs), which have been described by Wenger and others as a type of informal learning organization, have received increasing attention in the health care sector; however, the lack of uniform operating definitions of CoPs has resulted in considerable variation in the structure and function of these groups, making it difficult to evaluate their effectiveness.

Objective

To critique the evolution of the CoP concept as based on the germinal work by Wenger and colleagues published between 1991 and 2002.

Discussion

CoP was originally developed to provide a template for examining the learning that happens among practitioners in a social environment, but over the years there have been important divergences in the focus of the concept. Lave and Wenger's earliest publication (1991) centred on the interactions between novices and experts, and the process by which newcomers create a professional identity. In the 1998 book, the focus had shifted to personal growth and the trajectory of individuals' participation within a group (i.e., peripheral versus core participation). The focus then changed again in 2002 when CoP was applied as a managerial tool for improving an organization's competitiveness.

Summary

The different interpretations of CoP make it challenging to apply the concept or to take full advantage of the benefits that CoP groups may offer. The tension between satisfying individuals' needs for personal growth and empowerment versus an organization's bottom line is perhaps the most contentious of the issues that make CoPs difficult to cultivate. Since CoP is still an evolving concept, we recommend focusing on optimizing specific characteristics of the concept, such as support for members interacting with each other, sharing knowledge, and building a sense of belonging within networks/teams/groups. Interventions that facilitate relationship building among members and that promote knowledge exchange may be useful for optimizing the function of these groups.

Background

Type 2 diabetes is an increasingly prevalent chronic illness and is an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of the primary care team. Studies of the quality of care for patients with diabetes suggest less than optimum care in a number of areas.

Aim

The aim of this study is to improve the quality of care for patients with diabetes cared for in primary care in the UK by identifying individual, team, and organisational factors that predict the implementation of best practice.

Design

Participants will be clinical and non-clinical staff within 100 general practices sampled from practices who are members of the MRC General Practice Research Framework. Self-completion questionnaires will be developed to measure the attributes of individual health care professionals, primary care teams (including both clinical and non-clinical staff), and their organisation in primary care. Questionnaires will be administered using postal survey methods. A range of validated theories will be used as a framework for the questionnaire instruments. Data relating to a range of dimensions of the organisational structure of primary care will be collected via a telephone interview at each practice using a structured interview schedule. We will also collect data relating to the processes of care, markers of biochemical control, and relevant indicator scores from the quality and outcomes framework (QOF). Process data (as a proxy indicator of clinical behaviours) will be collected from practice databases and via a postal questionnaire survey of a random selection of patients from each practice. Levels of biochemical control will be extracted from practice databases. A series of analyses will be conducted to relate the individual, team, and organisational data to the process, control, and QOF data to identify configurations associated with high quality care.

Study registration

UKCRN ref:DRN120 (ICPD)