Martin P Eccles

Welcome to Implementation Science

AbstractImplementation research is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care. This relatively new field includes the study of influences on healthcare professional and organisational behaviour.nImplementation Science will encompass all aspects of research in this field, in clinical, community and policy contexts. This online journal will provide a unique platform for this type of research and will publish a broad range of articles – study protocols, debate, theoretical and conceptual articles, rigorous evaluations of the process of change, and articles on methodology and rigorously developed tools – that will enhance the development and refinement of implementation research. No one discipline, research design, or paradigm will be favoured.nImplementation Science looks forward to receiving manuscripts that facilitate the continued development of the field, and contribute to healthcare policy and practice.

The Diabetes Health Profile (DHP): a new instrument for assessing the psychosocial profile of insulin requiring patients--development and psychometric evaluation.

The aim of the studies was to evaluate the psychometric properties and construct validity of the Diabetes Health Profile (DHP-1). Content for the DHP-1 was derived following in-depth interviews with 25 insulin dependent and insulin requiring patients, a review of the literature and discussions with health care professionals. Initial analysis of the factor structure of the DHP-1 was carried out on the responses of 239 insulin dependent and insulin requiring patients, with a mean age of 40.85 years (SD=13.0), resulting in a 43 item three factor solution. The 43 item version of the DHP-1 was completed by 2,239 insulin dependent/requiring patients (mean age = 39.8, SD=10) years. Fifty-one per cent were men. A forced three factor Principal Factoring Analysis with varimax rotation was carried out. Eleven items were excluded with item factor cross loadings >0.30 or item factor loadings <0.30. PAF analysis of the 32 items resulted in a three factor solution accounting for 33% of the total explained variance. The three factors were interpreted as Psychological Distress, Barriers to Activity and Disnhibited Eating. Factor congruence between subsamples were: Psychological distress (0.93), Barriers to Activity (0.93) and Disinhibited Eating (0.99). Coefficients of congruence between men and women were 0.94, 0.92 and 0.99 for Psychological Distress, Barriers to Activity and Disinhibited Eating respectively. Internal consistency of the three factors (Cronbachs α) were: Psychological Distress (0.86), Barriers to Activity (0.82), and Disinhibited Eating (0.77). Construct-convergent validity was investigated on a sample of 233 insulin dependent and insulin requiring patients (mean age = 51.46 years). Psychological Distress and Barriers to Activity subscales correlated with the Hospital Depression and Anxiety Scale = 0.50 to 0.62, p<0.01 and subscales of the SF-36 (range: r=−0.17 to -0.62, p<0.01). These findings lend support to the construct validity and reliability of the DHP-1 and that it is suitable for further development.

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.

Development of a symptom based outcome measure for asthma.

Measuring symptom specific health outcome is complex, but the methodologies now exist to develop measures with the appropriate properties. As one element of a major programme to develop multidomain health outcome measures for chronic disease, a symptom based measure for asthma care has been developed for use in general practice and outpatient departments. This article outlines the development process, which used a framework recently described in the theoretical literature to show the constraints that scientific criteria place on the development of outcome measures and the means of overcoming such limiting factors. Although substantial effort is required to undertake a rigorous process of development, useful tools are the result. Two five item, symptom based outcome measures for adult asthma are described.

Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool

Objective: To understand participants’ experiences and understandings of the interventions in the trial of a computerised decision support tool in patients with atrial fibrillation being considered for anti-coagulation treatment. Design: Qualitative process evaluation carried out alongside the trial: non-participant observation and semistructured interviews. Participants: 30 participants aged >60 years taking part in the trial of a computerised decision support tool. Results: Qualitative evidence provided the rationale to undertake a decision to discontinue one arm of the trial on the basis that the intervention in that arm, a standard gamble values elicitation exercise was causing confusion and was unlikely to produce valid data on participant values. Conclusions: Qualitative methods used alongside a trial allow an understanding of the process and progress of a trial, and provide evidence to intervene in the trial if necessary, including evidence for the rationale to discontinue an intervention arm of the trial.

Ethical issues in implementation research: a discussion of the problems in achieving informed consent.

BackgroundImproved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.DiscussionThe appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.SummaryWhile ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees.

A new self-completion outcome measure for diabetes: is it responsive to change?

Self-completion instruments assessing subjective health are increasingly being used to measure patient outcome. However, there is very little evidence as yet of existing instruments responsiveness to change. This paper describes a study to evaluate the responsiveness to change of a self-completion instrument for the measurement of clinical outcome in patients with diabetes. A prospective follow-up study of 48 patients with non-insulin-dependent diabetes commencing insulin therapy was carried out, with assessments at baseline (i.e. pre-intervention), 6 weeks and 3 months post-intervention. The outcome measures used were the changes in scores on the self-completion instrument for symptom level, physical function, energy, depression, psychological distress and barriers to activity, HbA1c, non-fasting serum cholesterol and the body mass index (BMI). There were significant improvements in HbA1c and non-fasting serum cholesterol and worsening of the BMI, as expected. The self-completion instrument detected significant improvements in patient-reported symptoms within 6 weeks of the intervention (p<0.01) and in energy levels (p<0.05). There is evidence from this study of the self-completion instruments ability to respond to change and it has potential for use in evaluative studies.

A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030].

BackgroundWhilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide extended system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines.MethodsThe study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial

AbstractBackgroundFollowing the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide extended, computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines.MethodsThe study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations.ResultsPatients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these.ConclusionThis study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality.nTrial registration: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Is organizational justice associated with clinical performance in the care for patients with diabetes in primary care? Evidence from the improving Quality of care in Diabetes study

BACKGROUNDnType 2 diabetes is an increasingly prevalent illness, and there is considerable variation in the quality of care provided to patients with diabetes in primary care.nnnOBJECTIVESnThe aim of this study was to explore whether organizational justice and organizational citizenship behaviour are associated with the behaviours of clinical staff when providing care for patients with diabetes.nnnMETHODSnThe data were from an ongoing prospective multicenter study, the improving Quality of care in Diabetes (iQuaD) study. Participants (N = 467) were clinical staff in 99 primary care practices in the UK. The outcome measures were six self-reported clinical behaviours: prescribing for glycaemic control, prescribing for blood pressure control, foot examination, giving advice about weight management, providing general education about diabetes and giving advice about self-management. Organizational justice perceptions were collected using a self-administered questionnaire. The associations between organizational justice and behavioural outcomes were tested using linear multilevel regression modelling.nnnRESULTSnHigher scores on the procedural component of organizational justice were associated with more frequent weight management advice, self-management advice and provision of general education for patients with diabetes. The associations between justice and clinical behaviours were not explained by individual or practice characteristics, but evidence was found for the partial mediating role of organizational citizenship behaviour.nnnCONCLUSIONSnQuality improvement efforts aimed at increasing advice and education provision in diabetes management in primary care could target also perceptions of procedural justice.