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      Developing and evaluating complex interventions: the new Medical Research Council guidance

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          Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance

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          Most cited references 28

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          Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

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            A taxonomy of behavior change techniques used in interventions.

            Without standardized definitions of the techniques included in behavior change interventions, it is difficult to faithfully replicate effective interventions and challenging to identify techniques contributing to effectiveness across interventions. This research aimed to develop and test a theory-linked taxonomy of generally applicable behavior change techniques (BCTs). Twenty-six BCTs were defined. Two psychologists used a 5-page coding manual to independently judge the presence or absence of each technique in published intervention descriptions and in intervention manuals. Three systematic reviews yielded 195 published descriptions. Across 78 reliability tests (i.e., 26 techniques applied to 3 reviews), the average kappa per technique was 0.79, with 93% of judgments being agreements. Interventions were found to vary widely in the range and type of techniques used, even when targeting the same behavior among similar participants. The average agreement for intervention manuals was 85%, and a comparison of BCTs identified in 13 manuals and 13 published articles describing the same interventions generated a technique correspondence rate of 74%, with most mismatches (73%) arising from identification of a technique in the manual but not in the article. These findings demonstrate the feasibility of developing standardized definitions of BCTs included in behavioral interventions and highlight problematic variability in the reporting of intervention content.
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              Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

              Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field.

                Author and article information

                Role: programme manager
                Role: professor
                Role: director
                Role: professor
                Role: director
                Role: professor
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                29 September 2008
                : 337
                [1 ]MRC Population Health Sciences Research Network, Glasgow G12 8RZ
                [2 ]Nuffield Department of Orthopaedic Surgery, University of Oxford, Nuffield Orthopaedic Centre, Oxford OX3 7LD
                [3 ]MRC Social and Public Health Sciences Unit, Glasgow G12 8RZ
                [4 ]Centre for Outcomes Research and Effectiveness, University College London, London WC1E 7HB
                [5 ]MRC General Practice Research Framework, London NW1 2ND
                [6 ]Public and Environmental Health Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London WC1E 7HT
                Author notes
                Correspondence to: P Craig peter@
                © BMJ Publishing Group Ltd 2008
                Research Methods and Reporting



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