Activities in Daily Living: The development of a new client-centred ADL intervention for persons with stroke

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Abstract

An intervention that contains several interacting components can be defined as a complex intervention. This intervention was developed in accordance with the Medical Research Council (MRC) guidance for complex interventions.

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

Peter Craig, Paul Dieppe, Sally Macintyre … (2008)

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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Process evaluation of complex interventions: Medical Research Council guidance

Graham Moore, Suzanne Audrey, Mary Barker … (2015)

Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies

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Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

Isabelle Boutron, David Moher, Douglas G. Altman … (2008)

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.