Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Trials
Bridget CandyMichael King

Abstract

Inadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving. We aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting...Continue Reading

References

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Citations

Mar 22, 2019·Clinical Trials : Journal of the Society for Clinical Trials·Ethan Basch, Allison Barz Leahy
Dec 4, 2019·BMC Medical Research Methodology·Jose Francisco Meneses-EchavezJulia Bidonde
May 2, 2020·International Journal of Environmental Research and Public Health·Justine TrompetteFrançois Alla
Aug 22, 2018·Pilot and Feasibility Studies·Ho-Yan Yvonne ChunWilliam N Whiteley
Jul 17, 2020·Journal of the American Medical Directors Association·Carole RatsimbazafyPatrick Hindlet
Jun 21, 2021·Journal of Physiotherapy·Katharine ScrivenerSarah Tyson
Jun 23, 2020·Journal of Hand Therapy : Official Journal of the American Society of Hand Therapists·Jennifer O'NeilMarie Deanna Westby
Apr 27, 2020·Gynecologic Oncology·Fabrice LecuruBernard Asselain

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Software Mentioned

CONSORT
EQUATOR
TIDieR
Stata
Ovid
ProQuest

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