Intended for healthcare professionals


Getting the “balance” right in clinical trials

BMJ 2021; 375 doi: (Published 24 November 2021) Cite this as: BMJ 2021;375:n2869
  1. Christina Abdel Shaheed, academic fellow12,
  2. Fiona Blyth, professor1,
  3. Ann-Mason Furmage, consumer advocate and co-chair34,
  4. Fiona Stanaway, senior lecturer1
  1. 1Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
  2. 2Institute for Musculoskeletal Health, University of Sydney and Sydney Local Health District, Sydney, Australia
  3. 3Disability Action Plan Steering Group, Sydney Local Health District, Sydney, Australia
  4. 4Consumer Advisory Council, the Clinical Council and the Disability Action Plan Working Group, Sydney Dental Hospital, Sydney, Australia
  1. Correspondence to: C Abdel Shaheed

Co-interventions that could influence results must be recorded and reported

Co-interventions are additional treatments, advice, or other interventions received by trial participants that are not specified in the protocol and may influence a trial’s chosen outcomes.1 Poor reporting of co-interventions is relatively common and occurs across all health disciplines. Over two thirds of major cardiovascular trials, for example, did not adequately report co-interventions in a recent systematic review.2

Although the SPIRIT statement on reporting of trial protocols encourages researchers to consider co-interventions when designing a trial,3 there are currently no requirements to report these interventions in publications or other trial reports.456 International reporting checklists such as the CONSORT statement5 for randomised controlled trials and the STROBE statement6 do not contain specific items on co-interventions.

Clinical trials inform decisions made by patients, clinicians, guideline committees, and policy makers.7 It is therefore critical for researchers to report …

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