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Time to improve the reporting of harms in randomized controlled trials

      Estimates of treatment effects in randomized controlled trials (RCTs) are comprised of efficacy and harm outcomes. Similarly, treatment decisions rely on accurate knowledge of both efficacy and harms. Harms can be measured as pre-specified outcomes and may be detected through systematic assessment (e.g., checklists or laboratory tests) or emergent non-anticipated events detected through systematic or non-systematic assessment (e.g., regular application of questionnaires (systematic) or spontaneous reporting (non-systematic)) [
      • Hodkinson A
      • Kirkham JJ
      • Tudur-Smith C
      • Gamble C
      Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension.
      ,
      • Zarin DA
      • Tse T
      • Williams RJ
      • Carr S
      Trial Reporting in ClinicalTrials.gov - The Final Rule.
      . The frequency of harm outcomes detected in RCTs vary depending on how the outcomes were collected, the frequency of the collection, and also on factors such as the condition under investigation, the investigational treatment, demographic characteristics of the participants, and time dependence between treatment implementation and the development of the adverse event. The many different ways to identify and measure harms in RCTs generates multitudes of complex data and arbitrary decisions regarding reporting are often used [
      • Saini P
      • Loke YK
      • Gamble C
      • Altman DG
      • Williamson PR
      • Kirkham JJ
      Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.
      ]. To compound the problem, clinical trials are typically designed, analyzed and reported to focus on efficacy outcomes [
      • Califf RM
      • Zarin DA
      • Kramer JM
      • Sherman RE
      • Aberle LH
      • Tasneem A
      Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.
      ], and harms tend to receive less attention at both the design stage as well as in reports of published RCTs [
      • Scurr JH
      • Machin SJ
      • Bailey-King S
      • Mackie
      • McDonald S
      • Smith PDC
      Frequency and prevention of symptomless deep-vein thrombosis in long-haul flights: a randomised trial.
      ,
      • Cornelius VR
      • Sauzet O
      • Williams JE
      • Ayis S
      • Farquhar-Smith P
      • Ross JR
      • et al.
      Adverse event reporting in randomised controlled trials of neuropathic pain: Considerations for future practice.
      .

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