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Poor adherence of randomised trials in surgery to CONSORT guidelines for non-pharmacological treatments (NPT): a cross-sectional study
  1. Myura Nagendran1,
  2. Daniel Harding2,
  3. Wendy Teo3,
  4. Christian Camm4,
  5. Mahiben Maruthappu5,
  6. Peter McCulloch6,
  7. Sally Hopewell7,8
  1. 1Green Templeton College, University of Oxford, Oxford, UK
  2. 2Magdalen College, University of Oxford, Oxford, UK
  3. 3Keble College, University of Oxford, Oxford, UK
  4. 4New College, University of Oxford, Oxford, UK
  5. 5Brigham and Women's Hospital, Center for Surgery and Public Health, Boston, USA
  6. 6Nuffield Department of Surgery, John Radcliffe Hospital, University of Oxford, Oxford, UK
  7. 7Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  8. 8INSERM U738 Paris, France; Centre d’Épidémiologie Clinique, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Paris, France
  1. Correspondence to Dr Myura Nagendran; myura.nagendran{at}imperial.ac.uk

Abstract

Objective To systematically assess adherence of randomised trials in surgery to Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-pharmacological treatments (NPT). Surgical trials are considered more difficult to design and execute than pharmacological trials. Furthermore, the original CONSORT statement does not address some aspects that are vital to the transparent reporting of surgical trials. The CONSORT-NPT extension was designed to address these issues but adherence in medical and surgical journals has not been assessed.

Design Cross-sectional study.

Sample We identified eight general medical and eight surgical journals, indexed in PubMed and published in 2011, with the highest impact factors in their respective categories.

Main outcomes Adherence to CONSORT statement and CONSORT-NPT extension items.

Results We identified 54 surgical trials (22 published in medical journals and 32 in surgical journals). There were eight items for which there was less than 30% overall compliance (seven were specific to the CONSORT-NPT extension). These seven items are related to: a full description of the care providers, centres and blinding status in the abstract (n=7/54, 13%), eligibility criteria for centres performing the interventions (n=13/54, 24%), how adherence of care providers with the protocol was assessed or enhanced (n=7/54, 13%), how clustering by care providers or centres was addressed as it relates to sample size (n=3/54, 6%), how care providers were allocated to each group (n=9/54, 17%), how clustering by care providers or centres was addressed as it relates to statistical methods (n=2/54, 4%), a description of care providers (case volume, qualification, expertise, etc) and centres (volume) in each group (n=0/54, 0%).

Conclusions Adherence of surgical trials to CONSORT-NPT extension items is much poorer than to the standard CONSORT statement. Adherence also appears to be superior in general medical journals compared with surgical journals. Raising awareness and conducting qualitative research to identify areas for specific intervention will be important going forward.

  • SURGERY

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