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Reproducible research practices, openness and transparency in health economic evaluations: study protocol for a cross-sectional comparative analysis
  1. Ferrán Catalá-López1,2,3,
  2. Lisa Caulley3,4,5,6,
  3. Manuel Ridao7,
  4. Brian Hutton3,8,
  5. Don Husereau9,10,
  6. Michael F Drummond11,
  7. Adolfo Alonso-Arroyo12,13,
  8. Manuel Pardo-Fernández14,
  9. Enrique Bernal-Delgado7,
  10. Ricard Meneu15,
  11. Rafael Tabarés-Seisdedos2,
  12. José Ramón Repullo1,
  13. David Moher3,8
  1. 1 Department of Health Planning and Economics, National School of Public Health, Institute of Health Carlos III, Madrid, Spain
  2. 2 Department of Medicine, University of Valencia/INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain
  3. 3 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  4. 4 Otolaryngology-Head and Neck Surgery Department, Ottawa Hospital, Ottawa, Ontario, Canada
  5. 5 Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands
  6. 6 Ear, Nose and Throat Department, Guy's Hospital, London, UK
  7. 7 Instituto Aragonés de Ciencias de la Salud (IACS), Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Zaragoza, Spain
  8. 8 School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
  9. 9 Institute of Health Economics, Edmonton, Alberta, Canada
  10. 10 Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  11. 11 Centre for Health Economics, University of York, York, UK
  12. 12 Department of History of Science and Documentation, University of Valencia, Valencia, Spain
  13. 13 Information and Social and Health Research Unit (UISYS), University of Valencia and Spanish National Research Council (CSIC), Valencia, Spain
  14. 14 Spanish Medicines and Healthcare Products Agency (AEMPS), Madrid, Spain
  15. 15 Fundación Instituto de Investigación en Servicios de Salud, Valencia, Spain
  1. Correspondence to Dr Ferrán Catalá-López; ferran_catala{at}outlook.com

Abstract

Introduction There has been a growing awareness of the need for rigorously and transparent reported health research, to ensure the reproducibility of studies by future researchers. Health economic evaluations, the comparative analysis of alternative interventions in terms of their costs and consequences, have been promoted as an important tool to inform decision-making. The objective of this study will be to investigate the extent to which articles of economic evaluations of healthcare interventions indexed in MEDLINE incorporate research practices that promote transparency, openness and reproducibility.

Methods and analysis This is the study protocol for a cross-sectional comparative analysis. We registered the study protocol within the Open Science Framework (osf.io/gzaxr). We will evaluate a random sample of 600 cost-effectiveness analysis publications, a specific form of health economic evaluations, indexed in MEDLINE during 2012 (n=200), 2019 (n=200) and 2022 (n=200). We will include published papers written in English reporting an incremental cost-effectiveness ratio in terms of costs per life years gained, quality-adjusted life years and/or disability-adjusted life years. Screening and selection of articles will be conducted by at least two researchers. Reproducible research practices, openness and transparency in each article will be extracted using a standardised data extraction form by multiple researchers, with a 33% random sample (n=200) extracted in duplicate. Information on general, methodological and reproducibility items will be reported, stratified by year, citation of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement and journal. Risk ratios with 95% CIs will be calculated to represent changes in reporting between 2012–2019 and 2019–2022.

Ethics and dissemination Due to the nature of the proposed study, no ethical approval will be required. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences. Study findings will be disseminated at scientific conferences and published in peer-reviewed journals.

  • cost-effectiveness analysis
  • data sharing
  • methodology
  • quality
  • reporting
  • reproducibility
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Twitter @donhusereau, @chromosome8, @repunomada, @dmoher

  • Contributors All authors contributed to conceptualising and designing the study. FC-L drafted the manuscript. LC, MR, BH, DH, MFD, AA-A, MP-F, EB-D, RM, RT-S, JRR and DM commented for important intellectual content and made revisions. All authors read and approved the final version of the manuscript. FC-L accepts full responsibility for the finished manuscript and controlled the decision to publish.

  • Funding FC-L and RT-S are supported by the Institute of Health Carlos III/CIBERSAM. BH is supported by a New Investigator Award from the Canadian Institutes of Health Research and the Drug Safety and Effectiveness Network. MR and EB-D are supported by the Institute of Health Carlos III/Spanish Health Services Research on Chronic Patients Network (REDISSEC). DM is supported by a University Research Chair, University of Ottawa. The funders were not involved in the design of the protocol or decision to submit the protocol for publication nor will they be involved in any aspect of the study conduct.

  • Disclaimer The views expressed in this manuscript are those of the authors and many not be understood or quoted as being made on behalf of, or reflecting the position of, the funder(s) or any institution.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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