Noninferiority Margin Size and Acceptance of Trial Results: Contingent Valuation Survey of Clinician Preferences for Noninferior Mortality

Sandra Pong, Robert A. Fowler, Nicholas Mitsakakis, Srinivas Murthy, Jeffrey M. Pernica, Elaine Gilfoyle, Asha Bowen, Patricia Fontela, Winnie Seto, Michelle Science, James S. Hutchison, Philippe Jouvet, Asgar Rishu and Nick Daneman
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Sandra Pong: Department of Pharmacy, The Hospital for Sick Children, Toronto, ON, Canada
Robert A. Fowler: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto ON, Canada
Nicholas Mitsakakis: Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada
Srinivas Murthy: Department of Pediatrics, Division of Critical Care, University of British Columbia, Vancouver, BC, Canada
Jeffrey M. Pernica: Division of Infectious Diseases, McMaster University, Hamilton, ON, Canada
Elaine Gilfoyle: Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, ON, Canada
Asha Bowen: Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia Perth Children’s Hospital, Nedlands, WA, Australia
Patricia Fontela: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada
Winnie Seto: Department of Pharmacy, The Hospital for Sick Children, Toronto, ON, Canada
Michelle Science: Division of Infectious Diseases, Department of Paediatric Medicine, The Hospital for Children, Toronto, ON, Canada
James S. Hutchison: Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, ON, Canada
Philippe Jouvet: Pediatric Intensive Care Unit, Sainte-Justine Hospital University Center, Montreal, QC, Canada
Asgar Rishu: Critical Care Research Unit, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
Nick Daneman: Division of Infectious Diseases, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

Medical Decision Making, 2022, vol. 42, issue 6, 832-836

Abstract: Objectives We used modified contingent valuation methodology to determine how noninferiority margin sizes influence clinicians’ willingness to accept clinical trial results that compare mortality in critically ill children. Methods We surveyed pediatric infectious diseases and critical care clinicians in Canada, Australia, and New Zealand and randomized respondents to review 1 of 9 mock abstracts describing a noninferiority trial of bacteremic critically ill children assigned to 7 or 14 d of antibiotics. Each scenario showed higher mortality in the 7-d group but met noninferiority criterion. We explored how noninferiority margins and baseline mortality rates influenced respondent acceptance of results. Results There were 106 survey respondents: 65 (61%) critical care clinicians, 28 (26%) infectious diseases physicians, and 13 (12%) pharmacists. When noninferiority margins were 5% and 10%, 73% (24/33) and 79% (27/33) respondents would accept shorter treatment, compared with 44% (17/39) when the margin was 20% ( P = 0.003). Logistic regression adjusted for baseline mortality showed 5% and 10% noninferiority margins were more likely to be associated with acceptance of shorter treatment compared with 20% margins (odds ratio [OR] 3.5, 95% confidence interval [CI]: 1.3–9.6, P = 0.013; OR 5.1, 95% CI: 1.8–14.6, P = 0.002). Baseline mortality was not a significant predictor of acceptance of shorter treatment. Conclusions Clinicians are more likely to accept shorter treatment when noninferiority margins are ≤10%. However, nearly half of respondents who reviewed abstracts with 20% margins were still willing to accept shorter treatment. This is a novel application of contingent valuation methodology to elicit acceptance of research results among end users of the medical literature. Highlights Clinicians are more likely to accept shorter treatment durations based on noninferior mortality results when the noninferiority margin is 5% or 10% than if the margin is 20%. However, nearly half of clinicians would still accept shorter-duration treatment as noninferior with margins of 20%. Baseline mortality does not independently predict acceptance of shorter-duration treatment. Contingent valuation is a novel approach to elicit the acceptance of research design parameters from the perspective of endusers of the medical literature.

Keywords: antimicrobials; contingent valuation; duration of therapy; evidence uptake; mortality; noninferiority margin (search for similar items in EconPapers)
Date: 2022
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Persistent link: https://EconPapers.repec.org/RePEc:sae:medema:v:42:y:2022:i:6:p:832-836

DOI: 10.1177/0272989X221099493

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