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Development of a Core Set of Outcomes for Randomized Controlled Trials with Multiple Outcomes – Example of Pulp Treatments of Primary Teeth for Extensive Decay in Children

Author

Listed:
  • Violaine Smaïl-Faugeron
  • Hélène Fron Chabouis
  • Pierre Durieux
  • Jean-Pierre Attal
  • Michèle Muller-Bolla
  • Frédéric Courson

Abstract

Objectives: Evidence-based comparisons of interventions can be challenging because of the diversity of outcomes in randomized controlled trials (RCTs). We aimed to describe outcomes in RCTs assessing pulp treatments for primary teeth and to develop a core set of component outcomes to be part of composite outcome defining the failure of a pulp treatment. Methods: We systematically reviewed articles of RCTs comparing pulp treatments for primary molars published up to February 2012. We abstracted all outcomes assessed in each trial, then used a small-group consensus process to group similar outcomes, which were reduced to a composite outcome of failure of a pulp treatment by a 3-round Delphi process involving expert authors and dentists. Results: We included 47 reports of RCTs in the review, for 83 reported outcomes (median 11 outcomes per RCT). These outcomes were grouped into 24 overarching outcome categories. We contacted 210 experts for the Delphi process and 25% to 30% participated. The process identified the following 5 component outcomes as part of a composite outcome of failure of a pulp treatment: soft-tissue pathology, pain, pathologic mobility, pathologic radiolucency and pathologic root resorption. Conclusions: RCTs of pulp treatments for primary teeth investigate diverse outcomes. Our consensus process, involving clinicians but no patient, allowed for compiling a core set of component outcomes to define the composite outcome failure of a pulp treatment for primary teeth.

Suggested Citation

  • Violaine Smaïl-Faugeron & Hélène Fron Chabouis & Pierre Durieux & Jean-Pierre Attal & Michèle Muller-Bolla & Frédéric Courson, 2013. "Development of a Core Set of Outcomes for Randomized Controlled Trials with Multiple Outcomes – Example of Pulp Treatments of Primary Teeth for Extensive Decay in Children," PLOS ONE, Public Library of Science, vol. 8(1), pages 1-9, January.
    • Handle: RePEc:plo:pone00:0051908
    DOI: 10.1371/journal.pone.0051908
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    References listed on IDEAS

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    1. Fink, A. & Kosecoff, J. & Chassin, M. & Brook, R.H., 1984. "Consensus methods: Characteristics and guidelines for use," American Journal of Public Health, American Public Health Association, vol. 74(9), pages 979-983.
    2. Kerry Dwan & Douglas G Altman & Juan A Arnaiz & Jill Bloom & An-Wen Chan & Eugenia Cronin & Evelyne Decullier & Philippa J Easterbrook & Erik Von Elm & Carrol Gamble & Davina Ghersi & John P A Ioannid, 2008. "Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias," PLOS ONE, Public Library of Science, vol. 3(8), pages 1-31, August.
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    1. Katherine Davis & Sarah L Gorst & Nicola Harman & Valerie Smith & Elizabeth Gargon & Douglas G Altman & Jane M Blazeby & Mike Clarke & Sean Tunis & Paula R Williamson, 2018. "Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries," PLOS ONE, Public Library of Science, vol. 13(2), pages 1-14, February.

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