International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy
Beuscart, Jean-Baptiste; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Jansen, Paul A F; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne
(2018) BMC Medicine, volume 16, issue 1
(Article)
Abstract
BACKGROUND: Comparisons of clinical trial findings in systematic reviews can be hindered by the heterogeneity of the outcomes reported. Moreover, the outcomes that matter most to patients might be underreported. A core outcome set can address these issues, as it defines a minimum set of outcomes that should be reported
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in all clinical trials in a particular area of research. The objective in this study was to develop a core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy. METHODS: Firstly, eligible outcomes were identified through a systematic review of trials of medication review in older patients (≥65 years) and interviews with 15 older patients. Secondly, an international three-round Delphi survey in four countries involving patients, healthcare professionals, and experts was conducted to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. RESULTS: Of the 164 participants invited to take part in the Delphi survey, 150 completed Round 1, including 55 patients or family caregivers, 55 healthcare professionals, and 40 experts. A total of 129 participants completed all three rounds. Sixty-four eligible outcomes were extracted from 47 articles, 32 clinical trial protocols, and patient interviews. Thirty outcomes were removed and one added after Round 1, 18 outcomes were removed after Round 2, and seven after Round 3. Results were discussed during consensus meetings. Consensus was reached on seven outcomes, which constitute the core outcome set: drug-related hospital admissions; drug overuse; drug underuse; potentially inappropriate medications; clinically significant drug-drug interactions; health-related quality of life; pain relief. CONCLUSIONS: We developed a core outcome set of seven outcomes which should be used in future trials of medication review in multi-morbid older patients with polypharmacy.
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Keywords: Consensus, Core outcome set, Delphi survey, Medication review, Multi-morbidity, Older patients, Polypharmacy, General Medicine
ISSN: 1741-7015
Publisher: BioMed Central
Note: Funding Information: This work is part of the OPERAM project supported by the European Union's Horizon 2020 research and innovation programme under grant agreement number 6342388, and by SERI under contract number 15.0137. The funding bodies did not play any role in the design of the study or in collection, analysis, and interpretation of data, or in writing the manuscript. Funding Information: This work is part of the project OPERAM: OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly supported by the European Union's Horizon 2020 research and innovation programme under grant agreement number 6342388, and by the Swiss State Secretariat for Education, Research and Innovation (SERI) under contract number 15.0137. The opinions expressed and arguments employed herein are those of the authors and do not necessarily reflect the official views of the EC and the Swiss government. The authors are grateful to all the patients, health professionals, researchers, and other experts who gave up their time to participate in the Delphi surveys and consensus meetings. The health professionals and experts who consented to have their name cited and participated in this study are listed here in alphabetical order: S. Armitage, I. Aujoulat, L. Bachely, G. Beuken, J. E. M. Bootsma, P. Cornette, M. De Jonghe, C. T. M. de Kanter, M. De Saint Hubert, M. De Schuiteneer, P. D'Ottrepe, W. R. Doucette, R. A. Elliott, T. P. Fahey, V. Flabat, P. Gallagher, H. C. J. Geers, T. Grimes, J. Gussekloo, M. Hanset, W. J. Hoffmann, C. Hughes, C. Huizinga, C. J. P. W. Keizers, M-L. Laroche, E. Lechanteur, V. M. Maio, Z. A. Marcum, A. McGillicuddy, J. R. Mort, A. Mouzon, G. Önder, D. O'Riordan, A. Peltier, J. Petermans, M. Petrovic, D. Petty, K. Power, S. Prins, D. K. T. Raynor, S. Ronan, L. Roughead, C. Ryan, C. Schunk, S. Shakib, C. Sinnott, F. Slooter, S. Smulders, M. E. Snyder, M. A. Steinman, J. Straand, R. M. Tamblyn, C. Tannenbaum, J. Turner, P. Van Den Bemt, C. J. A. van der Linden, F. van Gorp, D. G. van Harten-Krouwel, P. Vanmeerbeek, R. W. Vingerhoets, K. Walsh, D. Weir, M. A. Weterman, J. A. M. Witte. We would also like to thank, for their invaluable help and constructive advice, Prof. Marteen Boers and Dr Liz Gargon. We would also like to thank Kaoutar Abdellaoui and Emilie Lamy for the excellent quality of their work during the analysis of the qualitative study. Publisher Copyright: © 2018 The Author(s).
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