Quantitative benefit–harm assessment for setting research priorities: the example of roflumilast for patients with COPDReport as inadecuate




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BMC Medicine

, 13:157

First Online: 02 July 2015Received: 07 November 2014Accepted: 12 June 2015DOI: 10.1186-s12916-015-0398-0

Cite this article as: Puhan, M.A., Yu, T., Boyd, C.M. et al. BMC Med 2015 13: 157. doi:10.1186-s12916-015-0398-0

Abstract

BackgroundWhen faced with uncertainties about the effects of medical interventions regulatory agencies, guideline developers, clinicians, and researchers commonly ask for more research, and in particular for more randomized trials. The conduct of additional randomized trials is, however, sometimes not the most efficient way to reduce uncertainty. Instead, approaches such as value of information analysis or other approaches should be used to prioritize research that will most likely reduce uncertainty and inform decisions.

DiscussionIn situations where additional research for specific interventions needs to be prioritized, we propose the use of quantitative benefit–harm assessments that illustrate how the benefit–harm balance may change as a consequence of additional research. The example of roflumilast for patients with chronic obstructive pulmonary disease shows that additional research on patient preferences e.g., how important are exacerbations relative to psychiatric harms? or outcome risks e.g., what is the incidence of psychiatric outcomes in patients with chronic obstructive pulmonary disease without treatment? is sometimes more valuable than additional randomized trials.

SummaryWe propose that quantitative benefit–harm assessments have the potential to explore the impact of additional research and to identify research priorities Our approach may be seen as another type of value of information analysis and as a useful approach to stimulate specific new research that has the potential to change current estimates of the benefit–harm balance and decision making.

KeywordsBenefit–harm assessment Chronic obstructive pulmonary disease Randomized trials Research priorities AbbreviationsAHRQAgency for Healthcare Research and Quality

COPDChronic obstructive pulmonary disease

FDAFood and Drug Administration

RCTRandomized controlled trial

VOIValue of information

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Author: Milo A. Puhan - Tsung Yu - Cynthia M. Boyd - Gerben ter Riet

Source: https://link.springer.com/







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