title: Quantitative benefit-harm assessment for setting research priorities: the example of roflumilast for patients with COPD.
abstract: BACKGROUND
  When 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.
  
  
  CONCLUSIONS
  In 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. We 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.
authors.affiliation: Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland. miloalan.puhan@uzh.ch.|Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. miloalan.puhan@uzh.ch.
authors.forename: Milo A
authors.initials: MA
authors.lastname: Puhan
authors.affiliation: Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland. tsung.yu@uzh.ch.|Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. tsung.yu@uzh.ch.
authors.forename: Tsung
authors.initials: T
authors.lastname: Yu
authors.affiliation: Center on Aging and Health, Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, USA. cyboyd@jhmi.edu.
authors.forename: Cynthia M
authors.initials: CM
authors.lastname: Boyd
authors.affiliation: Academic Medical Center, Department of General Practice, University of Amsterdam, Amsterdam, Netherlands. g.terriet@amc.uva.nl.
authors.forename: Gerben
authors.initials: G
authors.lastname: Ter Riet
mesh_terms: D000631:Aminopyridines / Q000494:pharmacology*; D001549:Benzamides / Q000494:pharmacology*; D003521:Cyclopropanes / Q000494:pharmacology; D003625:Data Collection; D006801:Humans; D058988:Phosphodiesterase 4 Inhibitors / Q000494:pharmacology; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D012106:Research; D012107:Research Design; D018570:Risk Assessment
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast