@article {613390,
	title = {Patients and investigators preferred measures of absolute risk in subgroups for pragmatic randomized trials},
	journal = {J Clin Epidemiol},
	year = {2018},
	month = {2018 Jun 29},
	abstract = {OBJECTIVES: Pragmatic randomized trials are important tools for shared decision-making, but no guidance exists on patients{\textquoteright} preferences for types of causal information. We aimed to assess preferences of patients and investigators towards causal effects in pragmatic randomized trials. STUDY DESIGN AND SETTING: We: (a) held 3 focus groups with patients (n=23) in Boston, MA; (b) surveyed (n=12) and interviewed (n=5) investigators with experience conducting pragmatic trials; and (c) conducted a systematic literature review of pragmatic trials (n=63). RESULTS: Patients were distrustful of new-to-market medications unless substantially more effective than existing choices, preferred stratified absolute risks, and valued adherence-adjusted analyses when they expected to adhere. Investigators wanted both intention-to-treat and per-protocol effects, but felt methods for estimating per-protocol effects were lacking. When estimating per-protocol effects, many pragmatic trials used inappropriate methods to adjust for adherence and loss to follow-up. CONCLUSION: We make 4 recommendations for pragmatic trials to improve patient centeredness: (1) focus on superiority in effectiveness or safety, rather than noninferiority; (2) involve patients in specifying a priori subgroups; (3) report absolute measures of risk, and (4) complement intention-to-treat effect estimates with valid per-protocol effect estimates.},
	issn = {1878-5921},
	doi = {10.1016/j.jclinepi.2018.06.009},
	url = {https://authors.elsevier.com/a/1XS1b3BcJPuv3w},
	author = {Murray, Eleanor J and Caniglia, Ellen C and Swanson, Sonja A and Hern{\'a}ndez-D{\'\i}az, Sonia and Hern{\'a}n, Miguel A}
}
