Alice Yu1, Yaanu Jeyakumar2, Mei Wang3, Justin Lee4, Maura Marcucci3, Anne Holbrook5. 1. Faculty of Medicine and Dentistry, University of Alberta, 8440 112 St NW, Edmonton, Alberta T6G 2R7, Canada. 2. Faculty of Medicine, University of Toronto, 1 King's College Cir, Toronto, Ontario M5S 1A8, Canada. 3. Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada. 4. Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada; Division of Geriatric Medicine, Department of Medicine, McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada. 5. Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, 1280 Main St W, Hamilton, Ontario L8S 4L8, Canada; Division of Clinical Pharmacology & Toxicology, Department of Medicine, McMaster University, 50 Charlton Ave E, Hamilton, Ontario L8S 4A6, Canada. Electronic address: holbrook@mcmaster.ca.
Abstract
OBJECTIVES: This study aimed to review the degree of personalization of benefit and harm in the reporting of recent high-profile randomized controlled trials (RCTs) involving pharmacological interventions. STUDY DESIGN AND SETTING: This study is a systematic review of RCTs published between 2012 and 2017 with at least one intervention evaluating drug therapy and meeting the "high-profile" threshold in a premier academic literature abstraction service. Our primary outcome was the proportion of trials reporting subgroup analyses of a combined benefit-harm outcome. Secondary outcomes included the proportion of trials reporting subgroup analyses or clinical prediction guide for benefits or harms. We assessed the quality of the subgroup analyses using a modified version of previously published credibility criteria. RESULTS: Of 296 eligible RCTs, nine studies (3%) reported a combined benefit-harm endpoint. We found subgroup analyses of a combined benefit-harm endpoint in three studies (1%), a benefit endpoint in 167 studies (56.4%), and a harm endpoint in 18 studies (6.1%). The overall quality of the subgroup analyses was poor. Only one study reported a clinical prediction guide for an outcome. CONCLUSION: Despite great interest in the personalization of therapies, it is rarely reported in high-profile trials. Lack of rigorous and widely accepted methods may be the major barrier.
OBJECTIVES: This study aimed to review the degree of personalization of benefit and harm in the reporting of recent high-profile randomized controlled trials (RCTs) involving pharmacological interventions. STUDY DESIGN AND SETTING: This study is a systematic review of RCTs published between 2012 and 2017 with at least one intervention evaluating drug therapy and meeting the "high-profile" threshold in a premier academic literature abstraction service. Our primary outcome was the proportion of trials reporting subgroup analyses of a combined benefit-harm outcome. Secondary outcomes included the proportion of trials reporting subgroup analyses or clinical prediction guide for benefits or harms. We assessed the quality of the subgroup analyses using a modified version of previously published credibility criteria. RESULTS: Of 296 eligible RCTs, nine studies (3%) reported a combined benefit-harm endpoint. We found subgroup analyses of a combined benefit-harm endpoint in three studies (1%), a benefit endpoint in 167 studies (56.4%), and a harm endpoint in 18 studies (6.1%). The overall quality of the subgroup analyses was poor. Only one study reported a clinical prediction guide for an outcome. CONCLUSION: Despite great interest in the personalization of therapies, it is rarely reported in high-profile trials. Lack of rigorous and widely accepted methods may be the major barrier.