Zafira Bhaloo1, Denise Adams1, Yali Liu1, Namrata Hansraj1, Lisa Hartling2, Caroline B Terwee3, Sunita Vohra4. 1. CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton Continuing Care Center, Unit 8B, 11111 Jasper Avenue, Edmonton, Alberta T5K 0L4, Canada. 2. Alberta Research Center for Health Evidence, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton Clinic Health Academy, 11405-87 Avenue, Edmonton, Alberta T6T 1C9, Canada. 3. Knowledgecenter Measurement Instruments, Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands. 4. CARE Program, Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton Continuing Care Center, Unit 8B, 11111 Jasper Avenue, Edmonton, Alberta T5K 0L4, Canada. Electronic address: svohra@ualberta.ca.
Abstract
OBJECTIVE: Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures. STUDY DESIGN AND SETTING: Systematic review with screening and simultaneous data extraction conducted by two independent reviewers. Electronic searches of six general medicine and four pediatric journals were conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. RCTs of a single phase/step in a single publication, published in English between 2000 and 2010 with participants less than 21 years of age were included. RESULTS: A random sample of 20% (n = 445) of 2,229 initial references was screened and 206 (46%) met inclusion criteria. Half (48.5%) of included studies reported a singular primary outcome, 27% did not identify any primary outcome, and 24% identified multiple primary outcomes (range 2-20). Twenty-one trials used an instrument to measure their primary outcome, but only 7 (33%) reported its psychometric properties. CONCLUSION: Pediatric trials published in top medical journals have inadequate reporting of their primary outcomes and the psychometric properties of their outcome measures. Whether the issue is one of poor reporting and/or poor validation will be further investigated.
OBJECTIVE: Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures. STUDY DESIGN AND SETTING: Systematic review with screening and simultaneous data extraction conducted by two independent reviewers. Electronic searches of six general medicine and four pediatric journals were conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. RCTs of a single phase/step in a single publication, published in English between 2000 and 2010 with participants less than 21 years of age were included. RESULTS: A random sample of 20% (n = 445) of 2,229 initial references was screened and 206 (46%) met inclusion criteria. Half (48.5%) of included studies reported a singular primary outcome, 27% did not identify any primary outcome, and 24% identified multiple primary outcomes (range 2-20). Twenty-one trials used an instrument to measure their primary outcome, but only 7 (33%) reported its psychometric properties. CONCLUSION: Pediatric trials published in top medical journals have inadequate reporting of their primary outcomes and the psychometric properties of their outcome measures. Whether the issue is one of poor reporting and/or poor validation will be further investigated.
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