Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials.
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.



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.



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.



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.
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.
Zafira
Z
Bhaloo
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.
Denise
D
Adams
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.
Yali
Y
Liu
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.
Namrata
N
Hansraj
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.
Lisa
L
Hartling
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.
Caroline B
CB
Terwee
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.
Sunita
S
Vohra
D002648:Child; D015340:Epidemiologic Research Design; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000379:methods* / Q000706:statistics & numerical data; D011594:Psychometrics; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D015203:Reproducibility of Results
Outcome measure; Pediatric; Primary outcome; Randomized controlled trial; Reporting; Systematic review