PMID- 29191447
OWN - NLM
STAT- MEDLINE
DCOM- 20190909
LR  - 20190909
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 95
DP  - 2018 Mar
TI  - Comparative evidence on harms in pediatric randomized clinical trials from less 
      developed versus more developed countries is limited.
PG  - 63-72
LID - S0895-4356(17)30240-8 [pii]
LID - 10.1016/j.jclinepi.2017.11.016 [doi]
AB  - OBJECTIVES: Evaluate comparative harm rates from medical interventions in 
      pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less 
      developed countries (LDCs). STUDY DESIGN AND SETTING: Meta-epidemiologic 
      empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) 
      meta-analyses reporting clinically important harm-outcomes (severe adverse events 
      [AEs], discontinuations due to AEs, any AE, and mortality) that included at least 
      one pediatric RCT from MDCs and at least one from LDCs. We estimated relative 
      odds ratios (RORs) for each harm, within each meta-analysis, between RCTs from 
      MDCs and LDCs and calculated random-effects-summary-RORs (sRORs) for each harm 
      across multiple meta-analyses. RESULTS: Only 1% (26/2,363) of meta-analyses with 
      clinically important harm-outcomes in the entire Cochrane Database of Systematic 
      Reviews included pediatric RCTs both from MDCs and LDCs. We analyzed 26 
      meta-analyses with 244 data sets from pediatric RCTs, 116 from MDCs and 128 from 
      LDCs (64 and 66 unique RCTs respectively). The summary ROR was 0.92 (95% 
      confidence intervals: 0.78-1.08) for severe AEs; 1.13 (0.54-2.34) for 
      discontinuations due to AEs; 1.10 (0.77-1.59) for any AE; and 0.99 (0.61-1.61) 
      for mortality and for the all-harms-combined-end point 0.96 (0.83-1.10). 
      Differences of ROR-point-estimates >/=2-fold between MDCs and LDCs were identified 
      in 35% of meta-analyses. CONCLUSION: We found no major systematic differences in 
      harm rates in pediatric trials between MDCs and LDCs, but data on harms in 
      children were overall very limited.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Tedesco, Dario
AU  - Tedesco D
AD  - Department of Biomedical and Neuromotor Sciences, University of Bologna, Via San 
      Giacomo, 12, 40126, Bologna, Italy.
FAU - Farid-Kapadia, Mufiza
AU  - Farid-Kapadia M
AD  - Department of Pediatrics, Child Health Evaluative Sciences, Research Institute, 
      The Hospital for Sick Children University of Toronto, 555 University Avenue, 
      Toronto, Ontario M5G-1X8, Canada.
FAU - Offringa, Martin
AU  - Offringa M
AD  - Department of Pediatrics, Child Health Evaluative Sciences, Research Institute, 
      The Hospital for Sick Children University of Toronto, 555 University Avenue, 
      Toronto, Ontario M5G-1X8, Canada.
FAU - Bhutta, Zulfiqar A
AU  - Bhutta ZA
AD  - Department of Pediatrics, Child Health Evaluative Sciences, Research Institute, 
      The Hospital for Sick Children University of Toronto, 555 University Avenue, 
      Toronto, Ontario M5G-1X8, Canada; Centre for Global Child Health, The Hospital 
      for Sick Children, 686 Bay Street, Suite 11.9805, Toronto, ON, M5G-0A4, Canada; 
      Center of Excellence in Women and Child Health, The Aga Khan University, Stadium 
      Road, P.O. Box 3500, Karachi, 74800, Pakistan.
FAU - Maldonado, Yvonne
AU  - Maldonado Y
AD  - Division of Infectious Diseases, Department of Pediatrics, Stanford University 
      School of Medicine, 300 Pasteur Drive, Room G312, Stanford, CA 94305, USA; 
      Department of Health Research and Policy, Stanford University School of Medicine, 
      150 Governor's Lane, HRP Redwood Building, Stanford, CA 94305, USA; Senior 
      Associate Dean for Faculty Development and Diversity, Stanford University School 
      of Medicine, Stanford, CA 94305, USA.
FAU - Ioannidis, John P A
AU  - Ioannidis JPA
AD  - Department of Health Research and Policy, Stanford University School of Medicine, 
      150 Governor's Lane, HRP Redwood Building, Stanford, CA 94305, USA; Department of 
      Medicine, Stanford Prevention Research Center, Stanford University School of 
      Medicine, 1265 Welch Road, Stanford, CA 94305, USA; Meta Research Innovation 
      Center at Stanford (METRICS), 1070 Arastradero Road, Palo Alto, CA 94304, USA.
FAU - Contopoulos-Ioannidis, Despina G
AU  - Contopoulos-Ioannidis DG
AD  - Division of Infectious Diseases, Department of Pediatrics, Stanford University 
      School of Medicine, 300 Pasteur Drive, Room G312, Stanford, CA 94305, USA; Meta 
      Research Innovation Center at Stanford (METRICS), 1070 Arastradero Road, Palo 
      Alto, CA 94304, USA. Electronic address: dcontop@stanford.edu.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20171128
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
SB  - IM
MH  - Child
MH  - Databases, Factual
MH  - Developed Countries
MH  - Developing Countries
MH  - Humans
MH  - Meta-Analysis as Topic
MH  - Odds Ratio
MH  - Patient Harm/*statistics & numerical data
MH  - *Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Cochrane Database of Systematic Reviews
OT  - Comparative
OT  - Harms
OT  - Meta-analyses
OT  - Mortality
OT  - Pediatrics
OT  - Randomized trials
EDAT- 2017/12/02 06:00
MHDA- 2019/09/10 06:00
CRDT- 2017/12/02 06:00
PHST- 2017/03/16 00:00 [received]
PHST- 2017/11/15 00:00 [revised]
PHST- 2017/11/22 00:00 [accepted]
PHST- 2017/12/02 06:00 [pubmed]
PHST- 2019/09/10 06:00 [medline]
PHST- 2017/12/02 06:00 [entrez]
AID - S0895-4356(17)30240-8 [pii]
AID - 10.1016/j.jclinepi.2017.11.016 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2018 Mar;95:63-72. doi: 10.1016/j.jclinepi.2017.11.016. Epub 
      2017 Nov 28.