PMID- 27063207
OWN - NLM
STAT- MEDLINE
DCOM- 20170630
LR  - 20180921
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 78
DP  - 2016 Oct
TI  - Comparative rates of harms in randomized trials from more developed versus less 
      developed countries may be different.
PG  - 10-21
LID - S0895-4356(16)30028-2 [pii]
LID - 10.1016/j.jclinepi.2016.02.032 [doi]
AB  - OBJECTIVES: We set up to evaluate the relative risk of harms in trials performed 
      in less developed vs. more developed countries. STUDY DESIGN AND SETTING: 
      Meta-epidemiologic evaluation using the Cochrane Database of Systematic Reviews. 
      We considered meta-analyses with at least one randomized clinical trial (RCT) in 
      a less developed country and one RCT in a more developed country. We targeted 
      severe adverse events (AEs), discontinuations due to AEs, any AE, organ 
      system-specific AEs, individual AEs, and all discontinuations due to any reason. 
      We estimated the relative odds ratio (ROR) of harms between more and less 
      developed countries for each topic and the summary ROR (sROR) across topics under 
      each category of harms. RESULTS: We identified 42 systematic reviews (128 
      meta-analyses, 521 independent RCTs). Summary sRORs did not differ significantly 
      from 1.00 for any harm category. Nominally significant RORs were found in only 
      6/128 meta-analyses. However, in 27% (35/128) of meta-analyses the ROR point 
      estimates indicated relative differences between country settings >2-fold. 
      Considering also ROR 95% confidence intervals, in 92% (118/128) of meta-analyses 
      one could not exclude a 2-fold difference in both directions. CONCLUSIONS: We 
      identified limited comparative evidence on harms in trials from these two country 
      settings. Substantial differences in the risk point estimates were common; the 
      potential for modest differences could rarely be excluded with confidence.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Contopoulos-Ioannidis, Despina
AU  - Contopoulos-Ioannidis D
AD  - Department of Pediatrics, Division of Infectious Diseases, Stanford University 
      School of Medicine, 300 Pasteur Drive, Stanford, CA, 94305-5107, USA; Palo Alto 
      Medical Foundation Research Institute, 795 El Camino Real, Ames Building, Room 
      2A027B, Palo Alto, CA, 94301, USA; Meta-Research Innovation Center at Stanford 
      (METRICS), 1070 Arastradero Road, Palo Alto, CA, 94304, USA. Electronic address: 
      dcontop@stanford.edu.
FAU - Tseretopoulou, Xanthippi
AU  - Tseretopoulou X
AD  - Leeds Teaching Hospital, NHS Trust, Great George Street, Leeds LS1 3EX, UK.
FAU - Ancker, Megan
AU  - Ancker M
AD  - Medecins San Frontieres, 8 Rue Saint-Sabin, Paris 75011, France.
FAU - Walterspiel, Juan N
AU  - Walterspiel JN
AD  - Mendocino Coast District Hospital, 700 River Dr, Fort Bragg, CA 95437, USA.
FAU - Panagiotou, Orestis A
AU  - Panagiotou OA
AD  - Division of Cancer Epidemiology & Genetics, National Cancer Institute, National 
      Institute of Health, 9609 Medical Center Dr., Room 7E136, Bethesda, MD 20892, 
      USA.
FAU - Maldonado, Yvonne
AU  - Maldonado Y
AD  - Department of Pediatrics, Division of Infectious Diseases, Stanford University 
      School of Medicine, 300 Pasteur Drive, Stanford, CA, 94305-5107, USA; Department 
      of Health Research and Policy, Stanford University School of Medicine, Redwood 
      Building T152, 150 Governor's Lane, Stanford, CA 94305-5405, USA; Faculty 
      Development and Diversity, Stanford University School of Medicine, 291 Campus 
      Drive, Stanford, CA 94305, USA.
FAU - Ioannidis, John P A
AU  - Ioannidis JP
AD  - Meta-Research Innovation Center at Stanford (METRICS), 1070 Arastradero Road, 
      Palo Alto, CA, 94304, USA; Department of Health Research and Policy, Stanford 
      University School of Medicine, Redwood Building T152, 150 Governor's Lane, 
      Stanford, CA 94305-5405, USA; Stanford Prevention Research Center, Department of 
      Medicine, Stanford University School of Medicine, Medical School Office Building, 
      1265 Welch Road, Stanford, CA 94305, USA; Department of Statistics, Stanford 
      University School of Humanities and Sciences, Sequoia Hall, 390 Serra Mall, 
      Stanford, CA 94305-4065, USA.
LA  - eng
PT  - Journal Article
DEP - 20160406
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
SB  - IM
MH  - Developed Countries/*statistics & numerical data
MH  - Developing Countries/*statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - *Epidemiologic Studies
MH  - Humans
MH  - Meta-Analysis as Topic
MH  - Odds Ratio
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Review Literature as Topic
MH  - *Risk
OTO - NOTNLM
OT  - Comparative harms
OT  - Comparative safety
OT  - Less developed countries
OT  - Meta-analyses
OT  - More developed countries
OT  - Randomized trials
EDAT- 2016/04/12 06:00
MHDA- 2017/07/01 06:00
CRDT- 2016/04/12 06:00
PHST- 2015/04/23 00:00 [received]
PHST- 2016/01/04 00:00 [revised]
PHST- 2016/02/04 00:00 [accepted]
PHST- 2016/04/12 06:00 [pubmed]
PHST- 2017/07/01 06:00 [medline]
PHST- 2016/04/12 06:00 [entrez]
AID - S0895-4356(16)30028-2 [pii]
AID - 10.1016/j.jclinepi.2016.02.032 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2016 Oct;78:10-21. doi: 10.1016/j.jclinepi.2016.02.032. Epub 
      2016 Apr 6.