Skip to main content
Journal cover image

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis.

Publication ,  Journal Article
Mayo-Wilson, E; Fusco, N; Li, T; Hong, H; Canner, JK; Dickersin, K; MUDS investigators,
Published in: J Clin Epidemiol
June 2017

OBJECTIVE: To identify variations in outcomes and results across reports of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic (e.g., clinical study reports) sources by 2015. We prespecified outcome domains. From each source, we collected "outcomes" (i.e., domain, measure, metric, method of aggregation, and time point); "treatment effect" (i.e., outcome plus the methods of analysis [e.g., how missing data were handled]); and results (i.e., numerical contrasts of treatment and comparison groups). We assessed whether results included sufficient information for meta-analysis. RESULTS: We found 21 gabapentin (68 public, 6 nonpublic reports) and seven quetiapine RCTs (46 public, 4 nonpublic reports). For four (gabapentin) and seven (quetiapine) prespecified outcome domains, RCTs reported 214 and 81 outcomes by varying four elements. RCTs assessed 605 and 188 treatment effects by varying the analysis of those outcomes. RCTs reported 1,230 and 661 meta-analyzable results, 305 (25%) and 109 (16%) in public reports. CONCLUSION: RCTs included hundreds of outcomes and results; a small proportion were in public reports. Trialists and meta-analysts may cherry-pick what they report from multiple sources of RCT information.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Epidemiol

DOI

EISSN

1878-5921

Publication Date

June 2017

Volume

86

Start / End Page

39 / 50

Location

United States

Related Subject Headings

  • gamma-Aminobutyric Acid
  • Treatment Outcome
  • Randomized Controlled Trials as Topic
  • Quetiapine Fumarate
  • Outcome Assessment, Health Care
  • Neuralgia
  • Humans
  • Gabapentin
  • Epidemiology
  • Cyclohexanecarboxylic Acids
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mayo-Wilson, E., Fusco, N., Li, T., Hong, H., Canner, J. K., Dickersin, K., & MUDS investigators, . (2017). Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol, 86, 39–50. https://doi.org/10.1016/j.jclinepi.2017.05.007
Mayo-Wilson, Evan, Nicole Fusco, Tianjing Li, Hwanhee Hong, Joseph K. Canner, Kay Dickersin, and Kay MUDS investigators. “Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis.J Clin Epidemiol 86 (June 2017): 39–50. https://doi.org/10.1016/j.jclinepi.2017.05.007.
Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K, et al. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol. 2017 Jun;86:39–50.
Mayo-Wilson, Evan, et al. “Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis.J Clin Epidemiol, vol. 86, June 2017, pp. 39–50. Pubmed, doi:10.1016/j.jclinepi.2017.05.007.
Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K, MUDS investigators. Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. J Clin Epidemiol. 2017 Jun;86:39–50.
Journal cover image

Published In

J Clin Epidemiol

DOI

EISSN

1878-5921

Publication Date

June 2017

Volume

86

Start / End Page

39 / 50

Location

United States

Related Subject Headings

  • gamma-Aminobutyric Acid
  • Treatment Outcome
  • Randomized Controlled Trials as Topic
  • Quetiapine Fumarate
  • Outcome Assessment, Health Care
  • Neuralgia
  • Humans
  • Gabapentin
  • Epidemiology
  • Cyclohexanecarboxylic Acids