Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials
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Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. / Savović, Jelena; Jones, Hayley E; Altman, Douglas G; Harris, Ross J; Jüni, Peter; Pildal, Julie; Als-Nielsen, Bodil; Balk, Ethan M; Gluud, Christian; Gluud, Lise Lotte; Ioannidis, John P A; Schulz, Kenneth F; Beynon, Rebecca; Welton, Nicky J; Wood, Lesley; Moher, David; Deeks, Jonathan J; Sterne, Jonathan A C.
I: Annals of Internal Medicine, Bind 157, Nr. 6, 18.09.2012, s. 429-38.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials
AU - Savović, Jelena
AU - Jones, Hayley E
AU - Altman, Douglas G
AU - Harris, Ross J
AU - Jüni, Peter
AU - Pildal, Julie
AU - Als-Nielsen, Bodil
AU - Balk, Ethan M
AU - Gluud, Christian
AU - Gluud, Lise Lotte
AU - Ioannidis, John P A
AU - Schulz, Kenneth F
AU - Beynon, Rebecca
AU - Welton, Nicky J
AU - Wood, Lesley
AU - Moher, David
AU - Deeks, Jonathan J
AU - Sterne, Jonathan A C
PY - 2012/9/18
Y1 - 2012/9/18
N2 - Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear (vs. adequate) random-sequence generation (ratio of odds ratios, 0.89 [95% credible interval {CrI}, 0.82 to 0.96]) and with inadequate or unclear (vs. adequate) allocation concealment (ratio of odds ratios, 0.93 [CrI, 0.87 to 0.99]). Lack of or unclear double-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes.
AB - Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear (vs. adequate) random-sequence generation (ratio of odds ratios, 0.89 [95% credible interval {CrI}, 0.82 to 0.96]) and with inadequate or unclear (vs. adequate) allocation concealment (ratio of odds ratios, 0.93 [CrI, 0.87 to 0.99]). Lack of or unclear double-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes.
KW - Bayes Theorem
KW - Bias (Epidemiology)
KW - Double-Blind Method
KW - Humans
KW - Meta-Analysis as Topic
KW - Odds Ratio
KW - Randomized Controlled Trials as Topic
KW - Research Design
U2 - 10.7326/0003-4819-157-6-201209180-00537
DO - 10.7326/0003-4819-157-6-201209180-00537
M3 - Journal article
C2 - 22945832
VL - 157
SP - 429
EP - 438
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 6
ER -
ID: 48998769