A meta-regression analysis shows no impact of design characteristics on outcome in trials on tension-type headaches.
OBJECTIVE
In the conduct of a systematic review or meta-analysis, many possible sources of bias exist, such as bias caused by design characteristics. We studied the influence of the methodological study characteristics of randomized clinical trials (RCTs) on the outcome in a systematic review on conservative treatments in patients with tension-type headache (TTH).


METHODS
Included were RCTs from a systematic review on TTH, which were a control group receiving a placebo or no treatment and presented data on recovery or headache severity, intensity, or frequency. Design characteristics were assessed using the Delphi list. Regression analysis is performed on separate design characteristics on size of treatment effect.


RESULTS
Out of the original data set of 146 trials, 61 trials fulfilled our selection criteria. The number of trials presenting only dichotomous data was larger than trials presenting only continuous data. All study characteristics show a nonsignificant relation with the effect estimate. Whether outcome is presented dichotomous or continuous appears to have a significant impact on treatment effect estimates.


CONCLUSIONS
In this study, sample design characteristics do not show to have an impact on treatment effect estimates, but the way the treatment effect is measured has a significant impact.
Verhagen
A P
AP
Department General Practice, ErasmusMC, University Medical Centre Rotterdam, PO Box 2040, Room Ff318, 3000 CA Rotterdam, The Netherlands. a.verhagen@erasmusmc.nl
de Vet
H C W
HC
Willemsen
S
S
Stijnen
Th
T
D003627:Data Interpretation, Statistical; D003697:Delphi Technique; D006801:Humans; D015201:Meta-Analysis as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012044:Regression Analysis; D012107:Research Design; D012196:Review Literature as Topic; D018781:Tension-Type Headache / Q000628:therapy*; D016896:Treatment Outcome