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To check that stratifying by study centre was the correct approach, we ran two preliminary Cox models including, firstly, bandage type and trial and, secondly, bandage type, trial, and centre as predictors.
Next, we generated a Cox proportional hazards model with time to healing in days as the dependent variable, healing as the event, and bandage type as a covariate.
The dependent variable was time to healing in days, the event was a healed ulcer, and the factor was bandage type.
For each of these outcomes, we assessed the effect of bandage type on the incidence of adverse events using the odds ratio with associated 95% confidence intervals.
The next Cox model (five trials, 797 patients, 75/797 cases dropped) included all significant covariates identified during univariate analyses: bandage type, patient's age, ulcer duration, ulcer area, and ankle mobility.
We re-ran the analysis on a subset of four trials (747 patients, 83/747 dropped) for which additional covariates were available: primary or recurrent ulceration and patients' mobility.w1 w4 w5 w6 The final model contained bandage type, ulcer area, ulcer duration, and primary or recurrent ulceration.
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Available data from two trials did not suggest a difference in the adverse event profiles of the two bandage types.
Data from two trials showed no evidence of a difference in adverse event profiles between the two bandage types.
The result of this unadjusted analysis indicated no significant difference between bandage types: hazard ratio 1.15, 95% confidence interval 0.97 to 1.37; P=0.1.37
Two trials provided data on adverse events.w1 w6 For incidence of any type of adverse event, the pooled odds ratio (fixed effect) was 1.15 (95% confidence interval 0.81 to 1.62; P=0.43) (fig 4), providing no evidence of a difference between bandage types.
One of the trials additionally reported healing rates at one year and time to healing, with no significant differences observed between bandage types.w3 Estimates of the frequency of wound healing at fixed time points are less informative than time to healing as the latter has major implications for patients' health related quality of life and use of health service resources.
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