Appendix 2b: Study criteria for inclusion in review
Studies had to fulfill the following criteria in order to be eligible for inclusion:
1. Study design
a. Randomized controlled trial, regardless of blinding 2. Study population
a. Adults
b. Disease extent up to 20cm from the anal verge (studies with the descriptors “proctitis”,
“rectitis” or “inflammation limited to the rectum” were also considered eligible) c. Inflammation caused by UC (and not, for instance, radiation)
d. At least 10 patients with UP included in the trial 3. Intervention and control group
a. Any drug therapy as intervention, with placebo or another drug therapy as control b. With a treatment duration of at least 4 weeks or 3 months (for induction and
maintenance studies, respectively) 4. Outcome measure
a. Clinical remission rates or maintained clinical remission rates (for induction and maintenance studies, respectively)
Over time, various methods for scoring UC disease activity have been proposed and used, resulting in different definitions of “clinical remission”. Nevertheless, there are common factors in these definitions (e.g. no rectal bleeding), as such all studies that clearly define “clinical remission” in their manuscript were considered eligible in respect to their outcome measure.
