Nikolaus 2017.
| Study characteristics | ||
| Methods |
Study design: prospective RCT Study duration: NR Setting: multicentre (tertiary referral centre; specialised community hospital; specialised private practice) |
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| Participants |
State of disease at beginning of study per IG/CG:Intention to treat group Clinical activity assessed by the Colitis Activity Index (CAI) N (%):
Disease type per IG/CG: all participants had UC Inclusion criteria: age ≥ 18 years, with diagnosis of UC confirmed by colonoscopy and histology, and a minimum duration of disease of 2 years. Individual exceptions by the lead principal investigator could be given to included patients ≥ 16 years. At inclusion, disease activity had to reflect remission or mild disease CAI ≤ 9), and the participant had to be on a treatment with oral (not rectal) mesalamine (irrespectively of any other treatment) or had to be willing to start a treatment with oral mesalamine with a dose of 1.2 g to 4.8 g/day upon inclusion (medication was provided to all participants by the insurance system, without patients having to pay for it). All participants had to give written informed consent and be willing and able to follow a standardised education programme. Exclusion: people with CD or indeterminate colitis, significant comorbidities, a CAI > 9 or an intolerance/contraindication to mesalamine; people after colectomy or with a current ostomy. Age at beginning of study per IG/CG: intention to treat (ITT) group: median (range) IG: 46.68 (19.61–88.09); CG: 44.6 (18.41–81.02) Sex per IG/CG: intention to treat group: IG: Male 68 (54.4%) Female 58 (45.6%); CG: Male 66 (54.6%) Female 60 (45.4%) Disease duration per IC/CG: median (range) years IG: 5.34 (0.35–40.36); CG: 5.71 (0.27–26.64) Number randomised per IG/CG: IG: 126; CG: 122 Number reaching end of study per IG/CG: IG: 47; CG: 52 |
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| Interventions |
IG: a standardised education programme delivered by either a certified nurse or the trial physician using a standardised slide set, followed by a group session in which all participants asked questions and a contact for further individual questions (e.g. by telephone or email) was established. CG: participants received standard care and were also offered participation in the education programme after the study ended. |
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| Outcomes |
Duration of follow ‐up: 14 months Primary outcomes as defined by study authors: adherence to mesalamine treatment measured using the Morisky Medication Adherence Scale (MMAS) Secondary outcomes as defined by study authors: secondary endpoints included short‐term adherence, quality of life, disease activity, and self‐assessment of adherence. Self‐assessment of adherence was measured by the MMAS21 as described above. To evaluate short‐term adherence, adherence data at the end of the supervision phase were used. Data of the MMAS‐scale were correlated with results of the 5‐aminosalicylic acid measurements in the urine and corrected, if applicable. |
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| Notes |
Funding source: supported by a non‐conditional grant of Shire Germany given to the German Competence Network. Conflicts of interest: NS, SS, SB, BB, BE, BO, GD, HU, SM, and KW have no relevant conflicts of interest concerning the instant publication. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not specified. Author was contacted, no response received. |
| Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment. Author was contacted, no response received. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind the participants to the intervention (education) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Author states that it was a "non‐blinded trial" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Large number of withdrawals but balanced and reasons given for all. No imbalance between groups. However, it's not unclear how many people were randomised as the text mentions 248 but the flow‐diagram 258. It's not explained neither in the text nor the flow diagram what happened to the remaining 10 participants, only that one patient withdrew consent before randomisation. Author was contacted, no response received. |
| Selective reporting (reporting bias) | Unclear risk | Results of all outcomes mentioned in trial registration were included in the methods.However, a statement on several secondary outcomes was made with no specific data. The authors were contacted but no response received. Trial number: DRKS00008905 |
| Other bias | Low risk | No baseline imbalance between IG and CG. No other concerns. |