Robinson 2001.
Methods | Randomised, individual, multisite (4 site) trial, 14 months (median follow‐up) | |
Participants | UK; 4 hospital gastroenterology departments (203 participants); ulcerative colitis; 98 men, 105 women; mean age 48 years CONT, 49 years INT | |
Interventions | INT (n = 101): participants to contact helpline for clinical advice or appointments as necessary. Participants also received a personalised guided self‐management regimen. Participants requiring routine monitoring of blood or urine were asked to attend their primary‐care centre. Safety net – none. CONT (n = 102): consultant‐led (schedule NR), availability of emergency appointments unclear. |
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Outcomes | Time between symptom development and start of treatment (patient diaries and medical records) Number of consultations (primary and secondary care): 14 months (patient diaries and medical records) Cost to patient: 14 months (patient diaries and medical records) Acceptability of intervention: 14 months (patient diaries) Quality of life: baseline and 14 months (IBDQ) |
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Notes | Estimated costs to participants from expenditure on public transport, or motoring costs (by use of data from the Automobile Association, UK). Time spent visiting a doctor was calculated as the time between participants leaving and returning home or to work. Funded by MRC Training Fellowship in Health Services Research. COI NR. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The first 20 participants in each centre were randomly allocated to groups by random number tables. |
Allocation concealment (selection bias) | Low risk | Subsequent participants were allocated by the process of minimisation which was done by an assistant not involved in the rest of the trial. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of study personnel not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of study personnel not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for loss to follow‐up were given for both groups, which were similar across groups (more lost from CONT group than INT group). |
Selective reporting (reporting bias) | High risk | All outcomes mentioned in methods section were reported (although full details were not given for non‐significant results). |
Other bias | Low risk | No obvious signs of other bias. |