Hewlett 2000.
| Methods | Randomised. individual, single site trial, 24, 48 and 72 months | |
| Participants | UK; 1 outpatient rheumatology clinic (209 participants); RA; 58 men 124 women; mean age 59 years CONT, 57 years INT | |
| Interventions | INT (n = 105): participants contacted nurse‐run help line if any problems/as needed. GP provided with information leaflets and could also initiate hospital appointment. Participants could also ask for OT or PT appointment (maximum wait 10 days). Safety net – 3 monthly questionnaire to assess clinical status. CONT (n = 104): consultant‐led every 3–4 months, emergency appointments available. |
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| Outcomes | RA status: 24, 48 and 72 months (many clinical physiological measures) Clinical and psychological status: every 3, 48 and 72 months (VAS, HAQ, AHI, HADS) Self‐efficacy and changes in medication: SF‐36 added at 48, 60 and 72 months Satisfaction with intervention: every 3 months (VAS) Satisfaction and confidence with intervention: every 12 months at 12, 24, 36, 48 (VAS) (only reported at 48 months) Resource use: 24 months (medical records, patient diaries and published unit cost data) Contact with health professionals: 72 months (medical records) |
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| Notes | Funded by NHS Research and Development National Programme Grant. COI NR. Contacted authors for more information, further data provided for all outcome measures. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated. |
| Allocation concealment (selection bias) | Low risk | Concealed in envelopes prepared by third party. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | NR. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Unclear who collected data; lead rheumatologist was not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and deaths reported and were similar for both groups. |
| Selective reporting (reporting bias) | High risk | Only analysed those who completed 4/9 assessments. |
| Other bias | Low risk | No obvious signs of other bias. |