Hay 2006.
| Methods | Randomised 3‐armed trial | |
| Participants | 325 patients with knee pain (enhanced pharmacy intervention 108; community physiotherapy intervention 109; control 108) 15 general practices North Staffordshire, England Year of study: May 2001 to March 2004. |
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| Interventions | All participants were given a leaflet on knee osteoarthritis about self‐help and exercises. Enhanced pharmacy intervention aimed to optimise pharmacological pain control through drug therapy and reinforce self‐help messages (6 sessions over 10 weeks). Community physiotherapy intervention, which was exercises led by musculoskeletal community physiotherapists (3 ‐ 6 sessions over 10 weeks). Control was just written information (initial visit and 1 phone call 1 week later). | |
| Outcomes | WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score at 12 months | |
| Notes | Funding source: Arthritis Research Campaign, North Staffordshire Primary Care Research Consortium, and the Department of Health National Co‐ordinating Centre for Research Capacity Development. NEF funded by a primary care career scientist award from the Department of Health and NHS R&D. Conflict of interest:None stated. The sponsors of the study had no role in the study design, data collection,data analysis,data interpretation,or writing of the report. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised random‐number generator |
| Allocation concealment (selection bias) | Low risk | Quote: "We assigned each participant a unique study number, which corresponded with that on a sealed opaque envelope that contained information about participants’ allocated treatment and was issued to the participant by the study nurse." |
| Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | High risk | By necessity, participants and the health professionals delivering the interventions were not blind to allocation. |
| Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Study nurses and researchers who collected, entered, and analysed data were unaware of treatment allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. Overall completion rate >80% |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None identified |