Montgomery 2000.
| Study characteristics | ||
| Methods | Cluster‐randomised controlled trial, parallel group (1:1:1) | |
| Participants | Adults aged 60‐79 years with high blood pressure from 27 general practices from UK Unit of randomisation: general practice Exclusion criteria: non‐ambulatory patients, life‐threatening illness, recent major surgery Total randomised at baseline: 27 general practices with 715 participants (n = 269 computerised decision support + risk chart, n = 264 risk chart, n = 182 usual care) Mean age: 71 years, 54% women, 11% diabetes mellitus, 11% history of MI or stroke |
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| Interventions | Intervention groups:
In the "CVD risk chart" group, CVD risk information was manually extracted by nurses and included in the medical record Comparison group: usual care |
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| Outcomes | Primary outcome: percentage of participants in each group with 5‐year CVD risk ≥ 10% Secondary outcomes: systolic and diastolic blood pressure, CVD drug prescription Total analysed at 12 months follow‐up 531 participants (n = 202 computerised decision support + risk chart, n = 199 risk chart, n = 1 usual care) Follow‐up: 12 months |
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| Study funding sources | NHS Wales Office of Research and Development, grant number RC016, NHS Research and Development Primary Care Career Scientist Award | |
| Notes | For the analyses in this systematic review, participants randomised to both intervention groups were combined (both these groups received CVD risk scores) and were compared with usual care (did not receive systematic provision of a CVD risk score) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was performed with a table of random numbers by a researcher not involved in the study and who was blind to the identity of the practices." |
| Allocation concealment (selection bias) | Low risk | See above |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Because of the nature of the study, neither the doctors and nurses nor the patients were blind to their study group." |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were unblinded clinic staff |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 41% of participants had missing cholesterol data |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available for review |
| Other bias | Low risk | Other sources of bias not identified |