Krska 2001.
| Study characteristics | ||
| Methods |
Aim of study: to evaluate the effects of pharmacist‐led medication review on outcomes such as presence of pharmaceutical care issues (PCIs), hospitalisation, medication costs, and HRQoL Study design: RCT (6 general medical clinics; individual patients randomised) Number of arms/groups: 2 |
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| Participants |
Description: patient/consumer Geographic location: Scotland Setting: primary care clinic (general medical practices) Inclusion criteria: ≥ 65 years, ≥ 4 medications (via computerised repeat prescribing system), ≥ 2 chronic conditions (Note: a maximum of 70 patients from each practice were invited to participate) Exclusion criteria: dementia, GP considered patient unable to cope with study Number of participants randomised: 381 Number of participants included in analysis: 332 (168 and 164) Age: mean ± SD (range): 74.8 ± 6.2 (65 to 90) intervention vs 75.2 ± 6.6 (65 to 93) control Gender: female: 95 (56.5%) vs 106 (64.6%) Ethnicity: not specified Number of medications: medications actually being taken (prescription and non‐prescription): mean ± SD (range) 7.3 ± 2.7 (3 to 16) vs 7.6 ± 2.7 (3 to 17) Frailty/Functional impairment: not specified Cognitive impairment: dementia excluded Comorbidities: chronic diseases: 3.9 ± 1.4 (2 to 8) vs 3.8 ± 1.4 (2 to 9) |
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| Interventions |
Group 1 ‐ Pharmacist medication review and pharmaceutical care planning: pharmaceutical care plan drawn up via medical notes and home interview (actual and potential PCIs, actions planned, desired outputs). Copies of plan put in medical notes and given to GP. GP asked to indicate level of agreement with each PCI identified and with actions. Pharmacist then implemented agreed actions Group 2 ‐ Interviewed and PCIs identified: no pharmaceutical care plan written or implemented, just usual care (but if serious PCI identified, independent medical assessor decided whether to withdraw patient, n = 1) Co‐intervention: patients interviewed at home about medications, health services, SF‐36, medication costs Provider: pharmacist Where: GP practice/Home When and how often: 1 home visit Intervention personalised: Yes ‐ individualised care plan |
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| Outcomes |
Timing of outcome assessment: baseline and 3 months Medication adherence (subjective): potential/actual compliance ‐ pharmacist review identified pharmaceutical care issues, including potential or actual compliance issues. Results as total number of issues at baseline and number resolved at 3 months Health‐related quality of life (subjective): SF‐36 (data not reported in paper) |
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| Notes | Trial registration: N/A Consumer involvement: not specified Funding source: Grampians Healthcare NHS Trust Dropout: 24 and 25 (excluded after randomisation ‐ hospital, ill health, holidays), 1 withdrew |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | After stratification by number of drugs, number of CV drugs and presence of NSAIDs, patients allocated randomly to intervention or control |
| Allocation concealment (selection bias) | Unclear risk | Not specified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawal explained. No differences in demography or medicine use between groups |
| Selective reporting (reporting bias) | High risk | Not all results listed (e.g. HRQoL just says not significant) |
| Other bias | Low risk | None apparent |