Bond 2007.
| Methods | Randomized controlled trial | |
| Participants | The study location was 9 primary care organizations, England, UK 980 participants were randomized to the intervention group and 513 participants were randomized to the control group The inclusion criteria were registered with the general practices, aged over 17 years, and with CHD (previous myocardial infarction, angina, coronary artery bypass graft, and/or angioplasty) The exclusion criteria were illiterate/innumerate, history of alcohol/drug misuse, terminal/serious illness, severe mental illness, and unable to provide informed consent or otherwise unsuitable for the trial |
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| Interventions | Intervention: MEDICINE MANAGEMENT SERVICE (MEDMAN)
The intervention was a comprehensive, community pharmacy‐led medicines management called MEDMAN. This intervention comprised of an initial consultation with a community pharmacist to review the appropriateness of therapy, compliance, lifestyle, social, and support issues. Further consultations were provided according to pharmacist‐determined patient need. Recommendations were recorded on a referral form which was sent to the GP, who returned annotated copies to the pharmacists. The intervention lasted 12 months Control: STANDARD CARE Control group patients not provided with MEDMAN intervention. Follow‐up data were collected at 12 months by audit clerks and postal questionnaire as at baseline. Intervention patients were also asked about their experience of the medicine management service |
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| Outcomes | The measures of adherence were self reported compliance. 12 statements about medicine taking were included and summated to derive a self reported compliance score. Data were collected from participants at baseline and at 12 months. Baseline and follow‐up data were collected by audit clerks and postal questionnaire The patient outcomes were health status, 5‐year risk of cardiovascular death, and patient satisfaction. Health status was assessed using SF‐3619 Euro‐Quality of Life questionnaire. 5‐year risk of cardiovascular death was assessed based on an existing score modified to allow for the absence of data on history of stroke and creatinine concentration. The final satisfaction score included experience of and satisfaction with the community pharmacy service and was assessed by measuring response to 15 positive and negative statements regarding their most recent pharmacy visit. Possible responses ranged from 5 to 1 for strongly agree to strongly disagree for positive statements and from 1 to 5 for negative statements, summated to give an overall satisfaction score. Data were collected at baseline and 12 months by audit clerks and research assistants who were blinded |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomized in a ratio of 2:1, intervention to control group. This was done independently of the research team using a password protected computer programme in permuted blocks stratified by practice." (pg 190) |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided ‐ (pg 190) Community pharmacists were given an indicative allocation of 20 patients. If more than 20 patients chose 1 pharmacy, the pharmacist could choose to go 'over quota', or refuse the patient who was asked to choose another pharmacy, or was excluded (designated over quota in Figure 1) |
| Selective reporting (reporting bias) | Unclear risk | None detected but protocol not available |
| Other bias | Unclear risk | Insufficient information provided |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "Audit clerks performing data extraction were blind to the randomization status of participants, as were the researchers conducting the statistical analyses." (pg 193) |
| Blinding of outcome assessment (detection bias) Patient outcome | Low risk | (PRIMARY) HEALTH STATUS ‐ "Audit clerks performing data extraction were blind to the randomization status of participants, as were the researchers conducting the statistical analyses." (pg 192) |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE (pg 192) "Patients could not be blind to trial intervention because of its nature." |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) HEALTH STATUS ‐ "Patients could not be blind to trial intervention because of its nature." (pg 193) |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Except participants, community pharmacists, audit clerks performing data extraction, and researchers conducting the statistical analyses were blinded. "Community pharmacists were not informed which control patients had nominated their pharmacy. Audit clerks performing data extraction were blind to the randomization status of participants, as were the researchers conducting the statistical analyses." (pg 190) |
| Blinding of personnel (performance bias) Patient outcome | Low risk | (PRIMARY) HEALTH STATUS ‐ Except participants, community pharmacists, audit clerks performing data extraction, and researchers conducting the statistical analyses were blinded. "Community pharmacists were not informed which control patients had nominated their pharmacy. Audit clerks performing data extraction were blind to the randomization status of participants, as were the researchers conducting the statistical analyses." (pg 190) |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Missing data not balanced, especially with regards to withdrawn patients. ITT analysis done, but bias is unclear |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) HEALTH STATUS ‐ Missing data not balanced, especially with regards to withdrawn patients. ITT analysis done, but the potential for bias is unclear |