Nola 2000.
Methods | Design: RT Groups: intervention group (lipid management program); control group (usual care) |
|
Participants | Pharmacies: not targeted Pharmacy worker: not targeted ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user: 51 patients at risk of coronary artery disease (25 intervention; 26 control)
Setting: urban Country: USA |
|
Interventions |
Pharmacy worker‐directed intervention: not reported ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user‐directed intervention: patients received the lipid management program: diet and exercise evaluation and instruction, monitoring of cholesterol levels, monitoring of drug therapy, collaboration with physicians, education.
Pharmacy user control: usual treatment |
|
Outcomes |
Pharmacy worker: not assessed ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Pharmacy user:
|
|
Notes | Study/intervention name: none given Funding source: Pharmacia‐Upjohn Corporation and education grant from Novartiz and Bristol‐Myers Squibb |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A randomization schedule was developed using a computer‐generated list of random numbers" |
Allocation concealment (selection bias) | Low risk | As above |
Baseline outcome measures similar | Low risk | No significant differences between groups at baseline |
Baseline characteristics similar | Low risk | No significant differences between groups at baseline |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not clear how missing data managed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information on blinding but objective outcomes |
Protection against contamination | High risk | In‐pharmacy randomisation |
Selective reporting (reporting bias) | Low risk | Nothing noted |
Other bias | Unclear risk | Possible that seasonal fluctuations influenced outcomes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Pharmacists must have been aware of group allocation. |