Neto 2011.
| Study characteristics | ||
| Methods |
Effect of a 36‐month pharmaceutical care program on coronary heart disease risk in elderly diabetic and hypertensive patients Patient RCT, conducted in Primary Health Care Unit of the Brazilian public health system, Salto Grande, Sao Paulo State, Brazil Two arms: 1. Control group (control arm) and 2. Intervention group (intervention arm) |
|
| Participants | Control arm N: 18 Intervention arm N: 17 Diabetes type: unclear/not reported Mean age: NR ± NR % Male: NR Longest follow‐up: 36 months |
|
| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management 5) Patient reminders |
|
| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.7 (0.5), post 7.7 (NR) Intervention arm: pre 7.7 (0.5), post 7.0 (NR) |
|
| Funding source | This study was supported by Fundação de Apoio ao Desenvolvimento Científico (FADEC) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Software which… Quote: "provided computer‐generated random sequences…" |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Patient's baseline characteristics (selection bias) | Low risk | Quote: "…indicated that the baseline characteristics of the patients in the intervention group closely matched those of the patients in the control group." Table with P values also provided. |
| Patient's baseline outcomes (selection bias) | Low risk | SBP (P = 0.79); DBP (P = 0.36); HbA1c (P = 0.69); LDL (P = 0.90). |
| Incomplete outcome data (attrition bias) | High risk | Although only 3% lost to follow‐up in each arm, specific reasons for loss to follow‐up not provided. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Outcome assessor blinded and laboratory methods used to assess outcomes go into detail for SBP and DBP. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match results. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |