Fischer 2012.
| Study characteristics | ||
| Methods |
Nurse‐run, telephone‐based outreach to improve lipids in people with diabetes Patient RCT, conducted at Denver Health's Westside Family Health Center (Westside Clinic). Serves a large Latino minority population. In USA. Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 381 Intervention arm N: 381 Diabetes type: type 1 and type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 20 months |
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| Interventions |
Control arm: 1) Patient reminders Intervention arm: 1) Case management 2) Promotion of self‐management 3) Patient reminders |
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| Outcomes | 1) Controlled hypertension (< 130/80 mmHg), N under control (%) Control arm: pre 168 (44), post 170 (45) Intervention arm: pre 186 (49), post NR (NR) |
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| Funding source | This study was funded by the American Diabetes Association | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Does not describe, states that they were randomised. |
| Allocation concealment (selection bias) | Unclear risk | Does not describe, states that they were randomised. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Gender (P = 0.05), creatine levels (P = 0.01), cerebrovascular disease (P = 0.04). |
| Patient's baseline outcomes (selection bias) | Low risk | LDL (P = 0.84); HbA1c (P = 0.13); SBP (P = 0.96); DBP (P = 0.86); statin (P = 0.69); antihypertensive ACE (P = 0.58); beta‐blocker (P = 0.49). |
| Incomplete outcome data (attrition bias) | High risk | Intention‐to‐treat analysis done, numbers and reasons for loss to follow‐up not provided; they state that 65 of those in intervention group lost to follow‐up. Baseline based on those randomised. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective laboratory methods not described. Data analysts were not blinded. Nurse who had delivered the intervention was also not blinded. However, it seems like they gathered the laboratory data from the clinic's medical records, which would mean that despite blinding status, there would be little influence for altering these laboratory results. |
| Selective reporting (reporting bias) | Low risk | Protocol matches and the study design was published: Fischer H, Mackenzie T, McCullen K, Everhart R, Estacio RO. Design of a nurse‐run, telephone‐based intervention to improve lipids in diabetics. Contemporary Clinical Trials. 2008; 29: 809‐816. |
| Risk of contamination (other bias) | High risk | Quote: "…participants may have used services in other healthcare centres…given the nurse also interacted with control patients, contamination of the intervention was a possibility." |
| Other bias | Low risk | Information not available. |