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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
Interventions Control arm:
1) Patient reminders
Intervention arm:
1) Case management
2) Promotion of self‐management
3) Patient reminders
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)
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.