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

Aleo 2015.

Study characteristics
Methods Improving eye care follow‐up adherence in diabetic patients with ocular abnormalities: the effectiveness of patient contracts in a free, pharmacy‐based eye screening
Quasi‐RCT (NA clusters and NA providers), conducted in 1) Participants were recruited from an urban outpatient pharmacy in Philadelphia, PA. Community‐based pharmacy setting to screen for ocular diseases. 2) Eye screening done in community‐based setting. Contract administered by research assistants and the follow‐up was done by an ophthalmologist in adherent patients in United States of America.
2 arms: 1) Control non‐contract group (control arm) and 2) Intervention contract group (intervention arm)
Participants Control arm N: NR
Intervention arm N: NR, NA, NA
Diabetes type: 4
Mean age: 54.7 ± NR
% Male: 43.4
Longest follow‐up: 3 months
Interventions Control arm: (non‐contract group)
1) Case management
2) Facilitated relay of clinical information
3) Patient reminders
Intervention arm: (contract group)
1) Case management
2) Facilitated relay of clinical information
3) Promotion of self‐management
4) Patient reminders
Outcomes 1) Retinopathy screening (fundus exam follow‐up adherence)
Funding source This study was funded by the Centers for Disease Control and Prevention 5U58DP002655‐02
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk The participants were assigned to groups by alternating weeks; the 250 patients who attended screenings during odd weeks were assigned to the contract group and the 250 patients who attended screenings during even weeks were assigned to the non‐contract group.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk There were no significant differences in the demographic composition of the contract and non‐contract groups. No P values reported.
Patient's baseline outcomes (selection bias) Unclear risk Not reported.
Incomplete outcome data (attrition bias) High risk They initially randomised 500 patients. 113 (22.6%) were found to have DR or another ocular abnormality. Of the 113 participants who had abnormal results, 83 (74.3%) were able to be contacted and complete the 3‐month follow‐up questionnaire regarding their follow‐up eye care utilisation. 30 patients were lost to follow‐up (27%).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) High risk Outcome self‐reported by patients. Research assistants administered a follow‐up questionnaire to all participants with abnormal findings by telephone 3 months after the screening results were distributed. The questionnaire addressed follow‐up eye care utilisation. Patients who signed a contract agreed to inform research staff if/when they completed an eye care appointment. Nothing about blinding.
Selective reporting (reporting bias) Unclear risk No registered or published protocol. The outcome of interest is not reported at baseline.
Risk of contamination (other bias) Low risk Patient‐randomised. It is unlikely that control patients signed a contract.
Other bias Low risk None.