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

Ayadurai 2018.

Study characteristics
Methods Structured tool to improve clinical outcomes of type 2 diabetes mellitus patients: a randomized controlled trial
RCT (NA clusters and NA providers), conducted in 1) The participating sites were 7 government‐funded primary care clinics in Johor, Malaysia. These practices, known as health clinics (Klinik Kesihatan), provide comprehensive medical care for ambulatory patients. 2) Intervention delivered by 14 pharmacists using the Simpler tool, a structured clinical guidelines tool. In Malaysia.
2 arms: 1) Control (UC: pharmacists providing usual care) (control arm) and 2) Intervention (SC: Simpler care by trained pharmacist) (intervention arm)
Participants Control arm N: 77
Intervention arm N: 77, NA, NA
Diabetes type: 2
Mean age: 56.67 ± 12.12
% Male: 42.75
Longest follow‐up: 6 months
Interventions Control arm: (UC: pharmacists providing usual care)
Intervention arm: (SC: Simpler care by trained pharmacist)
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Patient reminders
Outcomes 1) Lipid lowering drugs
2) Glycated haemoglobin
3) Systolic blood pressure
4) Diastolic blood pressure
5) Low‐density lipoprotein
6a) Hypertension control (SBP ≤ 135 mmHg)
6b) Hypertension control (DBP ≤ 75 mmHg)
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients at each of the 7 sites were randomised using overall equal randomisation (1: 1) to either the intervention group, namely to receive Simpler care (SC), or the control group to receive usual care (UC). The randomisation numbers were predetermined using an online random number generator based on a one block randomised block design (http://www.randomization.com/, accessed 10 March 2016).
Allocation concealment (selection bias) Unclear risk Upon receiving written consent, pharmacists opened the envelopes (opaque?) in ascending order and, depending on the randomisation code, allocated patients to either the intervention or control arm of the study.
Patient's baseline characteristics (selection bias) Unclear risk There were no significant differences between the SC and UC groups with regard to demographic characteristics, family history, types and number of comorbidities and current employment. There was a significant difference between patients’ overall highest education level between the SC and UC arms; highest education level (P value = 0.028)
Patient's baseline outcomes (selection bias) Low risk There were no significant differences between the SC and UC groups with regard to clinical parameters.
Incomplete outcome data (attrition bias) High risk They analysed 55/77 (29% lost) patients randomised in the intervention group and 69/77 (10% lost) in the control group. Unbalanced numbers and reasons.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c (primary outcome), LDL and blood pressure were objectively measured. Method to collect statin data not reported.
Selective reporting (reporting bias) High risk A registered protocol is available. Protocol outlines primary outcomes as "clinical outcomes and health‐related QOL of patients", which is in line with the manuscript primary outcome of "significant improvement in HbA1c". Protocol secondary outcome was "pharmacists’ compliance", manuscript secondary outcomes were "improved lipid profiles and blood pressure (BP)." There was also an additional analysis in the manuscript, which was not described in the protocol: "Comparison of participants in the Simpler care (SC) and usual care (UC) arms of the study who achieved at least a 1% decrease in HbA1c". They provide guidelines about aspirin therapy, but they do not report it as an outcome. There were no significant changes in the number of antihypertensive medications prescribed at 6 months of the study between the SC and UC arms, but they do not report data about it. Not all HbA1c and lipid results were available for each patient due to laboratory tests not scheduled at the exact time before the trial commenced or at completion. Hence, the values obtained ranged from the previous month to the previous 4 months.
Risk of contamination (other bias) High risk Patient‐randomised. Quote: "In addition, because patients in both the intervention and control groups were recruited from the same primary health center, “contamination” of the control group could occur. This is because it is possible that the same doctor treating patients in the intervention would be treating the control patients and therefore may use the pharmacist’s recommendations for the intervention group in the control group throughout the trial period. Nevertheless, the effect of any contamination did not mask the improvements seen in the SC group."
Other bias Low risk No evidence of other risk of bias.