Fairall 2016.

Study characteristics
Methods	Educational outreach with an integrated clinical tool for nurse‐led non‐communicable chronic disease management in primary care in South Africa: a pragmatic cluster randomised controlled trial Clustered RCT (38 clusters and 90 providers), conducted in 1) 38 public sector primary care clinics in the Western Cape Province (Eden and Overberg districts, socio‐economically deprived areas), South Africa, were randomised. 2) Nurses in the intervention clinics were trained to use the PC101 management tool in South Africa 2 arms: 1. Control (PALSA‐PLUS management tool) (control arm) and 2. Intervention (PC101 management tool) (intervention arm)
Participants	Control arm N: 991 Intervention arm N: 851, NA, NA Diabetes type: 4 Mean age: 52.01 ± 17.18 % Male: 25 Longest follow‐up: 14 months
Interventions	Control arm: (PALSA‐PLUS management tool) Intervention arm: (PC101 management tool) 1) Team change 2) Clinician education 3) Clinician reminder 4) Continuous quality improvement
Outcomes	Anti‐platelet drugs Glycated haemoglobin
Funding source	This project has been funded in part with Federal funds by the United States National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268200900030C (http://www.nhlbi.nih.gov/). Funding was also received from United Health, USA; the Department of Health of the Provincial Government of the Western Cape; the Department of Medicine, University of Cape Town, South Africa; the United Kingdom Department for International Development; and the University of Cape Town Lung Institute, South Africa. Funding was received by NL.
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Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was completed by the trial statistician using nQuery Advisor (Sample Size software) after recruitment of clinics, independently of the managers giving permission for the clinics to be included in the trial, and prior to patient recruitment and implementation of the intervention.
Allocation concealment (selection bias)	Low risk	Clustered RCT.
Provider's baseline characteristics (selection bias)	High risk	Baseline clinic characteristics are provided in Table A in S1 Appendix (no P values). Intervention and control clinics had similar numbers of nurses and doctors. Control clinics tended to be larger and, by chance, had more psychiatric services and on‐site pharmacy facilities.
Patient's baseline characteristics (selection bias)	Unclear risk	Table 2. Baseline patient characteristics were generally well balanced between arms (4 cohorts pooled, but no P values provided). Supplementary tables, Table D, only for diabetes patients, n = 1842, significant P values for Mossel Bay Stratum (P = 0.006) and history of CVD (P = 0.019).
Patient's baseline outcomes (selection bias)	High risk	Table 2. Baseline patient characteristics were generally well balanced between arms (4 groups pooled, but no P values provided). Supplementary tables, Table D, only for diabetes patients, n = 1842, more patients with BMI> 30 in the intervention group (P = 0.009).
Incomplete outcome data (attrition bias)	High risk	They only analysed a subgroup of diabetes patients for HbA1c: 394/991 (39.8%) and 310/851 (36.4%) for the control and intervention group, respectively. They have data for 333/394 (15.5% lost) for the control group and 285/310 (8.1%) for the intervention group at 14 months follow‐up, respectively. High and unbalanced numbers. Insufficient resources to measure important health outcomes, such as HbA1c, at follow‐up.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Objective outcomes: HbA1c (pre‐planned blood sampling) and aspirin addition (at follow‐up, prescription data for the period since baseline were extracted, photocopied, analysed and documented in the same way as at baseline).
Selective reporting (reporting bias)	High risk	Unclear if protocol was prospectively or retrospectively registered. However, secondary outcomes listed in the protocol for diabetic patients are not reported (proportion reporting dilated eye exam, proportion reporting foot exam).
Risk of contamination (other bias)	Unclear risk	Other strengths of the study include the cluster‐randomised design (appropriate to reduce the risk of contamination in an intervention directed at groups of nurses working in clinics). However, the PC101 tool used for the intervention is available online so control group had access to it (Quote: "For examples of updated content, see http://knowledgetranslation.co.za/programmes/pack‐adult/").
Other bias	Unclear risk	Some variation in uptake of the management tool by nurses was reported. A further potential reason for the failure to show differences between groups was the effect of a co‐intervention, the concurrent Chronic Disease Season campaign, instituted by the clinic managers in both control and intervention clinics. The impact of this unforeseen development is seen in the higher rates of treatment intensification for hypertension and diabetes (the focus of the campaign) than for chronic respiratory disease or depressive symptoms in both the intervention and control clinics. Other limitations of the study design include dependence on self‐reported diagnoses for inclusion in the patient cohorts. Follow‐up visits being only every 3 to 6 months limited opportunities for treatment intensification. The expanded prescribing provisions initially resulted in some tensions between nurses, doctors and pharmacists. These were resolved through a facilitated group session and informal communication within clinics, sometimes involving the nurse trainer. This intervention was the only modification to the training during the trial.