van Dijk‐de Vries 2015.

Study characteristics
Methods	Pragmatic cluster‐randomised trial, the Netherlands
Participants	40 practice nurses specialised in diabetes mellitus in general practitioner practices (19 intervention versus 21 control). 264 patients (117 intervention, 147 usual care; 46% female patients, average age 65years).
Interventions	Biopsychosocial self‐management support (SMS)   Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: Daily Functioning Thermometer (DFT), Distress Screener (DS), Four‐Dimensional Symptom Questionnaire (4DSQ) Constructs measured: Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (mental health ‐ emotional distress, physical health ‐ diabetes)   Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) and non‐clinical setting How administered: Both self‐administered and interviewer‐administered Format of PROMs questionnaire(s): Paper   Feedback features Format of PROMs feedback: Paper How often information fed back: 3 times (baseline, 4 months, and 12 months) Who information fed back to: Clinicians, Patients Information fed back: Scores
Outcomes	Main outcome: dichotomised Visual Analog Scale on perceived effect of diabetes on daily functioning Other outcomes: patients’ diabetes‐related distress (PAID), quality of life (SF12), autonomy and participation (IPA), self‐efficacy (GSES‐12), self‐ management (PIH)
Notes	The study was supported by the Dutch Diabetes Research Foundation (Diabetes Fonds) (grant# 2010.13.1366). The study period was not reported. The authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number seed computer program to assign PNs to study arms, assuming an allocation ratio of 1:1.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not possible due to cluster randomisation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to nature of intervention not possible to blind patients and personnel.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention.
Baseline outcome measurements similar	Low risk	Patients of both groups were comparable for the primary and secondary outcomes at the baseline measurement except for the sum score on the PIH scale.
Baseline characteristics similar	Low risk	Table 1 had similar baseline characteristics for both groups
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Missing items were imputed using patients’ individual mean score if at least 50% of items were available.
Was study protected against contamination	Low risk	Risk of contamination was considered by the research team and practice was done to avoid it
Selective reporting (reporting bias)	Unclear risk	Unclear whether selective reporting took place