Pouwer 2001.

Study characteristics
Methods	Randomised trial, the Netherlands
Participants	400 outpatients with diabetes treated at the outpatient diabetes clinic of Vrije Universiteit Medical Center. Mean age of participants was 53 years for the monitoring group and 54 for the standard care group and were mainly female for the monitoring group (57%) and male for the standard care group (52%)
Interventions	The standard care group had regular appointments with an internist (3‐ to 4‐month intervals) and, if needed, other members of the diabetes team, as well as at least two 15‐minute consultations with the diabetes nurse specialist (DNS) in which various topics related to diabetes were discussed (including psychosocial issues). No formal assessment of psychological well‐being was performed. The diabetes nurse specialist assessed and discussed psychological well‐being with the patient (with an interval of 6 months) in addition to standard care for patients in the monitoring group.   Intervention features Multiple simple feedback (one PROM at multiple times) PROM(s) used as intervention: Computerized Well‐being Questionnaire (W‐BQ) Constructs measured: Functioning Instrument categories/domains: Domain/Disease specific (mental health)   Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc)  How administered: Interviewer‐administered Format of PROMs questionnaire(s): Electronic   Feedback features Format of PROMs feedback: Unclear How often information fed back: 3 times Who information fed back to: Clinicians Information fed back: Scores, Previous scores
Outcomes	Main outcome: mood, HbA1c, quality of diabetes care at 1‐year follow‐up (Well‐being Questionnaire). Other outcomes: number of referrals to the psychologist. The study was conducted between May 1997 and December 1999. Conflicts of interest were not reported.
Notes	The study was funded by Dutch Diabetes Research Foundation (grant# 95.805).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers were used.
Allocation concealment (selection bias)	Unclear risk	It was unclear whether patients were aware of their allocation. Formal assessments were made in the intervention group by clinicians thus they may have known
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible due to study design (nurse discussion with patient about their psychological well‐being versus standard care).
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	None apparent
Baseline characteristics similar	Low risk	Tables provided and paper states Quote:"The monitoring group did not differ signifi‐cantly from the standard care group with regard to demographic, clinical, and psy‐chological variables at baseline."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analysis was intention‐to‐treat and complete‐case analysis
Was study protected against contamination	High risk	Possible contamination by the nurses administering the measurements
Selective reporting (reporting bias)	Low risk	None apparent