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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

Kendrick 2017.

Study characteristics
Methods Partly individually randomised, partly cluster‐randomised controlled trial, UK
Participants 47 adults with new episodes of depression, in 9 general practices in Southern England.
Interventions Patient Health Questionnaire, Distress Thermometer Analogue Scale and PSYCHLOPS problem profile for monitoring depression, following diagnosis and at 10–35 days later. Feedback of scores to patients was determined by practitioners.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: PHQ‐9 for depressive symptoms, Distress Thermometer Analogue Scale for distress, PSYCHLOPS profile rating of one or two problems individual to the patient
Constructs measured: Health related Quality of Life, Symptoms, Functioning, Other (Rating of one or two problems individual to the patient ‐ PSYCHLOPS)
Instrument categories/domains: Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical and non‐clinical setting
How administered: Self‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: Twice (follow up consultation 10‐35 days later)
Who information fed back to: Clinicians
Information fed back: Scores, Interpretation guidance
Outcomes Main outcome: Beck Depression Inventory (BDI‐II).
Other outcomes: Work and Social Adjustment Scale (WSAS), EuroQol Five‐item, Five‐level (EQ‐5D‐5L), Scale for quality of life, modified Client Service Receipt Inventory for costs, Medical Informant Satisfaction Scale (MISS)
Notes The study was supported by National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme (grant number PB‐PG‐0613‐31004). 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 Trial statistician used computer sequence generation.
Allocation concealment (selection bias) High risk Due to (part) cluster‐randomised design not possible to conceal allocation from clinicians.
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 High risk Control group patients had higher scores for depression, social functioning was whose and anxiety higher at baseline.
Baseline characteristics similar Low risk Reasonably balanced ‐ but there were more married/cohabiting patients in intervention group.
Incomplete outcome data (attrition bias)
All outcomes High risk Did not mention how they would deal with incomplete data ‐ but this was a feasibility study.
Was study protected against contamination Low risk Control did not complete any PROMs.
Selective reporting (reporting bias) Low risk All outcome measurements mentioned in methods section was reported in results.