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 |
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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) |
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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. |
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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. |