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

Schmidt 2006.

Study characteristics
Methods Randomised trial, UK
Participants 61 patients with eating disorder who received 14 sessions of cognitive behavioural guided self‐care
Interventions Adding personalised feedback on current physical and psychological status, risk and problems, and variables facilitating or hindering change.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: TREAT‐EAT, Short Evaluation of Eating Disorders (SEED), Hospital Anxiety and Depression Scale (HADS)
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Self‐administered and interviewer‐administered
Format of PROMs questionnaire(s): Electronic
 
Feedback features
Format of PROMs feedback: Electronic, Paper
How often information fed back: 14 sessions (10 weekly, 4 monthly booster sessions)
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores, Management recommendations
Outcomes Main outcome: patient‐rated measures of bulimic symptoms at the end of treatment and at 6‐month follow‐up.
Notes Funding source not disclosed. The study period was not reported. Conflicts of interest were not reported. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation sequence was generated by an independent investigator using a random numbers table.
Allocation concealment (selection bias) Low risk Allocation sequences were contained in sequentially numbered, sealed opaque envelopes that were opened by the clinical assessor after the initial assessment during which eligibility and willingness to participate had been obtained.
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 Table 1 presented similar baseline outcme measurements for both groups
Baseline characteristics similar Low risk Table 1 presented similar characteristics of patients in both groups
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing data was dealt with using bootstrapping methods
Was study protected against contamination Unclear risk Unclear as to whether the patients knew which group they were in
Selective reporting (reporting bias) Unclear risk Unclear whether selective reporting took place