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

Blonigen 2015.

Study characteristics
Methods Pilot randomised trial, USA
Participants 30 patients entering a 90‐day residential substance use disorder treatment program.
Mean age 49 (range 26‐64) years, 93.3% male.
Interventions Patients completed assessments of sociodemographics, treatment history, substance‐ related functioning, and personality and worked with an Intervention Co‐ordinator (IC) to work on assessment questions. At patient‐centred feedback session (13.8 mean days after treatment entry) they received a summary of their personality profile and recommendation to help address problematic behavior tendencies. At 1‐month follow‐up sessions patient completed assessment regarding their adjustment to the residential program.
response time: 13.8 mean days via face‐to‐face
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: The Brief Addiction Monitor, The NEO PI‐R measure of normal‐range personality, The Assessment Questionnaire (AQ) measuring satisfaction with the patient‐centred assessment process.
Constructs measured: Functioning, Other (Satisfaction)
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
Format of PROMs questionnaire(s): Unclear
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: At feedback session and one month follow up
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Interpretation guidance, Management recommendations
Outcomes Main outcome: assessment Questionnaire (AQ)
Other outcomes: length of stay in the program and whether or not patient dropped out of the program
Notes The study was supported by Career Development Award‐2, VA Office of Research and Development (Clinical Sciences R&D); Locally Initiated Project (LIP13DB1), VA Palo Alto Centre for Innovation to Implementation (Ci2i). The study period was not reported. The authors declared no competing interesting. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Numbers randomly added to an excel spreadsheet
Allocation concealment (selection bias) Unclear risk Patients notified of their status
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible due to study design (crossed design; study looking at feedback).
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 No information on baseline measurements
Baseline characteristics similar Low risk None apparent
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No discussion on missing data
Was study protected against contamination Unclear risk No discussion on whether the clinician delivering the intervention interacted with the control group patients
Selective reporting (reporting bias) Low risk All outcome measurements mentioned in methods section was reported in results