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

Santana 2010.

Study characteristics
Methods Randomised trial, USA
Participants 213 outpatient lung transplant patients in routine clinical care
Interventions Feedback to cliniicians (of Health utilities Index Mark 2 and 3)
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3)
Constructs measured: Health related Quality of Life, Symptoms, Functioning
Instrument categories/domains: Generic
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) 
How administered: Self‐administered
Format of PROMs questionnaire(s): Electronic
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: Every clinic visit for up to 6 months
Who information fed back to: Clinicians
Information fed back: Scores, Previous scores
Outcomes Main outcomes: issues discussed, changes in clinical management (medication changes, number of referrals and test ordered), EQ‐5D
Notes The study was funded by Institute of Health Economics (IHE), Edmonton, AB, Canada. The study period was not reported. The authors reported that David Feeny has a proprietary interest in Health Utilities Incorporated, Dundas, Ontario, Canada. HUInc. distributes copyrighted Health Utilities Index (HUI) materials and provides methodological advice on the use of HUI.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization scheme was generated by using the Web site Randomization.com"
Allocation concealment (selection bias) Low risk Computer conducted the assignment and the patients were unaware of assignment
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 2 presented similar baseline outcome 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 Unclear risk An intention to treat analysis where missing values were imputed using the last value carried forward
Was study protected against contamination Unclear risk Unlikely as the patients completed the touch screen questionnaire and went in the consultation immediately
Selective reporting (reporting bias) Unclear risk All measures mentioned in the methods section were reported in the results