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 |
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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 |