A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs)
Patient-reported outcome measures (PROMs) could play an important role in identifying patients’ needs and goals in clinical encounters, improving communication and decision-making with clinicians, while making care more patient-centred. Comprehensive evidence that PROMS are an effective intervention is lacking in single randomised controlled trials (RCTs).
A systematic search was performed using controlled vocabulary related to the terms: clinical care setting and patient-reported outcome. English language studies were included if they were a RCT with a PROM as an intervention in a patient population. Included studies were analysed and their methodologic quality was appraised using the Cochrane Risk of Bias tool. The protocol was registered with PROSPERO (CRD42016034182).
Of 4302 articles initially identified, 115 underwent full-text review resulting in 22 studies reporting on 25 comparisons. The majority of included studies were conducted in USA (11), among cancer patients (11), with adult participants only (20). Statistically significant and robust improvements were reported in the pre-specified outcomes of the process of care (2) and health care (3). Additionally, five, eight and three statistically significant but possibly non-robust findings were reported in the process of care, health and patient satisfaction outcomes, respectively.
Overall, studies that compared PROM to standard care either reported a positive effect or were not powered to find pre-specified differences. There is justification for the use of a PROM as part of standard care, but further adequately powered studies on their use in different contexts are necessary for a more comprehensive evidence base.
KeywordsPatient-reported outcome measures PROMs Health-related quality of life HRQL HRQoL Quality of life QOL Patient outcomes Patient-reported outcomes Clinical care
- ± PROM studies
Studies that compared patient completion of a PROM with standard care in the control group
- PROM ± summary studies
Studies in which all patients completed a PROM and compared the presentation of PROM summary scores to clinicians vs. no presentation of summary scores
Food and drug administration
Health-related quality of life
Patient-reported outcome measure
Quality of life
Randomised controlled trial
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This review does not contain any studies with human participants performed by any of the authors.
Informed Consent was not applicable to this review as no primary data were collected.
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