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A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs)

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Abstract

Background

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).

Methods

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).

Results

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.

Conclusions

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.

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Abbreviations

± 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

FDA:

Food and drug administration

HRQL:

Health-related quality of life

PRO:

Patient-reported outcomes

PROM:

Patient-reported outcome measure

QOL:

Quality of life

RCT:

Randomised controlled trial

SR:

Systematic review

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Authors and Affiliations

  1. School of Public Health, University of Adelaide, Adelaide, Australia

    S. Ishaque, J. Karnon & A. B. Salter

  2. Centre for Health Economics, Monash Business School, Monash University, Clayton, Australia

    G. Chen

  3. School of Dentistry, University of Adelaide, Adelaide, Australia

    R. Nair

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  1. S. Ishaque
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  2. J. Karnon
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  3. G. Chen
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Correspondence to S. Ishaque.

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This review does not contain any studies with human participants performed by any of the authors.

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Informed Consent was not applicable to this review as no primary data were collected.

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Ishaque, S., Karnon, J., Chen, G. et al. A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (PROMs). Qual Life Res 28, 567–592 (2019). https://doi.org/10.1007/s11136-018-2016-z

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