Quality of Life Research

, Volume 28, Issue 3, pp 567–592 | Cite as

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

  • S. IshaqueEmail author
  • J. Karnon
  • G. Chen
  • R. Nair
  • A. B. Salter



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.


Patient-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 outcomes


Patient-reported outcome measure


Quality of life


Randomised controlled trial


Systematic review


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

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

Informed consent

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

Supplementary material

11136_2018_2016_MOESM1_ESM.docx (51 kb)
Supplementary material 1 (DOCX 50 KB)


  1. 1.
    Mayo, E. N., et al. (2015). ISOQOL dictionary of quality of life and health outcomes measurement. First Edition.Google Scholar
  2. 2.
    Varadhan, R., Segal, J. B., Boyd, C. M., Wu, A. W., & Weiss, C. O. (2013). A framework for the analysis of heterogeneity of treatment effect in patient-centered outcomes research. Journal of Clinical Epidemiology, 66, 818–825.PubMedPubMedCentralCrossRefGoogle Scholar
  3. 3.
    Greenhalgh, J., & (Feb (2009). The applications of PROs in clinical practice: What are they, do they work, and why? Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care & Rehabilitation, 18(1), 115–123.CrossRefGoogle Scholar
  4. 4.
    Ahmed, S., Berzon, R. A., Revicki, D. A., Lenderking, W. R., Moinpour, C. M., Basch, E., et al. (2012). The use of patient-reported outcomes (PRO) within comparative effectiveness research: Implications for clinical practice and health care policy. Medical Care, 50(12), 1060–1070.PubMedCrossRefGoogle Scholar
  5. 5.
    Wu, A. W., Snyder, C., Clancy, C. M., & Steinwachs, D. M. (2010). Adding the patient perspective to comparative effectiveness research. Health Affairs, 29(10), 1863–1871.PubMedCrossRefGoogle Scholar
  6. 6.
    Antunes, B., Harding, R., Irene, J. H., & on behalf EUROIMPACT (2014). Implementing patient-reported outcome measures in palliative care clinical practice: A systematic review of facilitators and barriers. Palliative Medicine, 28(2), 158–175.PubMedCrossRefGoogle Scholar
  7. 7.
    Burns, P. B., Rohrich, R. J., & Chung, K. C. (2011). The levels of evidence and their role in evidence-based medicine. Plastic and Reconstructive Surgery, 128(1), 305–310. Scholar
  8. 8.
    Greenhalgh, J., & Meadows, K. (1999). The effectiveness of the use of patient-based measures of health in routine practice in improving the process and outcomes of patient care: A literature review. Journal of Evaluation in Clinical Practice, 5(4), 401–416.PubMedCrossRefGoogle Scholar
  9. 9.
    Espallargues, M., Valderas, J. M., & Alonso, J. (2000). Provision of feedback on perceived health status to health care professionals: A systematic review of its impact. Medical Care, 38(2), 175–186.PubMedCrossRefGoogle Scholar
  10. 10.
    Gilbody, S. M., House, A. O., & Sheldon, T. (2002). Routine administration of health related quality of life (HRQoL) and needs assessment instruments to improve psychological outcome—A systemic review. Psychological Medicine, 32(8), 1345–1356.PubMedCrossRefGoogle Scholar
  11. 11.
    Kotronoulas, G., Kearney, N., Maguire, R., Harrow, A., Di Domenico, D., Croy, S., et al. (2014). What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. Journal of Clinical Oncology, 32(14), 1480–1501.PubMedCrossRefGoogle Scholar
  12. 12.
    Valderas, J. M., Kotzeva, A., Espallargues, M., Guyatt, G., Ferrans, C. E., Halyard, M. Y., et al. (2008). The impact of measuring patient-reported outcomes in clinical practice: A systematic review of the literature. Quality of Life Research, 17(2), 179–193.PubMedCrossRefGoogle Scholar
  13. 13.
    Marshall, S., Haywood, K., & Fitzpatrick, R. (2006). Impact of patient-reported outcome measures on routine practice: A structured review. Journal of Evaluation in Clinical Practice, 12(5), 559–568.PubMedCrossRefGoogle Scholar
  14. 14.
    Alsaleh, K. (2013). Routine administration of standardized questionnaires that assess aspects of patients’ quality of life in medical oncology clinics: A systematic review. Journal of the Egyptian National Cancer Institute, 25(2), 63–70. Scholar
  15. 15.
    Boyce, M. B., & Browne, J. P. (2013). Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Quality of Life Research, 22(9), 2265–2278. Scholar
  16. 16.
    Chen, J., Ou, L., & Hollis, S. J. (2013). A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Services Research. Scholar
  17. 17.
    Greenhalgh, J., Dalkin, S., Gooding, K., Gibbons, E., Wright, J., Meads, D., et al. (2017). Functionality and feedback: A realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. Health Services and Delivery Research, 5(2), 1–280.CrossRefGoogle Scholar
  18. 18.
    Etkind, S. N., Daveson, B. A., Kwok, W., Witt, J., Bausewein, C., Higginson, I. J., et al. (2015). Capture, transfer, and feedback of patient-centered outcomes data in palliative care populations: Does it make a difference? A systematic review. Journal of Pain and Symptom Management, 49(3), 611–624. Scholar
  19. 19.
    Gutteling, J. J., Darlington, A. S., Janssen, H. L., Duivenvoorden, H. J., Busschbach, J. J. V., & De Man, R. A. (2008). Effectiveness of health-related quality-of-life measurement in clinical practice: A prospective, randomized controlled trial in patients with chronic liver disease and their physicians. Quality of Life Research, 17(2), 195–205. Scholar
  20. 20.
    Lambert, M. J., Whipple, J. L., Hawkins, E. J., Vermeersch, D. A., Nielsen, S. L., & Smart, D. W. (2003). Is it time for clinicians to routinely track patient outcome? A meta-analysis. Clinical Psychology: Science and Practice, 10(3), 288–301. Scholar
  21. 21.
    Luckett, T., Butow, P. N., & King, M. T. (2009). Improving patient outcomes through the routine use of patient-reported data in cancer clinics: Future directions. Psycho-oncology, 18(11), 1129–1138.PubMedCrossRefGoogle Scholar
  22. 22.
    Guyatt, G. H., Van Zanten, S. V., Feeny, D. H., & Patrick, D. L. (1989). Measuring quality of life in clinical trials: A taxonomy and review. CMAJ: Canadian Medical Association Journal, 140(12), 1441–1448.PubMedGoogle Scholar
  23. 23.
    Williams, K., Sansoni, J., Morris, D., Grootemaat, P., & Thompson, C. (2016). Patient-reported outcome measures: Literature review. Sydney: ACSQHC.Google Scholar
  24. 24.
    Boyce, M. B., Browne, J. P., & Greenhalgh, J. (2014). The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: A systematic review of qualitative research. BMJ Quality and Safety, 23(6), 508–518. Scholar
  25. 25.
    Duncan, E. A. S., & Murray, J. (2012). The barriers and facilitators to routine outcome measurement by allied health professionals in practice: A systematic review. BMC Health Services Research. Scholar
  26. 26.
    Valderas, J. M., & Alonso, J. (2008). Patient reported outcome measures: A model-based classification system for research and clinical practice. Quality of Life Research, 17(9), 1125–1135. Scholar
  27. 27.
    Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. Journal of Clinical Epidemiology, 63(8), 834–840. Scholar
  28. 28.
    Ishaque, S., Salter, A., Karnon, J., Chan, G., Nair, R. (2016). A systematic review of randomized clinical trials evaluating the use of patient reported outcome measures (PROMs) to improve patient outcomes. PROSPERO CRD42016034182. Available from:
  29. 29.
    Moher, D., Shamseer, L., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., et al. (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews. CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    Higgins, J. P. T., Altman, D. G., Gøtzsche, P. C., Jüni, P., Moher, D., Oxman, A. D., et al. (2011). The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ, 343, d5928.PubMedPubMedCentralCrossRefGoogle Scholar
  31. 31.
    Basch, E., Deal, A. M., Kris, M. G., Scher, H. I., Hudis, C. A., Sabbatini, P., et al. (2016). Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. Journal of Clinical Oncology, 34(6), 557–565.PubMedCrossRefGoogle Scholar
  32. 32.
    Berry, D. L., Blumenstein, B. A., Halpenny, B., Wolpin, S., Fann, J. R., Austin-Seymour, M., et al. (2011). Enhancing patient-provider communication with the electronic self-report assessment for cancer: A randomized trial. Journal of Clinical Oncology, 29(8), 1029–1035.PubMedPubMedCentralCrossRefGoogle Scholar
  33. 33.
    Boyes, A., Newell, S., Girgis, A., McElduff, P., & Sanson-Fisher, R. (2006). Does routine assessment and real-time feedback improve cancer patients’ psychosocial well-being? European Journal of Cancer Care, 15(2), 163–171.PubMedCrossRefGoogle Scholar
  34. 34.
    Calkins, D. R., Rubenstein, L. V., Cleary, P. D., Davies, A. R., Jette, A. M., Fink, A., et al. (1994). Functional disability screening of ambulatory patients—A randomized controlled trial in a hospital-based group practice. Journal of General Internal Medicine, 9(10), 590–592.PubMedCrossRefGoogle Scholar
  35. 35.
    Cleeland, C. S., Wang, X. S., Shi, Q., Mendoza, T. R., Wright, S. L., Berry, M. D., et al. (2011). Automated symptom alerts reduce postoperative symptom severity after cancer surgery: A randomized controlled clinical trial. Journal of Clinical Oncology, 29(8), 994–1000.PubMedPubMedCentralCrossRefGoogle Scholar
  36. 36.
    De Wit, M., Delemarre-van De Waal, H. A., Bokma, J. A., Haasnoot, K., Houdijk, M. C., Gemke, R. J., et al. (2008). Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: A randomized controlled trial. Diabetes Care, 31(8), 1521–1526.PubMedPubMedCentralCrossRefGoogle Scholar
  37. 37.
    Detmar, S. B., Muller, M. J., Schornagel, J. H., Wever, L. D. V., & Aaronson, N. K. (2002). Health-related quality-of-life assessments and patient-physician communication: A randomized controlled trial. Journal of the American Medical Association, 288(23), 3027–3034.PubMedCrossRefGoogle Scholar
  38. 38.
    Goldsmith, G., & Brodwick, M. (1989). Assessing the functional status of older patients with chronic illness. Family Medicine, 21(1), 38–41.PubMedGoogle Scholar
  39. 39.
    Hoekstra, J., de Vos, R., van Duijn, N. P., Schade, E., & Bindels, P. J. (2006). Using the symptom monitor in a randomized controlled trial: The effect on symptom prevalence and severity. Journal of Pain & Symptom Management, 31(1), 22–30.CrossRefGoogle Scholar
  40. 40.
    Kazis, L. E., Callahan, L. F., Meenan, R. F., & Pincus, T. (1990). Health status reports in the care of patients with rheumatoid arthritis. Journal of Clinical Epidemiology, 43(11), 1243–1253.PubMedCrossRefGoogle Scholar
  41. 41.
    McLachlan, S. A., Allenby, A., Matthews, J., Wirth, A., Kissane, D., Bishop, M., et al. (2001). Randomized trial of coordinated psychosocial interventions based on patient self-assessments versus standard care to improve the psychosocial functioning of patients with cancer. Journal of Clinical Oncology, 19(21), 4117–4125.PubMedCrossRefGoogle Scholar
  42. 42.
    Mills, M. E., Murray, L. J., Johnston, B. T., Cardwell, C., & Donnelly, M. (2009). Does a patient-held quality-of-life diary benefit patients with inoperable lung cancer? Journal of Clinical Oncology, 27(1), 70–77.PubMedCrossRefGoogle Scholar
  43. 43.
    Qureshi, N., Standen, P. J., Hapgood, R., & Hayes, J. (2001). A randomized controlled trial to assess the psychological impact of a family history screening questionnaire in general practice. Family Practice, 18(1), 78–83.PubMedCrossRefGoogle Scholar
  44. 44.
    Rosenbloom, S. K., Victorson, D. E., Hahn, E. A., Peterman, A. H., & Cella, D. (2007). Assessment is not enough: A randomized controlled trial of the effects of HRQL assessment on quality of life and satisfaction in oncology clinical practice. Psycho-oncology, 16(12), 1069–1079.PubMedCrossRefGoogle Scholar
  45. 45.
    Rubenstein, L. V., Calkins, D. R., Young, R. T., Cleary, P. D., Fink, A., Kosecoff, J., et al. (1989). Improving patient function: A randomized trial of functional disability screening. Annals of Internal Medicine, 111(10), 836–842.PubMedCrossRefGoogle Scholar
  46. 46.
    Rubenstein, L. V., McCoy, J. M., Cope, D. W., Barrett, P. A., Hirsch, S. H., Messer, K. S., et al. (1995). Improving patient quality of life with feedback to physicians about functional status. Journal of General Internal Medicine, 10(11), 607–614.PubMedCrossRefGoogle Scholar
  47. 47.
    Ruland, C. M., Holte, H. H., Røislien, J., Heaven, C., Hamilton, G. A., Kristiansen, J., et al. (2010). Effects of a computer-supported interactive tailored patient assessment tool on patient care, symptom distress, and patients’ need for symptom management support: A randomized clinical trial. Journal of the American Medical Informatics Association, 17(4), 403–410.PubMedPubMedCentralCrossRefGoogle Scholar
  48. 48.
    Street, R. L., Gold, W. R., & McDowell, T. (1994). Using health status surveys in medical consultations. Medical Care, 32(7), 732–744.PubMedCrossRefGoogle Scholar
  49. 49.
    Velikova, G., Booth, L., Smith, A. B., Brown, P. M., Lynch, P., Brown, J. M., et al. (2004). Measuring quality of life in routine oncology practice improves communication and patient well-being: A randomized controlled trial. Journal of Clinical Oncology, 22(4), 714–724.PubMedCrossRefGoogle Scholar
  50. 50.
    Wagner, A. K., Ehrenberg, B. L., Tran, T. A., Bungay, K. M., Cynn, D. J., & Rogers, W. H. (1997). Patient-based health status measurement in clinical practice: A study of its impact on epilepsy patients’ care. Quality of Life Research, 6(4), 329–341.PubMedCrossRefGoogle Scholar
  51. 51.
    Wasson, J., Hays, R., Rubenstein, L., Nelson, E., Leaning, J., Johnson, D., et al. (1992). The short-term effect of patient health status assessment in a health maintenance organization. Quality of Life Research, 1(2), 99–106.PubMedCrossRefGoogle Scholar
  52. 52.
    Wolfe, J., Orellana, L., Cook, E. F., Ullrich, C., Kang, T., Geyer, J. R., et al. (2014). Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: Results from the PediQUEST randomized controlled trial. Journal of Clinical Oncology, 32(11), 1119–1126.PubMedPubMedCentralCrossRefGoogle Scholar
  53. 53.
    Measuring Impact—SF-36. (2018). Accessed September 2, 2018, from
  54. 54.
    Skelly, A. C. (2011). Probability, proof, and clinical significance. Evidence-Based Spine-Care Journal, 2(4), 9–11.PubMedPubMedCentralCrossRefGoogle Scholar
  55. 55.
    Hays, R. D., & Woolley, J. M. (2000). The concept of clinically meaningful difference in health-related quality-of-life research: How meaningful is it? PharmacoEconomics, 18(5), 419–423.PubMedCrossRefGoogle Scholar
  56. 56.
    El Gaafary, M. (2016). A guide to PROMs methodology and selection criteria. In Y. El Miedany (Ed.), Patient reported outcome measures in rheumatic diseases (pp. 21–58). Cham: Springer.CrossRefGoogle Scholar
  57. 57.
    Cappelleri, J. C., & Bushmakin, A. G. (2014). Interpretation of patient-reported outcomes. Statistical Methods in Medical Research, 23(5), 460–483. Scholar
  58. 58.
    Coon, C. D., & Cappelleri, J. C. (2016). Interpreting change in scores on patient-reported outcome instruments. Therapeutic Innovation and Regulatory Science, 50(1), 22–29. Scholar
  59. 59.
    Dreyer, R. P., Jones, P. G., Kutty, S., et al. (2016). Quantifying clinical change: Discrepencies between patient’s and providers’ perspectives. Quality of Life Research, 25(9), 2213–2220.PubMedCrossRefGoogle Scholar
  60. 60.
    Hemmingsson, H., Ólafsdóttir, L. B., & Egilson, S. T. (2017). Agreements and disagreements between children and their parents in health-related assessments. Disability and Rehabilitation, 39(11), 1059–1072.PubMedCrossRefGoogle Scholar
  61. 61.
    Shamseer, L., Moher, D., Clarke, M., Ghersi, D., Liberati, A., Petticrew, M., et al. (2015). Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: Elaboration and explanation. BMJ: British Medical Journal. Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.School of Public HealthUniversity of AdelaideAdelaideAustralia
  2. 2.Centre for Health Economics, Monash Business SchoolMonash UniversityClaytonAustralia
  3. 3.School of DentistryUniversity of AdelaideAdelaideAustralia

Personalised recommendations