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American Journal of Kidney Diseases

Patient-Reported Outcome Measures in CKD Care: The Importance of Demonstrating Need and Value

  • Meghan J. Elliott
    Correspondence
    Address for Correspondence: Meghan J. Elliott, MD, MSc, FRCPC, Department of Medicine, Division of Nephrology, University of Calgary, 1403 29 Street NW, Calgary, Alberta T2N 2T9, Canada.
    Affiliations
    Department of Medicine, University of Calgary, Calgary, Alberta, Canada

    Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
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  • Brenda R. Hemmelgarn
    Affiliations
    Department of Medicine, University of Calgary, Calgary, Alberta, Canada

    Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
    Search for articles by this author
      Related Article, p. 167
      Individuals with advanced chronic kidney disease (CKD) often experience symptom clusters, including fatigue, pruritus, and nausea, that precede their need to initiate dialysis and negatively affect their health-related quality of life.
      • Almutary H.
      • Bonner A.
      • Douglas C.
      Symptom burden in chronic kidney disease: a review of recent literature.
      Established indicators of health or “hard” clinical outcomes such as hospitalization may not adequately reflect the symptomatic or functional aspects of living with kidney disease that patients consider most important, including quality of life and mental and physical well-being.
      • Finkelstein F.O.
      • Wuerth D.
      • Finkelstein S.H.
      Health related quality of life and the CKD patient: challenges for the nephrology community.
      • Nissenson A.R.
      Improving outcomes for ESRD patients: shifting the quality paradigm.
      As such, patient-reported outcome measures (PROMs) are validated questionnaires developed for patients to report directly how they function and feel with respect to a health condition and the associated treatment, avoiding interpretation of their responses by a clinician or anyone else.
      National Quality Forum
      Patient-reported outcomes.
      Whereas PROMs have been widely used in research to describe disease burden and explore relationships between symptoms and clinical outcomes, they are being increasingly applied in the clinical setting to inform patient care.
      • Black N.
      Patient reported outcome measures could help transform healthcare.
      Their use in the routine care of persons living with CKD has recently gained traction as clinicians and patients explore new opportunities to enhance person-centered care delivery.
      In this issue of AJKD, to inform the implementation and use of electronic PROMs (ePROMs) in clinical care, Aiyegbusi et al
      • Aiyegbusi O.L.
      • Kyte D.
      • Cockwell P.
      • et al.
      Patient and clinician perspectives on electronic patient-reported outcome measures in the management of advanced CKD: a qualitative study.
      undertook a qualitative study to explore patient and clinician views on the use of a CKD ePROM system. The proposed ePROM system will require patients with advanced CKD to enter monthly self-reports regarding their health status.
      • Aiyegbusi O.L.
      • Kyte D.
      • Cockwell P.
      • et al.
      Using patient-reported outcome measures (PROMs) to promote quality of care and safety in the management of patients with advanced chronic kidney disease (PRO-trACK project): a mixed-methods project protocol.
      The system would then give customized information to patients to facilitate self-management and alert the clinical team if there is deterioration in the patient’s health status.
      Using semi-structured interviews and a focus group, Aiyegbusi et al sought the views of 12 patients with stages 4 and 5 CKD (non–dialysis dependent) and 22 clinicians (6 CKD nurses, 1 clinical psychologist, 10 nephrologists, 3 specialist registrars, and 2 renal surgeons) regarding the ePROM system. Participants, all from the University Hospitals Birmingham National Health Service Foundation Trust in the United Kingdom, received copies of the Kidney Disease Quality of Life-36 (KDQOL-36) and Integrated Patient Outcome Scale-Renal (IPOS-Renal) questionnaires in advance. Topic guides for patient interviews and clinician focus groups and interviews were used to explore system design and potential barriers and facilitators to implementation.
      Overall, patients reported that they would be willing to complete ePROMs on a regular basis, although clinicians were concerned about burden to the patients and were cautious about their practical performance in practice, including the potential that they may raise patient expectations beyond what is achievable. Practical issues were also raised regarding the ability of patients to complete ePROMs due to age, computer literacy, access to the internet, and language difficulties. The need to emphasize the significance of the questions and results and their consequent impact on patient outcomes to demonstrate value were believed to be the strongest facilitators for the future adoption of ePROMs in clinical care.
      A variety of PROM tools are available that can be broadly classified as generic or disease specific and have been validated across a number of health populations. Whereas generic measures (eg, EQ-5D-5L
      EuroQol Group
      EQ-5D-5L | About.
      ) facilitate comparisons between populations and interventions, disease-specific measures (eg, KDQOL-36, IPOS-Renal, and the modified Edmonton Symptom Assessment Scale-renal) may be more sensitive for detecting and quantifying aspects of health important to specific patient populations, including those with advanced CKD or who are dialysis dependent.
      • Raj R.
      • Ahuja K.
      • Frandsen M.
      • Murtagh F.E.M.
      • Jose M.
      Validation of the IPOS-Renal symptom survey in advanced kidney disease: a cross-sectional study.
      • Aiyegbusi O.L.
      • Kyte D.
      • Cockwell P.
      • et al.
      Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review.
      • Yang F.
      • Lau T.
      • Lee E.
      • Vathsala A.
      • Chia K.S.
      • Luo N.
      Comparison of the preference-based EQ-5D-5L and SF-6D in patients with end-stage renal disease (ESRD).
      In the study by Aiyegbusi et al, the KDQOL-36 and IPOS-Renal questionnaires were provided to participants to prompt discussion on their views of ePROM use in CKD care. Although these tools will also be used in the authors’ eventual ePROM intervention, there is no evidence to suggest the superiority of any one PROM questionnaire; the study team’s patient advisory group selected these PROMs based on their perceived acceptability, burdensomeness, and relevance. Certainly, involving those individuals in the tool selection process who may ultimately stand to benefit from PROMs and seeking to understand their views and preferences are important steps. However, in balance, there must be careful consideration as to how to realistically and effectively implement and sustain the use of such PROMs in routine clinical care.
      The clinical use of PROMs has been most extensively studied in the oncology literature, in which randomized trials have reported improved outcomes in several areas, including patient-provider communication, quality of life, care satisfaction, and even survival.
      • Basch E.
      Patient-reported outcomes - harnessing patients' voices to improve clinical care.
      • Basch E.
      • Deal A.M.
      • Kris M.G.
      • et al.
      Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.
      • Kotronoulas G.
      • Kearney N.
      • Maguire R.
      • et al.
      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.
      • Berry D.L.
      • Blumenstein B.A.
      • Halpenny B.
      • et al.
      Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial.
      • Berry D.L.
      • Hong F.
      • Halpenny B.
      • et al.
      Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.
      However, to derive such benefits from the routine use of PROMs, they must be incorporated into clinical care in such a way that anticipates and addresses potential barriers or challenges to their use. Similar to the findings of Aiyegbusi et al, systematic reviews of quantitative and qualitative data suggest that demonstrating clinical utility to clinicians is a key factor for successful implementation of PROMs in clinical practice.
      • Boyce M.B.
      • Browne J.P.
      • Greenhalgh J.
      The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research.
      • Antunes B.
      • Harding R.
      • Higginson I.J.
      EUROIMPACT
      Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.
      Other identified factors supporting effective PROM use include appropriately using technology, embedding PROMs into routine workflow, improving interpretability of PROM data, and engaging providers in intervention planning. Simply put, the investment of time and resources to carefully design the PROM implementation strategy and ensure specific organizational preparedness should not be undervalued.
      • Foster A.
      • Croot L.
      • Brazier J.
      • Harris J.
      • O'Cathain A.
      The facilitators and barriers to implementing patient reported outcome measures in organisations delivering health related services: a systematic review of reviews.
      Following PROMs acceptance and adoption into clinical care, questions often arise about how to use them to guide patient care. Recall that PROMs are questionnaires that patients complete about a variety of symptomatic and quality-of-life concerns. Ideally patients’ PROM results would be fed back to their relevant responsible health care providers, who would use that information to tailor patient care, similarly to how laboratory measures are routinely used.
      • Greenhalgh J.
      The applications of PROs in clinical practice: what are they, do they work, and why?.
      However, there are currently no standardized approaches on what to do with patients’ identified concerns, such as thresholds to prompt a clinician response or strategies to address symptoms beyond acknowledging them. This is particularly important in the CKD and dialysis populations, whose symptomatic burden can be challenging to address given the limited availability of effective therapeutic options and lack of high-quality evidence supporting their use. How routine use of PROMs might influence patient expectations about addressing identified symptoms remains to be determined, although findings from this qualitative study from Aiyegbusi et al suggest that this is more of a concern for clinicians than for patients, who seemed to acknowledge the complexity and feasibility of managing their progressive disease.
      Outstanding questions also remain regarding administration of PROMs, including their timing, frequency, and format. Whereas participants in the study from Aiyegbusi et al suggested that completion of ePROMs more often than monthly would become too burdensome for patients, there is no consensus from the kidney community as to the optimal frequency and timing of PROM administration. For patients with non–dialysis-dependent CKD or those receiving home dialysis modalities, tying in completion of PROM surveys with scheduled clinic visits (eg, every 3 months) may be an acceptable approach to enhance utility and minimize burden.
      • Schick-Makaroff K.
      • Molzahn A.
      Brief communication: patient satisfaction with the use of tablet computers: a pilot study in two outpatient home dialysis clinics.
      • Schick-Makaroff K.
      • Molzahn A.E.
      Evaluation of real-time use of electronic patient-reported outcome data by nurses with patients in home dialysis clinics.
      In contrast, integrating PROM assessments into the routine care of persons receiving conventional hemodialysis could provide consistency and reassurance for those with the greatest symptom burden.
      • Peipert J.D.
      • Hays R.D.
      Using patient-reported measures in dialysis clinics.
      The views from only 12 patients in the study by Aiyegbusi et al may limit the extent to which the authors’ conclusions apply more broadly to those who stand to benefit from an ePROM intervention, which includes patients with lived experiences of various stages of CKD. The ability to complete PROMs electronically by computer or portable technology such as a tablet (ie, ePROMs) offers an attractive option that could address efficiency and accessibility concerns but requires further study. If ePROMs were captured remotely and transmitted to the care team, surveillance of a patient’s data could identify emerging concerns and help determine appropriate follow-up. This would complement other elements of routine CKD care, such as blood work, and promote a self-management approach to patient care.
      Demonstrating a positive impact on outcomes was the most important facilitator of ePROM use for clinicians in the study of Aiyegbusi et al. However, in contrast to other disciplines such as oncology, there is limited evidence on the effect of PROM use in the routine care of persons with CKD or receiving dialysis. This relates in part to the fact that PROMs use in CKD care is in its nascency and that PROMs can be considered complex health interventions.
      • Craig P.
      • Dieppe P.
      • Macintyre S.
      • et al.
      Developing and evaluating complex interventions: the new Medical Research Council guidance.
      As such, understanding how context interacts with the intervention and its implementation is crucial for developing an effective PROM implementation strategy and evaluating individual- and system-level outcomes.
      • Pfadenhauer L.M.
      • Gerhardus A.
      • Mozygemba K.
      • et al.
      Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework.
      • Moore G.F.
      • Audrey S.
      • Barker M.
      • et al.
      Process evaluation of complex interventions: Medical Research Council guidance.
      As validated PROMs are increasingly incorporated into CKD care, data regarding their impact will become available to help direct future research efforts and inform person-centered CKD care delivery.
      In the meantime, obtaining patient and clinician perspectives to inform the development and use of an ePROM system is an important first step. Although the results by Aiyegbusi et al provide insights to inform the implementation and delivery of such a system in clinical practice, the extent to which findings can be applied to other settings or contexts must be carefully considered. For example, the majority of views were sought from clinicians, whose input contributed to all themes, while no patient-specific themes were identified. It is also unclear if or how findings might apply to other areas of nephrology, such as the dialysis population. Further, identified themes are pragmatic, without offering insight into the motivations and attitudes underlying participant views, which would be critical for providing context and addressing behavioral change through an intervention such as PROMs. Perhaps most important, this study reports participant views about an anticipated ePROM system that has yet to be implemented. Revisiting participants’ views, experiences, and outcomes upon application in practice will be crucial to tailor the intervention before promoting its widespread adoption.

      Article Information

      Authors’ Full Names and Academic Degrees

      Meghan J. Elliott, MD, MSc, FRCPC, and Brenda R. Hemmelgarn, MD, PhD, FRCPC.

      Support

      None.

      Financial Disclosure

      The authors declare that they have no relevant financial interests.

      Peer Review

      Received March 12, 2019, in response to an invitation from the journal. Direct editorial input from an Associate Editor and a Deputy Editor. Accepted in revised form April 13, 2019.

      References

        • Almutary H.
        • Bonner A.
        • Douglas C.
        Symptom burden in chronic kidney disease: a review of recent literature.
        J Ren Care. 2013; 39: 140-150
        • Finkelstein F.O.
        • Wuerth D.
        • Finkelstein S.H.
        Health related quality of life and the CKD patient: challenges for the nephrology community.
        Kidney Int. 2009; 76: 946-952
        • Nissenson A.R.
        Improving outcomes for ESRD patients: shifting the quality paradigm.
        Clin J Am Soc Nephrol. 2014; 9: 430-434
        • National Quality Forum
        Patient-reported outcomes.
        • Black N.
        Patient reported outcome measures could help transform healthcare.
        BMJ. 2013; 346: f167
        • Aiyegbusi O.L.
        • Kyte D.
        • Cockwell P.
        • et al.
        Patient and clinician perspectives on electronic patient-reported outcome measures in the management of advanced CKD: a qualitative study.
        Am J Kidney Dis. 2019; 74: 167-178
        • Aiyegbusi O.L.
        • Kyte D.
        • Cockwell P.
        • et al.
        Using patient-reported outcome measures (PROMs) to promote quality of care and safety in the management of patients with advanced chronic kidney disease (PRO-trACK project): a mixed-methods project protocol.
        BMJ Open. 2017; 7e016687
        • EuroQol Group
        EQ-5D-5L | About.
        • Raj R.
        • Ahuja K.
        • Frandsen M.
        • Murtagh F.E.M.
        • Jose M.
        Validation of the IPOS-Renal symptom survey in advanced kidney disease: a cross-sectional study.
        J Pain Symptom Manage. 2018; 56: 281-287
        • Aiyegbusi O.L.
        • Kyte D.
        • Cockwell P.
        • et al.
        Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review.
        PLoS One. 2017; 12e0179733
        • Yang F.
        • Lau T.
        • Lee E.
        • Vathsala A.
        • Chia K.S.
        • Luo N.
        Comparison of the preference-based EQ-5D-5L and SF-6D in patients with end-stage renal disease (ESRD).
        Eur J Health Econ. 2015; 16: 1019-1026
        • Basch E.
        Patient-reported outcomes - harnessing patients' voices to improve clinical care.
        N Engl J Med. 2017; 376: 105-108
        • Basch E.
        • Deal A.M.
        • Kris M.G.
        • et al.
        Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial.
        J Clin Oncol. 2016; 34: 557-565
        • Kotronoulas G.
        • Kearney N.
        • Maguire R.
        • et al.
        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.
        J Clin Oncol. 2014; 32: 1480-1501
        • Berry D.L.
        • Blumenstein B.A.
        • Halpenny B.
        • et al.
        Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial.
        J Clin Oncol. 2011; 29: 1029-1035
        • Berry D.L.
        • Hong F.
        • Halpenny B.
        • et al.
        Electronic self-report assessment for cancer and self-care support: results of a multicenter randomized trial.
        J Clin Oncol. 2014; 32: 199-205
        • Boyce M.B.
        • Browne J.P.
        • Greenhalgh J.
        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 Qual Saf. 2014; 23: 508-518
        • Antunes B.
        • Harding R.
        • Higginson I.J.
        • EUROIMPACT
        Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers.
        Palliat Med. 2014; 28: 158-175
        • Foster A.
        • Croot L.
        • Brazier J.
        • Harris J.
        • O'Cathain A.
        The facilitators and barriers to implementing patient reported outcome measures in organisations delivering health related services: a systematic review of reviews.
        J Patient Rep Outcomes. 2018; 2: 46
        • Greenhalgh J.
        The applications of PROs in clinical practice: what are they, do they work, and why?.
        Qual Life Res. 2009; 18: 115-123
        • Schick-Makaroff K.
        • Molzahn A.
        Brief communication: patient satisfaction with the use of tablet computers: a pilot study in two outpatient home dialysis clinics.
        Can J Kidney Health Dis. 2014; 1: 22
        • Schick-Makaroff K.
        • Molzahn A.E.
        Evaluation of real-time use of electronic patient-reported outcome data by nurses with patients in home dialysis clinics.
        BMC Health Serv Res. 2017; 17: 439
        • Peipert J.D.
        • Hays R.D.
        Using patient-reported measures in dialysis clinics.
        Clin J Am Soc Nephrol. 2017; 12: 1889-1891
        • Craig P.
        • Dieppe P.
        • Macintyre S.
        • et al.
        Developing and evaluating complex interventions: the new Medical Research Council guidance.
        BMJ. 2008; 337: a1655
        • Pfadenhauer L.M.
        • Gerhardus A.
        • Mozygemba K.
        • et al.
        Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework.
        Implement Sci. 2017; 12: 21
        • Moore G.F.
        • Audrey S.
        • Barker M.
        • et al.
        Process evaluation of complex interventions: Medical Research Council guidance.
        BMJ. 2015; 350: h1258

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