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      Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review

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          Abstract

          Background

          Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD.

          Methods

          Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM.

          Results

          The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients.

          Conclusions

          We suggest considering the KDQOL-36 for use in pre-dialysis patients; the KDQOL-SF or KDQOL-36 for dialysis patients and the ESRD-SCLTM for use in transplant recipients. However, further research is required to evaluate the measurement error, structural validity, responsiveness and patient acceptability of PROMs used in CKD.

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          Most cited references 93

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          Statistical methods for assessing agreement between two methods of clinical measurement.

          In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old. Such investigations are often analysed inappropriately, notably by using correlation coefficients. The use of correlation is misleading. An alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability.
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            The applications of PROs in clinical practice: what are they, do they work, and why?

            Precisely defining the different applications of patient-reported outcome measures (PROs) in clinical practice can be difficult. This is because the intervention is complex and varies amongst different studies in terms of the type of PRO used, how the PRO is fed back, and to whom it is fed back. A theory-driven approach is used to describe six different applications of PROs in clinical practice. The evidence for the impact of these applications on the process and outcomes of care are summarised. Possible explanations for the limited impact of PROs on patient management are then discussed and directions for future research are highlighted. The applications of PROs in clinical practice include screening tools, monitoring tools, as a method of promoting patient-centred care, as a decision aid, as a method of facilitating communication amongst multidisciplinary teams (MDTs), and as a means of monitoring the quality of patient care. Evidence from randomised controlled trials suggests that the use of PROs in clinical practice is valuable in improving the discussion and detection of HRQoL problems but has less of an impact on how clinicians manage patient problems or on subsequent patient outcomes. Many of the reasons for this may lie in the ways in which PROs fit (or do not fit) into the routine ways in which patients and clinicians communicate with each other, how clinicians make decisions, and how healthcare as a whole is organised. Future research needs to identify ways in with PROs can be better incorporated into the routine care of patients by combining qualitative and quantitative methods and adopting appropriate trial designs.
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              Associations of estimated glomerular filtration rate and albuminuria with mortality and renal failure by sex: a meta-analysis

              Objective To assess for the presence of a sex interaction in the associations of estimated glomerular filtration rate and albuminuria with all-cause mortality, cardiovascular mortality, and end stage renal disease. Design Random effects meta-analysis using pooled individual participant data. Setting 46 cohorts from Europe, North and South America, Asia, and Australasia. Participants 2 051 158 participants (54% women) from general population cohorts (n=1 861 052), high risk cohorts (n=151 494), and chronic kidney disease cohorts (n=38 612). Eligible cohorts (except chronic kidney disease cohorts) had at least 1000 participants, outcomes of either mortality or end stage renal disease of ≥50 events, and baseline measurements of estimated glomerular filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration equation (mL/min/1.73 m2) and urinary albumin-creatinine ratio (mg/g). Results Risks of all-cause mortality and cardiovascular mortality were higher in men at all levels of estimated glomerular filtration rate and albumin-creatinine ratio. While higher risk was associated with lower estimated glomerular filtration rate and higher albumin-creatinine ratio in both sexes, the slope of the risk relationship for all-cause mortality and for cardiovascular mortality were steeper in women than in men. Compared with an estimated glomerular filtration rate of 95, the adjusted hazard ratio for all-cause mortality at estimated glomerular filtration rate 45 was 1.32 (95% CI 1.08 to 1.61) in women and 1.22 (1.00 to 1.48) in men (Pinteraction<0.01). Compared with a urinary albumin-creatinine ratio of 5, the adjusted hazard ratio for all-cause mortality at urinary albumin-creatinine ratio 30 was 1.69 (1.54 to 1.84) in women and 1.43 (1.31 to 1.57) in men (Pinteraction<0.01). Conversely, there was no evidence of a sex difference in associations of estimated glomerular filtration rate and urinary albumin-creatinine ratio with end stage renal disease risk. Conclusions Both sexes face increased risk of all-cause mortality, cardiovascular mortality, and end stage renal disease with lower estimated glomerular filtration rates and higher albuminuria. These findings were robust across a large global consortium.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                21 June 2017
                2017
                : 12
                : 6
                Affiliations
                [1 ]Centre for Patient Reported Outcomes Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom
                [2 ]Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom
                [3 ]Department of Renal Medicine, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom
                [4 ]Oxford Policy Management Ltd, Oxford, United Kingdom
                [5 ]PAREXEL International, London, United Kingdom
                Medizinische Universitat Graz, AUSTRIA
                Author notes

                Competing Interests: OLA is funded by the Health Foundation’s PhD Awards for Improvement Science. DK is funded by the National Institute for Health Research (NIHR) Fellowship. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research, Health Education England or the Department of Health. The funder had no role with respect to study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. TM is partly funded by the NIHR through the Collaborations for Leadership in Applied Health Research and Care for West Midlands (CLAHRC-WM). This paper presents independent research and the views expressed in this publication are not necessarily those of the NIHR, the Department of Health, NHS Partner Trusts, University of Birmingham or the CLAHRC-WM Management Group. AG is employed by Oxford Policy Management Ltd. TK is employed by PAREXEL International. MC reports grants from the NIHR, Macmillan Cancer Support, personal fees from Ferring and Astellas Pharma, outside the submitted work; and co-Chairs the International Society for Quality of Life Research Best Practices for PROs in Trials Taskforce. These affiliations do not alter our adherence to PLOS ONE policies on sharing data and materials.

                • Conceptualization: MC DK PC TM OLA.

                • Data curation: OLA TK AG AS.

                • Formal analysis: OLA AS.

                • Funding acquisition: MC DK PC TM.

                • Investigation: OLA TK AG AS.

                • Methodology: MC DK PC TM OLA.

                • Project administration: MC DK PC TM OLA.

                • Supervision: MC DK PC TM.

                • Visualization: MC DK PC TM OLA.

                • Writing – original draft: OLA.

                • Writing – review & editing: MC DK PC TM OLA TK AG AS.

                Article
                PONE-D-17-13305
                10.1371/journal.pone.0179733
                5479575
                28636678
                © 2017 Aiyegbusi et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 1, Tables: 5, Pages: 27
                Product
                Funding
                Funded by: Health Foundation
                Award Recipient :
                This project was funded as part of the Health Foundation’s Improvement Science Programme. Website: http://www.health.org.uk/ OLA is the recipient of the Health Foundation’s PhD Awards for Improvement Science (Ref: 7452). The Health Foundation is an independent charity committed to bringing about better health and health care for people in the UK. The funder did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. AG is employed by Oxford Policy Management Ltd. Oxford Policy Management Ltd provides support in the form of salary for Dr. Gheorghe, but did not have any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. TK is employed by PAREXEL International. PAREXEL International provides support in the form of salary for Dr. Keeley, but did not have any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. MC receives consultancy fees from Ferring and Astellas Pharma. Ferring and Astellas Pharma did not have any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of all the authors are articulated in the ‘author contributions’ section.
                Categories
                Research Article
                Medicine and Health Sciences
                Nephrology
                Medical Dialysis
                Medicine and Health Sciences
                Nephrology
                Chronic Kidney Disease
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Transplantation
                Organ Transplantation
                Renal Transplantation
                Medicine and Health Sciences
                Surgical and Invasive Medical Procedures
                Urinary System Procedures
                Renal Transplantation
                Biology and Life Sciences
                Anatomy
                Renal System
                Kidneys
                Medicine and Health Sciences
                Anatomy
                Renal System
                Kidneys
                Medicine and Health Sciences
                Health Care
                Quality of Life
                Research and Analysis Methods
                Database and Informatics Methods
                Database Searching
                Research and Analysis Methods
                Research Design
                Survey Research
                Questionnaires
                Research and Analysis Methods
                Research Assessment
                Research Validity
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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