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

Introduction Advanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for ‘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, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD. Methods and analysis The project will use a mixed-methods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system—this will involve qualitative face-to-face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM. Ethics and dissemination This project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017. The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients’ Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peer-reviewed journals.

[1]  Giri N. K. Rangan,et al.  Committee , 2019, 2019 International Conference on Radar, Antenna, Microwave, Electronics, and Telecommunications (ICRAMET).

[2]  I. Dasgupta,et al.  Health-Related Quality of Life Impacts Mortality but Not Progression to End-Stage Renal Disease in Pre-Dialysis Chronic Kidney Disease: A Prospective Observational Study , 2016, PloS one.

[3]  A. Gheorghe,et al.  Measurement properties of patient-reported outcome measures ( PROMs ) used in adult patients with chronic kidney disease : , 2016 .

[4]  Ming-Cheng Wang,et al.  Psychometric Properties of the Kidney Disease Quality of Life–36 Questionnaire (KDQOL-36™) , 2016, Western journal of nursing research.

[5]  G. Guyatt,et al.  Minimally important difference estimates and methods: a protocol , 2015, BMJ Open.

[6]  Lawrence R. Ness,et al.  Are We There Yet - Data Saturation in Qualitative Research (TQR Published).pdf , 2015 .

[7]  Xingjuan Tao,et al.  Determining the validity and reliability of the Chinese version of the Kidney Disease Quality of Life Questionnaire (KDQOL-36™) , 2014, BMC Nephrology.

[8]  Erik Riiskjær,et al.  Use of Patient-Reported Outcome (PRO) Measures at Group and Patient Levels: Experiences From the Generic Integrated PRO System, WestChronic , 2014, Interactive journal of medical research.

[9]  C. Douglas,et al.  Symptom burden in chronic kidney disease: a review of recent literature. , 2013, Journal of renal care.

[10]  S. Vasuvattakul,et al.  Validity and Reliability of KDQOL-36 in Thai Kidney Disease Patient. , 2013, Value in health regional issues.

[11]  Praveen Sharma,et al.  The natural history of, and risk factors for, progressive Chronic Kidney Disease (CKD): the Renal Impairment in Secondary care (RIISC) study; rationale and protocol , 2013, BMC Nephrology.

[12]  N. Luo,et al.  Validation of the English Version of the Kidney Disease Quality of Life Questionnaire (KDQOL-36) in Haemodialysis Patients in Singapore , 2013, The Patient - Patient-Centered Outcomes Research.

[13]  A. Go,et al.  Validation of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36) US Spanish and English versions in a cohort of Hispanics with chronic kidney disease. , 2013, Ethnicity & disease.

[14]  David Andrich,et al.  An Expanded Derivation of the Threshold Structure of the Polytomous Rasch Model That Dispels Any “Threshold Disorder Controversy” , 2013 .

[15]  Y. Cheung,et al.  Measurement properties of the Chinese Version of the Kidney Disease Quality of Life-Short Form (KDQOL-SF™) in end-stage renal disease patients with poor prognosis in Singapore. , 2012, Journal of pain and symptom management.

[16]  Ethan Basch,et al.  Electronic patient‐reported outcome systems in oncology clinical practice , 2012, CA: a cancer journal for clinicians.

[17]  Josef Coresh,et al.  Chronic kidney disease , 2012, The Lancet.

[18]  E. Basch,et al.  Use of patient-reported outcomes to improve the predictive accuracy of clinician-reported adverse events. , 2011, Journal of the National Cancer Institute.

[19]  C. Terwee,et al.  Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist , 2011, Quality of Life Research.

[20]  Mark Woodward,et al.  Lower estimated GFR and higher albuminuria are associated with adverse kidney outcomes. A collaborative meta-analysis of general and high-risk population cohorts. , 2011, Kidney international.

[21]  A. Pakpour,et al.  Validity and reliability of short form-12 questionnaire in Iranian hemodialysis patients. , 2011, Iranian journal of kidney diseases.

[22]  M. Tavakol,et al.  Making sense of Cronbach's alpha , 2011, International journal of medical education.

[23]  N. Tangri,et al.  A predictive model for progression of chronic kidney disease to kidney failure. , 2011, JAMA.

[24]  G. Bonsel,et al.  Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) , 2011, Quality of Life Research.

[25]  K. J. Miller,et al.  Evaluation of the psychometric properties of the upper limb subscales of the Motor Assessment Scale using a Rasch analysis model. , 2010, Journal of rehabilitation medicine.

[26]  Jordi Alonso,et al.  The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: A clarification of its content , 2010, BMC medical research methodology.

[27]  Naomi Vaisrub,et al.  Biostatistics: The Bare Essentials , 2009 .

[28]  Rommel P. Bataclan,et al.  Cultural adaptation and validation of the Filipino version of Kidney Disease Quality of Life – Short Form (KDQOL‐SF version 1.3) , 2009, Nephrology.

[29]  C. Maher,et al.  Global Rating of Change Scales: A Review of Strengths and Weaknesses and Considerations for Design , 2009, The Journal of manual & manipulative therapy.

[30]  H. Draper,et al.  Offering payments, reimbursement and incentives to patients and family doctors to encourage participation in research. , 2009, Family practice.

[31]  N. Kearney,et al.  Patients' perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS) to monitor and manage chemotherapy related toxicity. , 2009, European journal of cancer care.

[32]  J. Petter Gustavsson,et al.  Using the Rasch model in nursing research: an introduction and illustrative example. , 2009, International journal of nursing studies.

[33]  Alan Tennant,et al.  The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper? , 2007, Arthritis and rheumatism.

[34]  Roxanna Gapstur Symptom burden: a concept analysis and implications for oncology nurses. , 2007, Oncology nursing forum.

[35]  M. Kohzuki,et al.  Reliability and Validity of the Korean Version of Kidney Disease Quality of Life Instrument (KDQOL-SFTM) , 2007 .

[36]  Julie F Pallant,et al.  An introduction to the Rasch measurement model: an example using the Hospital Anxiety and Depression Scale (HADS). , 2007, The British journal of clinical psychology.

[37]  Linda Bren,et al.  The importance of patient-reported outcomes...it's all about the patients. , 2006, FDA consumer.

[38]  V. Braun,et al.  Using thematic analysis in psychology , 2006 .

[39]  F. Pouwer,et al.  Are factor analytical techniques used appropriately in the validation of health status questionnaires? A systematic review on the quality of factor analysis of the SF-36 , 2005, Quality of Life Research.

[40]  Charles E McCulloch,et al.  Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. , 2004, The New England journal of medicine.

[41]  Galina Velikova,et al.  Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[42]  J. Thonnard,et al.  Assessing and Adjusting for Cross-Cultural Validity of Impairment and Activity Limitation Scales Through Differential Item Functioning Within the Framework of the Rasch Model: The PRO-ESOR Project , 2004, Medical care.

[43]  Menno D. T. de Jong,et al.  Retrospective vs. concurrent think-aloud protocols: testing the usability of an online library catalogue , 2003, Behav. Inf. Technol..

[44]  M. D. de Jong,et al.  Retrospective vs. concurrent think-aloud protocols: Testing the usability of an online library catalogue , 2003 .

[45]  J. Alonso,et al.  Classical test theory versus Rasch analysis for quality of life questionnaire reduction , 2003, Health and quality of life outcomes.

[46]  J. Grimshaw,et al.  Improving the detection and management of depression in primary care , 2003, Quality & safety in health care.

[47]  D. Streiner Starting at the Beginning: An Introduction to Coefficient Alpha and Internal Consistency , 2003, Journal of personality assessment.

[48]  F. Dekker,et al.  Validation of the KDQOL-SFTM: A dialysis-targeted health measure , 2002, Quality of Life Research.

[49]  R. Poveda,et al.  Goodpasture syndrome during the course of a Schönlein-Henoch purpura. , 2002, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[50]  Gordon H Guyatt,et al.  Methods to explain the clinical significance of health status measures. , 2002, Mayo Clinic proceedings.

[51]  R. MacCallum,et al.  Sample size in factor analysis. , 1999 .

[52]  J E Ware,et al.  Methods for testing data quality, scaling assumptions, and reliability: the IQOLA Project approach. International Quality of Life Assessment. , 1998, Journal of clinical epidemiology.

[53]  W. Velicer,et al.  Affects of variable and subject sampling on factor pattern recovery. , 1998 .

[54]  Jeffrey A. Johnson,et al.  Valuation of EuroQOL (EQ-5D) Health States in an Adult US Sample , 1998, PharmacoEconomics.

[55]  W. Tierney,et al.  The psychometric properties of the SF-36 health survey among older adults in a clinical setting. , 1996 .

[56]  F. D. Wolinsky,et al.  A measurement model of the Medical Outcomes Study 36-Item Short-Form Health Survey in a clinical sample of disadvantaged, older, black, and white men and women. , 1996, Medical care.

[57]  M. Liang,et al.  Comparisons of Five Health Status Instruments for Orthopedic Evaluation , 1990, Medical care.

[58]  G. Guyatt,et al.  Measurement of health status. Ascertaining the minimal clinically important difference. , 1989, Controlled clinical trials.

[59]  P. Stratford Reliability: consistency or differentiating among subjects? , 1989, Physical therapy.

[60]  Lewis E. Kazis,et al.  Effect Sizes for Interpreting Changes in Health Status , 1989, Medical care.

[61]  J. Fleiss,et al.  Intraclass correlations: uses in assessing rater reliability. , 1979, Psychological bulletin.

[62]  Benjamin D. Wright,et al.  Solving measurement problems with the Rasch model. , 1977 .

[63]  R. Cattell The Scree Test For The Number Of Factors. , 1966, Multivariate behavioral research.

[64]  H. Kaiser The Application of Electronic Computers to Factor Analysis , 1960 .

[65]  L. Cronbach Coefficient alpha and the internal structure of tests , 1951 .

[66]  Diana Adler,et al.  Using Multivariate Statistics , 2016 .

[67]  P. Jones,et al.  A critique of Rasch analysis using the Dyspnoea-12 as an illustrative example. , 2012, Journal of advanced nursing.

[68]  J.,et al.  The New England Journal of Medicine , 2012 .

[69]  C. Terwee,et al.  Quality criteria were proposed for measurement properties of health status questionnaires. , 2007, Journal of clinical epidemiology.

[70]  M. Kohzuki,et al.  Reliability and validity of the Korean version of Kidney Disease Quality of Life instrument (KDQOL-SF). , 2007, The Tohoku journal of experimental medicine.

[71]  Nicholas Walliman,et al.  Social research methods , 2006 .

[72]  J. Gliem,et al.  Calculating, Interpreting, And Reporting Cronbach’s Alpha Reliability Coefficient For Likert-Type Scales , 2003 .

[73]  Dh Confidentiality: NHS Code of Practice , 2003 .

[74]  Everett V. Smith Detecting and evaluating the impact of multidimensionality using item fit statistics and principal component analysis of residuals. , 2002, Journal of applied measurement.

[75]  John M Linacre,et al.  Optimizing rating scale category effectiveness. , 2002, Journal of applied measurement.

[76]  Kdoqi Disclaimer K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. , 2002, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[77]  Jakob Nielsen,et al.  Usability engineering , 1997, The Computer Science and Engineering Handbook.

[78]  K. McGraw,et al.  Forming inferences about some intraclass correlation coefficients. , 1996 .

[79]  B. Tabachnick,et al.  Using Multivariate Statistics , 1983 .