Measuring quality in living donation and kidney transplantation: moving beyond survival metrics

Abstract

One-year patient and allograft survival have improved dramatically since the first successful kidney transplant in 1954. At many programs, 1-year allograft survival now exceeds 95%. Short-term survival metrics, such as 1-year patient and/or graft survival, are commonly used as a gauge to determine the “quality” of a transplant program. Although most patients and clinicians have some understanding of what quality means, it is not easily defined in the health care setting. In a landmark report, the Institute of Medicine characterized high-quality health care as being safe, effective, patient-centered, timely, efficient, and equitable (Table 1).1Institute of Medicine (US)Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press, Washington, DC2001Google Scholar When quality is viewed from this wider lens, it becomes evident that the use of one or two survival metrics can in no way fully capture whether high-quality transplant care has been delivered. In fact, using survival measures in isolation, without balancing metrics, can lead to reduced quality by denying access to higher-risk candidates and the under-utilization of increased risk donor organs, leading to fewer transplants.2Schold J.D. Patzer R.E. Pruett T.L. Mohan S. Quality metrics in kidney transplantation: current landscape, trials and tribulations, lessons learned, and a call for reform.Am J Kidney Dis. 2019; 74: 382-389Abstract Full Text Full Text PDF PubMed Scopus (20) Google ScholarTable 1Domains of health care quality as defined by the Institute of Medicine1Institute of Medicine (US)Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academies Press, Washington, DC2001Google ScholarDomain of qualityDefinitionSafeAvoiding injuries to patients from the care that is intended to help themEffectiveProviding services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefitPatient-centeredProviding care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisionsTimelyReducing waits and sometimes harmful delays for both those who receive and those who give careEfficientAvoiding waste, including waste of equipment, supplies, ideas, and energyEquitableProviding care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status Open table in a new tab A systematic review of quality indicators in transplantation has shown a considerable gap between the ideal measurement of quality, as defined by the Institute of Medicine, and what is currently being measured in kidney transplantation.3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar Although over 300 transplantation quality indicators have been reported in the literature, most have focused on safety and effectiveness, with very few addressing other domains of quality such as equity and patient centeredness. In addition, virtually no patient involvement has been seen in the development or selection of kidney transplantation quality indicators. In a recent qualitative interview study, patients and clinicians had a more holistic view of transplantation quality.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar Although measures of safety and effectiveness were still discussed and considered important, other domains such as access to care, timeliness of services, patient satisfaction, communication, and quality of life were critical to study participants.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar The International Consortium for Health Outcomes Measurement (ICHOM) recently published a report on patient-centred outcomes for chronic kidney disease.5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar Within these recommendations were treatment-specific outcomes important to kidney transplant patients such as allograft function, allograft survival, acute rejection, and malignancy. Patients involved with the ICHOM process, however, ranked health-related quality of life as the most relevant outcome with approximately 95% ranking it as an essential outcome to track.5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar The National Surgical Quality Program has recently developed a kidney transplant–specific platform (“National Surgical Quality Program Transplant”) to establish benchmarks for surgical outcomes beyond patient and allograft survival.6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar They have developed standard definitions and have already shown important variations in practice that can serve as a starting point for quality improvement measures at the site level.6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar The highlighted work indicates how the field of kidney transplantation is evolving from a “survival-focused” quality paradigm to a multidimensional approach that includes patient experience, clinical outcomes beyond survival, and outcomes that are important to patients, such as quality of life, physical functioning, and daily activity.4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar, 5Verberne W.R. Das-Gupta Z. Allegretti A.S. et al.Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the international consortium for health outcomes measurement (ICHOM) CKD working group.Am J Kidney Dis. 2019; 73: 372-384Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 6Parekh J.R. Hirose R. Foley D.P. et al.Beyond death and graft survival: variation in outcomes after kidney transplantation—results from the NSQIP Transplant beta phase.Am J Transplant. 2019; 19: 2622-2630Crossref PubMed Scopus (7) Google Scholar To better define which of the many proposed quality indicators are important and should be measured, we held a Canadian consensus workshop involving key stakeholders in kidney transplantation. The stakeholder groups, which would be similar in other jurisdictions around the globe, included patient partners and patient organizations; nephrologists and surgeons involved in living kidney donation and kidney transplantation; government agencies involved in health care delivery and data collection; health quality and safety organizations; and representatives from organ donation organizations, professional societies, and health care charities (details of meeting process and participants can be found in the Supplementary Appendix). A comprehensive set of potential quality indicators was compiled from the findings of our systematic review,3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar qualitative interviews,4Brett K.E. Ertel E. Grimshaw J. Knoll G.A. Perspectives on quality of care in kidney transplantation: a semi-structured interview study.Transplant Direct. 2018; 4: e383Crossref PubMed Scopus (8) Google Scholar and an environmental scan. Participants were preassigned into groups of diverse stakeholders to capture a range of opinions. Each table reviewed the potential quality indicators according to prespecified selection criteria as to whether the metric was important and/or relevant, measurable, actionable, evidence-based, feasible, interpretable, and based on sound data quality (Table 2).7How indicators are selected to measure Ontario’s health system performanceHealth Quality Ontario.https://www.hqontario.ca/System-Performance/Measuring-System-Performance/How-Indicators-are-SelectedDate accessed: April 30, 2020Google Scholar Groups rated each selection criterion (e.g., strongly agree, agree, disagree, strongly disagree) and based on these ratings provided a final recommendation of either essential, optional, or exclude. In situations in which groups did not reach consensus on an indicator, the workshop steering committee reviewed the relevant worksheets and key discussion points to determine the final recommendation for the indicator. Implementation issues and recommendations were developed by the groups focusing on the systems required for quality indicator collection and how to use quality measurement to effect system change. To put this process in context, currently in Canada there is limited reporting of quality indicators in kidney transplantation even at the center level. Canada does have a national registry (Canadian Organ Replacement Register), but because of its voluntary nature, the data are incomplete and insufficient in scope to inform practice. Some reporting to provincial agencies occurs in the provinces of Ontario and British Columbia, but little elsewhere. As such, the development of these indicators was a first and necessary step toward the development of a Canadian performance measurement system.Table 2Criteria to select a quality indicator7How indicators are selected to measure Ontario’s health system performanceHealth Quality Ontario.https://www.hqontario.ca/System-Performance/Measuring-System-Performance/How-Indicators-are-SelectedDate accessed: April 30, 2020Google ScholarCriteriaDefinitionImportant and/or relevantThe indicator reflects an issue that is important to the general population and to relevant stakeholders in the health system.MeasurableData sources can be used to measure the indicator.ActionableThe indicator is likely to inform and influence public policy or funding, alter behavior of health care providers, and/or increase general understanding by the public to improve quality of care and population health.Evidence-basedGood evidence supports the process, or evidence of the importance of the outcome of measuring and reporting on the indicator.FeasibleThe indicator is calculable; data are timely.InterpretableThe indicator is clear and can be easily interpreted by a range of audiences; the results of the indicator are comparable and easy to understand, including what constitutes improved performance, such as clear directionality (i.e., a lower number is better).Data qualityThe indicator includes data quality such as technical definition, calculation methodology, validity and reliability of measurement, and timeliness of data. Open table in a new tab The quality indicators deemed essential for kidney transplantation are listed in Table 3. Effectiveness measures, such as patient and graft survival, remained important and were the most frequently represented domain of quality. In contrast to the findings of the systematic review,3Brett K.E. Ritchie L.J. Ertel E. Knoll G.A. Quality metrics in solid organ transplantation: a systematic review.Transplantation. 2018; 102: e308-e330Crossref PubMed Scopus (22) Google Scholar several quality indicators in the domains of equity, timeliness, and patient-centeredness were deemed essential. Novel patient-reported outcome and experience measures were considered important and included in the essential list of quality indicators, particularly relating to patient satisfaction with the process. Many of the proposed quality indicators focused on access to transplantation, which has previously been identified as a crucial aspect of care by patients.8Husain S.A. Brennan C. Michelson A. et al.Patients prioritize waitlist over post-transplant outcomes when evaluating kidney transplant centers.Am J Transplant. 2018; 18: 2781-2790Crossref PubMed Scopus (30) Google Scholar It is important to point out the need for including balancing metrics. Implementing an indicator for the percentage of dialysis patients referred for transplantation may incentivize a dialysis unit to increase referral rates. However, if many referrals are inappropriate, that particular unit would be a poor-performing outlier for the indicator measuring the percentage accepted for transplantation from that dialysis program. The quality indicators deemed essential for living kidney donation are listed in Table 4 and are well balanced across the 6 domains of quality.Table 3Kidney transplantation quality indicators and definitions by domain of qualityKidney transplantation quality indicatorDefinitionEQUITABLE Percentage of CKD and/or dialysis patients who have a documented discussion about their consideration for transplantationDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who have a documented discussion about their consideration for transplantationPoints to consider for implementation: consideration for transplantation can denote whether patient would be a candidate for transplantation Percentage of CKD and/or dialysis patients who have a documented discussion about the option or possibility of receiving a living donor transplant.Denominator: total number of CKD and/or dialysis patients who have a documented discussion about their consideration for transplantationNumerator: number of people in the denominator who have a documented discussion about the option or possibility of receiving a living donor transplant Percentage of CKD and/or dialysis patients who are referred for transplant evaluationDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who are referred for transplant evaluation (i.e., to determine transplantation suitability)Points to consider for implementation: (i) CKD program and dialysis unit will be calculated separately; (ii) consider measuring by sociodemographic or disease subgroups Percentage of CKD and/or dialysis patients referred for evaluation who are accepted for transplantationDenominator: total number of CKD and/or dialysis patients who are referred for transplant evaluationNumerator: number of people in the denominator who are accepted for transplantationPoints to consider for implementation: (i) separate measure can be calculated for transplant program, CKD program, and dialysis unit; (ii) consider measuring by sociodemographic or disease subgroups Percentage of deceased donor kidney offers that are accepted by the transplant programDenominator: total number of deceased donor kidney offersNumerator: number of offers in the denominator that are accepted by the transplant programPoints to consider for implementation: (i) consider measuring percentage of refused deceased donor kidney offers that are transplanted at another transplant program; (ii) separate measure can be calculated for individual physicians as well as entire transplant program Number of kidney transplants performedCalculation: can be measured as mean, or median of the number of transplants (living and deceased donor) performed annually over a certain period (e.g., 5 yr).Points to consider for implementation: stratify by demographic and risk factor categories (e.g., number of females undergoing transplantation, number patients >65 yr receiving transplants, etc.) Percentage of CKD and/or dialysis patients who receive a kidney transplantDenominator: total number of CKD and/or dialysis patientsNumerator: number of people in the denominator who receive a kidney transplantPoints to consider for implementation: (i) separate measure can be calculated for CKD program and dialysis unit; (ii) need to include pre-emptive transplants in numerator and denominatorTIMELY Number of days from when patient starts dialysis to when the transplant referral is madeCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patient starts dialysis to when they are referred for transplant evaluation Number of days from when the referral is made to when the patient is seen for transplant evaluationCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patients are referred for transplant evaluation to when they are seen by the transplant program Number of days from when patient starts evaluation to when suitability for kidney transplantation is determinedCalculation: can be measured as mean, median, or distribution of wait times (in days) from when patient starts the transplant evaluation to when patient suitability for kidney transplantation is determinedEFFECTIVE Percentage of CKD and/or dialysis patients on the wait list who die before receiving a kidney transplantDenominator: total number of CKD and/or dialysis patients on the kidney transplant wait listNumerator: number of people in the denominator who die before receiving a kidney transplantPoints to consider for implementation: include patients who die while active on the wait list as well as those who die within 12 months after removal from the wait list Percentage of CKD patients who receive a living donor kidney transplant before starting dialysisDenominator: total number of CKD patients who have not started dialysisNumerator: number of people in the denominator who receive a living donor kidney transplant Percentage of transplant recipients who receive a living donor kidney transplant before starting dialysisDenominator: total number of transplant recipientsNumerator: number of people in the denominator who receive a living donor transplant before starting dialysis Percentage of patients who receive dialysis in the first week after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who receive dialysis in the first week after kidney transplantationPoints to consider for implementation: stratification by donor (ECD or high KDPI, DCD, living) Percentage of patients who have a complication during the first 30 days after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a complication during the first 30 days after kidney transplantationNote: a complication can be an infection (pneumonia, urinary tract infection, bacteremia, surgical site infection); cardiovascular (myocardial infarction, cardiac arrest, DVT, PE, stroke); blood transfusion; or need for an unplanned operationPoints to consider for implementation: (i) overall measure of 30-day complication rate as well as separate measures for infection, cardiovascular, transfusion, and unplanned operation; (ii) consider incorporating NSQIP Transplant Percentage of patients with an unplanned readmission to any hospital within 30 days of discharge after kidney transplantationDenominator: total number of kidney transplant recipients discharged from hospitalNumerator: number of people in the denominator who have an unplanned readmission to any hospital within 30 days of discharge after kidney transplantation Percentage of patients who have a complication from day 31 to day 365 after kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a complication from day 31 to day 365 after kidney transplantationNote: a complication can be an infection (cytomegalovirus, BK, pneumonia, urinary tract infection, bacteremia, surgical site infection), or cardiovascular (myocardial infarction, cardiac arrest, DVT, PE, stroke)Points to consider for implementation: overall measure of 30-day complication rate as well as separate measures for infection and cardiovascular Percentage of patients with an unplanned readmission to any hospital within 31 to 365 days of discharge after kidney transplantationDenominator: total number of kidney transplant recipients discharged from hospitalNumerator: number of people in the denominator who have an unplanned readmission to any hospital within 31 to 365 days of discharge after kidney transplantation Percentage of patients who have a rejection after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who have a rejection of their kidney transplantPoints to consider for implementation: (i) overall measure as well cellular and antibody-mediated rejection rate are options; (ii) time period will need to be determined—i.e., percentage rejection at 6 months, 12 months, or some other time point post-transplantation Percentage of patients diagnosed with cancer after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who are newly diagnosed with cancerNote: cancers of interest would be those most associated with transplantation, such as PTLD, nonmelanoma skin cancer, lip cancer, melanoma, kidney cancer, and ano-genital cancersPoints to consider for implementation: time period will need to be determined (i.e., total number of patients transplanted over 1 yr, 5 yr, etc.) for correct calculation of incidence Percentage of patients who are alive after kidney transplantationDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who are alivePoints to consider for implementation: time period will need to be determined—i.e., percentage alive at 1 yr, 5 yr, or some other time post-transplant Percentage of patients who have a functioning kidney transplantDenominator: total number of kidney transplant recipientsNumerator: number of people in the denominator who have a functioning kidney transplantPoints to consider for implementation: time period will need to be determined—i.e., percentage with functioning transplant at 1 yr, 5 yr, or some other time point post-transplant Percentage of nondiabetic patients screened for diabetes after kidney transplantationDenominator: total number of nondiabetic kidney transplant recipientsNumerator: number of people in the denominator who are screened for diabetesPoints to consider for implementation: (i) KDIGO transplant recipient guideline recommends screening for diabetes weekly × 4, then every 3 months for the first year and then annually thereafter; (ii) successful screening will need to be determined—do you need to be screened 8 times in the first year or is once acceptable? Percentage of patients who are diagnosed with new-onset diabetes after kidney transplantationDenominator: total number of nondiabetic kidney transplant recipientsNumerator: number of people in the denominator who are diagnosed with new-onset diabetesPoints to consider for implementation: (i) time period will need to be determined—i.e., percentage with new-onset diabetes at 1 yr, 3 yr, or some other time post-transplant; (ii) consider alternate denominator of number of nondiabetic kidney transplant recipients screened for diabetes Percentage of diabetic kidney transplant recipients who meet current treatment targets for glycemic controlDenominator: total number of kidney transplant recipients with diabetesNumerator: number of people in the denominator who meet current treatment targets for glycemic control Percentage of kidney transplant recipients who had their blood lipid profile measured at least once in the past yearDenominator: total number of patients who are at least 1-yr post-transplantNumerator: number of people in the denominator who had a blood lipid profile measuredPoints to consider for implementation: KDIGO transplant recipient guideline recommends screening for dyslipidemia at 3 months post-transplant and then annually thereafter Percentage of kidney transplant recipients who meet current guidelines for lipid managementDenominator: total number of patients who are at least 1 yr post-transplantNumerator: number of people in the denominator who meet current guidelines for lipid managementPoints to consider for implementation: guidelines evolving but may indicate a specific treatment target (e.g., low-density lipoprotein < 2.0 mmol/l) or that a treatment is given (e.g., patient on a statin) Percentage of kidney transplant recipients who meet current guidelines for BP managementDenominator: total number of patients who are at least 6 months post-transplantNumerator: number of people in the denominator who meet current guidelines for BP managementPoints to consider for implementation: (i) assumes BP is measured at each clinic visit; (ii) BP guidelines evolving so exact BP target not indicated for this metric; (iii) will need to decide which BP value to use (i.e., last recorded BP, average of last 3 visits, etc.)EFFICIENT Number of days from admission to discharge after kidney transplantation (length of stay)Calculation: can be measured as mean, median, or distribution of length of stay (in days) from time patient admitted until discharged after kidney transplantationSAFE Percentage of patients who die during the initial hospitalization for kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who die during the initial hospitalization for kidney transplantation Percentage of patients who experience a serious safety event during the initial hospitalization for kidney transplantationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who have a serious safety event during the initial hospitalization for kidney transplantationNote: a serious safety event can be an erroneous and/or incompatible blood transfusion, major medication error, retained foreign body, pressure ulcer, fracture, fallPATIENT-CENTERED Percentage of patients evaluated for kidney transplantation who report a high level of satisfaction with the educational resources providedDenominator: total number of patients being evaluated for kidney transplantationNumerator: number of people in the denominator who report a high level of satisfaction with the educational resources providedNote: educational resources (e.g., information sessions, videos, handouts) may be provided by CKD program, dialysis unit, or transplant programPoints to consider for implementation: (i) separate measure can be calculated for transplant program, CKD program, and dialysis unit; (ii) questionnaire will need to be developed Percentage of patients undergoing evaluation who consider themselves to have a good understanding of the kidney transplant processDenominator: total number of patients evaluated for kidney transplantationNumerator: number of people in the denominator who consider themselves to have a good understanding of the kidney transplant processNote: this is a self-assessment done by the patientPoints to consider for implementation: (i) measure soon after evaluation process completed; (ii) questionnaire will need to be developed Percentage of kidney transplant patients who thought they were well informed about the procedureDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who thought they were well informed about the procedureNote: this is a self-assessment done by the patientPoints to consider for implementation: (i) measure near the day of discharge from hospital; (ii) questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received during the pretransplant evaluation processDenominator: total number of patients being evaluated for transplantationNumerator: number of people in the denominator who report a high level of satisfaction with the care receivedPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received during the transplant hospitalizationDenominator: total number of kidney transplant patientsNumerator: number of people in the denominator who report a high level of satisfaction with the care received during the hospitalizationPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report a high level of satisfaction with the care received in the post-transplant clinicDenominator: total number of kidney transplant patients discharged from hospitalNumerator: number of people in the denominator who report a high level of satisfaction with the care received in post-transplant clinicPoints to consider for implementation: questionnaire will need to be developed Percentage of patients who report excellent HR