Original Paper Nephron Clin Pract 2014;126:135–143 DOI: 10.1159/000361050
Received: August 7, 2013 Accepted: February 24, 2014 Published online: April 15, 2014
Knowing What We Do and Doing What We Should: Quality Assurance in Hemodialysis Maria Alquist a Juan P. Bosch a Claudia Barth c Christian Combe d John T. Daugirdas h Jörgen B.A. Hegbrant b Georges Martin e Christopher W. McIntyre j Donal J. O’Donoghue k Hector J. Rodriguez i Antonio Santoro m James E. Tattersall l Georges Vantard f David B. Van Wyck i Bernard Canaud g a
Medical and Safety Office, Gambro AB, and b Medical Office, Diaverum Renal Services Group, Lund, Sweden; Kuratorium for Dialysis and Renal Transplantation (KfH), Neu-Isenberg, Germany; d Centre Hospitalier Universitaire de Bordeaux, Université Bordeaux Segalen, Bordeaux, e Global Marketing Gambro, Colombes, f Gambro Research, Meyzieu, and g Nephrology, Dialysis and Intensive Care Unit, Lapeyronie University Hospital, Montpellier, France; h Department of Medicine, University of Illinois College of Medicine, Chicago, Ill., and i DaVita Inc., Denver, Colo., USA; j Department of Renal Medicine, Royal Derby Hospital, Derby, k Salford Royal NHS Foundation Trust, London, and l Department of Renal Medicine, Leeds Teaching Hospital NHS Trust, Leeds, UK; m Division of Nephrology, University Hospital Bologna, Bologna, Italy c
Key Words Hemodialysis · Quality assurance · Clinical performance measures · Clinical information technology · On-line data
processes and quality measures supporting quality assurance that have been agreed across the expert panel. It also notes areas where more understanding is required. © 2014 S. Karger AG, Basel
© 2014 S. Karger AG, Basel 1660–2110/14/1263–0135$39.50/0 E-Mail [email protected] www.karger.com/nec
Introduction ‘In physical science the first essential step in the direction of learning any subject is to find principles of numerical reckoning and practicable methods for measuring some quality connected with it.’ Lord Kelvin, Popular Lectures and Addresses, vol. 1: ‘Electrical Units of Measurement’, May 3, 1883
End-stage renal disease (ESRD) requiring hemodialysis, along with its associated and growing healthcare costs, represents a major healthcare challenge [1, 2]. A significant concern is to improve quality of care while simultaneously containing costs, promote patient safety and better quality of life (QoL) [3, 4]. Quality of care can be defined as ‘the Maria Alquist, MD Medical and Safety Office Gambro AB PO Box 10101, SE–220 10 Lund (Sweden) E-Mail maria.alquist @ gambro.com
Downloaded by: University of Tokyo 157.82.153.40 - 5/28/2015 3:20:24 PM
Abstract An international group of around 50 nephrologists and scientists, including representatives from large dialysis provider organisations, formulated recommendations on how to develop and implement quality assurance measures to improve individual hemodialysis patient care, population health and cost effectiveness. Discussed were methods thought to be of highest priority, those clinical indicators which might be most related to meaningful patient outcomes, tools to control treatment delivery and the role of facilitating computerized expert systems. Emphasis was given to the use of new technologies such as measurement of online dialysance and ways of assessing fluid status. The current evidence linking achievement of quality criteria with patient outcomes was reviewed. This paper summarizes useful
Methods During a two-day symposium, an international expert group of nephrologists, including representatives from large dialysis providers, and scientist involved in dialysis care, met to debate hemodialysis care QA. Considering current experience, evidence and practices, the expert group worked to develop consensus proposals for desired components of QA. Emphasis was placed on clinical indicators where implementing and monitoring related quality measures would be expected to impact patient outcomes. A variety of tools to help control and monitor hemodialysis treatments, including data capturing and sharing, were discussed. Also considered were present-day gaps in our knowledge, and areas where future research was clearly needed. The consensus proposals were peer-reviewed by the expert panel. The process was not designed to follow a formal guideline development protocol, nor was the goal to produce some sort of definitive scoring systems against which to judge or compare hemodialysis services; rather, the aim was to point to those quality measurement approaches which were thought to be of highest priority and which would be likely to lead to improved patient outcomes.
Quality Assurance Components in Hemodialysis
Clinical Performance Measures (CPMs) Clinical performance measurement includes the evaluation of the process by which healthcare is delivered and 136
Nephron Clin Pract 2014;126:135–143 DOI: 10.1159/000361050
the outcomes that patients experience. Clinical performance measurement might focus on how a particular chronic disease is managed, how patients fare as a result of interventions to treat that disease, and/or what the costs are of the services that were provided [12, 13]. CPMs are increasingly used to rank hospitals, dialysis clinics and treatment provider networks and may be used to bring centers and physicians to account for discrepancies in clinical outcomes relative to national or international norms [14–16]. The best CPMs are simple to measure, not prone to misinterpretation, and are modifiable to enhance their utility. A CPM should be related to the treatment and associated with one or more ‘hard’ outcomes such as morbidity, hospitalization, and survival. Meaningful outcomes also include patient well-being and QoL, costs of care, and staff satisfaction. The measures should be validated and the gaps in care following not reaching target should demonstrate the importance of the measure. Evidence-based guidelines such as Kidney Disease Outcomes Quality Initiative [17], the European Best Practice Guidelines [18, 19] and European Renal Best Practices [20] provide a foundation for patient level clinical indicators. Since some outcomes can only be assessed after several years it is important to assess ‘surrogate’ outcome indicators that reflect changes in biological status which ultimately are thought to affect ‘hard’ outcomes [21]. In terms of the latter, in addition to traditional ‘hard’ outcomes such as overall survival rates or suitability for renal transplantation, one also needs to consider patientreported outcomes such as treatment tolerance and recovery time after treatment, as well as overall QoL [22– 24]. For elderly patients, improvements in well-being may be of paramount importance, whereas in younger patients the principal concerns may be minimizing uremic injury prior to transplantation, ability to attend school or continuing employment. The Dialysis Outcomes and Practice Patterns Study (DOPPS) has provided some insights into the potential importance of facility level CPMs; for example, one analysis by the DOPPS group found improved facility level survival in those centers having lower rates of catheter and graft use [25]; better survival also was found in centers that reported higher delivered dialysis dose, improved phosphate control, partial correction of anemia, higher serum albumin and reduced intradialytic weight gain [26]. A practice-related composite risk score derived from DOPPS, which is based on the percentage of patients with single-pool (sp) Kt/V ≥1.2, hemoglobin (Hb) ≥11 g/dl, albumin ≥4.0 g/dl and access other than venous Alquist et al.
Downloaded by: University of Tokyo 157.82.153.40 - 5/28/2015 3:20:24 PM
degree to which health services for individuals and populations increase the likelihood of desired health outcomes’ [5]. Poor-quality hemodialysis care, as defined by failure to adhere to established targets for clinical indicators such as minimum delivered dialysis dose (Kt/V urea) or dialysis time or to implement processes for optimizing fluid management, has been associated with increased morbidity, hospitalization, mortality and cost of care [6–10]. A quality assurance (QA) process in hemodialysis provides an opportunity to optimize dialysis-related medical practice and services, to the benefit of patients, healthcare professionals, dialysis providers and healthcare payers [3, 4]. QA processes are complex, as they involve assessment of an array of clinical indicators, and the setting of targets that cover many aspects of control of uremia. Achievement of such targets must then be monitored on a regular basis and the targets need to be periodically revalidated to ensure that they relate to meaningful clinical outcomes [11]. This report provides an overview of clinical indicators that can be used to set and achieve quality targets in hemodialysis care. It includes a series of proposals and tools that were compiled by an expert group of dialysis practitioners and scientists assembled for this purpose.
Audit and Collaboration Clinical audit and governance programs encourage healthcare teams to be accountable for continuously improving quality and safeguarding high standards of care. One example of such a program is the United Kingdom National Health Service Institute for Innovation and Improvement [36]. Such programs provide a means to implement measures to improve clinical indicators, while highlighting the importance of teamwork. They also often help with methods of capturing patient satisfaction. Many audit programs adopt a PDSA cycle – a Plan-DoStudy-Act cycle [37, 38] devised to document, provide visibility and to encourage the adoption of best practices. Collaborative approaches to auditing data can help imQuality Assurance in Hemodialysis
Table 1. QA components: domains suggested where monitoring quality measures may be of most importance
Water and hemodialysis fluid purity Adequacy (dose, frequency, duration, modality) Extracellular volume/blood pressure control Dry weight achievement Intradialytic hypotension Acid-base status/potassium Anemia (hemoglobin, iron status) Mineral bone disorder Nutrition/inflammation Vascular access type Patient-reported outcomes Quality of life, patient well-being and satisfaction Staff training, education and satisfaction Nephrology referral prior to dialysis initiation Access to kidney transplantation and home dialysis therapies Costs of services
Table 2. CPMs used to assess quality in a large dialysis service provider network (Diaverum Renal Services Group)
Kt/V (single pool) ≥1.4 Serum albumin ≥35 g/l (3.5 g/dl) Normalized protein catabolic rate ≥1 g/kg/day Blood hemoglobin ≥10.0 and ≤12.0 g/dl Serum ferritin ≥200 and ≤500 μg/l Serum phosphorus ≥2.5 and ≤5.5 mg/dl (≥0.8 and ≤1.8 mmol/l) Serum calcium × phosphorus product
Received: August 7, 2013 Accepted: February 24, 2014 Published online: April 15, 2014
Knowing What We Do and Doing What We Should: Quality Assurance in Hemodialysis Maria Alquist a Juan P. Bosch a Claudia Barth c Christian Combe d John T. Daugirdas h Jörgen B.A. Hegbrant b Georges Martin e Christopher W. McIntyre j Donal J. O’Donoghue k Hector J. Rodriguez i Antonio Santoro m James E. Tattersall l Georges Vantard f David B. Van Wyck i Bernard Canaud g a
Medical and Safety Office, Gambro AB, and b Medical Office, Diaverum Renal Services Group, Lund, Sweden; Kuratorium for Dialysis and Renal Transplantation (KfH), Neu-Isenberg, Germany; d Centre Hospitalier Universitaire de Bordeaux, Université Bordeaux Segalen, Bordeaux, e Global Marketing Gambro, Colombes, f Gambro Research, Meyzieu, and g Nephrology, Dialysis and Intensive Care Unit, Lapeyronie University Hospital, Montpellier, France; h Department of Medicine, University of Illinois College of Medicine, Chicago, Ill., and i DaVita Inc., Denver, Colo., USA; j Department of Renal Medicine, Royal Derby Hospital, Derby, k Salford Royal NHS Foundation Trust, London, and l Department of Renal Medicine, Leeds Teaching Hospital NHS Trust, Leeds, UK; m Division of Nephrology, University Hospital Bologna, Bologna, Italy c
Key Words Hemodialysis · Quality assurance · Clinical performance measures · Clinical information technology · On-line data
processes and quality measures supporting quality assurance that have been agreed across the expert panel. It also notes areas where more understanding is required. © 2014 S. Karger AG, Basel
© 2014 S. Karger AG, Basel 1660–2110/14/1263–0135$39.50/0 E-Mail [email protected] www.karger.com/nec
Introduction ‘In physical science the first essential step in the direction of learning any subject is to find principles of numerical reckoning and practicable methods for measuring some quality connected with it.’ Lord Kelvin, Popular Lectures and Addresses, vol. 1: ‘Electrical Units of Measurement’, May 3, 1883
End-stage renal disease (ESRD) requiring hemodialysis, along with its associated and growing healthcare costs, represents a major healthcare challenge [1, 2]. A significant concern is to improve quality of care while simultaneously containing costs, promote patient safety and better quality of life (QoL) [3, 4]. Quality of care can be defined as ‘the Maria Alquist, MD Medical and Safety Office Gambro AB PO Box 10101, SE–220 10 Lund (Sweden) E-Mail maria.alquist @ gambro.com
Downloaded by: University of Tokyo 157.82.153.40 - 5/28/2015 3:20:24 PM
Abstract An international group of around 50 nephrologists and scientists, including representatives from large dialysis provider organisations, formulated recommendations on how to develop and implement quality assurance measures to improve individual hemodialysis patient care, population health and cost effectiveness. Discussed were methods thought to be of highest priority, those clinical indicators which might be most related to meaningful patient outcomes, tools to control treatment delivery and the role of facilitating computerized expert systems. Emphasis was given to the use of new technologies such as measurement of online dialysance and ways of assessing fluid status. The current evidence linking achievement of quality criteria with patient outcomes was reviewed. This paper summarizes useful
Methods During a two-day symposium, an international expert group of nephrologists, including representatives from large dialysis providers, and scientist involved in dialysis care, met to debate hemodialysis care QA. Considering current experience, evidence and practices, the expert group worked to develop consensus proposals for desired components of QA. Emphasis was placed on clinical indicators where implementing and monitoring related quality measures would be expected to impact patient outcomes. A variety of tools to help control and monitor hemodialysis treatments, including data capturing and sharing, were discussed. Also considered were present-day gaps in our knowledge, and areas where future research was clearly needed. The consensus proposals were peer-reviewed by the expert panel. The process was not designed to follow a formal guideline development protocol, nor was the goal to produce some sort of definitive scoring systems against which to judge or compare hemodialysis services; rather, the aim was to point to those quality measurement approaches which were thought to be of highest priority and which would be likely to lead to improved patient outcomes.
Quality Assurance Components in Hemodialysis
Clinical Performance Measures (CPMs) Clinical performance measurement includes the evaluation of the process by which healthcare is delivered and 136
Nephron Clin Pract 2014;126:135–143 DOI: 10.1159/000361050
the outcomes that patients experience. Clinical performance measurement might focus on how a particular chronic disease is managed, how patients fare as a result of interventions to treat that disease, and/or what the costs are of the services that were provided [12, 13]. CPMs are increasingly used to rank hospitals, dialysis clinics and treatment provider networks and may be used to bring centers and physicians to account for discrepancies in clinical outcomes relative to national or international norms [14–16]. The best CPMs are simple to measure, not prone to misinterpretation, and are modifiable to enhance their utility. A CPM should be related to the treatment and associated with one or more ‘hard’ outcomes such as morbidity, hospitalization, and survival. Meaningful outcomes also include patient well-being and QoL, costs of care, and staff satisfaction. The measures should be validated and the gaps in care following not reaching target should demonstrate the importance of the measure. Evidence-based guidelines such as Kidney Disease Outcomes Quality Initiative [17], the European Best Practice Guidelines [18, 19] and European Renal Best Practices [20] provide a foundation for patient level clinical indicators. Since some outcomes can only be assessed after several years it is important to assess ‘surrogate’ outcome indicators that reflect changes in biological status which ultimately are thought to affect ‘hard’ outcomes [21]. In terms of the latter, in addition to traditional ‘hard’ outcomes such as overall survival rates or suitability for renal transplantation, one also needs to consider patientreported outcomes such as treatment tolerance and recovery time after treatment, as well as overall QoL [22– 24]. For elderly patients, improvements in well-being may be of paramount importance, whereas in younger patients the principal concerns may be minimizing uremic injury prior to transplantation, ability to attend school or continuing employment. The Dialysis Outcomes and Practice Patterns Study (DOPPS) has provided some insights into the potential importance of facility level CPMs; for example, one analysis by the DOPPS group found improved facility level survival in those centers having lower rates of catheter and graft use [25]; better survival also was found in centers that reported higher delivered dialysis dose, improved phosphate control, partial correction of anemia, higher serum albumin and reduced intradialytic weight gain [26]. A practice-related composite risk score derived from DOPPS, which is based on the percentage of patients with single-pool (sp) Kt/V ≥1.2, hemoglobin (Hb) ≥11 g/dl, albumin ≥4.0 g/dl and access other than venous Alquist et al.
Downloaded by: University of Tokyo 157.82.153.40 - 5/28/2015 3:20:24 PM
degree to which health services for individuals and populations increase the likelihood of desired health outcomes’ [5]. Poor-quality hemodialysis care, as defined by failure to adhere to established targets for clinical indicators such as minimum delivered dialysis dose (Kt/V urea) or dialysis time or to implement processes for optimizing fluid management, has been associated with increased morbidity, hospitalization, mortality and cost of care [6–10]. A quality assurance (QA) process in hemodialysis provides an opportunity to optimize dialysis-related medical practice and services, to the benefit of patients, healthcare professionals, dialysis providers and healthcare payers [3, 4]. QA processes are complex, as they involve assessment of an array of clinical indicators, and the setting of targets that cover many aspects of control of uremia. Achievement of such targets must then be monitored on a regular basis and the targets need to be periodically revalidated to ensure that they relate to meaningful clinical outcomes [11]. This report provides an overview of clinical indicators that can be used to set and achieve quality targets in hemodialysis care. It includes a series of proposals and tools that were compiled by an expert group of dialysis practitioners and scientists assembled for this purpose.
Audit and Collaboration Clinical audit and governance programs encourage healthcare teams to be accountable for continuously improving quality and safeguarding high standards of care. One example of such a program is the United Kingdom National Health Service Institute for Innovation and Improvement [36]. Such programs provide a means to implement measures to improve clinical indicators, while highlighting the importance of teamwork. They also often help with methods of capturing patient satisfaction. Many audit programs adopt a PDSA cycle – a Plan-DoStudy-Act cycle [37, 38] devised to document, provide visibility and to encourage the adoption of best practices. Collaborative approaches to auditing data can help imQuality Assurance in Hemodialysis
Table 1. QA components: domains suggested where monitoring quality measures may be of most importance
Water and hemodialysis fluid purity Adequacy (dose, frequency, duration, modality) Extracellular volume/blood pressure control Dry weight achievement Intradialytic hypotension Acid-base status/potassium Anemia (hemoglobin, iron status) Mineral bone disorder Nutrition/inflammation Vascular access type Patient-reported outcomes Quality of life, patient well-being and satisfaction Staff training, education and satisfaction Nephrology referral prior to dialysis initiation Access to kidney transplantation and home dialysis therapies Costs of services
Table 2. CPMs used to assess quality in a large dialysis service provider network (Diaverum Renal Services Group)
Kt/V (single pool) ≥1.4 Serum albumin ≥35 g/l (3.5 g/dl) Normalized protein catabolic rate ≥1 g/kg/day Blood hemoglobin ≥10.0 and ≤12.0 g/dl Serum ferritin ≥200 and ≤500 μg/l Serum phosphorus ≥2.5 and ≤5.5 mg/dl (≥0.8 and ≤1.8 mmol/l) Serum calcium × phosphorus product
![[Quality of life. Do we know what we are doing?].](/assets/img/hold.png)
