- Email: [email protected]
Health information management for research and quality assurance: The Comprehensive Renal Transplant Research Information System
ORIGINAL ARTICLE
Health information management for research and quality assurance: The Comprehensive Renal Transplant Research Information System Olusegun Famure, MPH, MEd, CHE; Nicholas Anh-Tuan Phan, BSc; Sang Joseph Kim, MD, PhD, MHS, FRCPC
Abstract—The Kidney Transplant Program at the Toronto General Hospital uses numerous electronic health record platforms housing patient health information that is often not coded in a systematic manner to facilitate quality assurance and research. To address this, the comprehensive renal transplant research information system was conceived by a multidisciplinary healthcare team. Data analysis from comprehensive renal transplant research information system presented at programmatic retreats, scientific meetings, and peer-reviewed manuscripts contributes to quality improvement and knowledge in kidney transplantation.
O
ver the past several decades, healthcare organizations have appreciated the need to achieve quality improvement and improve cost savings through the effective use of health information. Healthcare data in the form of Electronic Health Records (EHRs) are important constituents of performance assessment strategies and are increasingly used as reference tools for targeting quality improvement efforts.1,2 Over the past decade, there has been a movement among healthcare institutions to enhance the comprehensiveness of health records for improving the measurement of quality indicators. This has been achieved by merging administrative data, often derived from healthcare delivery and reimbursements for services rendered, with patient clinical information.3 In Canada, there has been an increasing trend to adopt EHRs, albeit to a lesser extent among primary care practices.4 Progress continues to be made via system transformational practices in embracing EHRs. However, the challenge in data management processes lies not only in the capture of reliable patient data at the point of care but also in the coding/formatting of this information in a manner appropriate for its use in quality improvement and research by decision-makers and scientists.2,3,5
The Kidney Transplant Program The Kidney Transplant Program (KTP) at the Toronto General Hospital, University Health Network (UHN), is part of the Multi-Organ Transplant Program—an internationally renowned transplant program serving the needs of From the Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. Corresponding author: Olusegun Famure, MPH, MEd, CHE, Toronto General Hospital, University Health Network, 585 University Avenue, 11C1198b, Toronto, Ontario, Canada, M5G 2N2. (e-mail: [email protected]) Healthcare Management Forum 2014 27:30–36 0840-4704/$ - see front matter & 2014 Canadian College of Health Leaders. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.hcmf.2013.11.002
patients from the greater Toronto area and the international community. Since the inception of the KTP in 1966, more than 3500 kidney transplant procedures have been performed. Currently, the program performs approximately 150 transplants a year. Half of its activity is attributed to living donors. In addition, patient data and accompanying blood/tissue samples have been collected and analyzed in various clinical trials and observational research studies. This has led to advances in the medical management of kidney transplant patients and several peer-reviewed publications over the past 5 decades. Historically, the KTP has maintained small-scale databases for the purposes of programmatic quality initiatives and clinical research. These ad hoc databases were rarely maintained after the completion of their associated projects. Patient information security and confidentiality issues became a common theme owing to a lack of procedure to define fully data ownership and responsibilities. The practice of ad hoc data collection also precipitated repetitive data collection for similar projects that resulted in undue expenditures in time, effort, and resources. Variability in data quality across different projects was another recurring issue. To address these problems, we devised a central quality/ research database system (including both the technology and processes) that ensures reliable data for programmatic needs, while rigorously protecting patient confidentiality. The overarching project objective was to create a comprehensive, accurate, and up-to-date clinical research database for the purposes of quality improvement and clinical research. This database came to be known as the Comprehensive Renal Transplant Research Information System (CoReTRIS). This system was designed to house individual-level data on all patients with End-Stage Renal Disease (ESRD) followed up in the KTP at the UHN from January 1, 2000 to the present. CoReTRIS was also constructed to link with data on biological specimen samples from referred patients with ESRD such as blood, serum, and urine for use in clinical research.
HEALTH INFORMATION MANAGEMENT FOR RESEARCH AND QUALITY ASSURANCE: THE COMPREHENSIVE RENAL TRANSPLANT RESEARCH INFORMATION SYSTEM
METHODS In describing the methodology adopted in the development of this information system, it is important to differentiate between “data management” and “data analysis.” DAMA international—the professional organization of data management professionals—describes data management as the “development, execution and supervision of plans, policies, programs and practices that control, protect, deliver and enhance the value of data and information assets.”6 For practical purposes, this highlights the 8 core process steps described later. By contrast, data analysis can be described as “the process of inspecting, cleaning, transforming and modelling data with the goal of discovering useful information and supporting decisionmaking.”7 Both the discovery of useful information and the need to use reliable data to support clinical decisionmaking make up the core purpose of CoReTRIS.
Environmental scan of existing data systems Pursuant to the conceptual design of a comprehensive information system, an environmental scan was conducted in Canada and the United States of available clinical research databases used by similar chronic patient care management centres, particularly transplant care facilities. Consideration was given to their functionality, professed product attributes, and setup/maintenance costs.
Consultation from hospital administration The University Health Network Research Ethics Board and relevant hospital administration departments were consulted
throughout the entire developmental process of CoReTRIS. Governance surrounding the transfer of data from external sources was put in place to certify that the information housed in the database system was compliant with the patient health information protection act or PHIPA guidelines, thus safeguarding patient rights and confidentiality.
Patient flow: Identifying sources of client data Transplant patients, like many other recipients of chronic care management services, may be treated in a variety of settings and for a variety of conditions. Aggregating information for each patient and his or her respective donor is critical to forming a complete picture of the “patient health journey.” In the process of developing CoReTRIS, 5 main data sources were identified to support the management of kidney transplant patients: (1) Quadramed (MYSIS), (2) Organ Transplant Tracking Record (OTTR), (3) hospital paper medical charts, (4) Trillium Gift-of-Life Network “TOTAL” database system, and (5) the histocompatibility laboratory’s “HISTOTRAK” system (Fig. 1). Quadramed (MYSIS) system: This system is fully integrated to the hospital’s admissions, discharge, and transfer system. It is the foundation for managing and monitoring all patient activity within the UHN. All patients with any clinical encounters at UHN have their data automatically linked through MYSIS. The types of information stored in MYSIS include patient demographic information, clinical data, laboratory findings, diagnostic testing results, consultation notes, and discharge summaries. OTTR: This proprietary information system is specifically designed for the management of organ transplant
Figure 1. Source documentation and information flow in CoReTRIS.
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recipients. It has been in operation at the UHN multi-organ transplant program since 1999. It is used as the primary patient record in the outpatient setting. Some of the most frequently used features of OTTR at UHN include the following: (1) transcribing notes and information on outpatient visits, (2) maintaining up-to-date lists of diagnoses, (3) medication lists and changes, (4) communication between physicians and coordinators, and (5) tracking/reviewing laboratory and other test results. Hospital paper medical charts: Hard copies of medical records on transplant patients are often retained on site in the outpatient clinics. The records consist mainly of laboratory/diagnostic test results as well as discharge summaries, often faxed from external healthcare facilities. Most inpatient paper charts are now being scanned into MYSIS for easier access. The Trillium Gift-of-Life Network “TOTAL” Information System: This information system is used by the provincial organ donation organization, Trillium Gift-of-Life Network, to manage organ donor referrals and offers. TOTAL is also used to manage organ transplant candidate information provided by each transplant centre to allow Trillium to run the organ-specific transplant waiting lists. The histocompatibility laboratory’s “HISTOTRAK” system: Data from baseline and longitudinal immunologic testing on organ transplant recipients at UHN are housed in this system. For clinical and quality purposes, this laboratory also stores biological specimens such as blood drawn from these patients. Appropriate agreements have been arranged through relevant hospital and research authorities to periodically receive the discarded samples from the histocompatibility laboratory for long-term storage and use in future research projects.
Data dictionary development A team of multidisciplinary professionals within the KTP developed the data dictionary framework for CoReTRIS. The data domains that constitute CoReTRIS include administrative information (such as admissions/discharge information and performance measures), clinical variables, laboratory/diagnostic testing, patient outcomes, healthcare costs, and quality-of-life surveys. We also referred to the data dictionary of a highly successful and long-standing in-centre database that has been developed/maintained by Dr. Arthur Matas, director of the Renal Transplant Program at the University of Minnesota Medical Center.8 This resource was invaluable in providing us a framework to devise our own CoReTRIS data dictionary.
Database platform design Microsoft Access 2007 was the adopted database application platform for the construction of CoReTRIS, which uses a power-builder front-end data tool. We chose this software because of its formatting capabilities to enter and manage large amounts of patient data using user-friendly front-end data forms. Another rationale for selecting this 32
platform stems from its flexibility to interact with other clinical software applications currently used by the KTP (eg, OTTR is built on an Oracle platform).
Data which collection procedures and interface with clinical care staff Research assistants and data coordinators prospectively gather health information from the patients’ medical records and other sources, such as the OTTR, MYSIS, and the TOTAL databases. Human biological specimens such as blood serum are obtained from the histocompatibility laboratory storage facility. Periodic consultations with the physicians and other healthcare professionals are conducted to ensure that these processes are both accurate and logical.
Educational training tools Extensive training manuals and e-learning tools for data abstraction, entry, and validation were created to ensure all data management procedures were systematically performed and reproducible. To reduce human resource costs for this project, trained personnel from the Multi-Organ Transplant Student Research Training Program under healthcare staff supervision play a significant role in the data management exercises.9
Data ownership Patient health information retained in CoReTRIS is the property of the Kidney Transplant Program, Division of Nephrology, University Health Network, with distribution rights of patient protected information given solely to the head of clinical research and quality assurance. Any sharing of data from CoReTRIS with investigators within or outside of UHN requires review and approval by the UHN Research Ethics Board.
RESULTS CoReTRIS and its composition CoReTRIS consists of 3 linked databases—the pretransplant, posttransplant, and biological specimen repository information systems. CoReTRIS contains extensive recipient, donor, transplant, laboratory, pathology, treatment, and follow-up data on all kidney transplant recipients at Toronto General Hospital since January 1, 2000 and all referred patients with ESRD since January 1, 2003. More than 50 domains and 700 data elements constitute the total database. The CoReTRIS pretransplant component contains health information of patients with ESRD obtained prior to their kidney transplant, including details of the medical workup leading to wait-listing as well as the trajectory of the patient while waiting for a kidney transplant. Patients’ posttransplant-related medical management and outcomes are stored in the posttransplant section of the database. The biological specimen repository stores
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HEALTH INFORMATION MANAGEMENT FOR RESEARCH AND QUALITY ASSURANCE: THE COMPREHENSIVE RENAL TRANSPLANT RESEARCH INFORMATION SYSTEM
information from available biological specimens of patients with ESRD referred to the UHN for kidney transplant evaluations (Fig. 2). To facilitate both accurate and consistent data abstraction, training manuals and interactive e-learning tools were developed. These e-learning tools facilitate an interactive environment. Exercises following each session assess the readiness of trainees to initiate actual data abstraction practices. In addition to the built-in validation checks in the MS Access data platform, Stata statistical software (StataCorp, College Station, TX) was used to develop a set of statistical codes which are employed to perform more extensive validation checks to maintain the quality of database’s content and to produce standardized analytical data sets for quality improvement and clinical research projects.10
Program quality initiatives and scientific research The benefits of developing and implementing an information system such as CoReTRIS have had a number of positive effects. Some of the benefits are as follows: ▪ Improvements in the management of clinical and other patient-related data for programmatic quality initiatives such as the provision of the kidney transplant program’s activities at its annual retreats. ▪ The generation of new scientific knowledge, which has been shared among healthcare professionals at national and international conferences through oral/poster presentations as well as peer-reviewed publications. ▪ The assessment of patients’ quality of life and satisfaction. ▪ Seamless integration of clinical trials and medical practice by allowing efficient screening of eligible patients, which leads to improved recruitment rates and follow-up. ▪ Training of future transplant professionals on the principles and conduct of clinical research, which is necessary to advance the care of kidney transplant patients. ▪ Fostering the development of a culture of inquiry, quality improvement, evaluation, and innovation within the KTP owing in large part to the existence of comprehensive, accessible, timely, and accurate data (Fig. 3). The production of high-quality clinical research is another area of achievement for the UHN KTP following the launch of CoReTRIS.11-14 A comprehensive data system housing numerous data domains of interest to healthcare staff from various disciplines has made possible the completion of several health quality and research projects. Such successes are instrumental in positioning the KTP as a centre of excellence in transplant care and research for years to come.
DISCUSSION Effective health services delivery within the KTP is reliant on the availability and communication of appropriate health information. Although the receipt, synthesis, and application of varied health information are critical to the successful management of a kidney transplant patient, the availability of these data for the evaluation of existing clinical practices and patient-oriented research to improve kidney transplant outcomes is vital. The KTP has taken steps to achieve these goals via the implementation of CoReTRIS. Furthermore, the experiences accrued in developing a reliable and comprehensive database have fostered a joint collaboration with transplant healthcare staff—creating systematic procedures outlining the collection and entry of patient health information in a more appreciable quality format for meaningful analytical purposes. Entry of a patient’s record once at the point of care in an acceptable uniform format would eliminate the need for multiple actions of data manipulation and diminishes the risks of errors. Long-term cost savings is another factor. Although the efforts and costs of developing a database such as CoReTRIS may be experienced upfront, the use of this system may lead to improvements in the efficiency and effectiveness of healthcare delivery within the KTP. It also offset the need to develop ad hoc databases for quality and research projects (as was the case previously). These benefits may allow the costs of CoReTRIS to recompense itself in the long term. The numerous quality and research projects generated by the use of data from CoReTRIS have helped to shape clinical processes and decision-making within the KTP. Two examples where this was evident include (1) the use of expanded criteria donors for potential kidney recipients and (2) the effect of Body Mass Index (BMI) at the time of transplant on the clinical outcomes of kidney transplant recipients. In the former case, data from CoReTRIS were used to determine the outcomes of recipients whose kidneys had characteristics that made them at increased risk for longterm failure (eg, older age). These “expanded criteria donor” or ECD kidneys may still benefit patients who have a high risk of mortality while waiting on dialysis. Our analyses showed that patients receiving ECD kidneys were actually doing as well as patients receiving non-ECD kidneys, despite a lower level of achieved kidney function in the former group. This may reflect intensive monitoring after transplant and aggressive risk factor management to improve the likelihood of long-term survival with these kidneys. Because of these data, eligible patients are now counselled to consider the outcomes of ECD kidneys on par with non-ECD kidneys in our program and thus increasing the opportunities for patients to benefit from these organs. The results of these analyses are currently being prepared in a scientific manuscript.
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Figure 2. Summary of the description of CoReTRIS’s data domains and their contents.
In the latter case, owing to the absence of national BMI standards for accepting or declining kidney transplant candidates, the KTP embarked on a project to determine the association of BMI at the time of transplant and typical transplant-related outcomes.14 Accounting for potential confounders, the findings showed that high BMI (Z35) is associated with an increased risk of delayed graft function, acute rejection, and kidney transplant failure.14 The results from these analyses have enabled the KTP to better counsel their patients on the risks of a kidney transplant in the setting of an elevated BMI and thus improve the 34
effectiveness of interventions to optimize BMI while waiting for a kidney transplant. It has also altered our approach to immunosuppression in patients with elevated BMI as there is a heightened risk of acute rejection. Moving forward, there are plans to implement an initiative to review the rates, predictors, and outcomes of hospital readmission after the kidney transplantation in our KTP. Moreover, the financial effect of readmissions to the KTP and the hospital will be assessed. The information gleaned from this analysis would not only inform the KTP on the current state of affairs but could also serve as a
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HEALTH INFORMATION MANAGEMENT FOR RESEARCH AND QUALITY ASSURANCE: THE COMPREHENSIVE RENAL TRANSPLANT RESEARCH INFORMATION SYSTEM
means to benchmark its performance against other transplant centres.
Limitations It is important to note that the information in any database is only as good as (1) the records used for data abstraction, (2) the quality of data abstraction, (3) the quality of data entry/management, and (4) the quality of the analyses and presentation.8 Although quality control measures are built into both the database configuration and the Stata data management statistical codes developed to detect data errors across data fields, there is no substitute to optimizing the method and quality of the data entered by healthcare staff at the point of care. In addition, performing a retrospective review of patient information can be an expensive endeavour. To help reduce costs, an organizational framework using both healthcare staff and data personnel (comprised of university undergraduate and graduate trainees) was adopted.7 However, adequate educational resources were essential to ensure each trainee’s adherence to quality data practices. This was accomplished through the development of training manuals (ie, standard operating procedures) and interactive e-learning tools. Lastly, it is important to note that in the development of the data dictionary for CoReTRIS, we could not rely on a uniformly acceptable standard for the data elements employed as no such standard currently exists. Instead, data definitions were developed based on current local practices, the synthesis of the available literature, and templates from existing data systems used in the management of transplant care in other centres. Despite CoReTRIS’s beginnings as a local initiative, there are plans to use substantial sections of the current data dictionary to support the development of a broader information system for kidney transplantation at the national level. In addition, performance metrics implemented in CoReTRIS to track waiting times from referral to wait-listing to transplantation at the Toronto General Hospital are also being used by both provincial and national transplant agencies to assess the quality of services provided to kidney transplant candidates. These initiatives may become the platform for future data linkages and the sharing of aggregate information between transplant centres nationwide.
CONCLUSION The KTP at UHN possesses an outstanding team of dedicated healthcare professionals and state-of-the-art technologies relevant to the clinical management of kidney transplant candidates and recipients. Appropriate provisions must be made to facilitate seamless access to data for quality and research purposes with the goal of improving the experience and outcomes of patients in the program. The CoReTRIS platform helps to fulfill this role as it pertains to the management of patient data in an aggregate form.
Monitoring patient outcomes via periodic quality assurance practices and conducting research are a significant part of the program’s mandate and are critical to the ongoing expansion and success of the KTP’s services. Data analysis from CoReTRIS presented at programmatic retreats and scientific meetings continues to contribute to quality improvement and the knowledge base of kidney transplantation. CoReTRIS provides high-quality data for reasonable financial costs, thus a similar framework has applicability to chronic care disease management databases in other healthcare institutions.
ACKNOWLEDGMENTS The authors would like to thank the hospital staff of the Kidney Transplant Program at the Toronto General Hospital, University Health Network, for their contributions in developing the CoReTRIS data dictionary. A special thanks to the students and mentors of the Multi-Organ Transplant Student Research Training Program (MOTSRTP) for their tireless efforts in bringing this project to fruition.
APPENDIX:
SUPPLEMENTARY INFORMATION
Supplementary material associated with this article can be found in the on-line version at http://dx.doi.org/10.1016/j. hcmf.2013.11.002.
REFERENCES 1. Pine M, Sonneborn M, Schindler J, et al. Harnessing the power of enhanced data for healthcare quality improvement: lessons from a Minnesota hospital association pilot project. J Healthc Manag 2012;57(6):406–418. 2. Blumenthal D. Stimulating the adoption of health information technology. N Engl J Med 2009;360(15):1477–1479. 3. Enhancing the clinical content of administrative data. Agency for healthcare research and quality. www.hccup-us.ahrq. gov/datainnovations/clinicaldata/lvback.jsp; 2010 Accessed 13.09.13. 4. McGinn CA. Comparisons of user groups’ perspectives of barriers and facilitators in implementing electronic health records: a systematic review. BMC Med 2011;9:46. 5. Schwartz RM, Gagnon DE, Muri JH, Zhao QR, Kellogg R. Administrative data for quality improvement. Paediatrics 1999; 103(1 suppl E):291–301. 6. DAMA Intl. “DAMA-DMBOK guide (Data management body of knowledge) introduction and project status.” http://www. dama.org/files/public/DI_DAMA_DBMBOK_Guide_Presentation_ 2007.pdf; 2007 Accessed 23.09.13. 7. Ader HJ. Chapter 14: Phases and initial steps in data analysis. In: Ader HJ, Mellenbergh GJ, eds. [with contributors by D.J. Hand] Advising on Research Methods: A Consultant’s Companion. Huizen the Netherlands: Johannes van Kessel Publishing; 2008:333–350. 8. McHugh L, Matas, A. Copyright 1989. Transplant outcomes database manual: kidney and pancreas transplantation. University of Minnesota Medical Centre. Retrieved edition 14 May, 2008.
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9. Famure O, Li A, Ross H, Kim SJ. Integrating research and education into clinical practice: the multi-organ transplant student research training program. Healthc Manag Forum 2012;25(2):80–85. 10. Kruse RL, Mehr DR. Data management for prospective research studies using SAS software. BMC Med Res Methodol 2008;8:61. 11. Sultan H, Famure O, Phan N, Van J, Kim SJ. Performance measures for the evaluation of patients referred to the Toronto General Hospital Kidney Transplant Program. Healthc Manag Forum 2013;26(4):184–190.
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12. Jamal AJ, Husain S, Li Y, Famure O, Kim SJ. Risk factors for late-onset cytomegalovirus infection or disease in kidney transplant recipients. Transplantation, in press. 13. Sapir-Pichhadze R, Wang Y, Famure O, Li Y, Kim SJ. Timedependent variability in tacrolimus trough blood levels and the risk of late kidney transplant failure. Kidney Int, Dec 11, 2013. 14. Curran SP, Li Y, Famure O, Kim SJ. Increased recipient body mass index is associated with acute rejection and other adverse outcomes after kidney transplantation. Transplantation 2014;97(1):64–70.
Healthcare Management Forum Forum Gestion des soins de sante – Spring/Printemps 2014
Health information management for research and quality assurance: The Comprehensive Renal Transplant Research Information System Olusegun Famure, MPH, MEd, CHE; Nicholas Anh-Tuan Phan, BSc; Sang Joseph Kim, MD, PhD, MHS, FRCPC
Abstract—The Kidney Transplant Program at the Toronto General Hospital uses numerous electronic health record platforms housing patient health information that is often not coded in a systematic manner to facilitate quality assurance and research. To address this, the comprehensive renal transplant research information system was conceived by a multidisciplinary healthcare team. Data analysis from comprehensive renal transplant research information system presented at programmatic retreats, scientific meetings, and peer-reviewed manuscripts contributes to quality improvement and knowledge in kidney transplantation.
O
ver the past several decades, healthcare organizations have appreciated the need to achieve quality improvement and improve cost savings through the effective use of health information. Healthcare data in the form of Electronic Health Records (EHRs) are important constituents of performance assessment strategies and are increasingly used as reference tools for targeting quality improvement efforts.1,2 Over the past decade, there has been a movement among healthcare institutions to enhance the comprehensiveness of health records for improving the measurement of quality indicators. This has been achieved by merging administrative data, often derived from healthcare delivery and reimbursements for services rendered, with patient clinical information.3 In Canada, there has been an increasing trend to adopt EHRs, albeit to a lesser extent among primary care practices.4 Progress continues to be made via system transformational practices in embracing EHRs. However, the challenge in data management processes lies not only in the capture of reliable patient data at the point of care but also in the coding/formatting of this information in a manner appropriate for its use in quality improvement and research by decision-makers and scientists.2,3,5
The Kidney Transplant Program The Kidney Transplant Program (KTP) at the Toronto General Hospital, University Health Network (UHN), is part of the Multi-Organ Transplant Program—an internationally renowned transplant program serving the needs of From the Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. Corresponding author: Olusegun Famure, MPH, MEd, CHE, Toronto General Hospital, University Health Network, 585 University Avenue, 11C1198b, Toronto, Ontario, Canada, M5G 2N2. (e-mail: [email protected]) Healthcare Management Forum 2014 27:30–36 0840-4704/$ - see front matter & 2014 Canadian College of Health Leaders. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.hcmf.2013.11.002
patients from the greater Toronto area and the international community. Since the inception of the KTP in 1966, more than 3500 kidney transplant procedures have been performed. Currently, the program performs approximately 150 transplants a year. Half of its activity is attributed to living donors. In addition, patient data and accompanying blood/tissue samples have been collected and analyzed in various clinical trials and observational research studies. This has led to advances in the medical management of kidney transplant patients and several peer-reviewed publications over the past 5 decades. Historically, the KTP has maintained small-scale databases for the purposes of programmatic quality initiatives and clinical research. These ad hoc databases were rarely maintained after the completion of their associated projects. Patient information security and confidentiality issues became a common theme owing to a lack of procedure to define fully data ownership and responsibilities. The practice of ad hoc data collection also precipitated repetitive data collection for similar projects that resulted in undue expenditures in time, effort, and resources. Variability in data quality across different projects was another recurring issue. To address these problems, we devised a central quality/ research database system (including both the technology and processes) that ensures reliable data for programmatic needs, while rigorously protecting patient confidentiality. The overarching project objective was to create a comprehensive, accurate, and up-to-date clinical research database for the purposes of quality improvement and clinical research. This database came to be known as the Comprehensive Renal Transplant Research Information System (CoReTRIS). This system was designed to house individual-level data on all patients with End-Stage Renal Disease (ESRD) followed up in the KTP at the UHN from January 1, 2000 to the present. CoReTRIS was also constructed to link with data on biological specimen samples from referred patients with ESRD such as blood, serum, and urine for use in clinical research.
HEALTH INFORMATION MANAGEMENT FOR RESEARCH AND QUALITY ASSURANCE: THE COMPREHENSIVE RENAL TRANSPLANT RESEARCH INFORMATION SYSTEM
METHODS In describing the methodology adopted in the development of this information system, it is important to differentiate between “data management” and “data analysis.” DAMA international—the professional organization of data management professionals—describes data management as the “development, execution and supervision of plans, policies, programs and practices that control, protect, deliver and enhance the value of data and information assets.”6 For practical purposes, this highlights the 8 core process steps described later. By contrast, data analysis can be described as “the process of inspecting, cleaning, transforming and modelling data with the goal of discovering useful information and supporting decisionmaking.”7 Both the discovery of useful information and the need to use reliable data to support clinical decisionmaking make up the core purpose of CoReTRIS.
Environmental scan of existing data systems Pursuant to the conceptual design of a comprehensive information system, an environmental scan was conducted in Canada and the United States of available clinical research databases used by similar chronic patient care management centres, particularly transplant care facilities. Consideration was given to their functionality, professed product attributes, and setup/maintenance costs.
Consultation from hospital administration The University Health Network Research Ethics Board and relevant hospital administration departments were consulted
throughout the entire developmental process of CoReTRIS. Governance surrounding the transfer of data from external sources was put in place to certify that the information housed in the database system was compliant with the patient health information protection act or PHIPA guidelines, thus safeguarding patient rights and confidentiality.
Patient flow: Identifying sources of client data Transplant patients, like many other recipients of chronic care management services, may be treated in a variety of settings and for a variety of conditions. Aggregating information for each patient and his or her respective donor is critical to forming a complete picture of the “patient health journey.” In the process of developing CoReTRIS, 5 main data sources were identified to support the management of kidney transplant patients: (1) Quadramed (MYSIS), (2) Organ Transplant Tracking Record (OTTR), (3) hospital paper medical charts, (4) Trillium Gift-of-Life Network “TOTAL” database system, and (5) the histocompatibility laboratory’s “HISTOTRAK” system (Fig. 1). Quadramed (MYSIS) system: This system is fully integrated to the hospital’s admissions, discharge, and transfer system. It is the foundation for managing and monitoring all patient activity within the UHN. All patients with any clinical encounters at UHN have their data automatically linked through MYSIS. The types of information stored in MYSIS include patient demographic information, clinical data, laboratory findings, diagnostic testing results, consultation notes, and discharge summaries. OTTR: This proprietary information system is specifically designed for the management of organ transplant
Figure 1. Source documentation and information flow in CoReTRIS.
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recipients. It has been in operation at the UHN multi-organ transplant program since 1999. It is used as the primary patient record in the outpatient setting. Some of the most frequently used features of OTTR at UHN include the following: (1) transcribing notes and information on outpatient visits, (2) maintaining up-to-date lists of diagnoses, (3) medication lists and changes, (4) communication between physicians and coordinators, and (5) tracking/reviewing laboratory and other test results. Hospital paper medical charts: Hard copies of medical records on transplant patients are often retained on site in the outpatient clinics. The records consist mainly of laboratory/diagnostic test results as well as discharge summaries, often faxed from external healthcare facilities. Most inpatient paper charts are now being scanned into MYSIS for easier access. The Trillium Gift-of-Life Network “TOTAL” Information System: This information system is used by the provincial organ donation organization, Trillium Gift-of-Life Network, to manage organ donor referrals and offers. TOTAL is also used to manage organ transplant candidate information provided by each transplant centre to allow Trillium to run the organ-specific transplant waiting lists. The histocompatibility laboratory’s “HISTOTRAK” system: Data from baseline and longitudinal immunologic testing on organ transplant recipients at UHN are housed in this system. For clinical and quality purposes, this laboratory also stores biological specimens such as blood drawn from these patients. Appropriate agreements have been arranged through relevant hospital and research authorities to periodically receive the discarded samples from the histocompatibility laboratory for long-term storage and use in future research projects.
Data dictionary development A team of multidisciplinary professionals within the KTP developed the data dictionary framework for CoReTRIS. The data domains that constitute CoReTRIS include administrative information (such as admissions/discharge information and performance measures), clinical variables, laboratory/diagnostic testing, patient outcomes, healthcare costs, and quality-of-life surveys. We also referred to the data dictionary of a highly successful and long-standing in-centre database that has been developed/maintained by Dr. Arthur Matas, director of the Renal Transplant Program at the University of Minnesota Medical Center.8 This resource was invaluable in providing us a framework to devise our own CoReTRIS data dictionary.
Database platform design Microsoft Access 2007 was the adopted database application platform for the construction of CoReTRIS, which uses a power-builder front-end data tool. We chose this software because of its formatting capabilities to enter and manage large amounts of patient data using user-friendly front-end data forms. Another rationale for selecting this 32
platform stems from its flexibility to interact with other clinical software applications currently used by the KTP (eg, OTTR is built on an Oracle platform).
Data which collection procedures and interface with clinical care staff Research assistants and data coordinators prospectively gather health information from the patients’ medical records and other sources, such as the OTTR, MYSIS, and the TOTAL databases. Human biological specimens such as blood serum are obtained from the histocompatibility laboratory storage facility. Periodic consultations with the physicians and other healthcare professionals are conducted to ensure that these processes are both accurate and logical.
Educational training tools Extensive training manuals and e-learning tools for data abstraction, entry, and validation were created to ensure all data management procedures were systematically performed and reproducible. To reduce human resource costs for this project, trained personnel from the Multi-Organ Transplant Student Research Training Program under healthcare staff supervision play a significant role in the data management exercises.9
Data ownership Patient health information retained in CoReTRIS is the property of the Kidney Transplant Program, Division of Nephrology, University Health Network, with distribution rights of patient protected information given solely to the head of clinical research and quality assurance. Any sharing of data from CoReTRIS with investigators within or outside of UHN requires review and approval by the UHN Research Ethics Board.
RESULTS CoReTRIS and its composition CoReTRIS consists of 3 linked databases—the pretransplant, posttransplant, and biological specimen repository information systems. CoReTRIS contains extensive recipient, donor, transplant, laboratory, pathology, treatment, and follow-up data on all kidney transplant recipients at Toronto General Hospital since January 1, 2000 and all referred patients with ESRD since January 1, 2003. More than 50 domains and 700 data elements constitute the total database. The CoReTRIS pretransplant component contains health information of patients with ESRD obtained prior to their kidney transplant, including details of the medical workup leading to wait-listing as well as the trajectory of the patient while waiting for a kidney transplant. Patients’ posttransplant-related medical management and outcomes are stored in the posttransplant section of the database. The biological specimen repository stores
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information from available biological specimens of patients with ESRD referred to the UHN for kidney transplant evaluations (Fig. 2). To facilitate both accurate and consistent data abstraction, training manuals and interactive e-learning tools were developed. These e-learning tools facilitate an interactive environment. Exercises following each session assess the readiness of trainees to initiate actual data abstraction practices. In addition to the built-in validation checks in the MS Access data platform, Stata statistical software (StataCorp, College Station, TX) was used to develop a set of statistical codes which are employed to perform more extensive validation checks to maintain the quality of database’s content and to produce standardized analytical data sets for quality improvement and clinical research projects.10
Program quality initiatives and scientific research The benefits of developing and implementing an information system such as CoReTRIS have had a number of positive effects. Some of the benefits are as follows: ▪ Improvements in the management of clinical and other patient-related data for programmatic quality initiatives such as the provision of the kidney transplant program’s activities at its annual retreats. ▪ The generation of new scientific knowledge, which has been shared among healthcare professionals at national and international conferences through oral/poster presentations as well as peer-reviewed publications. ▪ The assessment of patients’ quality of life and satisfaction. ▪ Seamless integration of clinical trials and medical practice by allowing efficient screening of eligible patients, which leads to improved recruitment rates and follow-up. ▪ Training of future transplant professionals on the principles and conduct of clinical research, which is necessary to advance the care of kidney transplant patients. ▪ Fostering the development of a culture of inquiry, quality improvement, evaluation, and innovation within the KTP owing in large part to the existence of comprehensive, accessible, timely, and accurate data (Fig. 3). The production of high-quality clinical research is another area of achievement for the UHN KTP following the launch of CoReTRIS.11-14 A comprehensive data system housing numerous data domains of interest to healthcare staff from various disciplines has made possible the completion of several health quality and research projects. Such successes are instrumental in positioning the KTP as a centre of excellence in transplant care and research for years to come.
DISCUSSION Effective health services delivery within the KTP is reliant on the availability and communication of appropriate health information. Although the receipt, synthesis, and application of varied health information are critical to the successful management of a kidney transplant patient, the availability of these data for the evaluation of existing clinical practices and patient-oriented research to improve kidney transplant outcomes is vital. The KTP has taken steps to achieve these goals via the implementation of CoReTRIS. Furthermore, the experiences accrued in developing a reliable and comprehensive database have fostered a joint collaboration with transplant healthcare staff—creating systematic procedures outlining the collection and entry of patient health information in a more appreciable quality format for meaningful analytical purposes. Entry of a patient’s record once at the point of care in an acceptable uniform format would eliminate the need for multiple actions of data manipulation and diminishes the risks of errors. Long-term cost savings is another factor. Although the efforts and costs of developing a database such as CoReTRIS may be experienced upfront, the use of this system may lead to improvements in the efficiency and effectiveness of healthcare delivery within the KTP. It also offset the need to develop ad hoc databases for quality and research projects (as was the case previously). These benefits may allow the costs of CoReTRIS to recompense itself in the long term. The numerous quality and research projects generated by the use of data from CoReTRIS have helped to shape clinical processes and decision-making within the KTP. Two examples where this was evident include (1) the use of expanded criteria donors for potential kidney recipients and (2) the effect of Body Mass Index (BMI) at the time of transplant on the clinical outcomes of kidney transplant recipients. In the former case, data from CoReTRIS were used to determine the outcomes of recipients whose kidneys had characteristics that made them at increased risk for longterm failure (eg, older age). These “expanded criteria donor” or ECD kidneys may still benefit patients who have a high risk of mortality while waiting on dialysis. Our analyses showed that patients receiving ECD kidneys were actually doing as well as patients receiving non-ECD kidneys, despite a lower level of achieved kidney function in the former group. This may reflect intensive monitoring after transplant and aggressive risk factor management to improve the likelihood of long-term survival with these kidneys. Because of these data, eligible patients are now counselled to consider the outcomes of ECD kidneys on par with non-ECD kidneys in our program and thus increasing the opportunities for patients to benefit from these organs. The results of these analyses are currently being prepared in a scientific manuscript.
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Figure 2. Summary of the description of CoReTRIS’s data domains and their contents.
In the latter case, owing to the absence of national BMI standards for accepting or declining kidney transplant candidates, the KTP embarked on a project to determine the association of BMI at the time of transplant and typical transplant-related outcomes.14 Accounting for potential confounders, the findings showed that high BMI (Z35) is associated with an increased risk of delayed graft function, acute rejection, and kidney transplant failure.14 The results from these analyses have enabled the KTP to better counsel their patients on the risks of a kidney transplant in the setting of an elevated BMI and thus improve the 34
effectiveness of interventions to optimize BMI while waiting for a kidney transplant. It has also altered our approach to immunosuppression in patients with elevated BMI as there is a heightened risk of acute rejection. Moving forward, there are plans to implement an initiative to review the rates, predictors, and outcomes of hospital readmission after the kidney transplantation in our KTP. Moreover, the financial effect of readmissions to the KTP and the hospital will be assessed. The information gleaned from this analysis would not only inform the KTP on the current state of affairs but could also serve as a
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means to benchmark its performance against other transplant centres.
Limitations It is important to note that the information in any database is only as good as (1) the records used for data abstraction, (2) the quality of data abstraction, (3) the quality of data entry/management, and (4) the quality of the analyses and presentation.8 Although quality control measures are built into both the database configuration and the Stata data management statistical codes developed to detect data errors across data fields, there is no substitute to optimizing the method and quality of the data entered by healthcare staff at the point of care. In addition, performing a retrospective review of patient information can be an expensive endeavour. To help reduce costs, an organizational framework using both healthcare staff and data personnel (comprised of university undergraduate and graduate trainees) was adopted.7 However, adequate educational resources were essential to ensure each trainee’s adherence to quality data practices. This was accomplished through the development of training manuals (ie, standard operating procedures) and interactive e-learning tools. Lastly, it is important to note that in the development of the data dictionary for CoReTRIS, we could not rely on a uniformly acceptable standard for the data elements employed as no such standard currently exists. Instead, data definitions were developed based on current local practices, the synthesis of the available literature, and templates from existing data systems used in the management of transplant care in other centres. Despite CoReTRIS’s beginnings as a local initiative, there are plans to use substantial sections of the current data dictionary to support the development of a broader information system for kidney transplantation at the national level. In addition, performance metrics implemented in CoReTRIS to track waiting times from referral to wait-listing to transplantation at the Toronto General Hospital are also being used by both provincial and national transplant agencies to assess the quality of services provided to kidney transplant candidates. These initiatives may become the platform for future data linkages and the sharing of aggregate information between transplant centres nationwide.
CONCLUSION The KTP at UHN possesses an outstanding team of dedicated healthcare professionals and state-of-the-art technologies relevant to the clinical management of kidney transplant candidates and recipients. Appropriate provisions must be made to facilitate seamless access to data for quality and research purposes with the goal of improving the experience and outcomes of patients in the program. The CoReTRIS platform helps to fulfill this role as it pertains to the management of patient data in an aggregate form.
Monitoring patient outcomes via periodic quality assurance practices and conducting research are a significant part of the program’s mandate and are critical to the ongoing expansion and success of the KTP’s services. Data analysis from CoReTRIS presented at programmatic retreats and scientific meetings continues to contribute to quality improvement and the knowledge base of kidney transplantation. CoReTRIS provides high-quality data for reasonable financial costs, thus a similar framework has applicability to chronic care disease management databases in other healthcare institutions.
ACKNOWLEDGMENTS The authors would like to thank the hospital staff of the Kidney Transplant Program at the Toronto General Hospital, University Health Network, for their contributions in developing the CoReTRIS data dictionary. A special thanks to the students and mentors of the Multi-Organ Transplant Student Research Training Program (MOTSRTP) for their tireless efforts in bringing this project to fruition.
APPENDIX:
SUPPLEMENTARY INFORMATION
Supplementary material associated with this article can be found in the on-line version at http://dx.doi.org/10.1016/j. hcmf.2013.11.002.
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