Improving data quality in observational research studies: Report of the Cure Glomerulonephropathy (CureGN) network.

BACKGROUND: High data quality is of crucial importance to the integrity of research projects. In the conduct of multi-center observational cohort studies with increasing types and quantities of data, maintaining data quality is challenging, with few published guidelines. METHODS: The Cure Glomerulonephropathy (CureGN) Network has established numerous quality control procedures to manage the 70 participating sites in the United States, Canada, and Europe. This effort is supported and guided by the activities of several committees, including Data Quality, Recruitment and Retention, and Central Review, that work in tandem with the Data Coordinating Center to monitor the study. We have implemented coordinator training and feedback channels, data queries of questionable or missing data, and developed performance metrics for recruitment, retention, visit completion, data entry, recording of patient-reported outcomes, collection, shipping and accessing of biological samples and pathology materials, and processing, cataloging and accessing genetic data and materials. RESULTS: We describe the development of data queries and site Report Cards, and their use in monitoring and encouraging excellence in site performance. We demonstrate improvements in data quality and completeness over 4 years after implementing these activities. We describe quality initiatives addressing specific challenges in collecting and cataloging whole slide images and other kidney pathology data, and novel methods of data quality assessment. CONCLUSIONS: This paper reports the CureGN experience in optimizing data quality and underscores the importance of general and study-specific data quality initiatives to maintain excellence in the research measures of a multi-center observational study.

Life and expectations post-kidney transplant: a qualitative analysis of patient responses.

BACKGROUND: The effect of a kidney transplant on a recipient extends beyond the restoration of kidney function. However, there is limited qualitative analysis of recipient perspectives on life following transplantation, particularly in the United States. To understand the full patient experience, it is necessary to understand recipient views on life adjustments after kidney transplantation, medical management, and quality of life. This could lead to improvements in recipient care and sense of well-being. METHODS: We conducted a paper-based survey from March 23 to October 1, 2015 of 476 kidney transplant recipients at the University of Michigan Health System in Ann Arbor, Michigan. We analyzed their open-ended responses using qualitative research methods. This is a companion analysis to a previous quantitative report on the closed-ended responses to that survey. RESULTS: Common themes relating to changes following transplantation included: improvements in quality of life, a return to normalcy, better health and more energy. Concerns included: duration of graft survival, fears about one day returning to dialysis or needing to undergo another kidney transplant, comorbidities, future quality of life, and the cost and quality of their healthcare. Many recipients were grateful for their transplant, but some were anxious about the burdens transplantation placed on their loved ones. CONCLUSIONS: While most recipients reported meaningful improvements in health and lifestyle after kidney transplantation, a minority of participants experienced declines in energy or health status. Worries about how long the transplant will function, future health, and cost and quality of healthcare are prevalent. Future research could study the effects of providing additional information, programs, and interventions following transplantation that target these concerns. This may better prepare and support kidney recipients and lead to improvements in the patient experience.

Confidence in Women's Health: A Cross Border Survey of Adult Nephrologists.

A range of women's health issues are intimately related to chronic kidney disease, yet nephrologists' confidence in counseling or managing these issues has not been evaluated. The women's health working group of Cure Glomerulonephropathy (CureGN), an international prospective cohort study of glomerular disease, sought to assess adult nephrologists' training in, exposure to, and confidence in managing women's health. A 25-item electronic questionnaire was disseminated in the United States (US) and Canada via CureGN and Canadian Society of Nephrology email networks and the American Society of Nephrology Kidney News. Response frequencies were summarized using descriptive statistics. Responses were compared across provider age, gender, country of practice, and years in practice using Pearson's chi-squared test or Fisher's exact test. Among 154 respondents, 53% were women, 58% practiced in the US, 77% practiced in an academic setting, and the median age was 41⁻45 years. Over 65% of respondents lacked confidence in women's health issues, including menstrual disorders, preconception counseling, pregnancy management, and menopause. Most provided contraception or preconception counseling to less than one woman per month, on average. Only 12% had access to interdisciplinary pregnancy clinics. Finally, 89% felt that interdisciplinary guidelines and/or continuing education seminars would improve knowledge. Participants lacked confidence in both counseling and managing women's health. Innovative approaches are warranted to improve the care of women with kidney disease and might include the expansion of interdisciplinary clinics, the development of case-based teaching materials, and interdisciplinary treatment guidelines focused on this patient group.

CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease.

RATIONALE & OBJECTIVES: Glomerular diseases, including minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and immunoglobulin A (IgA) nephropathy, share clinical presentations, yet result from multiple biological mechanisms. Challenges to identifying underlying mechanisms, biomarkers, and new therapies include the rarity of each diagnosis and slow progression, often requiring decades to measure the effectiveness of interventions to prevent end-stage kidney disease (ESKD) or death. STUDY DESIGN: Multicenter prospective cohort study. SETTING & PARTICIPANTS: Cure Glomerulonephropathy (CureGN) will enroll 2,400 children and adults with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or IgA nephropathy (including IgA vasculitis) and a first diagnostic kidney biopsy within 5 years. Patients with ESKD and those with secondary causes of glomerular disease are excluded. EXPOSURES: Clinical data, including medical history, medications, family history, and patient-reported outcomes, are obtained, along with a digital archive of kidney biopsy images and blood and urine specimens at study visits aligned with clinical care 1 to 4 times per year. OUTCOMES: Patients are followed up for changes in estimated glomerular filtration rate, disease activity, ESKD, and death and for nonrenal complications of disease and treatment, including infection, malignancy, cardiovascular, and thromboembolic events. ANALYTICAL APPROACH: The study design supports multiple longitudinal analyses leveraging the diverse data domains of CureGN and its ancillary program. At 2,400 patients and an average of 2 years' initial follow-up, CureGN has 80% power to detect an HR of 1.4 to 1.9 for proteinuria remission and a mean difference of 2.1 to 3.0mL/min/1.73m2 in estimated glomerular filtration rate per year. LIMITATIONS: Current follow-up can only detect large differences in ESKD and death outcomes. CONCLUSIONS: Study infrastructure will support a broad range of scientific approaches to identify mechanistically distinct subgroups, identify accurate biomarkers of disease activity and progression, delineate disease-specific treatment targets, and inform future therapeutic trials. CureGN is expected to be among the largest prospective studies of children and adults with glomerular disease, with a broad goal to lessen disease burden and improve outcomes.

Comparison of patient and provider goals, expectations, and experiences following kidney transplantation.

OBJECTIVE: This study examined whether kidney transplant recipients' post-transplant goals and expectations align with those as perceived by their healthcare providers. METHODS: Post-transplant goals and expectations across four domains were assessed via a descriptive survey of healthcare providers (N=72) and kidney transplant recipients (N=476) at the University of Michigan from March 23 - October 1, 2015. Demographic and transplant-related data were collected via a retrospective review of medical records, and survey responses were compared using Chi-square tests, Wilcoxon two-sample tests, and logistic regression. RESULTS: Patients expressed higher quality of life (mean Neuro-QOL T-score 60.2 vs. 52.7), were less likely to report that they were currently experiencing complications (11% vs. 24%), and anticipated their transplants to last longer (median 25 vs. 15 years) and to live longer (median 80 vs. 71 years) than providers expected for their typical patient. However, provider perceptions of patients' future ability to feel well, perform daily activities and work were significantly higher than those expressed by patients (all p<0.05). CONCLUSION: Kidney transplant patient and provider expectations differ in significant ways. PRACTICE IMPLICATIONS: Identified areas of discordance may provide opportunities for patients and providers to better evaluate treatment option tradeoffs in post-transplant clinical interactions.

Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study.

BACKGROUND AND OBJECTIVES: Most kidney donors view their experience positively, but some may experience psychosocial and financial burdens. We hypothesized that certain donor characteristics, poor outcome of the recipient, negative perceptions of care, and lack of support may be associated with poor psychosocial outcomes for donors. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The Renal and Lung Living Donors Evaluation Study (RELIVE) examined long-term medical and psychosocial outcomes for kidney donors (at three U.S. transplant centers) who donated between 1963 and 2005. Standardized questionnaires evaluated donor perspectives, recovery time, social support, motivation, financial impact, insurability after donation, and current psychological status. Questionnaires were mailed to 6909 donors. RESULTS: Questionnaires were returned by 2455 donors, who had donated 17 ± 10 years earlier (range, 5-48 years), a response rate of 36%. Most (95%) rated their overall donation experience as good to excellent. Rating the overall donor experience more negatively was associated with donor complications, psychological difficulties, recipient graft failure, and longer time since donation. Nine percent (n=231) reported one or more of the following poor psychosocial outcomes: fair or poor overall donor experience, financial burden, regret or discomfort with decision to donate, or psychological difficulties since donation. Recipient graft failure was the only predictor for reporting one or more of these poor psychosocial outcomes (odds ratio, 1.77; 95% confidence interval, 1.33 to 2.34). Donors with lower educational attainment experienced greater financial burden. One of five employed donors took unpaid leave; 2% reported health and life insurability concerns. CONCLUSIONS: Although the majority of donors viewed their overall donation experience positively, almost 1 in 10 donors reported at least one negative consequence related to donation. Recipient graft failure was associated with poor psychosocial outcome, defined as one or more of these negative consequences. Some donors were financially disadvantaged, and some experienced insurance difficulties. Interventions to avoid negative psychosocial and financial consequences are warranted.

Patterns and predictors of sexual function after liver donation: The Adult-to-Adult Living Donor Liver Transplantation Cohort study.

Although sexual functioning is an important facet of a living donor's quality of life, it has not received an extensive evaluation in this population. Using data from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study, we examined donor sexual functioning across the donation process from the predonation evaluation to 3 months and 1 year after donation. Donors (n = 208) and a comparison group of nondonors (n = 155) completed self-reported surveys with specific questions on sexual desire, satisfaction, orgasm, and (for men) erectile function. Across the 3 time points, donor sexual functioning was lower at the evaluation phase and 3 months after donation versus 1 year after donation. In the early recovery period, abdominal pain was associated with difficulty reaching orgasm [odds ratio (OR), 3.98; 95% confidence interval (CI), 1.30-12.16], concerns over appearance were associated with lower sexual desire (OR, 4.14; 95% CI, 1.02-16.79), and not feeling back to normal was associated with dissatisfaction with sexual life (OR, 3.58; 95% CI, 1.43-8.99). Efforts to educate donors before the surgery and prepare them for the early recovery phase may improve recovery and reduce distress regarding sexual functioning.

Predictors of donor follow-up after living donor liver transplantation.

Donor safety in living liver donation is of paramount importance; however, information on long-term outcomes is limited by incomplete follow-up. We sought to ascertain factors that predicted postdonation follow-up in 456 living liver donors in the Adult-to-Adult Living Donor Liver Transplantation Cohort Study. Completed donor follow-up was defined as physical, phone, or laboratory contact at a given time point. Univariate and multivariate mixed effects logistic regression models, using donor and recipient demographic and clinical data and donor quality-of-life data, were developed to predict completed follow-up. Ninety percent of the donors completed their follow-up in the first 3 months, and 83% completed their follow-up at year 1; rates of completed follow-up ranged from 57% to 72% in years 2 to 7 and from 41% to 56% in years 8 to 10. The probability of completed follow-up in the first year was higher for white donors [odds ratio (OR) = 3.27, 95% confidence interval (CI) = 1.25-8.58] but lower for donors whose recipients had hepatitis C virus or hepatocellular carcinoma (OR = 0.34, 95% CI = 0.17-0.69). After the first year, an older age at donation predicted more complete follow-up. There were significant center differences at all time points (OR range = 0.29-10.11), with center variability in both returns for in-center visits and the use of phone/long-distance visits. Donor follow-up in the first year after donation was excellent but decreased with time. Predictors of follow-up varied with the time since donation. In conclusion, adapting best center practices (enhanced through the use of telephones and social media) to maintain contact with donors represents a significant opportunity to gain valuable information about long-term donor outcomes.

Computerized assessment of competence-related abilities in living liver donors: the Adult-to-Adult Living Donor Liver Transplantation Cohort Study.

BACKGROUND: Despite its importance, determination of competence to consent to organ donation varies widely based on local standards. We piloted a new tool to aid transplant centers in donor assessment. METHODS: We assessed competence-related abilities among potential living liver donors (LDs) in the nine-center A2ALL study. Prospective LDs viewed an educational video and were queried to assess Understanding, Appreciation, Reasoning, and ability to express a Final Choice using the MacArthur Competence Assessment Tool for Clinical Research, adapted for computerized administration in LDs ("MacLiver"). Videotaped responses were scored by a clinical neuropsychologist (JF). RESULTS: Ninety-three LDs were assessed. Mean (standard deviation; domain maximum) scores were as follows: Understanding: 18.1 (2.6; max = 22), Appreciation: 5.1 (1.0; max = 6), Reasoning: 3.1 (0.8; max = 4), and Final Choice: 3.8 (0.5; max = 4). Scores did not differ by demographics, relationship to the recipient, eligibility to donate, or eventual donation (p > 0.4). Higher education was associated with greater Understanding (p = 0.004) and Reasoning (p = 0.03). CONCLUSION: Standardized, computerized education with independent ratings of responses may (1) alert the clinical staff to potential donors who may not be competent to donate and (2) highlight areas needing further assessment and education, leading to better informed decision making.