Optimizing Enrollment of Patients into Nephrology Research Studies.
ABSTRACT: Advances in medical care and biomedical research depend on the participation of human subjects. Poor patient enrollment in research has limited past clinical and translational research endeavors in nephrology. Simultaneously, patients and their caregivers are seeking better diagnostic, monitoring, and therapeutic approaches to improve or restore kidney and overall health. This manuscript will discuss a framework and strategies to optimize patient enrollment within nephrology research and provide examples of success from existing nephrology research programs.
Project description:BACKGROUND AND OBJECTIVES: Renal disease disproportionately affects African-American patients. Trust has been implicated as an important factor in patient outcomes. Higher levels of trust and better interpersonal care have been reported when race of patient and physician are concordant. The purpose of this analysis was to examine trends in the racial background of U.S. medical school graduates, internal medicine residents, nephrology fellows, and patients with ESRD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data for medical school graduates were obtained from the Association of American Medical Colleges and data for internal medicine and nephrology trainees from GME Track. ESRD data were obtained from U.S. Renal Data System (USRDS) annual reports. RESULTS: A significant disparity continues to exist between the proportional race makeup of African-American nephrology fellows (3.8%) and ESRD patients (32%). The low numbers of African-American nephrology fellows, and consequently new nephrologists, in light of the increase in ESRD patients has important implications for patient-centered nephrology care. CONCLUSIONS: Efforts are needed to increase minority recruitment into nephrology training programs, to more closely balance the racial background of trainees and patients in hopes of fostering improved trust between ESRD caregivers and patients, increasing access to care, alleviating ESRD health care disparities, and improving patient care.
Project description:Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.
Project description:The COVID-19 epidemic represents a special risk for kidney patients due to their comorbidities and advanced age, and the need for hemodialysis treatment in group rooms. It also represents a risk for professionals responsible for their attention. This manuscript contains a proposal for action to prevent infection of professionals in the Nephrology Services, one of the most valuable assets at the present time.
Project description:<h4>Background</h4>Fewer trainees are choosing to pursue nephrology. Only 60.1% of positions filled in the 2018 fellowship Match, which is concerning given the rising prevalence of end-stage kidney disease. Identifying factors influential in career choices is critical to inform focused approaches to recruit qualified applicants.<h4>Methods</h4>To understand perceptions of nephrology and assess factors influential in specialty choice among early career trainees, an anonymous survey was distributed to upper-level medical students and internal medicine residents at programs identified through the American Association of Medical Colleges (AAMC) and American Medical Association's Fellowship and Residency Electronic Interactive Database (FREIDA).<h4>Results</h4>Of 4199 recipients, 644 (15.3%) participants responded, including 315 upper-level medical students, 308 residents, and three chief residents from 30 institutions. An interest in the subject was the most critical factor in selecting a specialty (92%). Other key factors included a suitable work-life balance (73%), access to mentors (70%), and subject exposure (66%). Lack of interest was the most frequently-cited reason to forgo a nephrology fellowship (79%), followed by concerns regarding remuneration (43%), work-life balance (39%), and subject exposure (32%). In free-text responses, several participants described frustration with managing patients on hemodialysis and desired combined training with specialties such as critical care. Respondents who had considered nephrology at any point cited an interest in physiology or interface with a mentor as key driving factors.<h4>Conclusions</h4>A lack of interest in and exposure to the subject, perceptions of poor earning potential and patient nonadherence, and concerns regarding work-life balance were influential in participants' decisions to forgo nephrology training. Incorporating novel educational tools and broadening the scope of the nephrology elective, highlighting ongoing areas of clinical and research innovation, expanding opportunities for interdisciplinary collaboration and procedural skills, and cultivating strategies to reduce burnout may be useful areas on which to focus future recruitment efforts.
Project description:Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical trials in nephrology. The Network has not only been successful in engaging the nephrology community in Australia and New Zealand but also in forming collaborations with leading researchers from other countries. This article describes the establishment, development, and functions of the Network. The article also discusses the current and future funding strategies to ensure uninterrupted conduct of much needed clinical trials in nephrology to improve the outcomes of patients affected by kidney diseases with cost-effective interventions.
Project description:<h4>Background and objectives</h4>Recent evidence supports a link between caregivers' health literacy and their children's health and use of health services. Disruptions in children's health insurance coverage have been linked to poor health care and outcomes. We examined young children's Medicaid enrollment patterns in a well-characterized cohort of child/caregivers dyads and investigated the association of caregivers' low health literacy with the incidence of enrollment gaps.<h4>Methods</h4>We relied upon Medicaid enrollment data for 1208 children (mean age?=?19 months) enrolled in the Carolina Oral Health Literacy project during 2008-09. The median follow-up was 25 months. Health literacy was measured using the Newest Vital Sign (NVS). Analyses relied on descriptive, bivariate, and multivariate methods based on Poisson modeling.<h4>Findings</h4>One-third of children experienced one or more enrollment gaps; most were short in duration (median?=?5 months). The risk of gaps was inversely associated with caregivers' age, with a 2% relative risk decrease for each added year. Low health literacy was associated with a modestly elevated risk increase [Incidence Rate Ratio (IRR)?=?1.17 (95% confidence interval (CI) 0.88-1.57)] for enrollment disruptions; however, this estimate was substantially elevated among caregivers with less than a high school education [IRR?=?1.52 (95% CI 0.99-2.35); homogeneity p<0.2].<h4>Conclusions</h4>Our findings provide initial support for a possible role of caregivers' health literacy as a determinant of children's Medicaid enrollment gaps. Although the association between health literacy and enrollment gaps was not confirmed statistically, we found that it was markedly stronger among caregivers with low educational attainment. This population, as well as young caregivers, may be the most vulnerable to the negative effects of low health literacy.
Project description:Importance:Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown. Objective:To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis. Design, Setting, and Participants:This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016. Main Outcomes and Measures:Perceived acceptability of the early enrollment strategy. Results:Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients' medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility. Conclusion and Relevance:Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.
Project description:<b>Background:</b> This paper explores how implementation and refinement of an early intervention (EI) program for children with delayed development was informed by an iterative, intentional and structured process of measurement. Providing access to early intervention therapy for children in rural areas of India is challenging due to a lack of rehabilitation therapists and programs. Following a biopsychosocial framework and principles of community-based rehabilitation, a non-governmental organization, Amar Seva Sangam (ASSA), overcame those barriers by designing a digital technology supported EI program in rural Tamil Nadu, India. Program objectives included providing service access; supporting program engagement, child development and school enrollment; and positioning the intervention for scale-up. This paper contributes to a growing body of literature on how program design and implementation can be informed through a cyclical process of data collection, analysis, reflection, and adaptation. <b>Methods:</b> Through several strands of data collection, the design and implementation of the EI program was adapted and improved. This included qualitative data from focus groups and interviews with caregivers and service providers, and a mobile application that collected and monitored longitudinal quantitative data, including program engagement rates, developmental progression, caregiver outcomes, and school enrollment status. <b>Results:</b> Measurements throughout the program informed decision-making by identifying facilitators and barriers to service providers' quality of work-life, family program engagement, and school enrollment. Consultation with key stakeholders, including caregivers and service providers, and data driven decision making led to continual program changes that improved service provider quality of work-life, program engagement and school enrollment. These changes included addressing gender-related work challenges for service providers; forming caregiver support networks; introducing psychological counseling for caregivers; providing medical consultations and assistive devices; creating community awareness programs; improving access to therapy services; focusing on caregiver education, motivation and support; and advocacy for accessibility in schools. <b>Conclusion:</b> The process of using evidence-informed and stakeholder driven adaptations to the early intervention program, led to improved service provider quality of work-life, greater program engagement, improved school enrollment and positioned the intervention for scale-up, providing lessons that may be beneficial in other contexts.
Project description:BACKGROUND AND OBJECTIVES:Medical specialty and subspecialty fellowship programs administer subject-specific in-training examinations to provide feedback about level of medical knowledge to fellows preparing for subsequent board certification. This study evaluated the association between the American Society of Nephrology In-Training Examination and the American Board of Internal Medicine Nephrology Certification Examination in terms of scores and passing status. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:The study included 1684 nephrology fellows who completed the American Society of Nephrology In-Training Examination in their second year of fellowship training between 2009 and 2014. Regression analysis examined the association between In-Training Examination and first-time Nephrology Certification Examination scores as well as passing status relative to other standardized assessments. RESULTS:This cohort included primarily men (62%) and international medical school graduates (62%), and fellows had an average age of 32 years old at the time of first completing the Nephrology Certification Examination. An overwhelming majority (89%) passed the Nephrology Certification on their first attempt. In-Training Examination scores showed the strongest association with first-time Nephrology Certification Examination scores, accounting for approximately 50% of the total explained variance in the model. Each SD increase in In-Training Examination scores was associated with a difference of 30 U (95% confidence interval, 27 to 33) in certification performance. In-Training Examination scores also were significantly associated with passing status on the Nephrology Certification Examination on the first attempt (odds ratio, 3.46 per SD difference in the In-Training Examination; 95% confidence interval, 2.68 to 4.54). An In-Training Examination threshold of 375, approximately 1 SD below the mean, yielded a positive predictive value of 0.92 and a negative predictive value of 0.50. CONCLUSIONS:American Society of Nephrology In-Training Examination performance is significantly associated with American Board of Internal Medicine Nephrology Certification Examination score and passing status.
Project description:Survey research is an important research method used to determine individuals' attitudes, knowledge, and behaviors; however, as with other research methods, inadequate reporting threatens the validity of results. This study aimed to describe the quality of reporting of surveys published between 2001 and 2011 in the field of nephrology.The top nephrology journals were systematically reviewed (2001-2011: American Journal of Kidney Diseases, Nephrology Dialysis Transplantation, and Kidney International; 2006-2011: Clinical Journal of the American Society of Nephrology) for studies whose primary objective was to collect and report survey results. Included were nephrology journals with a heavy focus on clinical research and high impact factors. All titles and abstracts were screened in duplicate. Surveys were excluded if they were part of a multimethod study, evaluated only psychometric characteristics, or used semi-structured interviews. Information was collected on survey and respondent characteristics, questionnaire development (e.g., pilot testing), psychometric characteristics (e.g., validity and reliability), survey methods used to optimize response rate (e.g., system of multiple contacts), and response rate.After a screening of 19,970 citations, 216 full-text articles were reviewed and 102 surveys were included. Approximately 85% of studies reported a response rate. Almost half of studies (46%) discussed how they developed their questionnaire and only a quarter of studies (28%) mentioned the validity or reliability of the questionnaire. The only characteristic that improved over the years was the proportion of articles reporting missing data (2001-2004: 46.4%; 2005-2008: 61.9%; and 2009-2011: 84.8%; respectively) (P<0.01).The quality of survey reporting in nephrology journals remains suboptimal. In particular, reporting of the validity and reliability of the questionnaire must be improved. Guidelines to improve survey reporting and increase transparency are clearly needed.