Reimbursement of Travel and Subsistence Expenses for Living Organ Donation (HRSA)
Quality Improvement Collaboratives
Childhood Liver Disease Research Network Data Coordinating Center (NIH)
National Hypertension Control Initiative – Technical Assistance, Data Collection, and Evaluation Program (HRSA)
Pancreatic Cancer Early Detection Consortium (TrovaNOW)
Worldwide Integration of Natural History Database-PSC Data Coordinating Center (PSC Partners)
Real-world Utilization of Tenapanor in the US Dialysis Setting (Ardelyx)
Post-Approval Safety Study of Vafseo® in the US Dialysis Setting (Akebia)
Optimizing Prevention of Peritoneal Dialysis-Associated Peritonitis in the United States (AHRQ)
Registry of European Hemodialysis Patients Prescribed Difelikefalin for CKD-associated Pruritus (CSL Vifor)
Leveraging over 20 years of experience, Arbor Research supports multiple Collaborative Quality Initiatives (CQIs) to improve healthcare across practice areas. For each CQI, multiple measures of outcomes and appropriate processes of care are calculated and published to track attainment of best practices. Measures are used by champions at each provider to understand opportunities for improvement, share best approaches, and reward providers using value-based purchasing models.
Leveraging over 20 years of experience, Arbor Research supports multiple Collaborative Quality Initiatives (CQIs) to improve healthcare across practice areas. For each CQI, multiple measures of outcomes and appropriate processes of care are calculated and published to track attainment of best practices. Measures are used by champions at each provider to understand opportunities for improvement, share best approaches, and reward providers using value-based purchasing models.
Arbor Research works with teams from the University of Michigan and providers across the state in the Michigan Emergency Department Improvement Collaborative (MEDIC, since 2020), Michigan Oncology Quality Consortium (MOQC, since 2021), and Michigan Urological Surgery Improvement Collaborative (MUSIC, since 2023). Arbor Research supports these collaboratives by providing its ArborLink secure data platform for abstraction of information, including ingestion of Electronic Health Records where available. ArborLink is designed to be specifically responsive to the data capture needs of each collaborative, and to assemble data as evidence for best practices associated with improved patient outcomes. We manage data quality, calculate measure attainment, and securely publish performance dashboards used by the collaborative as a whole and by individual providers. Physician Champions and other provider staff can drill-in to explore opportunities for population subgroups.
Arbor Research is partnering with the University of Michigan Department of Emergency Medicine as a vendor to implement a leading-edge Software as a Service (SaaS) clinical registry and abstraction platform to support the Michigan Emergency Department Improvement Collaborative (MEDIC). MEDIC is an integrated adult and pediatric, emergency medicine led, hospital-based Collaborative Quality Initiative (CQI) sponsored by Blue Cross Blue Shield of Michigan.
As an organization, their goal is to encourage, respond to, and initiate change whenever and wherever it will help them excel. Arbor strives to cultivate a challenging, stimulating, and supportive environment, where their employees are expected to be inquisitive, take initiative, and demonstrate ingenuity.
Joan Williams, BioPharma Research, LLCSupporting these initiatives, Arbor Research programming staff combine expertise in application design and development, measure development, and data visualization. With an interactive reporting platform informed by experience in developing and communicating quality measures, we empower caregivers with efficient tools for data aggregation, interpretation, and communication; letting them focus their energy on improving patient care.
Project Personnel
Publications and Reports
The vision of Primary Sclerosing Cholangitis (PSC) Partners Seeking a Cure was to create an observational data set collected to rigorous standards that will hold up to US Food and Drug Administration (FDA) scrutiny as part of an interventional study.
PSC Partners’ leadership drew on their decades of experience conducting interventional studies, particularly the adjudication of clinical outcome events and clinical safety events deemed to be study-related. Typically, an event is recorded, then assessed to determine whether the event is serious and/or PSC-related. Coders classify that event using the Medical Dictionary for Regulatory Activities (MedDRA). In the experience of PSC Partners leadership, the logging of such events typically involved recording on spreadsheets.
Arbor Research suggested that the various contributors to the logging and assessing of these events could instead collaborate directly within Arbor Research’s proprietary data capture and management system, ArborLink. Because the events are entered into ArborLink, they are automatically integrated with other collected data. During a contributor’s editing session, they can also query other parts of the patient’s record, such as current medications, to assist with proper classification.
This implementation delighted our client, exceeding expectations.
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Publications and Press Releases
Project Personnel
Through a National Institutes of Health (NIH) cooperative agreement, the Childhood Liver Disease Research Network (ChiLDReN) addresses a high-priority research area with substantial involvement from NIH scientific staff at the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK).
NIDDK supports ChiLDReN to advance scientific knowledge and engender practice improvements for the treatment of rare pediatric liver diseases. For example, ChiLDReN developed a working definition for clinically evident portal hypertension, an important indicator of disease progression. In collaboration with the International Consortium for Innovation and Quality in Pharmaceutical Development initiative on drug-induced liver injury, ChiLDReN developed custom monitoring and stopping criteria for patients with biliary atresia participating in clinical trials.
The deep knowledge of data collected in ChiLDReN’s numerous protocols positions Arbor Research to advise clinical investigators on feasible data elements, trends evident in the data, and analytical pitfalls. Thus, the guidance issued to practitioners is useful and implementable.
Arbor Research manages all study data, creates data dictionaries and SAS data sets for use internally and externally, and has completed analyses of study data, resulting in 95 publications.
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Publications and Press Releases
Project Personnel
Arbor Research designed and carried out a mixed methods evaluation that examined implementation and performance among a subgroup of health centers participating in the US Health Resources and Services Administration’s (HRSA’s) National Hypertension Control Initiative (NHCI). NHCI sought to improve hypertension control among patients in historically underserved communities by implementing evidence-based practices and use of self-measured blood pressure (SMBP) technology. Arbor Research examined two key challenges faced by program participants—how to enroll and engage underserved patient populations in SMBP programs and how to assure adequate BP data transmission from these devices back to health care providers. Evaluation data were used to inform technical assistance efforts. Arbor Research focused on helping health centers navigate these problems and share best practices to successfully use SMBP technology for improved hypertension control. Arbor Research also examined programmatic impact, including associations between program participation and rates of BP control. Final analyses showed that the median BP control in participating health centers improved significantly, from 29% at the start to 59% by the end of the initiative.
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Publications and Press Releases
Project Personnel
We developed and maintain a public website to disseminate its mission, objectives, background, key personnel, and contact information, as well as a secured, password-protected web portal for management of the creation, progress, and approval of NLDAC reimbursement applications. We assist with website content creation, including videos and web-based surveys, developed based on team expertise, existing literature, user feedback and testing, and collaborative input from HRSA.
We also support the project with quantitative and qualitative data analysis and mixed methods research. Our team has conducted focus groups with transplant center staff to identify best practices and pain points with regard to program implementation and usage and has conducted interviews with living organ donors and those considering organ donation on decision making and the facilitators and barriers to organ donation.
The primary objective of the Lost Wages project is to assess the effect of reimbursement of lost wages on the decision of individuals to initiate evaluation for living organ donation. This project will also inform the US Health Resources and Services Administration (HRSA) on the most effective and efficient mechanism to provide this support to living donors.
Arbor Research coordinated the IRB submission for the study, designed the protocol, and developed communication materials and the program application.
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Publications and Press Releases
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Arbor Research supported formation of the largest global effort for early detection of pancreatic cancer. To date, the Pancreatic Cancer Early Detection (PRECEDE) Consortium consists of over 50 participating cancer centers and has recruited more than 7,000 participants for the standardized longitudinal collection of clinical, demographic, genetic, family history, behavioral, and imaging data, paired with serial biospecimens. Academic and industry collaborators partner with PRECEDE to use these resources in early detection imaging and biomarker .
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Publications and Press Releases
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Real-world evidence (RWE) studies are crucial for newly approved medications. Randomized controlled trials (RCTs) are the gold standard for evidence when testing efficacy. Real-world studies allow understanding of how the medication is used in everyday clinical practice and how adherence may impact effectiveness. Real world studies complement RCT data by addressing gaps and offering insights that are critical for patients, healthcare providers, regulators, and policymakers.
With support from Ardelyx, Arbor Research is investigating several aspects of real-world utilization of tenapanor (Xphozah®), a medication recently approved by the United States Food and Drug Administration (FDA) to treat hyperphosphatemia in dialysis patients. With access to large databases of electronic health record (EHR) data representing over 45,000 dialysis patients and multiple dialysis providers in the US, Arbor Research is well-positioned to identify and analyze over 1,000 tenapanor initiators within one year of approval. The goals of this study are two-fold:
- Part 1: In a single arm study of tenapanor initiators, characterize real-world utilization – including rate of uptake, characteristics of initiators, dose trajectories, time on therapy, concomitant phosphate binder utilization, and overall phosphate-lowering pill burden – and investigate short-term effectiveness in lowering serum phosphorus levels.
- Part 2: Compare real-world effectiveness of tenapanor to traditional phosphate binder therapy by utilizing an active comparator arm of patients already using a traditional phosphate binder and initiating use of another non-tenapanor phosphate binder.
Arbor Research has the technical capabilities to not only carry out these analyses reliably and efficiently, but to do so with a very large database reflecting a unique combination of US dialysis provider EHRs with minimal lag time (<1 month) from measurement to analysis. Arbor Research is well-experienced working with sponsors to investigate a variety of aspects of real-world utilization for newly approved medications, including treatment patterns (Karaboyas 2022 AJKD) and comparative effectiveness (Karaboyas 2022 Kidney Medicine).
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Publications and Press Releases
Project Personnel
Post Authorization Safety Studies (PASS) are crucial for newly approved medications. While randomized controlled trials (RCTs) are the gold standard for evidence when testing efficacy, small sample sizes and short follow-up periods limit their ability to fully evaluate safety profiles for rare events or side effects that may take years to develop. A PASS can complement RCT data by offering key safety insights that are critical for patients, healthcare providers, regulators, and policymakers. A PASS is often required by the United States Food and Drug Administration (FDA) for newly approved medications.
With support from Akebia, Arbor Research is fulfilling the FDA requirements for a PASS by evaluating the long-term safety profile of vadadustat (Vafseo®), a medication recently approved for treatment of anemia in dialysis patients. With access to CMS claims data – including well over 150,000 US dialysis patients per year with Medicare Fee-For-Service coverage – Arbor Research is identifying vadadustat initiators and assessing their rate and cumulative incidence of safety outcomes including cancer, vascular access thrombosis, heart failure, and GI bleeds for up to 5 years of follow-up. Arbor Research is will also investigate comparative safety vs. erythropoietin stimulating agents, the standard of care for treating anemia in the dialysis setting, using complex biostatistical methods to limit confounding by indication bias. In addition to the FDA-mandated safety outcomes, Arbor Research will also report several aspects of real-world utilization, including characteristics of vadadustat initiators, frequency of administration, dose trajectory, and time to discontinuation.
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Publications and Press Releases
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Treatment registries are crucial to investigate a number of aspects of medication utilization that are often not possible in randomized clinical trials with limited sample sizes and durations. Registries can generate valuable data on how drugs are utilized in routine clinical practice, helping optimize treatment strategies to improve patient outcomes. Real-world effectiveness can be assessed – including the potential for comparative effectiveness using an external control group – to complement randomized trial data. Further, this post-marketing surveillance allows for longer-term monitoring of drug safety in a real-world setting, aiding in evaluation of potential adverse events, and ultimately the risk-benefit profile. Together, these treatment registry data can play an important role in advancing medical knowledge by evaluating utilization patterns, safety, and effectiveness of newly approved medications, and can provide supporting evidence for label changes and regulatory decision-making.
With support from CSL-Vifor, Arbor Research is well-positioned to design and create this registry of difelikefalin (DFK; Kapruvia®) users in European hemodialysis (HD) facilities. Arbor Research has 25+ years of experience administering the Dialysis Outcome and Practice Patterns Study (DOPPS), a prospective cohort study of HD patients across 20+ countries, which required primary data collection at over 100 European HD facilities. DOPPS included descriptive baseline data on demographics and comorbidity history, and rich longitudinal data on medication prescriptions, laboratory values, and prospective follow-up for mortality and hospitalizations. Our clinical investigator contacts and staff expertise can be leveraged to carry out primary data collection in the dialysis and non-dialysis CKD setting.
For this treatment registry of DFK users, we will target enrollment of at least 400 patients initiating DFK therapy at European HD sites between 2025-2028. Follow-up will continue for a minimum 12 months – and beyond for patients who remain on therapy – with regular assessment of patient-reported outcomes (PROs) and extraction of medical records for case-mix information, prescription records, and laboratory values. Scientific objectives of the registry include (1) characterization of users, (2) exploration of treatment patterns, (3) real-world effectiveness, (4) safety, and (5) healthcare resource utilization (HCRU) patterns. These data can help understand key aspects of DFK utilization and management of itch severity.
Arbor Research has demonstrated expertise, experience, and capabilities to successfully execute this treatment registry, including:
- long-standing relationships with nephrologists and clinical investigators in leadership positions at dialysis provider organizations across Europe
- navigation of legal and administrative hurdles to gain ethics approval across a number of individual European countries;
- proprietary ArborLink system to capture and upload data from questionnaires administered directly to patients via paper or electronically (phone/tablet/laptop);
- programming expertise to seamlessly create analysis-ready files from the raw data
- the biostat/epi expertise to design the study and questionnaires, and to identify and implement the appropriate methods to carry out the analyses;
- and the clinical/nephrology leadership in designing and executing the registry, with senior staff in prominent positions to promote the registry via social media and scientific/nephrology conference presentations
Given past performance and current capabilities, Arbor Research is well-positioned to design, create, and carry out registries – particularly in the nephrology space thanks to our credibility and long-standing relationships built on the DOPPS foundation.
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Publications and Press Releases
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The US currently does not have comprehensive, standardized reporting of PD-related peritonitis. Without standardized reporting, it is difficult to compare peritonitis rates, microbiology, and outcomes between dialysis facilities. Being able to compare such data between providers would ultimately lead to the ability to identify patient and facility characteristics that affect peritonitis risk and eventually the establishment of best clinical practices and benchmarks that would lead to the reduction in PD-related peritonitis. The OPPUS project demonstrated the feasibility of standardized, uniform peritonitis reporting over 1 year in a diverse sample of 54 US-based PD facilities that could be expanded to the US PD population. The operation of this OPPUS Peritonitis Tracker Pilot Study was facilitated by Arbor Research’s development of an ArborLink-based data collection platform (OPPUSLink) that was customized for this project.
This study resulted in 12 publications, including ones that demonstrated large inter-facility variation in peritonitis rates across 103 US-based PD facilities. US peritonitis rates were higher with younger age, diabetes, by race (Black>White>Asian), or having prior peritonitis episode(s). Peritonitis cure differed greatly between certain types of typically used antibiotics. Numerous new relationships with peritonitis and related outcomes were discovered regarding other patient-, facility-, and treatment-related factors.
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Publications and Press Releases
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- Ronald Pisoni, PhD, MS Distinguished Research Scientist
- Jeffrey Perl, MD, MS