Clinical Outcome Assessments and Digital Health Technologies Supporting Clinical Trial Endpoints in Early Parkinson's Disease: Roundtable Proceedings and Roadmap for Research.

This article summarizes the Parkinson's Disease (PD) Endpoints Roundtable, which was held in Washington, D.C., on November 2-3, 2022, and hosted by The Michael J. Fox Foundation for Parkinson's Research, Parkinson's UK, and Parkinson Canada. This event brought representatives from academia and industry together with those from regulatory agencies, community partners, and research funders to discuss challenges in clinical outcome assessment development for treatments in early PD and to identify priorities for the field and opportunities for collaboration. This article provides a summary of the presentations given and topics discussed at the roundtable and synthesizes the discussions about the development of clinical outcome assessments and the use of digital health technologies for developing clinical trial endpoints.

Monitoring Practices After Pediatric Liver Transplantation.

OBJECTIVES: This study sought to understand the current monitoring practices after pediatric liver transplantation (LT), specifically regarding follow-up clinic visits, outpatient laboratory testing, protocol biopsies, and diagnostic imaging, and to identify potential center and provider characteristics associated with such practices. METHODS: A cross-sectional survey of pediatric LT providers at centers participating in the Society of Pediatric Liver Transplantation (SPLIT) registry was conducted from February 2020 to April 2021. RESULTS: The overall response rate was 79% (38/48 SPLIT centers), with the majority representing large volume centers (>10 LTs per year). Frequency of clinic visits and laboratory monitoring varied by center, but all centers decreased frequency after the first post-transplant year. The most common practice included an annual clinic visit and laboratory sampling every 2-3 months. Surveillance liver biopsy is seldom done during the first post-transplant year, while being routinely performed by 50% of centers after this time period. Centers forgoing surveillance biopsies assert that the results would likely not change management. Only 39% of centers have a hepatologist perform the liver biopsy while the remaining centers consult interventional radiology. Most diagnostic imaging is obtained only as needed. Routine abdominal ultrasounds were obtained by only 50% of responding centers after the first year post-transplant. CONCLUSIONS: SPLIT centers vary widely in the routine management of LTs after the first year post-transplant. While common themes emerge, future studies will be needed to connect protocols to outcomes to determine best practice.

Diagnostic role of fractional exhaled nitric oxide in pediatric eosinophilic esophagitis, relationship with gastric and duodenal eosinophils.

BACKGROUND: Eosinophilic esophagitis (EoE) is an eosinophilic-predominant inflammation of the esophagus diagnosed by upper endoscopy and biopsies. A non-invasive and cost-effective alternative for management of EoE is being researched. Previous studies assessing utility of fractional exhaled nitric oxide (FeNO) in EoE were low powered. None investigated the contribution of eosinophilic inflammation of the stomach and duodenum to FeNO. AIM: To assess the utility of FeNO as a non-invasive biomarker of esophageal eosinophilic inflammation for monitoring disease activity. METHODS: Patients aged 6-21 years undergoing scheduled upper endoscopy with biopsy for suspected EoE were recruited in our observational study. Patients on steroids and with persistent asthma requiring daily controller medication were excluded. FeNO measurements were obtained in duplicate using a chemiluminescence nitric oxide analyzer (NIOX MINO, Aerocrine, Inc.; Stockholm, Sweden) prior to endoscopy. Based on the esophageal peak eosinophil count (PEC)/high power field on biopsy, patients were classified as EoE (PEC ≥ 15) or control (PEC ≤ 14). Mean FeNO levels were correlated with presence or absence of EoE, eosinophil counts on esophageal biopsy, and abnormal downstream eosinophilia in the stomach (PEC ≥ 10) and duodenum (PEC ≥ 20). Wilcoxon rank-sum test, Spearman correlation, and logistic regression were used for analysis. P value < 0.05 was considered significant. RESULTS: We recruited a total of 134 patients, of which 45 were diagnosed with EoE by histopathology. The median interquartile range FeNO level was 17 parts per billion (11-37, range: 7-81) in the EoE group and 12 parts per billion (8-19, range: 5-71) in the control group. After adjusting for atopic diseases, EoE patients had significantly higher FeNO levels as compared to patients without EoE (Z = 3.33, P < 0.001). A weak yet statistically significant positive association was found between the number of esophageal eosinophils and FeNO levels (r = 0.30, P < 0.005). On subgroup analysis within the EoE cohort, higher FeNO levels were noted in patients with abnormal gastric (n = 23, 18 vs 15) and duodenal eosinophilia (n = 28, 21 vs 14); however, the difference was not statistically significant. CONCLUSION: After ruling out atopy as possible confounder, we found significantly higher FeNO levels in the EoE cohort than in the control group.

The effect of neuropsychiatric medication on pediatric nonalcoholic fatty liver disease.

Obese and overweight children are at risk of developing nonalcoholic fatty liver disease (NAFLD), which can lead to steatohepatitis, cirrhosis, and liver transplantation. Neuropsychiatric conditions affect an increasing proportion of children and often require neuropsychiatric medications (NPMs) that are associated with weight gain and/or drug-induced liver injury. We sought to evaluate the role that the extended use of NPMs play in pediatric NAFLD. Medical chart review was conducted for 260 patients with NAFLD (NPM = 77, non-NPM = 183) seen in the Liver Care Center at Children's Mercy Hospital between 2000 and 2016. Outcome measures included body mass index (BMI) percentile, BMI z-score, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and gamma glutamyltransferase, and were collected at diagnosis, 6-18 month follow-up, and 18-36 months. Controlling for race and metformin, there was a significant increase over time in BMI z-score (p < 0.01) and total bilirubin (p = 0.03), with only initial decreases in ALT (p < 0.01) and AST (p < 0.01). Except for higher total bilirubin in the non-NPM group, no main effect of group or interaction effect was found. Similar patterns remained when subjects were analyzed by NPM drug class. Further study is needed to confirm these findings and to evaluate the effects of NPM dose and duration of exposure, by drug class, on pediatric NAFLD outcomes.

Health and Social Services in Puerto Rico Before and After Hurricane Maria: Predisaster Conditions, Hurricane Damage, and Themes for Recovery.

"In September 2017, Puerto Rico was struck by two major hurricanes-Irma and Maria-that intensified existing challenges in Puerto Rico's health and social services infrastructure. In the aftermath, the government of Puerto Rico created a long-term recovery plan built on an evidence-based assessment of the damage from the hurricanes and the ongoing needs across Puerto Rico. Development of the recovery plan was supported by the Federal Emergency Management Agency, other federal agencies, local stakeholders, and analysis from the Homeland Security Operational Analysis Center (HSOAC), operated by RAND Corporation under contract with the U.S. Department of Homeland Security. HSOAC research provided the foundation for the 31 courses of action in the recovery plan addressing the health and social services sector. These actions are a mix of social, governmental, fiscal, and economic policies and reforms. This collection of actions presents an opportunity to build a more resilient health and social services infrastructure and regional health care networks to ensure reliable access to services, promote health and well-being, and more efficiently and effectively respond to public health crises and future disasters. The actions span the areas of health care, public health and emergency preparedness, environmental health, mental and behavioral health, and social services. The damage and needs assessment and courses of actions cover four major themes: building system capacity to respond both during disasters and routine times; strengthening the health and social services workforce; strengthening support services for at-need populations; and creating health-promoting communities.

Adherence to laboratory testing in pediatric liver transplant recipients.

BACKGROUND: The objectives of this retrospective cohort study are to describe rates of adherence to laboratory testing 6 months to 3 years post-liver transplantation and to examine demographic and clinical factors related to lab non-adherence and the association with medication adherence and clinical outcomes. METHODS: Medical chart review was conducted for 54 youth (mean age = 5.0 years) transplanted between 2003 and 2014. Lab adherence (≥80%) was measured as the proportion of completed labs out of the number expected. Immunosuppressant drug-level variability was used as a proxy for medication adherence. Clinical outcomes included LAR, viral infection, hospitalization, and non-routine clinic visit ≥12 months after transplant. RESULTS: Lab adherence decreased substantially over time. Single-parent household (aOR 5.86; 95% CI: 1.38-24.93) and no history of early rejection (aOR 3.96; 95% CI: 1.04-15.24) were independently associated with non-adherence. Lab non-adherence was significantly associated with medication non-adherence (P < .05), LAR (P = .02), and non-routine clinic visits (P = .03). CONCLUSIONS: Systematic monitoring of lab adherence may help in identifying pediatric LT recipients at increased risk for excessive healthcare use and adverse outcomes possibly due to poor disease management.

Association of Primary and Specialty Care Integration on Physician Communication and Cancer Screening in Safety-Net Clinics.

INTRODUCTION: Primary care providers who lack reliable referral relationships with specialists may be less likely than those who do have such relationships to conduct cancer screenings. Community health centers (CHCs), which provide primary care to disadvantaged populations, have historically reported difficulty accessing specialty care for their patients. This study aimed to describe strategies CHCs use to integrate care with specialists and examine whether more strongly integrated CHCs have higher rates of screening for colorectal and cervical cancers and report better communication with specialists. METHODS: Using a 2017 survey of CHCs in 12 states and the District of Columbia and administrative data, we estimated the association between a composite measure of CHC/specialist integration and 1) colorectal and cervical cancer screening rates, and 2) 4 measures of CHC/specialist communication using multivariate regression models. RESULTS: Integration strategies commonly reported by CHCs included having specialists deliver care on-site (80%) and establishing referral agreements with specialists (70%). CHCs that were most integrated with specialists had 5.6 and 6.8 percentage-point higher colorectal and cervical cancer screening rates, respectively, than the least integrated CHCs (P < .05). They also had significantly higher rates of knowing that specialist visits happened (67% vs 42%), knowing visit outcomes (65% vs 42%), receiving information after visits (47% vs 21%), and timely receipt of information (44% vs 27%). CONCLUSION: CHCs use various strategies to integrate primary and specialty care. Efforts to promote CHC/specialist integration may help increase rates of cancer screening.

Effects of Health Care Payment Models on Physician Practice in the United States: Follow-Up Study.

This study, sponsored by the American Medical Association (AMA), describes how alternative payment models (APMs) affect physicians, physicians' practices, and hospital systems in the United States and also provides updated data to the original 2014 study. Payment models discussed are core payment (fee for service, capitation, episode-based and bundled), supplementary payment (shared savings, pay for performance, retainer-based), and combined payment (medical homes and accountable care organizations). The effects of changes since 2014 in the Affordable Care Act (ACA) and of new alternative payment models (APMs), such as the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program (QPP), are also examined. This project uses the same qualitative multiple-case study method as the 2014 study, relying primarily on semistructured interviews with physician practice leaders, physicians, and other observers. Findings describe the challenges posed by APMs, strategies adopted to deal with APMs, the effects of rapidly changing and increasingly complex payment models, and how risk aversion influences physician practices' decisions to engage in new payment models. Project findings are intended to help guide efforts by the AMA and other stakeholders to improve current and future APMs and help physician practices succeed in them.

Conservative Management of Pneumatosis Intestinalis and Portal Venous Gas After Pediatric Liver Transplantation.

BACKGROUND: Pneumatosis intestinalis (PI) is a rare pathologic finding in pediatric liver transplant (PLT) recipients. The presentation and course of PI can range from asymptomatic and clinically benign to life threatening, with no consensus regarding management of PI in children. We aim to review the clinical presentation and radiologic features of PLT recipients with PI and to report the results of conservative management. METHODS: A retrospective medical chart review was conducted on PLT recipients between November 1995 and May 2016. Parameters evaluated at PI diagnosis included pneumatosis location, presence of free air or portal venous gas (PVG), symptoms, laboratory findings, and medication regimen. RESULTS: PI developed in 10 of 130 PLT patients (7.7%) between 8 days and 7 years (median: 113 days) posttransplant. Five of the patients were male, and the median age was 2 years (range, 1-17 years). PI was located in 1 to 2 abdominal quadrants in 6 patients, and 3 patients had PVG. At diagnosis, all patients were on steroids and immunosuppressant medication and 6 patients had a concurrent infection. Laboratory findings were unremarkable. Symptoms were present in 7 patients. Nine patients were managed conservatively, and 1 patient received observation only. All patients had resolution of PI at a median of 7 days (range, 2-14 days). CONCLUSIONS: PI can occur at any time after PLT and appears to be associated with steroid use and infectious agents. If PI/PVG is identified and the patient is clinically stable, initiation of a standard management algorithm may help treat these patients conservatively, thus avoiding surgical intervention.

The New Xpert MTB/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing.

The Xpert MTB/RIF assay (Xpert) is a rapid test for tuberculosis (TB) and rifampin resistance (RIF-R) suitable for point-of-care testing. However, it has decreased sensitivity in smear-negative sputum, and false identification of RIF-R occasionally occurs. We developed the Xpert MTB/RIF Ultra assay (Ultra) to improve performance. Ultra and Xpert limits of detection (LOD), dynamic ranges, and RIF-R rpoB mutation detection were tested on Mycobacterium tuberculosis DNA or sputum samples spiked with known numbers of M. tuberculosis H37Rv or Mycobacterium bovis BCG CFU. Frozen and prospectively collected clinical samples from patients suspected of having TB, with and without culture-confirmed TB, were also tested. For M. tuberculosis H37Rv, the LOD was 15.6 CFU/ml of sputum for Ultra versus 112.6 CFU/ml of sputum for Xpert, and for M. bovis BCG, it was 143.4 CFU/ml of sputum for Ultra versus 344 CFU/ml of sputum for Xpert. Ultra resulted in no false-positive RIF-R specimens, while Xpert resulted in two false-positive RIF-R specimens. All RIF-R-associated M. tuberculosis rpoB mutations tested were identified by Ultra. Testing on clinical sputum samples, Ultra versus Xpert, resulted in an overall sensitivity of 87.5% (95% confidence interval [CI], 82.1, 91.7) versus 81.0% (95% CI, 74.9, 86.2) and a sensitivity on sputum smear-negative samples of 78.9% (95% CI, 70.0, 86.1) versus 66.1% (95% CI, 56.4, 74.9). Both tests had a specificity of 98.7% (95% CI, 93.0, 100), and both had comparable accuracies for detection of RIF-R in these samples. Ultra should significantly improve TB detection, especially in patients with paucibacillary disease, and may provide more-reliable RIF-R detection.IMPORTANCE The Xpert MTB/RIF assay (Xpert), the first point-of-care assay for tuberculosis (TB), was endorsed by the World Health Organization in December 2010. Since then, 23 million Xpert tests have been procured in 130 countries. Although Xpert showed high overall sensitivity and specificity with pulmonary samples, its sensitivity has been lower with smear-negative pulmonary samples and extrapulmonary samples. In addition, the prediction of rifampin resistance (RIF-R) in paucibacillary samples and for a few rpoB mutations has resulted in both false-positive and false-negative results. The present study is the first demonstration of the design features and operational characteristics of an improved Xpert Ultra assay. This study also shows that the Ultra format overcomes many of the known shortcomings of Xpert. The new assay should significantly improve TB detection, especially in patients with paucibacillary disease, and provide more-reliable detection of RIF-R.

How High-Need Patients Experience Health Care in the United States. Findings from the 2016 Commonwealth Fund Survey of High-Need Patients.

Issue: Health care costs are highly concentrated among people with multiple chronic conditions, behavioral health problems, and those with physical limitations or disabilities. With a better understanding of these patients' challenges, health care systems and providers can address patients' complex social, behavioral, and medical needs more effectively and efficiently. Goal: To investigate how the challenges faced by this population affect their experiences with the health care system and examine potential opportunities for improvement. Methods: Analysis of the 2016 Commonwealth Fund Survey of High-Need Patients, June­September 2016. Key findings and conclusions: The health care system is currently failing to meet the complex needs of these patients. High-need patients have greater unmet behavioral health and social issues than do other adults and require greater support to help manage their complex medical and nonmedical requirements. Results indicate that with better access to care and good patient­provider communication, high-need patients are less likely to delay essential care and less likely to go to the emergency department for nonurgent care, and thus less likely to accrue avoidable costs. For health systems to improve outcomes and lower costs, they must assess patients' comprehensive needs, increase access to care, and improve how they communicate with patients.

Errors and Nonadherence in Pediatric Oral Chemotherapy Use.

BACKGROUND: Nonadherence and medication error both limit the effectiveness of oral chemotherapy. The overlap between nonadherence and medication error is not well studied in children, and interventions strategies differ for each. Our objective was to describe nonadherence and errors in children with cancer to inform future interventions. METHODS: Nonadherence was measured using two self-report tools. Medication error was measured using medication review and observation of administration at home. Two clinicians made judgments about whether each error also represented an episode of nonadherence. RESULTS: Of 72 errors detected in 92 home visits, 27 were also instances of nonadherence. For example, parents gave a child 1 tablet of mercaptopurine every day rather than the prescribed 1 tablet 5 days a week and ½ tablet on weekends. Clinician reviewers judged that family interventions and health system interventions would be most effective in preventing the errors and nonadherence identified in this population of children with cancer. DISCUSSION: The relationship between medication errors and nonadherence is not well described in the literature. Our data indicate that medication error and nonadherence coexist in the same population and in the same patient. Interventions should address both to most effectively support self-management.

Child Attitude Toward Illness Scale (CATIS): A systematic review of the literature.

OBJECTIVE: The objective of this study was to systematically review the literature utilizing the Child Attitude Toward Illness Scale (CATIS) as a measure of illness attitudes within pediatric chronic illness, including epilepsy, and provide recommendations for its use. This review includes an examination of the psychometric properties of the CATIS and the relationship between the CATIS and psychological, academic, behavioral, and illness variables. METHOD: Electronic searches were conducted using Medline and PsychINFO to identify twenty-two relevant publications. RESULTS: The CATIS was identified as a reliable and valid self-report assessment tool across chronic illnesses, including pediatric epilepsy. Although originally developed for children ages 8-12, the CATIS has demonstrated reliability and validity in youth ages 8-22. The CATIS scores were reliably associated with cognitive appraisal variables and internalizing symptoms. Initial support exists for the relation between illness attitudes and externalizing behavior, academic functioning, and psychosocial care needs. Mixed findings were reported with regard to the relation between illness attitudes and demographic and disease variables, as well as both social and family functioning. CONCLUSION: The CATIS is a psychometrically sound self-report instrument for measuring illness attitudes and demonstrates clinical utility for examining adjustment outcomes across chronic illnesses, particularly pediatric epilepsy.

Effect of Oral Lipid Matrix Supplement on Fat Absorption in Cystic Fibrosis: A Randomized Placebo-Controlled Trial.

Pancreatic enzyme therapy does not normalize dietary fat absorption in patients with cystic fibrosis and pancreatic insufficiency. Efficacy of LYM-X-SORB (LXS), an easily absorbable lipid matrix that enhances fat absorption, was evaluated in a 12-month randomized, double-blinded, placebo-controlled trial with plasma fatty acids (FA) and coefficient of fat absorption (CFA) outcomes. A total of 110 subjects (age 10.4 ±â€Š3.0 years) were randomized. Total FA increased with LXS at 3 and 12 months (+1.58, +1.14 mmol/L) and not with placebo (P = 0.046). With LXS, linoleic acid (LA) increased at 3 and 12 months (+298, +175 nmol/mL, P ≤ 0.046), with a 6% increase in CFA (P < 0.01). LA increase was significant in LXS versus placebo (445 vs 42 nmol/mL, P = 0.038). Increased FA and LA predicted increased body mass index Z scores. In summary, the LXS treatment improved dietary fat absorption compared with placebo as indicated by plasma FA and LA and was associated with better growth status.

How High-Need Patients Experiences the Health Care System in Nine Countries.

U.S. health care costs are disproportionately concentrated among older adults with multiple chronic conditions or functional limitations--a population often referred to as "high-need" patients. This analysis uses data from the Commonwealth Fund 2014 International Health Policy Survey of Older Adults to investigate health care use, quality, and experiences among high-need patients in nine countries compared with other older adults. High-need patients use a greater amount of health care services and also experience more coordination problems and financial barriers to care compared with other older adults. Disparities are particularly pronounced in the United States. The comparative success of other countries, particularly in reducing financial barriers to care, may be a product of policies that specifically target high-need patients. Similarly focusing on these populations in the U.S. and effectively managing their care may improve their health status while reducing overall costs.

Quality of Life Changes and Health Care Charges Among Youth With Epilepsy.

OBJECTIVE: To examine differences in health care charges following a pediatric epilepsy diagnosis based on changes in health-related quality of life (HRQOL). METHODS: Billing records were obtained for 171 youth [M (SD) age = 8.9 (4.1) years] newly diagnosed with epilepsy. Differences in health care charges among HRQOL groups (stable low, declining, improving, or stable high as determined by PedsQL(™) scores at diagnosis and 12 months after diagnosis) were examined. RESULTS: Patients with persistently low or declining HRQOL incurred higher total health care charges in the year following diagnosis (g = .49, g = .81) than patients with stable high HRQOL after controlling for epilepsy etiology, seizure occurrence, and insurance type. These relationships remained consistent after excluding health care charges for behavioral medicine or neuropsychology services (g = .49, g = .80). CONCLUSIONS: Monitoring HRQOL over time may identify youth with epilepsy at particular risk for higher health care charges.

Models of Care for High-Need, High-Cost Patients: An Evidence Synthesis.

This brief analyzes experts' reviews of evidence about care models designed to improve outcomes and reduce costs for patients with complex needs. It finds that successful models have several common attributes: targeting patients likely to benefit from the intervention; comprehensively assessing patients' risks and needs; relying on evidence-based care planning and patient monitoring; promoting patient and family engagement in self-care; coordinating care and communication among patients and providers; facilitating transitions from the hospital and referrals to community resources; and providing appropriate care in accordance with patients' preferences. Overall, the evidence of impact is modest and few of these models have been widely adopted in practice because of barriers, such as a lack of supportive financial incentives under fee-for-service reimbursement arrangements. Overcoming these challenges will be essential to achieving a higher-performing health care system for this patient population.

How Strong Is the Primary Care Safety Net? Assessing the Ability of Federally Qualified Health Centers to Serve as Patient-Centered Medical Homes.

By expanding access to affordable insurance coverage for millions of Americans, the Affordable Care Act will likely increase demand for the services provided by federally qualified health centers (FQHCs), which provide an important source of care in low-income communities. A pair of Commonwealth Fund surveys asked health center leaders about their ability to function as medical homes. Survey findings show that between 2009 and 2013, the percentage of centers exhibiting medium or high levels of medical home capability almost doubled, from 32 percent to 62 percent. The greatest improvement was reported in patient tracking and care management. Despite this increased capability, health centers reported diminished ability to coordinate care with providers outside of the practice, particularly specialists. Ongoing federal funding and technical support for medical home transformation will be needed to ensure that FQHCs can fulfill their mission of providing high-quality, comprehensive care to low-income and minority populations.

Health care charges for youth with newly diagnosed epilepsy.

OBJECTIVES: To estimate first-year health care charges for youth with newly diagnosed epilepsy seen within an interdisciplinary pediatric epilepsy team and examine demographic, clinical, and psychosocial predictors of annual charges. METHODS: Retrospective chart review was conducted to extract medical, hospital, and physician billing data from the year following an epilepsy diagnosis for 258 patients (aged 2-18 years) seen in a New Onset Seizure Clinic between July 2011 and December 2012. Descriptive statistics were used to estimate per-patient total first-year charges and health care utilization patterns (e.g., hospitalizations, emergency department visits, outpatient visits). Univariate analyses examined differences in health care charges between demographic, clinical, and psychosocial factors. Predictors of health care charges were examined using hierarchical multiple regression analysis. RESULTS: The estimated per-patient total first-year health care charge was $20,084 (95% confidence interval [CI] $16,491-$23,677). Charges were higher for patients who reported having seizures since diagnosis ($25,509; 95% CI $20,162-$30,856) and were associated with more antiepileptic drug side effects (r = 0.18; 95% CI 0.03-0.32). Controlling for demographic and clinical factors, poorer baseline health-related quality of life was associated with higher per-patient health care charges (B = -445.40; 95% CI -865 to -25). CONCLUSIONS: The economic impact of pediatric epilepsy in the year following diagnosis is substantial. Cost reduction efforts would be optimized by improving seizure control and targeting health-related quality of life, an outcome amenable to behavioral intervention.

The Affordable Care Act's payment and delivery system reforms: a progress report at five years.

In addition to its expansion and reform of health insurance coverage, the Affordable Care Act (ACA) contains numerous provisions intended to resolve underlying problems in how health care is delivered and paid for in the United States. These provisions focus on three broad areas: testing new delivery models and spreading successful ones, encouraging the shift toward payment based on the value of care provided, and developing resources for systemwide improvement. This brief describes these reforms and, where possible, documents their initial impact at the ACA's five-year mark. While it is still far too early to offer any kind of definitive assessment of the law's transformation-seeking reforms, it is clear that the ACA has spurred activity in both the public and private sectors, and is contributing to momentum in states and localities across the U.S. to improve the value obtained for our health care dollars.