Real-world eligibility for FSGS clinical trials: insights from a US health system.

1% Steps for Health Care Reform: Implications for health care policy and for researchers.

America's cancer care crisis

Initiating Human Papillomavirus Vaccination at Age 9: Strategies for Success From 5 US Health Systems.

Suicide is a major public health concern, and as most individuals have contact with health care practitioners before suicide, health systems are essential for suicide prevention. The Zero Suicide (ZS) model is the recommended approach for suicide prevention in health systems, but more evidence is needed to support its widespread adoption. To examine suicide attempt rates associated with implementation of the ZS model in outpatient mental health care within 6 US health systems. This quality improvement study with an interrupted time series design used data collected from January 2012 through December 2019, from patients aged 13 years or older who received mental health care at outpatient mental health specialty settings within 6 US health systems located in 5 states: California, Oregon, Washington, Colorado, and Michigan. Analyses were conducted from January through December 2024. The ZS model was implemented in 4 health systems at different points during the observation period (2012-2019) and compared with health systems that implemented the model before the observation period (postimplementation). Implementation included suicide risk screening, assessment, brief intervention (safety plan, means safety protocol), and behavioral health treatment. The primary outcome was a measure of standardized monthly suicide attempt rates captured using health system records and government mortality records. Suicide death rates were also measured as a secondary outcome. There was a median of 309 107 (range, 55 354-451 837) unique patients per month. In 2017, there were 317 939 eligible individuals (63.2% female). Baseline suicide attempt rates were at least 30 to 40 per 100 000 individuals at each implementation site and decreased to less than 30 per 100 000 individuals at 3 sites by 2019. Decreases in suicide attempt rates were observed at 3 intervention health systems after site-specific implementation: health systems A and B had decreases of 0.7 per 100 000 individuals per month and C, 0.1 per 100 000 individuals per month. System D evidenced a similar suicide attempt rate after implementation (before implementation: median rate: 35.0 [range, 11.0-50.3] per 100 000 patients per month; after implementation: median rate: 34.3 [range, 18.5-42.0] per 100 000 patients per month). The 2 postimplementation health systems maintained low or declining suicide attempt rates throughout the observation period. The rate at system Y decreased by 0.3 per 100 000 individuals per month across the observation period. The rate at system Z began at 11 per 100 000 individuals per month and declined by 0.03 per 100 000 individuals per month during the observation period. Two systems evidenced reductions in the suicide death rate after implementation: system B declined by 0.2 per 100 000 individuals per month and system C by 0.1 per 100 000 individuals per month. In this quality improvement study, ZS model implementation was associated with a reduction in suicide attempt rates among patients accessing outpatient mental health care at most study sites, which supports widespread efforts to implement the ZS model in these settings within US health systems.

BackgroundHow do health systems in the United States view the concept of merger and acquisition (M&A) in a post-COVID 19 “new normal”? How do new entrants to the market and incumbents influence horizontal and vertical integration of health systems? Traditionally, it has been argued that M&A activity is designed to reduce inequities in the market, shift toward value-based care, or enhance the number and quality of health care offerings in a given market. However, the recent history of M&A activity has yielded fewer noble results. As might be expected, the smaller the geographical region in which M&A activity is pursued, the higher the likelihood that monopolistic tendencies will result.ObjectiveWe focused on three types of competition perceptions, external environment uncertainty–related competition, technology disruption–driven competition, and customer service–driven competition, and two integration plans, vertical integration and horizontal integration. We examined (1) how health system characteristics help discern competition perceptions and integration decisions, and (2) how environment-, technology-, and service-driven competition aspects influence vertical and horizontal integration among US health systems in the post-COVID-19 new normal.MethodsWe used data for this study collected through a consultant from a robust group of health system chief executive officers (CEOs) across the United States from February to March 2021. Among the 625 CEOs, 135 (21.6%) responded to our survey. We considered competition and integration aspects from the literature and ratified them via expert consensus. We collected secondary data from the Agency for Healthcare Research and Quality (AHRQ) Compendium of the US Health Systems, leading to a matched data set for 124 health systems. We used inferential statistical comparisons to assess differences across health systems regarding competition and integration, and we used ordered logit estimations to relate competition and integration.ResultsHealth systems generally have a high level of the four types of competition perceptions, with the greatest concern being technology disruption–driven competition rather than environment uncertainty–related competition and customer service–driven competition. The first set of estimation results showed that size, teaching status, revenue, and uncompensated care burden are the main contingent factors influencing the three competition perceptions. The second set of estimation results revealed the relationships between different competition perceptions and integration plans. For vertical integration, environment uncertainty–related competition had a significant positive influence (P<.001), while the influence of technology disruption–driven competition was significant but negative (P<.001). The influence of customer service–driven competition on vertical integration was not evident. For horizontal integration, the results were similar for environment uncertainty–related competition and technology disruption–driven competition; however, the significance of technology disruption–driven competition was weak (P=.05). The influence of customer service–driven competition in the combined model was significant and negative (P<.001).ConclusionsCompetition-driven integration has subtle influences across health systems. Environment uncertainty–related competition is a significant factor, with underlying contingent factors such as revenue concerns and leadership as the leading causes of integration plans. However, technology disruption may hinder integrations. Undoubtedly, small- and low-revenue health systems facing a high level of competition are likely to merge to navigate the health care business successfully. This trend should be a focus of policy to avoid monopolistic markets.

Last month I visited Boston in the United States, and in particular the Beth Israel Deaconess Hospital. On a sample of one, it struck me that healthcare for those served by the US health system and for those who work in it is vastly different to the UK experience. A sense of calm and dignity pervaded the hospital. Staff, and even patients, smiled as you passed them on corridors and in lifts. A harpist strummed soothing melodies, and ‘public safety officers’ lurked discreetly in case the harpist's notes failed to keep the peace. A visitor might easily fall in love with US healthcare. But then the US system struggles to match UK health outcomes on around double the per capita spend. The US health system is ranked 50th for life expectancy and scores low on some measures of responsiveness and quality of healthcare. Just under 50 million people are uninsured and find healthcare hard to access. This blot on US healthcare's landscape is its most visible. US healthcare, then, is a story of success and failure travelling hand in hand. The success stories are instructive for health systems everywhere, indeed the obsession of UK health leaders for over a decade has been to seek guidance from their US counterparts. But the failures are an equally potent warning, a lesson in how not to do it. This month's issue carries several pieces comparing the US and UK approaches to disparities in healthcare – and healthcare more broadly. Just as economic arguments are now driving our healthcare agenda and further restructuring, the US debate is driven by economics. Should the state really bear the cost of universal coverage? While the UK's decision and passion has been that it should, the US has traditionally taken the opposite view. President Obama has now lurched towards better healthcare for the uninsured, a seismic shift in the US health system, and a legacy policy that will dominate history lessons about his presidency. Now the US debate has become even more passionate with Republicans defending the American Way to the last sharp intake of breath. It is in this political firestorm that a Harvard professor has become the focus of furious debate. Don Berwick, paediatrician and head of the Institute of Healthcare Improvement, is Obama's nominated head of the Centers of Medicare and Medicaid Services, a role that will be influential in US health reform. It is hard to criticize Berwick as a doctor, leader or champion of quality improvement. Yet Berwick has become a target for Republicans opposed to Obama's reforms. And Berwick's sin is a simple one: he once declared his love, albeit reservedly, for the NHS. Naughty man, I hear he also enjoys tea.

US health systems receive up to 200 M monthly website visitors. Connecting patient searches to the appropriate workflow requires accurate classification. A dataset of searches on ~15 US health system websites was annotated, characterized, and used to train and evaluate a multi-label, multi-class, deep neural network. This classifier was deployed to health systems touching patients in all 50 states and compared to an LLM. The training dataset contained 504 unique classes with performance of the model in classifying searches among those classes ranging from ~0.90 to ~0.70 across metrics depending on the number of classes included. GPT-4 performed similarly if given a master list and demonstrated value in providing added coverage to augment the supervised classifier’s performance. The collected data revealed characteristics of patient searches in the largest, multi-center, national study of US health systems to date.

Drug expenditures in the US are higher than in any other country and are projected to continue increasing, so US health systems may benefit from evaluating international regulatory and reimbursement decision-making of new drugs. To evaluate regulatory decisions and health technology assessments (HTAs) in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration (FDA) in 2017 through 2020, as well as to estimate the US cost per patient per year for drugs receiving negative recommendations. In this cross-sectional study, recommendations issued by agencies in Australia, Canada, and the UK were collected for new drugs approved by the FDA in 2017 through 2020. All data were current as of May 31, 2022. Authorizations and HTAs in selected countries. All FDA-approved drugs were matched by active ingredient to decision summary reports published by drug regulators and HTA agencies in Australia, Canada, and the UK. Regulatory approval concordance and reasons for negative recommendations were assessed using descriptive statistics. For drugs not recommended by an international agency, the annual US drug cost per patient was estimated from FDA labeling and wholesale acquisition costs. The FDA approved 206 new drugs in 2017 through 2020, of which 162 (78.6%) were granted marketing authorization by at least 1 other regulatory agency at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved drugs were refused marketing authorization by an international regulatory agency due to unfavorable benefit-to-risk assessments. An additional 42 FDA-approved drugs received negative reimbursement recommendations from HTA agencies in Australia, Canada, or the UK due to uncertainty of clinical benefits or unacceptably high prices. The median (IQR) US cost of the 47 drugs refused authorization or not recommended for reimbursement by an international agency was $115 281 ($166 690) per patient per year. Twenty drugs were for oncology indications, and 36 were approved by the FDA through expedited regulatory pathways or the Orphan Drug Act. This cross-sectional study assessed reasons for which drugs recently approved by the FDA were refused marketing authorization or not recommended for public reimbursement in other countries. Drugs with limited international market presence may require close examination by US health care professionals and health systems.

Overuse of health care is a pervasive threat to patients that requires measurement to inform the development of interventions. To measure low-value health care use within health systems in the US and explore features of the health systems associated with low-value care delivery. In this cross-sectional analysis, we identified occurrences of 17 low-value services in 3745 hospitals and affiliated outpatient sites. Hospitals were linked to 676 health systems in the US using the Agency for Healthcare Research and Quality (AHRQ) Compendium of Health Systems. The participants were 100% of Medicare beneficiaries with claims from 2016 to 2018. We identified occurrences of 17 low-value services in 3839 hospitals and affiliated outpatient sites. Hospitals were linked to health systems using AHRQ's Compendium of Health Systems. Between March and August 2021, we modeled overuse occurrences with a negative binomial regression model including the year-quarter, procedure indicator, and a health system indicator. The model included random effects for hospital and beneficiary age, sex, and comorbidity count specific to each indicator, hospital, and quarter. The beta coefficients associated with the health system term, normalized, reflect the tendency of that system to use low-value services relative to all other systems. With ordinary least squares regression, we explored health system characteristics associated with the Overuse Index (OI), expressed as a standard deviation where the mean across all health systems is 0. There were 676 unique health systems assessed in our study that included from 1 to 163 hospitals (median of 2). The mean age of eligible beneficiaries was 75.5 years and 76% were women. Relative to the lowest tertile, health systems in the upper tertile of medical groups count and bed count had an OI that was higher by 0.38 standard deviations (SD) and 0.44 SD, respectively. Health systems that were primarily investor owned had an OI that was 0.56 SD higher than those that were not investor owned. Relative to the lowest tertile, health systems in the upper tertile of primary care physicians, upper tertile of teaching intensity, and upper quartile of uncompensated care had an OI that was lower by 0.59 SD, 0.45 SD, and 0.47 SD, respectively. In this cross-sectional study of US health systems, higher amounts of overuse among health systems were associated with investor ownership and fewer primary care physicians. The OI is a valuable tool for identifying potentially modifiable drivers of overuse and is adaptable to other levels of investigation, such as the state or region, which might be affected by local policies affecting payment or system consolidation.

BackgroundThe COVID-19 pandemic, with all its virus variants, remains a serious situation. Health systems across the United States are trying their best to respond. On average, the health care workforce is relatively homogenous, even though it cares for a highly diverse array of patients. This perennial problem in the US health care workforce has only been accentuated during the COVID-19 pandemic. Medical workers should reflect on the variety of patients they care for and strive to understand their mindsets within the larger contexts of culture, gender, sexual orientation, religious beliefs, and socioeconomic realities. Along with talent and skills, diversity and inclusion (D&I) are essential for maintaining a workforce that can treat the myriad needs and populations that health systems serve. Developing hiring strategies that will help achieve greater workforce diversity remains a challenge for health system leaders.ObjectiveThe primary aims of this study were to: (1) explore the characteristics of US health systems and their associations with D&I practices and benefits, (2) examine the associations between D&I practices and three pathways to equip workforces, and (3) examine the associations between the three pathways to better equip workforces and business and service benefits. The three pathways are: (1) improving D&I among existing employees (IMPROVE), (2) using multiple channels to find and recruit the workforce (RECRUIT), and (3) collaborating with universities to find new talent and establish plans to train students (COLLABORATE).MethodsDuring February to March 2021, 625 health systems in the United States were surveyed with the help of a consultant, 135 (21.6%) of whom responded. We assessed workforce talent- and diversity-relevant factors. We collected secondary data from the Agency for Healthcare Research and Quality Compendium of the US Health Systems, leading to a matched data set of 124 health systems for analysis. We first explored differences in diversity practices and benefits across the health systems. We then examined the relationships among diversity practices, pathways, and benefits.ResultsHealth system characteristics such as size, location, ownership, teaching, and revenue have varying associations with diversity practices and outcomes. D&I and talent strategies exhibited different associations with the three workforce pathways. Regarding the mediating effects, the IMPROVE pathway seems to be more effective than the RECRUIT and COLLABORATE pathways, enabling the diversity strategy to prompt business or service benefits. Moreover, these pathway effects go hand-in-hand with a talent strategy, indicating that both talent and diversity strategies need to be aligned to achieve the best results for a health system.ConclusionsDiversity and talent plans can be aligned to realize multiple desired benefits for health systems. However, a one-size-fits-all approach is not a viable strategy for improving D&I. Health systems need to follow a multipronged approach based on their characteristics. To get D&I right, proactive plans and genuine efforts are essential.

Background: Fidaxomicin is a macrocyclic antibiotic approved in 2011 by the US Food and Drug Administration for treatment of Clostridium difficile-associated diarrhoea (CDAD). Objective: Herein, we present an epidemiological method to estimate, on a case mix basis, and from the perspective of the US health system, the warranted (justifiable) price per day for fidaxomicin, as a percent of the wholesale acquisition cost (WAC) per day for fidaxomicin ($US280). Methods: Data from two randomized controlled studies (Optimer-003 [n = 596] and Optimer-004 [n = 509]) were used to discern the number-needed-to-treat (NNT = 7.1) for sustained clinical response. Sustained clinical res ponse was defined as clinical response at the end of treatment, and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment. National data for primary and secondary cases (the case mix) of CDAD (mean hospital length of stay [LOS], and mean cost) were derived from the 2009 US Healthcare Cost and Utilization Project. The method for attribution of hospital LOS for secondary cases of CDAD was derived from a study published by O’Brien et al. in 2007. Comparative regi mens of vancomycin were: (i) injectable used orally, 125 mg four times daily (qid; WAC of $US6/day), with use of vancomycin hydrochloride (HCl) cap sules, 125 mg qid (WAC of $US106/day) post-hospital discharge; (ii) vanco mycin HCl capsules, 125 mg qid; and (iii) vancomycin HCl capsules, 250 mg qid (WAC of $US196/day). Findings are expressed in 2011 US dollars. The study perspective is that of the US health system. Results: The warranted price per day for fidaxomicin represented 95% of the WAC per day for fidaxomicin compared with use of injectable vancomycin (orally) 125mg qid (with subsequent use of vancomycin HCl capsules, 125mg qid post-hospital discharge); 109% of the WAC per day for fidaxomicin compared with use of vancomycin HCl capsules, 125mg qid; and 141% of the WAC per day for fidaxomicin when compared with use of vancomycin HCl capsules, 250mg qid. Conclusion: From the perspective of the US health system, fidaxomicin represents value for money in the treatment of CDAD. The methodology employed in this research has application beyond antimicrobial pharmacotherapy.

European health systems face scrutiny in US debate

RET germline pathogenic variants cause multiple endocrine neoplasia type 2 (MEN2), which is associated with medullary thyroid cancer. With increasing incidental identification of these variants in asymptomatic individuals outside family screening, these individuals' risk of medullary thyroid cancer and all-cause mortality without intervention remain unknown in this context. To evaluate the risk of medullary thyroid cancer and all-cause mortality in clinically unselected individuals with incidentally identified RET variants and assess whether the risk of medullary thyroid cancer differs from those with clinically ascertained RET variants. This prospective cohort study of 383 914 unrelated individuals from the clinically unselected UK population (UK Biobank, recruited in 2006-2010, with follow-up to June 2023) and 122 640 unrelated individuals from a US health system (Geisinger MyCode cohort, recruited 2004-2020, with follow-up to October 2023) compared medullary thyroid cancer risk in these cohorts with 1078 individuals who were clinically ascertained with suspicion of MEN2 from a UK routine practice. RET germline pathogenic variants causing MEN2. Frequency and the spectrum of pathogenic RET variants, risk of clinically present medullary thyroid cancer, and all-cause mortality without thyroidectomy were assessed using proportions with exact binomial 95% CIs and survival analysis adjusted for age at recruitment and sex. In the UK Biobank, 169 unrelated individuals (mean [SD] age at recruitment, 57.0 [8.1] years; 94 male [55.6%]) had a pathogenic RET variant (prevalence, 0.04% [95% CI, 0.04%-0.05%]). In the US health system-based cohort, 77 unrelated individuals (mean [SD] age at recruitment, 56.2 [17.8] years; 45 female [58.4%]) had a pathogenic RET variant (prevalence, 0.06% [95% CI, 0.05%-0.78%]). The variants were predominantly from the moderate-risk category per American Thyroid Association guidelines (168 individuals [99.4%] and 75 individuals [94.8%], respectively). The Kaplan-Meier estimated medullary thyroid cancer risk by age 75 years in variant carriers in the UK population was 2.2% (95% CI, 0.7%-6.9) and 19.3% (95% CI, 6.4%-30.2%) in US health system cohort. These risks were significantly lower compared with the clinically ascertained cohort with the matched variants (95.7% [95% CI, 82.1%-99.7%]). In the UK Biobank, most variant carriers (166 [98.2%]) did not undergo thyroidectomy, and their all-cause mortality by age 75 years was similar to noncarriers (6.1% [95% CI, 2.7%-13.8%] vs 5.7% [95% CI, 5.6%-5.8%]), with consistent findings in the US health system cohort. In this cohort study, moderate-risk RET variants were most common in incidental cases. The variants were associated with a substantially lower medullary thyroid cancer risk than clinically ascertained cases. This evidence addresses a current knowledge gap, enabling more informed clinical decision-making.

BackgroundProspective patients are increasingly going to health systems’ online directories to find their next primary care providers (PCP), making this channel of communication important to assess to determine if it is meeting patients’ needs. When seeking a new PCP, patients want to know not only educational credentials but also providers’ communication traits, and personal information to showcase providers as real people. Offering this information, to help patients find providers best suited to meet their needs, is a key attribute of patient-centered care.ObjectiveTo analyze whether health systems’ online PCP biographies are including the information prospective patients deem important when selecting a PCP.DesignUsing the AHRQ’s Compendium of US Health Systems, 523 health systems’ PCP biographies were content analyzed (n = 5004 biographies) from December 2019 to March 2020.Main MeasuresForty-eight unique pieces of information were coded for either their presence or absence (e.g., education, photo, languages spoken, insurance accepted, patient reviews, philosophy of care, video provided, personal hobbies/interests). Providers’ alphabetic credentials (e.g., MD, DO, APRN) were also documented.Key ResultsThe majority of biographies stated the provider’s medical education (83.6%) and included a photo (81.4%). However, information patients also desire (e.g., communication traits and personal information) were less prevalent. Only 33.7% listed languages spoken, 18.2% offered patient reviews, 14.4% had personal hobbies/interests, and 10.6% included a video. There were also 192 unique alphabetic credential combinations listed next to providers’ names. Two health systems clearly included information within biographies to help prospective patients understand what these credentials meant.ConclusionsHealth systems could make simple changes to their providers’ online biographies in order to help patients make more informed decisions of PCPs. Doing so may decrease doctor shopping, and also lead to a greater likelihood of developing longer-term relationships with PCPs.

Public and private payers continue to expand use of alternative payment models, aiming to use value-based payment to affect the care delivery of their contracted health system partners. In parallel, health systems and their employment of physicians continue to grow. However, the degree to which health system physician compensation reflects an orientation toward value, rather than volume, is unknown. To characterize primary care physician (PCP) and specialist compensation arrangements among US health system-affiliated physician organizations (POs) and measure the portion of total physician compensation based on quality and cost performance. This study was a cross-sectional mixed-methods analysis of in-depth multimodal data (compensation document review, interviews with 40 PO leaders, and surveys conducted between November 2017 and July 2019) from 31 POs affiliated with 22 purposefully selected health systems in 4 states. Data were analyzed from June 2019 to September 2020. The frequency of PCP and specialist compensation types and the percentage of compensation when included, including base compensation incentives, quality and cost performance incentives, and other financial incentives. The top 3 actions physicians could take to increase their compensation. The association between POs' percentage of revenue from fee-for-service and their physicians' volume-based compensation percentage. Volume-based compensation was the most common base compensation incentive component for PCPs (26 POs [83.9%]; mean, 68.2% of compensation; median, 81.4%; range, 5.0%-100.0% when included) and specialists (29 POs [93.3%]; mean, 73.7% of compensation; median, 90.5%; range, 2.5%-100.0% when included). While quality and cost performance incentives were common (included by 83.9%-56.7% of POs for PCPs and specialists, respectively), the percentage of compensation based on quality and cost performance was modest (mean, 9.0% [median, 8.3%; range, 1.0%-25.0%] for PCPs and 5.3% [median, 4.5%; range, 0.5%-16.0%] for specialists when included). Increasing the volume of services was the most commonly cited action for physicians to increase compensation, reported as the top action by 22 POs (70.0%) for PCPs and specialists. We observed a very weak, nonsignificant association between the percentage of revenue of POs from fee for service and the PCP and specialist volume-based compensation percentage (r = 0.08; P = .78 and r = -0.04; P = .89, respectively). The results of this cross-sectional study suggest that PCPs and specialists despite receiving value-based reimbursement incentives from payers, the compensation of health system PCPs and specialists was dominated by volume-based incentives designed to maximize health systems revenue.