US Health Care Research Articles

Implementation of a Secure Firearm Storage Program in Pediatric Primary Care

Increased secure firearm storage can reduce youth firearm injury and mortality, a leading cause of death for children and adolescents in the US. Despite the availability of evidence-based secure firearm storage programs and recommendations from the American Academy of Pediatrics, few pediatric clinicians report routinely implementing these programs. To compare the effectiveness of an electronic health record (EHR) documentation template (nudge) and the nudge plus facilitation (ie, clinic support to implement the program; nudge+) at promoting delivery of a brief evidence-based secure firearm storage program (SAFE Firearm) that includes counseling about secure firearm storage and free cable locks during all pediatric well visits. The Adolescent and Child Suicide Prevention in Routine Clinical Encounters (ASPIRE) unblinded parallel cluster randomized effectiveness-implementation trial was conducted from March 14, 2022, to March 20, 2023, to test the hypothesis that, relative to nudge, nudge+ would result in delivery of the firearm storage program to an additional 10% or more of the eligible population, and that this difference would be statistically significant. Thirty pediatric primary care clinics in 2 US health care systems (in Michigan and Colorado) were included, excluding clinics that were not the primary site for participating health care professionals and a subset selected at random due to resource limitations. All pediatric well visits at participating clinics for youth ages 5 to 17 years were analyzed. Clinics were randomly assigned in a 1:1 ratio to receive either the nudge or nudge+. Patient-level outcomes were modeled to estimate the primary outcome, reach, which is a visit-level binary indicator of whether the parent received both components of the firearm storage program (counseling and lock), as documented by the clinician in the EHR. Secondary outcomes explored individual program component delivery. A total of 47 307 well-child visits (median [IQR] age, 11.3 [8.1-14.4] years; 24 210 [51.2%] male and 23 091 [48.8%] female) among 46 597 children and 368 clinicians were eligible to receive the firearm storage program during the trial and were included in analyses. Using the intention-to-treat principle, a higher percentage of well-child visits received the firearm storage program in the nudge+ condition (49%; 95% CI, 37-61) compared to nudge (22%; 95% CI, 13-31). In this study, the EHR strategy combined with facilitation (nudge+) was more effective at increasing delivery of an evidence-based secure firearm storage program compared to nudge alone. ClinicalTrials.gov Identifier: NCT04844021.

Updating and calibrating the Real-World Progression In Diabetes (RAPIDS) model in a non-Veterans Affairs population.

To present the Real-World Progression In Diabetes (RAPIDS) 2.0 Risk Engine, the only simulation model to study the long-term trajectories of outcomes arising from dynamic sequences of glucose-lowering treatments in type 2 diabetes (T2DM). The RAPIDS model's risk equations were re-estimated using a Least Absolute Shrinkage and Selection Operator (LASSO)-based regularization of features that spanned baseline data from the last two quarters of current time and interactions with age. These equations were supplemented with estimates for the impact of dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium-glucose cotransporter-2 inhibitor classes of drugs as monotherapies and their combinations with metformin based on newer trial data and comprehensive meta-analyses. The probabilistic RAPIDS 2.0 model was calibrated (N = 25 000) and validated (N = 263 816) using electronic medical records (EMR) data between 2008 and 2021 from a national network of US healthcare organizations. The EMR-based cohort had a mean age of 61 years at baseline, with 50% women, 70% non-Hispanic White individuals and 20% non-Hispanic Black individuals, and was followed for 17.5 quarters (range: 3-50). The final RAPIDS 2.0 risk engine accurately predicted the long-term trajectories of all nine biomarkers and nine outcomes in the hold-out validation sample. Similar accuracies in predictions were observed in each of the 14 subgroups studied. The RAPIDS 2.0 model demonstrated valid long-term predictions of outcomes in individuals with T2DM in the United States as a function of dynamic sequences of treatment use patterns. This highlights its potential to project long-term comparative effectiveness between alternative sequences of glucose-lowering treatment uses in the United States.

Perceptions of Government-Assisted Payors: A Survey and Analysis of American Shoulder and Elbow Surgeons Current Medicare, Medicare Advantage and Medicaid Practice Allocation

Significant discrepancy and variance exist in the United States health care system with regard to patient access to medical care based on a patient's insurance type, whether that be government-assisted or a private insurer. There are currently 3 major government-assisted insurance programs, Medicare, Medicare Advantage, and Medicaid, each of which has its own patient mix and regulatory processes that govern care delivery. The purpose of this study was to evaluate the current perceptions of shoulder and elbow surgeons surrounding practice patterns and barriers to access for patients whose primary insurance is a government-assisted payor. This was a national, observational study that surveyed the American Shoulder and Elbow Surgeons (ASES) society membership. This 15-question survey assessed surgeon demographics, practice types, reimbursement models, as well as rates and trends of their access to patients with government-assisted insurance. Subgroup analysis between practice type and barriers to access for patients with one of these 3 government-assisted insurance were also analyzed and compared. Pearson χ2 test or Fisher exact test was used to test association between categorical responses and categorical/binary respondent characteristics. A P value<.05 was deemed statistically significant. A total of 257 ASES members completed the survey. Mean years in practice for respondents was 14. For Medicare patients, the most common perceived barriers were reimbursement (49%) followed by administrative burden (33%) and then implant reimbursement at the surgeon's primary surgical facility (32%). For Medicare Advantage patients, the most common barrier to access was administrative burden (52%), reimbursement (50%), and the patient's ability to access perioperative services such as physical therapy and home health (40%). The most common barriers for Medicaid patients were relatively evenly distributed between reimbursement (62%), low patient engagement in their care (61%), and patient's ability to access perioperative services (60%). Among members of the ASES, barriers to patient access varied by government-assisted payor. For Medicare advantage, administrative burden was the largest barrier to access. Whereas for Medicare and Medicaid, reimbursement was the most significant barrier. Further investigation and understanding of these barriers to patient access are necessary to improve availability of shoulder and elbow subspecialized care to a broader population of patients insured by government-assisted payors.

Health Care Workers’ Trust in Leadership: Why It Matters and How Leaders Can Build It

Rebuilding patient trust in the US health care system has received considerable attention recently, but there has been little focus on health care workers' (HCWs) trust in the leaders of health care delivery organizations. This study explores (1) the professional impact on HCWs of trusting the leaders of the organizations where they work and (2) the leadership actions that build HCWs' trust. The authors examined these questions using a survey that was crowdsourced to 353 HCWs through social media posts and e-mails from national health organizations. For each open-ended question, qualitative codes were identified, iteratively finalized, and applied to each response. Descriptive statistics were used to analyze the closed-ended questions and examine how often each qualitative code was raised. One in five (20.2%) HCWs trusted leadership "very much," more than a third (36.9%) trusted "somewhat," and 42.9% had lower levels of trust. Almost all (97.7%) reported that the degree of trust they had in their organization's leadership affected them professionally. Among HCWs who trusted their organization's leadership, the most common impact was feeling professional satisfaction, followed by providing higher-quality work. HCWs described three main ways health care organization leaders earned their trust: communicating effectively (being transparent and soliciting HCWs' input), treating HCWs well (with respect and kindness and providing good compensation), and prioritizing patient care. The findings suggest health care organizations would benefit from leaders seeking to earn HCWs' trust. With trust in leadership, HCWs report higher work quality and greater professional satisfaction.

Private Equity Acquisitions Of Hospices Are Increasing; Ownership Remains Opaque.

Private equity ownership across the US health care system is rapidly increasing, yet ownership structures are complex and opaque. We used an economic data set tracking mergers and acquisitions linked to Medicare data to identify private equity hospice acquisitions. Given the influence of for-profit ownership on hospice quality, transparent data on private equity investment are fundamental to ensuring high-quality end-of-life care.

A Few Doctors Will See Some of You: The Critical Role of Underrepresented in Medicine (URiM) Family Physicians in the Care of Medicaid Beneficiaries.

Despite being key to better health outcomes for patients from racial and ethnic minority groups, the proportion of underrepresented in medicine (URiM) physicians remains low in the US health care system. This study linked a nationally representative sample of family physicians (FPs) with Medicaid claims data to explore the relative contributions to care of Medicaid populations by FP race and ethnicity. This descriptive cross-sectional study used 2016 Medicaid claims data from the Transformed Medicaid Statistical Information System and from 2016-2017 American Board of Family Medicine certification questionnaire responses to examine the diversity and Medicaid participation of FPs. We explored the diversity of FP Medicaid patient panels and whether they saw ≥150 beneficiaries in 2016. Using logistic regression models, we controlled for FP demographics, practice characteristics, and characteristics of the communities in which they practiced. Of 13,096 FPs, Latine, Hispanic, or of Spanish Origin (LHS) FPs and non-LHS Black FPs saw more Medicaid beneficiaries compared with non-LHS White and non-LHS Asian FPs. The patient panels of URiM FPs had a much greater proportion of Medicaid beneficiaries from racial and ethnic minority groups. Overall, non-LHS Black and LHS FPs had greater odds of seeing ≥150 Medicaid beneficiaries in 2016. These findings clearly show the critical role URiM FPs play in caring for Medicaid beneficiaries, suggesting physician race and ethnicity are correlated with Medicaid participation. Diversity in the health care workforce is essential for addressing racial health inequities. Policies need to address problems in pathways to medical education, including failures to recruit, nurture, and retain URiM students.

A high-performance framework to integrate primary care and behavioural health

This paper describes a large statewide initiative in Arizona led by the Arizona Medicaid programme to integrate the delivery of primary care and behavioural services. Healthcare in the USA remains fragmented, as reflected in no small measure by the separation of primary care and mental health services, in both structure and delivery. The fact that this historical separation continues to be perpetuated is detrimental to the goals of the Triple Aim. The fragmentation between both clinical service lines is further compounded by the high rate of co-occurring physical and mental illness, shortage of mental health professionals, under-skilling of primary care providers in the management of mental health, and stigma associated with mental illness. Underserved communities, where trust deficits of healthcare systems are commonplace, are especially vulnerable to the untoward effects of fragmented services. In this paper a framework is described to integrate primary care and behavioural health, implemented as a multi-year, multi-stakeholder programme at microsystem level, with policy implications for improving access, outcomes, costs and disparities.

O26 SUSTAINED BLOOD PRESSURE CONTROL FOLLOWING A HOME BLOOD PRESSURE TELEMONITORING PROGRAM

Background and Objective: Home blood pressure telemonitoring (HBPT) facilitates HBP monitoring and reduces office BP. Evidence whether BP control can be sustained via HBPT is lacking. We examined the effects of a HBPT program on sustained BP control. Methods: We included patients enrolled in a HBPT program at a large integrated US healthcare system from November 2019-June 2022. Patients with uncontrolled hypertension were enrolled by a clinician, given a BP device and provided consent through an app. Patients were asked to measure their BP three mornings and three evenings each week before taking antihypertensive medication. BP readings were synced to the app, and non-physician providers titrated medications. Patients were successfully discharged from the program after achieving control (at least two 1-week average BPs and last BP in one month &lt;135/85 mmHg). We examined mean clinic BP reduction before and after enrollment to HBPT and sustained BP control (last clinic BP &lt;140/90 mmHg in the 12 months following discharge). Multivariable robust Poisson regression was used to identify factors associated with sustained BP control at 12 months. Results: A total of 3574 patients were enrolled and 2123 (59%) consented; of these, 63 (3%) did not submit &gt;1 BP, 780 (37%) were actively enrolled, 644 (30%) disenrolled without meeting BP control and 636 (30%) achieved control and were discharged after a mean of 4 months. Among the 636 successfully discharged, 527 (83%) had clinic BP during follow-up. Compared with the last clinic BP prior to HBPT enrollment, mean (SD) clinic SBP and DBP was reduced by 16.3 (22.6) mmHg and 10.0 (12.3) mmHg, respectively (p&lt;.0001 for both) and 75% of patients sustained BP control at 12 months. Younger patients and patients with high SBP prior to HBPT were less likely to sustain BP control at 12 months (Figure). Conclusions: While the HBPT program in this healthcare system shows promise for sustained BP control, strategies to enroll/consent patients and spread the program are warranted.

Evaluating the Effect of Financial Penalty on Hospital-Acquired Infections.

This study explores the effects of CMS reimbursement financial penalties from the Hospital-Acquired Condition Reduction Program (HACRP) on hospital-acquired infections (HAI) in hospitals across the United States. Hospital-level data for 2896 hospitals in the United States were evaluated using multiple linear regression models with random effects analysis through a difference-in-differences study design to examine HAIs under the HACRP between hospitals that were financially penalized or not from calendar years 2013 to 2020. This study showed significant differences from the pre-program Total HAC scores to the most recent reviewed year, validating the efficacy of the HACRP, and showing a reduction of overall HAIs over the years evaluated in the study. The multiple linear regression model with random effects analysis produced a significant (p < 0.001) interaction term between hospitals expected to be penalized in 2013 and each year evaluated in the study (-0.412 estimate) confirming decreases in HAI scores, and overall decreases in HAIs across the years of the study. Notably, 98% of hospitals in the worst-performing, expected to be financially penalized quartile from 2013, were found to have decreased their HAIs in their facilities, while only 38.8% of hospital in the performing, non-penalized quartiles showed decreases in HAIs across their facilities, by 2020. Our research indicates that implementing financial disincentives through reimbursement reductions could potentially decrease the incidence of HAIs. Our study further suggests that incorporating financial penalties and incentives for HAIs annually across all hospitals may lead to significant reductions in HAIs throughout the US healthcare system.

US cost-utility model of lenacapavir plus optimized background regimen (OBR) vs fostemsavir plus OBR and ibalizumab plus OBR for people with HIV with multidrug resistance.

Heavily treatment-experienced (HTE) people with HIV (PWH) have limited treatment options owing to multidrug resistance (MDR). Lenacapavir (LEN) is indicated, in combination with other antiretrovirals, for the treatment of adults with MDR HIV-1 experiencing failure of their current antiretroviral regimen because of resistance, intolerance, or safety considerations. To evaluate the cost-utility of LEN in combination with an optimized background regimen (OBR) vs alternative recently approved treatments for HTE PWH, fostemsavir (FTR)+OBR and ibalizumab (IBA)+OBR, for the treatment of PWH with MDR, from a mixed US health care payer perspective. A Markov state-transition model with a lifetime time horizon was developed. Transition probabilities between viral load categories were based on individual participant data from the CAPELLA trial for LEN+OBR and on relative efficacy parameters obtained from indirect treatment comparisons for comparators. Health state utilities were sourced from the literature. Costs included drug acquisition costs, drug administration costs, disease management costs, adverse event costs, AIDS-related event costs, and treatment switching costs and were sourced from red book costs, Medicare and Medicaid fees, and the literature. Costs and outcomes were discounted at 3% annually. The model was used to estimate total and incremental costs, life-years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. A deterministic and a probabilistic sensitivity analysis, as well as scenario analyses, were performed to address elements of uncertainty in the model and to explore the robustness of the results. Over a lifetime time horizon, LEN+OBR was associated with the highest absolute QALYs (9.41) and the greatest number of LYs (12.09) compared with FTR+OBR (QALYs: 8.75; LYs: 11.26) and IBA+OBR (QALYs: 8.36; LYs: 10.78). LEN+OBR was also associated with the lowest total lifetime costs of the 3 interventions (LEN+OBR: $1,441,122 [US dollars]; FTR+OBR: $1,504,986; IBA+OBR: $1,524,396) and therefore was dominant over both comparators in the base case. LEN+OBR remained dominant vs FTR+OBR and IBA+OBR across the range of scenarios tested and LEN+OBR had a 99% probability of being cost-effective compared with FTR+OBR and IBA+OBR in the probabilistic sensitivity analysis at a willingness-to-pay threshold of $50,000/QALY. This economic evaluation demonstrated that LEN+OBR provides meaningful increases in QALYs and LYs, and is dominant over a lifetime time horizon, compared with FTR+OBR and IBA+OBR for the treatment of PWH with MDR in the United States.

Real-world treatment patterns, health care resource utilization, and costs in a US Medicare population with bronchiectasis.

Bronchiectasis carries a significant economic burden with high health care expenditures associated with frequent hospitalizations, physician visits, and treatments, including oral and intravenous antibiotics for repeated lung infections, airway-clearance therapy, and oxygen administration. Bronchiectasis exacerbations can contribute to this burden. To estimate US health care resource utilization (HCRU) and costs associated with bronchiectasis and with bronchiectasis exacerbations. This retrospective study used the 100% Medicare Fee-for-Service database (January 2014 to December 2020) to compare HCRU and costs among patients with bronchiectasis with those of patients without bronchiectasis (controls). For patients with bronchiectasis, the index date was a randomly selected bronchiectasis claim after more than 1 year of disease history and, for controls, a claim closest to their matched bronchiectasis patient's index date. All patients had continuous enrollment for at least 12 months pre-index (baseline) and at least 12 months post-index. Primary outcomes were all-cause, respiratory-related, and bronchiectasis-related HCRU and health care costs, which were presented by the overall sample and by segmented patient cohorts based on the number of exacerbations during baseline (0, 1, or ≥2). 92,529 patients with bronchiectasis (mean [SD] age, 76.7 [8.8] years; 72.3% female) and 92,529 matched controls qualified for the study. Compared with controls, patients with bronchiectasis presented greater mean (SD) all-cause physician visits (15.4 [10.0] vs 13.2 [9.7]; P < 0.001) and respiratory-related physician visits (5.2 [4.3] vs 1.9 [3.1]), pulmonologist visits (1.9 [2.2] vs 0.3 [1.0]), hospitalizations (0.4 [0.9] vs 0.3 [0.8]), emergency department visits (0.33 [1.0] vs 0.26 [1.0]), and total health care costs ($10,224 [$23,263] vs $6,704 [$19,593]). Respiratory-related HCRU was also greater in patients with more baseline exacerbations, with total health care costs of $8,506, $10,365, and $14,790 for patients with 0, 1, and at least 2 exacerbations, respectively (P < 0.01). This real-world study demonstrates the high disease burden associated with bronchiectasis and with exacerbations, highlighting the need to improve management and reduce exacerbations.

Fraud in genetic testing: Swindling the system

PurposeHealth care fraud comprises a sizable portion of US health care expenditure and inflicts undue burden on payers, patients, and the health care system overall. The genetic testing industry is rapidly growing, which propagates opportunities for health care fraud. Although federal organizations have highlighted it as an issue, there is limited research exploring genetic testing fraud. MethodsA retrospective review of federal websites, news articles, and a legal database resulted in 42 cases of fraud involving outpatient genetic testing published between February 2019 and December 2023. These cases were analyzed for themes via inductive conventional content analysis. ResultsThemes of fraudulent activity included submission of fraudulent claims, kickback or bribe payments, minimal or no contact with patients for whom testing was ordered for, inappropriate billing and documentation practices, and further actions to conceal fraud. Repercussions imposed on defendants included monetary penalty, imprisonment, business restrictions, and seizure of property. ConclusionHigh rates of medically inappropriate testing in fraud cases highlight the value of genetics experts in ordering or reviewing claims for genetic testing. Examining fraudulent activity in genetic testing can help providers identify and report fraud and provide awareness of optimal health care allocation in the genetic testing industry.

Why Is US Health Care Failing? Some Reasons Are Obvious, but Fixes Are Harder.

Why Is US Health Care Failing? Some Reasons Are Obvious, but Fixes Are Harder.

Exercise With Unstable Objects: A Descriptive Survey Among Health Care and Fitness Professionals

Exercise with unstable objects is a popular intervention used by health care and fitness professionals. Understanding different professional beliefs and usage patterns might provide insight for future research and development of evidence-based guidelines. The purpose of this survey study was to document the perceptions, beliefs, and the use of exercise with unstable objects among health care and fitness professionals in the United States. Six hundred and sixteen respondents completed the survey. Most respondents used unstable objects for musculoskeletal postinjury fitness/return to performance (72%). Most believed the main therapeutic effects were enhanced motor control (88%), balance (86%), and somatosensory (85%) function. Most reported using the foam pad (80%) and BOSU (84%). The most used subjective measure was the Activities-specific Balance Confidence scale. Most respondents used single limb stance (85%) to measure static motor control and the single leg squat assessment (51%) for dynamic motor control. Respondents used variables such as dynamic movement, repetition and sets, and time during training. Respondents considered recent injury or surgery and neurological or vestibular conditions as the top precautions. Respondents considered acute injury or surgery and neurological or vestibular conditions as the top contraindications. This survey provides insight into health care and fitness professionals perceptions, beliefs, and use of exercise with unstable objects.

A Comparison of Working Conditions Between Immigrant and Non-immigrant Healthcare Workers in the United States: Evidence From the National Health Interview Survey

Immigrants in the United States (U.S.) healthcare workforce face challenging working conditions. This study aimed to compare the working conditions of healthcare workers based on immigration status. Using National Health Interview Survey (NHIS) 2015 data, we compared the sociodemographic characteristics and working conditions between 374 non-U.S. born and 1,986 U.S. born healthcare workers. Multivariable logistic regression was used to examine associations between immigration status and selected working conditions. It was found that non-U.S. born and U.S. born healthcare workers differed in sociodemographic and occupational characteristics. After adjusting for sociodemographic covariates, non-U.S. born healthcare workers had higher odds of non-permanent contract work (aOR: 1.87, 95% CI [1.25, 2.79], p < 0.01) and lower odds of workplace harassment (aOR: 0.51, 95% CI [0.31, 0.83], p < 0.01), compared to U.S. born healthcare workers. Immigrant healthcare workers' occupational experiences should be further explored to improve organizational and psychosocial working conditions.

The Clinical Nurse Specialist: Maximizing Return on Investment.

The United States health care system is facing an unprecedented nursing shortage, increasing complexity of care, and fewer experienced nurse mentors. These factors contribute to a cycle of burnout, turnover, decreased quality and safety, and a worsening financial bottom line. Improving these contributing factors depends on our ability to mitigate the structural causes of burnout and turnover. The clinical nurse specialist role is essential to improving the work environment, advancing evidence-based nursing practice, reducing turnover, and stabilizing the bottom line.

Prevalence of low vitamin D levels among older US Asian and Pacific Islander adults.

US Asian and Pacific Islander (PI) adults generally have lower 25-hydroxyvitamin D [25(OH)D] levels than non-Hispanic White (NHW) adults, but subgroup data remain limited. We compared sex- and ethnicity-specific prevalence of low 25(OH)D among older Asian/PI and NHW adults. Data from 102,556 Asian/PI and 381,724 NHW adults aged 50-89years with measured 25(OH)D in 2012-2019 and body mass index (BMI, within ± 1year) were examined in a California healthcare system. Low 25(OH)D < 20ng/mL (50nmol/L) was examined by race and ethnicity. Covariates included age, smoking, BMI, and season of measurement. Modified Poisson regression was used to estimate prevalence ratios (aPR), adjusting for covariates. Among 31,287 Asian/PI men and 71,269 Asian/PI women, the prevalence of low 25(OH)D was 22.6% and 14.7%, respectively, significantly higher than observed for 122,162 NHW men (12.3%) and 259,562 NHW women (9.9%). Within Asian/PI subgroups, low 25(OH)D prevalence ranged from 17 to 18% (Korean, Japanese, Filipino), 22 to 24% (Chinese, Vietnamese), 28% (South Asian), and 35% (Native Hawaiian/PI) among men and 11 to 14% (Japanese, Filipina, Chinese, Korean), 17 to 18% (South Asian, Vietnamese), and 26% (Native Hawaiian/PI) among women. The corresponding aPRs (NHW reference) for men and women were as follows: NativeHawaiian/PI, 2.70 and 2.34; South Asian, 2.56 and 2.07; Vietnamese, 2.17 and 2.31; Chinese, 2.04 and 1.89; Korean, 1.60 and 1.85; Filipino, 1.58 and 1.52; and Japanese, 1.58 and 1.49 (p < 0.001). In a large US healthcare population of older Asian/PI adults, low 25(OH)D prevalence was 1.5- to 2.7-fold higher for Asian/PI compared to NHW adults, with substantial variation by sex and ethnicity.

Varying the intensity of cystoscopic surveillance for high-risk non-muscle-invasive bladder cancer.

To compare the clinical, economic, and health utility outcomes associated with alternative cystoscopic surveillance regimens for high-risk non-muscle-invasive bladder cancer (HRNMIBC). We performed real-world clinical data-driven microsimulations of a hypothetical cohort of 100 000 patients diagnosed with HRNMIBC at age 70 years. The cohort was simulated to undergo alternative surveillance regimens recommended by five guidelines, and two hypothetical regimens-surveillance intensity escalation and de-escalation-which had a surveillance intensity moderately higher and lower, respectively, than the guideline-recommended regimens. We evaluated the 10-year cumulative incidence of muscle-invasive bladder cancer (MIBC), cancer-specific survival (CSS), overall survival (OS), and cost-effectiveness from a United States healthcare payer perspective. The guideline-recommended surveillance regimens led to an estimated 10-year cumulative incidence of MIBC ranging from 11.0% to 11.6%, CSS 95.0% to 95.2%, and OS 69.7% to 69.8%. Surveillance intensity escalation resulted in a 10-year cumulative incidence of MIBC of 10.5% (95% confidence interval [CI] 10.3-10.7%), CSS of 95.4% (95% CI 95.2-95.5%), and OS of 69.9% (95% CI 69.6-70.1%), vs 11.9% (95% CI 11.7-12.1%), 94.9% (95% CI 94.8-95.1%), and 69.6% (95% CI 69.3-69.9%), respectively, from surveillance intensity de-escalation. By increasing surveillance intensity, the number-needed-to-treat to prevent one additional MIBC progression over 10 years was ≥80, and ≥257 to avoid one additional cancer-related mortality. Compared to surveillance intensity de-escalation, higher-intensity regimens incurred an incremental cost of ≥$336 000 per incremental quality-adjusted life year gained, which well exceeded conventional willingness-to-pay thresholds, ≥$686 000 per additional MIBC progression prevented, and ≥$2.2 million per additional cancer-related mortality avoided. In microsimulations testing a wide range of cystoscopic surveillance intensity for patients newly diagnosed with HRNMIBC, moderate surveillance de-escalation appears associated with an insignificant change in 10-year OS and furthermore is cost-effective vs higher-intensity surveillance regimens. These results suggest that moderate surveillance de-escalation can reduce costs of care without compromising life expectancy for many patients.

Challenges in Receiving Care for Long COVID: A Qualitative Interview Study Among Primary Care Patients About Expectations and Experiences.

For many patients with post-COVID-19 condition (long COVID), primary care is the first point of interaction with the health care system. In principle, primary care is well situated to manage long COVID. Beyond expressions of disempowerment, however, the patient's perspective regarding the quality of long COVID care is lacking. Therefore, this study aimed to analyze the expectations and experiences of primary care patients seeking treatment for long COVID. A phenomenological approach guided this analysis. Using purposive sampling, we conducted semistructured interviews with English-speaking, adult primary care patients describing symptoms of long COVID. We deidentified and transcribed the recorded interviews. Transcripts were analyzed using inductive qualitative content analysis. This article reports results from 19 interviews (53% female, mean age = 54 years). Patients expected their primary care practitioners (PCPs) to be knowledgeable about long COVID, attentive to their individual condition, and to engage in collaborative processes for treatment. Patients described 2 areas of experiences. First, interactions with clinicians were perceived as positive when clinicians were honest and validating, and negative when patients felt dismissed or discouraged. Second, patients described challenges navigating the fragmented US health care system when coordinating care, treatment and testing, and payment. Primary care patients' experiences seeking care for long COVID are incongruent with their expectations. Patients must overcome barriers at each level of the health care system and are frustrated by the constant challenges. PCPs and other health care professionals might increase congruence with expectations and experiences through listening, validating, and advocating for patients with long COVID.Annals Early Access article.

Emulating Randomized Trials by Observational Database Studies: The RCT-DUPLICATE Initiative in COPD and Asthma.

Observational studies are increasingly used to provide real-world evidence in regulatory decision-making. The RCT-DUPLICATE initiative conducted observational studies emulating two trials in patients with asthma and three in COPD. For each trial, new-user cohorts were constructed from two US healthcare claims databases, comparing initiators of the study and comparator drugs, matched on propensity scores. Proportional hazards models were used to compare the treatments on study outcomes. The observational studies involved more subjects than the corresponding trials, with treatment arms well-matched on baseline characteristics. An asthma example involved emulation of the 26-week FDA-mandated D5896 trial. With 6,494 asthma patients per arm, the hazard ratio (HR) of a serious asthma-related event with budesonide-formoterol versus budesonide was 1.29 (95% CI: 0.63-2.65), compared with 1.07 (95% CI: 0.70-1.65) in the trial. A COPD example is the emulation of the one-year IMPACT trial. With 4,365 COPD patients per arm, the HR of a COPD exacerbation with triple therapy versus dual bronchodilators was 1.08 (95% CI: 1.00-1.17), compared with 0.84 (95% CI: 0.78-0.91) in the trial. We found mainly discordant results between observational analyses and randomized trials, likely from the forced discontinuation of treatments prior to randomization in the trials, not mimicable in the observational analyses.