Assessing the properties of patient-specific treatment effect estimates from causal forest algorithms under essential heterogeneity.

Background: Treatment variation from observational data has been used to estimate patient-specific treatment effects. Causal Forest Algorithms (CFAs) developed for this task have unknown properties when treatment effect heterogeneity from unmeasured patient factors influences treatment choice - essential heterogeneity.

Methods: We simulated eleven populations with identical treatment effect distributions based on patient factors.

Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial.

Background: Cigarette smoking remains the leading cause of preventable disease and death in the United States. Primary care offers an ideal setting to reach adults who smoke cigarettes and improve uptake of evidence-based cessation treatment. Although U.

"And then I found $5": Optimizing recruitment efficiency in remote clinical trials.

Introduction: As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward.

Cost-effectiveness of peer-delivered physical activity promotion and maintenance programs for initially sedentary breast cancer survivors.

The evidence for the survival and health benefits of physical activity (PA) among cancer survivors is well documented. However, it has been challenging to maintain PA among cancer survivors. To evaluate the cost-effectiveness of peer support to encourage maintenance of moderate-to-vigorous physical activity (MVPA) among breast cancer survivors.

Participation in the CenteringPregnancy Program and Pregnancy-Induced Hypertension.

Introduction: CenteringPregnancy emphasizes nutrition, learning, and peer support through a group meeting format in contrast to the standard of prenatal care that maximizes a pregnant patient's time with their provider. It was hypothesized that the program may yield a reduced risk of pregnancy-induced hypertension. In this observational study, authors examined the impacts of the CenteringPregnancy program versus those of standard of prenatal care on pregnancy-induced hypertension.

Differential patterns of opioid misuse between younger and older adults - a retrospective observational study using data from South Carolina's prescription drug monitoring program.

Most research on opioid misuse focuses on younger adults, yet opioid-related mortality has risen fastest among older Americans over age 55. To assess whether there are differential patterns of opioid misuse over time between younger and older adults and whether South Carolina's mandatory Prescription Drug Monitoring Program (PDMP) affected opioid misuse differentially between the two groups. We used South Carolina's Reporting and Identification Prescription Tracking System from 2010 to 2018 to calculate an opioid misuse score for 193,073 patients (sex unknown) using days' supply, morphine milligram equivalents (MME), and the numbers of unique prescribers and dispensaries.

Assessing the ability of an instrumental variable causal forest algorithm to personalize treatment evidence using observational data: the case of early surgery for shoulder fracture.

Background: Comparative effectiveness research (CER) using observational databases has been suggested to obtain personalized evidence of treatment effectiveness. Inferential difficulties remain using traditional CER approaches especially related to designating patients to reference classes a priori. A novel Instrumental Variable Causal Forest Algorithm (IV-CFA) has the potential to provide personalized evidence using observational data without designating reference classes a priori, but the consistency of the evidence when varying key algorithm parameters remains unclear.

Liability Waivers for COVID-19: Law, Policy, and Practice.

As businesses reopen, the practice of asking customers to sign COVID-19 liability waivers is increasing throughout the United States. Although the courts have not yet decided the enforceability of COVID-19-related liability waivers, existing case law, as well as new executive and legislative actions, suggests that such waivers may offer some protection to businesses from liability. Nevertheless, we believe that the legal and ethical rationales underlying liability waivers are not applicable to a pandemic.

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.

The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to reference products and to encourage market competition. Between 2007 and 2020, 33 biosimilars for oncology were approved by the European Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

Associations Between Physician Supply Levels and Amenable Mortality Rates: An Analysis of Taiwan Over Nearly 4 Decades.

Access to health care is an important determinant of health, but it remains unclear whether having more physicians reduces mortality. In this study, we used Taiwan's population-level National Death Certification Registry data to investigate whether a greater supply of physicians is associated with lower rates of amenable mortality, defined as deaths that can be delayed with appropriate and timely medical treatment. Our baseline regression analysis adjusting only for age and sex shows that an increase in the number of physicians per 1000 is associated with a reduction of 1.

Are quality-adjusted medical prices declining for chronic disease? Evidence from diabetes care in four health systems.

Improvements in medical treatment have contributed to rising health spending. Yet there is relatively little evidence on whether the spending increase is "worth it" in the sense of producing better health outcomes of commensurate value-a critical question for understanding productivity in the health sector and, as that sector grows, for deriving an accurate quality-adjusted price index for an entire economy. We analyze individual-level panel data on medical spending and health outcomes for 123,548 patients with type 2 diabetes in four health systems: Japan, The Netherlands, Hong Kong and Taiwan.

Early evidence from South Carolina's Medicare-Medicaid dual-eligible financial alignment initiative: an observational study to understand who enrolled, and whether the program improved health?

Background: Individuals dually eligible for Medicare and Medicaid coverage are among the sickest patients in the United States. Prior literature has identified a lack of care coordination or even conflicts of interest between the two programs as barriers to more efficient care and better health outcomes among dual-eligibles. The purpose of this study is to assess characteristics of dual eligibles who participated in South Carolina's 2015 voluntary Medicare-Medicaid financial alignment demonstration project, and to evaluate whether their participation led to better observable health outcomes.

Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition.

Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics.

Avoidable Hospital Admissions From Diabetes Complications In Japan, Singapore, Hong Kong, And Communities Outside Beijing.

Improving the quality of primary care may reduce avoidable hospital admissions. Avoidable admissions for conditions such as diabetes are used as a quality metric in the Health Care Quality Indicators of the Organization for Economic Cooperation and Development (OECD). Using the OECD indicators, we compared avoidable admission rates and spending for diabetes-related complications in Japan, Singapore, Hong Kong, and rural and peri-urban Beijing, China, in the period 2008-14.

Patient Copayments, Provider Incentives and Income Effects: Theory and Evidence from the Essential Medications List under China's 2009 Healthcare Reform.

Expanding access through insurance expansion can increase healthcare utilization through moral hazard. Reforming provider incentives to introduce more cost sharing is increasingly viewed as crucial for affordable, sustainable access. Using both difference-in-differences and segmented regression analyses on a panel of 1,466 hypertensive and diabetic patients, we empirically examine Shandong province's initial implementation of China's 2009 Essential Medications List policy.

Forecasting Trends in Disability in a Super-Aging Society: Adapting the Future Elderly Model to Japan.

Japan has experienced pronounced population aging, and now has the highest proportion of elderly adults in the world. Yet few projections of Japan's future demography go beyond estimating population by age and sex to forecast the complex evolution of the health and functioning of the future elderly. This study estimates a new state-transition microsimulation model - the Japanese Future Elderly Model (FEM) - for Japan.

Parity, Age at First Birth, and Risk of Death from Bladder Cancer: A Population-Based Cohort Study in Taiwan.

The evidence is limited on the relationship between reproductive factors and bladder cancer (BC). We studied 1,292,462 women who had a first and singleton delivery between 1 January 1978 and 31 December 1987. Each woman in the study cohort was tracked from their first childbirth to 31 December 2009.

Generic oncology drugs: are they all safe?

Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel).

Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns.

Statins are Associated With a Reduced Risk of Brain Cancer: A Population-Based Case-Control Study.

The aim of this study was to investigate whether statin utilization is associated with brain cancer risk.A population-based case-control study was conducted using nationally representative claims data from the National Health Insurance Bureau in Taiwan. Cases included all patients 50 years and older who received an index diagnosis of brain cancer between 2004 and 2011.

Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

Introduction: Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown.

Objectives: To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims.

Parity, Age at First Birth, and Risk of Death from Non-Hodgkin's Lymphoma: A Population-Based Cohort Study in Taiwan.

We undertook this study to examine whether there exists an association between parity and age at first birth and risk of death from non-Hodgkin's lymphoma (NHL). Our sample included a total of 1,292,462 women who had a first and singleton childbirth between 1 January 1978 and 31 December 1987. We followed each subject from their first childbirth to 31 December 2009, and determined their vital status by merging natality data with Taiwan's national death certificate database.

Travel distances, socioeconomic characteristics, and health disparities in nonurgent and frequent use of Hospital Emergency Departments in South Carolina: a population-based observational study.

Background: Nonurgent use of hospital emergency departments (ED) is a controversial topic. It is thought to increase healthcare costs and reduce quality, but is also considered a symptom of unequal access to health care. In this article, we investigate whether convenience (as proxied by travel distances to the hospital ED and to the closest federally qualified health center) is associated with nonurgent ED use, and whether evidence of health disparities exist in the way vulnerable populations use the hospital ED for medical care in South Carolina.