A framework for setting enrollment goals to ensure participant diversity in sponsored clinical trials in the United States.

BACKGROUND: Diversity in clinical trials (CTs) has the potential to improve health equity and close health disparities. Underrepresentation of historically underserved groups compromises the generalizability of trial findings to the target population, hinders innovation, and contributes to low accrual. The aim of this study was to establish a transparent and reproducible process for setting trial diversity enrollment goals informed by the disease epidemiology. METHOD: An advisory board of epidemiologists with expertise in health disparities, equity, diversity, and social determinants of health was convened to evaluate and strengthen the initial goal-setting framework. Data sources used were the epidemiologic literature, US Census, and real-world data (RWD); limitations were considered and addressed where appropriate. A framework was designed to safeguard against the underrepresentation of historically medically underserved groups. A stepwise approach was created with Y/N decisions based on empirical data. RESULTS: We compared race and ethnicity distributions in the RWD of six diseases from Pfizer's portfolio chosen to represent different therapeutic areas (multiple myeloma, fungal infections, Crohn's disease, Gaucher disease, COVID-19, and Lyme disease) to the distributions in the US Census and established trial enrollment goals. Enrollment goals for potential CTs were based on RWD for multiple myeloma, Gaucher disease, and COVID-19; enrollment goals were based on the Census for fungal infections, Crohn's disease, and Lyme disease. CONCLUSIONS: We developed a transparent and reproducible framework for setting CT diversity enrollment goals. We note how limitations due to data sources can be mitigated and consider several ethical decisions in setting equitable enrollment goals.

Long COVID and Medicine's Two Cultures.

Medicine has separated the two cultures of biological science and social science in research, even though they are intimately connected in the lives of our patients. To understand the cause, progression, and treatment of long COVID , biology and biography, the patient's lived experience, must be studied together.

Defining Essential Surgery in the US During the COVID-19 Pandemic Response.

This cohort study compares the volume of performed surgical procedures classified as essential, urgent, and nonurgent before and after elective surgeries were restricted during the COVID-19 pandemic in the US.

Disease-Specific Health Disparities: A Targeted Review Focusing on Race and Ethnicity.

BACKGROUND: Wide disparities in health status exist in the United States across race and ethnicity, broadly driven by social determinants of health-most notably race and ethnic group differences in income, education, and occupational status. However, disparities in disease frequency or severity remain underappreciated for many individual diseases whose distribution in the population varies. Such information is not readily accessible, nor emphasized in treatment guidelines or reviews used by practitioners. Specifically, a summary on disease-specific evidence of disparities from population-based studies is lacking. Our goal was to summarize the published evidence for specific disease disparities in the United States so that this knowledge becomes more widely available "at the bedside". We hope this summary stimulates health equity research at the disease level so that these disparities can be addressed effectively. METHODS: A targeted literature review of disorders in Pfizer's current pipeline was conducted. The 38 diseases included metabolic disorders, cancers, inflammatory conditions, dermatologic disorders, rare diseases, and infectious targets of vaccines under development. Online searches in Ovid and Google were performed to identify sources focused on differences in disease rates and severity between non-Hispanic Whites and Black/African Americans, and between non-Hispanic Whites and Hispanics. As a model for how this might be accomplished for all disorders, disparities in disease rates and disease severity were scored to make the results of our review most readily accessible. After primary review of each condition by one author, another undertook an independent review. Differences between reviewers were resolved through discussion. RESULTS: For Black/African Americans, 29 of the 38 disorders revealed a robust excess in incidence, prevalence, or severity. After sickle cell anemia, the largest excesses in frequency were identified for multiple myeloma and hidradenitis suppurativa. For Hispanics, there was evidence of disparity in 19 diseases. Most notable were metabolic disorders, including non-alcoholic steatohepatitis (NASH). CONCLUSIONS: This review summarized recent disease-specific evidence of disparities based on race and ethnicity across multiple diseases, to inform clinicians and health equity research. Our findings may be well known to researchers and specialists in their respective fields but may not be common knowledge to health care providers or public health and policy institutions. Our hope is that this effort spurs research into the causes of the many disease disparities that exist in the United States.

Population health science as a unifying foundation for translational clinical and public health research.

Separated both in academics and practice since the Rockefeller Foundation effort to "liberate" public health from perceived subservience to clinical medicine a century ago, research in public health and clinical medicine have evolved separately. Today, translational research in population health science offers a means of fostering their convergence, with potentially great benefit to both domains. Although evidence that the two fields need not and should not be entirely distinct in their methods and goals has been accumulating for over a decade, the prodigious efforts of biomedical and social sciences over the past year to address the COVID-19 pandemic has placed this unifying approach to translational research in both fields in a new light. Specifically, the coalescence of clinical and population-level strategies to control disease and novel uses of population-level data and tools in research relating to the pandemic have illuminated a promising future for translational research. We exploit this unique window to re-examine how translational research is conducted and where it may be going. We first discuss the transformation that has transpired in the research firmament over the past two decades and the opportunities these changes afford. Next, we present some of the challenges-technical, cultural, legal, and ethical- that need attention if these opportunities are to be successfully exploited. Finally, we present some recommendations for addressing these challenges.

Trends in US Surgical Procedures and Health Care System Response to Policies Curtailing Elective Surgical Operations During the COVID-19 Pandemic.

Importance: The COVID-19 pandemic has affected every aspect of medical care, including surgical treatment. It is critical to understand the association of government policies and infection burden with surgical access across the United States. Objective: To describe the change in surgical procedure volume in the US after the government-suggested shutdown and subsequent peak surge in volume of patients with COVID-19. Design, Setting, and Participants: This retrospective cohort study was conducted using administrative claims from a nationwide health care technology clearinghouse. Claims from pediatric and adult patients undergoing surgical procedures in 49 US states within the Change Healthcare network of health care institutions were used. Surgical procedure volume during the 2020 initial COVID-19-related shutdown and subsequent fall and winter infection surge were compared with volume in 2019. Data were analyzed from November 2020 through July 2021. Exposures: 2020 policies to curtail elective surgical procedures and the incidence rate of patients with COVID-19. Main Outcomes and Measures: Incidence rate ratios (IRRs) were estimated from a Poisson regression comparing total procedure counts during the initial shutdown (March 15 to May 2, 2020) and subsequent COVID-19 surge (October 22, 2020-January 31, 2021) with corresponding 2019 dates. Surgical procedures were analyzed by 11 major procedure categories, 25 subcategories, and 12 exemplar operative procedures along a spectrum of elective to emergency indications. Results: A total of 13 108 567 surgical procedures were identified from January 1, 2019, through January 30, 2021, based on 3498 Current Procedural Terminology (CPT) codes. This included 6 651 921 procedures in 2019 (3 516 569 procedures among women [52.9%]; 613 192 procedures among children [9.2%]; and 1 987 397 procedures among patients aged ≥65 years [29.9%]) and 5 973 573 procedures in 2020 (3 156 240 procedures among women [52.8%]; 482 637 procedures among children [8.1%]; and 1 806 074 procedures among patients aged ≥65 years [30.2%]). The total number of procedures during the initial shutdown period and its corresponding period in 2019 (ie, epidemiological weeks 12-18) decreased from 905 444 procedures in 2019 to 458 469 procedures in 2020, for an IRR of 0.52 (95% CI, 0.44 to 0.60; P < .001) with a decrease of 48.0%. There was a decrease in surgical procedure volume across all major categories compared with corresponding weeks in 2019. During the initial shutdown, otolaryngology (ENT) procedures (IRR, 0.30; 95% CI, 0.13 to 0.46; P < .001) and cataract procedures (IRR, 0.11; 95% CI, -0.11 to 0.32; P = .03) decreased the most among major categories. Organ transplants and cesarean deliveries did not differ from the 2019 baseline. After the initial shutdown, during the ensuing COVID-19 surge, surgical procedure volumes rebounded to 2019 levels (IRR, 0.97; 95% CI, 0.95 to 1.00; P = .10) except for ENT procedures (IRR, 0.70; 95% CI, 0.65 to 0.75; P < .001). There was a correlation between state volumes of patients with COVID-19 and surgical procedure volume during the initial shutdown (r = -0.00025; 95% CI, -0.0042 to -0.0009; P = .003), but there was no correlation during the COVID-19 surge (r = -0.00034; 95% CI, -0.0075 to 0.00007; P = .11). Conclusions and Relevance: This study found that the initial shutdown period in March through April 2020, was associated with a decrease in surgical procedure volume to nearly half of baseline rates. After the reopening, the rate of surgical procedures rebounded to 2019 levels, and this trend was maintained throughout the peak burden of patients with COVID-19 in fall and winter; these findings suggest that after initial adaptation, health systems appeared to be able to self-regulate and function at prepandemic capacity.

The impact of novel coronavirus COVID-19 on noncommunicable disease patients and health systems: a review.

Coronavirus disease 2019 (COVID-19) is an ongoing global pandemic affecting all levels of health systems. This includes the care of patients with noncommunicable diseases (NCDs) who bear a disproportionate burden of both COVID-19 itself and the public health measures enacted to combat it. In this review, we summarize major COVID-19-related considerations for NCD patients and their care providers, focusing on cardiovascular, pulmonary, renal, haematologic, oncologic, traumatic, obstetric/gynaecologic, operative, psychiatric, rheumatologic/immunologic, neurologic, gastrointestinal, ophthalmologic and endocrine disorders. Additionally, we offer a general framework for categorizing the pandemic's disruptions by disease-specific factors, direct health system factors and indirect health system factors. We also provide references to major NCD medical specialty professional society statements and guidelines on COVID-19. COVID-19 and its control policies have already resulted in major disruptions to the screening, treatment and surveillance of NCD patients. In addition, it differentially impacts those with pre-existing NCDs and may lead to de novo NCD sequelae. Likely, there will be long-term effects from this pandemic that will continue to affect practitioners and patients in this field for years to come.