Predictors of high-intensity care at the end of life among older adults with solid tumors: A population-based study.

INTRODUCTION: High-intensity end-of-life (EoL) care can be burdensome for patients, caregivers, and health systems and does not confer any meaningful clinical benefit. Yet, there are significant knowledge gaps regarding the predictors of high-intensity EoL care. In this study, we identify risk factors associated with high-intensity EoL care among older adults with the four most common malignancies, including breast, prostate, lung, and colorectal cancer. MATERIALS AND METHODS: Using SEER-Medicare data, we conducted a retrospective analysis of Medicare beneficiaries aged 65 and older who died of breast, prostate, lung, or colorectal cancer between 2011 and 2015. We used multivariable logistic regression to identify clinical, demographic, socioeconomic, and geographic predictors of high-intensity EoL care, which we defined as death in an acute care hospital, receipt of any oral or parenteral chemotherapy within 14 days of death, one or more admissions to the intensive care unit within 30 days of death, two or more emergency department visits within 30 days of death, or two or more inpatient admissions within 30 days of death. RESULTS: Among 59,355 decedents, factors associated with increased likelihood of receiving high-intensity EoL care were increased comorbidity burden (odds ratio [OR]:1.29; 95% confidence interval [CI]:1.28-1.30), female sex (OR:1.05; 95% CI:1.01-1.09), Black race (OR:1.14; 95% CI:1.07-1.23), Other race/ethnicity (OR:1.20; 95% CI:1.10-1.30), stage III disease (OR:1.11; 95% CI:1.05-1.18), living in a county with >1,000,000 people (OR:1.23; 95% CI:1.16-1.31), living in a census tract with 10%-<20% poverty (OR:1.09; 95% CI:1.03-1.16) or 20%-100% poverty (OR:1.12; 95% CI:1.04-1.19), and having state-subsidized Medicare premiums (OR:1.18; 95% CI:1.12-1.24). The risk of high-intensity EoL care was lower among patients who were older (OR:0.98; 95% CI:0.98-0.99), lived in the Midwest (OR:0.69; 95% CI:0.65-0.75), South (OR:0.70; 95% CI:0.65-0.74), or West (OR:0.81; 95% CI:0.77-0.86), lived in mostly rural areas (OR:0.92; 95% CI:0.86-1.00), and had poor performance status (OR:0.26; 95% CI:0.25-0.28). Results were largely consistent across cancer types. DISCUSSION: The risk factors identified in our study can inform the development of new interventions for patients with cancer who are likely to receive high-intensity EoL care. Health systems should consider incorporating these risk factors into decision-support tools to assist clinicians in identifying which patients should be referred to hospice and palliative care.

County-Level Mandates Were Generally Effective At Slowing COVID-19 Transmission.

Throughout the COVID-19 pandemic in the US, counties adopted numerous nonpharmaceutical interventions, such as mask mandates and stay-at-home orders, to slow COVID-19 transmission and prevent hospitals from reaching full capacity. Early evidence has been mixed about whether these interventions are effective. However, most studies only covered the early waves of COVID-19 and did not account for county-level variation in the adoption and repeal of such policies. Using daily county-level data from the Centers for Disease Control and Prevention, we evaluated the joint impact of bans on large gatherings, stay-at-home orders, mask mandates, and bar and restaurant closures on slowing COVID-19 transmission during waves 1-4 of the pandemic in the US (March 1, 2020-June 30, 2021). Our survival analysis showed that these interventions were generally effective at slowing COVID-19 transmission during this period. The mitigating effect was particularly strong during waves 2 and 3 and less substantial during waves 1 and 4. We also found strong evidence of the overall protective effect of mask mandates and, to a lesser degree, anticongregation policies. These study findings provide crucial evidence for public health officials to reference for support when using nonpharmaceutical interventions to flatten the curve of future waves of COVID-19 or other infectious disease outbreaks.

Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies.

Objectives: The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum data set for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved. Results: Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data. Conclusions: The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.

Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.

Objectives: A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies. Design: We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated and analyzed by a study design team from Weill Cornell Medicine. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved. Results: Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes. Conclusions: The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.

Development of a coordinated registry network for pelvic organ prolapse technologies.

Objectives: The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements important to assess POP technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum dataset for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved. Results: Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors. Conclusions: The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.