IMPORTANCE: The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. OBSERVATIONS: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.

INTRODUCTION: COVID-19 causes significant morbidity in the USA, particularly among American Indian/Alaska Native (AI/AN) persons. Estimates of COVID-19 burden among AI/AN communities are needed to identify health outcome disparities and inform prevention strategies, but under-ascertainment of AI/AN status in national data may result in underestimation of COVID-19 disease burden. METHODS: Surveillance for acute respiratory illness was conducted among AI/AN persons at eight healthcare facilities in Arizona and Alaska to identify COVID-19-associated hospitalizations and outpatient visits. Weekly and annual incidence rates of COVID-19-associated hospitalizations per 100,000 persons were calculated overall and by site and age. Risk factors for COVID-19-associated hospitalizations (versus outpatient visits) were assessed. RESULTS: From January 2021 to December 2022, 1159 COVID-19-associated hospitalizations were identified. Incidence rates were 439.8 per 100,000 in 2021 and 332.6 per 100,000 in 2022 and highest among adults ≥ 65 years at all sites. Compared to national estimates from 2021 to 2022, incidence rates by time and age were similar among older adults, whereas incidence rates among AI/AN children were over twice as high. Among adults, older age, chronic lung disease, chronic kidney disease, and diabetes increased the risk of hospitalization; frequent mask use outside the home and COVID-19 vaccination were protective, particularly if vaccinated within the past year. Among children, younger age and heart conditions increased the risk of hospitalization. CONCLUSIONS: The findings demonstrate a substantial burden of COVID-19 in AI/AN persons and provide critically needed data regarding the risks for severe outcomes. AI/AN children experience a disproportionate burden of COVID-19 disease.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. METHODS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. RESULTS: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators and other reviewers.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

IMPORTANCE: Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. OBSERVATIONS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS AND RELEVANCE: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.

Long-term effects of COVID-19 on multiple organ systems have been reported. Indigenous persons experienced disproportionate morbidity and mortality from COVID-19; however, Post-COVID-19 Conditions (PCC) have not been well described in this population. We conducted a longitudinal cohort study among Indigenous persons living in the Navajo Nation or White Mountain Apache Tribal lands in the Southwest United States who tested positive for SARS-CoV-2 between February 1, 2021 and August 31, 2022. Participants were enrolled during their acute illness and followed for three months. PCC was defined as the presence of any self-reported symptom and/or any sequelae or new condition recorded in the electronic health record at the 3-month visit. Risk factors for PCC were evaluated using Poisson regression with robust standard errors. The analysis included 258 adults and 84 children. Most participants (98.4% of adults, 90.5% of children) experienced a mild, symptomatic acute illness. Over half of adults (57.8%) and a third (39.3%) of children experienced six or more symptoms during the acute illness. Three months post-acute COVID-19, 39.8% of adults and 15.9% of children had symptoms consistent with PCC. Commonly reported symptoms were fatigue/tiredness, cough, headache, runny nose, and myalgia. Among adults enrolled during Omicron predominance, older age and hospitalization for COVID-19 were significantly associated with an increased risk of PCC, and COVID-19 vaccination was significantly associated with a decreased risk of PCC in univariable analysis. In a multivariable analysis, COVID-19 vaccination (risk ratio: 0.56; 95% confidence interval: 0.34, 0.90) remained significantly associated with a decreased risk of PCC. In this cohort of Indigenous persons in the Southwest US, PCC at three months post-acute COVID-19 illness were common, including among individuals with mild acute illness. While the absence of a control group is a limitation, these findings highlight the potential ongoing healthcare needs related to PCC in Indigenous populations.

PURPOSE: Cancer incidence declined during the COVID-19 pandemic in part due to health care delivery challenges. We examined the impact of the COVID-19 pandemic on changes in lung cancer incidence. METHODS: We used 2019-2020 US Cancer Statistics data from 49 cancer registries covering 97% of the US population. We calculated the number of new lung cancer diagnoses in 2019 and 2020, age-adjusted lung cancer incidence rates per 100,000 persons, and 2019-to-2020 percentage changes in incidence rates. We also calculated number and percentage of new lung cancer diagnoses by month and stage at diagnosis. RESULTS: The age-adjusted lung cancer incidence rate per 100,000 persons was 47.9 in 2019 vs. 41.4 in 2020-a 13.6% decrease. Differences in the percentage change in incidence rates were observed by age, race and ethnicity, US census region, histology, and stage at diagnosis. A higher percentage of people were diagnosed at distant stage in 2020 than 2019. CONCLUSIONS: This report provides new insight into subgroups that experienced the greatest decline in observed lung cancer incidence during the first year of the COVID-19 pandemic. The findings can be used to inform intervention efforts to improve lung cancer screening, diagnosis, and treatment.

BACKGROUND: Data modernization efforts to strengthen surveillance capacity could help assess trends in use of preventive services and diagnoses of new chronic disease during the COVID-19 pandemic, which broadly disrupted health care access. METHODS: This cross-sectional study examined electronic health record data from US adults aged 21 to 79 years in a large national research network (PCORnet), to describe use of 8 preventive health services (N = 30,783,825 patients) and new diagnoses of 9 chronic diseases (N = 31,588,222 patients) during 2018 through 2022. Joinpoint regression assessed significant trends, and health debt was calculated comparing 2020 through 2022 volume to prepandemic (2018 and 2019) levels. RESULTS: From 2018 to 2022, use of some preventive services increased (hemoglobin A(1c) and lung computed tomography, both P < .05), others remained consistent (lipid testing, wellness visits, mammograms, Papanicolaou tests or human papillomavirus tests, stool-based screening), and colonoscopies or sigmoidoscopies declined (P < .01). Annual new chronic disease diagnoses were mostly stable (6% hypertension; 4% to 5% cholesterol; 4% diabetes; 1% colonic adenoma; 0.1% colorectal cancer; among women, 0.5% breast cancer), although some declined (lung cancer, cervical intraepithelial neoplasia or carcinoma in situ, cervical cancer, all P < .05). The pandemic resulted in health debt, because use of most preventive services and new diagnoses of chronic disease were less than expected during 2020; these partially rebounded in subsequent years. Colorectal screening and colonic adenoma detection by age group aligned with screening recommendation age changes during this period. CONCLUSION: Among over 30 million patients receiving care during 2018 through 2022, use of preventive services and new diagnoses of chronic disease declined in 2020 and then rebounded, with some remaining health debt. These data highlight opportunities to augment traditional surveillance with EHR-based data.

A comprehensive understanding of the spatial distribution and correlates of infection are key for the planning of disease control programs and assessing the feasibility of elimination and/or eradication. In this work, we used species distribution modeling to predict the environmental suitability of the Guinea worm (Dracunculus medinensis) and identify important climatic and sociodemographic risk factors. Using Guinea worm surveillance data collected by the Chad Guinea Worm Eradication Program (CGWEP) from 2010 to 2022 in combination with remotely sensed climate and sociodemographic correlates of infection within an ensemble machine learning framework, we mapped the environmental suitability of Guinea worm infection in Chad. The same analytical framework was also used to ascertain the contribution and influence of the identified climatic risk factors. Spatial distribution maps showed predominant clustering around the southern regions and along the Chari River. We also identified areas predicted to be environmentally suitable for infection. Of note are districts near the western border with Cameroon and southeastern border with Central African Republic. Key environmental correlates of infection as identified by the model were proximity to permanent rivers and inland lakes, farmlands, land surface temperature, and precipitation. This work provides a comprehensive model of the spatial distribution of Guinea worm infections in Chad 2010-2022 and sheds light on potential environmental correlates of infection. As the CGWEP moves toward elimination, the methods and results in this study will inform surveillance activities and help optimize the allocation of intervention resources.

BACKGROUND: Knowledge of specific health-related events encountered by students studying abroad and the availability and use of pre-travel healthcare for these students is lacking. METHODS: Anonymous web-based questionnaires were sent to study abroad offices, student health centers, and undergraduate students after studying abroad at eight institutions of higher education in the United States and Ireland from 2018-2021. Analyses were descriptive; relative risks and 95% confidence intervals were calculated for health-related events. RESULTS: One study abroad office required a pre-travel consultation. All student health centers had pre-travel counseling available. Among 686 students, there were 307 infectious and 1,588 non-infectious health-related issues; 12 students (2%) were hospitalized. Duration of travel and timing of a pre-travel consultation impacted the risk of health-related events. Certain mental health conditions were associated with increased risk of alcohol and drug use. CONCLUSION: Future studies should address the optimal timing and best practices to optimize health for students studying abroad.

INTRODUCTION: Therapeutic options for men with metastatic prostate cancer have increased in the past decade. We studied recent treatment patterns for men with metastatic prostate cancer and how treatment patterns have changed over time. METHODS: Using the Surveillance, Epidemiology, and End Results‒Medicare database, we identified fee-for-service Medicare beneficiaries who either were diagnosed with metastatic prostate cancer or developed metastases following diagnosis, as indicated by the presence of claims with diagnoses codes for metastatic disease, between 2007 and 2017. We evaluated treatment patterns using claims. RESULTS: We identified 29,800 men with metastatic disease, of whom 4721 (18.8%) had metastatic disease at their initial diagnosis. The mean age was 77 years, and 77.9% of patients were non-Hispanic White. The proportion receiving antineoplastic agents within 3 years of the index date increased over time (from 9.7% in 2007 to 25.9% in 2017; P < .001). Opioid use within 3 years of prostate cancer diagnosis was stable during 2007 to 2013 (around 73%) but decreased through 2017 to 65.5% (P < .001). Patients diagnosed during 2015 to 2017 had longer median survival (32.6 months) compared to those diagnosed during 2007 to 2010 (26.6 months; P < .001). CONCLUSIONS: Most metastatic prostate cancer patients do not receive life-prolonging antineoplastic therapies. Improved adoption of effective cancer therapies when appropriate may increase length and quality of survival among metastatic prostate cancer patients.

BACKGROUND: The Middle East respiratory syndrome coronavirus (MERS-CoV) was discovered September 2012 in the Kingdom of Saudi Arabia (KSA). The first US case of MERS-CoV was confirmed on 2 May 2014. METHODS: We summarize the clinical symptoms and signs, laboratory and radiologic findings, and MERS-CoV-specific tests. RESULTS: The patient is a 65-year-old physician who worked in a hospital in KSA where MERS-CoV patients were treated. His illness onset included malaise, myalgias, and low-grade fever. He flew to the United States on day of illness (DOI) 7. His first respiratory symptom, a dry cough, developed on DOI 10. On DOI 11, he presented to an Indiana hospital as dyspneic, hypoxic, and with a right lower lobe infiltrate on chest radiography. On DOI 12, his serum tested positive by real-time reverse transcription polymerase chain reaction (rRT-PCR) for MERS-CoV and showed high MERS-CoV antibody titers, whereas his nasopharyngeal swab was rRT-PCR negative. Expectorated sputum was rRT-PCR positive the following day, with a high viral load (5.31 × 10(6) copies/mL). He was treated with antibiotics, intravenous immunoglobulin, and oxygen by nasal cannula. He was discharged on DOI 22. The genome sequence was similar (>99%) to other known MERS-CoV sequences, clustering with those from KSA from June to July 2013. CONCLUSIONS: This patient had a prolonged nonspecific prodromal illness before developing respiratory symptoms. Both sera and sputum were rRT-PCR positive when nasopharyngeal specimens were negative. US clinicians must be vigilant for MERS-CoV in patients with febrile and/or respiratory illness with recent travel to the Arabian Peninsula, especially among healthcare workers.

BACKGROUND: Few studies have comprehensively compared health-related quality of life (HRQoL) between metastatic prostate cancer survivors, survivors with non-metastatic disease, and men without a cancer history. METHODS: We used the Surveillance, Epidemiology, and End Results-Medicare Health Outcomes Survey (SEER-MHOS) data linkage to identify men aged ≥ 65 years enrolled in Medicare Advantage (MA) plans. Prostate cancer survivors were diagnosed between 1988 and 2017 and completed MHOS surveys between 1998 and 2019. We analyzed data from 752 metastatic prostate cancer survivors (1040 survey records), 19,583 localized or regional prostate cancer survivors (non-metastatic; 30,121 survey records), and 784,305 men aged ≥ 65 years without a cancer history in the same SEER regions (1.15 million survey records). We used clustered linear regressions to compare HRQoL measures at the person-level using the Veterans RAND 12 Item Health Survey (VR-12) T-scores for general health and physical and mental component summaries. RESULTS: Compared to men without a cancer history, prostate cancer survivors were older, more likely to be married, and had higher socioeconomic status. Compared to men without a cancer history, metastatic prostate cancer survivors reported lower general health (T-score differences [95% confidence interval]: - 6.26, [- 7.14, - 5.38], p < .001), physical health (- 4.33, [- 5.18, - 3.48], p < .001), and mental health (- 2.64, [- 3.40, - 1.88], p < .001) component summaries. Results were similar for other VR-12 T-scores. In contrast, non-metastatic prostate cancer survivors reported similar VR-12 T-scores as men without a cancer history. Further analyses comparing metastatic and non-metastatic prostate cancer survivors support these findings. CONCLUSION: Interventions to improve health-related quality of life for men diagnosed with metastatic prostate cancer merit additional investigation. IMPLICATIONS FOR CANCER SURVIVORS: Interventions to improve health-related quality of life for metastatic prostate cancer survivors merit additional investigation.

Immunizations are an important tool to reduce the burden of vaccine preventable diseases and improve population health.(1) High-quality immunization data is essential to inform clinical and public health interventions and respond to outbreaks of vaccine-preventable diseases. To track COVID-19 vaccines and vaccinations, CDC established an integrated network that included vaccination provider systems, health information exchange systems, immunization information systems, pharmacy and dialysis systems, vaccine ordering systems, electronic health records, and tools to support mass vaccination clinics. All these systems reported data to CDC's COVID-19 response system (either directly or indirectly) where it was processed, analyzed, and disseminated. This unprecedented vaccine tracking effort provided essential information for public health officials that was used to monitor the COVID-19 response and guide decisions. This paper will describe systems, processes, and policies that enabled monitoring and reporting of COVID-19 vaccination efforts and share challenges and lessons learned for future public health emergency responses.

The mission of child welfare is to ensure children's safety, permanency, and well-being. It is also charged with preserving and strengthening families and with avoiding the removal of children who can be kept at home safely. This paper addresses some of the challenges in meeting these concurrent goals in work with children prenatally exposed to alcohol and their families. Current child welfare practices are unlikely to identify prenatal alcohol exposure or children with fetal alcohol spectrum disorders (FASD). Yet if this exposure is identified when families come into contact with child welfare, a jurisdiction's laws and safety and risk assessment processes may lead to unnecessary removal of children from their homes, particularly for Black and American Indian/Alaska Native families. Drawing from research and discourse in the field, strategies are described that could help the child welfare system care for children who may be impacted by FASD while preserving their families. A crucial strategy is partnering with key child and family service providers to identify and respond to FASD.

This article presents findings from a mixed-methods study exploring child welfare agency practices addressing children with prenatal substance exposure and their families. Data sources include: (a) interviews with 159 professionals in child welfare; (b) surveys with 271 professionals in child welfare; and (c) a systematic review of state and local child welfare documents guiding processes in the five states in the study sample. Findings from descriptive statistics of survey data, grounded theory analysis of interviews, and content analysis of documents suggest practices center on infants identified by hospitals as affected by prenatal substance exposure. Without practice guidance and access to treatment services, the needs of older children whose prenatal exposure to substances, including alcohol and other types of legal and illegal substances, is not recognized at birth may be overlooked.

The article describes the challenges for child welfare professionals in meeting goals in work with children prenatally exposed to alcohol and their families, as well as ways to address those challenges. Topics include the use and misuse of information on children's prenatal exposure to alcohol, the use of information on a child's prenatal exposure to alcohol to label children as at high risk for future maltreatment, and the need for training to inform service delivery and reduce bias.

Ebola virus disease (EVD) caused by Ebola virus species Zaire ebolavirus (EBOV) is a major global health challenge causing sporadic outbreaks with high mortality. The minimum incubation period of EBOV, or the time from infection with the virus to the development of first symptoms, is thought to be 2 days and was initially established during the first EVD investigation in 1976.1 A published observation from the investigation noted that, “in one case of the disease, the only possible source of infection was contact with a probable case 48 hours before the latter developed symptoms”, and this observation was restated in another publication.2, 3 However, concluding that the minimum incubation period for EBOV is 2 days based on these reports is flawed for several reasons. First, the presumed source of the infection was a probable case of EVD and was not laboratory-confirmed; it is therefore uncertain whether the source truly had EVD. Second, since the report describes the contact between the source and the case occurring before the source developed symptoms, this implies asymptomatic transmission, which has been established to not occur with EBOV.4, 5, 6 Finally, the report's description of 48 h refers to the time between the case's contact with the alleged source and the source's onset of symptoms, which is itself not an incubation period.

Geographic information systems (GIS) can be used to map mosquito larval and adult habitats and human populations at risk for mosquito exposure and possible arbovirus transmission. GIS can help simplify and target mosquito control efforts during routine surveillance and post-disaster (e.g., hurricane-related flooding) to protect emergency workers and public health. A practical method for prioritizing areas for emergency mosquito control has been developed and is described here. North Carolina (NC) One Map was used to identify state-level data layers of interest based on human population distribution and mosquito habitat in Brunswick, Columbus, Onslow, and Robeson Counties in eastern NC. Relevant data layers were included to create mosquito control treatment areas for targeted control and an 18-step protocol for map development is discussed. This protocol is expected to help state, territorial, tribal, and/or local public health officials and associated mosquito control programs efficiently create treatment area maps to improve strategic planning in advance of a disaster. This protocol may be applied to any NC county and beyond, thereby increasing local disaster preparedness. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.

BACKGROUND: Recent advancements in the clinical management of metastatic prostate cancer include several costly therapies and diagnostic tests. The objective of this study was to provide updated information on the cost to payers attributable to metastatic prostate cancer among men aged 18 to 64 years with employer-sponsored health plans and men aged 18 years or older covered by employer-sponsored Medicare supplement insurance. METHODS: By using Merative MarketScan commercial and Medicare supplemental data for 2009-2019, the authors calculated differences in spending between men with metastatic prostate cancer and their matched, prostate cancer-free controls, adjusting for age, enrollment length, comorbidities, and inflation to 2019 US dollars. RESULTS: The authors compared 9011 patients who had metastatic prostate cancer and were covered by commercial insurance plans with a group of 44,934 matched controls and also compared 17,899 patients who had metastatic prostate cancer and were covered by employer-sponsored Medicare supplement plans with a group of 87,884 matched controls. The mean age of patients with metastatic prostate cancer was 58.5 years in the commercial samples and 77.8 years in the Medicare supplement samples. Annual spending attributable to metastatic prostate cancer was $55,949 per person-year (95% confidence interval [CI], $54,074-$57,825 per person-year) in the commercial population and $43,682 per person-year (95% CI, $42,022-$45,342 per person-year) in the population covered by Medicare supplement plans, both in 2019 US dollars. CONCLUSIONS: The cost burden attributable to metastatic prostate cancer exceeds $55,000 per person-year among men with employer-sponsored health insurance and $43,000 among those covered by employer-sponsored Medicare supplement plans. These estimates can improve the precision of value assessments of clinical and policy approaches to the prevention, screening, and treatment of prostate cancer in the United States.

INTRODUCTION: We sought to estimate per patient and annual aggregate health care costs related to metastatic prostate cancer. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified fee-for-service Medicare beneficiaries ages 66 and older diagnosed with metastatic prostate cancer or claims with diagnosis codes for metastatic disease (indicating tumor progression following diagnosis) between 2007 and 2017. We measured annual health care costs and compared costs between cases and a sample of beneficiaries without prostate cancer. RESULTS: We estimate that per-patient annual costs attributable to metastatic prostate cancer are $31,427 (95% CI: $31,219-$31,635; 2019 dollars). Annual attributable costs rose over time, from $28,311 (95% CI: $28,047-$28,575) in 2007-2013 to $37,055 (95% CI: $36,716-$37,394) in 2014-2017. In aggregate, health costs attributable to metastatic prostate cancer are $5.2 to $8.2 billion per year. CONCLUSIONS: The per patient annual health care costs attributable to metastatic prostate cancer are substantial and have increased over time, corresponding to the approval of new oral therapies used in treating metastatic prostate cancer.

BACKGROUND: Despite the disproportionate morbidity and mortality expeHealth Equity and Health Disparitiesrienced by American Indian and Alaska Native (AI/AN) persons during the coronavirus disease 2019 (COVID-19) pandemic, few studies have reported vaccine effectiveness (VE) estimates among these communities. METHODS: We conducted a test-negative case-control analysis among AI/AN persons aged ≥12 years presenting for care from January 1, 2021, through November 30, 2021, to evaluate the effectiveness of mRNA COVID-19 vaccines against COVID-19-associated outpatient visits and hospitalizations. Cases and controls were patients with ≥1 symptom consistent with COVID-19-like illness; cases were defined as those test-positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and controls were defined as those test-negative for SARS-CoV-2. We used unconditional multivariable logistic regression to estimate VE, defined as 1 minus the adjusted odds ratio for vaccination among cases vs controls. RESULTS: The analysis included 207 cases and 267 test-negative controls. Forty-four percent of cases and 78% of controls received 2 doses of either BNT162b2 or mRNA-1273 vaccine. VE point estimates for 2 doses of mRNA vaccine were higher for hospitalized participants (94.6%; 95% CI, 88.0-97.6) than outpatient participants (86.5%; 95% CI, 63.0-95.0), but confidence intervals overlapped. CONCLUSIONS: Among AI/AN persons, mRNA COVID-19 vaccines were highly effective in preventing COVID-associated outpatient visits and hospitalizations. Maintaining high vaccine coverage, including booster doses, will reduce the burden of disease in this population.

Geographic information systems (GIS) can be used to map mosquito larval and adult habitats and human populations at risk for mosquito exposure and possible arbovirus transmission. Along with traditional methods of surveillance-based targeted mosquito control, GIS can help simplify and target efforts during routine surveillance and post-disaster (e.g., hurricane-related flooding) to protect emergency workers and public health. A practical method for prioritizing areas for emergency mosquito control has been developed and is described here. North Carolina (NC) One Map was used to identify state-level data layers of interest based on human population distribution and mosquito habitat in Brunswick, Columbus, Onslow, and Robeson Counties in eastern NC. Relevant data layers were included to create mosquito control treatment areas for targeted control and an 18-step protocol for map development is discussed. This protocol is expected to help state, territorial, tribal, and/or local public health officials and associated mosquito control programs efficiently create treatment area maps to improve strategic planning in advance of a disaster. This protocol may be applied to any NC county and beyond, thereby increasing local disaster preparedness.

Acute stroke care begins before hospital arrival, and several prehospital factors are critical in influencing overall patient care and poststroke outcomes. This topical review provides an overview of the state of the science on prehospital components of stroke systems of care and how emergency medical services systems may interact in the system to support acute stroke care. Topics include layperson recognition of stroke, prehospital transport strategies, networked stroke care, systems for data integration and real-time feedback, and inequities that exist within and among systems.

IMPORTANCE: Since 1996, the US Preventive Services Task Force has recommended against cervical cancer screening in average-risk women 65 years or older with adequate prior screening. Little is known about the use of cervical cancer screening-associated services in this age group. OBJECTIVE: To examine annual use trends in cervical cancer screening-associated services, specifically cytology and human papillomavirus (HPV) tests, colposcopy, and cervical procedures (loop electrosurgical excision procedure, cone biopsy, and ablation) in Medicare fee-for-service beneficiaries during January 1, 1999, to December 31, 2019, and estimate expenditures for services performed in 2019. DESIGN, SETTING, AND PARTICIPANTS: This population-based, cross-sectional analysis included health service use data across 21 years for women aged 65 to 114 years with Medicare fee-for-service coverage (15-16 million women per year). Data analysis was conducted between July 2021 and April 2022. MAIN OUTCOMES AND MEASURES: Proportion of testing modalities (cytology alone, cytology plus HPV testing [cotesting], HPV testing alone); annual use rate per 1 000 women of cytology and HPV testing, colposcopy, and cervical procedures from 1999 to 2019; Medicare expenditure for these services in 2019. RESULTS: There were 15 323 635 women 65 years and older with Medicare fee-for-service coverage in 1999 and 15 298 656 in 2019. In 2019, the mean (SD) age of study population was 76.2 (8.1) years, 5.1% were Hispanic, 0.5% were non-Hispanic American Indian/Alaska Native, 3.0% were non-Hispanic Asian/Pacific Islander, 7.4% were non-Hispanic Black, and 82.0% were non-Hispanic White. From 1999 to 2019, the percentage of women who received at least 1 cytology or HPV test decreased from 18.9% (2.9 million women) in 1999 to 8.5% (1.3 million women) in 2019, a reduction of 55.3%; use rates of colposcopy and cervical procedures decreased 43.2% and 64.4%, respectively. Trend analyses showed a 4.6% average annual reduction in use of cytology or HPV testing during 1999 to 2019 (P < .001). Use rates of colposcopy and cervical procedures decreased before 2015 then plateaued during 2015 to 2019. The total Medicare expenditure for all services rendered in 2019 was about $83.5 million. About 3% of women older than 80 years received at least 1 service at a cost of $7.4 million in 2019. CONCLUSIONS AND RELEVANCE: The results of this cross-sectional study suggest that while annual use of cervical cancer screening-associated services in the Medicare fee-for-service population older than 65 years has decreased during the last 2 decades, more than 1.3 million women received these services in 2019 at substantial costs.

BACKGROUND: The club cell secretory protein (CC16) has anti-inflammatory and antioxidant effects and is a potential early biomarker of lung damage. The CC16 single nucleotide polymorphism (SNP) rs3741240 risk allele (A) has been inconsistently linked to asthma; other tagging SNPs in the gene have not been explored. The aim was to determine whether CC16 tagging polymorphisms are associated with adult asthma, asthma subtypes or asthma control in the Agricultural Lung Health Study (ALHS). METHODS: The ALHS is an asthma case-control study nested in the Agricultural Health Study cohort. Asthma cases were individuals with current doctor diagnosed asthma, likely undiagnosed asthma, or asthma-COPD overlap defined by questionnaire. We also examined asthma subtypes and asthma control. Five CC16 tagging SNPs were imputed to 1000 Genomes Integrated phase 1 reference panel. Logistic regression was used to estimate associations between CC16 SNPs and asthma outcomes adjusted for covariates. RESULTS: The sample included 1120 asthma cases and 1926 controls of European ancestry, with a mean age of 63 years. The frequency of the risk genotype (AA) for rs3741240 was 12.5% (n=382). CC16 rs3741240 was not associated with adult asthma outcomes. A tagging SNP in the CC16 gene, rs12270961 was associated with uncontrolled asthma (n=208, OR(adj)= 1.4, 95% CI 1.0, 1.9; p=0.03). CONCLUSION: This study, the largest study to investigate associations between CC16 tagging SNPs and asthma phenotypes in adults, did not confirm an association of rs3741240 with adult asthma. A tagging SNP in CC16 suggests a potential relationship with asthma control.