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Establishing shared definitions of virological failure and discontinuation for long-acting injectable cabotegravir and rilpivirine therapy (the CONSENSUS-LAI Study): an international survey and Delphi process
No full textBACKGROUND: Definitions of virological failure and treatment discontinuation for long-acting injectable (LAI) cabotegravir and rilpivirine antiretroviral therapy are inconsistent in clinical practice and observational studies, which complicates interpretation and implementation of findings. The CONSENSUS-LAI study aimed to establish consistent definitions of virological failure and treatment discontinuation to enhance evidence transferability and support optimal clinical outcomes. METHODS: The study had two phases. Phase 1 was an international online survey exploring existing definitions of virological and treatment discontinuation, conducted between April 25 and July 1, 2024. Eligible participants were health-care professionals working in infectious disease or sexual health services who had provided care to at least ten people living with HIV in the past 6 months, had prescribed LAI cabotegravir and rilpivirine in clinical trials or clinical practice, and were able to give informed consent. Participants were recruited via social media and mailing lists of medical specialist societies. Phase 2 was a Delphi process, in which a panel of experts, selected to ensure representation from all six WHO regions, scored leading definitions from phase 1 on a 9-point Likert scale. The proposed definitions were scored according to four validity criteria: clarity, usability in the expert\u27s setting, appropriateness across clinical purposes, and applicability across relevant population groups. Revisions were suggested in iterative rounds until consensus was reached. Consensus was predefined as at least 75% of experts agreeing or strongly agreeing (scores 7-9) with the validity criteria. FINDINGS: 386 LAI cabotegravir and rilpivirine prescribers across 28 countries completed the survey, revealing 15 definitions for virological failure on LAI cabotegravir and rilpivirine and nine for treatment discontinuation. 52 experts participated in the Delphi process. Consensus agreement on both definitions was reached after two rounds for all validity criteria. For virological failure, the consensus definition was as follows: (a) viral load 200 copies or more per mL or more on two occasions 2-4 weeks apart, or (b) a single viral load of more than 1000 copies per mL, and/or (c) emergent resistance, in the context of timely injections and prior suppression of less than 200 copies per mL, OR (d) unable to suppress viral load to less than 200 copies per mL on continuous therapy. For treatment discontinuation the consensus definition was as follows: people on LAI cabotegravir and rilpivirine who have missed two consecutive injections and have not taken oral bridging in the interim, irrespective of reason for discontinuation. INTERPRETATION: The consensus definitions provide a foundation for aligning practice and evaluating patient outcomes. Further validation of the viral load threshold for virological failure and the optimal viral load retesting window is required. FUNDING: ViiV Healthcare
The Evolution and Strategic Impact of the Chief Wellness Officer Role at George Washington University Medicine
No full textThe educational foundation for acute care surgery: Evolution of the specialty
No full textAcute care surgery (ACS) was conceived in the early 2000s in response to a growing crisis in access to emergency general surgical care. The ACS fellowship was created to train general surgeons in this subspecialty. The purpose of this review is to discuss the origin of ACS and its evolution over the last 20 years and to survey the subspecialty\u27s current status and future directions. Since the first programs were certified in 2008, the fellowship curriculum has undergone many changes. There is now more emphasis on emergency general surgery and a movement toward competency-based evaluations. Additionally, pediatrics and burn subtracks have been developed, and other programs emphasizing robotic surgery are being created. The didactic curriculum has been updated, and new programs highlighting community and networking, such as the Meet the Mentors discussions, fellow journal club, and boot camp, have also been formed. Acute care surgery has effectively leveraged the knowledge base of trauma surgery and surgical critical care to meet the changing needs of the healthcare system. Acute care surgery surgeons are well positioned for leadership roles both locally and nationally. Future challenges include building a more robust research base and further highlighting the scope and brand of ACS. ACS as a subspecialty has matured over the last two decades. In the coming years, ACS will continue to adapt to meet the needs of patients suffering from acute surgical illness or injury
Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma
No full textBACKGROUND: Patients who have cutaneous squamous-cell carcinoma with high-risk features are at risk for recurrence after definitive local therapy. The benefit of systemic adjuvant therapy options has not been well established in clinical trials. METHODS: In a phase 3, randomized trial, we enrolled patients with local or regional cutaneous squamous-cell carcinoma, after surgical resection and postoperative radiotherapy, at high risk for recurrence owing to nodal features (extracapsular extension with largest node ≥20 mm in diameter or at least three involved nodes) or nonnodal features (in-transit metastases, T4 lesion [with bone invasion], perineural invasion, or locally recurrent tumor with ≥1 additional risk feature). Patients were assigned in a 1:1 ratio to receive adjuvant cemiplimab (350 mg) or placebo, administered intravenously every 3 weeks for 12 weeks, followed by a dose increase to 700 mg administered every 6 weeks for up to 36 weeks (≤48 weeks total). The primary end point was disease-free survival. Secondary end points included freedom from locoregional recurrence, freedom from distant recurrence, and safety. RESULTS: A total of 415 patients were assigned to cemiplimab (209) or placebo (206). The median follow-up was 24 months. Cemiplimab was superior to placebo with respect to disease-free survival (24 vs. 65 events; hazard ratio for disease recurrence or death, 0.32; 95% confidence interval [CI], 0.20 to 0.51; P\u3c0.001). The estimated 24-month disease-free survival was 87.1% (95% CI, 80.3 to 91.6) with cemiplimab and 64.1% (95% CI, 55.9 to 71.1) with placebo. Cemiplimab led to lower risks of locoregional recurrence (9 events, vs. 40 with placebo; hazard ratio, 0.20; 95% CI, 0.09 to 0.40) and distant recurrence (10 vs. 26 events; hazard ratio, 0.35; 95% CI, 0.17 to 0.72). Adverse events of grade 3 or higher occurred in 23.9% of the patients who received cemiplimab and in 14.2% of those who received placebo; discontinuation due to adverse events occurred in 9.8% and 1.5%, respectively. CONCLUSIONS: Adjuvant cemiplimab therapy led to longer disease-free survival than placebo among patients at high risk for recurrence of cutaneous squamous-cell carcinoma. (Funded by Regeneron Pharmaceuticals and Sanofi; C-POST ClinicalTrials.gov number, NCT03969004.)
Metrics of Urbanicity and Rurality in US-Based Epidemiologic Studies of Ambient Temperature and Health: A Scoping Review
No full textBACKGROUND: The impacts of environmental health risk factors, including temperature, vary across urban and rural areas. Application of different metrics of rurality and urbanicity can yield different risk characterizations. We aimed to identify, describe, and quantify how urban/rural metrics are used in epidemiologic studies of ambient temperature and health across the United States (US). METHODS: Using PubMed and Scopus, we identified epidemiologic studies published between January 2010 and March 2025 that examined ambient temperature and health in the US and included a defined, quantitative metric of urbanicity/rurality. Titles, abstracts, and full texts were evaluated by two independent reviewers. Data from included studies were extracted using a predetermined tool. RESULTS: Of the 11,013 studies resulting from our search, 36 were included. We identified 23 metrics drawing from 10 data sources. The most frequently used metrics were population density and size from the US Census (n = 11 studies). Other metrics reflected connectivity and proximity to surrounding areas, such as the US Census’s Urban-Rural Classification (n = 7 studies), and the US Department of Agriculture’s Rural-Urban Commuting Area Codes (n = 4 studies) and Rural-Urban Continuum Codes (n = 2 studies). Additional metrics captured features related to the natural environment, built environment, and employment. Many studies did not provide a rationale for metric selection. DISCUSSION: Urbanicity and rurality metrics have moved beyond population size and density to include other features. Providing rationales for choice of metric or the differential vulnerability or adaptive capacity captured by the metric could bolster understanding of urban-rural differences in the impact of temperature on health. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40572-025-00494-7
Patient Engagement in the Design and Conduct of the HOPE Trial: Addressing Chronic Pain in Hemodialysis Patients
No full textThe HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) was a randomized, controlled trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Patients on hemodialysis suffering from chronic pain were randomly assigned to receive usual care or a 12-week pain coping skills training program (PCST) delivered remotely by trained coaches followed by 12 weeks of skills reinforcement via interactive voice response. Patient Advisors participated in all stages of the study, including study design and development of recruitment materials. During the trial, Patient Advisors met monthly as an Advisory Board. In addition, Patient Advisors participated in all Steering Committee meetings, including in-person meetings and biweekly remote meetings. Patient Advisors were represented on all study committees, with particularly extensive involvement in the Recruitment and Retention Committee. Patient Advisors made important contributions to study design and conduct. Their involvement was critical to the study\u27s successful enrollment and retention of study participants. Patient Advisors characterized their involvement positively. They attributed their satisfaction with the experience to their full integration into in all aspects of the study and their treatment as equal partners. Several Patient Advisors have subsequently taken on other research, patient advocacy, or leadership roles, facilitated in part through their participation in the HOPE Trial. This paper details the ways Patient Advisors were enlisted and decided to participate; outlines their many contributions; describes their experience; and provides guidance on how researchers can successfully incorporate Patient Advisors into future studies
Factors Affecting Non-response in a Cohort Study of Female Participants: The Korea Nurses\u27 Health Study
No full textBACKGROUND: The major drawback of a cohort study design is the loss of follow-up participants, which increases selection bias and threatening external validity, particularly in online website surveys. It is important to identify factors beyond population or demographics that influence non-response rates relevant to cohort studies. OBJECTIVE: This study aimed to examine the non-response rate and factors over a 10-year follow-up period among female participants, using data from initial and subsequent surveys. METHODS: The Korea Nurses\u27 Health Study recruited 20,613 female nurses in 2013, using simple random sampling. The participants were followed up ten times through 2022. We identified the demographic, work-related, survey-related, and psychological characteristics of non-responding nurses with 10-year follow-up and compared them with those who continued to participate. Descriptive, chi-square, and multivariate logistic regression models were used. RESULTS: The non-response rate of the follow-up surveys from the 2nd to the 11th varied between 25.5% (second survey) and 61.2% (sixth survey). The influence of age, education, and the usability of survey websites on non-response lasted up to the 11th survey. Nurses in their 20s were more likely not to respond to the follow-up surveys than those in their 30s. Those who had an associate degree and neutral feelings about the usability of the survey websites were less likely to respond to follow-up surveys than those who were satisfied with the initial survey. The influence of geographic region, hospital size, and psychological factors-including stress, fatigue, and sleep disturbance-was evident from the second to the sixth survey. CONCLUSIONS: When designing and recruiting female nurse participants for community-based cohort studies, researchers should consider the factors that influence non-response and adopt tailored strategies based on demographic characteristics. In addition, it is recommended that the usability of survey websites be improved to reduce non-response at follow-up in cohort studies involving female participants. INTERNATIONAL REGISTERED REPORT: RR2-DOI: https://doi.org/10.4178/epih.e2024048
Mental and Behavioral Health Services Provided by Schools in the United States: A National Survey of School Nurses
No full textBACKGROUND: School nurses are often tasked with identifying and managing mental and behavioral health concerns. The objective of this study was to better understand school nurse and school preparedness to identify and manage mental health conditions and psychological stressors. METHODS: The authors developed a questionnaire, which was electronically distributed to several National Association of School Nurses members during the 2021-2022 school year. RESULTS: A total of 994 questionnaires were completed and analyzed, a 50% response rate. Of school nurse respondents, 76% felt responsible for identifying depression; 40% reported that their school has naloxone; 22% reported that their school has an emergency preparedness and response plan for opioid overdose; and 18% screened for bullying in the past year. IMPLICATIONS FOR SCHOOL HEALTH POLICY, PRACTICE, AND EQUITY: School policies and guidelines for the critical areas identified in the present study should be considered. CONCLUSIONS: Based on our national sample of school nurses, we have identified strengths and areas for improvement in school nurse and school preparedness to identify and manage mental health conditions and psychological stressors
Brace yourself (Part-time): part-time bracing leads to curve improvement in juvenile idiopathic scoliosis
No full textPURPOSE: The efficacy of bracing for juvenile idiopathic scoliosis (JIS) remains controversial. Although full-time bracing is standard for curves \u3e 25°, part-time bracing for smaller curves (\u3c 25°) may prevent progression. This study evaluates the effectiveness of part-time bracing compared to observation in JIS patients with 15-24° curves, hypothesizing that part-time bracing reduces curve progression and the need for full-time bracing. METHODS: This retrospective cohort study reviewed skeletally immature JIS patients (4-10 years old) with 15-24° curves. Patients underwent either observation or part-time bracing (8-12 h/day). Minimum two-year outcomes included: (1) curve change (\u3e 5°), (2) progression to \u3e 25° requiring full-time bracing, and (3) prescription for full-time bracing. RESULTS: Eighty-three patients (59% observed, 41% braced) were analyzed. The braced cohort demonstrated slightly higher baseline curves (+ 1.6°, p = 0.01). By final follow-up, braced patients improved by 3.2° (p = 0.05), while the observed cohort worsened by 3.4° (p = 0.05). More braced patients improved \u3e 5° (69% vs. 21%, p \u3c 0.001), whereas more observed patients progressed \u3e 5° (54% vs. 11%, p \u3c 0.001) and to \u3e 25° (54% vs. 20%, p = 0.002). Full-time bracing was prescribed for 63% of observed patients but only 17% of braced patients (p \u3c 0.001). CONCLUSION: Part-time bracing not only prevents curve progression, but also frequently leads to improved curve magnitude in JIS patients with smaller curves, minimizing the need for full-time bracing
Improving the quality of atopic dermatitis epidemiological research in the United States- A systematic review of disease definitions and related content in national surveys
No full textEpidemiologic study of atopic dermatitis has been critical to improve our understanding of disease burden and to identify numerous atopic and non-atopic comorbidities. Despite widespread use, atopic dermatitis case definitions and related content in population-based surveys have not been comprehensively evaluated. To characterize the state of population-based health-related surveys in the United States that include atopic dermatitis or eczema, we conducted a systematic review searching Ovid MEDLINE for population-based surveys to study atopic dermatitis in the United States from database inception through March 26, 2025. Of 916 articles screened, 24 articles were included for analysis which included 11 independent surveys. Most surveys relied on self-report of physician diagnosis of atopic dermatitis or the International Study of Asthma and Allergies in Childhood (ISAAC) criteria, including a modified version of the ISAAC criteria which has not been validated. National surveys yielded the largest samples and were typically repeated annually, but some national surveys did not include questions on atopic dermatitis in recent years. National surveys do not use standardized definitions to identify atopic dermatitis and do not adequately capture key aspects of atopic dermatitis burden. Future population-based surveys should be designed to fill these important gaps