Economic evaluations of eHealth interventions targeting mental health problems in the workplace: a systematic review.

BACKGROUND: Work-related mental health problems impose significant economic and personal burdens. eHealth interventions may offer low-cost, practical solutions, but guidance on their cost-effectiveness in workplace mental health is limited. OBJECTIVE: The objective of this study was to systematically review economic evaluations of workplace eHealth interventions for mental health, offering insights into methodologies and cost-effectiveness outcomes. METHODS: Adhering to PRISMA guidelines, searches were conducted in Embase, MEDLINE, Web of Science, Google Scholar, Cochrane library, PsycInfo and EconLit databases in May 2022, selecting peer-reviewed papers that performed economic evaluations on workplace eHealth interventions for adult mental health. Quality was assessed using the Drummond checklist. RESULTS: From 3213 references, eight met the inclusion criteria. These studies varied in economic perspective, types of economic analysis type, primary outcome measures, intervention focus (e.g. stress, alcohol, insomnia & return-to-work) and direct non-medical costs. Five eHealth interventions were found to be cost-effective and/or have a positive return on investment, with seven studies rated as high quality according to the Drummond checklist. CONCLUSIONS: The study outcomes unveiled the potential cost-effectiveness of eHealth interventions targeting mental health issues, particularly these focusing on workplace stress. However, generalization is challenging due to variations in the methodologies across studies.

Moms in the NICU: developing a pilot to engage and empower women who have delivered a prematurely born infant.

BACKGROUND: Mothers spend long hours at their preterm infant's bedside in the Neonatal Intensive Care Unit (NICU), giving clinicians the opportunity to engage mothers in caring for their own health. OBJECTIVE: To develop a NICU based intervention to reduce the risk of a future premature birth by engaging and empowering mothers to improve their own health and identify barriers to implementing their improvement. DESIGN: Development based on a framework of narrative discourse refined by the Quality Improvement Plan Do Study Act Approach. SETTING: Level II Stepdown Neonatal Intensive Care Unit. PARTICIPANTS: 14 mothers of preterm infants, ages 24-39 years. METHODS: A team of Maternal Fetal Medicine Physicians, obstetricians, neonatologists, neonatal nurses, and parents developed guidelines to elicit the mother's birth story, review the story with a clinical expert to fill in knowledge gaps, identify strategies to improve health to reduce the risk of future preterm birth, and facilitate mother developing an action plan with specific six week goals. A phone interview was designed to assess success and identify barriers to implementing their health plan. The protocol was modified as needed after each intervention to improve the interventions. RESULTS: "Moms in the NICU" toolkit is effective to guide any clinical facilitator to engage, identify health improvement strategies, and co-develop an individualized health plan and its take home summary reached stability after the 5th mother. Mothers reported experiencing reassurance, understanding, and in some cases, relief. Participants were enthusiastic to inform future quality improvement activities by sharing the six week barriers faced implementing their health plan. CONCLUSION: Engaging in the NICU provides an opportunity to improve mothers' understanding of potential factors that may be linked to preterm birth, and promote personally selected actions to improve their health and reduce the risk of a future preterm birth.

Firefighter Occupational Cancer Risk: Starting the Conversation.

This study was conducted to determine if an educational session would increase the firefighter's knowledge of their occupational cancer risk and increase their motivation and confidence to have a conversation with their primary care provider (PCP) in regard to their occupational cancer risk. This study was an exploratory descriptive interventional pilot study. Firefighters self-reported using a pre-/post-educational intervention survey. Results were analyzed using a paired t test in IBM SPSS Version 23 to compare the pre-/post-test mean scores. There were statistically significant differences noted in the mean scores of the pre-/post-interventional survey tool. It seems an educational intervention can motivate and increase the firefighter's confidence to have a conversation with their PCP in regard to their occupational cancer risk. Firefighter perceptions of their "lived" care experience at the PCP level shared during study sessions also contributed to some key conclusions. These conclusions lead to the development of an informational wallet card for the firefighter to use as a conversational tool during a visit with their PCP. Motivating firefighters to have a conversation with their PCP in regard to their occupational cancer risk could potentially increase firefighter occupational cancer awareness at the PCP level and result in earlier detection of cancers in firefighters leading to decreased firefighter cancer mortality rates. Increasing informed firefighter conversations at the PCP level in regard to their occupational cancer risk could potentially increase appropriate cancer prevention guidance and earlier cancer screenings at the primary care level.

Fostering and sustaining transnational solidarities for transformative social change: Advancing community psychology research and action.

As we planned this special issue, the world was in the midst of a pandemic, one which brought into sharp focus many of the pre-existing economic, social, and climate crises, as well as, trends of widening economic and social inequalities. The pandemic also brought to the forefront an epistemic crisis that continues to decentre certain knowledges while maintaining the hegemony of Eurocentric ways of knowing and being. Thus, we set out to explore the possibilities that come with widening our ecology of knowledge and approaches to inquiry, including the power of critical reflective praxis and consciousness, and the important practices of repowering marginalised and oppressed groups. In this paper, we highlight scholarship that reflects a breadth of theories, methods, and practices that forge alliances, in and outside the academy, in different solidarity relationships toward liberation and wellbeing. Our desire as co-editors was not to endorse the plurality of solidarities expressed in the papers as an unyielding methodological or conceptual framework, but rather to hold them lightly within thematic spaces as invitations for readers to consider. Through editorial collaboration, we arrived at the following three thematic spaces: (1) ecologies of being and knowledge: Indigenous knowledge, networks, and plurilogues; (2) naming coloniality in context: Histories in the present and a wide lens; (3) relational knowledge practices: Creative joy of knowing beyond disciplines. From these thematic spaces we conclude that through repowering epistemic communities and narratives rooted in truth-telling, a plurality of solidarities are fostered and sustained locally and transnationally. Underpinned by an ethic of care, solidarity relationships are simultaneously unsettling dominant forms of knowledge and embrace ways of knowing and being that advances dignity, community, and nonviolence.

Affecting behavioural change through empowerment: conceptual insights from theory and agricultural case studies in South Asia.

Affecting behavioural change is a common underlying goal across environmental and agricultural sciences, from climate change mitigation and adaptation, biodiversity conservation, water management, to crop diversification. However, many projects fail to drive or sustain change despite sound science and good intentions. This paper draws on existing theories of behavioural change to construct a conceptual framework that explores pathways to initiate and sustain change through the lens of empowerment, self-efficacy and agency. The framework is demonstrated with case studies from a project in India and Bangladesh that examined social inclusion of marginalised and poor farmers in the context of intensifying agriculture. The framework and case studies highlight that a number of conditions are needed to affect meaningful change including that target beneficiaries are suitably motivated, believe in their own capability and power to enact change and have access to the necessary resources. We propose the framework as a tool to help project teams explore the underlying elements of the process of change when designing, implementing and assessing agricultural or environmental projects and interventions. We contend that behavioural and social change needs to be explicitly fostered in such endeavours to achieve better and longer-term outcomes for the people and environment. Supplementary Information: The online version contains supplementary material available at 10.1007/s10113-022-01939-7.

The Effect of Peer-to-Peer Education about the Significance of Specialty Certification on Empowering Nurses Working in Dialysis.

Specialty certification demonstrates knowledge and expertise in an area of nursing practice resulting in significant benefits to nurses, patients, public, and hiring organizations, empowering professional practice, and improving nurse retention and patient outcomes. However, a large majority of nurses working in dialysis have never validated their knowledge and skills through specialty certification. A one-group pre- and post-intervention study was conducted, with a sample group of registered nurses working in dialysis, using an asynchronous peer-to-peer education regarding empowering practice through specialty certification. The effect on psychological empowerment was measured using a 2-tailed t test with a comparison of enrollments in pre-certification courses. Results showed a 25% increase in course enrollments, but no statistical significance in psychological empowerment. Future study is needed on how nephrology nursing certification impacts patient outcomes, empowerment, workplace environment, and staff retention in nephrology.

Operator-assisted vs self-achieved basketing during ureteroscopy: results from an in vitro preference study.

OBJECTIVES: A recently introduced device (LithoVue Empower™ or LE, Boston Scientifics, USA) allows the surgeon to directly control the stone-retrieving basket without the need of an assistant during flexible ureteroscopy. We aimed to evaluate the stone-retrieval performance of this device. METHODS: We used a bench-training model for flexible ureteroscopy, the Key-box (K-Box®, Porgès-Coloplast, France), to compare the LE configured with a 1.9F stone-retrieval tipless basket (ZeroTip™, Boston Scientific, USA) and a traditional assistant-maneuvered 1.9F stone-retrieval tipless basket. Seven experienced endo-urologists and seven residents-in-training retrieved a fake stone from three different renal cavities of the K-Box with increasing access complexity first with the traditional basket and then with the LE device. We recorded retrieval time and all the operators filled in the NASA Task Load Index (TLI) for the self-evaluation of their performance. We then compared the use of LE in terms of retrieval time, failure rates, and NASA-TLI scores. RESULTS: Stone retrieval times and failure rates were similar according to the retrieval technique, although residents had non-statistically significant shorter times with the LE. NASA-TLI scores revealed lower frustration (p = 0.03) when LE was used by experienced urologists as compared to the traditional basketing. When stratifying the analyses according to surgical experience, fully trained urologists performed faster stone retrieval and showed lower effort scores than residents-in-training (p < 0.05). CONCLUSIONS: The individually controlled retrieval system is an effective device assisting stone retrieval and does not necessitate specific training among experienced endo-urologists. Young residents might benefit from LE during their learning curve.

Empowering caregivers in the radiotherapy process: the results of a randomized controlled trial.

PURPOSE: The present study aims to evaluate the effectiveness of a mobile-assisted empowerment program developed specifically for caregivers of cancer patients undergoing radiotherapy. METHODS: In this study, seventy-four individuals who gave care for cancer patients that received radiotherapy between September 2019 and May 2020 were randomized to receive a mobile-assisted empowerment program or standard care. The mobile-assisted empowerment program comprised of education and information related to the radiotherapy process, videos, activities, and question-and-answer modules to support caregivers during the radiotherapy process. Outcome measures were collected at baseline (day 1 of radiotherapy) and on day 21 and included caregiver demographics, distress, quality of life, and coping style using validated questionnaires. RESULTS: Compared with baseline, individuals' mean scores of distress were lower in the empowerment group than the control group (p < 0.001). General quality of life and sub-dimension mean scores were higher in the empowerment group than the control group (p ≤ 0.05). There was no difference in the coping style average scores (p ≥ 0.05) between the two groups. CONCLUSIONS: This study supports the findings that a mobile-supported empowerment program reduced the level of caregiver distress and increased quality of life during their loved one's treatment with radiotherapy.

Nontransvenous Cardiovascular Implantable Electronic Device Technology-A Review for the Anesthesiologist.

There has been a recent shift in bradycardia pacing and defibrillation therapy to leadless pacemakers and extrathoracic cardioverter-defibrillator technology due to complications associated with transvenous devices. These innovations have implications for anesthesia care, as these novel devices have design and functionality features different from transvenous devices. Current perioperative guidelines do not address management of leadless pacemakers and the subcutaneous implantable cardioverter-defibrillator, although implantation rates are increasing globally. This article addresses the features and capabilities of nontransvenous cardiac implantable electronic devices, such as the Micra and the subcutaneous implantable cardioverter-defibrillator, and provides guidance for perioperative management.

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

OBJECTIVE: Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS: EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION: The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

An Alternative View of Self-Discharge Against Medical Advice: An Opportunity to Demonstrate Empathy, Empowerment, and Care.

In this article, we present the experiences of discharging against medical advice from the perspectives of 17 hospital and community-based health care practitioners, and 16 patients, and relatives from a range of medical and surgical wards. Semistructured, in-depth interviews were conducted and thematically analyzed. We identified that practitioners, patients, and relatives frequently expressed empathy for each other during the interviews, and discharge against medical advice was presented as a way for patients to have control over their health. Contrary to predominantly negative framings that highlight increased mortality and morbidity, and portray people who discharge against medical advice as poor decision makers, we conclude discharge against medical advice can be framed positively. It can be an opportunity to empathize, empower, and care. We recommend that the vocabulary used in hospital discharge against medical advice policies and documents should be updated to reflect a culture of medicine that values patient autonomy, patient centeredness, and shared decision making.

Group-Based Interventions in Lifestyle Medicine.

Group-based interventions in health care have demonstrated a positive influence on patient outcomes by strengthening patient-healthcare professional relationships and providing an avenue for patient empowerment through shared experiences and belongingness. Groups have been shown to enhance social and psychological support, improve self-management behaviors, and encourage peer-support. However group settings also present challenges, such as discomforts in sharing within a group context and managing diverse group dynamics. We outline the efficacy and dynamics of group-based activities in health care settings. This includes key behavioral components of groups, such as creating a safe, supportive, and cohesive environment in group activities where confidentiality is paramount. By recognizing principles for group and moderator behaviors, individuals are more likely to maximize the potential of these interventions.

Fostering Digital Life Skills Through Social Media With Adolescents in 6 German States: Protocol for an Accessibility Study According to the RE-AIM Framework.

BACKGROUND: Social media is essential in the lives of adolescents, with 97% of US teenagers engaging daily. While it facilitates communication, learning, and identity development, it also poses risks like harmful content exposure and psychological distress, particularly for adolescents in their critical developmental stage. Teaching digital life skills innovatively counters these risks, adapting traditional competencies such as decision-making, problem-solving, creative and critical thinking, communication, interpersonal skills, self-awareness, empathy, and emotional and stress management to digital challenges. OBJECTIVE: This study evaluates the accessibility of the "leduin" program, a novel intervention designed to impart digital life skills through Instagram. The program aims to leverage social media's educational potential, focusing on effective strategies to engage adolescents. Emphasizing accessibility is crucial, as it determines the program's overall impact. METHODS: The leduin program, developed through intervention mapping, applies behavior change techniques via social media for 9th and 10th graders. It is a 14-week spaced learning curriculum with daily sessions <5 minutes. Emphasizing the "reach" aspect of the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) model, the recruitment targets diverse educational settings across 6 German states, aiming for inclusivity. Recruitment will involve schools, youth centers, and therapeutic facilities. The study seeks at least 128 participants, a calculated minimum to detect medium-sized effects in the quasi-experimental design and explore varying engagement levels and program responses. Data collection includes preintervention, postintervention, and 6-month follow-up surveys, using multilevel regression, latent growth models, and qualitative analysis to extensively assess reach and gain first insights on effectiveness, acceptance, implementation, and maintenance. The study aims to reveal key factors influencing program participation and interaction; a detailed analysis of engagement patterns will reveal the effectiveness of the recruitment strategies and barriers to participation. Additionally, initial indications of the program's impact on life skills, social media-related skills, health status, risk behaviors, and academic performance will be analyzed. RESULTS: Recruitment was planned from May 2023 until the beginning of the leduin program in October 2023. As of March 2024, we have recruited 283 participants. CONCLUSIONS: The leduin program stands as an innovative and essential initiative in adolescent health promotion, harnessing the power of social media to teach important digital life skills. This study highlights the critical role of accessibility in the success of social media interventions. Effective adolescent engagement strategies are imperative, as they dictate the overall impact of such interventions. The insights gained from this study will be instrumental in shaping future programs, laying groundwork for a subsequent, more comprehensive cluster-randomized controlled trial. The study's design acknowledges the limitations of the current quasi-experimental approach, including the anticipated sample size and the absence of a control group, and aims to provide a foundational understanding for future research in this field. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00032308; https://drks.de/search/de/trial/DRKS00032308. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51085.

The experiences of caring for disabled older adults in long-term: A qualitative study from the perspective of spousal caregivers.

OBJECTIVE: To explore the care experiences of spouses as long-term and primary caregivers for disabled older adults in China. METHODS: A descriptive phenomenological method was used in this study, as well as purposive and convenient sampling. Semi-structured interviews were conducted with 15 spousal caregivers in Guangdong, China, from March to December 2021. Interview audio-recordings were transcribed verbatim and data were analyzed using Colaizzi's phenomenological analysis method. RESULTS: We identified four themes from the data: spousal care motivation; sacrifices in caregiving; obstacles in caregiving; spousal caregivers' positive experiences. CONCLUSIONS: Spouses took responsibility for providing care for their disabled partners regardless of their willingness. They had positive experiences while providing care, but negative experiences were dominant, especially for spouses of severely disabled older adults. Spouses are always perfect in caregiving roles, although they may also need medical assistance. To prevent a decline in spousal caregivers' quality of life and relieve their care burdens, health care providers should support them as soon as possible or offer formal care for disabled older adults. It is necessary to intervene considering disabled older adults and their spousal caregivers as a unit to empower their confidence in coping with life together.

Donor-side and user-side evaluation of the Atlantic blue crab invasion on a Mediterranean lagoon.

The recent invasion of Callinectes sapidus in the Lesina Lagoon has raised great concern about its potential impacts on the ecosystem and on local fisheries. The effects of the blue crab presence on the receiving ecosystem were evaluated from both a donor-side perspective, through the application of emergy analysis, and a user-side perspective, by means of interviews to the local fishermen. While emergy analysis showed that C. sapidus brings to an increase of both natural capital and ecosystem functions values, results from interviews highlighted that the major problem caused by the presence of the blue crab in the lagoon concerned the local economy. As the first quantitative assessment of the ecological and economic impact of C. sapidus in invaded habitats, the present investigation provided original and useful information for a comprehensive risk assessment of the species in European waters and in Mediterranean Sea.

The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study.

BACKGROUND: Family caregivers of patients who are critically ill have a high prevalence of short- and long-term symptoms, such as fatigue, anxiety, depression, symptoms of posttraumatic stress, and complicated grief. These adverse consequences following a loved one's admission to an intensive care unit (ICU) are also known as post-intensive care syndrome-family. Approaches such as family-centered care provide recommendations for improving the care of patients and families, but models for family caregiver follow-up are often lacking. OBJECTIVE: This study aims to develop a model for structuring and individualizing the follow-up of family caregivers of patients who are critically ill, starting from the patients' ICU admission to after their discharge or death. METHODS: The model was developed through a participatory co-design approach using a 2-phased iterative process. First, the preparation phase included a meeting with stakeholders (n=4) for organizational anchoring and planning, a literature search, and interviews with former family caregivers (n=8). In the subsequent development phase, the model was iteratively created through workshops with stakeholders (n=10) and user testing with former family caregivers (n=4) and experienced ICU nurses (n=11). RESULTS: The interviews revealed how being present with the patient and receiving adequate information and emotional care were highly important for family caregivers at an ICU. The literature search underlined the overwhelming and uncertain situation for the family caregivers and identified recommendations for follow-up. On the basis of these recommendations and findings from the interviews, workshops, and user testing, The Caregiver Pathway model was developed, encompassing 4 steps: within the first few days of the patient's ICU stay, the family caregivers will be offered to complete a digital assessment tool mapping their needs and challenges, followed by a conversation with an ICU nurse; when the patient leaves the ICU, a card containing information and support will be handed out to the family caregivers; shortly after the ICU stay, family caregivers will be offered a discharge conversation by phone, focusing on how they are doing and whether they have any questions or concerns; and within 3 months after the ICU stay, an individual follow-up conversation will be offered. Family caregivers will be invited to talk about memories from the ICU and reflect upon the ICU stay, and they will also be able to talk about their current situation and receive information about relevant support. CONCLUSIONS: This study illustrates how existing evidence and stakeholder input can be combined to create a model for family caregiver follow-up at an ICU. The Caregiver Pathway can help ICU nurses improve family caregiver follow-up and aid in promoting family-centered care, potentially also being transferrable to other types of family caregiver follow-up.

Get up and Get Moving: a nutrition and physical activity after-school program for Latino adolescents of Erie Neighborhood House.

Obesity among Latino children in the United States is a serious health concern that poses a risk to develop other chronic illnesses such as Type 2 Diabetes, cancer, and heart disease. The following paper is focused on a 6-week health education intervention that was developed for 12- to 14-year-old Latino youth of an after -school program at a social service agency in the West Town neighborhood of Chicago. Within Chicago, childhood obesity rates in children of all ages were shown to be the second highest among Latino communities for both boys and girls. Implications from this article will provide insight into the need for public health professionals to further research and use that information to formulate ideas to create nutrition and physical activity programs that will address obesity among Latino and other ethnic youth populations-to promote and encourage them to adopt and maintain a healthy lifestyle.

Stability Indicating RP-HPLC and Spectrophotometric Methods for Simultaneous Estimation of Sodium Benzoate and Cefdinir in the Presence of its Degradation Products-Application to Blank Subtraction Method.

Objectives: Empower 3 software is important in modeling, optimization, and reducing the time of manual calculation of related substance by subtracting the baseline of a blank chromatogram from the unknown sample automatically; so, the major objective of the developed method is to introduce a new, selective, and economical high performance liquid chromatography (HPLC) and spectrophotometric method for simultaneous estimation of sodium benzoate (SDB) and cefdinir (CFR) in the presence of its degradation products. Materials and Methods: Chromatographic separation is optimized and adjusted using two methods; method (I) is characterized for separation of active pharmaceutical ingredient (CFR) in pure and dosage forms using Atlantis dC18 column [4.6 mm x 250 mm (5 µm particle size or equivalent)] with a mobile phase consisting of methanol: 0.02 M phosphate buffer solution pH 3.0 (40:60 v/v) at a flow rate of 1.0 mL/minute, injection volume 10 µL and wavelength 254 nm. Method (II) is identified for related substances in a Hichrom C18 column (15 x 0.46 cm), 5 µm particle size or equivalent, using a binary gradient consisting of solution A [0.1% tetramethylammonium hydroxide solution (pH: 5.5) with 0.1 M EDTA (1000:0.4 v/v)] and solution B (0.1% tetramethylammonium hydroxide solution (pH 5.5): acetonitrile: methanol : 0.1 M EDTA (500:300:200:0.4 v/v) using injection volume 10 µL for reversed-phase HPLC with a wavelength equals to 254 nm and flow rate 1.0 mL/min. Two ecofriendly spectrophotometric methods were successfully used to resolve the spectral overlap of drugs. Results: Method A, the first derivative of ratio spectra spectrophotometric method (1stDD) where CFR was determined at two wavelengths 283.5 nm, 313.4 nm and SDB was determined at 216.7 nm, 235.5 nm. Method B, ratio subtraction method is performed to overcome the interference between CFR and the preservative SDB. The ultraviolet spectrum of the laboratory mixture is divided by that of CFR (20 µg/mL) as a divisor then subtracting the amplitudes in the plateau region at 250-315 nm (the constant) from that of the ratio spectrum. The zero-order spectra of SDB were obtained at 225 nm by multiplying the resulting ratio spectra by the divisor (CFR), zero order of CFR was been estimated at a wavelength value of 283 nm after multiplication of the divisor by the obtained constant. Conclusion: The optimized method was adjusted and validated as per International Conference on Harmonization guidelines and could be easily utilized by quality control laboratories and for laboratory-prepared mixtures.

Impact of the treatment crossover design on comparative efficacy in EMPOWER-Lung 1: Cemiplimab monotherapy as first-line treatment of advanced non-small cell lung cancer.

Objectives: In randomized-controlled crossover design trials, overall survival (OS) treatment effect estimates are often confounded by the control group benefiting from treatment received post-progression. We estimated the adjusted OS treatment effect in EMPOWER-Lung 1 (NCT03088540) by accounting for the potential impact of crossover to cemiplimab among controls and continued cemiplimab treatment post-progression. Methods: Patients were randomly assigned 1:1 to cemiplimab 350 mg every 3 weeks (Q3W) or platinum-doublet chemotherapy. Patients with disease progression while on or after chemotherapy could receive cemiplimab 350 mg Q3W for ≤108 weeks. Those who experienced progression on cemiplimab could continue cemiplimab at 350 mg Q3W for ≤108 additional weeks with four chemotherapy cycles added. Three adjustment methods accounted for crossover and/or continued treatment: simplified two-stage correction (with or without recensoring), inverse probability of censoring weighting (IPCW), and rank-preserving structural failure time model (RPSFT; with or without recensoring). Results: In the programmed cell death-ligand 1 ≥50% population (N=563; median 10.8-month follow-up), 38.2% (n=107/280) crossed over from chemotherapy to cemiplimab (71.3%, n=107/150, among those with confirmed progression) and 16.3% (n=46/283) received cemiplimab treatment after progression with the addition of histology-specific chemotherapy (38.7%, n=46/119, among those with confirmed progression). The unadjusted OS hazard ratio (HR) with cemiplimab versus chemotherapy was 0.566 (95% confidence interval [CI]: 0.418, 0.767). Simplified two-stage correction-the most suitable method based on published guidelines and trial characteristics-produced an OS HR of 0.490 (95% CI: 0.365, 0.654) without recensoring and 0.493 (95% CI: 0.361, 0.674) with recensoring. The IPCW and RPSFT methods produced estimates generally consistent with simplified two-stage correction. Conclusions: After adjusting for treatment crossover and continued cemiplimab treatment after progression with the addition of histology-specific chemotherapy observed in EMPOWER-Lung 1, cemiplimab continued to demonstrate a clinically important and statistically significant OS benefit versus chemotherapy, consistent with the primary analysis.

Change in Objectively Measured Activity Levels Resulting from the EMPOWER Study Lifestyle Intervention.

Purpose: To examine changes in physical activity (PA) during a behavioral weight-loss intervention and determine baseline factors associated with PA goal achievement. Methods: Overweight/obese community-dwelling adults with valid PA accelerometer data (N=116; mean age 51.7 years; 89% female; 83% non-Hispanic White) were recruited into a single-arm prospective cohort study examining the effects of a 12-month intervention that included 24 in-person group sessions, weight-loss, calorie, fat gram, and PA goals, self-monitoring, and feedback. Minutes of moderate-to-vigorous (MV) PA and steps were measured using a waist-worn accelerometer (ActiGraph GT3x) at baseline, 6 months, and 12 months. Achievement of the 150 minute/week MVPA goal was examined using total minutes and bout minutes (i.e., counting only PA occurring in bouts ≥10 minutes in length). Change in PA was analyzed using non-parametric tests for multiple comparisons. Associations of factors with meeting the PA goal were modeled using binary logistic regression. Results: At 6 months, there were increases from baseline in MVPA (median [p25, p75]: 5.3 [-0.9, 17.6] minutes/day) and steps (863 [-145, 2790] steps/day), both p<0.001. At 12 months, improvements were attenuated (MVPA: 2.4 [-2.0, 11.4] minutes/day, p=0.047; steps: 374[-570, 1804] p=0.14). At 6 months, 33.6% of individuals met the PA goal (using total or bout minutes). At 12 months, the percent meeting the goal using total MVPA [31%] differed from bout MVPA [22.4%]. Male gender (OR=4.14, p=0.027) and an autumn program start (versus winter; OR=3.39, p=0.011) were associated with greater odds of goal achievement at 6 months. Conclusions: The intervention increased PA goal achievement at 6 and 12 months with many making clinically meaningful improvements. Our results suggest female participants may require extra support toward improving PA levels.