"It's Incapacitated Me in so Many Ways": Older Adults' Lived Experience With Postoperative Symptoms at Home After Major Elective Surgery.

OBJECTIVE: This qualitative study aimed to explore the challenges faced by older adults regarding the postoperative symptom experience after major elective surgery. BACKGROUND: Although extensively studied in oncology settings, the impact of postoperative symptom burden remains largely underexplored in elective major surgery among older adults. METHODS: We employed convenience sampling to recruit adults aged 65 years or above undergoing major elective surgery at the University of California, San Francisco. Semistructured interviews regarding the surgical experience were conducted at 1 and 3 months postoperatively. An inductive qualitative approach was used to identify emerging themes. Symptoms revealed by participants during interviews were also captured. RESULTS: Nineteen participants completed a 1-month postoperative interview, and 17 additionally completed a 3-month interview. Three themes emerged: (1) postoperative symptoms significantly impacted valued life activities and psychosocial well-being, (2) participants felt "caught off guard" by the intensity and duration of postoperative symptoms, and (3) participants expressed the need for additional support, resources, and education on symptom management. The most frequently mentioned symptoms were postoperative pain (n=12, 63.1%), gastrointestinal discomfort (n=8, 42.1%), and anxiety/stress (n=8, 42.1%) at 1-month postsurgery compared with pain and depression (both n=6, 35.3%) at 3 months. CONCLUSIONS: Study participants were surprised by the negative impact of postoperative symptoms on their psychosocial well-being and ability to engage in valued life activities. Symptom burden is an important patient-reported outcome that should be assessed postoperatively. Interventions to minimize postoperative symptom burden in older adults could optimize quality of life and participation in meaningful activities during surgical recovery.

"There's So Much That They're Enduring": Experiences of Older Adults Undergoing Major Elective Surgery.

OBJECTIVE: This qualitative study aimed to explore the psychosocial experience of older adults undergoing major elective surgery from the perspective of both the patient and family caregiver. SUMMARY BACKGROUND DATA: Older adults face unique psychological and social vulnerabilities that can increase susceptibility to poor health outcomes. How these vulnerabilities influence surgical treatment and recovery is understudied in the geriatric surgical population. METHODS: Adults aged 65 and older undergoing a high-risk major elective surgery at the University of California, San Francisco and their caregivers were recruited. Semi-structured interviews were conducted at three time points: 1-2 weeks before surgery, and at 1- and 3-months following surgery. An inductive qualitative approach was used to identify underlying themes. RESULTS: Twenty-five older adult patients (age range 65-82 years, 60% male) and 11 caregivers (age range 53-78 years, 82% female) participated. Three themes were identified. First, older surgical patients experienced significant challenges to emotional well-being both before and after surgery, which had a negative impact on recovery. Second, older adults relied on a combination of personal and social resources to navigate these challenges. Lastly, both patients and caregivers desired more resources from the healthcare system to address "the emotional piece" of surgical treatment and recovery. CONCLUSIONS: Older adults and their caregivers described multiple overlapping challenges to emotional well-being that spanned the course of the perioperative period. Our findings highlight a critical component of perioperative care with significant implications for the recovery of older surgical patients.

Elder Mistreatment Experienced by Older Caregiving Adults: Results from a National Community-Based Sample.

BACKGROUND: With an aging population, older adults are increasingly serving as caregivers to others, which may increase their risk of adverse interpersonal experiences. OBJECTIVE: To investigate the prevalence and types of elder mistreatment experienced by older caregiving adults. DESIGN: Cross-sectional analysis PARTICIPANTS: National sample of community-dwelling US adults over age 60 in 2015-2016. MAIN MEASURES: Caregiving (assisting another adult with day-to-day activities) was assessed by interviewer-administered questionnaires. Experience of elder mistreatment was assessed by participant-reported questionnaire in three domains: emotional, physical, and financial. Multivariable logistic regression models examined associations between caregiving status and each domain of elder mistreatment, adjusting for age, race, ethnicity, gender, education, marital status, concomitant care-receiving status, overall physical and mental health, and cognitive function. Additional logistic regression models examined associations between being the primary caregiver (rather than a secondary caregiver) and each domain of mistreatment among older caregivers. KEY RESULTS: Of the 1898 participants over age 60 (including 1062 women and 836 men, 83% non-Hispanic white, and 64% married or partnered), 14% reported serving as caregivers for other adults, including 8% who considered themselves to be the primary caregiver. Among these older caregivers, 38% reported experiencing emotional, 32% financial, and 6% physical mistreatment after age 60. In multivariable models, caregiving was associated with experiencing both emotional mistreatment (AOR 1.61, 95% CI 1.15-2.25) and financial mistreatment (AOR 1.72, 95% CI 1.18-2.50). In analyses confined to caregiving older adults, those who served as primary rather than secondary caregivers for other adults had an over two-fold increased odds of emotional mistreatment (AOR 2.17, 95% CI 1.07, 4.41). CONCLUSION: In this national cohort of older community-dwelling adults, caregiving was independently associated with experiencing emotional and financial mistreatment after age 60. Findings suggest that efforts to prevent or mitigate elder mistreatment should put more emphasis on vulnerable older caregivers.

Global rural health disparities in Alzheimer's disease and related dementias: State of the science.

INTRODUCTION: Individuals living in rural communities are at heightened risk for Alzheimer's disease and related dementias (ADRD), which parallels other persistent place-based health disparities. Identifying multiple potentially modifiable risk factors specific to rural areas that contribute to ADRD is an essential first step in understanding the complex interplay between various barriers and facilitators. METHODS: An interdisciplinary, international group of ADRD researchers convened to address the overarching question of: "What can be done to begin minimizing the rural health disparities that contribute uniquely to ADRD?" In this state of the science appraisal, we explore what is known about the biological, behavioral, sociocultural, and environmental influences on ADRD disparities in rural settings. RESULTS: A range of individual, interpersonal, and community factors were identified, including strengths of rural residents in facilitating healthy aging lifestyle interventions. DISCUSSION: A location dynamics model and ADRD-focused future directions are offered for guiding rural practitioners, researchers, and policymakers in mitigating rural disparities. HIGHLIGHTS: Rural residents face heightened Alzheimer's disease and related dementia (ADRD) risks and burdens due to health disparities. Defining the unique rural barriers and facilitators to cognitive health yields insight. The strengths and resilience of rural residents can mitigate ADRD-related challenges. A novel "location dynamics" model guides assessment of rural-specific ADRD issues.

Improving Uptake of a National Web-Based Psychoeducational Workshop for Informal Caregivers of Veterans: Mixed Methods Implementation Evaluation.

BACKGROUND: Although web-based psychoeducational programs may be an efficient, accessible, and scalable option for improving participant well-being, they seldom are sustained beyond trial publication. Implementation evaluations may help optimize program uptake, but few are performed. When the US Department of Veterans Affairs (VA) launched the web-based psychoeducational workshop Building Better Caregivers (BBC) for informal caregivers of veterans nationwide in 2013, the workshop did not enroll as many caregivers as anticipated. OBJECTIVE: This study aims to identify the strengths and weaknesses of initial implementation, strategies likely to improve workshop uptake, whether the VA adopted these strategies, and whether workshop enrollment changed. METHODS: We used mixed methods and the Promoting Action on Research Implementation in Health Services (PARIHS) implementation evaluation framework. In stage 1, we conducted semistructured interviews with caregivers, local staff, and regional and national VA leaders and surveys with caregivers and staff. We collected and analyzed survey and interview data concurrently and integrated the results to identify implementation strengths and weaknesses, and strategies likely to improve workshop uptake. In stage 2, we reinterviewed national leaders to determine whether the VA adopted recommended strategies and used national data to determine whether workshop enrollment changed over time. RESULTS: A total of 54 caregivers (n=32, 59%), staff (n=13, 24%), and regional (n=5, 9%) and national (n=4, 7%) leaders were interviewed. We received survey responses from 72% (23/32) of caregivers and 77% (10/13) of local staff. In stage 1, survey and interview results were consistent across multiple PARIHS constructs. Although participants from low-enrollment centers reported fewer implementation strengths and more weaknesses, qualitative themes were consistent across high- and low-enrollment centers, and across caregiver, staff, and leadership respondent groups. Identified strengths included belief in a positive workshop impact and the use of some successful outreach approaches. Implementation weaknesses included missed opportunities to improve outreach and to better support local staff. From these, we identified and recommended new and enhanced implementation strategies-increased investment in outreach and marketing capabilities; tailoring outreach strategies to multiple stakeholder groups; use of campaigns that are personal, repeated, and detailed, and have diverse delivery options; recurrent training and mentoring for new staff; and comprehensive data management and reporting capabilities. In stage 2, we determined that the VA had adopted several of these strategies in 2016. In the 3 years before and after adoption, cumulative BBC enrollment increased from 2139 (2013-2015) to 4030 (2016-2018) caregivers. CONCLUSIONS: This study expands the limited implementation science literature on best practices to use when implementing web-based psychoeducational programs. We found that robust outreach and marketing strategies and support for local staff were critical to the implementation success of the BBC workshop. Other health systems may want to deploy these strategies when implementing their web-based programs.

Supporting caregivers during hematopoietic cell transplantation for children with primary immunodeficiency disorders.

BACKGROUND: Caregivers of children with primary immunodeficiency disorders (PIDs) experience significant psychological distress during their child's hematopoietic cell transplantation (HCT) process. OBJECTIVES: This study aims to understand caregiver challenges and identify areas for health care system-level improvements to enhance caregiver well-being. METHODS: In this mixed-methods study caregivers of children with PIDs were contacted in August to November 2017 through online and electronic mailing lists of rare disease consortiums and foundations. Caregivers were invited to participate in an online survey assessing sociodemographic variables, the child's medical characteristics, psychosocial support use, and the World Health Organization-5 Well-Being Index. Open-ended questions about health care system improvements were included. Descriptive statistics and linear multivariate regression analyses were conducted. A modified content analysis method was used to code responses and identify emergent themes. RESULTS: Among the 80 caregiver respondents, caregivers had a median age of 34 years (range, 23-62 years) and were predominantly female, white, and married with male children given a diagnosis of severe combined immune deficiency. In the adjusted regression model lower caregiver well-being was significantly associated with lower household income and medical complications. Challenges during HCT include maintaining relationships with partners and the child's healthy sibling or siblings, managing self-care, and coping with feelings of uncertainty. Caregivers suggested several organizational-level solutions to enhance psychosocial support, including respite services, online connections to other PID caregivers, and bedside mental health services. CONCLUSIONS: Certain high-risk subpopulations of caregivers might need more targeted psychosocial support to reduce the long-term effect of the HCT experience on their well-being. Caregivers suggested several organizational-level solutions for provision of this support.

Crowdsourced Health Data: Comparability to a US National Survey, 2013-2015.

OBJECTIVES: To determine the generalizability of crowdsourced, electronic health data from self-selected individuals using a national survey as a reference. METHODS: Using the world's largest crowdsourcing platform in 2015, we collected data on characteristics known to influence cardiovascular disease risk and identified comparable data from the 2013 Behavioral Risk Factor Surveillance System. We used age-stratified logistic regression models to identify differences among groups. RESULTS: Crowdsourced respondents were younger, more likely to be non-Hispanic and White, and had higher educational attainment. Those aged 40 to 59 years were similar to US adults in the rates of smoking, diabetes, hypertension, and hyperlipidemia. Those aged 18 to 39 years were less similar, whereas those aged 60 to 75 years were underrepresented among crowdsourced respondents. CONCLUSIONS: Crowdsourced health data might be most generalizable to adults aged 40 to 59 years, but studies of younger or older populations, racial and ethnic minorities, or those with lower educational attainment should approach crowdsourced data with caution. Public Health Implications. Policymakers, the national Precision Medicine Initiative, and others planning to use crowdsourced data should take explicit steps to define and address anticipated underrepresentation by important population subgroups.

Genetic influence on exercise-induced changes in physical function among mobility-limited older adults.

To date, physical exercise is the only intervention consistently demonstrated to attenuate age-related declines in physical function. However, variability exists in seniors' responsiveness to training. One potential source of variability is the insertion (I allele) or deletion (D allele) of a 287 bp fragment in intron 16 of the angiotensin-converting enzyme (ACE) gene. This polymorphism is known to influence a variety of physiological adaptions to exercise. However, evidence is inconclusive regarding the influence of this polymorphism on older adults' functional responses to exercise. This study aimed to evaluate the association of ACE I/D genotypes with changes in physical function among Caucasian older adults (n = 283) following 12 mo of either structured, multimodal physical activity or health education. Measures of physical function included usual-paced gait speed and performance on the Short Physical Performance Battery (SPPB). After checking Hardy-Weinberg equilibrium, we used using linear regression to evaluate the genotype*treatment interaction for each outcome. Covariates included clinic site, body mass index, age, sex, baseline score, comorbidity, and use of angiotensin receptor blockers or ACE inhibitors. Genotype frequencies [II (19.4%), ID (42.4%), DD (38.2%)] were in Hardy-Weinberg equilibrium (P > 0.05). The genotype*treatment interaction was statistically significant for both gait speed (P = 0.002) and SPPB (P = 0.020). Exercise improved gait speed by 0.06 ± 0.01 m/sec and SPPB score by 0.72 ± 0.16 points among those with at least one D allele (ID/DD carriers), but function was not improved among II carriers. Thus, ACE I/D genotype appears to play a role in modulating functional responses to exercise training in seniors.

The effects of a long-term physical activity intervention on serum uric acid in older adults at risk for physical disability.

Observational studies show a relationship between elevated serum uric acid (UA) and better physical performance and muscle function. The purpose of this paper was to determine whether regular participation in an exercise intervention, known to improve physical functioning, would result in increased serum UA. For this study, 424 older adults at risk for physical disability were randomized to participate in either a 12-mo moderate-intensity physical activity (PA) or a successful aging (SA) health education intervention. UA was measured at baseline, 6, and 12 mo (n = 368, 341, and 332, respectively). Baseline UA levels were 6.03 ± 1.52 mg/dl and 5.94 ± 1.55 mg/dl in the PA and SA groups, respectively. The adjusted mean UA at month 12 was 4.8% (0.24 mg/dl) higher in the PA compared with the SA group (p = .028). Compared with a health education intervention, a 1-yr PA intervention results in a modest increase in systemic concentration of UA in older adults at risk for mobility disability.

Older adults with overlapping caregiving responsibilities and care needs in a U.S. national community-based sample.

BACKGROUND: Community-dwelling older adults often serve as caregivers despite having their own health concerns and disabilities, yet little is known about their care needs. METHODS: Cross-sectional analysis including community-dwelling U.S. adults over age 60 years who self-identified as caregivers in the National Social Life, Health, and Aging Project in 2015-2016. Caregiving was defined by self-reported assistance of another adult with day-to-day activities due to age or disability; overlapping care-receiving was defined by simultaneous receipt of help for at least one activity of daily living (ADL) or independent ADL (IADL). Multivariable logistic regression models examined attributes associated with overlapping care-receiving among older caregivers, adjusted for caregiver characteristics (age, gender, spousal caregiving, self-reported physical and mental health, cognitive function, and household assets). RESULTS: Among the 444 caregivers, the mean age was 67.8 (SD 0.29) years, 55.8% were women, 78.1% were non-Hispanic White, 54.7% self-identified as primary caregivers, and 30.7% were caring for a spouse. Thirty-two percent of older caregivers were caregiving while themselves receiving assistance with at least one ADL or IADL. Thirty-four percent of caregivers reported <$50,000 in household assets and 10% did not answer the question. Given prior research that supports that most nonrespondents fall into the low-income group, subjects were combined. Analyses with and without nonrespondents did not substantially change the results. Compared to caregivers who were not simultaneously receiving care, caregivers reporting overlapping care-receiving had greater odds of being older (AOR 1.30, 95% confidence interval [CI] [1.14, 1.48] per each 5-year age increase), caregiving for a spouse (AOR 1.93, 95% CI [1.20, 3.13]), having limited household assets (AOR 2.10, 95% CI [1.17, 3.80], for <$50,000 compared to ≥$50,000), and having poor or fair self-reported physical health (AOR 2.94, 95% CI [1.43, 6.02]). CONCLUSIONS: Over 30% of older adult caregivers report simultaneously receiving care for their own daily activities. Older caregivers who receive care are more likely to be older, spousal caregivers, and have limited assets and worse physical health. Targeted strategies are needed to support older caregivers who are uniquely vulnerable due to their overlapping care needs.

Predictors of Psychological Distress Among Rural Family/Friend Caregivers of People Living With Dementia in the United States: Consequences of the COVID-19 Pandemic.

OBJECTIVES: Caregivers of persons living with dementia in rural United States are a vulnerable population. During the coronavirus disease 2019 (COVID-19) pandemic, rural communities experienced heightened disparities in social services, healthcare, suicides, and mortality. Guided by the Caregiving Stress Process Model, this study examines the relationship between the stressors and resources of rural caregivers of persons living with dementia and their experience of depression, stress, and COVID-19. METHODS: One hundred and fifty-two rural caregivers of persons living with dementia completed an online survey, March 1, 2021-April 30, 2022. Analyses used baseline responses to validated scales and an open-ended question, "How has COVID impacted your life as a caregiver?" Dependent variables were depressive symptoms and stress. Bivariate and hierarchical linear regression analyses examined associations of stressors and resources with depressive symptoms and stress. Thematic analysis examined open-ended question responses. RESULTS: Among examined stressors, high care burden (b = 1.94, p < .05) and loneliness (b = 0.76, p < .0001) were positively associated with depressive symptoms. Loneliness (b = 0.24, p < .05) and ≥41 hr spent caregiving per week (reference 10-20 hr; b = 0.99, p < .05) were associated with stress. Among examined resources, self-efficacy for caregiving (b = -0.21, p < .05) was inversely associated with stress. Qualitative results confirmed quantitative results and identified additional pandemic-related themes in stressors and resources. DISCUSSION: We found that caregiver burden, loneliness, and caregiving hours were associated with greater psychological distress among rural caregivers of persons living with dementia during the pandemic, whereas self-efficacy for caregiving was protective. Rural caregivers need increased support to address care burdens and enhance psychological resources for caregiving. CLINICAL TRIAL REGISTRATION NUMBER: NCT04428112.

An easily accessible Web-based minimization random allocation system for clinical trials.

BACKGROUND: Minimization as an adaptive allocation technique has been recommended in the literature for use in randomized clinical trials. However, it remains uncommonly used due in part to a lack of easily accessible implementation tools. OBJECTIVE: To provide clinical trialists with a robust, flexible, and readily accessible tool for implementing covariate-adaptive biased-coin randomization. METHODS: We developed a Web-based random allocation system, MinimRan, that applies Pocock-Simon (for trials with 2 or more arms) and 2-way (currently limited to 2-arm trials) minimization methods for trials using only categorical prognostic factors or the symmetric Kullback-Leibler divergence minimization method for trials (currently limited to 2-arm trials) using continuous prognostic factors with or without categorical factors, in covariate-adaptive biased-coin randomization. RESULTS: In this paper, we describe the system's essential statistical and computer programming features and provide as an example the randomization results generated by it in a recently completed trial. The system can be used in single- and double-blind trials as well as single-center and multicenter trials. CONCLUSIONS: We expect the system to facilitate the translation of the 3 validated random allocation methods into broad, efficient clinical research practice.

Translating an evidence-based lifestyle intervention program into primary care: lessons learned.

The E-LITE (Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care) trial evaluated the feasibility and potential effectiveness of translating an evidence-based lifestyle intervention for the management of obesity and related risk factors in a primary care setting. Delivered by allied health care providers, the intervention promoted at least 7% weight loss and at least 150 minutes per week of moderate-intensity physical activity through gradual, sustainable lifestyle changes. Activities included interactive group lessons, food tasting, guided physical activity, and technology-mediated self-monitoring and behavioral counseling. This article discusses insights and potential areas for improvement to strengthen program implementation for dissemination of the E-LITE program to other primary care settings. We focus on (a) the role of allied health professionals in program delivery, (b) strengthening program integration within a primary care clinic, and (c) the use of information technology to extend the reach and impact of the program. Our experience shows the feasibility of implementing an evidence-based lifestyle intervention program combining group-delivered nutrition and behavioral counseling, physical activity training, and technology-mediated follow-up in a primary care setting. Challenges remain, and we offer possible solutions to overcome them.

Faculty knowledge, actions, and perceptions of sponsorship: an institutional survey study.

BACKGROUND: Women and underrepresented in medicine and the health sciences (URiM) faculty face inequities in advancement. Career sponsorship may be a remedy. Few studies have described sponsorship in academic medicine and none across an institution. OBJECTIVE: To examine faculty awareness, experiences, and perceptions of sponsorship at a large academic health center. DESIGN: Anonymous online survey. PARTICIPANTS: Faculty with a ≥50% appointment. MAIN MEASURES: The survey contained 31 Likert, multiple-choice, yes/no, and open-ended questions about familiarity with the concept of sponsorship; experience of having or being a sponsor; receipt of specific sponsorship activities; sponsorship impact and satisfaction; mentorship and sponsorship co-occurrence; and perception of inequities. Open-ended questions were analyzed using content analysis. KEY RESULTS: Thirty-one percent of the surveyed faculty (903/2900) responded of whom 53% (477/903) were women and 10% (95/903) were URiM. Familiarity with sponsorship was higher among assistant (91%, 269/894) and associate (182/894; 64%) professors versus full professors (38%, 329/894); women (67%, 319/488) versus men (62%, 169/488); and URiM (77%, 66/517) versus non-URiM faculty (55%, 451/517). A majority had a personal sponsor (528/691; 76%) during their career and were satisfied with their sponsorship (64%, 532/828). However, when responses from faculty of different professorial ranks were stratified by gender and URiM identity, we observed possible cohort effects. Furthermore, 55% (398/718) of respondents perceived that women received less sponsorship than men and 46% (312/672) that URiM faculty received less than their peers. We identified seven qualitative themes: sponsorship importance, growing awareness and change, institutional biases and deficiencies, groups getting less sponsorship, people with sponsorship power, conflation with mentorship, and potential for negative impact. CONCLUSIONS: A majority of respondents at a large academic health center reported sponsorship familiarity, receipt, and satisfaction. Yet many perceived persistent institutional biases and the need for systematic change to improve sponsorship transparency, equity, and impact.

Off-label use of recombinant factor VIIa in U.S. hospitals: analysis of hospital records.

BACKGROUND: Recombinant factor VIIa (rFVIIa) is approved for treatment of bleeding in patients who have hemophilia with inhibitors but has been applied to a wide range of off-label indications. OBJECTIVE: To estimate patterns of off-label rFVIIa use in U.S. hospitals. DESIGN: Retrospective database analysis. SETTING: Data were extracted from the Premier Perspectives database (Premier, Charlotte, North Carolina), which contains discharge records from a sample of academic and nonacademic U.S. hospitals. PATIENTS: 12 644 hospitalizations for patients who received rFVIIa during a hospital stay. MEASUREMENTS: Hospital diagnoses and patient dispositions from 1 January 2000 to 31 December 2008. Statistical weights for each hospital were used to provide national estimates of rFVIIa use. RESULTS: From 2000 to 2008, off-label use of rFVIIa in hospitals increased more than 140-fold, such that in 2008, 97% (95% CI, 96% to 98%) of 18 311 in-hospital uses were off-label. In contrast, in-hospital use for hemophilia increased less than 4-fold and accounted for 2.7% (CI, 1.9% to 3.5%) of use in 2008. Adult and pediatric cardiovascular surgery (29% [CI, 21% to 33%]), body and brain trauma (29% [CI, 19% to 38%]), and intracranial hemorrhage (11% [CI, 7.7% to 14%]) were the most common indications for rFVIIa use. Across all indications, in-hospital mortality was 27% (CI, 19% to 34%) and 43% (CI, 26% to 59%) of patients were discharged to home. LIMITATION: Accuracy and completeness of the discharge diagnoses and patient medication records in the database sample cannot be verified. CONCLUSION: Off-label use of rFVIIa in the hospital setting far exceeds use for approved indications. These patterns raise concern about the application of rFVIIa to conditions for which strong supporting evidence is lacking.

Systematic review: benefits and harms of in-hospital use of recombinant factor VIIa for off-label indications.

BACKGROUND: Recombinant factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications. PURPOSE: To evaluate the benefits and harms of rFVIIa use for 5 off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy. DATA SOURCES: Ten databases (including PubMed, EMBASE, and the Cochrane Library) queried from inception through December 2010. Articles published in English were analyzed. STUDY SELECTION: Two reviewers independently screened titles and abstracts to identify clinical use of rFVIIa for the selected indications and identified all randomized, controlled trials (RCTs) and observational studies for full-text review. DATA EXTRACTION: Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence. DATA SYNTHESIS: 16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, -0.05 [CI, -0.02 to -0.08]). Mortality was higher in observational studies than in RCTs. LIMITATIONS: The amount and strength of evidence were low for most outcomes and indications. Publication bias could not be excluded. CONCLUSION: Limited available evidence for 5 off-label indications suggests no mortality reduction with rFVIIa use. For some indications, it increases thromboembolism.

Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia.

INTRODUCTION: Dementia caregiving is complex and disproportionally burdens caregivers living in rural areas due to fewer resources and formal support systems. There is an immediate need to identify effective, scalable, and accessible online programs to support rural caregivers' well-being. Building Better Caregivers (BBC), a possible solution, is an asynchronous online 6-week, interactive, and skills-building workshop developed for caregivers of persons with dementia. This research aims to assess the effectiveness and implementation of the BBC workshop when delivered among rural dementia caregivers in the United States. METHODS: A hybrid effectiveness and implementation trial applying mixed methods will be conducted in collaboration with local, state, and national partnering organizations. Eligible participants live in a rural area of the United States, give care at least 10 h a week for a family member or friend with dementia, and have internet access. Evaluation is based on the RE-AIM framework. Effectiveness outcomes are assessed using a randomized control trial. Caregivers are randomly assigned to the BBC workshop (intervention) or attention control group. Implementation outcomes are assessed using surveys and debriefing interviews from partnering organizations and participants. The study protocol including the study design, methods of recruitment and assessment, and outcomes are described. CONCLUSION: This is the first known study to evaluate both the effectiveness and implementation of a caregiver support intervention under real-world conditions in rural areas. If successful, this online workshop will be a practical and acceptable approach for promoting the health and well-being of geographically isolated rural dementia caregivers.

Building Better Caregivers: A Pragmatic 12-Month Trial of a Community-Based Workshop for Caregivers of Cognitively Impaired Adults.

Building Better Caregivers (BBC), a community 6-week, peer-led intervention, targets family caregivers of those with cognitive impairments. BBC was implemented in four geographically scattered areas. Self-report data were collected at baseline, 6 months, and 1 year. Primary outcome were caregiver strain and depression. Secondary outcomes included caregiver burden, stress, fatigue, pain, sleep, self-rated health, exercise, self-efficacy, and caregiver and care partner health care utilization. Paired t tests examined 6 month and 1-year improvements. General linear models examined associations between baseline and 6-month changes in self-efficacy and 12-month primary outcomes. Eighty-three participants (75% of eligible) completed 12-month data. Caregiver strain and depression improved significantly (Effect Sizes = .30 and .41). All secondary outcomes except exercise and caregiver health care utilization improved significantly. Baseline and 6-month improvements in self-efficacy were associated with improvements in caregiver strain and depression. In this pilot pragmatic study, BBC appears to assist caregivers while reducing care partner health care utilization. Self-efficacy appears to moderate these outcomes.