Practical Strategies for Co-design: The Case of Engaging Patients in Developing Patient-Facing Shared-Decision Making Materials for Lung Cancer Screening.

Co-design provides a meaningful way to engage patients in research. However, there is limited practical guidance. We used our co-design project to identify strategies for other researchers. An ethnographic case study design was used. Data included participant observation of co-design meetings, meeting minutes, analytic fieldnotes, qualitative patient interviews, and research team member self-reflections. Additionally, we got external feedback. We analyzed data iteratively. Our team included 5 patients and 6 researchers. We identified 3 strategies to include patients in co-design: (1) Deliberately build the team, from recruiting patients to specifying roles. (2) Tailor the meeting format to thoughtfully use patients' time and expertise. (3) Disrupt traditional hierarchies, to empower patients to actively participate. Researchers seeking to include patients as team members should consider: team composition and roles, leveraging meeting formats to optimize contributions and purposefully creating a culture of collaboration, so patient expertise informs the end product. Our work provides practical guidance for researchers to incorporate patient expertise in the co-design process and meaningfully involve them in their work.

Promoting Health and Wellbeing Through Non-Clinical Arts Programming: Multi-Stakeholder Perspectives From the Veterans Health Administration.

PURPOSE: While the value of art therapy is well-established and arts are increasingly leveraged to promote health and wellbeing more broadly, little is known about the impacts of non-clinical arts programs. In this preliminary investigation, we sought to fill this gap by exploring diverse stakeholders' perspectives on the impacts of non-clinical arts programming on Veterans receiving care at the Veterans Health Administration (VA). DESIGN: Semi-structured qualitative interviews with Veterans, VA staff, and community partners. SETTING: Interviewees were recruited from 7 VA medical centers that have recently implemented non-clinical arts programming to promote Veterans' health and wellbeing, some of them in partnership with community organizations. PARTICIPANTS: 33 individuals were interviewed, including 9 Veterans, 14 VA staff, and 10 community partners involved in non-clinical arts program implementation. METHOD: Interview transcripts were analyzed using iterative rounds of qualitative content analysis. RESULTS: The following impacts on Veterans were described: (1) mental health improvements, (2) renewed sense of purpose; (3) increased social connectedness, (4) improved self-esteem, and (5) self-driven engagement in art activities. CONCLUSION: Non-clinical arts programming was perceived by diverse stakeholders to offer important benefits for Veterans' health and well-being. Offering non-clinical arts programming inside and outside healthcare facilities' walls is a promising direction for the field of public health undergoing a shift towards holistic approaches to improving individual and population health outcomes.

Greater Protein Intake Emphasizing Lean Beef Does Not Affect Resistance Training-Induced Adaptations in Skeletal Muscle and Tendon of Older Women: A Randomized Controlled Feeding Trial.

BACKGROUND: Although experimental research supports that resistance training (RT), especially with greater dietary protein intake, improves muscle mass and strength in older adults, comparable research on tendons is needed. OBJECTIVES: We assessed the effects of a protein-rich diet emphasizing lean beef, compared with 2 control diets, on RT-induced changes in skeletal muscle and tendon size and strength in older women. METHODS: We randomly assigned women [age: 66 ± 1 y, body mass index (BMI): 28 ± 1] to groups that consumed 1) 0.8 g total protein/kg body weight/day from mixed food sources (normal protein control, n = 16); 2) 1.4 g/kg/d protein from mixed food sources (high protein control, n = 17); or 3) 1.4 g/kg/d protein emphasizing unprocessed lean beef (high protein experimental group, n = 16). Participants were provided with all foods and performed RT 3 times/wk, 70% of 1-repetition maximum for 12 wk. We measured quadriceps muscle volume via magnetic resonance imaging (MRI). We estimated patellar tendon biomechanical properties and cross-sectional area (CSA) using ultrasound and MRI. RESULTS: Dietary intake did not influence RT-induced increases in quadriceps strength (P < 0.0001) or muscle volume (P < 0.05). We noted a trend for an RT effect on mean tendon CSA (P = 0.07), with no differences among diets (P > 0.05). Proximal tendon CSA increased with RT (P < 0.05) with no difference between dietary groups (P > 0.05). Among all participants, midtendon CSA increased with RT (P ≤ 0.05). We found a decrease in distal CSA in the 0.8 g group (P < 0.05) but no change in the 1.4 g group (P > 0.05). Patellar tendon MRI signal or biomechanical properties were unchanged. CONCLUSIONS: Our findings indicated that greater daily protein intake, emphasizing beef, did not influence RT-induced changes in quadriceps muscle strength or muscle volume of older women. Although we noted trends in tendon CSA, we did not find a statistically significant impact of greater daily protein intake from beef on tendon outcomes. This trial was registered at clinicaltrials.gov as NCT04347447.

Association of serum phosphate, calcium and alkaline phosphatase with risk of incident fractures in healthy older adults.

BACKGROUND: Aging increases fracture risk through bone loss and microarchitecture deterioration due to an age-related imbalance in bone resorption and formation during bone remodelling. We examined the associations between levels of phosphate, calcium, and alkaline phosphatase, and fracture risk in initially-healthy older individuals. METHODS: A post-hoc analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial recruited 16,703 Australian participants aged ≥70 years and 2,411 US participants aged ≥65 years. Analyses were conducted on ASPREE-Fracture substudy participants from Australia with serum calcium, phosphate, and alkaline phosphatase measurement. Fracture data were collected post-randomization. Cox regression was used to calculate hazard ratios (HR) and 95% confidence intervals (CIs). Phosphate, calcium, and alkaline phosphatase were analysed in deciles (D1-D10), with deciles 4-7 (31-70%) as the reference category. Restricted cubic spline curves were used to identify nonlinear associations. RESULTS: Of the 9915 participants, 907 (9·2%) persons had incident fractures recorded over 3·9 (SD 1·4) years. In the fully adjusted model, males in the top decile (D10) of phosphate had 78% higher risk of incident fracture (HR 1·78, 95% CI 1·25-2·54). No such association was observed for females (HR 1·09, 95% CI 0·83-1·44). The population attributable fraction in men within the D10 phosphate category is 6·9%. CONCLUSION: This result confirms that, high-normal serum phosphate levels are associated with increased fracture risk in older men.

Strategies for engaging patients in co-design of an intervention.

OBJECTIVE: We provide practical guidance about using co-design methods to collaborate with patients to create patient-facing interventions, which others can use when undertaking similar projects. METHODS: This is a narrative review synthesizing co-design principles and published literature with our experience working alongside five Veteran patients of the U.S. Department of Veterans Affairs in New England to co-design a portfolio of patient-facing materials to improve patient-centered care coordination. Our process took 12 weeks (April - June 2022) and was conducted entirely via video conference. RESULTS: Co-design is a participatory research method. Its principles include sharing power over the research process and products, agency for all participants, embracing a plurality of forms of knowledge, and mutual and reciprocal benefit. We describe three stages of the co-design process (preparatory work; design and development; feedback and closure), strategies and techniques we used at each stage, challenges we faced, and considerations for addressing them. CONCLUSION: Co-designing patient-facing interventions blends different forms of knowledge to produce practical, contextually specific interventions with ownership by the people who will use them. PRACTICE IMPLICATIONS: Co-design is a feasible methodology for most health services research teams whose goal is to intensify patient engagement in research.

Early Deep Sedation Practices Worsened During the Pandemic Among Adult Patients Without COVID-19: A Retrospective Cohort Study.

BACKGROUND: There is substantial evidence that patients with COVID-19 were treated with sustained deep sedation during the pandemic. However, it is unknown whether such guideline-discordant care had spillover effects to patients without COVID-19. RESEARCH QUESTION: Did patterns of early deep sedation change during the pandemic for patients on mechanical ventilation without COVID-19? STUDY DESIGN AND METHODS: We used electronic health record data from 4,237 patients who were intubated without COVID-19. We compared sedation practices in the first 48 h after intubation across prepandemic (February 1, 2018, to January 31, 2020), pandemic (April 1, 2020, to March 31, 2021), and late pandemic (April 1, 2021, to March 31, 2022) periods. RESULTS: In the prepandemic period, patients spent an average of 13.0 h deeply sedated in the first 48 h after intubation. This increased 1.9 h (95% CI, 1.0-2.8) during the pandemic period and 2.9 h (95% CI, 2.0-3.8) in the late pandemic period. The proportion of patients that spent over one-half of the first 48 h deeply sedated was 18.9% in the prepandemic period, 22.3% during the pandemic period, and 25.9% during the late pandemic period. Ventilator-free days decreased during the pandemic, with a subdistribution hazard ratio of being alive without mechanical ventilation at 28 days of 0.87 (95% CI, 0.79-0.95) compared with the prepandemic period. Tracheostomy placement increased during the pandemic period compared with the prepandemic period (OR, 1.41; 95% CI, 1.08-1.82). In the medical ICU, early deep sedation increased 2.5 h (95% CI, 0.6-4.4) during the pandemic period and 4.9 h (95% CI, 3.0-6.9) during the late pandemic period, compared with the prepandemic period. INTERPRETATION: Among patients on mechanical ventilation without COVID-19, sedation use increased during the pandemic. In the subsequent year, these practices did not return to prepandemic standards.

Changes in Patient-Reported Outcomes Associated with Receiving Whole Health in the Veteran Health Administration (VHA)'s National Demonstration Project.

BACKGROUND: Whole Health (WH) is a patient-centered model of care being implemented by the Veterans Health Administration. Little is known about how use of WH services impacts patients' health and well-being. OBJECTIVE: We sought to assess the association of WH utilization with pain and other patient-reported outcomes (PRO) over 6 months. DESIGN: A longitudinal observational cohort evaluation, comparing changes in PRO surveys for WH users and Conventional Care (CC) users. Inverse probability of treatment weighting was used to balance the two groups on observed demographic and clinical characteristics. PARTICIPANTS: A total of 9689 veterans receiving outpatient care at 18 VA medical centers piloting WH. INTERVENTIONS: WH services included goal-setting clinical encounters, Whole Health coaching, personal health planning, and well-being services. MAIN OUTCOME MEASURES: The primary outcome was change in pain intensity and interference at 6 months using the 3-item PEG. Secondary outcomes included satisfaction, experiences of care, patient engagement in healthcare, and well-being. KEY RESULTS: By 6 months,1053 veterans had utilized WH and 3139 utilized only CC. Baseline pain PEG scores were 6.2 (2.5) for WH users and 6.4 (2.3) for CC users (difference p = 0.028), improving by - 2.4% (p = 0.006) and - 2.3% (p < 0.001), respectively. In adjusted analyses, WH use was unassociated with greater improvement in PEG scores compared to CC - 1.0% (- 2.9%, 1.2%). Positive trends were observed for 8 of 15 exploratory outcomes for WH compared to CC. WH use was associated with greater improvements at 6 months in likelihood to recommend VA 2.0% (0.9%, 3.3%); discussions of goals 11.8% (8.2%, 15.5%); perceptions of healthcare interactions 2.5% (0.4%, 4.6%); and engagement in health behaviors 2.2% (0.3%, 3.9%). CONCLUSION: This study provides early evidence supporting the delivery of WH patient-centered care services to improve veterans' experiences of and engagement in care. These are important first-line impacts towards the goals of better overall health and well-being outcomes for Veterans.

Proactively tailoring implementation: the case of shared decision-making for lung cancer screening across the VA New England Healthcare Network.

BACKGROUND: Shared Decision-Making to discuss how the benefits and harms of lung cancer screening align with patient values is required by the US Centers for Medicare and Medicaid and recommended by multiple organizations. Barriers at organizational, clinician, clinical encounter, and patient levels prevent SDM from meeting quality standards in routine practice. We developed an implementation plan, using the socio-ecological model, for Shared Decision-Making for lung cancer screening for the Department of Veterans Affairs (VA) New England Healthcare System. Because understanding the local context is critical to implementation success, we sought to proactively tailor our original implementation plan, to address barriers to achieving guideline-concordant lung cancer screening. METHODS: We conducted a formative evaluation using an ethnographic approach to proactively identify barriers to Shared Decision-Making and tailor our implementation plan. Data consisted of qualitative interviews with leadership and clinicians from seven VA New England medical centers, regional meeting notes, and Shared Decision-Making scripts and documents used by providers. Tailoring was guided by the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). RESULTS: We tailored the original implementation plan to address barriers we identified at the organizational, clinician, clinical encounter, and patient levels. Overall, we removed two implementation strategies, added five strategies, and modified the content of two strategies. For example, at the clinician level, we learned that past personal and clinical experiences predisposed clinicians to focus on the benefits of lung cancer screening. To address this barrier, we modified the content of our original implementation strategy Make Training Dynamic to prompt providers to self-reflect about their screening beliefs and values, encouraging them to discuss both the benefits and potential harms of lung cancer screening. CONCLUSIONS: Formative evaluations can be used to proactively tailor implementation strategies to fit local contexts. We tailored our implementation plan to address unique barriers we identified, with the goal of improving implementation success. The FRAME-IS aided our team in thoughtfully addressing and modifying our original implementation plan. Others seeking to maximize the effectiveness of complex interventions may consider using a similar approach.

VHA Whole Health Services and Complementary and Integrative Health Therapies: a Gateway to Evidence-Based Mental Health Treatment.

BACKGROUND: Engagement in evidence-based psychotherapy (EBP) among veterans with behavioral health conditions is often low. The Veterans Health Administration (VHA) is implementing a "Whole Health (WH)" system of care, to identify veteran personal health goals, align care with those goals, and offer services designed to engage and empower veterans to achieve well-being. OBJECTIVE: To examine the relationship between veteran WH utilization and subsequent engagement in EBP. DESIGN: Retrospective analysis of VHA administrative records from 18 facilities implementing WH. SUBJECTS: Veterans (n = 265,364) with a diagnosis of depression, post-traumatic stress disorder (PTSD), and/or anxiety who had a mental healthcare encounter but no EBP use in fiscal year (FY) 2018. Among this cohort, 33,146 (12.5%) began using WH in FY2019. MAIN MEASURES: We examined use of an EBP for depression, anxiety, and/or PTSD within 1 year of the index date of WH use compared to use of an EBP anytime during FY2019 for veterans not identified as using WH. We used multiple logistic regression to examine the association between veteran WH use and EBP engagement. KEY RESULTS: Approximately 3.0% (n = 7,860) of the veterans in our overall cohort engaged in an EBP in the year following their index date. Controlling for key demographic, health, and utilization variables, WH users had 2.4 (95% CI: 2.2-2.5) times higher odds of engaging in an EBP the following year than those with no WH utilization. Associations between utilization of specific WH services (vs. no utilization of that service) and engagement in an EBP in the subsequent year ranged from 1.6 (95% CI: 1.0-2.6) to 3.5 (95% CI: 3.2-3.9) across the different types of WH services used. CONCLUSIONS: WH use was associated with increased engagement in EBPs among veterans with depression, anxiety, and/or PTSD. Future interventions intended to promote veteran engagement in EBPs may benefit from leveraging WH services and therapies.

An Inflection Point in Cancer Protein Biomarkers: What was and What's Next.

Biomarkers remain the highest value proposition in cancer medicine today-especially protein biomarkers. Despite decades of evolving regulatory frameworks to facilitate the review of emerging technologies, biomarkers have been mostly about promise with very little to show for improvements in human health. Cancer is an emergent property of a complex system, and deconvoluting the integrative and dynamic nature of the overall system through biomarkers is a daunting proposition. The last 2 decades have seen an explosion of multiomics profiling and a range of advanced technologies for precision medicine, including the emergence of liquid biopsy, exciting advances in single-cell analysis, artificial intelligence (machine and deep learning) for data analysis, and many other advanced technologies that promise to transform biomarker discovery. Combining multiple omics modalities to acquire a more comprehensive landscape of the disease state, we are increasingly developing biomarkers to support therapy selection and patient monitoring. Furthering precision medicine, especially in oncology, necessitates moving away from the lens of reductionist thinking toward viewing and understanding that complex diseases are, in fact, complex adaptive systems. As such, we believe it is necessary to redefine biomarkers as representations of biological system states at different hierarchical levels of biological order. This definition could include traditional molecular, histologic, radiographic, or physiological characteristics, as well as emerging classes of digital markers and complex algorithms. To succeed in the future, we must move past purely observational individual studies and instead start building a mechanistic framework to enable integrative analysis of new studies within the context of prior studies. Identifying information in complex systems and applying theoretical constructs, such as information theory, to study cancer as a disease of dysregulated communication could prove to be "game changing" for the clinical outcome of cancer patients.

Longitudinal association between handgrip strength, gait speed and risk of serious falls in a community-dwelling older population.

OBJECTIVE: Both grip strength and gait speed can be used as markers of muscle function, however, no previous study has examined them in the same population with respect to risk of falls. METHODS: In this prospective cohort study, utilising data from the ASPirin in Reducing Events in the Elderly (ASPREE) trial and ASPREE-Fracture substudy, we analysed the association of grip strength and gait speed and serious falls in healthy older adults. Grip strength was measured using a handheld dynamometer and gait speed from 3-metre timed walks. Serious falls were confined to those involving hospital presentation. Cox regression was used to calculate hazard ratios (HR) and 95% confidence intervals (CI) for associations with falls. RESULTS: Over an average of 4.0±1.3 years, amongst 16,445 participants, 1,533 had at least one serious fall. After adjustment for age, sex, physical activity, body mass index, Short Form 12 (state of health), chronic kidney disease, polypharmacy and aspirin, each standard deviation (SD) lower grip strength was associated with 27% (HR 1.27, 95% CI 1.17-1.38) higher risk of falls. The results remained the same for males and females. There was a dose-response relationship in the association between grip strength and falls risk. The higher risk of falls was observed in males in all body mass index (BMI) categories, but only in obese females. The association between gait speed and falls risk was weaker than the association between grip strength and falls risk. CONCLUSIONS: All males and only obese females with low grip strength appear to be at the greatest risk of serious falls. These findings may assist in early identification of falls.

Association of Plasma High-Density Lipoprotein Cholesterol Level With Risk of Fractures in Healthy Older Adults.

Importance: Increased levels of high-density lipoprotein cholesterol (HDL-C) have been associated with osteoporosis. Preclinical studies have reported that HDL-C reduces bone mineral density by reducing osteoblast number and function. However, the clinical significance of these findings is unclear. Objective: To determine whether higher HDL-C levels are predictive of an increased fracture risk in healthy older adults. Design, Setting, and Participants: This cohort study is a post hoc analysis of data from the Aspirin in Reducing Events in the Elderly (ASPREE) clinical trial and the ASPREE-Fracture substudy. ASPREE was a double-blind, randomized, placebo-controlled primary prevention trial of aspirin that recruited participants between 2010 and 2014. These comprised community-based older adults (16 703 Australians aged ≥70 years, 2411 US participants ≥65 years) without evident cardiovascular disease, dementia, physical disability, and life-limiting chronic illness. The ASPREE-Fracture substudy collected data on fractures reported postrandomization from Australian participants. Cox regression was used to calculate hazard ratio (HR) and 95% CI. Data analysis for this study was performed from April to August 2022. Exposure: Plasma HDL-C. Main Outcomes and Measures: Fractures included were confirmed by medical imaging and included both traumatic and minimal trauma fractures. Fractures were adjudicated by an expert review panel. Results: Of the 16 262 participants who had a plasma HDL-C measurement at baseline (8945 female participants [55%] and 7319 male [45%]), 1659 experienced at least 1 fracture over a median (IQR) of 4.0 years (0.02-7.0 years). In a fully adjusted model, each 1-SD increment in HDL-C level was associated with a 14% higher risk of fractures (HR, 1.14; 95% CI, 1.08-1.20). The results remained similar when these analyses were stratified by sex. Sensitivity and stratified analyses demonstrated that these associations persisted when the analyses were repeated to include only (1) minimal trauma fractures, (2) participants not taking osteoporosis medications, (3) participants who were never smokers and reported that they did not drink alcohol, and (4) participants who walked outside for less than 30 minutes per day and reported no participation in moderate/vigorous physical activity and to examine only (5) statin use. No association was observed between non-HDL-C levels and fractures. Conclusions and Relevance: This study suggests that higher levels of HDL-C are associated with an increased fracture risk. This association was independent of common risk factors for fractures.

The feasibility and acceptability of a falls prevention e-learning program for physiotherapists.

OBJECTIVE: To examine the feasibility and acceptability of a falls prevention e-learning program for physiotherapists working with people with osteoarthritis (OA). METHODS: A prospective pre-post quasi-experimental approach was adopted. An e-learning program on falls prevention specific to the OA population was developed and delivered. Feasibility and acceptability data were obtained from recruitment records, MoodleTM activity logs, multiple choice quizzes and customized surveys. RESULTS: Of the 65 physiotherapists and near-graduate physiotherapy students who met the eligibility criteria, 50 (77%) completed the e-learning program. Participants were satisfied and considered the program to be acceptable. The program met their expectations (n = 45; 90%) and was highly relevant to their work (median 8-10 [interquartile range (IQR)] 2; range 0 [not at all relevant] to 10 [extremely relevant]). An overall improvement in knowledge was also observed (mean percentage difference 8%; 95% CI -3.49, -1.27). DISCUSSION: Given a heightened risk of falls among people with OA, ensuring physiotherapists are skilled in falls prevention is important. Our acceptability and outcomes data indicate that a falls prevention e-learning program can be feasibly delivered to physiotherapists working in OA care. Future research should assess subsequent changes in clinical practice to determine whether physiotherapists deliver care reflective of contemporary falls prevention evidence.

Falls prevention and osteoarthritis: time for awareness and action.

Osteoarthritis (OA) and falls both commonly affect older people. While high-level evidence exists to prevent falls in older people, falls prevention is rarely considered within contemporary OA management. OA care and falls prevention have for too long been considered as separate clinical constructs. In the context of ageing populations and growing numbers of people with OA, the time to raise awareness and enact appropriate action is now. This Perspectives on Rehabilitation article draws on the findings from a comprehensive mixed-methods falls and OA research program (which uniquely spanned population, clinician, and consumer perspectives) to better understand existing evidence-practice gaps and identify key opportunities for improvements in clinical care.IMPLICATIONS FOR REHABILITATIONWhile high-level evidence exists to prevent falls in older people, falls prevention is rarely considered within contemporary OA management and this represents a concerning knowledge-to-practice gap.Given ageing populations and growth in the number of people with OA, it is time for falls prevention to be incorporated within routine OA care for older people.To achieve this, we need to re-shape current messaging around falls prevention and develop targeted resources to optimise clinician knowledge and skills in this area.

Aged and Health Care Service Utilization by Older Australians Receiving Home Care Packages.

OBJECTIVES: To examine the (1) cohort of individuals living at home with Home Care Packages (HCPs) in 2016, (2) their access to other aged care services after HCP commencement, and (3) their hospital and ambulance service utilization. DESIGN: A cross-sectional study was conducted using integrated aged care and health care data contained within the National Historical Cohort of the Registry of Senior Australians. SETTING AND PARTICIPANTS: This study included people who accessed HCP between January 1, 2016 and December 31, 2016. METHODS: The access to permanent residential aged care, transition care, respite care, hospital and ambulance services among Australian HCP recipients ≥65 years old in 2016 was evaluated. Descriptive statistics were employed. RESULTS: In 2016, 84,681 individuals received HCPs, of which 68.4% (n = 57,942) accessed HCP levels 1‒2, 26.0% (n = 22,057) accessed HCP levels 3‒4, and 5.5% (n = 4682) accessed both care levels within the year. Of the individuals receiving HCP, 34.0% (n = 27,787) started services that year and 16.7% (n = 14,117) moved to permanent residential aged care, 18.4% (n = 15,592) used respite care and 5.8% (n = 4937) used transition care that year. Emergency department (ED) presentations [43.6%, 95% confidence interval (CI) 43.3‒44.0] were the most common hospital encounters, followed by inpatient hospitalizations for any reason (43.3%, 95% CI 42.9‒43.7), and unplanned hospitalizations (38%, 95% CI 37.6‒38.3). Forty-four percent (44.5%, 95% CI 43.9‒45.0) of individuals utilized ambulance services. ED presentations, hospitalization for any reason, and unplanned hospitalizations were more common in individuals receiving HCP levels 3‒4 compared with those accessing HCP levels 1‒2. CONCLUSIONS AND IMPLICATIONS: HCP recipients in Australia have frequent hospitalizations, including ED presentations. In addition, almost 1 in 5 access respite care and 16.7% transition to permanent residential care each year. As the population accessing HCP is increasing, adequate support for these individuals to live well at home and avoid health events that lead to hospitalizations are necessary.

Daily Low-Dose Aspirin and Risk of Serious Falls and Fractures in Healthy Older People: A Substudy of the ASPREE Randomized Clinical Trial.

Importance: Falls and fractures are frequent and deleterious to the health of older people. Aspirin has been reported to reduce bone fragility and slow bone loss. Objective: To determine if daily low-dose aspirin (100 mg) reduces the risk of fractures or serious falls (fall-related hospital presentations) in healthy older men and women. Design, Setting, and Participants: This substudy of a double-blind, randomized, placebo-controlled trial studied older adult men and women in 16 major sites across southeastern Australia. The ASPREE-FRACTURE substudy was conducted as part of the Australian component of the ASPREE trial. Between 2010 and 2014 healthy (free of cardiovascular disease, dementia or physical disability), community-dwelling volunteers aged 70 years or older were recruited to participate in the ASPREE trial. Potentially eligible participants were identified by medical practitioners and trial personnel and were then sent a letter of invitation to participate. Interested participants were screened for suitability. Eligible participants with medical practitioner authorization and adherent to a 4-week run-in medication trial were randomized. Data were analyzed from October 17, 2019, to August 31, 2022. Interventions: Participants in the intervention group received a daily dose of oral 100 mg enteric-coated (low-dose) aspirin. The control group received a daily identical enteric-coated placebo tablet. Main Outcomes and Measures: The primary outcome of ASPREE-FRACTURE was the occurrence of any fracture. The secondary outcome was serious fall resulting in hospital presentation. Results: In total, 16 703 people with a median (IQR) age of 74 (72-78) years were recruited, and 9179 (55.0%) were women. There were 8322 intervention participants and 8381 control participants included in the primary and secondary outcome analysis of 2865 fractures and 1688 serious falls over the median follow-up of 4.6 years. While there was no difference in the risk of first fracture between the intervention and control participants (hazard ratio, 0.97; 95% CI, 0.87-1.06; P = .50), aspirin was associated with a higher risk of serious falls (total falls 884 vs 804; incidence rate ratio, 1.17; 95% CI, 1.03-1.33; P = .01). Results remained unchanged in analyses that adjusted for covariates known to influence fracture and fall risk. Conclusions and Relevance: In this substudy of a randomized clinical trial, the failure of low-dose aspirin to reduce the risk of fractures while increasing the risk of serious falls adds to evidence that this agent provides little favorable benefit in a healthy, White older adult population. Trial Registration: This substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).

Protocol for a Mixed-Methods Process Evaluation of BetterBrains: A Person-Centered Online Intervention to Delay Cognitive Decline in Adults at Risk of Dementia.

BACKGROUND: The BetterBrains Randomized Controlled Trial (RCT) will evaluate the effectiveness of an online, person-centered, risk factor management, coaching intervention in community-dwelling, healthy adults at risk of cognitive decline. Multi-component interventions are challenging to evaluate due to program complexity and personalization to individual needs and contexts. This paper describes a multi-level process evaluation conducted alongside the BetterBrains RCT. OBJECTIVE: To understand how and why the BetterBrains intervention was effective or ineffective at reducing cognitive decline in healthy adults whilst considering the context in which it was implemented. METHODS: 1,510 non cognitively-deteriorated community-dwelling adults aged 40-70 years old at risk of cognitive decline will be recruited and randomly assigned to the intervention or control group. All BetterBrains intervention participants, coaches, and the research team will be included in the evaluation. A mixed-methods design will be used, guided by The Framework for Implementation Fidelity and the program logic model. Data will be sourced from interviews, focus groups, surveys, BetterBrains coach notes, participant weekly check-in surveys, and audio recordings of intervention coaching sessions. Quantitative data will be analyzed via descriptive and inferential statistics and qualitative data will be analyzed using content and thematic analysis. RESULTS: The process evaluation will provide information about contextual and influencing factors related to the implementation of BetterBrains and the RCT outcomes. CONCLUSION: Understanding how BetterBrains was implemented and its associated impacts will inform the translation of the program into community and clinical settings, providing easy access to online, personalized dementia prevention services.

'It Makes You Sit Back and Think Where You Wanna Go': Veteran experiences in virtual whole health peer-led groups.

BACKGROUND: The Veterans Health Administration (VHA) is building a Whole Health system of care that aspires to empower and equip each Veteran to pursue a personally meaningful vision of health and well-being. As part of this effort, VHA has developed Taking Charge of My Life and Health (TCMLH), a peer-led, group-based programme that seeks to support Veterans in setting and pursuing health and well-being goals. Prior research showed TCMLH groups to positively impact Veteran outcomes; yet, little is known about Veterans' own experiences and perspectives. METHODS: We completed semi-structured telephone interviews with 15 Veterans across 8 sites who had participated in TCMLH groups offered by the VHA in the virtual format between Summer 2020 and Fall 2021. Inductive thematic analysis was applied to interview transcripts to generate themes. FINDINGS: We identified five themes regarding Veterans' experiences with TCMLH: (1) navigating the virtual format; (2) internalizing the value of health engagement; (3) making healthy lifestyle changes; (4) forging social connections; and (5) taking on a more active role in healthcare. CONCLUSION: Veterans perceived virtual TCMLH groups as meaningful and beneficial, yet also highlighted several challenges. Their perspectives speak to the need to supplement time-limited programmes like TCMLH with ongoing, community-based support. Virtual group-based well-being programmes are a promising innovation. Other healthcare systems may draw on VHA's experience while tailoring format and content to the needs of their patient populations. PATIENT OR PUBLIC CONTRIBUTION: Veterans were involved as evaluation participants. A Veteran consultant, who is a coauthor on this paper, was engaged through the conceptualization of the evaluation, development of data collection materials (interview guide) and writing.