Matching study design to prescribing intention: The prevalent new-user design for studying abuse-deterrent formulations of opioids.

PURPOSE: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies. METHODS: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six-month washout period) or prevalent new users. RESULTS: We identified 8415 (NC claims) and 147 978 (MarketScan) ADF, and 10 114 (NC claims) and 232 028 (MarketScan) non-ADF ER/LA opioid initiators. Most had prior opioid exposure (ranging 64%-74%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non-ADF ER/LA initiators. Concurrent immediate-release opioid prescriptions at initiation were more common in prevalent new users than traditional new users. CONCLUSIONS: Careful consideration of the study design, comparator choice, and confounding by "indication" is crucial when examining ADF opioid use-related outcomes.

Higher First 30-Day Dose of Buprenorphine for Opioid Use Disorder Treatment Is Associated With Decreased Mortality.

OBJECTIVE: Buprenorphine is a medication for opioid use disorder that reduces mortality. This study aims to investigate the less well-understood relationship between the dose in the early stages of treatment and the subsequent risk of death. METHODS: We used Kentucky prescription monitoring data to identify adult Kentucky residents initiating transmucosal buprenorphine medication for opioid use disorder (January 2017 to November 2019). Average daily buprenorphine dose for days covered in the first 30 days of treatment was categorized as ≤8 mg, >8 to ≤16 mg, and >16 mg. Patients were followed for 365 days after the first 30 days of buprenorphine treatment. Endpoints were opioid-involved overdose death and death from other causes. Causes and dates of death were obtained using Kentucky death certificate records. Associations were evaluated using multivariable Fine and Gray models adjusting for patient baseline characteristics. RESULTS: In the cohort of 49,857 patients, there were 227 opioid-involved overdose deaths and 459 deaths from other causes. Compared with ≤8 mg, the adjusted subdistribution hazard ratio (aSHR) of opioid-involved overdose death decreased by 55% (aSHR, 0.45; 95% confidence interval [CI], 0.34-0.60) and 64% (aSHR, 0.36; 95% CI, 0.25-0.52) for patients receiving doses of >8 to ≤16 mg and >16 mg, respectively. The incidence of death from other causes was lower in patients receiving >8 to ≤16 mg (aSHR, 0.78; 95% CI, 0.62-0.98) and >16 mg (aSHR, 0.62; 95% CI, 0.47-0.80) versus ≤8 mg dose. CONCLUSIONS: Higher first 30-day buprenorphine doses were associated with reduced opioid-involved overdose death and death from other causes, supporting benefit of higher dosing in reducing mortality.

The Implementation of Recommender Systems for Mental Health Recovery Narratives: Evaluation of Use and Performance.

BACKGROUND: Recommender systems help narrow down a large range of items to a smaller, personalized set. NarraGive is a first-in-field hybrid recommender system for mental health recovery narratives, recommending narratives based on their content and narrator characteristics (using content-based filtering) and on narratives beneficially impacting other similar users (using collaborative filtering). NarraGive is integrated into the Narrative Experiences Online (NEON) intervention, a web application providing access to the NEON Collection of recovery narratives. OBJECTIVE: This study aims to analyze the 3 recommender system algorithms used in NarraGive to inform future interventions using recommender systems for lived experience narratives. METHODS: Using a recently published framework for evaluating recommender systems to structure the analysis, we compared the content-based filtering algorithm and collaborative filtering algorithms by evaluating the accuracy (how close the predicted ratings are to the true ratings), precision (the proportion of the recommended narratives that are relevant), diversity (how diverse the recommended narratives are), coverage (the proportion of all available narratives that can be recommended), and unfairness (whether the algorithms produce less accurate predictions for disadvantaged participants) across gender and ethnicity. We used data from all participants in 2 parallel-group, waitlist control clinical trials of the NEON intervention (NEON trial: N=739; NEON for other [eg, nonpsychosis] mental health problems [NEON-O] trial: N=1023). Both trials included people with self-reported mental health problems who had and had not used statutory mental health services. In addition, NEON trial participants had experienced self-reported psychosis in the previous 5 years. Our evaluation used a database of Likert-scale narrative ratings provided by trial participants in response to validated narrative feedback questions. RESULTS: Participants from the NEON and NEON-O trials provided 2288 and 1896 narrative ratings, respectively. Each rated narrative had a median of 3 ratings and 2 ratings, respectively. For the NEON trial, the content-based filtering algorithm performed better for coverage; the collaborative filtering algorithms performed better for accuracy, diversity, and unfairness across both gender and ethnicity; and neither algorithm performed better for precision. For the NEON-O trial, the content-based filtering algorithm did not perform better on any metric; the collaborative filtering algorithms performed better on accuracy and unfairness across both gender and ethnicity; and neither algorithm performed better for precision, diversity, or coverage. CONCLUSIONS: Clinical population may be associated with recommender system performance. Recommender systems are susceptible to a wide range of undesirable biases. Approaches to mitigating these include providing enough initial data for the recommender system (to prevent overfitting), ensuring that items can be accessed outside the recommender system (to prevent a feedback loop between accessed items and recommended items), and encouraging participants to provide feedback on every narrative they interact with (to prevent participants from only providing feedback when they have strong opinions).

Peer review of clinical and translational research manuscripts: Perspectives from statistical collaborators.

Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors. We describe components of clinical and translational science research manuscripts that require assessment including study design and hypothesis evaluation, sampling and data acquisition, interventions (for studies that include an intervention), measurement of data, statistical analysis methods, presentation of the study results, and interpretation of the study results. For each component, we describe what reviewers should look for and assess; how reviewers should provide helpful comments for fixable errors or omissions; and how reviewers should communicate uncorrectable and irreparable errors. We then discuss the critical concepts of transparency and acceptance/revision guidelines when communicating with responsible journal editors.

Second sensor to improve near-infrared spectroscopy flap monitor utility: A prospective study.

OBJECTIVE: This study assesses whether use of continuous noninvasive near-infrared spectroscopy (NIRS) sensor on head and neck free flap (FF) with a second sensor on nonoperated tissue improves distinction between systemic hypoperfusion and FF compromise. METHODS: Single-institution, prospective study of patients undergoing head and neck FF reconstruction from December 2018 to April 2020. FFs were continuously monitored using NIRS on a monitor paddle with a second (control) sensor on the shoulder. Crude StO2 and percent change in StO2 were compared between the FF and control sensors on each patient, and percent change and percent difference between the control and the monitor paddle were documented to assess for congruity. Sentinel events (e.g., hypotension and hematoma) were documented to assess the association with change in StO2. These events and timing of StO2 changes were noted to assess associations with change in StO2. RESULTS: A total of 48 patients had complete data. Donor sites included 35 soft-tissue FFs and 13 fibula FFs. Average StO2 was 73.7 ± 5.5 for FFs and 71.4 ± 5.0 for control sensors. There were seven sentinel events during the study. At the time of the events, StO2 dropped significantly more for the FF than the control sensor (FF = 52.2% drop; control = 6.2% drop; p = .016). NIRS signal denoted change prior to changes in implantable arterial Doppler in all cases. CONCLUSIONS: The addition of a second sensor when using NIRS as a primary modality for FF monitoring may improve distinction between FF compromise events and systemic hypoperfusion. By increasing accuracy of the monitor, there is a potential for decreased resident burden and decreased use of higher level of care nursing, which could reduce overall costs.

Building a strong collaborative biostatistics workforce: Strategies for effective intra-unit professional development activities.

Ongoing professional development is important for collaborative biostatisticians, as it enables them to remain current with the latest advances in statistical methodology and software, refine their analytical skills, and expand their domain knowledge, thereby facilitating their ability to contribute effectively to biomedical research. Although external opportunities for professional development, such as attending conferences and workshops, are widely recognized and valued in the field of biostatistics, there has been comparatively little attention given to internal opportunities for enhancing the skills and knowledge of biostatisticians which can be implemented with lower financial and time investment than external offerings. The purpose of this paper is to offer guidance for ongoing internal professional development activities that can be employed by collaborative biostatistics units in universities and academic medical centers to complement structured curricula and initial training. Specific examples of activities are provided so that collaborative biostatisticians and/or managers of biostatistical units can flexibly combine components to create an appropriately scaled, customized program that meets the needs of themselves or of the unit.

Essential team science skills for biostatisticians on collaborative research teams.

Introduction: Despite the critical role that quantitative scientists play in biomedical research, graduate programs in quantitative fields often focus on technical and methodological skills, not on collaborative and leadership skills. In this study, we evaluate the importance of team science skills among collaborative biostatisticians for the purpose of identifying training opportunities to build a skilled workforce of quantitative team scientists. Methods: Our workgroup described 16 essential skills for collaborative biostatisticians. Collaborative biostatisticians were surveyed to assess the relative importance of these skills in their current work. The importance of each skill is summarized overall and compared across career stages, highest degrees earned, and job sectors. Results: Survey respondents were 343 collaborative biostatisticians spanning career stages (early: 24.2%, mid: 33.8%, late: 42.0%) and job sectors (academia: 69.4%, industry: 22.2%, government: 4.4%, self-employed: 4.1%). All 16 skills were rated as at least somewhat important by > 89.0% of respondents. Significant heterogeneity in importance by career stage and by highest degree earned was identified for several skills. Two skills ("regulatory requirements" and "databases, data sources, and data collection tools") were more likely to be rated as absolutely essential by those working in industry (36.5%, 65.8%, respectively) than by those in academia (19.6%, 51.3%, respectively). Three additional skills were identified as important by survey respondents, for a total of 19 collaborative skills. Conclusions: We identified 19 team science skills that are important to the work of collaborative biostatisticians, laying the groundwork for enhancing graduate programs and establishing effective on-the-job training initiatives to meet workforce needs.

Better together? Comparing physical activity of parents walking outdoors with and without their child.

This study compares the physical activity levels and enjoyment of parents (n â€‹= â€‹50; age â€‹= â€‹41.8 â€‹± â€‹4.0 years) during outdoor, self-paced walking sessions while walking alone and when walking with their 6-to-12-year-old child. Step counts, moderate-to-vigorous physical activity (MVPA), vigorous physical activity, and enjoyment were compared using paired t-tests. Regression modeling was used to examine the impact of children's age and adults' and children's body mass index on the disparity in step counts experienced by adults. Adults attained high percentages of time spent in MVPA while walking alone (99.8%) and when walking with their child (96.6%). However, more of this time was categorized as vigorous physical activity when walking alone (13.6% vs. 3.0%, p â€‹= â€‹0.006). Adults' step counts decreased by an average of 6.4% while walking with their child compared to walking alone (p â€‹< â€‹0.001). This reduction was greater for parents of younger children (p â€‹= â€‹0.004). In obese adults, the reduction in step counts experienced while walking with their child was not as great as the reduction experienced by normal-weight adults (p â€‹= â€‹0.042). Although adults obtained higher step counts and vigorous physical activity while walking alone, they enjoyed walking more with their child (p â€‹< â€‹0.001). Health practitioners should be aware of this tradeoff when making recommendations for parent-child co-participation in physical activity, and parents may wish to supplement their physical activity obtained while walking with their child(ren) with additional activities that result in vigorous physical activity.

Optimizing team science in an academic medical center: A qualitative examination of investigator perspectives.

Introduction: Optimizing the effectiveness of a team-based approach to unite multiple disciplines in advancing specific translational areas of research is foundational to improving clinical practice. The current study was undertaken to examine investigators' experiences of participation in transdisciplinary team science initiatives, with a focus on challenges and recommendations for improving effectiveness. Methods: Qualitative interviews were conducted with investigators from twelve multidisciplinary teams awarded pilot research funding by the University of Kentucky College of Medicine to better understand the barriers and facilitators to effective team science within an academic medical center. An experienced qualitative researcher facilitated one-on-one interviews, which lasted about one hour. Structured consensus coding and thematic analysis were conducted. Results: The sample was balanced by gender, career stage (five were assistant professor at the time of the award, seven were senior faculty), and training (six were PhDs; six were MD physicians). Key themes at the team-level centered on the tension between clinical commitments and research pursuits and the limitations for effective team functioning. Access to tangible support from home departments and key university centers was identified as a critical organizational facilitator of successful project completion. Organizational barriers centered on operationalizing protected time for physicians, gaps in effective mentoring, and limitations in operational support. Conclusions: Prioritizing tailored mentoring and career development support for early career faculty, and particularly physician faculty, emerged as a key recommendation for improving team science in academic medical centers. The findings contribute to establishing best practices and policies for team science in academic medical centers.

Collaborative team dynamics and scholarly outcomes of multidisciplinary research teams: A mixed-methods approach.

Introduction: Impactful, transdisciplinary scientific discoveries are created by teams of researchers spanning multiple disciplines, but collaboration across disciplines can be challenging. We examined how team dynamics and collaboration are related to successes and barriers faced by teams of researchers from multiple disciplines. Methods: A mixed-methods approach was used to examine 12 research teams granted multidisciplinary pilot awards. Team members were surveyed to assess their team dynamics and individual views about transdisciplinary research. Forty-seven researchers (59.5%) responded, including two to eight members from each funded team. Associations were examined between collaborative dynamics and scholarly product outcomes, including manuscripts, grant proposals, and awarded grants. One member from each team was selected for an in-depth interview to contextualize and extend information about collaborative processes, successes, and barriers to performing transdisciplinary research. Results: Quality of team interactions was positively associated with achievement of scholarly products (r = 0.64, p = 0.02). Satisfaction with team members (r = 0.38) and team collaboration scores (r = 0.43) also demonstrated positive associations with achievement of scholarly products, but these were not statistically significant. Qualitative results support these findings and add further insight into aspects of the collaborative process that were particularly important to foster success on multidisciplinary teams. Beyond scholarly metrics, additional successes from the multidisciplinary teams were identified through the qualitative portion of the study including career development and acceleration for early career researchers. Conclusions: Both the quantitative and qualitative study results indicate that effective collaboration is critical to multidisciplinary research team success. Development and/or promotion of team science-based trainings for researchers would promote these collaborative skills.

Assessing Diversity and Inclusivity is the Next Frontier in Mental Health Recovery Narrative Research and Practice.

Demand for digital health interventions is increasing in many countries. The use of recorded mental health recovery narratives in digital health interventions is becoming more widespread in clinical practice. Mental health recovery narratives are first-person lived experience accounts of recovery from mental health problems, including struggles and successes over time. Helpful impacts of recorded mental health recovery narratives include connectedness with the narrative and validation of experiences. Possible harms include feeling disconnected and excluded from others. Diverse narrative collections from many types of narrators and describing multiple ways to recover are important to maximize the opportunity for service users to benefit through connection and to minimize the likelihood of harm. Mental health clinicians need to know whether narrative collections are sufficiently diverse to recommend to service users. However, no method exists for assessing the diversity and inclusivity of existing or new narrative collections. We argue that assessing diversity and inclusivity is the next frontier in mental health recovery narrative research and practice. This is important, but methodologically and ethically complex. In this viewpoint, we propose and evaluate one diversity and two inclusivity assessment methods. The diversity assessment method involves use of the Simpson Diversity Index. The two inclusivity assessment methods are based on comparator demographic rates and arbitrary thresholds, respectively. These methods were applied to four narrative collections as a case study. Refinements are needed regarding a narrative assessment tool in terms of its practicality and cultural adaptation.

Associations Among PTSD, Cognitive Functioning, and Health-Promoting Behavior in Post-9/11 Veterans.

INTRODUCTION: PTSD is associated with negative health behaviors that increase chronic disease risk, yet health behaviors and their determinants are not well investigated in this context. One understudied mechanism of health behaviors is cognitive functioning. Deficits in cognitive functioning may undermine engagement in health-promoting behavior, thereby increasing the negative impact of PTSD. We tested three hypotheses: (1) Greater PTSD symptom severity is associated with less health-promoting behavior; (2) greater PTSD symptom severity is associated with poorer cognitive functioning across verbal memory, processing speed, attention, and executive functioning domains; and (3) verbal memory and executive functioning exhibit indirect effects on the relationship between PTSD and health-promoting behavior. MATERIALS AND METHODS: We examined associations between PTSD symptom severity (Clinician-Administered PTSD Scale for DSM-IV), cognitive functioning, and health-promoting behavior (Health-Promoting Lifestyle Profile II) in 124 post-9/11 veterans (average age = 37.82; 85.5% male; 63.7% White; 18.5% Black; 26.6% Hispanic). Cognitive domains examined included verbal memory (California Verbal Learning Test), processing speed (Digit Symbol Coding), attention and working memory (Digit Span), and executive functions (Trail Making Test and Stroop Interference). RESULTS: Regression analyses indicated that greater PTSD symptom severity was associated with less health-promoting behavior (B = -.0101, SE = 0.0016, P < .0001; R2 = 0.3052). Path analyses revealed that verbal learning and memory partially accounted for this relationship (R2 = 0.037- 0.043; P < .05). CONCLUSIONS: Therapeutic targeting of these relationships may have implications for the prevention of long-term disease impact in veterans; longitudinal research is needed to elucidate the potential impact on chronic disease.

Medicaid expansion and access to naloxone in metropolitan and nonmetropolitan areas.

PURPOSE: The opioid crisis remains a major public health concern in the United States. Naloxone is used to reverse opioid overdoses. This study examined Medicaid expansion on naloxone prescriptions in retail pharmacies in metropolitan (metro) and nonmetropolitan (nonmetro) areas (2011-2017). METHODS: We used population average models to evaluate the association of Medicaid expansion at the state level on the number of naloxone prescriptions dispensed and the percentage paid by Medicaid, including adjustment for opioid-related and state-level policy covariates. Difference-in-difference modeling was performed as a sensitivity analysis. FINDINGS: States that expanded Medicaid had higher unadjusted naloxone dispensing rates and Medicaid-paid percentage of naloxone in metro and nonmetro areas. Medicaid expansion was not associated with the number of naloxone dispensed in either metro (adjusted rate ratio (ARR) = 1.26, 95% CI: [0.80, 1.97]) or nonmetro (ARR = 0.67, 95% CI: [0.37, 1.19]) areas after covariate adjustment. In metro areas, Medicaid expansion was associated with a significant increase of 3.86 percentage points (95% CI: [0.09, 7.63]) in the Medicaid-paid percentage of naloxone dispensing compared to nonexpansion states, but this association was not significant in nonmetro areas. There was also a significant time by Medicaid expansion interaction on the Medicaid-paid percentage of naloxone dispensed (metro: estimate = 0.74, 95% CI: [0.36, 1.12]; nonmetro: estimate = 0.68, 95% CI: [0.17, 1.18]). CONCLUSIONS: Medicaid expansion increased naloxone access by increasing the Medicaid-paid percentage of naloxone prescriptions in metro areas. States with Medicaid expansion had a faster rate of increase in the Medicaid-paid percentage of naloxone than states without Medicaid expansion in nonmetro areas.

Changes in transmucosal buprenorphine utilization for opioid use disorder treatment during the COVID-19 pandemic in Kentucky.

PURPOSE: With surging opioid-involved overdoses, maintaining access to opioid use disorder (OUD) treatment is critical during the COVID-19 pandemic. We examined changes in transmucosal buprenorphine prescribing for OUD treatment in Kentucky after the national COVID-19 emergency declaration, with a focus on rural-urban differences. METHODS: Using 2019-2020 prescription monitoring data, we performed segmented regression analysis for an interrupted time series design to evaluate changes in weekly rates (per 100,000 residents) of dispensed prescriptions, unique individuals with dispensed prescriptions, and average days' supply for dispensed prescriptions of transmucosal buprenorphine. FINDINGS: The weekly rates of dispensed prescriptions and unique individuals with dispensed prescriptions were higher for rural residents than urban residents. After the national COVID-19 emergency declaration, rural and urban residents experienced similar immediate drops in the rate of dispensed prescriptions (rural -33.4; urban -24.3) and unique patients with dispensed prescriptions (rural -25.0; urban -17.1), followed by similar sustained increases. Both measures surpassed the prepandemic levels in mid-June 2020. Patients residing in urban areas received averagely longer prescriptions at baseline (urban: 11.0 days; rural: 10.5 days). The average weekly days' supply increased in the week after the national emergency declaration, but the estimated increase was higher (P = .004) for urban (0.8 days) versus rural (0.5 days) residents. CONCLUSIONS: Transmucosal buprenorphine utilization increased during the COVID-19 pandemic after experiencing interruption during the initial weeks of the pandemic. Future studies should evaluate the contribution of the relaxed telemedicine buprenorphine prescribing regulations during the COVID-19 national emergency on initiation and maintenance of buprenorphine treatment.

The impact of ActiGraph's low-frequency extension filter on measurement of children's physical activity.

This study examines differences in accelerometer-based measurements of children's movement with and without applying ActiGraph's low-frequency extension (LFE) filter. Thirty children wore ActiGraph GT9X devices during structured physical activity (PA) periods. Raw accelerometry data for each activity period were processed with and without the LFE filter applied. For each activity period, paired t-tests were used to compare vector magnitude counts and minutes spent in moderate-to-vigorous physical activity (MVPA) with and without the LFE filter applied. Repeated measures MANOVA models were used for compositional data analysis of the percentage of time spent in sedentary behaviour and light, moderate, and vigorous PA with and without the LFE filter applied. Applying the LFE filter significantly increased vector magnitude counts and estimated minutes spent in MVPA for all activity periods when compared to the normal filter. For brisk walking, the LFE filter had a significant impact on the composition of time spent in sedentary behaviour and PA intensities. Children's activity data processed with the LFE filter may not be compatible with cut-points for activity levels developed with the normal filter, and caution should be taken when comparing children's activity levels or movement data between studies that do and do not use the LFE filter.

Effect of a Multimodal Analgesic Protocol on Short-Term and Long-Term Opioid Use After Orthopaedic Trauma.

OBJECTIVE: To determine whether the use of a multimodal analgesic protocol reduced short-term and long-term opioid use in patients hospitalized after orthopaedic trauma. DESIGN: Retrospective pre-post intervention study. SETTING: Regional, academic, Level 1 trauma center in Central Kentucky. PATIENTS/PARTICIPANTS: Patients were hospitalized after orthopaedic injury before (n = 393) and after (n = 378) the implementation of a multimodal analgesic protocol. INTERVENTION: The intervention involved a multimodal analgesic protocol consisting of acetaminophen, ibuprofen/ketorolac, gabapentinoids, skeletal muscle relaxants, and standardized doses of opioids plus standardized pain management education before hospital discharge. MAIN OUTCOME MEASUREMENTS: End points included discharge opioid prescription, days' supply and daily morphine milligram equivalent (MME), and long-term opioid use after hospitalization. Opioid use in the 90 days before and after hospitalization was assessed using state prescription drug monitoring program data. RESULTS: Discharge opioid prescription rates were similar in the intervention and control cohorts [79.9% vs. 78.4%, odds ratio (OR) 1.30 (0.83-2.03), P = 0.256]. Patients in the intervention cohort received a shorter days' supply [5.7 ± 4.1 days vs. 8.1 ± 6.2 days, rate ratio 0.70 (0.65-0.76), P < 0.001] and lower average daily MME [34.8 ± 24.9 MME vs. 51.5 ± 44.0 MME, rate ratio 0.68 (0.62-0.75), P < 0.001]. The incidence of long-term opioid use was also significantly lower in the intervention cohort [7.7% vs. 12.0%, OR 0.53 (0.28-0.98), P = 0.044]. CONCLUSIONS: Implementation of a multimodal analgesic protocol was associated with reductions in both short-term and long-term opioid use, including long-term opioid therapy, after orthopaedic trauma. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Temporal Sequencing of Mental Health Symptom Severity and Suicidal Ideation in Post-9/11 Men and Women Veterans Who Recently Separated from the Military.

BACKGROUND: Despite some evidence for gender differences in associations between military veterans' mental health and suicidal ideation (SI), gender-specific prospective studies are lacking. The aims of this prospective study were to: (1) examine gender differences in veterans' initial status and trajectories of mental health severity and SI status and (2) identify temporal sequencing of mental health predictors of SI. METHODS: Surveys of 1035 US veterans were administered at 3 time-points (T1, T2, T3) over a 7-year period following military separation, with an initial assessment within 2 years of military separation. RESULTS: Men reported higher baseline PTSD and alcohol misuse severity than women. No baseline gender difference in SI prevalence was detected. Baseline gender differences in mental health severity were maintained over time. For both men and women, remittance of SI was more likely from T1 to T2 than from T2 to T3 while chronic SI was more likely from T2 to T3. The strongest predictors of T3 SI were prior SI followed by alcohol misuse, depression, and PTSD severity with stronger effects for T2 predictors than T1. CONCLUSION: The maintenance of baseline gender differences throughout trajectories of mental health predictors of SI supports the need for ongoing gender-specific mental health services. Current governmental interorganizational efforts are focused on suicide prevention during the first year after military service completion. Our findings indicate a need to extend mental health screening and treatment beyond the early post-military period to reduce risk and recurrence of SI for both men and women.

Recorded Mental Health Recovery Narratives as a Resource for People Affected by Mental Health Problems: Development of the Narrative Experiences Online (NEON) Intervention.

BACKGROUND: The internet enables sharing of narratives about health concerns on a substantial scale, and some digital health narratives have been integrated into digital health interventions. Narratives describing recovery from health problems are a focus of research, including those presented in recorded (eg, invariant) form. No clinical trial has been conducted on a web-based intervention providing access to a collection of Recorded Recovery Narratives (RRNs). OBJECTIVE: This study presents knowledge produced through the development of the Narrative Experiences Online (NEON) Intervention, a web-based intervention incorporating the algorithmic recommendation of RRNs. METHODS: Knowledge was gathered through knowledge integration (KI) activities. KI1 synthesized previous studies to produce the NEON Impact Model describing how accessing RRNs produces health-related outcomes. KI2 developed curation principles for the NEON Collection of RRNs through consultation with the NEON Lived Experience Advisory Panel and the curation of a preliminary collection. KI3 identified harm minimization strategies for the NEON Intervention through consultation with the NEON International Advisory Board and Lived Experience Advisory Panel. The NEON Intervention was finalized through 2 research studies (RS). In RS1, mental health service users (N=40) rated the immediate impact of randomly presented narratives to validate narrative feedback questions used to inform the recommendation algorithm. In RS2, mental health service users (n=25) were interviewed about their immediate response to a prototype of the NEON Intervention and trial procedures and then were interviewed again after 1 month of use. The usability and acceptability of the prototype and trial procedures were evaluated and refinements were made. RESULTS: KI1 produced the NEON Impact Model, which identifies moderators (recipient and context), mechanisms of connection (reflection, comparison, learning, and empathy), processes (identification of change from narrative structure or content and internalization of observed change), and outcomes (helpful and unhelpful). KI2 identified 22 curation principles, including a mission to build a large, heterogeneous collection to maximize opportunities for connection. KI3 identified seven harm minimization strategies, including content warnings, proactive and reactive blocking of narratives, and providing resources for the self-management of emotional distress. RS1 found variation in the impact of narratives on different participants, indicating that participant-level feedback on individual narratives is needed to inform a recommender system. The order of presentation did not predict narrative feedback. RS2 identified amendments to web-based trial procedures and the NEON Intervention. Participants accessed some narratives multiple times, use reduced over the 4-week period, and narrative feedback was provided for 31.8% (105/330) of narrative accesses. CONCLUSIONS: RRNs can be integrated into web-based interventions. Evaluating the NEON Intervention in a clinical trial is feasible. The mixed methods design for developing the NEON Intervention can guide its extension to other clinical populations, the design of other web-based mental health interventions, and the development of narrative-based interventions in mental health.

Age and sex are associated with the plasma lipidome: findings from the GOLDN study.

BACKGROUND: Developing an understanding of the biochemistry of aging in both sexes is critical for managing disease throughout the lifespan. Lipidomic associations with age and sex have been reported, but prior studies are limited by measurements in serum rather than plasma or by participants taking lipid-lowering medications. METHODS: Our study included lipidomic data from 980 participants aged 18-87 years old from the Genetics of Lipid-Lowering Drugs and Diet Network (GOLDN). Participants were off lipid-lowering medications for at least 4 weeks, and signal intensities of 413 known lipid species were measured in plasma. We examined linear age and sex associations with signal intensity of (a) 413 lipid species; (b) 6 lipid classes (glycerolipids, glycerophospholipids, sphingolipids, sterol lipids, fatty acids, and acylcarnitines); and (c) 15 lipid subclasses; as well as with the particle sizes of three lipoproteins. RESULTS: Significant age associations were identified in 4 classes, 11 subclasses, 147 species, and particle size of one lipoprotein while significant sex differences were identified in 5 classes, 12 subclasses, 248 species, and particle sizes of two lipoproteins. For many lipid species (n = 97), age-related associations were significantly different between males and females. Age*sex interaction effects were most prevalent among phosphatidylcholines, sphingomyelins, and triglycerides. CONCLUSION: We identified several lipid species, subclasses, and classes that differ by age and sex; these lipid phenotypes may serve as useful biomarkers for lipid changes and associated cardiovascular risk with aging in the future. Future studies of age-related changes throughout the adult lifespan of both sexes are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT00083369 ; May 21, 2004.