Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey.

BACKGROUND: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe. Social media may be the key to recruiting a large diverse EDS sample. However, studies that have used social media to recruit have not been able to recruit diverse samples. OBJECTIVE: This study aims to discuss challenges, strategies, outcomes, and lessons learned from using social media to recruit a large sample of females with EDS. METHODS: Recruitment on social media for a cross-sectional survey examining dyspareunia (painful sexual intercourse) in females was examined. Inclusion criteria were (1) older than 18 years of age, (2) assigned female at birth, and (3) diagnosed with EDS. Recruitment took place on Facebook and Twitter (now X), from June 1 to June 25, 2019. RESULTS: A total of 1178 females with EDS were recruited from Facebook (n=1174) and X (n=4). On Facebook, participants were recruited via support groups. A total of 166 EDS support groups were identified, 104 permitted the principal investigator to join, 90 approved posting, and the survey was posted in 54 groups. Among them, 30 of the support groups posted in were globally focused and not tied to any specific country or region, 21 were for people in the United States, and 3 were for people outside of the United States. Recruitment materials were posted on X with the hashtag #EDS. A total of 1599 people accessed the survey and 1178 people were eligible and consented. The average age of participants was 38.6 (SD 11.7) years. Participants were predominantly White (n=1063, 93%) and non-Hispanic (n=1046, 92%). Participants were recruited from 29 countries, with 900 (79%) from the United States and 124 (11%) from Great Britain. CONCLUSIONS: Our recruitment method was successful at recruiting a large sample. The sample was predominantly White and from North America and Europe. More research needs to be conducted on how to recruit a diverse sample. Areas to investigate may include connecting with more support groups from outside the United States and Europe, researching which platforms are popular in different countries, and translating study materials into different languages. A larger obstacle to recruiting diverse samples may be the lack of health care providers that diagnose EDS outside the United States and Europe, making the pool of potential participants small. There needs to be more health care providers that diagnose and treat EDS in countries that are predominantly made up of people of color as well as research that specifically focuses on these populations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/53646.

Predictors of Sustained Response to Functional Restoration in a Military Population.

INTRODUCTION: The purpose of this study was to determine if improvement in pain impact and functional performance following a functional restoration (FR) program was sustained up to 6 months posttreatment and to identify predictors of sustained improvement. MATERIALS AND METHODS: Secondary analysis of data collected during randomized clinical trial. Study population included 108 US active duty service members who completed an FR program, as well as 3- and/or 6-month follow-up assessments. Primary outcome measure was the NIH Research Task Force (pain) impact score (PIS). Secondary outcome was a composite functional performance measure of treadmill, lifting, and carrying tolerances. Variables analyzed to determine their predictive value included demographics; treatment hours; measures of pain intensity, function, mood, sleep, social satisfaction, pain catastrophizing, kinesiophobia, self-efficacy, pain acceptance, patient activation, functional performance, and neuropathic pain. RESULTS: Mean PIS and functional performance improved significantly immediately following FR, but after 6 months, only improvement in functional performance sustained. Responder analysis showed that 6 months after FR, 42% of participants reported improvement that exceeded the minimal clinically important difference in PIS or functional performance. Predictors of sustained PIS improvement included younger age, absence of neuropathic pain features, less self-rated disability, better baseline functional performance, and worse baseline PIS. Predictors of sustained functional performance improvement included more treatment hours, lower baseline pain catastrophizing, and lower baseline functional performance. CONCLUSIONS: This study supports the investment of treatment time in FR to yield sustained clinically meaningful improvement, as observed in over 40% of this study's military participants. Pretreatment predictors of sustained response included lower pain catastrophizing and absence of neuropathic pain. Further research is needed to determine if treatments that improve pain catastrophizing and neuropathic pain will result in sustained improvement in pain impact and functional performance following FR program participation.

Pain Catastrophizing and Its Association with Military Medical Disability Among US Active Duty Service Members with Chronic Predominately Musculoskeletal Pain: A Retrospective Cohort Analysis.

Context: Pain catastrophizing is characterized by negative emotional and cognitive responses to pain and is a predictor of work-related disability. Its association with military medical disability has not been studied. Objective: To (1) identify the pain catastrophizing scale (PCS) score cut point most strongly associated with military medical disability, (2) measure the difference in rate of disability between service members with baseline PCS scores above versus below the cut point, and (3) determine if improvement in PCS score during pain specialty care is associated with decreased likelihood of disability. Methods: This was a retrospective cohort analysis comparing PCS scores collected from US Army active duty service members at time of initial visit to an interdisciplinary pain management center and periodically during pain treatment. Outcome was determination during the following year of a military service-disqualifying disability. Results: Receiver operating characteristic (ROC) curves determined that a PCS score of 20 was the single cut point most closely associated with subsequent disability. Kaplan-Meier curves showed significantly higher disability rate during the following year among those with baseline PCS scores ≥20 (52%) compared to those with lower scores (26%). Scheffe-adjusted contrasts showed that service members with PCS scores ≥20 whose scores improved to <20 at follow-up were significantly less likely to have a medical disability (42.6%; 95% CI, 0.07-0.58) than those whose PCS score remained ≥20 (76.3%; 95% CI, 68.0%-84.7%). Conclusion: A PCS score cut point of 20 distinguishes between high versus low likelihood of disability among service members. Those with high baseline PCS score had twice the likelihood of disability than those with low scores. Service members who decreased their PCS score from high to low during pain specialty care had lower likelihood of disability. Prospective research is needed to determine if treatments that lower pain catastrophizing yield reduced likelihood of subsequent disability.

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Association between sleep variability and time in range of glucose levels in patients with type 1 diabetes: Cross-sectional study.

OBJECTIVE: Sleep and circadian disturbances emerge as novel factors influencing glycemic control in type 1 diabetes (T1D). We aimed to explore the associations among sleep, behavioral circadian parameters, self-care, and glycemic parameters in T1D. METHODS: Seventy-six non-shift-working adult T1D patients participated. Blinded 7-day continuous glucose monitoring (CGM) and hemoglobin A1C (A1C) were collected. Percentages of time-in-range (glucose levels 70-180 mg/dL) and glycemic variability (measured by the coefficient of variation [%CV]) were calculated from CGM. Sleep (duration and efficiency) was recorded using 7-day actigraphy. Variability (standard deviation) of midsleep time was used to represent sleep variability. Nonparametric behavioral circadian variables were derived from actigraphy activity recordings. Self-care was measured by diabetes self-management questionnaire-revised. Multiple regression analyses were performed to identify independent predictors of glycemic parameters. RESULTS: Median (interquartile range) age was 34.0 (27.2, 43.1) years, 48 (63.2%) were female, and median (interquartile range) A1C was 6.8% (6.2, 7.4). Sleep duration, efficiency, and nonparametric behavioral circadian variables were not associated with glycemic parameters. After adjusting for age, sex, insulin delivery mode/CGM use, and ethnicity, each hour increase in sleep variability was associated with 9.64% less time-in-range (B = -9.64, 95% confidence interval [-16.29, -2.99], p ≤ .001). A higher diabetes self-management questionnaire score was an independent predictor of lower A1C (B = -0.18, 95% confidence interval [-0.32, -0.04]). CONCLUSION: Greater sleep timing variability is independently associated with less time spent in the desirable glucose range in this T1D cohort. Reducing sleep timing variability could potentially lead to improved metabolic control and should be explored in future research. DATA AVAILABILITY STATEMENT: Data are available upon a reasonable request to the corresponding author.

Distinct Dysphagia Profiles in Patients With Oral Cancer After Surgery.

OBJECTIVES: To determine distinct profiles based on symptom severity in patients undergoing surgery for oral cancer and examine whether these profiles differ by participant characteristics. SAMPLE & SETTING: 300 patients who underwent surgery for oral cancer at two outpatient clinics between June and December 2021. METHODS & VARIABLES: Symptoms were assessed using the MD Anderson Symptom Inventory-Head and Neck Cancer Module. Sociodemographic and clinical characteristics were collected. Latent profile analysis was performed. RESULTS: Five distinct dysphagia profiles were identified, which qualitatively differed regarding co-occurrence patterns of dysphagia, mucus-related symptoms, speech disturbances, and psychoneurologic symptoms. Significant differences were reported in interference to function, number of co-occurring symptoms, time since diagnosis and treatment completion, use of symptom management medications, oral cancer stage and site, and treatment completed. IMPLICATIONS FOR NURSING: Identifying distinct dysphagia profiles can improve patient outcomes and help in planning specific nursing interventions to influence nutritional and functional status in oral cancer survivors. Dysphagia and dry mouth can persist beyond one year post-treatment, so follow-up dysphagia assessments are needed.

Impart: findings from a prison-based model of HIV assisted partner notification in Indonesia.

INTRODUCTION: Assisted partner notification (APN) safely and effectively increases partner awareness of HIV exposure, testing and case identification in community settings. Nonetheless, it has not been specifically developed or evaluated for use in prison settings where people with HIV often are diagnosed and may have difficulty contacting or otherwise notifying partners. We developed Impart, a prison-based APN model, and evaluated its efficacy in Indonesia to increase partner notification and HIV testing. METHODS: From January 2020 to January 2021, 55 incarcerated men with HIV were recruited as index participants from six jail and prison facilities in Jakarta in a two-group randomized trial comparing the outcomes of self-tell notification (treatment as usual) versus Impart APN in increasing partner notification and HIV testing. Participants voluntarily provided names and contact information for sex and drug-injection partners in the community with whom they had shared possible HIV exposure during the year prior to incarceration. Participants randomized to the self-tell only condition were coached in how to notify their partners by phone, mail or during an in-person visit within 6 weeks. Participants randomized to Impart APN could choose between self-tell notification or anonymous APN by a two-person team consisting of a nurse and outreach worker. We compared the proportion of partners in each group who were notified of exposure by the end of 6 weeks, subsequently tested and HIV diagnosed. RESULTS: Index participants (n = 55) selected 117 partners for notification. Compared to self-tell notification, Impart APN resulted in nearly a six-fold increase in the odds of a named partner being notified of HIV exposure. Nearly two thirds of the partners notified through Impart APN (15/24) completed HIV testing within 6 weeks post notification compared to none of those whom participants had self-notified. One-third of the partners (5/15) who completed HIV testing post notification were diagnosed as HIV positive for the first time. CONCLUSIONS: Voluntary APN can be successfully implemented with a prison population and within a prison setting despite the many barriers to HIV notification that incarceration presents. Our findings suggest that the Impart model holds considerable promise to increase partner notification, HIV testing and diagnosis among sex and drug-injecting partners of HIV-positive incarcerated men.

Associations in Cigarette Smoking and Health Conditions by Race/Ethnicity Among a Diverse Sample of Patients Receiving Treatment in a Federally Qualified Health Care Setting in Chicago.

Purpose: To examine the association of cigarette use and smoking-related health conditions by race/ethnicity among diverse and low-income patients at a federally qualified health center (FQHC). Methods: Demographics, smoking status, health conditions, death, and health service use were extracted from electronic medical data for patients seen between September 1, 2018, and August 31, 2020 (n=51,670). Smoking categories included everyday/heavy smoker, someday/light smoker, former smoker, or never smoker. Results: Current and former smoking rates were 20.1% and 15.2%, respectively. Males, Black, White, non-partnered, older, and Medicaid/Medicare patients were more likely to smoke. Compared with never smokers, former and heavy smokers had higher odds for all health conditions except respiratory failure, and light smokers had higher odds of asthma, chronic obstructive pulmonary disease, emphysema, and peripheral vascular disease. All smoking categories had more emergency department visits and hospitalizations than never smokers. The associations between smoking status and health conditions differed by race/ethnicity. White patients who smoked had a greater increase in odds of stroke and other cardiovascular diseases compared with Hispanic and Black patients. Black patients who smoked had a greater increase in odds of emphysema and respiratory failure compared with Hispanic patients. Black and Hispanic patients who smoked had a greater increase in emergency care use compared with White patients. Conclusion: Smoking was associated with disease burden and emergency care and differed by race/ethnicity. Health Equity Implications: Resources to document smoking status and offer cessation services should be increased in FQHCs to promote health equity for lower income populations.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

The Role of Psychological Factors in Chronic Pain Treatment Outcomes in the Military.

PURPOSE: Chronic pain treatment in the military includes complementary and integrative health (CIH) therapies that may affect psychological factors such as pain catastrophizing, chronic pain acceptance, pain self-efficacy, and patient activation. The unique roles that psychosocial factors play in how CIH approaches reduce pain are not clear. This study examined if a holistic pain management program improved pain outcomes through psychological mediators in service members with chronic pain. DESIGN: Secondary analysis of a clinical trial. METHODS: Active-duty service members (n = 210) were randomly assigned to a 3-week course of standard rehabilitative care or standard rehabilitative care combined with CIH therapies. Both treatments were followed by a 3-week functional restoration program. Study measures were completed pre- and post-treatment using the Military Health System's Pain Assessment Screening Tool and Outcomes Registry. Mediation analyses tested the indirect effects of the change in psychological factors before functional restoration on the change in pain impact (e.g., pain intensity, pain interference, functional status) after functional restoration. RESULTS: All psychological factors except for chronic pain acceptance were related to improved pain impact (p<.05). Furthermore, a change in psychological factors prior to functional restoration was related to the change in pain impact after functional restoration. However, the addition of CIH therapies to standard rehabilitative care did not result in changes in pain outcomes mediated by the psychological factors. CONCLUSIONS: Although psychological factors were related to pain outcomes, the effect of CIH therapies on chronic pain did not occur via a change in the four psychological factors.

Pattern of Cumulative Treatment Hours on Pain Impact and PROMIS Outcomes.

INTRODUCTION: Participation in interdisciplinary treatments is associated with improvement in pain intensity, physical function, and additional pain-related outcome domains. However, the effect of cumulative treatment hours on outcomes remains unknown among military patients. The present analysis examined the relationship between cumulative interdisciplinary treatment hours and pain management outcomes at a single interdisciplinary pain management center (IPMC). MATERIALS AND METHODS: This is a retrospective observational study of data previously collected as standard of care at the Madigan Army Medical Center, approved by the Institutional Review Board. We included patients who received treatment at the IPMC and completed at least two self-report assessment batteries: one at baseline and at least one between 90 and 180 days after baseline (n = 882). The primary outcome was pain impact. Secondary outcomes included fatigue, depression, anxiety, and sleep-related impairment. RESULTS: Generalized additive models indicated that cumulative treatment hours were significantly associated with improvement in pain impact, fatigue, and depression. Patients who had higher baseline pain impact, who had mild or no depressive symptoms, and who were >40 years of age had greater improvements in pain impact following treatment, relative to those with lower pain impact, moderate-to-severe depressive symptoms, and were 40 years of age or younger, respectively. Additional research is needed to elucidate the effect of different therapies and additional patient factors in understanding the "therapeutic dose" of interdisciplinary pain management. CONCLUSIONS: A higher number of cumulative treatment hours was associated with improvement of pain impact, fatigue, and depression among military personnel receiving interdisciplinary pain treatment. At least 30 hours of sustained interdisciplinary treatment appears to be the threshold for improvement in pain impact and related outcomes.

Effectiveness of Telementoring in Improving Provider Knowledge, Attitudes, and Perceived Competence in Managing Chronic Pain: A Mixed Methods Study.

INTRODUCTION: Telementoring is an evidence-based approach to meet the educational needs of primary care providers (PCPs) and to improve the quality of chronic pain care. This mixed methods study evaluated the effectiveness of pain management telementoring in improving provider knowledge, attitudes, and perceived competence. MATERIALS AND METHODS: The study was conducted at Madigan Army Medical Center. Using a non-randomized quasi-experimental approach, 25 providers were assigned to intervention arm and control arm (14 intervention and 13 control). Providers in the intervention group attended telementoring sessions. Videoconference technology was used to deliver weekly 90-minute TelePain sessions to the PCPs in the intervention group. The first 25-30 minutes of each session consisted of a didactic presentation led by a panel of interdisciplinary pain management clinicians. During the remaining 60 minutes, all PCPs in the intervention group presented clinical histories and asked specific management questions regarding patients of their choosing. An interdisciplinary panel of pain management clinicians provided telementoring consultations. The panel included experts from pain medicine, primary care, psychology or psychiatry, chiropractic, clinical pharmacy, and nursing. Changes in provider knowledge, attitudes, and perceived competence were evaluated using the Knowledge and Attitudes Survey Regarding Pain, KnowPain-12, and the Perceived Competence Scale (n = 23; 12 intervention and 11 control). Qualitative interviews were conducted among a subset of providers (n = 12; 8 intervention and 4 control), and provider narratives were analyzed using content analysis. RESULTS: Increased provider knowledge (Z = 2.0, P = .046 [KnowPain-12]) and perceived competence (Z = 2.1, P = .033) were observed among intervention group providers. Provider narratives supported more implementation of non-pharmacological pain management strategies, use of strategies to engage patients in reducing reliance on opioids, and perception of TelePain as a helpful resource especially in the context of inadequate preparation in chronic pain management during professional training. CONCLUSIONS: Telementoring may hold significant potential to support providers in their efforts to decrease use of prescription opioids. Overall, this study provides further support for the value of telementoring in improving comprehensive chronic pain management in military settings.

Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture.

Introduction: Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia. Methods: Responses to the question: "Tell me about why you decided to participate in this study" were analyzed using conceptual content analysis to identify patterns in motivation for study participation. Results: Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers. Conclusion: Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture. Clinical Trial Registration: NCT03364127.

Sexual minority status, school-based violence, and current tobacco use among youth.

INTRODUCTION: Sexual minority individuals experience elevated risk for smoking and violence due to a combination of general and unique identity-based risk factors. This study examined associations among sexual minority status, school-based violence, and tobacco use, among youth. METHODS: Data for this secondary data analysis consisted of Chicago-specific data from the 2019 Youth Risk Behavior Surveillance System (n=1562). Current use (≥1 day during the previous 30 days) of any tobacco product (cigarettes, e-cigarettes, smokeless tobacco, and cigars) and school-based violence (avoided school because they felt unsafe, were threatened/injured with a weapon, were in a physical fight, and were bullied) were estimated by sexual orientation (heterosexual vs gay, lesbian, bisexual, and unsure). A chi-squared test was used to investigate associations among the variables. Path analysis was employed to examine possible mediation effects of school-based violence. RESULTS: Thirty percent of sexual minority youth and 11.5% of heterosexual youth reported current tobacco use (χ2=55.91; p<0.001). Nearly one-third (31.8%) of youth reported school-based violence, with a higher rate (41.2%) reported by sexual minority youth compared to heterosexual youth (28.1%; χ2=19.48; p<0.001). Path analysis confirmed these associations, controlling for sex, age, and race/ethnicity. The model showed that sexual minority status increased odds of current tobacco use by a factor of 1.8 (95% CI: 1.3-2.6) via its relationship with school-based violence, explaining 33.8% of the total association between sexual minority status and tobacco use. CONCLUSIONS: Tobacco use was higher among sexual minority youth. School-based violence partially mediated the association between sexual minority status and tobacco use. Findings highlight the need for tobacco prevention and treatment efforts for sexual minority youth and school-based interventions to reduce exposure to violence.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

Use of a treadmill, lift, and carry battery as a composite functional performance test: analysis of data from a pragmatic randomized controlled trial in a military population participating in a functional restoration program.

BACKGROUND: The treadmill, lift, and carry (TLC) battery is a composite functional performance test created to measure the effectiveness of a functional restoration (FR) program in a military population. PURPOSE: To determine the validity, reliability, and minimal clinically important differences (MCIDs) of the individual tests and the composite TLC battery. METHODS: We assessed the validity by mean differences, effect sizes, and standardized response means pre- and post-FR; and by correlations between the TLC battery and other established measures. We assessed reliability by correlating pre- and post-FR scores. We used principal component analysis (PCA) to create a composite measure. We determined MCIDs via distribution methods and receiver operator curve analysis. RESULTS: There were significant (p < .001) mean changes and large effect sizes (0.6-0.8) pre- to post-FR. Pre- and posttest Spearman's correlations ranged from 0.5 to 0.6. Spearman's correlations between TLC battery scores and other measures were small (± 0.3-0.4) and significant (p < .001). PCA supported use of a single-component composite. MCIDs were treadmill time: 3 minutes; metabolic equivalent of task: 1.5 units; floor-to-waist lift: 15 lbs; waist-to-shoulder lift: 10 lbs; 40-foot carry: 10 lbs; and composite score: 6 units. CONCLUSION: This secondary data analysis provides preliminary support for the validity and reliability of the TLC battery for use in military populations.

Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial.

BACKGROUND: Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life have also been linked to sleep variability and insufficient sleep duration. A significant gap of knowledge exists regarding interventions to improve sleep and the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration, and glycemic control (A1C); other glycemic parameters (glycemic variability, time-in-range [TIR]); diabetes distress; self-management behaviors; quality of life; and other patient-reported outcomes in adults with T1D and habitual increased sleep variability or short sleep duration. METHODS: A randomized controlled parallel-arm study will be employed in 120 adults (aged 18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 h/week) or insufficient sleep duration (< 6.5 h per night). Eligible subjects will be randomized to the Sleep-Opt intervention group or healthy living attention control group for 12 weeks. A 1-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and TIR using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life, and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking. Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. Baseline measures will be repeated at midpoint, program completion, and post-program (weeks 6, 12, and 24, respectively) to determine differences between the two groups and sustainability of the intervention. DISCUSSION: A better understanding of strategies to improve sleep in persons with T1D has the potential to be an important component of diabetes. TRIAL REGISTRATION: Clinical Trial Registration: NCT04506151 .

Alpha Test of the Donor Conception Tool to Empower Parental Telling and Talking.

OBJECTIVE: To conduct an alpha test of the prototype of a digital decision aid to help parents disclose donor conception to their children, the Donor Conception Tool to Empower Parental Telling and Talking (TELL Tool). DESIGN: Convergent mixed-methods design. SETTING: Virtual interviews in places convenient to the participants. PARTICIPANTS: A purposeful sample (N = 16) of nine gamete-donor and embryo-recipient parents and eight clinicians, as one parent was also a clinician. METHODS: We conducted cognitive interviews to explore participants' perceptions about the TELL Tool prototype and observe patterns of use. The International Patient Decision Aid Standards (i.e., usability, comprehensibility, and acceptability) guided the development of the qualitative interview guide and directed the qualitative analysis. We also collected data about participants' perceptions and ratings of the helpfulness of each of the prototype's webpages regarding parents' decision making about disclosure. Descriptive statistics were used to analyze the helpfulness ratings before we merged the two data sets to optimize understanding. RESULTS: Participants reported that the TELL Tool was a helpful digital decision aid to help parents tell their children how they were conceived. Most (93.7%) webpage rating scores indicated that the content was very helpful or helpful. The participants identified content and technical areas that needed refinement and provided specific recommendations such as adding concise instructions (usability), tailoring adolescent language (comprehensibility), and softening verbiage (acceptability). CONCLUSION: Alpha testing guided by the International Patient Decision Aid standards was an essential step in refining and improving the TELL Tool prototype before beta testing.

Loneliness mediates the association of minority stress and depression in sexual and gender minority populations in Thailand.

Loneliness is a significant risk factor for depression in adults. Sexual and gender minority (SGM) individuals are at risk for loneliness and depression due to stigma and discrimination. However, little is known about the influences of loneliness on the mental health of SGM populations. Guided by the Minority Stress and Integrative Mediation Frameworks, the authors aimed to examine loneliness's direct and indirect effects on the relationships between minority stressors and depression among Thai SGM adults. Data were drawn from a larger cross-sectional survey. Standardized measures of minority stressors (discrimination, victimization, identity concealment, and internalized sexual stigma), loneliness, and depression were selected and translated by expert panels. A convenience sample was recruited, and data were collected using online and in-person methods. Participants (N = 411, M = 29.5 years) were primarily male (90.5%), gay (79.3%), and cisgender (76.6%). More than 40% of participants reported clinically significant levels of loneliness (M = 38.59, standard deviation [SD] = 11.11) and depression (M = 9.46, SD = 8.43). Discrimination, identity concealment, and internalized sexual stigma were directly associated with loneliness (all p < 0.05). Minority stressors were significantly related to depression through indirect associations via loneliness accounting for 33%-54% of the total effect. Indirect effects (95% confidence interval) were 0.25 [0.12, 0.40] for discrimination, -0.41 [-0.67, -0.18] for identity concealment, and 0.42 [0.06, 0.79] for internalized sexual stigma. Loneliness was prevalent and played a mediating role in the associations between minority stressors and depression. Study findings have implications for the development of intervention research.