Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain.

OBJECTIVE: Psychosocial factors are known to predict chronic pain, and the use of complementary and integrative health (CIH) therapies to address pain is emerging among the military population. However, conflicting results on pain outcomes warrant additional research. This study aimed to 1) evaluate the benefit of adding a CIH pain management program to standard rehabilitative care (SRC), as compared with SRC alone, as a precursor to an intensive functional restoration (FR) program; 2) identify factors that predict improvement in pain outcomes after treatment; and 3) determine the proportion of participants who experience a clinically meaningful response. DESIGN: Pragmatic randomized controlled clinical trial. Participants were randomized to a 3-week course of either SRC alone or SRC+CIH (stage 1), followed by a 3- to 6-week course of FR (stage 2). SUBJECTS: Active duty service members with chronic pain. METHODS: Participants completed either SRC alone or SRC+CIH (stage 1), followed by a course of FR (stage 2). Patient-reported and provider-determined outcomes were collected at baseline, after stage 1, and after stage 2. A covariance pattern model with an unstructured residual covariance matrix was used to compare treatment arms while accounting for dependency due to repeated measurements. RESULTS: A total of 210 service members participated. Most were in the Army (82%) and were male (84%). Participants randomized to the SRC+CIH intervention had greater improvement in the pain impact score than did those in the SRC-alone group. Predictors of outcomes were baseline impact score, anger, depression, and educational status. CONCLUSIONS: This study found that military service members with the highest pain impact benefit the most from interdisciplinary pain care.

Sleep fragmentation increases blood pressure and is associated with alterations in the gut microbiome and fecal metabolome in rats.

The gut microbiota, via the production of metabolites entering the circulation, plays a role in blood pressure regulation. Blood pressure is also affected by the characteristics of sleep. To date, no studies have examined relationships among the gut microbiota/metabolites, blood pressure, and sleep. We hypothesized that fragmented sleep is associated with elevated mean arterial pressure, an altered and dysbiotic gut microbial community, and changes in fecal metabolites. In our model system, rats were randomized to 8 h of sleep fragmentation during the rest phase (light phase) or were undisturbed (controls) for 28 consecutive days. Rats underwent sleep and blood pressure recordings, and fecal samples were analyzed during: baseline (days -4 to -1), early sleep fragmentation (days 0-3), midsleep fragmentation (days 6-13), late sleep fragmentation (days 20-27), and recovery/rest (days 28-34). Less sleep per hour during the sleep fragmentation period was associated with increased mean arterial pressure. Analyses of gut microbial communities and metabolites revealed that putative short chain fatty acid-producing bacteria were differentially abundant between control and intervention animals during mid-/late sleep fragmentation and recovery. Midsleep fragmentation was also characterized by lower alpha diversity, lower Firmicutes:Bacteroidetes ratio, and higher Proteobacteria in intervention rats. Elevated putative succinate-producing bacteria and acetate-producing bacteria were associated with lower and higher mean arterial pressure, respectively, and untargeted metabolomics analysis demonstrates that certain fecal metabolites are significantly correlated with blood pressure. These data reveal associations between sleep fragmentation, mean arterial pressure, and the gut microbiome/fecal metabolome and provide insight to links between disrupted sleep and cardiovascular pathology.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Evaluation of a Randomized Clinical Trial Comparing the Effectiveness of a Culturally Targeted and Nontargeted Smoking Cessation Intervention for Lesbian, Gay, Bisexual, and Transgender Smokers.

PURPOSE: To examine the benefits of a culturally targeted compared with a nontargeted smoking cessation intervention on smoking cessation outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. METHODS: A prospective randomized design was used to evaluate the added benefits of an LGBT culturally targeted Courage to Quit (CTQ-CT) smoking cessation treatment (N = 172) compared with the standard intervention (CTQ; N = 173). The smoking cessation program consisted of six treatment sessions combined with 8 weeks of nicotine replacement therapy. The primary smoking cessation outcome was 7-day point prevalence quit rates. Secondary outcomes examined included changes in nicotine dependence, nicotine withdrawal, cigarettes per day, smoking urges, self-efficacy, and readiness to quit. RESULTS: Overall quit rates were 31.9% at 1 month, 21.1% at 3 months, 25.8% at 6 months, and 22.3% at 12 months. Quit rates did not differ between treatment groups [1 month OR = 0.81 (0.32, 2.09), 3 months OR = 0.65 (0.23, 1.78), 6 months OR = 0.45 (0.17, 1.21), 12 months OR = 0.70 (0.26, 1.91)]. Compared with baseline levels, all secondary smoking cessation outcomes measured were improved at 1 month and were maintained at 12-month follow-up. Compared with the CTQ, the CTQ-CT intervention was more highly rated on program effectiveness (d = 0.2, p = .011), intervention techniques (d = 0.2, p = .014), the treatment manual (d = 0.3, p < .001), and being targeted to the needs of LGBT smokers (d = 0.5, p < .0001). CONCLUSIONS: LGBT smokers receiving the CTQ intervention achieved smoking cessation outcomes in the range reported for other demographic groups. Cultural targeting improved the acceptability of the intervention but did not confer any additional benefit for smoking cessation outcomes. IMPLICATIONS: Study results have implications for understanding the benefits of culturally targeted compared with nontargeted smoking cessation interventions for improving smoking cessation outcomes among LGBT smokers. Shorter and longer term 7-day point prevalence quit rates associated with the targeted and nontargeted interventions were modest but comparable with other group-based interventions delivered in a community setting. Although cultural targeting improved the overall acceptability of the intervention, no added benefits were observed for the culturally targeted intervention on either the primary or secondary outcomes.

Patient-reported symptoms improve prediction of acute coronary syndrome in the emergency department.

Early diagnosis is critical in the management of patients with acute coronary syndrome (ACS), particularly ST-elevation myocardial infarction (STEMI), because effective therapies are time-dependent. Aims of this secondary analysis were to determine: (i) the prognostic value of symptoms for an ACS diagnosis in conjunction with electrocardiographic (ECG) and troponin results; and (ii) if any of 13 symptoms were associated with prehospital delay in those presenting to the emergency department (ED) with potential ACS. Patients receiving a cardiac evaluation in the ED were eligible for the study. Thirteen patient-reported symptoms were assessed in triage. Prehospital delay time was calculated as the time from symptom onset until registration in the ED. A total of 1,064 patients were enrolled in five EDs. The sample was 62% male, 70% white, and had a mean age of 60.2 years. Of 474 participants diagnosed with ACS, 118 (25%) had STEMI; 251 (53%) had non-ST elevation myocardial infarction (NSTEMI); and 105 (22%) had unstable angina. Sweating (OR = 1.42 CI [1.01, 2.00]) and shoulder pain (OR = 1.64 CI [1.13, 2.38]) added to the predictive value of an ACS diagnosis when combined with ECG and troponin results. Shortness of breath (OR = 0.71 CI [0.50, 1.00]) and unusual fatigue (OR = 0.60 CI [0.42, 0.84]) were predictive of a non-ACS diagnosis. Sweating predicted shorter prehospital delay (HR = 1.35, CI [1.10, 1.67]); shortness of breath (HR = 0.73 CI [0.60, 0.89]) and unusual fatigue (HR = 0.72, CI [0.57, 0.90]) were associated with longer prehospital delay. Patient-reported symptoms are significantly associated with ACS diagnoses and prehospital delay. Sweating and shoulder pain combined with ECG signs of ischemia may improve the timely detection of ACS in the ED.

Symptoms Suggestive of Acute Coronary Syndrome: When Is Sex Important?

BACKGROUND: Studies have identified sex differences in symptoms of acute coronary syndrome (ACS); however, retrospective designs, abstraction of symptoms from medical records, and variations in assessment forms make it difficult to determine the clinical significance of sex differences. OBJECTIVE: The aim of this study is to determine the influence of sex on the occurrence and distress of 13 symptoms for patients presenting to the emergency department for symptoms suggestive of ACS. METHODS: A total of 1064 patients admitted to 5 emergency departments with symptoms triggering a cardiac evaluation were enrolled. Demographic and clinical variables, symptoms, comorbid conditions, and functional status were measured. RESULTS: The sample was predominantly male (n = 664, 62.4%), white (n = 739, 69.5%), and married (n = 497, 46.9%). Women were significantly older than men (61.3 ± 14.6 vs 59.5 ± 13.6 years). Most patients were discharged with a non-ACS diagnosis (n = 590, 55.5%). Women with ACS were less likely to report chest pain as their chief complaint and to report more nausea (odds ratio [OR], 1.56; confidence interval [CI], 1.00-2.42), shoulder pain (OR, 1.76; CI, 1.13-2.73), and upper back pain (OR, 2.92; CI, 1.81-4.70). Women with ACS experienced more symptoms (6.1 vs 5.5; P = .026) compared with men. Men without ACS had less symptom distress compared with women. CONCLUSIONS: Women and men evaluated for ACS reported similar rates of chest pain but differed on other classic symptoms. These findings suggest that women and men should be counseled that ACS is not always accompanied by chest pain and multiple symptoms may occur simultaneously.

Role of Pain Catastrophizing in the Effects of Cognitive Behavioral Therapy for Chronic Pain in Different Subgroups: An Exploratory Secondary Data Analysis Using Finite Mixture Models.

INTRODUCTION: Providing effective treatment for debilitating chronic pain is a challenge among many populations including military service members. Cognitive behavioral therapy for chronic pain (CBT-CP) is a leading psychological pain treatment. Pain catastrophizing is a pivotal mediator of pain-related outcomes. The purpose of this study was (1) to identify patient subgroups who differ in response to CBT-CP and (2) to explore the characteristics that define these patient subgroups. The overall goal was to obtain a better understanding of factors that may influence response to CBT-CP. MATERIALS AND METHODS: This study was a secondary analysis of data from a clinical trial of 149 U.S. active duty service members with chronic pain. Participants underwent group-based CBT-CP for 6 weeks and completed pre- and posttreatment assessments. Finite mixture models were employed to identify subgroups in treatment response, with pain impact score as the primary outcome measure. RESULTS: We identified two classes of nearly equal size with distinct pain impact responses. One class reported improved pain impact scores following CBT-CP. This improvement was significantly associated with lower (better) baseline depression scores and greater improvement in posttreatment pain catastrophizing. In contrast, the other class reported slightly worse mean pain impact scores following CBT-CP treatment; this response was not related to baseline depression or change in pain catastrophizing. CONCLUSIONS: Our findings demonstrate that a sizable proportion of individuals with chronic pain may not respond to group-based CBT-CP and may require a more individualized treatment approach.

A Systematic Review and Meta-analysis of the Initial Literature Regarding COVID-19 Symptoms in Children in the United States.

INTRODUCTION: COVID-19 symptom presentation among adults is mostly understood. However, understanding COVID-19 symptom presentation in children lags. METHOD: A literature search was conducted in three electronic databases. Twenty-three initial publications addressing COVID-19 symptom presentation among hospitalized children in the United States met the criteria for review and meta-analysis. RESULTS: Fever, the most common symptom, was present in nearly all cases. Gastrointestinal, respiratory, oral symptoms, and rash occurred in over half of the cases. Disease severity assessment showed that comorbidities were present in one-third of patients; intensive care was needed for half of the patients, and supplemental oxygen and mechanical ventilation were needed by 13.3% and 7.1%, respectively. DISCUSSION: The magnitude and significance of COVID-19 symptoms in children compared with those in adults and three common childhood viral illnesses: influenza, respiratory syncytial virus, and gastroenteritis, are discussed. Important clinical differences were found that may help clinicians distinguish COVID-19 from other illnesses.

MiQuit: A Study Protocol to Link Low-Income Smokers to a State Tobacco Quitline.

Purpose: To conduct a randomized controlled trial to compare 3 implementation strategies and the impact of facilitated referrals on linkage of Federally Qualified Health Center patients to the Illinois Tobacco Quitline (ITQL). Methods: This study will be a hybrid type 3 implementation-effectiveness trial guided by 2 implementation science frameworks: reach, effectiveness, adoption, implementation, and maintenance and exploration preparation implementation sustainment. We will evaluate whether sending provider messages through the patient electronic health portal increases patient linkage to the ITQL. We will (1) randomly assign all eligible patients to receive 1 of 3 messages (information about quitting, advice to quit, and advice to quit or cut down), and (2) we will offer a facilitated linkage to the ITQL. For patients who opt into a facilitated referral, we will share their contact information with the ITQL, who will contact them. Four weeks after the initial message, patients who expressed interest in services but were not reached by the ITQL will be rerandomized to 1 of 2 arms, an offer to reconnect to the ITQL or an offer to engage a peer navigator who can help them reconnect to the ITQL. We will assess the implementation strategies' reach, adoption, linkage, and sustainability with the ITQL. Discussion: This study will provide a new cost-effective and efficient model to link low-income smokers to state tobacco quitlines. Message delivery via patient health portals has important implications for addressing other tobacco-related morbidities.

How deep is the cut? The influence of daily microaggressions on bisexual women's health.

Bisexual women experience disproportionately poorer health outcomes in comparison to lesbian and gay groups, and the general population, including inequities related to mental and physical health. Although bisexual-specific health inequities are increasingly well-documented, research examining putative causes of such inequities, as well as research that accounts for differences within bisexual populations - particularly among racial minorities- remains limited. To address these gaps, this paper reports findings from the Women's Daily Experiences Study (WoDES), a multi-method study that explored the relationship between microaggressions and health outcomes among racially/ethnically diverse cisgender, bisexual women in Chicago. Data from 28-day daily e-diaries (N = 2,104 observations; 99 participants, 57% women of color) were analyzed using multilevel modeling to (1) measure the frequency of microaggressions among bisexual women; (2) examine the influence of sexual orientation, racial, and gender microaggressions on mental and physical health; and (3) investigate how race influences relationships between microaggressions and health. Participants reported an average of 8.1 microaggressions in the previous 28 days, and at least one microaggression was reported for more than 42% of days (n = 802). Microaggressions of any type were associated with increased same-day negative affect and somatic complaints. Latina bisexual women experienced worse health outcomes in comparison to Black bisexual women. This study demonstrated the detrimental impact of microaggressions on the health of bisexual women and highlights the critical need for strategies on broader structural changes that could improve the health and well-being of bisexual women.

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.

Sleep-Opt-In: A Randomized Controlled Pilot Study to Improve Sleep and Glycemic Variability in Adults With Type 1 Diabetes.

PURPOSE: The purpose of this study was to evaluate the feasibility and acceptability of a technology-assisted behavioral sleep intervention (Sleep-Opt-In) and to examine the effects of Sleep-Opt-In on sleep duration and regularity, glucose indices, and patient-reported outcomes. Short sleep duration and irregular sleep schedules are associated with reduced glycemic control and greater glycemic variability. METHODS: A randomized controlled parallel-arm pilot study was employed. Adults with type 1 diabetes (n = 14) were recruited from the Midwest and randomized 3:2 to the sleep-optimization (Sleep-Opt-In) or Healthy Living attention control group. Sleep-Opt-In was an 8-week, remotely delivered intervention consisting of digital lessons, sleep tracker, and weekly coaching phone calls by a trained sleep coach. Assessments of sleep (actigraphy), glucose (A1C, continuous glucose monitoring), and patient-reported outcomes (questionnaires for daytime sleepiness, fatigue, diabetes distress, and depressive mood) were completed at baseline and at completion of the intervention. RESULTS: Sleep-Opt-In was feasible and acceptable. Those in Sleep-Opt-In with objectively confirmed short or irregular sleep demonstrated an improvement in sleep regularity (25 minutes), reduced glycemic variability (3.2%), and improved time in range (6.9%) compared to the Healthy Living attention control group. Patient-reported outcomes improved only for the Sleep-Opt-In group. Fatigue and depressive mood improved compared to the control. CONCLUSIONS: Sleep-Opt-In is feasible, acceptable, and promising for further evaluation as a means to improve sleep duration or regularity in the population of people with type 1 diabetes.

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.

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.

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.

The Use of Navigators to Increase Patient Portal Enrollment among Patients in a Federally Qualified Health Care System.

Purpose: To describe the training, preliminary results, and lessons learned from using patient navigators to increase the enrollment of low-income patients in a health system-supported and electronic health record-linked patient portal. Methods: Patient navigators (n=4) were trained to assist patients in a federally qualified health center to enroll in and use patient portals. Patient navigators were stationed at 3 clinic locations. Data from the electronic health record system (Epic) were used to compare MyChart patient portal activation rates and use among patients for the 8 months before and after patient navigation services were offered. Results: Navigators offered 83% of eligible patients with activation assistance. Sixty-four percent of the patients (n=1062) offered MyChart enrollment assistance accepted help. Seventy-four percent of assisted patients with no prior MyChart enrollment activated their accounts during that clinic visit. The primary reason for declining MyChart assistance was a lack of access to or comfort with technology. Patient portal activation increased during the 8 months when navigators were at the clinics (51%) compared to the previous 8 months (44%). Most new users viewed lab results and read a message [χ2(1)=49.3, p<.001], with significant increases evident for African Americans [44% before, 49% during; χ2(1)=40.4, p<.001] and Latinx patients [52% before, 60% during; χ2(1)=6.15, p=.013]. Conclusion: Study results suggest that using patient navigators is feasible and beneficial for increasing patient enrollment in the Federally Qualified Health Centers context. However, patient-, clinic-, and system-level factors were identified as barriers and should be addressed in future research studies.

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.

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.

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.

Preliminary Evaluation of a Citizen Scientist Educational Curriculum Aimed at Engaging Black Men in Lung Cancer Early Detection Screening.

This article describes an educational program to engage African American men as citizen scientists (CSs) and future research partners in a lung cancer screening project. We provide an overview of the curriculum used, the structure and format of the educational sessions, and associated educational outcomes. Furthermore, we describe lessons learned in the engagement of African American men as CS in community-based lung-health equity research. The CS educational program included five group-based sessions delivered through zoom. The educational curriculum was adapted from the University of Florida Citizen Scientist program and tailored to address lung health and the contextual experiences of African American men. Each session lasted 90 minutes. Pre- and post-test measures were collected to examine changes in knowledge, comfort, health literacy, research interests, and medical mistrust. Eight African American men completed the CS educational program. Attendance rates were high for each session (100%). Seven participants completed additional human subject research certification. Improvements were observed from pre- to post-test in participants' level of knowledge, comfort, and health literacy but not medical mistrust. CS reported the most interest in participating in research aimed to identify important community strengths and problems. Study findings suggest that it was feasible to deliver an online citizen scientist educational program designed to prepare participants to serve as partners in a lung cancer screening intervention for African American men. Results suggest the educational program has the potential to improve key outcomes including completion of regulatory training and increased research-related knowledge, comfort, and health literacy.