Tackling Brain and Muscle Dysfunction in Acute Respiratory Distress Syndrome Survivors: NHLBI Workshop Report.

Acute respiratory distress syndrome (ARDS) is associated with long-term impairments in brain and muscle function that significantly impact the quality of life of those who survive the acute illness. The mechanisms underlying these impairments are not yet well understood, and evidence-based interventions to minimize the burden on patients remain unproved. The NHLBI of the NIH assembled a workshop in April 2023 to review the state of the science regarding ARDS-associated brain and muscle dysfunction, to identify gaps in current knowledge, and to determine priorities for future investigation. The workshop included presentations by scientific leaders across the translational science spectrum and was open to the public as well as the scientific community. This report describes the themes discussed at the workshop as well as recommendations to advance the field toward the goal of improving the health and well-being of ARDS survivors.

Real-World Implications of Updated Surviving Sepsis Campaign Antibiotic Timing Recommendations.

OBJECTIVE: To evaluate real-world implications of updated Surviving Sepsis Campaign (SSC) recommendations for antibiotic timing. DESIGN: Retrospective cohort study. SETTING: Twelve hospitals in the Southeastern United States between 2017 and 2021. PATIENTS: One hundred sixty-six thousand five hundred fifty-nine adult hospitalized patients treated in the emergency department for suspected serious infection. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We determined the number and characteristics of patients affected by updated SSC recommendations for initiation of antibiotics that incorporate a risk- and probability-stratified approach. Using an infection prediction model with a cutoff of 0.5 to classify possible vs. probable infection, we found that 30% of the suspected infection cohort would be classified as shock absent, possible infection and thus eligible for the new 3-hour antibiotic recommendation. In real-world practice, this group had a conservative time to antibiotics (median, 5.5 hr; interquartile range [IQR], 3.2-9.8 hr) and low mortality (2%). Patients categorized as shock absent, probable infection had a median time to antibiotics of 3.2 hours (IQR, 2.1-5.1 hr) and mortality of 3%. Patients categorized as shock present, the probable infection had a median time to antibiotics 2.7 hours (IQR, 1.7-4.6 hr) and mortality of 17%, and patients categorized as shock present, the possible infection had a median time to antibiotics 6.9 hours (IQR, 3.5-16.3 hr) and mortality of 12%. CONCLUSIONS: These data support recently updated SSC recommendations to align antibiotic timing targets with risk and probability stratifications. Our results provide empirical support that clinicians and hospitals should not be held to 1-hour targets for patients without shock and with only possible sepsis.

Prescribing and Acceptance of Medications for Opioid Use Disorder in VA Primary Care: Veteran and Provider Perspectives.

BACKGROUND: Medications to treat opioid use disorder (MOUD) such as buprenorphine/naloxone can effectively treat OUD and reduce opioid-related mortality, but they remain underutilized, especially in non-substance use disorder settings such as primary care (PC). OBJECTIVE: To uncover the factors that can facilitate successful prescribing of MOUD and uptake/acceptance of MOUD by patients in PC settings in the Veterans Health Administration. DESIGN: Semi-structured qualitative telephone interviews with 77 providers (e.g., primary care providers, hospitalists, nurses, addiction psychiatrists) and 22 Veteran patients with experience taking MOUD. Interviews were recorded, transcribed, and analyzed thematically using a combination a priori/inductive approach. KEY RESULTS: Providers and patients shared their general perceptions and experiences with MOUD, including high satisfaction with buprenorphine/naloxone with few side effects and caveats, although some patients reported drawbacks to methadone. Both providers and patients supported the idea of prescribing MOUD in PC settings to prioritize patient comfort and convenience. Providers described individual-level barriers (e.g., time, stigma, perceptions of difficulty level), structural-level barriers (e.g., pharmacy not having medications ready, space for inductions), and organizational-level barriers (e.g., inadequate staff support, lack of nursing protocols) to PC providers prescribing MOUD. Facilitators centered on education and knowledge enhancement, workflow and practice support, patient engagement and patient-provider communication, and leadership and organizational support. The most common barrier faced by patients to starting MOUD was apprehensions about pain, while facilitators focused on personal motivation, encouragement from others, education about MOUD, and optimally timed provider communication strategies. CONCLUSIONS: These findings can help improve provider-, clinic-, and system-level supports for MOUD prescribing across multiple settings, as well as foster communication strategies that can increase patient acceptance of MOUD. They also point to how interprofessional collaboration across service lines and leadership support can facilitate MOUD prescribing among non-addiction providers.

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

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

Classification of Documented Goals of Care Among Hospitalized Patients with High Mortality Risk: a Mixed-Methods Feasibility Study.

BACKGROUND: The ability to classify patients' goals of care (GOC) from clinical documentation would facilitate serious illness communication quality improvement efforts and pragmatic measurement of goal-concordant care. Feasibility of this approach remains unknown. OBJECTIVE: To evaluate the feasibility of classifying patients' GOC from clinical documentation in the electronic health record (EHR), describe the frequency and patterns of changes in patients' goals over time, and identify barriers to reliable goal classification. DESIGN: Retrospective, mixed-methods chart review study. PARTICIPANTS: Adults with high (50-74%) and very high (≥ 75%) 6-month mortality risk admitted to three urban hospitals. MAIN MEASURES: Two physician coders independently reviewed EHR notes from 6 months before through 6 months after admission to identify documented GOC discussions and classify GOC. GOC were classified into one of four prespecified categories: (1) comfort-focused, (2) maintain or improve function, (3) life extension, or (4) unclear. Coder interrater reliability was assessed using kappa statistics. Barriers to classifying GOC were assessed using qualitative content analysis. KEY RESULTS: Among 85 of 109 (78%) patients, 338 GOC discussions were documented. Inter-rater reliability was substantial (75% interrater agreement; Cohen's kappa = 0.67; 95% CI, 0.60-0.73). Patients' initial documented goal was most frequently "life extension" (N = 37, 44%), followed by "maintain or improve function" (N = 28, 33%), "unclear" (N = 17, 20%), and "comfort-focused" (N = 3, 4%). Among the 66 patients whose goals' classification changed over time, most changed to "comfort-focused" goals (N = 49, 74%). Primary reasons for unclear goals were the observation of concurrently held or conditional goals, patient and family uncertainty, and limited documentation. CONCLUSIONS: Clinical notes in the EHR can be used to reliably classify patients' GOC into discrete, clinically germane categories. This work motivates future research to use natural language models to promote scalability of the approach in clinical care and serious illness research.

Using evidence-based co-design to develop a hybrid delivered exercise intervention that aims to increase confidence to exercise in people with haemophilia.

INTRODUCTION: Due to advances in treatments, people with haemophilia (PWH) are living longer. They are not as active as the general population due to joint damage and lack confidence to be active due to concerns about further bleeds and pain. There is a need to facilitate healthy aging through promotion of physical activity (PA) and exercise. Changing patient beliefs and increasing physical literacy and confidence to move are thought to be key to helping PWH become more active. AIM: This paper describes the development of an exercise and behaviour change intervention to improve confidence to exercise in PWH. METHODS: The 4-stage Medical Research Council framework for complex intervention development was used. RESULTS: Stakeholders included 17 PWH and 7 physiotherapists working in haemophilia. Seven online focus group meetings were held. The final intervention is a hybrid 12-week physiotherapist led progressive exercise programme. Classes are 45 min including Pilates, High intensity interval training and balance elements, together with discussion sessions focusing on PA recommendations, the types and benefits of different exercise styles and the effects of PA, together with the effects of aging for PWH. The COM-B model of behaviour change was used to develop the intervention. CONCLUSION: Co-design helps to produce an intervention that understands the stakeholders needs. Through this process the intervention developed to incorporate not only increasing PA but also confidence to exercise. The use of behaviour change theory identified the behaviour techniques included in the intervention and aims to increase physical literacy in this population.

"It's just part of who I am " Living with chronic headache: voices from the CHESS trial, a qualitative study.

BACKGROUND: Between 2015 and 2019 the Chronic Headache Education and Self-management Study (CHESS) developed and tested a supportive self-management approach that aimed to improve outcomes for people with chronic migraine or chronic tension type headache with/without episodic migraine. However, a paucity of qualitative research which explored the lived experiences of people with chronic headache was evidenced. In response, we undertook to explore the experiences of living with chronic headaches of people who participated in the CHESS study. METHODS: We adopted qualitative methodologies, inviting participants in the CHESS study to participate in semi-structured interviews. In phase 1 (feasibility study), a thematic analysis was conducted. In phase 2 (main CHESS trial), interviews were informed by topic guides developed from our learning from the phase 1 interviews. Pen portrait methodology and thematic analysis was employed allowing us to explore the data longitudinally. RESULTS: Phase 1, 15 interviews (10 female) age range 29 to 69 years (median 47 years) revealed the complexities of living with chronic headache. Six overarching themes were identified including the emotional impact and the nature of their headaches. Phase 2, included 66 interviews (26 participants; median age group 50s (range 20s-60s); 20 females. 14 were interviewed at three points in time (baseline, 4 and 12 months) Through an iterative process four overlapping categories of headache impact emerged from the data and were agreed: i) 'I will not let headaches rule my life'; ii) 'Headaches rule my life'; iii) 'Headaches out of control-something needs to change'; and iv) 'Headaches controlled-not ruling my life'. One of these categories was assigned to each pen portrait at each timepoint. The remaining 12 participants were interviewed at two time points during a year; pen portraits were again produced. Analysis revealed that the headache impact categories developed above held true in this sample also providing some validation of the categories. CONCLUSIONS: These data give an insight into the complexities of living with chronic headache. Chronic headache is unpredictable, permeating all aspects of an individual's life; even when an individual feels that their headache is controlled and not interfering, this situation can rapidly change. It shows us that more work needs to be done both medically and societally to help people living with this often-hidden condition. TRIAL REGISTRATION: ISRCTN79708100.

Bridging and Validation of the Specific Graves Ophthalmopathy Quality of Life Questionnaire With Health State Utility Values.

OBJECTIVE: In thyroid eye disease (TED), inflammation and expansion of orbital muscle and periorbital fat result in diplopia and proptosis, severely impacting patient quality of life (QOL). The reported health state utility (HSU) scores, which are QOL measures, allow quantification of TED impact and improvement with therapies; however, no current QOL instrument has been validated with HSU scores for TED. Here, we used the disease-specific Graves Ophthalmopathy Quality of Life (GO-QOL) questionnaire and HSU scores to validate QOL impact. METHODS: The GO-QOL scores from patients in 2 randomized, masked, placebo-controlled teprotumumab trials (N=171) were compared with 6 HSU values based on severity of proptosis/diplopia in those studies. Patient GO-QOL and HSU scores were compared at baseline and after 6-month treatment via regression analyses. GO-QOL and HSU scores were correlated for validation and quantification of QOL impact by severity state and to estimate quality-adjusted life year improvement. RESULTS: GO-QOL scores were correlated with TED severity, indicating that worse severity was associated with lower (worse) GO-QOL scores. Less severe health states were represented by higher (better) GO-QOL scores. Importantly, GO-QOL scores were positively correlated with utility scores of the 6 health states, allowing for conversion of the GO-QOL scores to utility scores. A positive (improved) 0.013 utility change was found for each 1-point (positive) improvement in GO-QOL score produced by teprotumumab versus placebo. CONCLUSION: Patients with moderate-to-severe active TED health states demonstrate increasing TED severity associated with declining utility values and worsening GO-QOL scores. These results indicate that the GO-QOL scores can be used to bridge to the HSU scores for benefit quantification.

Pre-implementation planning for a sepsis intervention in a large learning health system: a qualitative study.

BACKGROUND: Sepsis survivors experience high morbidity and mortality. Though recommended best practices have been established to address the transition and early post hospital needs and promote recovery for sepsis survivors, few patients receive recommended post-sepsis care. Our team developed the Sepsis Transition and Recovery (STAR) program, a multicomponent transition intervention that leverages virtually-connected nurses to coordinate the application of evidence-based recommendations for post-sepsis care with additional clinical support from hospitalist and primary care physicians. In this paper, we present findings from a qualitative pre-implementation study, guided by the Consolidated Framework for Implementation Research (CFIR), of factors to inform successful STAR implementation at a large learning health system prior to effectiveness testing as part of a Type I Hybrid trial. METHODS: We conducted semi-structured qualitative interviews (n = 16) with 8 administrative leaders and 8 clinicians. Interviews were transcribed and analyzed in ATLAS.ti using a combination deductive/inductive strategy based on CFIR domains and constructs and the Constant Comparison Method. RESULTS: Six facilitators and five implementation barriers were identified spanning all five CFIR domains (Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals and Process). Facilitators of STAR included alignment with health system goals, fostering stakeholder engagement, sharing STAR outcomes data, good communication between STAR navigators and patient care teams/PCPs, clinician promotion of STAR with patients, and good rapport and effective communication between STAR navigators and patients, caregivers, and family members. Barriers of STAR included competing demands for staff time and resources, insufficient communication and education of STAR's value and effectiveness, underlying informational and technology gaps among patients, lack of patient access to community resources, and patient distrust of the program and/or health care. CONCLUSIONS: CFIR proved to be a robust framework for examining facilitators and barriers for pre-implementation planning of post-sepsis care programs within diverse hospital and community settings in a large LHS. Conducting a structured pre-implementation evaluation helps researchers design with implementation in mind prior to effectiveness studies and should be considered a key component of Type I hybrid trials when feasible. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04495946 . Registered August 3, 2020.

Patient perspectives on the Tailored intervention for Anxiety and Depression Management in COPD (TANDEM): a qualitative evaluation.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is commonly associated with anxiety/depression which can affect self-management and quality of life. The TANDEM trial evaluated a cognitive behavioural approach intervention targeting COPD-related symptoms of anxiety and/or depression, comprising up to eight one-to-one sessions delivered by respiratory healthcare professionals prior to pulmonary rehabilitation (PR). The intervention showed no improvement in anxiety/depression or uptake/completion of PR. We present patient perspectives of the intervention to help understand these results. METHOD: Semi-structured individual interviews, using a semi-structured topic guide informed by Sekhon's Theoretical Framework of Acceptability, were conducted with 19 patients between September 2019 and April 2020. The interviews were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: The following could have limited the impact of the intervention: (1) The lives of patients were complex and commonly affected by competing comorbidities or other external stressors which they managed through previously adopted long-standing coping strategies. (2) Some patients were reluctant to talk about their mood despite the Facilitators' training and person centred-skills which aimed to enable patients to talk freely about mood. (3) The intervention handouts and 'home-practice' were perceived as helpful for some, but not suitable for all. (4) Many patients perceived improvements in their physical and mental health, but this was not sustained due to a mix of personal and external factors, and some did not perceive any benefits. (5) PR non-attendance/non-completion was a result of personal and PR service-related reasons. (6) Discussing COPD and mental health with the Facilitator was a novel experience. Many patients felt that TANDEM could be of benefit if it was offered earlier on/at different time points in the COPD illness journey. CONCLUSION: We found the delivery of TANDEM prior to PR was not helpful for patients with advanced COPD often experiencing other comorbidities, and/or difficult personal/external events. These patients already utilised long-standing coping strategies to manage their COPD. Holistic interventions, that address the impact of COPD in relation to wider aspects of a patients' life, may be more beneficial. TRIAL REGISTRATION: ISRCTN Registry 59,537,391. Registration date 20 March 2017.

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

Frictional Weakening of Vibrated Granular Flows.

We computationally study the frictional properties of sheared granular media subjected to harmonic vibration applied at the boundary. Such vibrations are thought to play an important role in weakening flows, yet the independent effects of amplitude, frequency, and pressure on the process have remained unclear. Based on a dimensional analysis and DEM simulations, we show that, in addition to a previously proposed criterion for peak acceleration that leads to breaking of contacts, weakening requires the absolute amplitude squared of the displacement to be sufficiently large relative to the confining pressure. The analysis provides a basis for predicting flows subjected to arbitrary external vibration and demonstrates that a previously unrecognized second process that is dependent on dissipation contributes to shear weakening under vibrations.

We Built it, But Did They Come: Veterans' Use of VA Healthcare System-Provided Complementary and Integrative Health Approaches.

BACKGROUND: Interest in complementary and integrative health (CIH) approaches, such as meditation, yoga, and acupuncture, continues to grow. The evidence of effectiveness for some CIH approaches has increased in the last decade, especially for pain, with many being recommended in varying degrees in national guidelines. To offer nonpharmacological health management options and meet patient demand, the nation's largest integrated healthcare system, the Veterans Health Administration (VA), greatly expanded their provision of CIH approaches recently. OBJECTIVE: This paper addressed the questions of how many VA patients might use CIH approaches and chiropractic care if they were available at modest to no fee, and would patients with some health conditions or characteristics be more likely than others to use these therapies. DESIGN: Using electronic medical records, we conducted a national, three-year, retrospective analysis of VA patients' use of eleven VA-covered therapies: chiropractic care, acupuncture, Battlefield Acupuncture, biofeedback, clinical hypnosis, guided imagery, massage therapy, meditation, Tai Chi/Qigong, and yoga. PARTICIPANTS: We created a national cohort of veterans using VA healthcare from October 2016-September 2019. KEY RESULTS: Veterans' use of these approaches increased 70% in three years. By 2019, use was 5.7% among all VA patients, but highest among patients with chronic musculoskeletal pain (13.9%), post-traumatic stress disorder (PTSD; 10.6%), depression (10.4%), anxiety (10.2%), or obesity (7.8%). The approach used varied by age and race/ethnicity, with women being uniformly more likely than men to use each approach. Patients having chronic musculoskeletal pain, obesity, anxiety, depression, or PTSD were more likely than others to use each of the approaches. CONCLUSIONS: Veterans' use of some approaches rapidly grew recently and was robust, especially among patients most in need. This information might help shape federal/state health policy on the provision of evidence-based CIH approaches and guide other healthcare institutions considering providing them.

Extragenital Sexually Transmitted Infection Testing Among Louisiana Parish Health Units, 2016-2019.

BACKGROUND: The Centers for Disease Control and Prevention recommends that men who have sex with men (MSM) get tested annually for urethral and rectal chlamydia (CT) and gonorrhea (NG), and pharyngeal NG. There are no national recommendations to screen women and heterosexual men at extragenital sites. We assessed extragenital CT/NG screening among men and women at Louisiana's Parish Health Units (PHU). METHODS: The Louisiana STD/HIV/Hepatitis Program piloted extragenital screening at 4 PHUs in February 2016 and expanded to 11 PHUs in 2017. Sexual histories were used to identify gender of sex partners and exposed sites. Because of billing restrictions, up to 2 anatomical sites were tested for CT/NG. RESULTS: From February 2016 to June 2019, 70,895 urogenital and extragenital specimens (56,086 urogenital, 13,797 pharyngeal, and 1,012 rectal) were collected from 56,086 patients. Pharyngeal CT positivity was 160 of 7,868 (2.0%) among women, 54 of 4,838 (1.1%) among men who have sex with women (MSW) and 33 of 1,091 (3.0%) among MSM. Rectal CT positivity was 51 of 439 (11.6%) among women and 95 of 573 (16.6%) among MSM. Pharyngeal NG positivity was 299 of 7,868 (3.8%) among women, 222 of 4,838 (4.6%) among MSW, and 97 of 1,091 (8.9%) among MSM. Rectal NG positivity was 20 of 439 (4.6%) among women and 134 of 573 (23.4%) among MSM.Urogenital-only screening would have missed: among women, 173 of 3,923 (4.4%) CT and 227 of 1,480 (15.3%) NG infections; among MSW, 26 of 2,667 (1%) CT and 149 of 1,709 (8.7%) NG infections; and among MSM, 116 of 336 (34.5%) CT and 127 of 413 (42.1%) NG infections. CONCLUSIONS: Many CT/NG infections would have been missed with urogenital-only screening. Men who have sex with men had much higher extragenital infection rates than women and MSW.

Health system approaches to providing posthospital care for survivors of sepsis and critical illness.

PURPOSE OF REVIEW: In the current review, we highlight developing strategies taken by healthcare systems to improve posthospital outcomes for sepsis and critical illness. RECENT FINDINGS: Multiple studies conducted in the adult population over the last 18 months have advanced current knowledge on postdischarge care after sepsis and critical illness. Effective interventions are complex and multicomponent, targeting the multilevel challenges that survivors face. Health systems can leverage existing care models such as primary care or invest in specialty programs to deliver postdischarge care. Qualitative and implementation science studies provide insights into important contextual factors for program success. Several studies demonstrate successful application of telehealth to improve reach of postdischarge support. Research is beginning to identify subtypes of survivors that may respond to tailored intervention strategies. SUMMARY: Several successful critical illness survivor models of care have been implemented and knowledge about effectiveness, cost, and implementation factors of these strategies is growing. Further innovation is needed in intervention development and evaluation to advance the field.

Chronic Headache Education and Self-Management Study (CHESS): a process evaluation.

BACKGROUND: The Chronic Headache Education and Self-Management Study (CHESS) multicentre randomised trial evaluated the impact a group education and self-management support intervention with a best usual care plus relaxation control for people living with chronic headache disorders (tension type headaches or chronic migraine, with or without medication overuse headache). Here we report the process evaluation exploring potential explanations for the lack of positive effects from the CHESS intervention. METHODS: The CHESS trial included 736 (380 intervention: 356 control) people across the Midlands and London UK. We used a mixed methods approach. Our extensive process evaluation looked at context, reach, recruitment, dose delivered, dose received, fidelity and experiences of participating in the trial, and included participants and trial staff. We also looked for evidence in our qualitative data to investigate whether the original causal assumptions underpinning the intervention were realised. RESULTS: The CHESS trial reached out to a large diverse population and recruited a representative sample. Few people with chronic tension type headaches without migraine were identified and recruited. The expected 'dose'of the intervention was delivered to participants and intervention fidelity was high. Attendance ("dose received") fell below expectation, although 261/380 (69%) received at least at least the pre-identified minimum dose. Intervention participants generally enjoyed being in the groups but there was little evidence to support the causal assumptions underpinning the intervention were realised. CONCLUSIONS: From a process evaluation perspective despite our extensive data collection and analysis, we do not have a clear understanding of why the trial outcome was negative as the intervention was delivered as planned. However, the lack of evidence that the intervention causal assumptions brought about the planned behaviour change may provide some insight. Our data suggests only modest changes in managing headache behaviours and some disparity in how participants engaged with components of the intervention within the timeframe of the study. Moving forwards, we need a better understanding of how those who live with chronic headache can be helped to manage this disabling condition more effectively over time. TRIAL REGISTRATION: ISRCTN79708100 .

Outpatient sexually transmitted infection testing and treatment patterns in the United States: a real-world database study.

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most common notifiable sexually transmitted infections (STIs) in the United States. Because symptoms of these infections often overlap with other urogenital infections, misdiagnosis and incorrect treatment can occur unless appropriate STI diagnostic testing is performed in clinical settings. The objective of this study was to describe STI diagnostic testing and antimicrobial treatment patterns and trends among adolescent and adult men and women with lower genitourinary tract symptoms (LGUTS). METHODS: We analyzed insurance claims data from the IBM® MarketScan® Research Databases. Patients included were between 14 and 64 years old with LGUTS as determined by selected International Classification of Diseases codes between January 2010 and December 2019. Testing of STIs and relevant drug claims were captured, and distribution of testing patterns and drug claims were described. RESULTS: In total, 23,537,812 episodes with LGUTS (87.4% from women; 12.6% from men) were analyzed from 12,341,154 patients. CT/NG testing occurred in only 17.6% of all episodes. For episodes where patients received treatment within 2 weeks of the visit date, 89.3% received treatment within the first 3 days (likely indicating presumptive treatment), and 77.7% received it on the first day. For women with pelvic inflammatory disease and men with orchitis/epididymitis and acute prostatitis, ≤ 15% received CT/NG testing, and around one-half received antibiotic treatment within 3 days. CONCLUSIONS: Our study revealed low CT/NG testing rates, even in patients diagnosed with complications commonly associated with these STIs, along with high levels of potentially inappropriate presumptive treatment. This highlights the need for timely and accurate STI diagnosis in patients with LGUTS to inform appropriate treatment recommendations.

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial.

Importance: Opioid use for chronic nonmalignant pain can be harmful. Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care. Design, Setting, and Participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020. Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months. Main Outcomes and Measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report. Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt). Conclusions and Relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities. Trial Registration: isrctn.org Identifier: ISRCTN49470934.

Telehealth Complementary and Integrative Health Therapies During COVID-19 at the U.S. Department of Veterans Affairs.

Background: Complementary and integrative health (CIH) therapies, such as in-person acupuncture, chiropractic care, and meditation, are evidence-based nonpharmaceutical treatment options for pain. During COVID-19, the Veterans Health Administration (VA) delivered several CIH therapies virtually. This study explores veterans' utilization, advantages/disadvantages, and delivery issues of yoga, Tai Chi, meditation/mindfulness (self-care), and massage, chiropractic, and acupuncture (practitioner-delivered care), using telephone/video at 18 VA sites during COVID-19. Methods: Use of virtual care was examined quantitatively with VA administrative data for six CIH therapies before and after COVID-19 onset (2019-2021). Advantages/disadvantages and health care delivery issues of these CIH therapies through virtual care were examined qualitatively using interview data (2020-2021). Results: Overall, televisits represented a substantial portion of all CIH self-care therapies delivered by VA in 2020 (53.7%) and 2021 (82.1%), as sites developed virtual group classes using VA secure online video platforms in response to COVID-19. In contrast, a small proportion of all encounters with acupuncturists, chiropractors, and massage therapists was telephone/video encounters in 2020 (17.3%) and in 2021 (5.4%). These were predominantly one-on-one care in the form of education, follow-ups, home exercises, assessments/evaluations, or acupressure. Delivery issues included technical difficulties, lack of access to needed technology, difficulty tracking virtual visits, and capacity restrictions. Advantages included increased access to self-care, increased patient receptivity to engaging in self-care, and flexibility in staffing online group classes. Disadvantages included patient preference, patient safety, and strain on staffing. Conclusion: Despite delivery issues or disadvantages of tele-CIH self-care, veterans' use of teleself-care CIH therapies grew substantially during the COVID-19 pandemic.

STOP- a training intervention to optimise treatment for smoking cessation in community pharmacies: cluster randomised controlled trial.

BACKGROUND: Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention. METHODS: We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation. The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date. RESULTS: The intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and 276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms. Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers. CONCLUSIONS: We found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit. TRIAL REGISTRATION: ISRCTN, ISRCTN16351033 . Retrospectively registered.