Active Treatment Group Research Articles

Telehealth and In-Person Behavioral Health Services in Rural Communities Before and During the COVID-19 Pandemic: Multisite Prospective Cohort Study.

The COVID-19 pandemic triggered widespread adjustments across the US health care system. Telehealth use showed a substantial increase in mental health conditions and services due to acute public health emergency (PHE) behavioral health needs on top of long-standing gaps in access to behavioral health services. How health systems that were already providing behavioral telehealth services adjusted services and staffing during this period has not been well documented, particularly in rural areas with chronic shortages of behavioral health providers and services. This study investigates patient and treatment characteristic changes from before the COVID-19 PHE to during the PHE within both telehealth and in-person behavioral health services provided in 95 rural communities across the United States. We used a nonrandomized, prospective, multisite research design involving 2 active treatment groups. The telehealth cohort included all patients who initiated telehealth treatment regimens during the data collection period. A comparison group included a cohort of patients who initiated in-person treatment regimen. Patient enrollment occurred on a rolling basis, and data collection was extended for 3 months after treatment initiation for each patient. Chi-square tests compared changes from pre-PHE to PHE time periods within telehealth and in-person treatment cohorts. The dependent measures included patient diagnosis, clinicians providing treatment services, and type of treatment services provided at each encounter. The 4780 patients in the telehealth cohort and the 6457 patients in the in-person cohort had an average of 3.5 encounters during the 3-month follow-up period. The encounters involving anxiety, dissociative, and stress-related disorders in the telehealth cohort increased from 30% (698/2352) in the pre-PHE period to 35% (4632/12,853) in the PHE period (P<.001), and encounters involving substance use disorders in the in-person cohort increased from 11% (468/4249) in the pre-PHE period to 18% (3048/17,047) in the PHE period (P<.001). The encounters involving treatment service codes for alcohol, drug, and medication-assisted therapy in the telehealth cohort increased from 1% (22/2352) in the pre-PHE period to 11% (1470/13,387) in the PHE period (P<.001); likewise, encounters for this type of service in the in-person cohort increased from 0% (0/4249) in the pre-PHE period to 16% (2687/17,047) in the PHE period (P<.001). From the pre-PHE to the PHE period, encounters involving 60-minute psychotherapy in the telehealth cohort increased from 8% (190/2352) to 14% (1802/13,387; P<.001), while encounters involving group therapy in the in-person cohort decreased from 12% (502/4249) to 4% (739/17,047; P<.001). The COVID-19 pandemic challenged health service providers, and they adjusted the way both telehealth and in-person behavioral therapy services were delivered. Looking forward, future research is needed to explicate the interaction of patient, provider, setting, and intervention factors that influenced the patterns observed as a result of the COVID-19 pandemic.

Evaluating the Effects of a Self-Help Mobile Phone App on Worry and Rumination Experienced by Young Adults: Randomized Controlled Trial.

Delivery of preventative interventions via mobile phone apps offers an effective and accessible way to address the global priority of improving the mental health of adolescents and young adults. A proven risk factor for anxiety and depression is elevated worry and rumination, also known as repetitive negative thinking (RNT). This was a prevention mechanism trial that aimed to investigate whether an RNT-targeting self-help mobile phone app (MyMoodCoach) reduces worry and rumination in young adults residing in the United Kingdom. A secondary objective was to test whether the app reduces symptoms of anxiety and depression and improves well-being. A web-based, single-blind, 2-arm parallel-group randomized controlled trial was conducted with 236 people aged between 16 and 24 years, who self-reported high levels of worry or rumination. Eligible participants were randomized to an active intervention group (usual practice, plus up to 6 weeks of using the RNT-targeting mobile app, n=119) or a waitlist control group (usual practice with no access to the app until after 6 weeks, n=117). The primary outcome was changes in worry and rumination 6 weeks after randomization. Secondary outcomes included changes in well-being and symptoms of anxiety and depression after 6 weeks and changes in all measures after 12 weeks. Participants randomly allocated to use the RNT-targeting self-help app showed significantly lower levels of rumination (mean difference -2.92, 95% CI -5.57 to -0.28; P=.03; ηp2=0.02) and worry (mean difference -3.97, 95% CI -6.21 to -1.73; P<.001; ηp2=0.06) at 6-week follow-up, relative to the waitlist control. Similar differences were observed for well-being (P<.001), anxiety (P=.03), and depression (P=.04). The waitlist control group also showed improvement when given access to the app after 6 weeks. Improvements observed in the intervention group after 6 weeks of using the app were maintained at the 12-week follow-up point. The MyMoodCoach app had a significant positive effect on worry and rumination, well-being, anxiety, and depression in young adults, relative to waitlist controls, providing proof-of-principle that an unguided self-help app can effectively reduce RNT. This app, therefore, has potential for the prevention of anxiety and depression although longer-term effects on incidence need to be directly evaluated. ClinicalTrials.gov NCT04950257; https://www.clinicaltrials.gov/ct2/show/NCT04950257. RR2-10.1186/s12888-021-03536-0.

Valbenazine for tardive dyskinesia: a systematic review and network meta-analysis.

To date, the role of valbenazine (VAL) in a dose-dependent increase in efficacy for tardive dyskinesia (TD) and in the worsening of acceptability and tolerability in a dose-dependent manner remains to be elucidated. Thus, in this systematic review and frequentist network meta-analysis, we compared 16 outcomes of VAL80 mg/d (VAL80) with VAL40 mg/d (VAL40) related to the efficacy, acceptability, tolerability, and safety in the treatment of patients with TD. Using a 95% confidence interval, we calculated the standardized mean difference for continuous variables and the risk ratio for dichotomous variables. Our results demonstrated that both VAL80 and VAL40 were superior to the placebo in terms of Abnormal Involuntary Movement Scale (AIMS) total score, Clinical Global Impression of Change-TD, and response to treatment, but VAL80 outperformed VAL40 in terms of AIMS score and response to treatment. However, any active therapy and placebo treatment groups did not have significant differences in acceptability, tolerability, and safety outcomes and similarly between VAL80 and VAL40 in any other outcomes. In conclusions, VAL could be increased from VAL40 to VAL80 if a patient with TD adequately tolerates VAL40 but treatment response is poor.

Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data

BackgroundBreast cancer (BC) is among the most common forms of cancer experienced by women. Up to 80% of BC survivors treated with chemotherapy experience chemotherapy-induced neuropathy (CIN), which degrades motor control, sensory function, and quality of life. CIN symptoms include numbness, tingling, and/or burning sensations in the extremities; deficits in neuromotor control; and increased fall risk. Physical activity (PA) and music-based medicine (MBM) are promising avenues to address sensorimotor symptoms. Therefore, we propose that we can combine the effects of music- and PA-based medicine through neurologic dance training (NDT) through partnered Adapted Tango (NDT-Tango). We will assess the intervention effect of NDT-Tango v. home exercise (HEX) intervention on biomechanically-measured variables. We hypothesize that 8 weeks of NDT-Tango practice will improve the dynamics of posture and gait more than 8 weeks of HEX.MethodsIn a single-center, prospective, two-arm randomized controlled clinical trial, participants are randomly assigned (1:1 ratio) to the NDT-Tango experimental or the HEX active control intervention group. Primary endpoints are change from baseline to after intervention in posture and gait. Outcomes are collected at baseline, midpoint, post, 1-month follow-up, and 6-month follow-up. Secondary and tertiary outcomes include clinical and biomechanical tests of function and questionnaires used to compliment primary outcome measures. Linear mixed models will be used to model changes in postural, biomechanical, and PROs. The primary estimand will be the contrast representing the difference in mean change in outcome measure from baseline to week 8 between treatment groups.DiscussionThe scientific premise of this study is that NDT-Tango stands to achieve more gains than PA practice alone through combining PA with MBM and social engagement. Our findings may lead to a safe non-pharmacologic intervention that improves CIN-related deficits.Trial registrationThis trial was first posted on 11/09/21 at ClinicalTrials.gov under the identifier NCT05114005.

Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of microfilaraemic loiasis in adult patients in Gabon: A randomized controlled assessor blinded clinical trial.

There is a lack of systematic evidence for strategies to control loiasis transmission in highly endemic regions. Here we assessed albendazole and ivermectin based treatment regimens to reduce Loa loa microfilaraemia in Gabon. Eligible adult patients with L. loa microfilaraemia between 5,000 and 50,000 microfilariae/ml were randomized to either a control or one of three intervention groups (1:2:2:2 allocation ratio) consisting of three-week twice daily 400mg oral albendazole followed by 1) no treatment, 2) two further weeks of twice daily 400mg albendazole, or 3) a single dose of ivermectin in this open label randomized assessor blinded controlled clinical trial. The primary outcome was the proportion of participants with L. loa microfilaraemia ≤ 100 mf/ml at Day 168. In the efficacy-population of 42 patients 0 (0%; control group), 1 (9%; 3-week albendazole), 5 (39%; 5-weeks albendazole) and 2 (22%; 3-week albendazole plus single dose ivermectin) participants met the primary outcome of microfilaraemia below 100/ml at day 168. A 80-90% reduction of microfilaraemia was observed in the active treatment groups. The 5-week regimen of albendazole or a 3-week regimen of albendazole followed by ivermectin were most efficacious to reduce microfilaraemia. All therapeutic regimens were well tolerated and safe. Trial registered at the Pan-African Clinical Trials Registry: PACTR201807197019027.

Effectiveness of cognitive behavioral group therapy, psychodrama, and their integration for treatment of social anxiety disorder: A randomized controlled trial

Background and objectivesAlthough cognitive behavioral group therapy (CBGT) is an effective treatment for social anxiety disorder, many socially anxious patients are still symptomatic after treatment. A possible improvement for CBGT could come from the more experiential group psychotherapy, psychodrama (PD). The integration of CBGT and PD (labeled CBPT) might offer an even more effective treatment than CBGT or PD alone. With the present study, we investigated first whether three kinds of group therapy (CBGT, PD, and CBPT) are superior to a waitlist (WL). Second, we investigated whether CBPT is more effective than CBGT or PD alone. MethodsOne hundred and forty-four social anxiety patients were randomly assigned to three active conditions or a WL. After wait, WL-participants were randomized over the active treatment conditions. ResultsThe results of a multilevel analysis showed that all treatments were superior to WL in reducing social anxiety complaints. Only CBGT and CBPT differed significantly from WL in reducing fear of negative evaluations. There were no significant differences between active conditions in any of the variables after treatment and after six-month follow up, neither were there significant differences in treatment dropout. LimitationsFirst there is the lack of a long-term follow-up. Second, because of loss of participants, we did not reach the planned numbers in the active treatment groups in comparison to WL. Moreover, this study was not designed as a non-inferiority or equivalence trial. ConclusionsAlthough the integrative CBPT showed good results, it was not more effective than the other treatments.

The effect of exercise and physical activity-interventions on step count and intensity level in individuals with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials.

Reduced physical activity is a worldwide challenge in individuals with multiple sclerosis (MS). The aim of this systematic review and meta-analysis was to identify devise-measured effects of physical activity, exercise and physiotherapy-interventions on step count and intensity level of physical activity in individuals with MS. A systematic search of the databases of PubMed (including Medline), Scopus, CINHAL and Web of Science was carried out to retrieve studies published in the English language from the inception to the first of May 2023. All trials concerning the effectiveness of different types of exercise on step count and intensity level in people with MS were included. The quality of the included studies and their risk of bias were critically appraised using The modified consolidated standards of reporting trials and the Cochrane Risk of Bias tool, respectively. The pooled standardized mean difference (SMD) and 95% CI of the step-count outcome and moderate to vigorous intensity level before versus after treatment were estimated in both Intervention and Control groups using the random effect model. The Harbord test were used to account for heterogeneity between studies and assess publication bias, respectively. Further sensitivity analysis helped with the verification of the reliability and stability of our review results. A total of 8 randomized clinical trials (involving 919 individuals with MS) were included. The participants (including 715 (77.8%) female and 204 (22.2%) male) had been randomly assigned to the Intervention (n = 493) or Control group (n = 426). The pooled mean (95% CI) age and BMI of participants were 49.4 years (95% CI: 47.4, 51.4 years) and 27.7 kg/m2 (95% CI: 26.4, 29 kg/m2), respectively. In terms of the comparison within the Intervention and the Control groups before and after the intervention, the results of the meta-analysis indicate that the pooled standardized mean difference (SMD) for step-count in the Intervention group was 0.56 (95% CI: -0.42, 1.54), while in the Control group it was 0.12 (95% CI: -0.05, 0.28). Furthermore, there was no significant difference in the pooled SMD of step-count in the physical activity Intervention group compared to the Controls after the intervention (pooled standard mean difference = 0.19, 95% CI: -0.36,0.74). Subgroup analysis on moderate to vigorous intensity level of physical activity revealed no significant effect of the physical activity intervention in the Intervention group compared to the Control group after the intervention, or within groups before and after the intervention. Results of meta regression showed that age, BMI, duration of disease and Expanded Disability Status Scale (EDSS) score were not the potential sources of heterogeneity (all p > 0.05). Data on the potential harms of the interventions were limited. The results of this meta-analysis showed no significant differences in step count and moderate to vigorous physical activity level among individuals with MS, both within and between groups receiving physical activity interventions. More studies that objectively measure physical activity are needed. https://www.crd.york.ac.uk/prospero/, identifier: CRD42022343621.

Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial

Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a setting without an established systemic standard-of-care treatment). In this multicentre phase 2 trial, patients (any stage, Eastern Cooperative Oncology Group performance status 0-1) at 20 academic medical centres in Germany and the Netherlands with completely resected MCC lesions were randomly assigned 2:1 to receive nivolumab 480 mg every 4 weeks for 1 year, or observation, stratified by stage (American Joint Committee on Cancer stages 1-2 vs stages 3-4), age (<65 vs ≥65 years), and sex. Landmark disease-free survival (DFS) at 12 and 24 months was the primary endpoint, assessed in the intention-to-treat populations. Overall survival and safety were secondary endpoints. This planned interim analysis was triggered when the last-patient-in was followed up for more than 1 year. This study is registered with ClinicalTrials.gov (NCT02196961) and with the EU Clinical Trials Register (2013-000043-78). Between Oct 1, 2014, and Aug 31, 2020, 179 patients were enrolled (116 [65%] stage 3-4, 122 [68%] ≥65 years, 111 [62%] male). Stratification factors (stage, age, sex) were balanced across the nivolumab (n=118) and internal control group (observation, n=61); adjuvant radiotherapy was more common in the control group. At a median follow-up of 24·3 months (IQR 19·2-33·4), median DFS was not reached (between-groups hazard ratio 0·58, 95% CI 0·30-1·12); DFS rates in the nivolumab group were 85% at 12 months and 84% at 24 months, and in the observation group were 77% at 12 months and 73% at 24 months. Overall survival results were not yet mature. Grade 3-4 adverse events occurred in 48 [42%] of 115 patients who received at least one dose of nivolumab and seven [11%] of 61 patients in the observation group. No treatment-related deaths were reported. Adjuvant therapy with nivolumab resulted in an absolute risk reduction of 9% (1-year DFS) and 10% (2-year DFS). The present interim analysis of ADMEC-O might suggest clinical use of nivolumab in this area of unmet medical need. However, overall survival events rates, with ten events in the active treatment group and six events in the half-the-size observation group, are not mature enough to draw conclusions. The explorative data of our trial support the continuation of ongoing, randomised trials in this area. ADMEC-O suggests that adjuvant immunotherapy is clinically feasible in this area of unmet medical need. Bristol Myers Squibb.

Breastfeeding initiation and duration among people with mild chronic hypertension: a secondary analysis of the Chronic Hypertension and Pregnancy trial

Increased duration of breastfeeding improves maternal cardiovascular health and may be especially beneficial in high-risk populations, such as those with chronic hypertension. Others have shown that individuals with hypertension are less likely to breastfeed, and there has been limited research aimed at supporting breastfeeding goals in this population. The impact of perinatal blood pressure control on breastfeeding outcomes among people with chronic hypertension is unknown. This study aimed to evaluate whether breastfeeding initiation and short-term duration assessed at the postpartum clinic visit differed according to perinatal blood pressure treatment strategy (targeting blood pressure <140/90 mm Hg vs reserving antihypertensive treatment for blood pressure ≥160/105 mm Hg). We performed a secondary analysis of the Chronic Hypertension and Pregnancy trial. This was an open-label, multicenter, randomized trial where pregnant participants with mild chronic hypertension were randomized to receive antihypertensive medications with goal blood pressure <140/90 mm Hg (active treatment) or deferredtreatment until blood pressure ≥160/105 mm Hg (control). The primary outcome was initiation and duration of breastfeeding, assessed at the postpartum clinic visit. We performed bivariate analyses and log-binomial and cumulative logit regression models, adjusting models for variables that were unbalanced in bivariate analyses. We performed additional analyses to explore the relationship between breastfeeding duration and blood pressure measurements at the postpartum visit. Of the 2408 participants from the Chronic Hypertension and Pregnancy trial, 1444 (60%) attended the postpartum study visit and provided breastfeeding information. Participants in the active treatment group had different body mass index class distribution and earlier gestational age at enrollment, and (by design) were more often discharged on antihypertensives. Breastfeeding outcomes did not differ significantly by treatment group. In the active and control treatment groups, 563 (77.5%) and 561 (78.1%) initiated breastfeeding, and mean durations of breastfeeding were 6.5±2.3and 6.3±2.1weeks, respectively. The probability of ever breastfeeding (adjusted relative risk, 0.99; 95% confidence interval, 0.93-1.05), current breastfeeding at postpartum visit (adjusted relative risk, 1.01; 95% confidence interval, 0.94-1.10), and weeks of breastfeeding (adjusted odds ratio, 0.87; 95% confidence interval, 0.68-1.12) did not differ by treatment group. Increased duration (≥2 vs <2 weeks) of breastfeeding was associated with slightly lower blood pressure measurements at the postpartum visit, but these differences were not significant in adjusted models. In a secondary analysis of the cohort of Chronic Hypertension and Pregnancy trial participants who attended the postpartum study visit and provided breastfeeding information (60% of original trial participants), breastfeeding outcomes did not differ significantly by treatment group. This suggests that maintaining goal blood pressure <140/90 mm Hg throughout the perinatal period is associated with neither harm nor benefit for short-term breastfeeding goals. Further study is needed to understand long-term breastfeeding outcomes among individuals with chronic hypertension and how to support this population in achieving their breastfeeding goals.

Clinical outcomes of different patent ductus arteriosus treatment in preterm infants born between 28 and 32 weeks in Taiwan.

The patent ductus arteriosus (PDA) treatment in very preterm infants is controversial. This study focused on preterm infants born at 28-32 weeks of gestation and analyzed the association between various PDA treatments and clinical outcomes. We conducted a retrospective cohort study of infants born at 28-32 weeks of gestation between 2016 and 2019at 22 hospitals in the Taiwan Premature Infant Follow-up Network. We categorized the infants into four groups according to treatment strategies: medication, primary surgery, medication plus surgery, or conservative treatment. A total of 1244 infants presented with PDA, and 761 (61.1%) were treated. Medication was the predominant treatment (50.0%), followed by conservative treatment (38.9%), medication plus surgery (7.6%), and primary surgery (3.5%). The risk of mortality was not reduced in the active treatment group compared to the conservative treatment group. There was a higher prevalence of severe intraventricular hemorrhage, necrotizing enterocolitis (NEC), and any degree of bronchopulmonary dysplasia (BPD) in both the primary surgery and medication plus surgery groups than in the conservative treatment group. After adjustment, both the primary surgery and medication plus surgery groups still had higher odds ratios for the occurrence of NEC and any degree of BPD. Compared with active PDA treatment, conservative treatment for PDA did not increase the risk of mortality and morbidity in very preterm infants born at 28-32 weeks of gestation. The risks and benefits of surgery (PDA ligation) in these infants must be considered cautiously.

Sexual satisfaction in prostate cancer: a multi-group comparison study of treated patients, patients under active surveillance, patients with negative biopsy, and controls.

Erectile function changes after prostate cancer (PCa) treatment are well documented, but less understood is the relative impact of prostate biopsy and active surveillance on sexual well-being. It is unknown whether potential negative impacts are exclusive to patients who have been treated for PCa, or whether the diagnosis itself or the experience of biopsy may also impact sexual well-being. Sexual satisfaction is an important yet understudied indicator of sexual well-being in this population. This study examines sexual satisfaction and its predictors across several comparison groups to explore relative impact. At baseline and 12months, questionnaire data was collected in four samples: (1) following PCa treatment, (2) active surveillance, (3) negative prostate biopsy result, and (4) controls receiving no biopsy or treatment. Predictors assessed included group, erectile function, communication style, and partner involvement. Sexual satisfaction declined in the active treatment group, no changes were observed in active surveillance or non-PCa control, and improvements were observed in the biopsy group. Predictors of sexual satisfaction over and above erectile function included restrictive communication (i.e. protective buffering) and perceived partner involvement. For higher levels of erectile function, a higher perceived degree of partner involvement was protective of sexual satisfaction. Sexual satisfaction is an important indicator of sexual well-being and is negatively impacted following PCa treatment, but not active surveillance or prostate biopsy. Communication and partner involvement are potentially modifiable factors to be considered for intervention and may promote sexual satisfaction following PCa treatment. Patients experiencing negative biopsy, who note lower sexual satisfaction may experience improved satisfaction with time, and those under active surveillance who worry about sexual satisfaction may find reassurance from these results.

Retatrutide as a Novel Treatment for Obesity and Type 2 Diabetes

Retatrutide is a triple hormone agonist of the receptors of glucagon-like peptide 1, glucose-dependent insulinotropic polypeptide (GIP) and glucagon that can be administered subcutaneously once a week. Different doses and escalation schedules of retatrutide were evaluated in 2 phase 2 American trials of subjects with obesity (n=338) and type 2 diabetes (n=281). In the obesity trial of 48 week-duration, percentage change in body weight from baseline after 24 weeks and 48 weeks were the primary and secondary outcomes respectively. At 24 weeks, the mean percentage decrease in weight ranged from 7.2% to 17.5% across retatrutide groups versus 1.6% with placebo. At 48 weeks, the decrease was 8.7% to 24.2% versus 2.1% with placebo. In the diabetes trial, the primary endpoint was a change in glycated hemoglobin (HbA1c) values from baseline to week 24. This trial included an active treatment group receiving dulaglutide 1.5mg once weekly. Secondary endpoints included change in HbA1c and body weight at 36 weeks. At 24 weeks, mean HbA1c reductions were 0.43% to 2.02% with retatrutide, 1.4% with dulaglutide and 0.01% with placebo. At 36 weeks, mean percentage weight reductions were 3.2% to 16.9% with retatrutide, 2.0% with dulaglutide and 3.0% with placebo. While the decrease in HbA1c levels reached a plateau at 24 weeks, weight loss in the 2 studies was progressive without evidence of attenuation effect up to the end of follow-up at 36-48 weeks. The most common adverse effects of retatrutide were gastrointestinal (GI) such as nausea, diarrhea, vomiting and constipation reported by 13-50% in the retatrutide groups compared with 35% in the dulaglutide group, and 13% in the placebo group. Discontinuation rates due to adverse effects were also higher with retatrutide being 16-17% compared with 2% with dulaglutide and 0-4% with placebo. In summary, retatrutide is highly effective drug in causing substantial weight loss and HbA1c reduction. Yet, tolerance to this drug seems sub-optimal. Phase 3 trials are urgently needed to clarify efficacy and safety of retatrutide.

The efficacy of tobacco cessation treatment for African American adults: a systematic review.

Despite proliferation of evidence-based tobacco cessation treatments, African American adults still suffer higher rates of tobacco-related diseases than White adults. Although tobacco cessation treatment is efficacious, there is a need to reassess the efficacy of tobacco cessation treatment for African American adults. Previous reviews of tobacco cessation treatment studies conducted through 2007 among African American adults highlight the limited research in this area and inconsistent findings on treatment characteristics impacting efficacy. This systematic review examined the efficacy of combined behavioral and pharmacological tobacco cessation treatment for African American adults. Database searches were used to identify studies examining tobacco cessation treatment for predominantly African American samples (>50%). Eligible studies were completed between 2007 and 2021 and (i) involved randomization comparing active combined treatment to a control comparison group and (ii) reported abstinence outcomes at 6 and/or 12 months. Ten studies met inclusion criteria. Active treatment groups typically consisted of a combination of nicotine replacement therapy and behavioral counseling. Abstinence rates for African American adults ranged from 10.0% to 34% in active treatment groups compared to 0.0%-40% in comparison control groups. Our results support the efficacy of combined treatment for tobacco cessation among African American adults. However, cessation rates for African American adults found in this review are lower than those in the general adult population (15%-88%). Additionally, our findings highlight the limited number of studies examining African American tobacco cessation rates and testing of tailored treatment for this population.

Comparison of edoxaban and enoxaparin in a rat model of AlCl3-induced thrombosis of the superior sagittal sinus

Cerebral sinus venous thrombosis (CSVT) is an uncommon disease that is usually treated with anticoagulation (heparin, low-molecular heparin, or vitamin K-antagonists). We compared treatment with edoxaban, an oral factor Xa-antagonist, that has not been approved in patients with CSVT, with enoxaparin, a well-established therapy, in a rat model of CSVT. Fifty male Wistar rats were randomized into 5 groups (10 animals each) and subjected to aluminum chloride (AlCl3)-induced thrombosis of the superior sagittal sinus (SSS) or sham procedure. Animals with thrombosis of the SSS were treated with edoxaban, enoxaparin, or placebo. Diagnostic workup included neurological examination, MRI imaging, MR-flow measurements of the SSS, and immunohistochemical staining. Neurological examination revealed no differences between treatment groups. Seven days after initial thrombosis, flow in the SSS was lower in the active treatment group as compared to sham-operated animals (p < 0.05). Flow in the SSS in the active treatment groups (edoxaban 1 h prior to thrombosis: 0.16 cm/s ± 0.06 cm/s; edoxaban 6 h after thrombosis: 0.13 cm/s ± 0.05 cm/s; enoxaparin: 0.13 cm/s ± 0.04 cm/s; placebo: 0.07 cm/s ± 0.02 cm/s) was higher as compared to placebo (p < 0.05), but there were no differences between the active treatment groups (p > 0.05). Immunohistochemical staining showed no differences in the actively treated animals. Edoxaban proved to be similar to enoxaparin in a model of experimental AlCl3-induced CSVT.

Patient-reported symptom monitoring linked to an alert algorithm: Effects on progression-free and overall survival in the SYMPRO-Lung trial.

12099 Background: Physician-initiated (active) monitoring of patient-reported outcomes (PROs) improves health-related quality of life (HRQOL) and overall survival (OS) in comparison to care as usual. We recently reported data from the SYMPRO-Lung trial showing for the first time that patient-initiated (reactive) PRO monitoring is equally effective as physician-initiated (active) monitoring in improving HRQOL. Here we investigate whether online PRO symptom monitoring via the active and reactive approach is also associated with improvements in 1-year progression-free survival (PFS) and OS compared to care as usual in lung cancer patients. Methods: SYMPRO-Lung is a Dutch multicenter randomized trial using a stepped wedge design. Inclusion criteria were (non-)small cell lung cancer stage I-IV, starting treatment. Patients in the intervention groups reported PRO symptoms weekly up to 1 year follow-up using the PRO-CTCAE lung cancer subset. If symptoms exceeded a pre-determined threshold, an alert was sent to a physician/nurse (active intervention group) or to the patient themselves (reactive intervention group). Survival was defined as time from start of treatment until progression (PFS), death (OS) or loss to follow-up. Follow-up time of all groups was calculated using the reverse Kaplan-Meier method. Cox proportional hazard analyses were performed to estimate the effect of PRO symptom monitoring on PFS and OS, adjusting for potential confounding (i.e. clinical characteristics and baseline EORTC QLQ-C30 domain scores). Results: 515 patients were included in the study (266 control, 249 intervention). The most pronounced uneven distribution in baseline characteristics was that the active intervention group had significantly more stage IV patients compared to the control group and the reactive intervention group (63% vs. 44% vs. 44%, p = 0.001). The median follow-up duration was 12 months for all groups. Age, sex, cancer staging, ECOG performance status and some baseline EORTC domain scores affected the association and were included as covariates in the analyses. Although not significant, we observed a tendency towards a PFS benefit for the active intervention group compared to care as usual (HR .78, 95%CI: .58 – 1.04) and an OS benefit for both of the intervention groups compared to care as usual (active: HR .80, 95% CI: .55 – 1.15; reactive: HR .69, 95% CI: .42 – 1.15). Conclusions: Although not significant, weekly PRO symptom monitoring linked to an alert algorithm showed a tendency towards a small 1-year survival benefit in lung cancer patients. Since we did not power the trial to demonstrate a survival benefit, the non-significant association might be due to a limited sample size. However, the positive results of symptom monitoring in improving HRQOL within our trial still provide sufficient evidence for implementation of PROMs in standard (lung) cancer care. Clinical trial information: NL7897 .

(129) Interim Analysis of a Sham-Controlled Randomized, Prospective Study Using Low Intensity Shockwave Therapy (LiSWT) for Improvement of Erectile Function

Abstract Introduction The Urogold 100 MTS™ electrohydraulic shockwave device is FDA cleared for improved blood flow and connective tissue activation; retrospective studies in ED patients have shown positive outcome. Objective To perform an interim analysis of sham and active treatment changes in primary outcome measures of grayscale ultrasound and DUS. Methods A single-blind, sham-controlled, randomized, prospective study in men with ED naïve to acoustic wave therapy was performed. Those meeting inclusion/exclusion were randomized to one of two treatment arms and assigned to active or sham, 2:1 within each arm. Arm 1 consisted of three treatments of 5000 shocks every three weeks, 4 Hz, 0.12 mJ/mm2; arm 2 consisted of 5000, 3000 and 3000 shocks, 4 Hz, 0.12 mJ/mm2; weeks one, two and three respectively, three weeks without treatment, then repeat treatments every three weeks. First follow-up was 20 weeks after initial treatment; DUS and grayscale imaging using a 15.4 MHz probe were repeated under pharmacologic erection 3-4/4 hardness. Post-treatment grayscale percent hypoechoic regions within the corpora cavernosa were assessed: none (0), mild (1), moderate (2) and severe (3) and compared to baseline. Post-treatment EDV and PSV were compared to baseline. Upon completion subjects were unblinded. Subjects assigned to sham were crossed over to the opposite arm for active treatment. Subjects initially in active treatment underwent a second follow-up 32 weeks after initial treatment. Data from each treatment arm were analyzed by two-way repeated measures ANOVA with Geisser-Greenhouse correction. Follow-up pairwise comparisons to baseline were performed using Dunnett’s multiple comparison test. In subjects with one on-treatment assessment, missing data due to early discontinuation from the study were imputed by the “last observation carried forward” method. Results Powered for 60 subjects, recruitment was stopped due to COVID after randomizing 36 subjects (22 active, 14 sham). The proximal penis exhibited greatest improvement (decreased heterogeneity score) on grayscale. The number of subjects with improved erectile tissue grayscale ratings in the proximal region was consistently higher in active treatment versus sham groups (Arm 1 = 88.9% vs. 11.1%; Arm 2 = 40.0% vs. 20.0%, respectively). Sham subjects rolled over to active LiSWT also had improved grayscale ratings (Arm 1 = 33.3% vs. 11.1%; Arm 2 = 40.0% vs. 20.0%). Change in heterogeneity was statistically significant for the proximal region in active treatment Arm 1 at both Week 20 (p=0.005) and Week 32 (p=0.001). (Fig 1) Mean IIEF-EF scores were nominally higher in subjects in active treatment with improved grayscale ratings versus those with no improvement on grayscale. Concerning penile blood flow, improvement after LiSWT greater numbers of patients had higher PSV or lower EDV relative to baseline; greater numbers of patients had no worsening in blood flow parameters. Decrease in EDV reached statistical significance in active treatment Arm 2 at Week 32 (p=0.003). Adverse events were transient. Conclusions Flaccid penile LiSWT appears to be safe and efficacious for treating ED based on statistically significant changes between sham and active treatments in primary outcome measures grayscale ultrasound and DUS. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: TRT, Cynosure.

Evaluating brain modularity benefits of an acting intervention: a discriminant-analysis framework.

Aging is associated with a reduction in brain modularity as well as aspects of executive function, namely, updating, shifting, and inhibition. Previous research has suggested that the aging brain exhibits plasticity. Further, it has been hypothesized that broad-based intervention models may be more effective in eliciting overall gains in executive function than interventions targeted at specific executive skills (e.g., computer-based training). To this end, we designed a 4-week theater-based acting intervention in older adults within an RCT framework. We hypothesized that older adults would show improvements in brain modularity and aspects of executive function, ascribed to the acting intervention. The participants were 179 adults from the community, aged 60-89 years and on average, college educated. They completed a battery of executive function tasks and resting state functional MRI scans to measure brain network modularity pre- and post-intervention. Participants in the active intervention group (n = 93) enacted scenes with a partner that involved executive function, whereas the active control group (n = 86) learned about the history and styles of acting. Both groups met two times/week for 75-min for 4 weeks. A mixed model was used to evaluate intervention effects related to brain modularity. Discriminant-analysis was used to determine the role of seven executive functioning tasks in discriminating the two groups. These tasks indexed subdomains of updating, switching, and inhibition. Discriminant tasks were subject to a logistic regression analysis to determine how post-intervention executive function performance interacted with changes in modularity to predict group membership. We noted an increase in brain modularity in the acting group, relative to pre-intervention and controls. Performance on updating tasks were representative of the intervention group. However, post-intervention performance on updating did not interact with the observed increase in brain modularity to distinguish groups. An acting intervention can facilitate improvements in modularity and updating, both of which are sensitive to aging and may confer benefits to daily functioning and the ability to learn.

Examining the possibilities for volitional character change in compassion and intellectual humility through a three-month online intervention

While recent research indicates that people can intentionally change specific personality traits associated with self-improvement, it is unclear whether such volitional personality change interventions can work for improving other-oriented character traits such as compassion or intellectual humility. We conducted a three-month pre-registered online intervention focused on these traits with a representative sample of U.S. established adults (NT1 = 500, 4,731 total observations) in two active intervention groups for mutual comparisons. Results of self-reported weekly (state) and global (trait) assessments showed that people who chose intellectual humility showed significant increases in both state and trait intellectual humility, while people who chose compassion showed significant increases in state compassion, but no increases in trait compassion. Enjoyment of weekly tasks significantly predicted change in both state intellectual humility and compassion. Techniques typically used in volitional personality change interventions were found to be somewhat effective in promoting change, although the observed effects were more robust for intellectual humility. This study provides novel insights into the challenges of promoting volitional change in character traits.

Active monitoring versus an abduction device for treatment of infants with centered dysplastic hips: study protocol for a randomized controlled trial (TReatment with Active Monitoring (TRAM)-Trial)

BackgroundDevelopmental Dysplasia of the Hip (DDH) is one of the most common pediatric orthopedic disorders, affecting 1–3% of all newborns. The optimal treatment of centered DDH is currently under debate. This randomized controlled trial aims to study the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH.MethodsThis is a multicenter, parallel-group, open-label, non-inferiority randomized controlled trial studying the (cost-)effectiveness of active monitoring versus abduction treatment for infants with centered DDH in fourteen hospitals in the Netherlands. In total, 800 infants with centered DDH (Graf IIa-/IIb/IIc), aged 10–16 weeks, will be randomly allocated to the active monitoring or abduction treatment group. Infants will be followed up until the age of 24 months. The primary outcome is the rate of normal hips, defined as an acetabular index lower than 25 degrees on an antero-posterior radiograph, at the age of 12 months. Secondary outcomes are the rate of normal hips at the age of 24 months, complications, time to hip normalization, the relation between baseline patient characteristics and the rate of normal hips, compliance, costs, cost-effectiveness, budget impact, health-related quality of life (HRQoL) of the infant, HRQoL of the parents/caregivers, and parent/caregiver satisfaction with the treatment protocol.DiscussionThe outcomes of this randomized controlled trial will contribute to improving current care-as-usual for infants with centered DDH.Trial registrationDutch Trial Register, NL9714, registered September 6, 2021. https://clinicaltrialregister.nl/en/trial/29596

Remotely Supervised tDCS for Persistent Post-Traumatic Headache in Veterans (ReStore) (P7-1.004)

<h3>Objective:</h3> Evaluate the feasibility and preliminary efficacy of a remotely supervised transcranial Direct Current Stimulation (RS-tDCS) intervention for persistent post-traumatic headache (PPTH) secondary to mild TBI (mTBI). <h3>Background:</h3> NA <h3>Design/Methods:</h3> Veterans with PPTH completed a 28-day baseline observation of headache days and received either active or sham RS-tDCS paired with mindfulness meditation. This 4-week intervention of 20-minutes daily (M-F) at home RS-tDCS was monitored via VA Video Connect. Feasibility was determined by the number of participants completing at least 80% of the intervention. Preliminary efficacy was measured by changes in number of moderate/severe headache days from baseline period to the end of treatment phase, and to at a 4-week post-treatment follow-up. Secondary endpoints included total number of headache days, acute pain medication use, as well as headache- and mTBI-related disability. <h3>Results:</h3> Twenty-six veterans (46.6±8.7 years) with PPTH completed baseline observations and were randomized to either active (n=13) or sham (n=13) treatment groups. A total of 22/26 (85%) participants fully completed either active (10/13) or sham (12/13) interventions (p=.0.59). Within-group analyses reveled significant reductions in moderate/severe headache days in the active (p=0.04) but not sham (p=0.54) groups. This resulted in a trend towards significant reductions in moderate/severe headache days in the active vs. sham groups (p = 0.07). Active participants also demonstrated a reduction in total number of headache days during treatment (p=0.04) where the sham group did not (p=0.70). This translated into a statistically significant reduction in total number of headache days during treatment for active vs. sham participants (p=0.03). No significant differences were maintained at the 4-week post-treatment follow-up (p’s&gt;0.05). <h3>Conclusions:</h3> RS-tDCS is feasible and effective for veterans with PPTH. Findings suggest that active RS-tDCS may reduce headache frequency and improve clinical outcomes. A larger phase II study is warranted to confirm these findings and inform evaluation for clinical use. <b>Disclosure:</b> Dr. Charvet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson &amp; Johnson. Dr. Charvet has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Springer Healthcare. Dr. Charvet has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for YBrain. Dr. Charvet has stock in Johnson&amp;Johnson. Miss Mangold has nothing to disclose. Taylor Marie Wynne has nothing to disclose. Dr. Moore has nothing to disclose. Dr. Guo has nothing to disclose. Dr. Zhang has nothing to disclose. Abhishek Datta has nothing to disclose. The institution of Dr. Androulakis has received research support from VA rehabilitation research .