Changes In Symptoms Research Articles

Pentoxifylline as a Novel Add-on Therapy for Major Depressive Disorder in Adult Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.

Evidence indicates an association between immune dysregulation and major depressive disorder (MDD). Pentoxifylline (PTX), a phosphodiesterase inhibitor, has been shown to reduce pro-inflammatory activities. The aim of this study was to evaluate changes in depressive symptoms and pro-inflammatory markers after administration of PTX as an adjunctive agent to citalopram in patients with MDD. One hundred patients were randomly assigned to either citalopram (20 mg/day) plus placebo (twice daily) (n=50) or citalopram (20 mg/day) plus PTX (400 mg) (twice daily) (n=50). The Hamilton Depression Rating Scale-17 (HAM-D-17) scores at baseline, weeks 2, 4, 6, 8, 10, and 12 and serum levels of interleukin1-β (IL-1-β), tumor necrosis factor-α, C-reactive protein, IL-6, serotonin, IL-10, and brain-derived neurotrophic factor (BDNF) at baseline and week 12 were evaluated. HAM-D-17 score in the PTX group significantly reduced in comparison to the control group after weeks 4, 6, 8,10, and 12 ((LSMD): - 2.193, p=0.021; - 2.597, p=0.036; - 2.916, p=0.019; - 4.336, p=0.005; and - 4.087, p=0.008, respectively). Patients who received PTX had a better response (83%) and remission rate (79%) compared to the placebo group (49% and 40%, p=0.006 and p=0.01, respectively). Moreover, the reduction in serum concentrations of pro-inflammatory factors and increase in serotonin and BDNF in the PTX group was significantly greater than in the placebo group (p<0.001). These findings support the safety and efficacy of PTX as an adjunctive antidepressant agent with anti-inflammatory effects in patients with MDD.

Australian trial of behavioural activation for people with schizophrenia experiencing negative symptoms: a feasibility randomised controlled trial protocol

IntroductionNegative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive–behavioural therapy...

Update on the Role of the Microbiome in Chronic Rhinosinusitis

Abstract Purpose of Review Chronic rhinosinusitis (CRS) is a common yet complex and heterogeneous inflammatory condition of the paranasal sinuses that is likely caused by a combination of infectious and inflammatory factors. The role of the microbiome in the pathogenesis of CRS remains poorly defined. The purpose of this review is to examine the role of the microbiome in CRS and evaluate current and emerging therapies that may alter the sinonasal microbiome. Recent Findings There are complex interactions among the various microorganisms that make up the sinonasal microbiome with a growing body of evidence that increased microbial biodiversity may be protective against the development of CRS and patients with improved biodiversity may have better treatment outcomes. Topical and systemic antimicrobials, intranasal corticosteroids, and surgery have demonstrated transient changes to the microbiome without significant change in symptoms. The use of probiotics and bacteriophages remain areas of active investigation regarding alterations to the sinonasal microbiome. Summary CRS seems to be associated with decreased sinonasal microbial diversity, but whether this is the cause of CRS or a downstream effect remains unclear. Additional evaluation into the role of the microbiome on CRS and the impact of therapies that may yet alter the microbiome are necessary.

Remote Between Visit Monitoring in Inflammatory Bowel Disease Care: A Qualitative Study of CAPTURE-IBD Participants and Care Team Members

Abstract Introduction We recently showed that CAPTURE-IBD—a care coordination intervention comprised of routine remote monitoring of patient reported outcomes and a care coordinator-triggered care pathway—was more effective at reducing symptom burden for patients with inflammatory bowel disease (IBD) compared to usual care. We aimed to understand how patients and care team providers experienced the intervention and evaluate purported mechanisms of action to plan for future implementation. Methods In this study, 205 patients were randomized to CAPTURE-IBD(n=100) or usual care(n=105). We conducted semi-structured interviews with 16 of the 100 participants in the CAPTURE-IBD arm and five care team providers to achieve thematic saturation. We used qualitative rapid analysis to generate a broad understanding of experiences, perceived impact, the coordinator role, and suggested improvements. Results Findings highlight that the intervention was acceptable and user-friendly, despite concerns regarding increased nursing workload. Both participants and care team providers perceived the intervention as valuable in supporting symptom monitoring, psychosocial care, and between visit action plans to improve IBD care and health outcomes. However, few participants leveraged the care coordinator as intended. Finally, participants reported that the intervention could be better tailored to capture day-to-day symptom changes and to meet the needs of patients with specific comorbid conditions (e.g., ostomies). Conclusion Remote PRO monitoring is acceptable and may be valuable in improving care management, promoting tight control, and supporting whole health in IBD. Future efforts should focus on testing and implementing refined versions of CAPTURE-IBD tailored to different clinical settings.

Detecting the symptoms of Parkinson’s disease with non-standard video

BackgroundNeurodegenerative diseases, such as Parkinson’s disease (PD), necessitate frequent clinical visits and monitoring to identify changes in motor symptoms and provide appropriate care. By applying machine learning techniques to video data, automated video analysis has emerged as a promising approach to track and analyze motor symptoms, which could facilitate more timely intervention. However, existing solutions often rely on specialized equipment and recording procedures, which limits their usability in unstructured settings like the home. In this study, we developed a method to detect PD symptoms from unstructured videos of clinical assessments, without the need for specialized equipment or recording procedures.MethodsTwenty-eight individuals with Parkinson’s disease completed a video-recorded motor examination that included the finger-to-nose and hand pronation-supination tasks. Clinical staff provided ground truth scores for the level of Parkinsonian symptoms present. For each video, we used a pre-existing model called PIXIE to measure the location of several joints on the person’s body and quantify how they were moving. Features derived from the joint angles and trajectories, designed to be robust to recording angle, were then used to train two types of machine-learning classifiers (random forests and support vector machines) to detect the presence of PD symptoms.ResultsThe support vector machine trained on the finger-to-nose task had an F1 score of 0.93 while the random forest trained on the same task yielded an F1 score of 0.85. The support vector machine and random forest trained on the hand pronation-supination task had F1 scores of 0.20 and 0.33, respectively.ConclusionThese results demonstrate the feasibility of developing video analysis tools to track motor symptoms across variable perspectives. These tools do not work equally well for all tasks, however. This technology has the potential to overcome barriers to access for many individuals with degenerative neurological diseases like PD, providing them with a more convenient and timely method to monitor symptom progression, without requiring a structured video recording procedure. Ultimately, more frequent and objective home assessments of motor function could enable more precise telehealth optimization of interventions to improve clinical outcomes inside and outside of the clinic.

Acupuncture therapy on myofascial pain syndrome: a systematic review and meta-analysis

PurposeTraditional Chinese medicine (TCM) therapies, especially acupuncture, have received increasing attention in the field of pain management. This meta-analysis evaluated the effectiveness of acupuncture in the treatment of myofascial pain syndrome.MethodsA comprehensive search was conducted across a number of databases, including PubMed, Cochrane Library, WOS, CNKI, WANFANG, Sinomed, and VIP. Furthermore, articles of studies published from the inception of these databases until November 22, 2023, were examined. This systematic review and meta-analysis encompassed all randomized controlled trials (RCTs) on acupuncture for myofascial pain syndromes, without language or date restrictions. Based on the mean difference (MD) of symptom change, we critically assessed the outcomes reported in these trials. The quality of evidence was assessed using the Cochrane Risk of Bias Tool. The study is registered with PROSPERO under registration number CRD42023484933.ResultsOur analysis included 10 RCTs in which 852 patients were divided into two groups: an acupuncture group (427) and a control group (425). The results of the study showed that acupuncture was significantly more effective than the control group in treating myofascial pain syndromes, which was reflected in a greater decrease in VAS scores (MD = −1.29, 95% [−1.65, −0.94], p &amp;lt; 0.00001). In addition, the improvement in PRI and PPI was more pronounced in the acupuncture group (PRI: MD = −2.04, 95% [−3.76, −0.32], p = 0.02) (PPI: MD = −1.03, 95% [−1.26, −0.79], p &amp;lt; 0.00001) compared to the control group. These results suggest that acupuncture is effective in reducing myofascial pain. It is necessary to further study the optimal acupoints and treatment time to achieve the best therapeutic effect.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023484933.

Abstract PO3-01-10: Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial

Abstract Background: The Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions Trial (POWER, NCT04272801) aims to determine whether 3 months of pre-operative endocrine therapy (pre-ET) affects decision-making regarding adjuvant radiation therapy (RT) among older women with early-stage, estrogen receptor (ER) positive breast cancer. The goal of the present study is to evaluate changes in patient-reported outcomes (PROs) during the course of pre-ET. We hypothesize that PROs will change over the course of pre-ET and that those changes can be used to identify patients who are at-risk for long-term noncompliance to adjuvant ET and who may benefit from RT. Methods: Participants in the POWER Trial receive 3 months of pre-ET prior to breast-conserving surgery and final treatment decisions regarding adjuvant RT. Health-related quality of life (HRQOL) (EORTC QLQ-C30 and QLQ-BR23), depression (Center for Epidemiologic Studies Depression Scale Revised), and general symptom burden (Breast Cancer Prevention Trial Symptom Checklist (BCPT-SCL)) are assessed at baseline and at day 90 after pre-ET. Perceived sensitivity to medicine (Perceived Sensitivity to Medicine (PSM) survey) is assessed at baseline. The BCPT-SCL was used to examine common ET side effects, including hot flashes, musculoskeletal symptoms, cognitive problems, weight gain, and bladder control. Graphical methods are used to display results. Results: The first 46 participants who completed pre-ET in the POWER trial were included in this preliminary assessment. From baseline to day 90, there was notable variability in HRQOL and no definitive shift towards worsening HRQOL with a median change (IQR) of 0 (-8.33, 8.33). Similarly, the median change in symptom profiles for the whole cohort was 0 over the 90 days of pre-ET. However, a subset of patients experienced changes in symptom burden throughout the 90-day period. Approximately one-fourth of participants reported an increase in hot flashes and musculoskeletal symptoms from baseline to day 90. There does not appear to be worsening fatigue, depression scores, cognitive problems, or weight gain. After stratifying by self-perceived sensitivity to medicine, patients with high PSM scores have a greater median change (0.5 and 0.33) in symptoms compared to those with low PSM scores (0 and 0) for hot flashes and musculoskeletal symptoms, respectively (Figure 1). Conclusions: When looking at this cohort, there was no change in symptoms or quality of life after the 3-month course of pre-ET. Evaluation of the changes in PROs identified a subset of participants with worsening symptoms after pre-ET. Future analyses, when trial accrual is complete, will examine the relationship between PROs and long-term adherence to adjuvant ET and will elucidate if the patients who experience worsening BCPT-SCL symptoms during the 90-day period are more likely to opt for RT. Figure 1 Change in symptoms after pre-ET Change in hot flash burden and musculoskeletal symptom burden is greater in patients with high perceived sensitivity to medicine. Citation Format: Trish Millard, Lena Turkheimer, Christiana Brenin, David Brenin, Patrick Dillon, Einsley Janowski, Anneke Schroen, Gina Petroni, Shayna Showalter. Changes in Patient-Reported Outcomes with 3 Months of Pre-operative Endocrine Therapy in the POWER Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-10.

Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial

IntroductionSymptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life...

Changes in depressive symptoms and antibody production following influenza vaccination in adolescents and adults

ObjectivePsychological distress has been associated with dampened antibody production following vaccination. Questions remain, however, about whether psychological distress influences vaccine response uniformly across the lifespan, and whether changes in distress result in changes in antibody production across the same period. MethodsParticipants (N = 148; Mage = 32.2 years, SD = 19.7, range = 12–80 years) took part in consecutive vaccine studies during the 2017–2018 and 2018–2019 influenza seasons. Each influenza season, they reported on their depressive symptoms, provided blood samples, and received the standard influenza vaccine. Participants then provided a second blood sample one month later. Antibody titers were examined pre- and post-vaccination. ResultsAnalyses examined both within-season and across-season effects of depressive symptoms, age, and their interaction on vaccine response. Within-season analyses revealed that age predicted antibody response during both seasons (2017–2018 and 2018–2019). Neither depressive symptoms nor the interaction with age were associated with antibody response to vaccination within either season. Across the two seasons, age significantly moderated the association between change in depressive symptoms and change in antibody production. For people who were 48 or older, increases in depressive symptoms across the two seasons were associated with a less robust response to the vaccine in the second season relative to the first season. For people younger than 48, changes in depressive symptoms were not significantly related to changes in antibody production. ConclusionsThese findings highlight the important role of mental health for older adults’ vaccine response, which could have clinical relevance for protection against disease.

Employ the 5H Model, Evaluate its Efficacy, And Illustrate the Change in Elderly Depression Levels and Symptoms

Introduction: Age-related disorders include mental health. This reduction in intergenerational cohesion and filial responsibilities has caused older people's dissatisfaction, sadness, and grief. Depression and dementia impair elderly people worldwide by taking away their independence and autonomy. Methodology: The authors use the experimental approach to implement the 5H model, evaluate its efficacy, and show the change in depression levels and symptoms in Quang Ngai's elderly. The author chose 26 senior persons from Truong Quang Trong Ward and 23 from Tinh Thien Village to engage in the intervention study. The semi-experimental study compared N=60 samples (Experimental Group=30 and Control Group=30). The elderly control group receives conventional therapy according to the local program, whereas the experimental group receives community intervention. The GDS-15 and ICD-10 examined the intervention's efficacy. Results: This study found that I mild depression had a significant change post-intervention; (ii) the mean score of depression through 2 assessments (GDS-15 scale and ICD-10 clinical assessment) both showed a significant reduction; (iii) females tended to change more than males; (iv) elderly aged 60-70 were easier to change than those over 80 years old; and (v) community-based psychosocial therapy had a significant impact on depression. Conclusion: Considering the aforementioned favourable results, the Quang Ngai city depression prevention intervention program for the elderly is practical and can reduce symptoms, severity, and reverse depression. Hence, the model is applicable across Quang Ngai City.

Efficacy of psilocybin for treating symptoms of depression: systematic review and meta-analysis

ObjectiveTo determine the efficacy of psilocybin as an antidepressant compared with placebo or non-psychoactive drugs.DesignSystematic review and meta-analysis.Data sourcesFive electronic databases of published literature (Cochrane Central Register of Controlled Trials,...

Resilience and psychosocial factors in adult with epilepsy: A longitudinal study

PurposeResilience is conceptually characterized as a dynamic process encompassing positive adaptation in the context of significant adversity. Our goal was to assess the resilience in people with epilepsy (PWE) and how it impacts longitudinally on psychosocial factors, with a particular focus on the manifestation of stigmatization-related feelings. MethodsWe consecutively enrolled 78 adults PWE (42.5 ± 16.2 years old); among them 36 (46.1 %) were seizure-free. All subjects completed at baseline (T0) the Resilience Scale (RS-14) and questionnaires for the assessment of depressive symptoms, anxiety and quality of life: respectively, Beck Depression Inventory-II (BD-II), Generalized Anxiety Disorder-7 (GAD-7) and QOLIE-31 (Q31). All patients were followed up prospectively and re-evaluated after 6–22 months (T1; mean: 14 ± 8 months; median 14 months); at follow up they also completed the Stigma Scale of Epilepsy (SSE) for the assessment of the stigma associated with epilepsy. We correlated resilience values with all psychosocial scores at T0 and T1. Factors associated with resilient and vulnerable outcomes were identified. Finally, a multiple stepwise regression analysis was applied to identify predictors for resilience and stigma perception. ResultsThe results showed for the RS-14 score a significant direct correlation with the Q31 (p < 0.001) and an inverse correlation with the depressive and anxiety symptoms at both times (T0 and T1), as evaluated with BDI-II (p < 0.001) and GAD-7 (p < 0.001). Finally, we found a significant inverse correlation between RS-14 at T0 and the levels of stigmatization assessed with SSE at T1 (p =.015). Using a multiple stepwise regression analysis separately for resilience and stigma perception, depressive symptoms turned out as the best predictors for both variables. Finally, considering longitudinal evaluation we did not observe significant changes in depressive and anxious symptoms, despite a significant reduction in the total number of seizures at follow up. ConclusionsOur study showed that depressive symptoms, anxiety and quality of life were significantly associated with resilience in PwE. Finally, as a novel finding resilience was proved to affect the perception of stigma related to epilepsy more than seizures.

EXERCISE TRAINING IMPROVES GASTROINTESTINAL SYMPTOMS IN PEOPLE WITH A DISORDER OF THE GUT BRAIN INTERACTION (DGBI): SYSTEMIC REVIEW AND META-ANALYSIS

INTRODUCTION &amp; AIMS Approximately 40% of the global population has criteria that meets at least one Disorder of the Gut-Brain Interaction (DGBI). DGBIs are characterised by the absence of structural abnormalities, with chronic symptoms, such as pain, altered bowel movements, and nausea. Current therapy options focus on treating the major symptoms, which can involve pharmacological and lifestyle advice (diet, exercise, and stress management). The aim of this study was to conduct a systematic review and meta-analysis investigating the efficacy of exercise for improving gastrointestinal symptoms in people with a DGBI. METHODS A search of relevant databases was completed in February 2023, for randomised controlled trials that applied an exercise intervention in people with DGBI. Comparator groups included usual care, pharmacological therapy, or diet advice. A pairwise random-effects meta-analysis estimated the standardised mean difference (SMD) (Hedges’ g) between exercise and comparator groups for changes in gastrointestinal symptoms. Risk of bias was analysed using the Cochrane Risk of Bias tool. RESULTS Ten studies published between 2004–2023 were included. Participants (n=653) were mostly female 77.6%. Eight studies included participants with irritable bowel syndrome and two included individuals with functional dyspepsia. Exercise interventions lasted an average duration of 8 weeks. The modes included yoga (n=5), low intensity (n=1) and moderate intensity aerobic exercise (n=4). Studies ranged from low to high-risk bias. Meta-analysis showed exercise interventions improved gastrointestinal symptoms (SMD=1.2, 95% CI 0.5 to 1.8; p&amp;lt;0.001). The effect was moderated by the intensity of exercise with moderate intensity aerobic exercise having a significant impact (SMD=1.6, 1.2 to 2.0; p&amp;lt;0.001) not evident with yoga and low intensity exercise interventions (SMD=0.9, -0.01 to 1.7; p=0.053). CONCLUSION Exercise interventions in people with DGBIs improve gastrointestinal symptoms. Moderate intensity aerobic exercise is more efficacious than yoga and lower intensity exercise.

Changes of motor symptoms and regional cerebral blood flow after transcranial direct current stimulation in Parkinson's disease

Changes of motor symptoms and regional cerebral blood flow after transcranial direct current stimulation in Parkinson's disease

Interpersonal sensitivity predicts slower change and less change in anxiety symptoms in cognitive behavioural therapy.

Patients in cognitive behavioural therapy (CBT) who are high in interpersonal sensitivity may have difficulty fully engaging in treatment because therapy sessions require intimate interpersonal interactions that are especially uncomfortable for these individuals. The current study tests the hypotheses that patients who are high in interpersonal sensitivity benefit less from CBT for symptoms of depression and anxiety, show a slower rate of change in those symptoms, and are more likely to drop out of treatment. Participants were 832 outpatients who received naturalistic CBT. We assessed interpersonal sensitivity before treatment began and depression and anxiety symptoms at every therapy session. We assessed early, premature, and uncollaborative termination after treatment ended. We constructed multilevel linear regression models and logistic regression models to assess the effects of baseline interpersonal sensitivity on the treatment outcome, the slope of change in depression and anxiety symptoms, and each type of dropout. Higher baseline interpersonal sensitivity was associated with a slower rate of change and less overall change in anxiety but not depressive symptoms. Baseline interpersonal sensitivity was not a predictor of dropout. Interpersonal sensitivity at baseline predicts less change and a slower rate of change in anxiety symptoms. Early detection of elevated interpersonal sensitivity can help therapists take action to address these barriers to successful treatment and help scientists build decision support tools that accurately predict the trajectory of change in anxiety symptoms for these patients.

Axial MR Angiography in Evaluating Revascularization after Indirect Bypass Surgery for Moyamoya.

At our institution, revascularization after indirect moyamoya surgery is routinely evaluated using magnetic resonance angiography (MRA) rather than catheter angiography. This study reviews how revascularization can be visualized on axial MRA versus catheter angiography and compares clinical outcomes of surgeries evaluated by routine postoperative MRA versus routine catheter angiography. We reviewed the records of all patients treated at our institution who underwent unilateral encephaloduroarteriosynangiosis (EDAS)/pial synangiosis 2004-2021 at 1-21 years of age. Inclusion criteria included undergoing preoperative MRA within 18 months of surgery and postoperative MRA 3 to 30 months after surgery. Clinical outcome measures included postoperative stroke and transient ischemic attacks (TIAs), changes in symptoms (improved, unchanged, worsened), and new postoperative symptoms. Measures were compared between surgeries evaluated by routine postoperative MRA versus routine postoperative angiograms. For each surgery, we determined the ratios of the diameters and areas of the donor and contralateral corresponding vessels and the relative signal intensities of these two vessels on preoperative- and 3-to-30-month postoperative MRA. We did the same for the middle meningeal artery (MMA) ipsilateral to the donor artery and the contralateral MMA. We assessed changes from pre- to post-operation in diameter ratios, area ratios, relative signal intensity, ivy sign, and brain perfusion on arterial spin labeled (ASL) imaging. MRI and MRA measures of revascularization and flow were compared to Matsushima grades in patients who had postoperative catheter angiograms. Fifty-one operations were included. There were no significant differences in rates of strokes, TIAs, changes or new symptoms after surgeries evaluated by routine postoperative MRA versus catheter angiogram. Significant associations existed between greater collateralization on postoperative MRA and greater median increases in preoperative-to-postoperative ratios of donor-vessel-over-contralateral-vessel diameter (p=0.0461) and ipsilateral-MMA-over-contralateral-MMA diameter (p=0.0135). The median increase in the ratio of the donor-vessel-over-corresponding-contralateral-vessel diameters was significantly higher for Matsushima grade A versus B (p=0.036). The median increase in the ratio of the sum of donor-and-ipsilateral-MMA diameters over the sum of the contralateral vessel diameters was significantly higher for improved-versus-unchanged perfusion on ASL imaging (p=0.0074). There was a nonsignificant association between greater postoperative collateralization on MRA and Matsushima grade (p=0.1160) Conclusion: Cerebral revascularization after EDAS/pial synangiosis can be evaluated on axial MRA by comparing the diameter and/or signal intensity of the donor vessel and ipsilateral MMA to those of the corresponding contralateral vessels on postoperative-versus-preoperative MRA. The use of routine postoperative MRA rather than catheter angiography does not appear to negatively affect outcomes.

Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD

BackgroundAttention-deficit/hyperactivity disorder (ADHD) remains underdiagnosed and undertreated in girls. Inattentive symptoms, often predominant in girls with ADHD, represent a key driver of impairment and often persist into adulthood. AKL-T01 is a regulated digital therapeutic targeting inattention. We examined potential sex differences in the efficacy of AKL-T01 in three separate trials for 1) children, 2) adolescents, and 3) adults.MethodsWe conducted secondary analyses of clinical outcomes by sex in three AKL-T01 randomized clinical trials in ADHD (n1 = 180 children 30.6% female, M(SD) age = 9.71 (1.32); n2 = 146 adolescents; 41.1% female, M(SD) age = 14.34 (1.26); n3 = 153 adults; 69.9% female, M(SD) age = 39.86 (12.84)). Active treatment participants used AKL-T01 for 25 min/day over 4–6 weeks. Primary outcomes included change in attention on the Test of Variables of Attention (TOVA) and symptom change on the clinician-rated ADHD Rating Scale (ADHD-RS). To evaluate study hypotheses, we conducted a series of robust linear regressions of TOVA and ADHD-RS change scores by sex, adjusting for baseline scores.ResultsIn children, girls demonstrated greater improvement in objective attention relative to boys following AKL-T01 (TOVA Attentional Composite Score; Cohen’s d = .36 and Reaction Time Mean Half; Cohen’s d = .54), but no significant sex differences in ADHD rating scale change. We did not observe significant sex differences in outcomes in the adolescent or adult trials. Limitations include binary sex categorization and slight study design variation across the three samples.ConclusionAKL-T01 might notably improve attentional functioning in girls with ADHD relative to boys. Objective attention measures may be particularly important in the assessment of attentional improvement in childhood, given known gender biases in ADHD symptom reporting. We emphasize the importance of considering sex and gender-specific factors in ADHD treatment evaluation.Trial registrationsSTARS ADHD CHILD: ClinicalTrials.gov ID NCT03649074;STARS ADHD ADOLESCENT: ClinicalTrials.gov ID NCT04897074;STARS ADHD ADULT: ClinicalTrials.gov ID NCT05183919.

Epidemiology of Disorders of the Gut-Brain Interaction: An Appraisal of the Rome IV Criteria and Beyond.

Disorders of the gut-brain interaction (DGBIs) are presently classified into mutually exclusive anatomical area-related symptom-based categories according to the Rome IV criteria. The pathophysiology of visceral nociception, which contributes to the wide range of symptoms of DGBIs, involves complex psychobiological processes arising from the bidirectional interactions of multiple systems at the gut and brain levels, which affect symptom expression and illness behaviors. The attitude toward an illness and expression of pain and bowel habit vary across cultures with variable interpretation based on sociocultural beliefs, which may not tally with the medical definitions. Thus, psychological factors impact DGBI definitions, their severity and health care utilization. Due to the poor localization and multisegment referral of visceral pain, the anatomical site of pain may not correspond to the affected segment, and there may be a variable degree of overlap among symptoms. The somewhat restrictively defined Rome IV criteria assume one-to-one correlation of symptoms with underlying pathophysiology and ignore overlapping DGBIs, nonstandardized symptom categories, and change or shift in category over time. The microorganic nature of DGBIs resulting from systemic, metabolic or motility disorders, gut dysbiosis and inflammation are not addressed in the Rome IV criteria. Although there is a multidimensional clinical profile that does address these factors, it is not followed rigorously in practice. Threshold changes for diagnostic criteria or addition/deletion of symptoms leads to wide variation among different DGBI criteria resulting in uncertain comparability of results. Although the Rome IV criteria are excellent for research studies and therapeutic trials in homogenous populations, further improvement is needed for their wider applicability in clinical practice.

Follow-up for human papillomavirus-related oropharynx cancer concentrated on unequal symptom change (FOCUS): Prospective patient-reported outcome collection.

Post-treatment surveillance recommendations for oropharyngeal cancer do not vary with p16 status despite the differences in outcomes. The optimal algorithm personalizing follow-up for these patients remains undefined. Here, we evaluate the feasibility and utility of incorporating electronic patient-reported outcomes (ePROs) and circulating tumor DNA (ctDNA) into routine surveillance for patients treated for p16+ oropharynx cancer. A prospective registry was developed in which ePROs and ctDNA were incorporated into routine surveillance among patients with oropharynx cancer. ePROs were emailed monthly for 1 year and blood HPV ctDNA testing was performed every 3-6 months. The primary objective was to assess patient compliance with ePRO-based surveillance with adequate compliance defined as ≥85% of patients completing monthly ePROs. Sensitivity, specificity, and positive/negative predictive values to detect recurrence were calculated for ePROs, HPV ctDNA, or the combination. Of 122 patients who initially expressed interest, 76 completed the electronic consent process and 44/76 (58%) were compliant with monthly surveys over 1 year; thus adequate compliance was not achieved. Technical difficulties associated with ePRO receipt through email largely limited participation. Provider feedback was significantly associated with heightened ePRO compliance. One hundred and six patients had ctDNA testing with a mean number of three tests per patient. Sensitivity to detect recurrence was 75% for the combination of ePROs and ctDNA. Despite lower than anticipated compliance with ePROs, our findings show promise for incorporation of HPV ctDNA into surveillance paradigms for HPV-related oropharynx cancer with suggestions of methods to optimize ePRO formats for personalized surveillance.

Randomized Feasibility Pilot of an Executive Functioning Intervention Adapted for Children's Mental Health Settings.

The critical role of executive functioning in autism as well as the co-occurring mental health challenges common among autistic youth support to the immense value of interventions targeting executive functioning for enhancing mental health services for autistic children. The goal of the present study was to conduct a randomized feasibility trial of Unstuck and On Target, an executive functioning intervention, adapted for delivery in children's community mental health setting. Mental health therapists (n = 26) enrolled with participating autistic clients (n = 32) were randomized to receive training in and deliver the adapted Unstuck intervention or to deliver care as usual. We completed masked observational measures of Unstuck strategy use (fidelity) during recorded sessions of participating therapist-client dyads and collected measures of acceptability from participating clients and their caregivers. We also collected measures of pre-post changes in executive functioning and mental health symptoms. Therapists trained in Unstuck demonstrated significantly higher use of Unstuck strategies compared to usual care therapists. Caregivers and autistic clients perceive adapted Unstuck as highly acceptability and helpful. Autistic clients whose therapists were trained in adapted Unstuck demonstrated larger pre-post changes in executive functioning compared to usual care. Across all participating clients, changes in executive functioning were significantly related to changes in mental health symptoms. Finally, clients of therapists trained in adapted Unstuck demonstrated moderate improvements in overall mental health symptoms. The current study provides preliminary evidence of the feasibility and impact of Unstuck and On Target for children's community mental health settings.