Entry Criteria Research Articles

Randomized, Placebo-Controlled, Phase 1 Safety Study of Oral Mucosal Immunotherapy in Peanut Allergic Adults.

Oral Mucosal Immunotherapy (OMIT) uses a specifically formulated toothpaste to deliver allergenic proteins to immunologically active areas of the oral cavity. This represents a new delivery mechanism with several features designed to improve food allergy desensitization. OMIT presents advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration. To determine the safety, tolerability, and adherence of OMIT with INT301 in peanut allergic adults. This Oral Mucosal Escalation Goal Assessment (OMEGA) study enrolled 32 adults, age 18-55, with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. Entry criteria included a positive SPT with a wheal diameter ≥ 3mm greater than control and/or psIgE ≥ 0.35 kU/L. Subjects were required to fail an oral food challenge ≤ 100 mg dose of peanut protein. Safety and tolerability were monitored during this 48-week trial. 100% of active subjects tolerated the pre-specified protocol highest dose. No moderate nor severe systemic reactions occurred in active participants. Non-systemic adverse reactions were mostly local (oral and nasal cavity), mild and transient. Active subjects adhered to treatment 97% of days on study, with no withdrawals due to study medication. In the OMEGA trial, INT301 met all primary and secondary endpoints of safety, tolerability, and adherence. OMIT appears to be a safe and convenient option for individuals with food allergies. These results support its further evaluation in the pediatric population.

Obinutuzumab in Combination with Alternative Chlorambucil Schedules in Front-Line Treatment of Chronic Lymphocytic Leukemia: A Study by KroHem, the Croatian Cooperative Group for Hematologic Diseases.

Background/Objectives: Obinutuzumab was approved for front-line treatment of chronic lymphocytic leukemia in combination with chlorambucil pulses administered every 2 wks. Alternative schedules of chlorambucil enable the administration of higher total chlorambucil doses, and have better antileukemia activity. So far, evidence on the feasibility of combining obinutuzumab with alternative chlorambucil schedules is lacking. We performed this retrospective analysis to analyze real life outcomes in chronic lymphocytic leukemia patients receiving a combination of obinutuzumab with different chlorambucil schedules. Methods: This was a retrospective survey performed in order to analyze the feasibility and efficacy of different obinutuzumab and chlorambucil combinations in a real-life setting. Patients receiving this combination as a front-line therapy for chronic lymphocytic leukemia in participating centers, outside of clinical trials, in 2017 and 2018 were included. Results: Seventy-three patients fulfilling entry criteria were identified. Their median age was 76 years, and ranged from 58 to 90 years. The median follow up time was 59 months. The response rate was 89%, with a median progression-free survival time of 27 months, and an overall survival time of 49 months. Chlorambucil was administered as planned in 15 of the 22 (79%) patients treated with chlorambucil pulses every 2 weeks; in 15 of the 42 (34%) patients treated with 7-day courses of chlorambucil administered every 4 weeks; and in 0 of the 10 patients treated with a continuous high dose of chlorambucil (p = 0.002). Changes in treatment schedules were made due to side effects. The progression-free and overall survival rates were similar between the three groups. Conclusions: The combinations of obinutuzumab with more intensive chlorambucil schedules are less feasible, preventing the administration of the intended higher total dose of chlorambucil, and do not improve outcomes in comparison to chlorambucil pulses administered every 2 weeks.

Subtype and Racial Erythema Variation for Cutaneous Lupus Trials

Regulatory guidance and standardization of disease outcome measures are essential to improve cutaneous lupus erythematosus (CLE) trial design and enhance the diversity of trial participants. To assess variability in erythema presentation across CLE subtypes and among race and ethnicity groups to determine whether these potential differences affect patient eligibility for erythema trials. This cross-sectional study included 377 patients with CLE enrolled in the University of Pennsylvania Cutaneous Lupus Erythematosus Database from January 2007 to December 2023. Data analyses were performed from December 2023 to February 2024. Race and CLE subtype. Mean erythema calculated per the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity total score divided by areas affected; then, the result was categorized as pink (1.00-1.49) or red (≥1.50) as surrogate estimates of scores per the Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA). The total study cohort included 377 adult patients with CLE (mean [SD; range] age, 45.2 [14.8; 18.4-88.8] years; 305 females [80.9%] and 72 males [19.1%]; 115 Black [30.5%], 228 White [60.5%], 34 patients of other races [9.0%; Asian, multiple races, Native American/Pacific Islander, or unknown], and 11 of Hispanic/Latino ethnicity [2.9%]). The most common CLE subtype was chronic CLE (CCLE), affecting 243 patients (64.5%), followed by subacute CLE (SCLE) in 103 patients (27.3%) and acute CLE (ACLE) in 31 patients (8.2%). Significant differences were observed in average erythema across subtypes, with mean (SD) SCLE of 1.62 (0.39) and hypertrophic CCLE of 1.78 (0.25) as the only subtypes routinely classified as red. Significant differences were also observed by race and ethnicity: mean (SD) erythema score in White patients was red (1.58 [0.45]) more frequently than in Black patients (1.36 [0.40]) and patients of other races (1.30 [0.39]), in whom, on average, it was scored as pink. Importantly, among patients who would meet typical CLASI entry criteria (score ≥8) for clinical trials, erythema in more Black patients than in White patients was classified as pink (42% [96 patients] vs 24% [28 patients]), which suggests exclusion from trial participation when a baseline of red lesions is required. The findings of this cross-sectional study suggest that using average erythema scores per the CLA-IGA scale imposes substantial limitations on trial eligibility, specifically by race and subtype. Given the critical need to standardize CLE trial outcome measures and increase diverse representation in clinical trials, our findings support the use of the CLASI as the primary scoring tool to determine erythema trial eligibility.

Obstacles to the Development of the Use of Artificial Intelligence from the Point of View of Physicians Working in Selected AJA Medical Centers: A Qualitative Content Analysis Study

Background: Considering the increasing use of decision support systems, specifically artificial intelligence (AI), in the field of medicine, our goal in this study was to identify, from the perspective of physicians working in AJA medical centers, the obstacles hindering the adoption and use of AI in the treatment and diagnosis of patients. Objectives: This study investigated the obstacles faced by specialist physicians working in AJA medical centers regarding the implementation of AI in their professional practice. Methods: A qualitative approach using contractual content analysis was employed. Data were collected through semi-structured, in-depth interviews and analyzed using the qualitative analysis method of Granheim and Lundman (2004) from May to July 2022. The study included 20 physicians working in selected AJA medical centers in Tehran. Sampling was conducted based on entry criteria and targeted to ensure maximum diversity. Results: The study involved 20 specialist physicians (15 men and 5 women) from selected AJA medical centers in Tehran, with an average age of 42 years and an average work experience of 14 years. The identified obstacles to the development of AI in these medical centers were categorized into three main groups: Extra-organizational and organizational factors, individual factors, and educational factors. These categories included 10 subcategories: Sanctions and economic issues, organizational attitudes, rules and regulations, available facilities, quality of facilities, knowledge and attitude, individual resistance to change, education quality, educational curriculum, and clinical professors. Conclusions: Iran's unique conditions pose challenges to the development and implementation of AI in its medical centers. This study highlights the need to address these obstacles by revising organizational rules and regulations and educating stakeholders on the benefits of AI. These measures could promote the use of AI in military medical centers and improve the quality of care.

Beyond RCTs: Short-term dual antiplatelet therapy in secondary prevention of ischemic stroke and transient ischemic attack.

Randomized controlled trials (RCTs) proved the efficacy of short-term dual antiplatelet therapy (DAPT) in secondary prevention of minor ischemic stroke or high-risk transient ischemic attack (TIA). We aimed at evaluating effectiveness and safety of short-term DAPT in real-world, where treatment use is broader than in RCTs. READAPT (REAl-life study on short-term Dual Antiplatelet treatment in Patients with ischemic stroke or Transient ischemic attack) (NCT05476081) was an observational multicenter real-world study with a 90-day follow-up. We included patients aged 18+ receiving short-term DAPT soon after ischemic stroke or TIA. No stringent NIHSS and ABCD2 score cut-offs were applied but adherence to guidelines was recommended. Primary effectiveness outcome was stroke (ischemic or hemorrhagic) or death due to vascular causes, primary safety outcome was moderate-to-severe bleeding. Secondary outcomes were the type of ischemic and hemorrhagic events, disability, cause of death, and compliance to treatment. We included 1920 patients; 69.9% started DAPT after an ischemic stroke; only 8.9% strictly followed entry criteria or procedures of RCTs. Primary effectiveness outcome occurred in 3.9% and primary safety outcome in 0.6% of cases. In total, 3.3% cerebrovascular ischemic recurrences occurred, 0.2% intracerebral hemorrhages, and 2.7% bleedings; 0.2% of patients died due to vascular causes. Patients with NIHSS score ⩽5 and those without acute lesions at neuroimaging had significantly higher primary effectiveness outcomes than their counterparts. Additionally, DAPT start >24 h after symptom onset was associated with a lower likelihood of bleeding. In real-world, most of the patients who receive DAPT after an ischemic stroke or a TIA do not follow RCTs entry criteria and procedures. Nevertheless, short-term DAPT remains effective and safe in this population. No safety concerns are raised in patients with low-risk TIA, more severe stroke, and delayed treatment start.

Comparison of Premature Ejaculation in Men with Focal Epilepsy and Generalized Tonic-Clonic Epilepsy

Abstract Introduction premature ejaculation (PE) is one of the most common sexual disorders in men. Objectives Considering the importance of sexual health in men, especially patients with epilepsy, this study was conducted with the aim of comparing premature ejaculation in men with focal epilepsy and generalized tonic-clonic seizure (GTCS). Methods In this cross-sectional and observational study, patients with epilepsy were included in the study. The examined patients were examined by psychiatrists and neurologists, and sampling was done according to the entry and exit criteria. The total sample size was 200 people, including 100 patients with focal epilepsy and 100 patients with GTCS. The tools used included demographic profile form, Men Sexual Health Questionnaire (MSHQ), Sexual Quality of Life-Men (SQOL-M), and Premature Ejaculation Diagnostic Tool (PEDT). The study was conducted to include patients referred to specialized clinics and hospitals and who had the necessary conditions to participate in the study. Considering that all the patients were male, the questioning was done by a male researcher. Then, the extracted data were entered into SPSS statistical software. Results Result showed, the M(SD) age of the patients in the focal epilepsy group was equal to 30.18(3.85). M(SD) score of MSHQ tool was equal to 51.81 (11.98), SQOL-M tool was equal to 34.75 (9.36) and PEDT tool was equal to 8.63 (4.79). In this study, although the M(SD) of the PE score in the focal epilepsy group was reported to be 9.17 (4.49) higher than that of the GTCS group with a rate of 8.09 (5.04), but this difference was not significant. also, the findings showed that there was a significant relationship between the status of the PEDT score, the status of the SQOL-M score, and the MSH score (p < 0.05). MSHQ score and SQOL-M score were reported to be lower in patients with PE disorder. Conclusion According to the findings, the prevalence of sexual disorders including PE in both groups of patients with epilepsy is significant. For this reason, it is necessary to carry out pharmacological and non-pharmacological interventions to reduce the rate of PE in these patients.

Impact of Gender-Affirming Rhinoplasty Techniques on Objective Facial Appearance.

To evaluate the impact of transfemale gender-affirming rhinoplasty on nasal appearance as evaluated by common facial analysis measures. Retrospective case series of patients undergoing gender-affirming nasal surgery at a single tertiary care center from March 2016 to July 2022. Pre- and postoperative photographs were analyzed, using iris width to normalize the measurements. Parametric tests were applied to identify differences in facial analytical measures. A total of 33 male to female transgender patients met the inclusion criteria for study entry. Reductive rhinoplasty techniques were frequently utilized. Osteotomies and dorsal reduction were performed in 90.9% and 72.7% of cases, respectively. Tip width decreased on average by 2.3 mm. There was a mean increase of 10.0° in nasolabial angle, and 5.5° increase in nasofrontal angle. Among the 51.5% of patients who underwent alar base reduction, there was a mean decrease of 2.3 mm in alar base width, and 3.1 mm decrease in nasal width. Alar base excision and nasal tip grafting were utilized in 51.5% and 63.6% cases respectively. Transfemale gender-affirming rhinoplasty techniques consistently and predictably altered facial analytical measures, and were effective in aligning nasal appearance with desired gender identity. Alar base excision and tip grafting were commonly employed techniques. Level 4-Quantitative cohort study Laryngoscope, 2024.

Clinical Characteristics, and Antibiotic Effectiveness in the First 48 Hours in Children Under 5 Years of Age with Bacterial Dysentery

Background: Bacterial dysentery is diarrhea with blood (plus or minus mucus), indicating an invasive infection. With effective antibiotic treatment, clinical improvement occurs within 48 hours, which leads to a reduction in the risk of serious complications and death, a shorter duration of illness, and a reduction in transmission. This study was conducted to investigate the clinical features, risk factors, and effectiveness of antibiotics in the first 48 hours in children under 5 years old with bacterial dysentery. Method: In this cross-sectional descriptive-analytical study, children less than 5 years old with bacterial dysentery were hospitalized in Ali Ibn Abitaleb and Ali Asghar Hospital in Zahedan, Iran. After obtaining the necessary permits from the ethics committee, the researcher extracted the information on 85 cases of patients diagnosed with bacterial dysentery, taking into account the entry and exit criteria in an accessible way. The information was entered into the questionnaire. Results: The mean age of the patients was 31.17±16.04 months. 52.9% of patients were girls (n=45). Fever was observed in 100% of patients(n=85). The severity of mild, moderate, and severe dehydration was observed in 36.47%, 40%, and 25.53% of the patients, respectively. The most injected antibiotic was ceftriaxone. White blood cell (WBC) levels decreased significantly after receiving treatment (antibiotic). (before treatment: 13.22±9.91 and after treatment: 8.57±2.71 cells/microliter, P-value=0.001). Conclusion: Our study showed that antibiotic treatment in bacterial dysentery effectively reduces the serum level of WBC. It is suggested that educational programs for mothers in the field of child nutrition be provided and that the effectiveness of different types of antibiotics be compared in future studies.

Study of the Experiences of the Family Counselors of the Judiciary System to Identify the Effective Features of the Family Counseling in Reducing Family Disputes and Strengthening the Family

Aim: The aim of this study was to investigate the experiences of the family counselors of the judiciary system to identify the effective features of the family counseling in reducing family disputes and strengthening the family. Methods: This was a phenomenonological type of qualitative research. The participants in the research included 20 people (13 women and 7 men) whoe were family counselors at the judiciary system in several Iranian cities during 1399-1400 Persian calendar. Participants were selected using the purposeful sampling method according the entry criteria. Sampling continued until saturation was reached. In order to analyze the data, first, the data were recorded and coded, then analyzed using Van Menen's interpretive phenomenological analysis method. Results: The findings of the research included 6 main themes and 33 sub-themes of counselors' experiences as effective therapeutic features. The main themes obtained include: goals pursued to reduce family disputes and strengthening the family, characteristics of counselors, facilitating and promoting measures of counseling alongside the court proceeding, failure of resistance in clients beside the court, interventions to achieve change in order to reduce family disputes and strengthen the family and the characteristics of the counseling location in order to increase the effectiveness of the counseling near the court. Conclusion: The results of this study indicated that the counselors of the judiciary system who have a lower divorce rate at the end of the counseling sessions and are more successful in solving family problems than their other colleagues, have personal characteristics and principles governing their meetings as such that it provides safe and favorable conditions for this group of clients and paves the way for raising issues, listening to them, and ultimately resolving their concerns.

Abstract 4138220: Traditional and HIV-specific Risk Factors Are Associated with Incident Non-valvular Atrial Fibrillation and Atrial Flutter among Underrepresented Racial and Ethnic Minority Groups Living with HIV

Introduction: With effective antiretroviral therapy (ART), HIV can now be managed as a chronic disease. Chronic disease and cardiovascular risk factor management is especially important for underrepresented racial and ethnic minority groups (UREG). Non-valvular atrial fibrillation and atrial flutter (NVAF) have not been adequately studied in UREG with HIV. Research Questions: Among UREG with HIV, what is the incidence of NVAF? What factors are associated with incident NVAF? Aims: To narrow an evidence gap among UREG with HIV by 1) describing the incidence of NVAF and 2) identifying factors associated with incident NVAF. Methods: This is an ancillary study of the Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial and Ethnic Minorities with HIV (PATHWAYS) study, a retrospective population-based study of HIV care patterns among UREG with HIV. Patients without a known history of NVAF entered our study cohort at the date of their first documented HIV diagnosis. We computed the cumulative incidence of NVAF over five years of follow-up (mean 3.4, SD 1.6), handling death as a competing risk. Cox regression analysis was used to examine the univariate associations between characteristics at HIV diagnosis and incident NVAF, adjusting for site and date of HIV diagnosis. Results: From 2015-2019, 10,945 UREG meeting entry criteria were identified. On average, patients were 67.1% male, 94.4% Black, and 8.5% Hispanic. Average CHA2DS2VASc score was 0.92 (SD 1.1) and 63.4% were on ART. Cumulative incidence of NVAF at one and five years after HIV diagnosis were 0.48% (95% CI 0.36-0.63) and 2.16% (95% CI 1.85-2.51), respectively. HIV-related factors associated with incident NVAF included baseline CD4 count <200 (HR 1.84, 95% CI 1.20-2.80) and initial ART including protease inhibitors (HR 1.56, 95% CI 1.14-2.13) and/or integrase strand transfer inhibitors (HR 1.47, 95% CI 1.08-1.99). Additional associated factors included older age, Medicare, cardiology visit(s) in prior year, and co-morbid diseases including hypertension, hyperlipidemia, coronary and peripheral artery disease, prior stroke/transient ischemic attack, heart failure, and chronic kidney disease. Conclusions: In a large cohort of UREG living with HIV, both traditional and HIV-specific risk factors are associated with increased risk of incident NVAF. Interventions to mitigate NVAF risk in this population will require interdisciplinary, team-based approaches.

SURG-14. PATTERNS OF PROGRESSION OF TEMPORAL LOBE GLIOBLASTOMAS: EVIDENCE FOR THE ROLE OF TEMPORAL LOBECTOMY

Abstract Glioblastomas extend beyond the contrast-enhancing tumor, and supramaximal resections into non-enhancing (NE) tumor improves survival. Yet, supramaximal resection is difficult to achieve in most cases. For temporal lobe tumors, supramaximal anterior temporal lobe resection is feasible and safe. Case series have shown a survival advantage by resecting the anterior temporal lobe. This study aims to explore patterns of tumor progression in temporal lobe glioblastomas and whether the presence of NE tumor in the temporal tip could be used as a biomarker to predict the site of progression. We searched a single institution tumor database looking for patients who had glioblastomas in the temporal lobe, who underwent complete resection of enhancing tumor, and went on to have chemoradiotherapy. Patients needed to have imaging demonstrating first progression. We determined pre-operatively if NE tumor had extended into the temporal tip. At progression, the direction of tumor progression was recorded and assessed if it would have been resected should a lobectomy have been performed. We identified 55 patients that fulfilled our entry criteria (mean age 57.7 years, range 19.6-72.9; 37 male). In 16 cases, the anterior temporal lobe was resected; these patients were not used in further assessments. In 25 cases (64.1%), the tumor progressed into the residual anterior temporal lobe. In 16 cases (41.0%), a lobectomy would have encompassed the area of progression. NE tumor was seen in the tip in 28 cases (71.8%). This could predict progression into the anterior temporal lobe with a sensitivity of 76.2% (95%CI: 54.9-90.6%) and specificity of 33.1% (95%CI: 11.8-61.6%). The likelihood ratio of tumor progression was 1.14 (95%CI: 0.75-1.74). We conclude that temporal lobe glioblastomas most commonly progress into the anterior temporal lobe, but NE tumor is not a suitable predictive biomarker. Developing suitable biomarkers and biomarker-driven trials of temporal lobectomy for glioblastomas are needed.

Knowledge, Attitude, and Practice of General Dentists Towards Tele-dentistry

Background: Considering the growing importance of tele-dentistry and its potential to enhance the delivery of dental services, this study aimed to assess the knowledge, attitude, and practice (KAP) of private dental offices towards this technology. Methods: This analytical cross-sectional study included 50 general dentists practicing in Semnan city, selected based on entry criteria through the enumeration method. Participants completed a demographic questionnaire (including gender and years since graduation) and a 15-item researcher-made questionnaire designed to assess their KAP towards tele-dentistry. Results: Among the participants, 54% (27 participants) were female, and 46% (23 participants) were male, with an average age of 30.2 ± 6.48 years. The mean number of years since graduation was 7.74 ± 5.13 years. The mean and standard deviation of KAP scores were 5.96 ± 1.07 (knowledge), 34.32 ± 3.41 (attitude), and 1.44 ± 0.50 (practice), respectively. Men scored significantly higher in knowledge compared to women (7.26 ± 0.91 vs. 6.70 ± 1.14; P = 0.037). There was a significant inverse correlation between knowledge scores and years since graduation (r = -0.292; P = 0.032). Additionally, 52% (26 participants) reported having used tele-dentistry, while 96% (48 participants) expressed an intention to use it in the future. Conclusions: The findings suggest that knowledge regarding tele-dentistry was notably higher among men and those with fewer years since graduation. Health policies should prioritize training programs to enhance general dentists' knowledge and practice of tele-dentistry, supporting its effective implementation in dental care.

Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned.

This study aimed to describe initial experiences and lessons learned conducting a trial focused on recruiting racially and ethnically diverse hospitalized patients with untreated alcohol use disorder (AUD). The parent trial is comparing the effectiveness of strategies including Brief Negotiation Interview (BNI), facilitated initiation of medications for AUD, and computer-based training for cognitive behavioral therapy (CBT4CBT) on AUD treatment engagement post-hospitalization. Guided by the Framework for Reporting Adaptations and Modifications-Enhanced, we catalogued protocol changes and evaluated outcomes using study and electronic medical record data during the first 18 months of recruitment. Recipients: (1) Selected entry criterion to intentionally include individuals most likely impacted by structural racism, (2) developed multipronged recruitment approaches, and (3) selected bilingual, multicultural, and ethnically diverse research staff. Intervention: (1) Added scripts in the BNI to consider how cultural factors influence and how racism may impact, alcohol use, and AUD treatment engagement, (2) offered tablets as a compensation alternative with support for CBT4CBT initiation (as relevant), and (3) anticipate and troubleshoot internet access challenges. Setting: (1) Identified community-based AUD treatment options with Spanish-speaking services and (2) identified resources to address social determinants of health. Study: (1) Audited data to monitor whether diverse enrollment is occurring. Among n = 132 randomized as of March 1, 2024, 25% endorsed Black, 24% endorsed Latine, 58% endorsed White, 1% endorsed Indigenous, and 15% endorsed race not listed or declined to disclose. We observed no difference by race or ethnicity in recruitment or retention experiences. Multilevel practices within a hospital-based AUD-focused trial can promote recruitment and retention of a racially and ethnically diverse sample.

Spatial Interpretation of Multi-Criteria Analysis: A Case Study with a Decreasing Number of Criteria and Subjective Approach to Determining Their Importance

Municipal activities should not be profitable. Their intention is to provide the highest possible quality of service to citizens and, in this way, contribute to improving their quality of life. For this reason, the evaluation of their performance is very complex and should include several aspects, or criteria. The aim of this study is to quantify the agreement of the financial health assessment of the territorial self-government entities in 2020 with the financial health assessment based on a gradually decreasing number of entry criteria. For this purpose, we use a TOPSIS technique, and a total of 26 combinations of criteria are created with a gradually decreasing number of criteria, i.e., five, four, three, and two criteria used. For a description of the results obtained, we use a wide range of mathematical and statistical methods. The tests used include the Jaccard index, Kolmogorov–Smirnov test, Levene test, Moran index, and others. Our results confirm the fact that the outcome of MCDM analysis is directly and significantly affected by the structure and number of entry criteria. The reduction in the number of criteria resulted in a change in the parameters of the overall results.

Reach, uptake, and psychological outcomes of two publicly funded internet-based cognitive behavioural therapy programs in Ontario, Canada: an observational study

BackgroundAccess to traditional mental health services in Canada remains limited, prompting exploration into digital alternatives. The Government of Ontario initiated access to two internet-based cognitive behavioral therapy (iCBT) programs, LifeWorks AbilitiCBT and MindBeacon TAiCBT, for adults with mental health issues.MethodsAn uncontrolled observational study utilizing secondary retrospective program data was conducted to evaluate the reach, uptake, and psychological symptom changes among participants engaging with either iCBT program.ResultsBetween May 2020 and September 2021, 56,769 individuals enrolled in LifeWorks AbilitiCBT, and 73,356 in MindBeacon TAiCBT. However, substantial exclusions were made: 56% of LifeWorks participants and 68% of MindBeacon participants were ineligible or failed to initiate treatment. Consequently, 25,154 LifeWorks participants and 23,795 MindBeacon participants were included in the analysis. Of these, 22% of LifeWorks and 26% of MindBeacon participants completed over 75% of iCBT treatment. On average, LifeWorks participants received 13 ± SD 7.1 therapist messages and sent 5 ± SD 10.3 messages, while MindBeacon participants received 25 ± SD 20.7 therapist messages and sent 13 ± SD 16.4 messages. LifeWorks included synchronous therapist contact averaging 1.4 ± SD 1.9 h per participant, while MindBeacon was purely asynchronous. Baseline severity of anxiety (37%) and depression symptoms (22%) was higher for LifeWorks participants compared to MindBeacon participants (24% and 10%, respectively). Clinically significant changes in anxiety and depression scores were observed: 22% of LifeWorks and 31% of MindBeacon participants exhibited reliable recovery in PHQ-9 scores, while 26% of LifeWorks and 25% of MindBeacon participants demonstrated reliable recovery in GAD-7 scores.ConclusionIn conclusion, iCBT programs show promise for engaged participants with varying levels of severity in anxiety and depression symptoms. Future iterations of iCBT should consider adopting a broad entry criterion to iCBT programming to increase accessibility, especially for those with severe symptoms, alongside integrated intake care pathways, and potential payment structure adjustments for iCBT service providers. Taken all together, these factors could temper high dropout rates post-intake assessment. This evaluation underscores the potential and value of digital mental health interventions for individuals with mild to severe anxiety or depression symptoms, emphasizing the importance of addressing participant dropout.

The effectiveness of group play therapy using sand on social skills and behavioral problems of 5-9-year-old children in Tehran

This research was conducted with the aim of investigating the effectiveness of group play therapy using sand on children's social skills and behavioral problems. The statistical population included all children aged 5 to 9 years in Tehran in 1403, and among them 30 students were selected by available sampling according to the entry criteria and placed in two experimental and control groups. Then, at first, the subjects were measured by Babadi and Meshkani's life skills questionnaire (1389) and Shahim and Yousefi's children's behavioral problems questionnaire (1378) and after receiving group play therapy training using sand according to the protocol, the subjects again They completed the questionnaires. The research findings were analyzed by SPSS software using covariance analysis method and the results indicated the high effectiveness of group play therapy using sand on improving social skills and reducing children's behavioral problems

PET/CT/MRI in Clinical Trials of Alzheimer's Disease.

With the advent of PET imaging in 1976, 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-PET became the preferred method for in vivo investigation of cerebral processes, including regional hypometabolism in Alzheimer's disease. With the emergence of amyloid-PET tracers, [11C]Pittsburgh Compound-B in 2004 and later [18F]florbetapir, [18F]florbetaben, and [18F]flumetamol, amyloid-PET has replaced FDG-PET in Alzheimer's disease anti-amyloid clinical trial treatments to ensure "amyloid positivity" as an entry criterion, and to measure treatment-related decline in cerebral amyloid deposits. MRI has been used to rule out other brain diseases and screen for 'amyloid-related imaging abnormalities' (ARIAs) of two kinds, ARIA-E and ARIA-H, characterized by edema and micro-hemorrhage, respectively, and, to a lesser extent, to measure changes in cerebral volumes. While early immunotherapy trials of Alzheimer's disease showed no clinical effects, newer monoclonal antibody trials reported decreases of 27% to 85% in the cerebral amyloid-PET signal, interpreted by the Food and Drug Administration as amyloid removal expected to result in a reduction in clinical decline. However, due to the lack of diagnostic specificity of amyloid-PET tracers, amyloid positivity cannot prevent the inclusion of non-Alzheimer's patients and even healthy subjects in these clinical trials. Moreover, the "decreasing amyloid accumulation" assessed by amyloid-PET imaging has questionable quantitative value in the presence of treatment-related brain damage (ARIAs). Therefore, future Alzheimer's clinical trials should disregard amyloid-PET imaging and focus instead on assessment of regional brain function by FDG-PET and MRI monitoring of ARIAs and brain volume loss in all trial patients.

The effect of acceptance and commitment therapy on work-related rumination and job fatigue of medical emergency and accident management center staff: an experimental study

BackgroundWorking in accident management centers and medical emergencies makes employees face psychological tensions and leads to a decrease in their work quality and endangering the lives of patients. Therefore, any solution to reduce their tension will be valuable. This study was conducted to investigate the effect of acceptance and commitment-based therapy (ACT) on work-related rumination and job fatigue among the employees of the Emergency and Medical Accident Management Center of Alborz Province, Iran.MethodsThis study is an experimental research with intervention and control groups conducted between January 16, 2019, and July 8, 2019. Sixty-four employees were selected based on the entry criteria and randomly assigned to two groups. People in the intervention group participated in 8 sessions of 2-hour therapy based on acceptance and commitment. Questionnaires for demographic information, work-related rumination, and occupational recovery/exhaustion were used to collect data. The intervention was conducted with univariate and multivariate covariance analysis.ResultsThe findings showed that the average job fatigue reached 16.78\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document} 11.44 from 37.06 ± 16.70 in the pre-test with a decrease of 20.28 points. Also, the average of all rumination dimensions related to work decreased in the post-test. The findings showed that the effectiveness of treatment based on acceptance and commitment therapy was confirmed on job fatigue and all its components and all dimensions of work-related rumination (p < 0.05). The partial eta square index was greater than 0.14 in all cases and showed the significant effectiveness of the intervention on all components of work-related rumination and job fatigue.ConclusionTreatment based on acceptance and commitment reduced rumination and job fatigue. It is recommended to practice this intervention to improve personnel’s mental health and the quality of services provided to patients.Clinical trial numberNot applicable.

Is HLA-DQ typing useful in screening for celiac disease among Arabs with type 1 diabetes? A case-control study.

The data on the usefulness of DQ-typing in screening for celiac disease (CD) among type 1 diabetic (T1D) patients came from the West. We conducted this study among T1D patients to: (1) determine the frequency of DQ-genotypes, (2) assess the risk associated with human leukocyte antigen (HLA)-DQ genotypes, and (3) identify the cost-effective screening strategy. HLA-DQ genotyping was performed on 67 T1D patients with CD (cases) (mean age 15 years) and 224 T1D patients without CD (controls) (mean age 18.29 years) (2021-2023). The entry criterion for the control group was duration of T1D ≥5 years and negative annual celiac serology assay. On comparison of the cases versus controls, T1D patients carrying homozygous DQ2.5 genotype (30% vs. 13.8%) or DR3-DQ2.5 haplotype (81.3% vs. 65.7%) showed significantly "higher risk" (odds ratio [OR] = 2.64, p = 0.002; OR = 2.3, p = 0.008, respectively) to develop CD. Only 4% do not harbor any of the CD-at risk genotypes (DQ2.5, DQ8, or DQ2.2) and none developed CD. Heterozygous DQ8 was associated with a significantly lower risk of developing CD with OR of 0.123 (1.5% in cases vs. 10.3% in controls, p = 0.022). Only 4% of Saudi patients with T1D carry DQ-genotypes at no risk to develop CD, which supports the European guidelines that recommend celiac serology test as the most cost-effective screening method. We identified the risk gradient associated with DQ-genotypes to develop CD in our population which could help in counseling patients for the risk to develop CD and planning follow-up serology tests.

How much is too much: A case study of local self-government units in Slovakia using absolute variability to determine the importance of financial criteria in MCDM analysis.

The performance evaluation of local self-government entities is very difficult, as their primary goal is not to make a profit, but to provide services to their residents that will contribute to an increase in their quality of life. In this context, it is necessary to evaluate their activity from the point of view of several available criteria, for which it is possible to find relevant and recognized sources. The presented research works with five criteria, identified by the Institute for Economic and Social Reforms, and aims to quantify the agreement of the results of the assessment of the financial health of territorial self-government entities in 2020 using the TOPSIS technique with a gradually decreasing number of criteria. For this purpose, a total of 26 combinations of criteria are created, with the number of 5, 4, 3 and 2 used criteria, the importance of which is determined based on their absolute variability using the standard deviation method. The results obtained in this way are interpreted using a wide range of mathematical and statistical methods including the Kolmogorov-Smirnov test, Levene test, Jaccard index and others. As a result, the multi-criteria evaluation of territorial self-government subjects (in our case, district cities) proved to be highly applicable. However, the result itself is largely determined by the structure and number of entry criteria. Based on the performed analyses, we can see that significant differences result from their reduction. Each such reduction has an impact on the overall results, but it is possible to find combinations that defy this conclusion.