Search

PurposeMethodsResultsConclusionsTo compare the long-term outcomes of mucosal-sparing mechanical endoscopic dacryocystorhinostomy (MMED) for primary acquired nasolacrimal duct obstruction (PANDO) with or without silicone intubation.An 11-year follow-up study of the Silicone intubation in Endoscopic Dacryocystorhinostomy (SEND) randomized controlled trial (RCT) was conducted at a university-affiliated dacryology clinic from December 2019 to March 2023. Questionnaires on symptoms, anterior segment examination, endoscopic examination with functional endoscopic dye test (FEDT) and FICI grading, and ostial size measurements using Image J software were performed by a masked ophthalmologist. The primary outcome was surgical success, defined by Munk’s score ≤1 and a positive fluorescein endoscopic dye test. Secondary outcomes included risk factors for failure and outcomes of revision surgeries.Fifty-three of the original 118 patients were evaluated at 155 ± 21 (136–218) months postoperatively. Seventy-seven percent (46/60) ostia remained successful, including 70% (19/27) of unstented and 82% (27/33) of stented ostia (p = .3). Stented ostia had larger size (p = .003), but this did not confer higher success (p = .14). Successful ostia had higher FICI scores and better ostial dynamicity (p < .05). Ostium movement was the only parameter associated with surgical success on multivariate analysis (OR 13.1, p = .01). Four (1 stented) underwent revision MMED, intraoperative mitomycin-C, and 12-week intubation. All revision ostia were functional after 141 ± 43 months.Surgical success of MMED after 11-years was 77%, a notable reduction compared to 96% success at 1-year. Statistical advantage of silicone intubation for primary MMED was not demonstrated, though clinically, stented ostia had a higher success (82% vs 70%). The presence of a dynamic internal common opening was highly associated with long-term surgical success. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants' perceptions of participating in the intervention. Design and methods: In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019–2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data. Results: There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: 'Meaningful perspectives on lifestyle changes' and 'Lifestyle change is not a linear process due to challenges faced along the way' putting ownership of their choices in life into picture. Conclusion: The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes. [ABSTRACT FROM AUTHOR]

Despite sedentary behavior being ubiquitous in students and detrimental to health, interventions specifically targeting it are mostly restricted to leisure time screen time reduction. With six weekly sessions alongside a poster campaign and an additional teacher intervention, the Let's Move It trial delivered environmental and psychological strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in vocational schools, an understudied environment for behavioral interventions. Participants in the intervention arm considerably reduced sedentary time post-intervention. To investigate how social cognitions about restricting SB, as defined by the Reasoned Action Approach, change in intervention and control arms, self-reported data on social cognitions was collected as part of a cluster-randomized controlled trial from 1166 students (59% female, mage = 18.7 years, range: 16–49) in six vocational schools before, post-intervention, and 14 months post-baseline. Data were analyzed using mixed between-within repeated measures ANOVA. We found greater improvements in intention (F(1, 833) = 9.69; η2p = 0.01; p =.018) and descriptive norms (F(1, 831) = 13.25; η2p = 0.016; p <.001) in the intervention than control arm, but these effects depended on the included control variables. Generally, intervention effects leveled off from post-intervention to follow-up. The Let's Move It intervention for SB reduction showed modest, short-lived effects on social cognitions, indicating that changes in behavior are likely due to other factors like changes to the classroom environment. Optimally, SB reduction interventions should not only change behavior but produce robust changes in conscious intentions to restrict one's sitting, so that positive effects generalize to other contexts. [ABSTRACT FROM AUTHOR]

To illustrate the challenges encountered when gathering rapidly synthesized evidence in response to the coronavirus disease 2019 (COVID-19) pandemic. In this article, we describe the challenges encountered when we performed a systematic literature review (SLR) of randomized controlled trials (RCTs) on the efficacy and safety of treatments for severe COVID-19. The methods of the SLR are described in full, to show the context of our objectives. Then we use the results of the SLR to demonstrate the problems of producing synthesized evidence in this setting. Various challenges were identified during this SLR. These were primarily a result of heterogeneity in the study methodology of eligible studies. Definitions of the patient populations and outcome measurements were highly variable and the majority of studies demonstrated a high risk of bias, preventing quantitative synthesis of the collated evidence. Consolidating evidence from RCTs evaluating COVID-19 interventions was problematic. Guidance is needed for scenarios with high rapid output in primary research. [ABSTRACT FROM AUTHOR]

Brief Admission by self-referral (BA) is a crisis-management intervention standardized for individuals with self-harm at risk of suicide. We analyzed its health-economic consequences. BA plus treatment as usual (TAU) was compared with TAU alone in a 12-month randomized controlled trial with 117 participants regarding costs for hospital admissions, coercive measures, emergency care and health outcomes (quality-adjusted life years; QALYs). Participants were followed from 12 months before baseline to up to five years after. Over one year BA was associated with a mean annual cost reduction of 4800 or incremental cost of 4600 euros, depending on bed occupancy assumption. Cost-savings were greatest for individuals with >180 admission days in the year before baseline. In terms of health outcomes BA was associated with a QALY gain of 0.078. Uncertainty analyses indicated a significant QALY gain and ambiguity in costs, resulting in BA either dominating TAU or costing 59 000 euros per gained QALY. BA is likely to produce QALY gains for individuals living with self-harm and suicidality. Cost-effectiveness depends on targeting high-need individuals and comparable bed utilization between BA and other psychiatric admissions. Future research should elaborate the explanatory factors for individual variations in the usage and benefit of BA. [ABSTRACT FROM AUTHOR]

This study investigated the impact of language learning in comparison to other complex learning activities on cognitive functioning and psychosocial well-being in cognitively healthy, community-dwelling older adults. In a randomized controlled trial, 43 Dutch functionally monolinguals aged 65–78 completed a three-month English course (n = 15), music training (n = 13), or a lecture series (n = 15). Cognitive functioning (global cognition, cognitive flexibility, episodic memory, working memory, verbal fluency, and attention) and psychosocial well-being were assessed before and immediately after the intervention, and at a four-month follow-up. The language learners significantly improved on episodic memory and cognitive flexibility. However, the magnitude of cognitive change did not significantly differ between the language learning and music training conditions, except for a larger positive change in cognitive flexibility for the language learners from pretest to follow-up. Our results suggest that language learning in later life can improve some cognitive functions and fluency in the additional language, but that its unique effects seem limited. [ABSTRACT FROM AUTHOR]

This study addresses a gap in resilience interventions for rural preschoolers by validating a 14-week play-based picture-book reading program involving 80 Chinese preschoolers aged 4–5 years. Participants were randomly assigned to non-intervention (NI), play intervention (PI), picture-book reading intervention (PRI), or play-based picture-book reading intervention (PPRI) groups. Kindergarten teachers and parents reported children's resilience with the Chinese version of Devereux Early Childhood Assessment for Preschoolers at pretest, post-test, and follow-up. Results revealed that intervention groups (PI, PRI, PPRI) exhibited higher resilience gain scores than the NI group. Notably, the PPRI group demonstrated greater resilience gains compared to the PRI and PI groups. Furthermore, the intervention effects of the PPRI group were maintained for two months following the intervention. Those findings suggest that PPRI may be a valuable intervention for enhancing resilience in preschoolers, with potential applications in kindergarten classrooms. [ABSTRACT FROM AUTHOR]

This randomized controlled trial examined the effects of fictive kin interaction on the physical health and psychological well-being of older adults living in a shared site nursing home in China. The results revealed that depression levels significantly decreased and self-efficacy and flourishing levels significantly increased among the participants who engaged in additional one-to-one pair activities with kindergartners, with the effect size ranging from medium to large. The research findings indicated that one-to-one fictive kinship interactions between older adults and young children can promote the self-perceived physical health and psychological well-being of older adults in a Chinese context. [ABSTRACT FROM AUTHOR]

The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients. In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales. The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals' SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group's outcomes at each assessment point. Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals' sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Online credit recovery will likely expand in the coming years as school districts try to address increased course failure rates brought on by the coronavirus pandemic. Some researchers and policymakers, however, raise concerns over how much students learn in online courses, and there is limited evidence about the effectiveness of online credit recovery. This article presents findings from a multisite randomized study, conducted prior to the pandemic, to expand the field's understanding of online credit recovery's effectiveness. Within 24 high schools from a large urban district, the study randomly assigned 1,683 students who failed Algebra 1 or ninth grade English to a summer credit recovery class that either used an online curriculum with in-class teacher support or the school's business-as-usual teacher-directed class. The results suggest that online credit recovery had relatively insignificant effects on student course experiences and content knowledge, but significantly lower credit recovery rates for English. There was limited heterogeneity in effects across students and schools. Non-response on the study-administered student survey and test limit our confidence in the student experience and content knowledge results, but the findings are robust to different approaches to handling the missing data (multiple imputation or listwise deletion). We discuss how the findings add to the evidence base about online credit recovery and the implications for future research. [ABSTRACT FROM AUTHOR]

Purpose: For individuals with atopic dermatitis (AD), interpreting scientific papers that present clinical outcomes including the Eczema Area and Severity Index (EASI) and Investigators Global Assessment may be difficult. When compared to tabulated data and graphs, images from before and after treatment are often far more meaningful to these patients that ultimately will be candidates for the treatment. This systematic review focused on determining the frequency of clinical image sharing in AD research. Materials and methods: Conducted in accordance with PRISMA guidelines, the review concentrated on randomized controlled trials that investigated predefined and available systemic treatments for AD. The search was performed in the MEDLINE database for studies published from the inception until 21 December 2023. Results: The review included 60 studies, encompassing 17,799 randomized patients. Across these studies, 16 images representing 6 patients were shared in the manuscripts, leading to a sharing rate of 0.3‰. Conclusions: The almost missing inclusion of patient images in clinical trial publications hinders patient understanding. Adding images to scientific manuscripts could significantly improve patients’ comprehension of potential treatment outcomes. This review highlights the need for authors, the pharmaceutical industry, study sponsors, and publishers to enhance and promote patient information through increased use of visual data. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman's correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. Results: A total of 488 patients (median age 51years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b=1.33, 95%CI:0.65-2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 - -0.49) and quality of life (12-item Short Form Survey physical score b=3.31, 95%CI:2.17-4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n=347, ρ=-0.12, p=0.02) and improved quality of life (n=217, ρ=0.16, p=0.02). Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25. [ABSTRACT FROM AUTHOR]

Little is known about the scope of use-of-force incidents in carceral settings, nor the impact of efforts to control it. Correctional agencies have recently begun adopting body-worn cameras (BWCs) to mitigate such incidents and improve institutional management. We conducted a one-year randomized controlled trial of BWCs among the 12 housing units in the Loudoun County Adult Detention Center in Virginia. We collected data on the 97 response-to-resistance (RTR) events that occurred during our study period, including deputies' control methods (physical controls, restraints, weapons) and residents' resistance levels (passive, active, aggressive) during these events. Using negative binomial regression, we found a 40% decrease in RTR events in unit-months with BWCs. We also found 37% and 52% reductions in the use of physical controls by deputies and the occurrence of resident active resistance, respectively. We situate these findings in the correctional context and discuss their implications for policy and future research. [ABSTRACT FROM AUTHOR]

Despite recent calls for more peer support initiatives aimed at promoting mental health in postsecondary institutions, those initiatives remain scarce. In this study, a multisite randomized controlled trial was designed to assess the effect of an online peer support intervention based on acceptance and commitment therapy using mental health and school indicators. Undergraduate students were recruited in three Canadian universities and randomly assigned to an intervention (n = 54) or a wait-list control group (n = 53). Compared to control participants, those who took part in the program self-reported reduced psychological inflexibility, stress, anxiety and depression, and increased psychological flexibility and well-being. The intervention had no effect on academic satisfaction and engagement. These results were found both in completer and intent-to-treat samples. The findings provide evidence that peer support may be a beneficial adjunct to mental health interventions offered to college and university students. [ABSTRACT FROM AUTHOR]

AbstractThe rich inflectional grammar of Finnish is often considered a challenge for second language (L2) learners. However, the inflectional variation is based on relatively systematic morphological and morphophonological rules. Smartphone applications could offer an effective way to train these rules by utilizing adaptive spaced repetition exercises. Currently there is little research on morphology learning via Mobile Assisted Language Learning (MALL) applications in morphologically rich languages. The present study introduces a newly developed Finnish Morphology Application (FMA) that aims to teach beginner-level Finnish morphology. In a randomized controlled trial, the test group participants (n = 33) practiced Finnish morphology with the FMA during a three-week period, and their improvements were compared to those of an active control group using a general Finnish language learning application (n = 38). The practiced morphological operations comprised transparent and semi-transparent inflections. Pre- and posttests included a visual lexical decision task and a morphological production task. In comparison to the control group, the FMA group improved substantially in written morphological production skills, especially in transparent inflections. In visual lexical decision task, there was an improvement in accuracy for trained words in the FMA group, but this improvement applied to both transparent and semi-transparent inflections as well as monomorphemic nouns. In reaction times, there were no differences between the groups. Self-ratings of perceived efficacy of the FMA regarding grammar and vocabulary varied from neutral to positive. The results suggest that the FMA is particularly useful for learning inflectional production skills in Finnish by adult beginner level learners but can also be used to train word recognition. [ABSTRACT FROM AUTHOR]

Cancer-related fatigue (CRF) is unrelenting. As neither rest nor sleep ameliorates cognitive, emotional, and physical symptoms, quality of life is diminished. This study examines resistance training (RT) effectiveness on CRF in cancer survivors. The secondary aims were to identify the dose-response relationship of RT frequency, intensity, and volume on CRF in different cancer survivor populations. Systematic searches via numerous databases for RCTs were performed in June 2022. Patient-reported outcome measures (PROM), were analysed, pre-to-post intervention, using a random-effects model. The Physiotherapy Evidence Database (PEDro) scale informed methodological quality assessment. Eight studies were included (cancer survivors: breast (BCS) = 5; endometrial (ECS) = 1; prostate (PCS) = 2). Overall, RT interventions ≥ 6 weeks elicited large significant reductions in CRF for FACIT-F (SMD = 0.932, p = <0.001) and moderate significant reductions in CRF for PFS-R (SMD = −0.622, p = 0.004). Main findings indicate that RT ameliorates CRF, especially in BCS; however, individualised approaches should be advocated. Supervised training elicited the greatest positive outcomes, thus should be a pivotal part of the cancer rehabilitation pathway. Future studies should be adequately powered, undertake discrete analyses of different cancer types, and investigate chronic RT effects. Cancer-related fatigue (CRF) is debilitating and distressing, leading to reduced quality of life and function in cancer survivors. Considerable heterogeneity exists in disease histology and clinical patient presentation. Individualised resistance training (RT) is an effective, safe, and accessible intervention to mitigat:e fatigue levels, thus aid function, most notably in breast cancer survivors [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Mindfulness interventions have become a common feature of worksite stress management provision. However, the evidence underpinning these interventions continues to attract scrutiny, with unresolved questions surrounding: the generalizability of mindfulness research findings to real-world workplace training applications, comparability of different mindfulness approaches offered in workplace settings, and effects on job performance. The current trial contributes to the literature by exploring effects of mindfulness training (MT) and acceptance and commitment therapy (ACT), which were delivered to staff in the same healthcare organization. Participants were randomly assigned to a 4-session MT program (n = 63), a 4-session ACT program (n = 67), or a waiting list control group (n = 69). Study measures were administered on five occasions spread across a 6-month period. Results indicated that both MT and ACT reduced perceived stress and improved mindfulness and sleep quality when compared to the control group. ACT showed slight superiority in helping employees align their behaviour with personal values. Neither MT nor ACT was effective in reducing work limitations. We consider explanations for equivocal effects on job performance outcomes, and highlight the importance of testing the effectiveness of worksite mindfulness interventions under ecologically valid conditions. [ABSTRACT FROM AUTHOR]

Coping Power (CP) is an evidence-based manualized group therapy targeting child conduct problems at the family level. We examined maternal-internalizing problems (e.g., depressive and anxiety symptoms) as a predictor of treatment response for children with disruptive behavior when comparing group treatment (CP) versus non-standardized individualized treatment. Ninety-three mothers participated. CP was similar or better than individual treatment for families with maternalinternalizing problems. Marginally significant improvements in child conduct problems and inconsistent discipline were found among mothers in CP with internalizing problems. Findings highlight the potential efficacy of CP for child and parenting needs among families with maternal-internalizing problems. [ABSTRACT FROM AUTHOR]

Entertainment-education has been touted as a potent delivery channel for health education campaigns. Yet, there is little evidence of its causal effects. This paper aims to fill the gap in the literature by using a field experiment in India to study two questions on the efficacy of health entertainment-education. First, can health entertainment-education, particularly through films that show role models and draw on emotions, lead to lasting, positive change in health knowledge and behavior? Second, can financial incentives for ex-post health literacy boost the effectiveness of health entertainment-education? The results show that health entertainment-education successfully increased health knowledge (e.g. knowledge about cleanliness and hygiene) by 16 percent. These gains persist almost one year later, although there were no observed impacts on health behaviors. Further, financial incentives do not appear to have any effects. These insights contribute to our knowledge of what works for health education in low-income settings, so that future education campaigns can be crafted with more meaningful impact. [ABSTRACT FROM AUTHOR]

Smoking is the single factor with the highest impact on reducing life expectancy of patients with mental illness. Patients experience difficulty in participating in smoking cessation programs but are concerned about the impact of tobacco on their health and finances. Smoking cessation advice via videoconferencing might be an alternative to an ordinary in-person consultation. Randomized controlled trial with follow-up at 6 months. We included patients with diagnoses of schizophrenia and affective disorder from psychiatric outpatient clinics. Intervention 1 involved daily video consultations; intervention 2 was treatment as usual. Seventy patients were included. For both/all groups/interventions, rates of smoking cessation were 45% and predictors for a 50% reduction in smoking were antipsychotic medication load [odds ratio (OR) 0.54; p = 0.045] and number of nicotine patches (OR 1.02; p = 0.06). Predictors for a reduction in the number of cigarettes to < 10 were antipsychotic medication load (OR 0.52; p = 0.04), number of nicotine patches (OR 1.01; p = 0.02) and number of cigarettes at baseline [OR 0.95 (p = 0.09); adjusted OR 0.94 (p = 0.02)]. Patients prevented weight gain during the cessation period. The smoking cessation rate was high. One of the reasons for the high cessation rate was that the intervention was carried out by highly experienced and professionally qualified staff. In addition, we used free nicotine patches to increase the patients' motivation to quit smoking. It is very important that we introduce these results into our clinical work with the patients. [ABSTRACT FROM AUTHOR]

AbstractBackground and objective: Cognitive–behavioral therapy (CBT) for somatoform disorders (SFDs) is understudied in China. Western findings may not be applicable to Chinese culture. This preliminary study evaluated the efficacy of CBT for patients in China, relative to treatment-as-usual (TAU). Methods: Seventy patients with SFDs randomly received either combined CBT and TAU (CBT + TAU), or TAU alone between January 2018 to May 2019. The CBT + TAU group received 12 weekly individual 50-minute CBT sessions. Participants were blindly assessed at 4 timepoints (baseline, week 6, end of treatment: week 12; 12 weeks post-treatment: week 24) using the following outcome measures: SQSS (Self-screening Questionnaire for Somatic Symptoms); PHQ-15 (Patient-Health-Questionnaire-15) and the WI (Whiteley Index); GAD-7 (General Anxiety Disorder-7); HAMD-17 (Hamilton Depression Rating Scale-17); Family Burden Interview Schedule (FBIS); Sheehan Disability Scale (SDS); and the Short Form of Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). The primary endpoint was the difference between the SQSS total score at week 24 and the baseline. A mixed model for repeated measures was used to analyze inter- and intra-group changes from the baseline. Results: At week 24, The least-squares mean (LSM) change of the total score on the SQSS was −18.87 points and −9.69 points, respectively in the CBT + TAU group and in the TAU group (LSM difference, −9.18 points; 95% confidence interval, −15.72 to −2.64; P = 0.0068). At week 24, the LSM changes from baseline in the WI, HAMD, PHQ15, FBIS and SDS total scores were significantly different between the two groups, however, there was no significant difference in the Q-LES-Q-SF. The SQSS of group effect sizes were 0.63 at 24 weeks. The dropout rates of the CBT + TAU and TAU groups were comparable (22.9% and 19.3%). Conclusions: These preliminary findings suggest that CBT may be helpful for improving the symptoms of patients with SFDs in China. [ABSTRACT FROM AUTHOR]

Frequent attenders in primary care (FAs) consume a disproportionate amount of healthcare resources and often have depression, anxiety, chronic health issues, and interpersonal problems. Despite extensive medical care, they remain dissatisfied with the care and report no improvement in quality of life. To pilot a Telephone-based Interpersonal Counseling intervention for Frequent Attenders (TIPC-FA) and assess its feasibility and efficacy in reducing symptoms and healthcare utilization. Top 10% of primary care visitors were randomly assigned to TIPC-FA, Telephone Supportive Contact (Support), or Treatment as Usual (TAU). TIPC-FA and Support groups received six telephone sessions over twelve weeks, while the TAU group was interviewed twice. Multilevel regression tested for changes over time, considering patient and counselor variance. TIPC-FA and Support groups demonstrated reduced depressive symptoms, and the TIPC-FA group showed decreased somatization and anxiety. The TIPC-FA group demonstrated a trend towards less healthcare utilization than the TAU group. This pilot study suggests that IPC via telephone outreach is a feasible approach to treating FAs, achieving a reduction in symptoms not seen in other groups. Promising reduction in healthcare utilization in the TIPC-FA group warrants further exploration in larger-scale trials. [ABSTRACT FROM AUTHOR]

Observational research suggests higher red and processed meat intakes predict greater risks of developing or dying from cardiovascular diseases (CVD) and type 2 diabetes mellitus (T2DM), but this research limits causal inference. This systematic review of reviews utilizes both observational and experimental research findings to infer causality of these relations. Reviews from four databases were screened by two researchers. Reviews included unprocessed red meat (URM), processed meat (PM), or mixed URM + PM intake, and reported CVD or T2DM outcomes. Twenty-nine reviews were included, and causality was inferred using Bradford Hill's Criteria. Observational assessments of CVD outcomes and all meat types consistently reported weak associations while, T2DM outcomes and PM and Mixed URM + PM assessments consistently reported strong associations. Experimental assessments of Mixed URM + PM on CVD and T2DM risk factors were predominately not significant which lacked coherence with observational findings. For all meat types and outcomes, temporality and plausible mechanisms were established, but specificity and analogous relationships do not support causality. Evidence was insufficient for URM and T2DM. More experimental research is needed to strengthen these inferences. These results suggest that red and processed meat intakes are not likely causally related to CVD but there is potential for a causal relationship with T2DM. [ABSTRACT FROM AUTHOR]

Mobile health applications (mHealth apps) may lead to health benefits. In recent years, the use of apps in multiple sclerosis (MS) has increased. Apps to train and improve dexterity in MS are scarce. This study investigated the effectiveness of a tablet app-based home-based training to improve dexterity in individuals with MS. In a randomized controlled trial, two standardized 4-week home-based interventions focussing on different aspects of dexterity and upper limb function were compared. Assessments were done at baseline, post-intervention and 12-week follow-up. The primary endpoint was the Arm Function in Multiple Sclerosis Questionnaire, a dexterity-related measure of patient-reported activities of daily living. Secondary endpoints were dexterous function, grip strength and health-related quality of life. Forty-eight individuals were randomly assigned to a tablet app-based program (n = 26) or a control strengthening exercise program (n = 22). No significant differences were found for the primary endpoint (p = 0.35). Some significant differences in favour of the app-group were found in fine coordinated finger movements and strength. No significant differences were found at the 12-week follow-up for all endpoints. Adherence in both groups was above 90%. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. However, app-based training was found to be effective in improving specific dimensions (finger movements and strength), and can easily be applied at home. Therefore, individuals living with MS with impaired dexterity should consider app-based training. Clinicaltrials.gov NCT03369470. This study provides initial evidence for the effectiveness of a home-based app-based program for improving dexterous function in individuals living with multiple sclerosis through the implementation of a tablet app-based dexterity training. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. Patients attending the app-based dexterity program showed some statistically significant improvements in fine coordinated finger movements and strength. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionThis study aims to comprehensively verify the efficacy of Buyang Huanwu Decoction in improving cognitive function in patients with diabetes.Patients clinically diagnosed with mild cognitive impairment (MCI) assigned to either the placebo group or the Buyang Huanwu Decoction group. After strict screening and exclusions, a total of 156 participants completed the clinical trial, with 76 in the placebo group and 80 in the Buyang Huanwu Decoction group.After treatment, Buyang Huanwu Decoction group showed higher Mini-Mental State Examination and Montreal Cognitive Assessment scores compared to placebo (p < 0.05). Memory and Executive Screening, Boston Naming Test, and Animal Fluency Test scores were also higher in the treatment group (p < 0.05). No significant differences were found in DST and CDT scores (p > 0.05). Trail Making Test scores were lower in the treatment group (p < 0.05). No significant difference was observed between the two groups in terms of complications (p > 0.05).Patients receiving Buyang Huanwu Decoction treatment demonstrated improvement in cognitive function, showing positive effects and providing preliminary evidence for the role of Buyang Huanwu Decoction in improving cognitive function in patients with diabetes. This suggests its potential for clinical application and further promotion. [ABSTRACT FROM AUTHOR]

Conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of individual humanistic-experiential therapies (HEPs) for depression. Database searches (Scopus, Medline, and PsycINFO) identified RCTs comparing any HEP intervention with a treatment-as-usual (TAU) control or active alternative intervention for the treatment of depression. Included studies were assessed using the Risk of Bias 2 tool and narratively synthesized. Post-treatment and follow-up effect sizes were aggregated using random-effects meta-analysis and moderators of treatment effect were explored (PROSPERO: CRD42021240485). Seventeen RCTs, synthesized across four meta-analyzes, indicated HEP depression outcomes were significantly better than TAU controls at post-treatment (g = 0.41, 95% CI [0.18, 0.65], n = 735), but not significantly different at follow-up (g = 0.14, 95% CI [−0.30, 0.58], n = 631). HEP depression outcomes were comparable to active treatments at post-treatment (g = −0.09, 95% CI [−0.26, 0.08], n = 2131), but significantly favored non-HEP alternative interventions at follow-up (g = −0.21, 95% CI [−0.35, −0.07], n = 1196). Relative to usual care, HEPs are effective in the short-term and comparable to non-HEP alternative interventions at post-treatment, but not at follow-up. However, imprecision, inconsistency, and risk of bias concerns were identified as limitations of the evidence included. Future large-scale trials of HEPs with equipoise between comparator conditions are required. [ABSTRACT FROM AUTHOR]

Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. R000038375 UMIN000033926 Individuals with stroke often collide with the paretic side while walking through narrow spaces. Training for walking through a narrow opening from the paretic side improved an individual's ability to avoid obstacles in similar tasks. Moreover, such training could improve patient outcomes/safety because such interventions may temporarily increase attentional focus to the paretic side in specific tasks. [ABSTRACT FROM AUTHOR]

Randomized experiments allow for consistent estimation of the average treatment effect based on the difference in mean outcomes without strong modeling assumptions. Appropriate use of pretreatment covariates can further improve the estimation efficiency. Missingness in covariates is nevertheless common in practice, and raises an important question: should we adjust for covariates subject to missingness, and if so, how? The unadjusted difference in means is always unbiased. The complete-covariate analysis adjusts for all completely observed covariates, and is asymptotically more efficient than the difference in means if at least one completely observed covariate is predictive of the outcome. Then what is the additional gain of adjusting for covariates subject to missingness? To reconcile the conflicting recommendations in the literature, we analyze and compare five strategies for handling missing covariates in randomized experiments under the design-based framework, and recommend the missingness-indicator method, as a known but not so popular strategy in the literature, due to its multiple advantages. First, it removes the dependence of the regression-adjusted estimators on the imputed values for the missing covariates. Second, it does not require modeling the missingness mechanism, and yields consistent estimators even when the missingness mechanism is related to the missing covariates and unobservable potential outcomes. Third, it ensures large-sample efficiency over the complete-covariate analysis and the analysis based on only the imputed covariates. Lastly, it is easy to implement via least squares. We also propose modifications to it based on asymptotic and finite sample considerations. Importantly, our theory views randomization as the basis for inference, and does not impose any modeling assumptions on the data-generating process or missingness mechanism. for this article are available online. [ABSTRACT FROM AUTHOR]

We systematically reviewed extant studies evaluating the efficacy and tolerability of xanomeline and xanomeline-trospium (KarXT) for treatment of adults with schizophrenia. In accordance with PRISMA guidelines, articles were systematically searched for in databases and clinical trial registries. A total of 4 preclinical trials and 3 randomized controlled trials (RCTs) were included in this review. A 4-week RCT observed a difference of 24.0 points (SD 21.0) in the Positive and Negative Syndrome Scale (PANSS) total score between xanomeline and placebo groups (p = 0.039). A 5-week RCT observed PANSS total score changes from baseline to week 5, including −17.4 and −5.9 points in KarXT and placebo groups, respectively (LSMD −11.6 points; 95% CI −16.1 to −7.1; p < 0.001; d = 0.75). Another 5-week RCT observed PANSS total score changes from baseline to week 5, including −21.2 (SE 1.7) and −11.6 (SE 1.6) points in KarXT and placebo groups, respectively (LSMD −9.6; 95% CI −13.9 to −5.2; p < 0.0001; d = 0.61). Side effects include constipation, nausea, vomiting, dyspepsia, and dry mouth. KarXT offers an innovative non-D2 blocking approach, representing a promising treatment avenue for schizophrenia. [ABSTRACT FROM AUTHOR]

This randomized controlled trial aimed to assess the efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered cognitive-emotional intervention, among the homebound older population presenting with mild cognitive impairment and depressive or anxiety symptoms. Participants were randomly assigned either to the intervention group or the treatment-as-usual group and completed baseline, post-intervention, and three-month follow-up assessments. Changes in episodic memory and symptoms of depression and anxiety were the primary outcomes. Secondary outcomes included changes in global cognition, attentional control, subjective memory complaints, functional status, and quality of life. Data were analyzed on an intention-to-treat basis employing a linear mixed models approach. ClinicalTrials.gov identifier: NCT05499767. Compared with the treatment-as-usual group, the HEPPI group reported significant immediate improvement in cognition, mood, and daily functional performance. Positive effects of HEPPI were maintained over the follow-up phase only in depressive symptomatology, perceived incapacity to perform advanced instrumental activities of daily living, and self-reported emotional ability. A significant impact of the intervention on the subjective memory complaints level was observed only three months after the intervention. This study suggests that HEPPI may be a promising home-delivered cognitive-emotional intervention to help homebound older adults improve their mental health. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of ubrogepant 50 mg versus 100 mg daily for migraine remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of ubrogepant 50 mg versus 100 mg daily on treatment in migraine patients. Methods: We have searched PubMed, EMbase, Web of science, EBSCO, Cochrane library databases and SCOPUS through 21 March 2022 for randomized controlled trials (RCTs) assessing the effect of ubrogepant 50 mg versus 100 mg on treatment efficacy in migraine patients. This meta-analysis was performed using the random-effect model. Results: Three RCTs were included in the meta-analysis. Overall, compared with ubrogepant 100 mg in migraine patients, ubrogepant 50 mg obtained comparable pain freedom at 2 h (OR = 0.86; 95% CI = 0.64–1.15; p = 0.310), sustained pain freedom 2–24 h (OR = 0.76; 95% CI = 0.54–1.07; p = 0.110), photophobia absence at 2 h (OR = 0.80; 95% CI = 0.63–1.02; p = 0.070), phonophobia absence at 2 h (OR = 1.07; 95% CI = 0.82–1.40; p = 0.620) and nausea absence at 2 h (OR = 1.02; 95% CI = 0.79–1.32; p = 0.880). In terms of safety, adverse events were found to be increased in ubrogepant 100 mg as compared to ubrogepant 50 mg (OR = 0.81; 95% CI = 0.67–0.99; p = 0.040), and there was no statistical difference of serious adverse events between two groups (OR = 0.87; 95% CI = 0.40–1.91; p = 0.720). Conclusions: Ubrogepant 50 mg and 100 mg may be equally effective to alleviate migraine, but ubrogepant 100 mg led to increase incidence of adverse events. [ABSTRACT FROM AUTHOR]

AbstractObjective: This randomized controlled trial investigated the efficacy of dynamic relational group therapy (DRT) relative to group psychodynamic supportive therapy (PST) in improving perfectionism-related attitudes and components of the perfectionistic self-relationship. Method: Based on a comprehensive conceptualization of perfectionism, 80 community-recruited, highly perfectionistic individuals were randomly allocated to 12 sessions of group DRT (n = 41; 5 groups) or group PST (n = 39; 5 groups). Patients completed measures of dysfunctional attitudes, self-criticism, self-esteem, and self-reassurance at pre-, mid-, and post-treatment, and six months post-treatment. Results: Multigroup latent growth curve modeling revealed significant (p < .05) decreases in dysfunctional attitudes, concern over mistakes, two types of self-criticism, and self-esteem problems, along with a significant increase in self-reassurance, from pre-treatment to six-month follow-up in both DRT and PST. Moderate-to-large between-group differences favoring DRT over PST were found for dysfunctional attitudes and self-reassurance. A majority of patients in both conditions maintained reliable improvement at six-month follow-up in dysfunctional attitudes, concern over mistakes, and self-criticism focused on inadequacy. Conclusion: Findings provide evidence for the use of psychodynamic group therapy approaches in treating perfectionism-related attitudes and self-relational elements of perfectionism, and support the relative efficacy of DRT for dysfunctional attitudes and self-reassurance. [ABSTRACT FROM AUTHOR]

This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia. This monocenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial (registration number: DRKS00003261) was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505–0.773, Student's t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student's t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment. Trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial was to evaluate an adapted cognitive behavioural therapy (CBT) programme for treating anxiety in adolescents with acquired brain injury (ABI). Participants with ABI (12–19 years, N = 36) recruited from two sites were randomly allocated into either the intervention receiving 11 sessions of CBT (n = 19) or a wait-list control group (n = 17). The primary outcome was participants' anxiety and secondary outcomes were participants' depression, self-perception, and participation in daily activities, and parental stress, measured at (i) pre-intervention, (ii) immediately post-intervention, (iii) 2 months post-intervention and (iv) 6 months post-intervention. Repeated measures ANOVAs revealed significant treatment effects with the intervention group demonstrating greater improvements in self-reported anxiety, as well as self- and parent-reported depression from pre- to immediately post-treatment, compared to wait-list controls. Little evidence of treatment effects was found for the remaining outcomes (parent-reported anxiety, self-perception, daily participation, and parental stress). Significant improvement in self-reported anxiety found immediately post-treatment was maintained at two- and six-month follow-up. Findings provide support for adapted CBT as an effective means of reducing anxious and depressive symptomatology in adolescents with ABI compared to waitlist controls, and offer support for the use of these techniques to manage anxiety in this population. [ABSTRACT FROM AUTHOR]

Private school choice programs' success depends partly on the supply of private schools. Many parents prioritize a religious education for their children. Therefore, it is important to consider how religious private schools may respond to various program regulations. We conducted an experimental study surveying a national sample of 354 leaders of Association of Christian Schools International (ACSI) member schools, the second largest private school organization of any kind in the United States. We find evidence that while over four-fifths of Christian school leaders are inclined to participate with no changes to school operations, open enrollment mandates reduce participation rates by 62 percentage points and employment regulations reduce participation rates by 79 percentage points. [ABSTRACT FROM AUTHOR]

This article provides a replication study of the National Writing Project's College, Career, & Community Writers Program (C3WP), which was found to be effective at improving student writing quality in two prior studies. C3WP is designed to improve students' source-based argument writing through intensive teacher professional development, instructional resources, and formative assessment. In this study, we used a randomized controlled trial design, randomizing 22 of 44 rural districts into 1 year of C3WP for their grade 7–9 English language arts teachers. We collected argument writing from all students using a performance task similar to those in many state assessments, and we scored the writing for attributes of writing quality and conventions. We found that C3WP led to statistically and meaningfully significant findings on all attributes measured (g = 0.20–0.22). We interpret this study as validating the effects of C3WP on student argument writing quality and providing evidence that C3WP also positively impacts students' writing conventions. These three separate studies of C3WP spanned 228 diverse schools in 20 states, providing an unusually robust body of rigorous, independent evidence of program effectiveness. [ABSTRACT FROM AUTHOR]

The evidence supporting the cardiovascular health benefits of physical activity and/or exercise training is well-established. While the role of physical activity in primary prevention is unequivocal, its significance in secondary prevention (among those with preexisting cardiovascular disease) is less definitive. Though guidelines universally recommend physical activity as part of the secondary preventive strategy, the empirical evidence underpinning these recommendations is not as robust as that for primary prevention. This review distills the body of available observational and interventional evidence on the relationship between physical activity, exercise, and adverse cardiovascular outcomes among those with preexisting cardiovascular disease. The postulated biologic mechanisms underlying the relationships, areas of prevailing uncertainty, and potential public health implications are also discussed. A physical activity level of 500 MET-min/week (equivalent to 150 min of moderate-intensity physical activity or 75 min of vigorous-intensity physical activity or an equivalent combination) may be a minimum requirement for patients with preexisting CVD. However, to reap the maximum benefits of physical activity and also minimize adverse effects, physical activity and/or exercise regimens should be tailored to unique factors such as individual's baseline physical activity habits, cardiovascular health status and the specific nature of their cardiovascular disease. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has tremendous impact on public mental health and on psychological resources such as optimism. In this context, positive psychological interventions like the best possible self (BPS) intervention may be useful tools for resource activation. Therefore, a randomized controlled trial, conducted between January and December 2021, compared BPS (n = 87), C-BPS (n = 85), and daily activity writing groups (DA; n = 82) on psychological outcomes. Each group completed a writing task over four consecutive weeks. Data were analysed using repeated measures ANCOVA, controlling for age, gender, educational attainment, relationship status, current work status, dyslexia (perceived or diagnosed), and perceived social support. The BPS led to short-term increases in positive affect and mood, and decreases in negative affect. However, this effect was limited to the first week, but the trajectories suggest temporal trends that warrant further investigation. In addition, the approach holds promise for specific groups (e.g. people with depression). [ABSTRACT FROM AUTHOR]

Current guidelines recommendations for the initial dose of prednisolone (PSL) in the treatment of subacute thyroiditis (SAT) are based on low-quality studies. We designed a randomized controlled trial (RCT) to compare the efficacy and safety of using a low initial dose of PSL with a standard initial dose of PSL in SAT patients. This open-label RCT was conducted at five hospitals in China from June 2019 to January 2022. SAT patients with moderate-to-severe pain or a poor response to non-steroidal anti-inflammatory drugs (NSAIDs) were randomly assigned in a 1:1 ratio to the experimental and control groups. The initial dose of PSL was 15 mg/d in the experimental group and 30 mg/d in the control group. The primary outcome was the total duration of PSL treatment, with non-inferiority prespecified with a margin of 7 days. Clinical trial registration number: ChiCTR1900023884. The full analysis set included 60 patients (30 in each group). The mean duration of PSL treatment in the experimental and control group was 34.62 ± 14.12 and 41.18 ± 16.89 days, respectively, meeting the non-inferiority criterion (pnon-inferiority = 0.0006). The total dose of PSL used in the experimental group was lower than in the control groups (330 vs 595 mg, p < 0.0001). There were no differences in the mean time to pain relief and complete resolution, the occurrence of recurrence, hypothyroidism, or adverse events between the groups. The initial dose of 15 mg/d of PSL was not inferior to the dose of 30 mg/d in terms of efficacy and showed a similar safety profile. A low initial dose of PSL could be recommended for Chinese adult SAT patients who have a suboptimal response using NSAIDs or experience moderate-to-severe pain. Low initial dose (15 mg/d) of prednisolone was non-inferior to the standard initial dose of prednisolone (30 mg/d) in treatment duration, time to pain relief, or the prevalence of hypothyroidism, recurrence, and adverse reactions in the treatment of subacute thyroiditis. Patients with subacute thyroiditis administered a low initial dose of prednisolone had a lower total dose of prednisolone compared to those receiving the standard dose of prednisolone. [ABSTRACT FROM AUTHOR]

This study was undertaken to compare the effect of the modified ultrasound-guided anterior superior laryngeal nerve block (SLNB) with the traditional ultrasound-guided posterior SLNB in providing intubation conditions during awake tracheal intubation (ATI) in patients without difficult airway. Randomized, assessor-blind. Registration number: ChiCTR2200058086. West China Hospital of Sichuan University, Chengdu, China. 104 patients aged 18–65 years, of American Society of Anesthesiologists status I-III, posted for elective general surgery with general endotracheal anesthesia. The patients were randomized into two groups (modified group, n = 52; traditional group, n = 52). Modified anterior SLNB or traditional posterior SLNB was performed under ultrasound guidance. The primary outcome was the proportion of acceptable intubation condition (AIC), which was analyzed in both per-protocol (PP) and intention-to-treat (ITT) populations. The prespecified non-inferiority margin was −4.8%. Secondary outcomes included intubation success rate on the first attempt, hemodynamic parameters during ATI, time taken for airway anesthesia and intubation, recall of intubation, patient perception of comfort, and incidence and severity of postoperative complications. In the PP population, the proportion of AIC in the modified group was 49/49 (100%) and that in the traditional group was 49/49 (100%), absolute difference 0, lower limit of 1-sided 95% CI, −0.3%. In the ITT population, the primary outcomes in the modified and traditional group were 52/52 (100%) and 51/52 (98.1%), respectively, with an absolute difference of 1.9% and a lower limit of 1-sided 95% CI of −1.2%. The non-inferiority of modified ultrasound-guided anterior SLNB was confirmed in both populations. Among adults without difficult airways during videolaryngoscope-assisted ATI, the modified ultrasound-guided anterior SLNB, compared to the traditional posterior approach, showed a statistically non-inferior effect in terms of providing AIC. [ABSTRACT FROM AUTHOR]

Septic shock is the development of sepsis to refractory circulatory collapse and metabolic derangements, characterized by persistent hypotension and increased lactate levels. Anisodamine hydrobromide (Ani HBr) is a Chinese medicine used to improve blood flow in circulatory disorders. The purpose of this study was to determine the therapeutic efficacy of Ani HBr in the treatment of patients with septic shock. This was a prospective, multicenter, randomized controlled trial focusing on patients with septic shock in 16 hospitals in China. Patients were randomly assigned in a 1:1 ratio to either the treatment group or the control group. The primary endpoint was 28-day mortality. The secondary outcomes included 7-day mortality, hospital mortality, hospital length of stay, vasopressor-free days within 7 days, etc. These indicators were measured and collected at 0, 6h, 24h, 48h, 72h and 7d after the diagnosis. Between September 2017 and March 2021, 404 subjects were enrolled. 203 subjects received Ani HBr and 201 subjects were assigned to the control group. The treated group showed lower 28-day mortality than the control group. Stratified analysis further showed significant differences in 28-day mortality between the two groups for patients with a high level of illness severity. We also observed significant differences in 7-day mortality, hospital mortality and some other clinical indicators between the two groups. Ani HBr might be an important adjuvant to conventional treatment to reduce 28-day mortality in patients with septic shock. A large-scale prospective randomized multicenter trial is warranted to confirm our results. [ABSTRACT FROM AUTHOR]

The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome. This multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints. No thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%, p <.05). Finally, adverse events were more frequent in warfarin-treated patients. This study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome. ChiCTR-IPR-17013428. [ABSTRACT FROM AUTHOR]

Purpose: To determine the effect of auricular acupuncture on preoperative blood pressure (BP) elevation in different age groups. Materials and methods: Auricular acupuncture treats elevated BP among patients before surgery. This prospective, randomized clinical trial was performed at Li Huili Hospital of Ningbo Medical Center, China, from January to June 2021. We prospectively enrolled 120 patients with elevated BP aged 45 to 75 and observed them in the inpatient department. Patients were randomly assigned in a 1:1 ratio to undergo auricular acupuncture or sham control groups. In addition to usual care, the study group underwent auricular acupuncture bilaterally at HX6 7i-Ear apex, TF4-Shen men, TF1-Superior triangular fossa, and CO15-Heart. Results: A total of 120 patients completed the study, 60 in the study group and 60 in the control group. Of these, 76 (63.3%) were men, and the mean (standard deviation) was 64.55 (9.48) years. The differences in systolic BP comparisons after intervention were significant (7.88 mmHg; 95% confidence interval [CI], 2.94 to 12.81; P = .002). Diastolic BP also showed statistical significance (5.85 mmHg; 95% CI, 3.05 to 8.64; P < .01. Neither AA-related adverse events nor serious adverse events occurred. Stratified by age, the differences comparisons of systolic BP (-10.13 mmHg; 95% confidence interval [CI], -16.69 to -3.57; P < .01) and diastolic BP (-7.65 mmHg; 95% confidence interval [CI], -11.17 to -4.14; P < .01) were statistically significant for participants aged 60-75 years; The differences comparison of systolic BP (-2.37 mmHg; 95% confidence interval [CI], -8.04 to 3.31; P = .40) and diastolic BP (-1.46 mmHg; 95% confidence interval [CI], -5.68 to 2.76; P = .48) were not significant aged 45-59. Conclusion: Auricular acupuncture can reduce BP before procedures. However, further research is needed on the antihypertensive effect on people aged 45-59. These findings provide clinicians with evidence of auricular acupuncture as a standard adjunctive therapy targeting this patient population. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials have demonstrated that Songling Xuemaikang capsule (SXC) is effective in blood pressure (BP) lowering for essential hypertension. However, the effectiveness of SXC in real-world clinical practice remains unknown. We aimed to investigate whether the BP-lowering effectiveness of SXC in the real-world practice setting is comparable to the efficacy of the intervention in a randomized controlled trial. Methods: We included 1325 patients treated with SXC monotherapy from a real-world registry and 300 from the SXC-BP trial. A propensity score matching (PSM) approach was used to select participants from the two cohorts. The primary outcome was a change in the office of BP from baseline to 8 weeks. Results: After PSM, there were 552 patients for the comparative analysis. Clinically meaningful BP reductions were observed both in the real world and in the RCT cohorts after 8-week SXC treatment. The 8-week systolic/diastolic BP was 129.50/81.33 mm Hg vs. 134.97/84.14 mm Hg in the real-world population and the RCT population, respectively. The changes in systolic BP (15.82 ± 10.71 vs. 10.48 ± 10.24; P < .001), and diastolic BP (10.01 ± 7.73 vs. 7.75 ± 8.14; P = .001) from baseline to 8 weeks were significantly greater in the real-world population. Conclusion: The current comparison demonstrated that SXC monotherapy is at least as effective in realworld settings as within the randomized controlled trial for BP lowering in patients with grade 1 hypertension. [ABSTRACT FROM AUTHOR]

To explore the efficacy and safety of ultrasound-guided injection acupotomy as a minimally invasive intervention treatment of cervical spondylotic radiculopathy (CSR). 160 CSR subjects were recruited who met the inclusion criteria in our hospital from October 2019 to December 2021. The subjects were randomly divided into the experimental and control group, with 80 cases in each. The experimental group received ultrasound-guided injection acupotomy as a minimally invasive intervention therapy. The control group received ultrasound-guided selective nerve root block (SNRB). The Odom's criteria clinical curative effect, visual analogue scale (VAS), neck disability index (NDI), and 36-Item Short Form Health Survey questionnaire (SF-36) were used to evaluate the outcome of subjects at several different points in time. At 30 min and 1 month after the end of treatment, there was no significant difference in any scores. However, after six months, the excellent and good rate was better in the experimental group compared to the control (RD = 0.175; 95% CI, 0.044–0.300, p = 0.009). The total effective rate was also better in the experimental group (RD = 0.126; 95% CI, 0.021–0.232, p = 0.018). In contrast, the VAS score (MD = −0.500; 95% CI, −1.000–0.000, p = 0.030) and NDI score (MD = −6.460; 95% CI, −11.067 to −1.852, p = 0.006) were lower in the experimental group compared to the control. The total SF-36 score was higher in the experimental group (MD = 7.568; 95% CI, 2.459–12.677, p = 0.004). Ultrasound-guided injection acupotomy minimally invasive interventional treatment of CSR has no significant difference in short-term curative effect compared with ultrasound-guided SNRB, but the data indicators are significantly better than the latter at 6 months after the end of the course of treatment, showing better long-term efficacy. [ABSTRACT FROM AUTHOR]

Obesity is a chronic disease characterised by excess adiposity, which impairs health. The high prevalence of obesity raises the risk of long-term medical complications including type 2 diabetes and chronic kidney disease. Several studies have focused on patients with obesity, type 2 diabetes and chronic kidney disease due to the increased prevalence of diabetic kidney disease. Several randomized controlled trials on sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 analogues, and bariatric surgery in diabetic kidney disease showed renoprotective effects. However, further research is critical to address the treatment of patients with obesity and chronic kidney disease to lessen morbidity. Obesity is a driver of chronic kidney disease, and type 2 diabetes, along with obesity, accelerates chronic kidney disease. Several randomized controlled trials on sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 analogues, and bariatric surgery in diabetic kidney disease demonstrate the improvement of renal outcomes. There is a need to address the treatment of patients with obesity and CKD to lessen morbidity. [ABSTRACT FROM AUTHOR]

The present study aimed to calculate the estimated size and confidence interval for the effects of adding visual aid to counselling on anxiety, stress and fear of patients undergoing upper gastrointestinal endoscopy. The secondary aim was to calculate confidence interval for endoscopy-related variables that predict which patients are likely to benefit from visual aids. In a randomized, single-blind, two arm, parallel group, superiority trial, 232 consecutive patients who were scheduled to undergo either gastroscopy or colonoscopy were randomly divided into two intervention groups; counselling with video of endoscopic procedure and counselling with no-video (n = 116 in each group). Primary outcome was anxiety and secondary outcomes were stress and fear. One-way ANCOVA showed that there was significant between group differences of anxiety, stress and fear after controlling for the effect of covariates. Planned contrasts revealed that counselling along with visual aid of endoscopy procedure significantly decreased anxiety [Mean difference at post; −4.26 (−4.47, −4.05), p <.001, partial η2 = 0.88], stress [−5.35 (−5.63, −5.07), p <.001, partial η2 = 0.86] and fear [−2.82 (−2.97, −2.67), p <.001, partial η2 = 0.86] compared to counselling alone. Linear regression showed that gender, nature of complaints and concern over seniority of endoscopist were significant negative predictors, however, satisfaction on briefing of endoscopy procedure was significant positive predictor of outcome variables in visual aid condition. The increase in anxiety, acute stress and fear related to endoscopic procedures can be alleviated with psychological counselling coupled with visual aids before the procedure. Visual aid could lead to supplementary benefits in reducing anxiety scores. Number: NCT05241158. Registered 16/11/2022; Counselling along with visual aid of endoscopy procedure significantly decreased anxiety, stress and fear as compared to counselling alone. Male patients were less stressed after visual aid intervention as compared to female patients. Patients who had chronic GI symptoms were less stressed after visual aid intervention as compared to those who had acute GI symptoms. Patients who had concern over seniority of endoscopist were less stressed after visual aid intervention as compared to those who had no concerns over seniority. Satisfaction on briefing of endoscopy procedure was significant positive predictor of stress and fear. [ABSTRACT FROM AUTHOR]

Approximately one-fifth of new parents struggle with unwanted intrusive thoughts (UITs) about intentionally harming their child. This study evaluated the initial efficacy, feasibility and acceptability of a novel online self-guided cognitive intervention for new parents with distressing UITs. Self-recruited parents (N = 43, 93% female, age 23–43 years) of children 0–3 years reporting daily distressing and impairing UITs were randomized to the 8-week self-guided online cognitive intervention or to waiting-list. The primary outcome was change on the Parental Thoughts and Behaviour Checklist (PTBC) from baseline to week 8 (post-intervention). The PTBC and negative appraisals (mediator) were assessed at baseline, weekly, post-intervention and at the 1-month follow-up. Results showed that the intervention led to statistically significant reductions in distress and impairment associated with UITs at post-intervention (controlled between-group d = 0.99, 95% CI 0.56 to 1.43), which were maintained at the 1-month follow-up (controlled between-group d = 0.90, 95% CI 0.41 to 1.39). The intervention was deemed to be feasible and acceptable by the participants. Change in negative appraisals mediated reductions in UITs but the model was sensitive to mediator-outcome confounders. We conclude that this novel online self-guided cognitive intervention can potentially reduce the distress and impairment associated with UITs in new parents. Large-scale trials are warranted. Abbreviations: UITs: Unwanted Intrusive Thoughts PTBC: Parental Thoughts and Behaviour Checklist. [ABSTRACT FROM AUTHOR]

Objective: Over the 2018-2019 flu season we conducted a randomized controlled trial examining the efficacy of a Twitter campaign on vaccination rates. Concurrently we investigated potential interactions between digital social network structure and vaccination status. Participants: Undergratuates at a large midwestern public university were randomly assigned to an intervention (n = 353) or control (n = 349) group. Methods: Vaccination data were collected via monthly surveys. Participant Twitter data were collected through the public-facing Twitter API. Intervention impact was assessed with logistic regression. Standard network science tools examined vaccination coverage over online social networks. Results: The campaign had no effect on vaccination outcome. Receiving a flu shot the prior year had a positive impact on participant vaccination. Evidence of an interaction between digital social network structure and vaccination status was detected. Conclusions: Social media campaigns may not be sufficient for increasing vaccination rates. There may be potential for social media campaigns that leverage network structure. [ABSTRACT FROM AUTHOR]