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Abstract Kidney stones, a persistent urological condition, continue to affect people globally. In this critical review, we examine the work of Borghi et al. who evaluated patients with idiopathic stone formation and randomised 99 patients to increased water intake (≥ 2 L/day) and 100 patients to usual care in a 5-year randomized controlled trial. The study examined baseline urine volume in individuals with idiopathic calcium stones, recurrence rates, and relevant biochemical factors. The study found reduced recurrence rate (12.1% vs. 27% (p = 0.008)), and time to recurrence with increased water intake (38.7 ± 13.2 months) vs. (25 ± 16.4 months) (p = 0.016). These findings inform clinical practice, contributing to the guideline recommendations that kidney stone patients should aim for fluid intake of at least 2.5 L per day to prevent stone recurrence.

Abstract In this critical review, we explore the study design, strengths and limitations of the paper: “Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.” The paper reports 24 month follow-up data of the landmark ROSETTA trial. This multi-centre, open-labelled parallel randomised trial allocated females 1:1 to receive Sacral Neuromodulation (SNM) or OnabotulinumtoxinA(BTX) 200 units (U). The primary outcome was change in mean daily urinary urgency incontinence episodes (UUIE) over 24 months. The study did not demonstrate a difference between treatments (-3.88 vs. -3.50 episodes per day), however women treated with BTX were more satisfied; but reported higher rates of UTI. The two treatments provide comparable third-line treatment options for patients with refractory urgency urinary incontinence.

Most nursing simulation programs focus on persons’ healthcare needs in hospital settings, and little is known about how to identify them in home settings. This study aims to develop and validate a virtual reality (VR) simulation program for nursing students to improve their clinical reasoning skills and confidence in assessing persons’ healthcare needs in home settings. We developed a VR simulation program based on a literature review and expert discussion. In Phase 1, home visit nurses or public health nurses will validate the program through their interviews in 2022. In Phase 2, we will conduct a pilot and main single-blinded randomized trial for nursing students to confirm the effectiveness from 2022 and 2023. Participants will be randomly allocated into an intervention group using VR simulations and a control group receiving videos regarding three kinds of community residents’ lives [1:1]. After obtaining informed consent, the students will submit their anonymous data to the researchers to prevent associating their grade evaluation. The primary outcome will be their clinical reasoning skills. The second outcome will include their satisfaction and self-confidence. This study will examine the effectiveness of improving their clinical reasoning skills and confidence in assessing persons’ healthcare needs in home settings.

BackgroundBiomedical research from low- and middle-income countries (LMICs) is poorly represented in Western European and North American psychiatric journals.AimsTo test the feasibility of trialling a capacity-building intervention to improve LMIC papers' representation in biomedical journals.MethodWe designed an enhanced peer-review intervention delivered to LMIC corresponding/first authors of papers rejected by the British Journal of Psychiatry. We conducted a feasibility study, inviting consenting authors to be randomised to intervention versus none, measuring recruitment and retention rates, outcome completion and author/reviewer-rated acceptability.ResultsOf the 26/121 consenting to participate, 12 were randomised to the intervention and 14 to the control arms. Outcome completion was 100% but qualitative feedback from authors/reviewers was mixed, with attrition from 5/12 (42%) of intervention reviewers.ConclusionsLow interest among eligible authors and variable participation of expert reviewers suggested low feasibility of a full trial and a need for intervention redesign.Declaration of interestA.P., P.T. and M.Y. are British Journal of Psychiatry editorial board members. During this study P.T. was British Journal of Psychiatry Editor, A.P. was a trainee editor and A.H. was an editorial assistant.

In this critical review, we explore the study design, strengths and limitations of the paper: "Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial." The paper reports 24 month follow-up data of the landmark ROSETTA trial. This multi-centre, open-labelled parallel randomised trial allocated females 1:1 to receive Sacral Neuromodulation (SNM) or OnabotulinumtoxinA(BTX) 200 units (U). The primary outcome was change in mean daily urinary urgency incontinence episodes (UUIE) over 24 months. The study did not demonstrate a difference between treatments (-3.88 vs. -3.50 episodes per day), however women treated with BTX were more satisfied; but reported higher rates of UTI. The two treatments provide comparable third-line treatment options for patients with refractory urgency urinary incontinence. [ABSTRACT FROM AUTHOR]

Kidney stones, a persistent urological condition, continue to affect people globally. In this critical review, we examine the work of Borghi et al. who evaluated patients with idiopathic stone formation and randomised 99 patients to increased water intake (≥ 2 L/day) and 100 patients to usual care in a 5-year randomized controlled trial. The study examined baseline urine volume in individuals with idiopathic calcium stones, recurrence rates, and relevant biochemical factors. The study found reduced recurrence rate (12.1% vs. 27% (p = 0.008)), and time to recurrence with increased water intake (38.7 ± 13.2 months) vs. (25 ± 16.4 months) (p = 0.016). These findings inform clinical practice, contributing to the guideline recommendations that kidney stone patients should aim for fluid intake of at least 2.5 L per day to prevent stone recurrence. [ABSTRACT FROM AUTHOR]

In the veterinary professional curriculum, methods of examination in many courses are transitioning from the traditional paper-based exams to electronic-based exams. Therefore, a controlled trial to evaluate the impact of testing methodology on examination performance in a veterinary physiology course was designed and implemented. Formalized surveys and focus group discussions were also used to determine student attitudes toward the examination formats. In total, 134 firstyear veterinary students and 11 PhD/MS students were administered a total of 4 exams throughout 1 semester (2 on paper and 2 electronically) using a split-halves design. The paper (P) and electronic (E) exams contained 25 identical multiple-choice questions. Students were randomly assigned to two groups and were given exams in one of two sequences (E-P-E-P or P-E-P-E). Participants consented to and completed two anonymous surveys vis à vis their experience. Out of a maximum raw score of 25, the mean score for electronic examinations (20.8; 95% confidence interval, 20.3-21.2) was significantly (P = 0.01) greater than that for paper examinations (20.3; 95% confidence interval, 20.0 -20.7). However, students expressed numerous concerns with the electronic examination format, and, at the completion of the study, 87% preferred to take their examination on paper rather than the electronic format. These data show that student attitudes concerning the examination format are not primarily determined by examination results, and that the additional anxiety related to the electronic examination format plays a large role in student attitudes. [ABSTRACT FROM AUTHOR]

Highlights • Caregivers who became physically active significantly lengthened in average telomere lengths compared to those in waitlist. • Caregivers who became physically active also improved in their cardiorespiratory fitness, BMI, and perceived chronic stress. • However, caregivers in either group didn't change in their telomerase activity levels. Abstract Study design Family members caring for chronically ill relatives are typically sedentary, chronically stressed, and at high risk of disease. Observational reports suggest caregivers have accelerated cellular aging as indicated by shorter leukocyte telomere lengths. We performed a randomized controlled trial to examine the effect of aerobic exercise on changes in telomerase levels (primary outcome) and telomere lengths (secondary outcome) in inactive caregivers. Methods 68 female and male community dwelling dementia caregivers who reported high stress and physical inactivity were randomly assigned to a highly supervised aerobic exercise intervention vs. waitlist control group for 24 weeks. Average leukocyte telomere lengths and peripheral blood mononuclear cells' telomerase activity were measured pre- and post-intervention. All staff completing blood draws, fitness testing and bioassays were blinded to group assignment. Results The intervention group completed approximately 40 min of aerobic exercise 3–5 times per week, verified by actigraphy. There was high (81%) adherence to 120 min/week of aerobic exercise. Groups did not significantly differ in telomerase activity changes across time, but had significant different telomere length changes across time (67.3 base pairs, 95%CI 3.1, 131.5). There were also significant reductions in body mass index and perceived stress and an increase in cardiorespiratory fitness (i.e., VO 2peak) in the exercising caregivers versus controls. Conclusion In the context of a highly controlled intervention, exercise can induce apparent telomere lengthening, though the mechanisms remain elusive. Our study underscores the importance of increasing participation in aerobic exercise to improve markers of health and attenuate cellular aging in high-risk samples. [ABSTRACT FROM AUTHOR]

Background: The Foods with Function Claim was introduced in Japan in April 2015 to make more products available that are labeled with health functions. A product's functionality of function claims must be explained by the scientific evidence presented in clinical trials (CTs) or systematic reviews, but the quality of recent CTs is unclear. The purpose of this study was to evaluate the risk of bias (RoB) using "a revised tool to assess risk (RoB 2)" published in 2018 for notifications based on all recent CTs published on the Consumer Affairs Agency website. Methods: A total of 38 submitted papers based on CTs that were published on the Consumer Affairs Agency website during the period from 1 January 2023 to 30 June 2024 were eligible. The RoB 2 tool provides a framework for considering the risk of bias in the findings of any type of randomized trial. This tool with five domains was used to evaluate the quality of research methods. Results: Eligible CTs were assessed as "low risk" (11%, n = 4), "medium risk" (13%, n = 5), and "high risk" (76%, n = 29). A number of highly biased papers were published. Bias occurred in all five domains, especially "bias in selection of the reported result (Domain 5)", which was the most serious ("high risk"; 75%). For elements correlated with RoB, there was no significant difference (p = 0.785) in the RoB 2 score between for-profit and academic research in the author's affiliated organization. There was no significant difference (p = 0.498) in the RoB score between the published year categories of 2000–2019 and 2020–2024, and no significant difference (p = 0.643) in the RoB score between English and Japanese language publications. Conclusion: Overall, the quality of the latest CTs submitted after 2023 was very low, occurring in all five domains, and was most serious for "bias in selection of the reported result (Domain 5)". [ABSTRACT FROM AUTHOR]

Most nursing simulation programs focus on persons' healthcare needs in hospital settings, and little is known about how to identify them in home settings. This study aims to develop and validate a virtual reality (VR) simulation program for nursing students to improve their clinical reasoning skills and confidence in assessing persons' healthcare needs in home settings. We developed a VR simulation program based on a literature review and expert discussion. In Phase 1, home visit nurses or public health nurses will validate the program through their interviews in 2022. In Phase 2, we will conduct a pilot and main single-blinded randomized trial for nursing students to confirm the effectiveness from 2022 and 2023. Participants will be randomly allocated into an intervention group using VR simulations and a control group receiving videos regarding three kinds of community residents' lives [1:1]. After obtaining informed consent, the students will submit their anonymous data to the researchers to prevent associating their grade evaluation. The primary outcome will be their clinical reasoning skills. The second outcome will include their satisfaction and self-confidence. This study will examine the effectiveness of improving their clinical reasoning skills and confidence in assessing persons' healthcare needs in home settings. [ABSTRACT FROM AUTHOR]

Background: The advantages of patient-held portable health files (PHF) and personal health records (PHR), paper or electronic, are said to include improved health-care provider continuity-of-care and patient empowerment in maintaining health. Top-down approaches are favored by public sector government and health managers. Bottom-up approaches include systems developed directly by health-care providers, consumers and industry, implemented locally on devices carried by patient-consumers or shared via web-based portals. These allow individuals to access, manage and share their health information, and that of others for whom they are authorized, in a private, secure and confidential environment. Few medical record technologies have been evaluated in randomized trials to determine whether there are important clinical benefits of these interventions. The COMMUNICATE trial will assess the acceptability and long-term clinical outcomes of an electronic and paper patient-held PHF. Methods/Design: This is a 48-month, open-label pragmatic, superiority, parallel-group design randomized controlled trial. Subjects (n=792) will be randomized in a 1:1:1 ratio to each of the trial arms: the electronic PHF added to usual care, the paper PHF added to usual care and usual care alone (no PHF). Inclusion criteria include those 60 years or older living independently in the community, but who have two or more chronic medical conditions that require prescription medication and regular care by at least three medical practitioners (general and specialist care). The primary objective is whether use of a PHF compared to usual care reduces a combined endpoint of deaths, overnight hospitalizations and blindly adjudicated serious out-of-hospital events. All primary analyses will be undertaken masked to randomized arm allocation using intention-to-treat principles. Secondary outcomes include quality of life and health literacy improvements. Discussion: Lack of blinding creates potential for bias in trial conduct and ascertainment of clinical outcomes. Mechanisms are provided to reduce bias, including balanced study contact with all participants, a blinded adjudication committee determining which out-of-hospital events are serious and endpoints that are objective (overnight hospitalizations and mortality). The PRECIS tool provides a summary of the trial's design on the Pragmatic-Explanatory Continuum. Trial registration: Registered with Clinicaltrials.gov (identifier: NCT01082978) on 8 March 2010. [ABSTRACT FROM AUTHOR]

Background Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed. Methods/design The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (escreening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paperbased form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health escreening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening. Trial registration ClinicalTrials.gov Identifier: NCT01899534 [ABSTRACT FROM AUTHOR]

Treatment guidelines are primarily based on randomized clinical trials (RCTs). RCTs tend to some extent to exclude older adults despite the fact that physicians need guidance when treating this patient group. By summarizing existing literature, we aimed to (a) quantify the proportion of RCTs and other clinical studies (CTs) that did not adequately include older adults; (b) identify the main barriers for this non‐inclusion; and (c) identify suggested solution for inclusion of older adults in RCTs and other CTs. In this umbrella review, Embase and PubMed were searched for relevant papers, and 2701 papers were identified. The subsequent screening resulted in 22 papers. The Critical Appraisal Skills Program was used as quality assessment tool to evaluate these 22 papers. We found that: (a) The most frequent outcome designating missing inclusion of older adults was the use of age limit as exclusion criterion in studies—the proportion of this was 10%‐60%; (b) barriers for inclusion were mainly exclusion criteria, logistic challenges and financial constraints; and (c) more extensive inclusion would require more explicit inclusion criteria, merely application of exclusion criteria when absolutely needed, change of researchers' attitude, further inclusion of supporting relatives to overcome the logistical challenges and more financial funding. [ABSTRACT FROM AUTHOR]

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients’ inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis. [ABSTRACT FROM AUTHOR]

Background: In this paper, we used search engine technology to study outcome analysis and cost awareness of child hydrocephalus in the literature. Methods: The aggregate hospital charges of hydrocephalus treatment procedures for patients <18 years old was extracted from the Nationwide Inpatient Sample (NIS) data. Hydrocephalus literature was probed through the PubMed biomedical search engine. Results: Aggregate hospital charges associated with ventriculo-peritoneal shunting as the principle procedure for patients <18 years old have increased 1.7-fold over a 13-year period to 235.6 million in 2009. Hospital discharges, however, decreased from 3,390 in 1997 to 2,525 in 2009 (25.5% decrease over 13 years). The number of papers in English language indexed by PubMed in relation to child hydrocephalus in humans increased from 81 papers in 1996 to 133 in 2010 (1.6-fold increase), totaling 1,694 over 15 years. Randomized controlled trials published in relation to child hydrocephalus totaled 16 over the same period (0.94% of child hydrocephalus papers). Papers related to child hydrocephalus with 'costs and cost analysis' as medical subject heading totaled 13 papers (0.77%). Conclusions: Over the past 15 years, disappointingly the number of printed child hydrocephalus papers appeared to have only plateaued. Strikingly, only a very small number of these papers were directed toward randomized control studies, the sine qua non of high-grade clinical evidence. Moreover, very few papers make reference to cost analysis or economics in the treatment of hydrocephalus - an issue coming increasingly before the nation at this point. [ABSTRACT FROM AUTHOR]

Background: Mild cognitive impairment (MCI) involves cognitive decline beyond typical age-related changes, but without significant daily activity disruption. It can encompass various cognitive domains as the causes of MCI are diverse. MCI as well as frequent comorbid neuropsychiatric conditions like depression and anxiety affect individuals' quality of life. Early interventions are essential, and computerized cognitive training (cCT) is an established treatment method. This paper presents the protocol for the NeuroNation MED Effectiveness Study, evaluating the self-administered mobile cCT intervention ("NeuroNation MED") in individuals with MCI to assess training effects on cognitive domains, health competence, neuropsychiatric symptoms, psychological well-being, and the general application usability. Methods: This study protocol presents a single-blinded multicenter randomized controlled trial that will be carried out in six study centers in Germany and Luxembourg. We included adults with MCI (existing F06.7 ICD-10-GM diagnosis and TICS ≥ 21 and ≤ 32). The intervention group will use a mobile, multi-domain cCT ("NeuroNation MED") for 12 weeks. Meanwhile, the wait list control group will receive standard medical care or no care. The eligibility of volunteers will be determined through a telephone screening. After completion of the baseline examination, patients will be randomly assigned to one of the experimental conditions in a 2:1 ratio. In total, 286 participants will be included in this study. The primary outcome is the change of cognitive performance measured by the index score of the screening module of the Neuropsychological Assessment Battery. Secondary outcomes are changes in the Cognitive Failures Questionnaire, Hospital Anxiety and Depression Scale, Health-49, Health Literacy Questionnaire, among others. All of the primary and secondary outcomes will be assessed at baseline and after the 12-week post-allocation period. Furthermore, the intervention group will undergo an assessment of the System Usability Scale, and the training data of the NeuroNation MED application will be analyzed. Discussion: This study aims to assess the effectiveness of a mobile self-administered cCT in enhancing cognitive abilities among individuals diagnosed with MCI. Should the findings confirm the effectiveness of the NeuroNation MED app, it may confer possible benefits for the care management of patients with MCI, owing to the accessibility, cost-effectiveness, and home-based setting it provides. Specifically, the cCT program could provide patients with personalized cognitive training, educational resources, and relaxation techniques, enabling participants to independently engage in cognitive training sessions at home without further supervision. Trial registration: German Clinical Trials Register DRKS00025133. Registered on November 5, 2021. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Journal of Tissue Engineering Research / Zhongguo Zuzhi Gongcheng Yanjiu is the property of Chinese Journal of Tissue Engineering Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Inflammatory bowel disease (IBD) entails physical, psychological, and social burden and holds a significant impact on quality of life. Experiential avoidance, cognitive fusion, shame, and self-criticism have been identified as possible therapeutic targets for improving mental health in people with IBD. Traditional face-to-face psychological therapy continues to provide obstacles for patients seeking assistance. Online psychological therapies centered on acceptance, mindfulness, and compassion have been shown to improve psychological distress in other populations. Objective: This paper presents the study protocol of a two-arm Randomized Controlled Trial (RCT) of an ACT and compassion-based, online intervention -- eLIFEwithIBD - on the improvement of psychological distress, quality of life, work and social functioning, IBD symptom perception, illness-related shame, psychological flexibility, and self-compassion. Methods: The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD programme (delivered through an in-person group format) and entails an ACT, mindfulness, and compassion-based intervention designed to be delivered as an e-health tool for people with IBD. This protocol outlines the structure and contents of the eLIFEwithIBD intervention. Participants were recruited by an advertisement on the social media platforms of Portuguese Associations for IBD in January 2022. A psychologist conducted a brief interview with 80 patients who were interested in participating. Fifty-five participants were selected and randomly assigned to one of two conditions [experimental group (eLIFEwithIBD + medical TAU; n = 37) or control group (medical TAU; n = 18)]. Outcome measurement took place at baseline, post-intervention, and 4-month followup. All analyses are planned as intent-to-treat (ITT). Results: The eLIFEwithIBD intervention is expected to empower people with IBD by fostering psychological strategies that promote illness adjustment and well-being and prevent subsequent distress. The eLIFEwithIBD aims to gain a novel and better understanding of the role of online contextual behavioral interventions on improving the quality of life and mental health of people with IBD. Clinical Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT05405855, NCT05405855. [ABSTRACT FROM AUTHOR]

Background: Mindfulness practices enhance executive function skills and academic achievement, spurring interest in integrating mindfulness interventions into education. Embedding mindfulness practice into a digital math game may provide a low‐cost, scalable way to induce mindfulness and boost game‐based learning, yet this approach remains unexplored. Objectives: We investigated the learning benefits of integrating mindfulness exercises in a digital math learning game and examined how students' trait mindfulness might moderate the outcomes. Methods: Two classroom studies were conducted with 404 5th and 6th grade students from six public schools in the U.S. (nStudy 1 = 227, nStudy 2 = 177). The two randomized controlled experiments assigned students to one of the three conditions: passive control (playing the digital learning game Decimal Point), story‐enriched active control, or mindfulness‐enriched condition. Trait mindfulness, learning gains, and in‐game problem‐solving (including problem‐solving duration, error count and correctness after reminder) were assessed. Study 2 included a manipulation check to better understand the effects of the mindfulness intervention. Results: Findings showed no significant differences in learning gains, problem‐solving duration or error count among the conditions. Students' trait mindfulness did not moderate these outcomes. Mindfulness reminders in the mindfulness‐enriched game led to more correct answers after errors than jokes in the story‐enriched game. Study 2 revealed that we failed to induce higher state mindfulness through the mindfulness inductions. Conclusions: Mindfulness prompts could be especially beneficial for students experiencing frustration during gameplay, warranting more exploration for digital game‐based instruction. We highlight barriers and future directions for fostering mindfulness through computer‐based instruction in classrooms. Lay Description: What is currently known about this topic?: Researchers focus on digital games as productive learning environments for math, with potential for higher learning gains compared with traditional methods. However, results are mixed, and not all games lead to improved math outcomes.Executive function (EF) skills are crucial for math learning, and mindfulness‐based interventions show promise in enhancing EF skills in school‐aged students.Embedding mindfulness practice into a digital math game may provide a low‐cost, scalable way to induce mindfulness and, in turn, boost EF skills and game‐based learning, yet this approach remains unexplored What does this paper add?: This paper presents the results of two randomized control trials investigating the feasibility and benefits of incorporating mindfulness exercises into a digital math game designed for middle school students. Benefits are compared to those of a story‐enriched and regular version of the same digital math learning game.The paper also explores variations in the effects of the mindfulness‐enriched game based on students' initial trait mindfulness levels.We observe that listening to mindfulness inductions at the beginning of game sessions do not induce mindfulness, and therefore does not benefit math learning.We find that mindfulness prompts received after recurrent errors can be beneficial for students' problem solving. Implications of study findings for practitioners: Our study provides important information on how digital learning game designers should attempt to induce mindfulness in a digital game to promote learning.Digital learning game designers should consider incorporating mindfulness exercises into their games strategically. Presenting mindfulness inductions in audio format at the beginning of game sessions may not induce mindfulness or benefit math learning. Instead, designers should focus on integrating mindfulness prompts at moments when students encounter frustration within the learning game.Beyond embedding audio mindfulness exercises in the game, learning designers should also consider alternative technological and game features to induce mindfulness within a learning game. [ABSTRACT FROM AUTHOR]

Background: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics. Trial registration: Clinicaltrials.gov – NCT05628207. Prospectively registered 11/28/2022, https://classic.clinicaltrials.gov/ct2/show/NCT05628207. [ABSTRACT FROM AUTHOR]

Copyright of Arthroskopie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: Nowadays, systematic literature reviews (SLRs) and meta-analyses are often placed at the top of the study hierarchy of evidence. The main objective of this paper is to evaluate the trends in SLRs of randomized controlled trials (RCTs) throughout the years. Methods: Medline database was searched, using a highly focused search strategy. Each paper was coded according to a specific ICD-10 code; the number of RCTs included in each evaluated SLR was also retrieved. All SLRs analyzing RCTs were included. Protocols, commentaries, or errata were excluded. No restrictions were applied. Results: A total of 7,465 titles and abstracts were analyzed, from which 6,892 were included for further analyses. There was a gradual increase in the number of annual published SLRs, with a significant increase in published articles during the last several years. Overall, the most frequently analyzed areas were diseases of the circulatory system (n = 750) and endocrine, nutritional, and metabolic diseases (n = 734). The majority of SLRs included between 11 and 50 RCTs each. Conclusions: The recognition of SLRs' usefulness is growing at an increasing speed, which is reflected by the growing number of published studies. The most frequently evaluated diseases are in alignment with leading causes of death and disability worldwide. [ABSTRACT FROM AUTHOR]

Aims: The study aimed to develop and evaluate the effects of a self‐determination theory‐based, nurse‐led, physical activity programme for postmenopausal women with rheumatoid arthritis. Methods: Between December 2019 and April 2020, this randomized controlled trial recruited 62 postmenopausal women with rheumatoid arthritis from a university‐affiliated hospital in South Korea. The intervention group participated in a self‐determination theory‐based, nurse‐led, physical activity programme that consisted of Tai Chi‐based physical activity, a supportive psychosocial strategy, and interactive counselling for 16 weeks, and the control group continued to undergo their usual care. Results: There were statistically significant group‐by‐time interactions in physical activity and perceived sarcopenia, which favoured the intervention group. Additionally, the intervention group showed significant improvements in the perceived therapeutic efficacy of physical activity, grip strength, walking speed, disease activity score, and health‐related quality of life. Conclusions: The programme developed in this study can be an effective and feasible approach for postmenopausal women with rheumatoid arthritis in improving physical activity, selected osteosarcopenic outcomes, and health‐related quality of life. Further research is required to investigate the long‐term effects of this theory‐based programme for postmenopausal women in diverse settings. Summary statement: What is already known about this topic? Tai Chi‐based physical activity has been known to be a component of self‐management for rheumatoid arthritis. What this paper adds? It highlights the efficacy of a theory‐based, nurse‐led, physical activity programme to improve the quality of life of postmenopausal women with rheumatoid arthritis.The evidenced‐based programme could be transferred to postmenopausal women with rheumatoid arthritis in clinical settings. The implications of this paper: The self‐determination theory‐based, nurse‐led, physical activity programme can improve physical and psychosocial outcomes in postmenopausal women with rheumatoid arthritis.Importantly, this nurse‐led and theory‐based programme is expected to be applicable to postmenopausal women with rheumatoid arthritis in clinical settings, including both hospitals and communities. [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]

Background: More new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs. Methods: The literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team's compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting. Results: A total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that "sequence generation" improved in and after 1990 (73%–80% of RCTs were rated as "low") and "blinding of outcome assessors" slightly improved in and after the 2000s (40%–50% judged as "low"). However, "high" or "unclear" remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or "placebo") needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s. Conclusions: The quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for "sequence generation." While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved. [ABSTRACT FROM AUTHOR]

Background: Human papillomavirus (HPV) infections can cause cancers of the cervix, vagina, vulva, penis, anus, and oropharynx. The most recently approved HPV vaccine, Gardasil-9, protects against HPV infection and can prevent HPV-associated invasive cancers. However, Gardasil-9 is one of the most underused vaccines in the US today. Young adults are at risk for HPV infection, but many are not vaccinated. This study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. In this paper, we describe the research protocol. Methods: The study uses a two by three factorial design. A total of 1200 young adults in Texas, age 18–26 years, who have not been previously fully vaccinated against HPV will be randomly assigned to one of six conditions to receive: (1) standard CDC information about HPV vaccination (control); (2) video narratives about HPV vaccination; (3) written narratives about HPV vaccination; or (4–6) enhanced access to HPV vaccine combined with (4) standard CDC information, (5) video narratives, or (6) written narratives. The two primary outcomes are the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-ups. We will determine the impact of the individual level intervention (i.e., persuasive narratives through video or written format), the systemic level intervention (i.e., enhanced access to HPV vaccines), and the combination of both levels, on HPV vaccination initiation and completion. We will also use purposive sampling to select participants to take part in semi-structured interviews/focus groups to better understand the mechanisms of the intervention. Discussion: Recruitment and data collection began in March 2022. We expect to complete data collection by March 2026. We expect that narratives, enhanced access, and the combination of both will improve HPV vaccination initiation and completion rates among young adults. If proven successful, these individual- and system-level interventions can be easily disseminated in regions with low HPV vaccination rates to improve HPV vaccination, and ultimately decrease HPV-related cancer burden. Trial Registration: NCT05057312. [ABSTRACT FROM AUTHOR]

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Background: We compared dissociative seizure specific cognitive behavior therapy (DS-CBT) plus standardized medical care (SMC) to SMC alone in a randomized controlled trial. DS-CBT resulted in better outcomes on several secondary trial outcome measures at the 12-month follow-up point. The purpose of this paper is to evaluate putative treatment mechanisms. Methods: We carried out a secondary mediation analysis of the CODES trial. 368 participants were recruited from the National Health Service in secondary / tertiary care in England, Scotland, and Wales. Sixteen mediation hypotheses corresponding to combinations of important trial outcomes and putative mediators were assessed. Twelve-month trial outcomes considered were final-month seizure frequency, Work and Social Adjustment Scale (WSAS), and the SF-12v2, a quality-of-life measure providing physical (PCS) and mental component summary (MCS) scores. Mediators chosen for analysis at six months (broadly corresponding to completion of DS-CBT) included: (a) beliefs about emotions, (b) a measure of avoidance behavior, (c) anxiety and (d) depression. Results: All putative mediator variables except beliefs about emotions were found to be improved by DS-CBT. We found evidence for DS-CBT effect mediation for the outcome variables dissociative seizures (DS), WSAS and SF-12v2 MCS scores by improvements in target variables avoidance behavior, anxiety, and depression. The only variable to mediate the DS-CBT effect on the SF-12v2 PCS score was avoidance behavior. Conclusions: Our findings largely confirmed the logic model underlying the development of CBT for patients with DS. Interventions could be additionally developed to specifically address beliefs about emotions to assess whether it improves outcomes. [ABSTRACT FROM AUTHOR]

Background: This paper describes the protocols for a randomized controlled trial using a parallel-group trial design that includes an intervention designed to address social isolation and loneliness among people experiencing homelessness known as Miracle Friends and an intervention that combines Miracles Friends with an economic poverty-reduction intervention known as Miracle Money. Miracle Friends pairs an unhoused person with a volunteer "phone buddy." Miracle Money provides guaranteed basic income of $750 per month for 1 year to Miracle Friends participants. The study will examine whether either intervention reduces social isolation or homelessness compared to a waitlist control group. Methods: Unhoused individuals who expressed interest in the Miracle Friends program were randomized to either receive the intervention or be placed on a waitlist for Miracle Friends. Among those randomized to receive the Miracle Friends intervention, randomization also determined whether they would be offered Miracle Money. The possibility of receiving basic income was only disclosed to study participants if they were randomly selected and participated in the Miracle Friends program. All study participants, regardless of assignment, were surveyed every 3 months for 15 months. Results: Of 760 unhoused individuals enrolled in the study, 256 were randomized to receive Miracle Friends, 267 were randomized to receive Miracle Money, and 237 were randomized to the waitlist control group. In the two intervention groups, 360 of 523 unhoused individuals were initially matched to a phone buddy. Of the 191 study participants in the Miracle Money group who had been initially matched to a volunteer phone buddy, 103 were deemed to be participating in the program and began receiving monthly income. Discussion: This randomized controlled trial will determine whether innovative interventions involving volunteer phone support and basic income reduce social isolation and improve housing outcomes for people experiencing homelessness. Although we enrolled unhoused individuals who initially expressed interest in the Miracle Friends program, the study team could not reach approximately 30% of individuals referred to the study. This may reflect the general lack of stability in the lives of people who are unhoused or limitations in the appeal of such a program to some portion of the unhoused population. Trial registration: ClinicalTrials.gov NCT05408884 (first submitted on May 26, 2022). [ABSTRACT FROM AUTHOR]

Background: Aggressive conduct among delinquents presents a pervasive issue, bearing substantial implications for not only society at large but also for the victims and the individuals displaying the aggression. Traditional approaches to treating aggression regulation deficiencies generally employ Cognitive Behavioral Therapy (CBT) in conjunction with analog role-playing exercises. A body of research supports the efficacy of various therapeutic models for aggression regulation, including Responsive Aggression Regulation Therapy (Re-ART). Role-playing within a therapeutic context has been shown to contribute significantly to reductions in violent reoffending. However, the practical application of these skills in real-world settings remains challenging due to the inherent risk of aggressive outbreaks. Additionally, the conventional role-playing scenarios, often conducted in a therapy room, lack contextual realism and may induce role confusion between the patient and the therapist. Virtual Reality (VR) technology could offer a viable solution to these limitations by allowing for skill training in both behavioral and cognitive domains within a realistic yet safe and controlled setting. The technology also facilitates realtime awareness of emotional states and tension levels in the patient. This paper describes the study protocol of a randomized controlled trial in which Re-ART offered in a virtual environment (Re-ART VR) is compared to Re-ART offered as treatment as usual. Methods and analysis: Adult forensic outpatients with aggression regulation problems are randomly assigned to either Re-ART VR or Re-ART. The Controlling Skills, Influence of Thinking and Handling Conflicts modules will be offered to both groups during 3-6 months. Pre- and post-intervention measurements are performed. The primary outcome measurement is the degree of aggression regulation, while secondary outcome measurements include impulsivity and cognitive biases. Additionally, patient motivation and therapist motivation are expected to act as moderating factors. Discussion: To date, scarcely previous research has been done on the effectiveness of VR in treatment of aggression regulation problems in forensic outpatients. Forensic outpatients who do not benefit sufficiently from mainly CBT-based interventions may benefit more from experiential learning. The unique capabilities of VR in this regard have the potential to enhance the treatment effect. [ABSTRACT FROM AUTHOR]

The utility of facebow might reduce the occurrence of occlusal interferences in fabrication of three unit fixed prosthesis. There is a lack of data regarding the clinical usefulness of facebow in fixed prosthesis fabrication. The purpose of this clinical trial was to study and compare the occlusal interferences in three unit fixed prosthesis fabricated with and without facebow transfer. 15 participants satisfying predefined inclusion and exclusion criteria were selected in this clinical trial. For each participant, 2 pair of three unit fixed prosthesis were fabricated. Prosthesis were fabricated one with and other without facebow transfer. The treatment involved single operator and single technician to minimize the error if any. After fabrication, the prosthesis were evaluated on the basis of the occlusal contacts and interferences of the three unit fixed prosthesis using a 40um articulating paper. The prosthesis with better occlusal contacts was cemented and the results were evaluated using chi square test. Nine out of 15 three unit fixed partial denture prosthesis fabricated using facebow transfer had reduced incidence of occlusal interferences. 6 out of 15 prosthesis fabricated without facebow transfer had reduced incidence of occlusal interferences. The results were evaluated using chi square test which was highly significant. (P>1), the three unit fixed prosthesis fabricated with facebow transfer had reduced no. of occlusal interferences. Taking into consideration of the complex and multiphase study design of the study with a finite number of participants and one specific arbitrary face-bow, the following result could be drawn as there is significant difference in three unit fixed partial denture prosthesis fabricated by the use of the arbitrary face-bow compared to a mean setting as compared to three unit fixed partial denture prosthesis fabricated without facebow transfer. The three unit fixed partial denture prosthesis fabricated with facebow transfer yields a better prosthesis and minimizes the harmful occlusal interferences as compared to the three unit fixed prosthesis fabricated without facebow transfer. Evidence based dentistry is needed to asses and abolish the unnecessary steps in clinical dentistry. Facebow is one such step which has been questioned for long by many clinicians and there is lack if clinical trials with its use in fixed prosthodontics. This study is to evaluated the importance of use of facebow transfer in fabrication of three unit fixed prosthesis. [ABSTRACT FROM AUTHOR]

Objectives: To conduct a meta-analysis to assess the efficacy of scalp acupuncture (SA) in patients with stroke and consequent hemiparesis regardless of brain infarction or intracerebral hemorrhage. Methods: A literature search of randomized controlled trials (RCTs) on SA for stroke was performed in five databases up to May 10, 2021. We investigated three types of outcome: motor function, sequelae of poststroke hemiparesis, and adverse effects. Methodological quality was assessed using the revised Cochrane risk of bias tool version 2.0. Results: Of 1,063 papers, 30 RCTs involving Fugl–Meyer Assessment were selected, among which 10 and four RCTs were selected for evaluation of courses lasting of 1 and 3 months, respectively. The meta-analysis of 1- and 3-month courses revealed significant differences in the motor function of the SA plus Western standard treatment group vs. Western standard treatment only (medication plus rehabilitation; P < 0.001). A 3-month course tended to result in better outcomes than a 1-month course. Conclusions: Our meta-analysis results reveal that SA improves motor function in patients with acute to chronic stroke, regardless of brain infarction or intracerebral hemorrhage. However, because of a lack of methodological quality, thoroughly planned clinical studies are still required. [ABSTRACT FROM AUTHOR]

The last two decades have seen a dramatic increase in randomized controlled trials (RCTs) conducted in community colleges. Yet, there is limited empirical information on the design parameters necessary to plan the sample size for RCTs in this context. For a blocked student-level random assignment research design, key design parameters for the minimum detectable true effect (MDTE) are the within-block outcome standard deviation (σ | S) and the within-block outcome variance explained by baseline covariates like student characteristics (R | S 2). We provide empirical estimates of these key design parameters, discussing the pattern of estimates across outcomes (enrollment, credits earned, credential attainment, and grade point average), semesters, and studies. The main analyses use student-level data from 8 to 14 RCTs including 5,649–7,099 students (depending on the outcome) with follow-up data for 3 years. The following patterns are observed: the within-block standard deviation (σ | S) and therefore the MDTE can be much larger in later semesters for enrollment outcomes and cumulative credits earned; there is substantial variation across studies in σ | S for degree attainment; and baseline covariates explain less than 10% of the variation in student outcomes. These findings indicate that when planning the sample size for a study, researchers should be mindful of the follow-up period, use a range of values to calculate the MDTE for outcomes that vary across studies, and assume a value of R | S 2 between 0 and 0.05. A public database created for this paper includes parameter estimates for additional RCTs and students. [ABSTRACT FROM AUTHOR]

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved. [ABSTRACT FROM AUTHOR]

Background: Caring for a loved one with Alzheimer’s disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer’s disease. Methods: This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer’s disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient’s dementia severity moderates the effects of the intervention. Discussion: If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer’s disease. Trial Registration: ClinicalTrials.gov NCT03610698. [ABSTRACT FROM AUTHOR]

Background: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible. This protocol paper describes a two-arm, multi-center, randomized controlled trial on the short- and longer-term effectiveness and cost-effectiveness of a brief, individually tailored behavioral parent training program for children with behavioral difficulties. Methods: Parents of children aged 2–12 years referred to a child mental healthcare center are randomized to (i) three sessions of behavioral parent training with optional booster sessions or (ii) care as usual. To evaluate effectiveness, our primary outcome is the mean severity of five daily ratings by parents of four selected behavioral difficulties. Secondary outcomes include measures of parent and child behavior, well-being, and parent–child interaction. We explore whether child and parent characteristics moderate intervention effects. To evaluate cost-effectiveness, the use and costs of mental healthcare and utilities are measured. Finally, parents' and therapists' satisfaction with the brief program are explored. Measurements take place at baseline (T0), one week after the brief parent training, or eight weeks after baseline (in case of care as usual) (T1), and six months (T2) and twelve months (T3) after T1. Discussion: The results of this trial could have meaningful societal implications for children with behavioral difficulties and their parents. If we find the brief behavioral parent training to be more (cost-)effective than care as usual, it could be used in clinical practice to make parent training more accessible. Trial registration: The trial is prospectively registered at ClinicalTrials.gov (NCT05591820) on October 24th, 2022 and updated throughout the trial. [ABSTRACT FROM AUTHOR]

Early adverse parenting predicts various negative outcomes, including psychopathology and altered development. Animal work suggests that adverse parenting might change amygdala–prefrontal cortex (PFC) circuitry, but work in humans remains correlational. The present study leveraged data from a randomized controlled trial examining the efficacy of an early parenting intervention targeting parental nurturance and sensitivity (Attachment and Biobehavioral Catch-up [ABC]) to test whether early parenting quality causally affects amygdala-PFC connectivity later in life. Participants (N = 60, mean age = 10.0 years) included 41 high-risk children whose parents were referred by Child Protective Services and randomly assigned to receive either ABC (n = 21) or a control intervention (n = 20) during the children's infancy and a comparison sample of low-risk children (n = 19). Amygdala-PFC connectivity was assessed via functional magnetic resonance imaging while children viewed fearful and neutral faces. Across facial expressions, ABC produced different changes than the control intervention in amygdala-PFC connectivity in response to faces. The ABC group also exhibited greater responses than the control intervention group to faces in areas classically associated with emotion regulation, including the orbitofrontal cortex and right insula. Mediation analysis suggested that the effect of ABC on PFC activation was mediated by the intervention's effect on amygdala-PFC connectivity. Results provide preliminary causal evidence for the effect of early parenting intervention on amygdala-PFC connectivity and on PFC responses to face viewing. Findings also highlight amygdala-PFC connectivity as a potential mediator of the effects of early parenting intervention on children's emotion regulation development. Intervening Early With Neglected Children; https://clinicaltrials.gov/ ; NCT02093052. We worked to ensure sex and gender balance in the recruitment of human participants. We worked to ensure race, ethnic, and/or other types of diversity in the recruitment of human participants. We worked to ensure that the study questionnaires were prepared in an inclusive way. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. One or more of the authors of this paper received support from a program designed to increase minority representation in science. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. [ABSTRACT FROM AUTHOR]

Accessible Summary: What is known on the subject?: Well conducted randomized controlled trials provide the highest level of evidence of effectiveness of healthcare interventions, including those delivered by mental health nurses.Trials have been conducted over the years but there has not been a comprehensive review since 2005, and never one including studies conducted outside the UK. What the paper adds to existing knowledge?: The paper provides a comprehensive overview of results from randomized controlled trials of mental health nurse‐delivered interventions conducted in the UK, Ireland, US, Australia, New Zealand, or Canada and reported 2005 to 2020.It highlights that the trial evidence is limited and offers only partial evidence for interventions that are central to mental health nursing practice. What are the implications for practice?: Much mental health nursing practice is not supported by the highest level trial evidence. Mental health nurses need to carefully select evidence on which to base their practice both from the mental health nursing literature and beyond.Mental health nurses and other stakeholders should demand greater investment in trials to strengthen the evidence base. Introduction: Nurses are the largest professional disciplinary group working in mental health services and have been involved in numerous trials of nursing‐specific and multidisciplinary interventions. Systematic appraisal of relevant research findings is rare. Aim: To review trials from the core Anglosphere (UK, US, Canada, Ireland, Australia, New Zealand) published from 2005 to 2020. Method: A systematic review reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta‐Analyses. Comprehensive electronic database searches were conducted. Eligible studies were randomized controlled trials of mental health nurse‐delivered interventions conducted in relevant countries. The risk of bias was independently assessed. Synthesis involved integration of descriptive statistics of standardized metrics and study bias. Results: Outcomes from 348 between‐group comparisons were extracted from K = 51 studies (N = 11,266 participants), Standardized effect sizes for 68 (39 very small/small, 29 moderate/large) statistically significant outcomes from 30 studies were calculable. All moderate/large effect sizes were at risk of bias. Discussion: Trial evidence of effective mental health nurse‐delivered interventions is limited. Many studies produced few or no measurable benefits; none demonstrated improvements related to personal recovery. Implications for Practice: Mental health nurses should look beyond gold standard RCT evidence, and to evidence‐based interventions that have not been trialled with mental health nurse delivery. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to determine the effect of web‐based patient education on anxiety in patients scheduled for thyroid surgery. A secondary aim was to evaluate the patients' postoperative recovery outcomes. Design: This study is a randomized controlled trial. Method: The study was conducted at a university hospital in Turkey between September 2018 and May 2019 with 76 patients scheduled for thyroidectomy surgery and randomly assigned into two groups. Patients in the intervention group received web‐based education, while those in the control group were given only routine care. Measurements were performed before surgery, on the day of surgery, and 1 week after discharge. Results: On the day of surgery, intervention group anxiety levels were lower than those of the control group, and the majority of early recovery parameters were significantly better in the intervention group than in the control group. One week after discharge, the intervention group patients' anxiety levels were significantly lower. Web‐based education had no impact on pain, time in the operating room, readmission to the hospital after discharge, or length of hospitalization. Conclusions: Nurse‐led web‐based education reduced patients' anxiety regarding surgery. The results also show that it may improve postoperative early recovery. Summary statement: What is already known about this topic? Preoperative anxiety can be associated with numerous symptoms, and recovery time may be prolonged but preoperative information is effective in reducing patient anxiety and hastening early recovery.Nurses have active roles in patient education and the information given by the nurse during preparation for surgery process can positively impact patient health outcomes.As technology has advanced, methods used by patients for acquiring information have changed, and written materials have been replaced by online platforms. What this paper adds? Nurse‐led patient education can exert positive effects on surgical patients.Web‐based education reduces patients' anxiety about surgery compared with the traditional approach. The implications of this paper: Nurse‐led web‐based patient education can be a useful method for reducing patients' anxiety and improving early recovery.Nurses can use this research to develop innovative approaches to the education of perioperative patients. [ABSTRACT FROM AUTHOR]