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Introduction: Pregnancy increases the risk of periodontitis due to the increase in progesterone and estrogen. Moreover, periodontitis during pregnancy is associated with development of pregnancy and birth related complications. The aim of this study is to determine, whether periodontal treatment during pregnancy can reduce systemic inflammation and lower the risk of adverse pregnancy and birth related outcomes. Methods and analysis: The PROBE study is a non-randomized controlled intervention study conducted among 600 pregnant women with periodontitis. The women will be recruited among all pregnant women at two Danish hospitals in Region Zealand during their nuchal translucency scan and will subsequently be screened for periodontitis. The intervention group includes 300 pregnant women, who will be offered state-of-the-art periodontal treatment during pregnancy. The control group includes additional 300 pregnant women, who will be offered periodontal treatment after giving birth. Outcome measures include periodontal measures, inflammatory, hormonal and glycaemic markers as well as the prevalence of preterm birth risk, low birth weight and risk markers of gestational diabetes mellitus (GDM) and preeclampsia that will be collected from all screened women and further during pregnancy week 20 and pregnancy week 35 for women enrolled in the intervention. Ethics and dissemination: The study's findings will be published in peer reviewed journals and disseminated at national and international conferences and through social media. The PROBE study is designed to provide important new knowledge as to whether periodontal treatment during pregnancy can reduce the prevalence of complications related to pregnancy and birth. Clinical trials registration: The study was registered on clinicaltrials.gov (NCT06110143). [ABSTRACT FROM AUTHOR]

While conducting a coordinated set of repeat runs of human evaluation experiments in NLP, we discovered flaws in every single experiment we selected for inclusion via a systematic process. In this squib, we describe the types of flaws we discovered, which include coding errors (e.g., loading the wrong system outputs to evaluate), failure to follow standard scientific practice (e.g., ad hoc exclusion of participants and responses), and mistakes in reported numerical results (e.g., reported numbers not matching experimental data). If these problems are widespread, it would have worrying implications for the rigor of NLP evaluation experiments as currently conducted. We discuss what researchers can do to reduce the occurrence of such flaws, including pre-registration, better code development practices, increased testing and piloting, and post-publication addressing of errors. [ABSTRACT FROM AUTHOR]

Introduction: This meta-analysis aims to evaluate the complications associated with prepectoral breast reconstruction (PBR) compared to subpectoral breast reconstruction (SBR) in patients diagnosed with breast cancer. Materials and methods: A comprehensive search was performed in four databases, including Medline, Embase, Web of Science and CENTRAL, to collect literature published up until December 31, 2024. In addition, we conducted a thorough manual examination of the bibliographies of the identified papers, as well as pertinent reviews and meta-analyses. We conducted a search on three clinical trial registries, namely ClinicalTrials.gov, Controlled-trials.com, and Umin.ac.jp/ctr/index.htm. Meta-analyses were conducted on total complications, hematoma, infection, wound healing issues, necrosis, capsular contracture, rippling, animation deformity, and reoperation. Results: A total of 40 studies were included in the meta-analysis. Compared with SBR, PBR significantly reduced the incidence of animated malformations (OR=0.37, 95% CI: 0.19 to 0.70, P=0.003, I ²=12%), but increased the incidence of ripples (OR=2.39, 95% CI: 1.53 to 3.72, P=0.0001, I ²=10%) and seroma (OR=1.55, 95% CI: 1.02 to 2.35, P=0.04, increasing I ²=70%). Conclusions: Our findings indicate that PBR and SBR have comparable safety profiles, with similar total complication rates. Specifically, PBR is more likely to cause rippling and seroma, whereas SBR is more prone to causing animation deformity. [ABSTRACT FROM AUTHOR]

Despite the introduction of targeted vaccines and screening protocols, locally advanced cervical cancer represents a median proportion of 37% among all cervical carcinomas. Compared to early stages, it presents significantly lower cure rates, with a 5-year disease-free survival rate of 68% and a 5-year overall survival rate of 74%. According to current guidelines, definitive radiotherapy with concomitant chemotherapy represents the gold standard for locally advanced cervical cancer treatment. However, a significant number of patients relapse and die from metastatic disease. The aim of this narrative review is to examine the recent advancements in treating locally advanced cervical cancer, exploring new frontiers in therapeutic approaches. The PubMed database and clinical trial registries were searched to identify relevant articles published on locally advanced cervical cancer treatment up to March 2024, mainly focusing on papers published in the last decade. Abstracts presented at major international congresses that bring relevant evidence were included. Progress achieved in refining radiotherapy techniques, recent evidence regarding neoadjuvant treatment preceding surgery or concurrent chemoradiotherapy, and key findings concerning adjuvant treatment are thoroughly explored. Furthermore, a comprehensive review of prominent phase II and phase III trials examining the integration of immune checkpoint inhibitors is conducted, analyzing the various contexts in which they are applied. In light of the new evidence that has emerged in recent years and is discussed in this article, the appropriate selection of the most suitable therapeutic approach for each patient remains a complex but crucial issue. [ABSTRACT FROM AUTHOR]

Introduction and aim Diabetic foot ulcer (DFU) is a chronic condition that affects an increasing number of people each year[1]. Healing the ulceration requires cooperation between patients, specialists and scientists in order to achieve satisfactory results. Treating this type of wound is not only a therapeutic challenge[1,2,3,4,5,6], but also an economic one, which is why so much scientific research has already been made on this phenomenon[2,3]. Still scientists continue their quest for new cost-effective alternatives to current therapeutic options that would be consistent with contemporary knowledge and available engineering capabilities in pursuance of creating techniques and new dressings that will accelerate the healing of DFUs[2,3,7,8]. Factors such as stress, obesity, certain medications, and chronic diseases appear to negatively affect the process of repair [1,9,10,4,6,11]. Studies prove that aloe vera gel due to its healing properties, can be considered as a potential dressing that will expedite the mending process of diabetic foot ulceration[12,13,14]. In this paper, we performed a literature review of the applicability of aloe vera in the healing process of DFUs. Materials and methods Searching the available literature, including randomized clinical trials and systematic reviews, we drew on databases focusing on the effects of treatment for diabetic foot ulceration using Aloe vera. Conclusion: The current scientific research on the use of Aloe vera gel in diabetic foot ulcer treatment indicates that this method is safe, effective and inexpensive[2,3]. However the difficulty of treatment and the increasing prevalence of this type of wound pose a challenge to finding new solutions and exploring mechanisms in which aloe vera can have a possible role in the wound healing process. Nevertheless, this paper presents a promising impact of Aloe vera gel applicability in the healing process of diabetic foot ulcer. [ABSTRACT FROM AUTHOR]

Background: The lower limb motor dysfunction caused by stroke is one of the main sequelae affecting patients' ability to live normally in the later period. Acupuncture treatment of limb movement dysfunction after stroke has been recommended by authoritative guidelines for reducing limb spasticity, enhancing limb strength and so on. However, the efficacy of different acupuncture methods in treating lower limb motor dysfunction after stroke remains controversial. Objective: In this paper, network meta-analysis (NMA) was used to prioritize various acupuncture intervention combinations commonly used in clinical practice, try to screen the acupuncture intervention scheme with the highest clinical efficacy and safety, and explore its rationality in guiding clinical practice. Methods: We searched a total of 4,312 studies from 8 databases and 2 clinical trial registries, and selected 43 articles for systematic review. We used pairwise meta-analysis and network meta-analysis to evaluate the efficacy and ranking of various acupuncture interventions. At the same time, the risk of bias, publication bias, and sensitivity of included randomized controlled trials were analyzed. The main outcome indicator was Fugl-Meyer assessment of lower extremity (FMA-LE), and the secondary outcome indicators were Modified Barthel Index (MBI), Berg balance scale (BBS) and Modified Ashworth scale (MAS). Results: A total of 4,134 patients in 43 studies were included. The intervention included 9 acupuncture-related treatments, of which 20.9% were classified as high-risk. Among the four outcome indicators in pairwise meta-analysis, the effect of body acupuncture combined with conventional rehabilitation has the highest comprehensive credibility in terms of efficacy and safety comparing with conventional rehabilitation [SMD= 1.14, 95%CI (0.81, 1.46)], [SMD= 1.35, 95%CI (0.97, 1.72)], [SMD= 1.22, 95%CI (0.39, 2.05)], [SMD= 1.21, 95%CI (0.74, 1.44)]. In addition, multiple intervention methods, for example, warm acupuncture plus rehabilitation treatment for MBI and electroacupuncture plus body acupuncture plus rehabilitation treatment for BBS, may increase certain additional effects on different outcome indicators. Conclusion: This study proves that body acupuncture combined with rehabilitation treatment is the most widely used intervention method with the highest evidence quality in the treatment of lower limb motor dysfunction after stroke. However, for some other acupuncture methods, large samples and high-quality clinical randomized controlled trials are still needed to be fully verified. [ABSTRACT FROM AUTHOR]

Background: Stroke survivors with aphasia want to improve their everyday talking (discourse). In current UK practice, 90% of speech and language therapists believe discourse assessment and treatment is part of their role but are hampered by barriers in resources, time and expertise. There is a clinical need for well-articulated discourse assessment and treatments. LUNA is a multi-level treatment targeting words, sentences and discourse macrostructure in personal stories that addresses this clinical need. Objectives: This study aimed to assess the feasibility and acceptability of LUNA trial procedures in a randomised waitlist-controlled trial; and to evaluate preliminary efficacy. Methods: This paper reports a phase II, waitlist-controlled, proof-of-concept feasibility trial. Participants with chronic aphasia (n = 28) were recruited from the community and randomised to an Immediate (n = 14) or Delayed (n = 14) group. LUNA treatment was delivered twice weekly for 10 weeks via the videoconferencing technology, Zoom. Feasibility was assessed in terms of participant recruitment and retention, adherence, missing data, and treatment fidelity. Preliminary treatment efficacy was assessed in terms of between group differences in outcome measures relating to discourse, language, and psychosocial state. Results: The remote LUNA trial was feasible: 85% of those eligible consented to the trial; trial retention was 86%; 87% of treatment sessions were delivered as scheduled, and 79% of participants completed 80%+ of the treatment programme; data was missing only for participants who withdrew; treatment fidelity was high at 92% adherence; and only one clinical outcome measure demonstrated ceiling effects. ANCOVA analysis of the clinical outcome measures revealed group differences with medium and large effect sizes, indicating, improvements in the production of words, sentences, discourse macrostructure, overall language functioning (WAB-R), and psychosocial state (VAMS) following LUNA treatment. For most outcomes measured, similar treatment benefits were suggested in a secondary, non-parametric analysis. Conclusions: Large-scale evaluation of the clinical efficacy and cost-effectiveness of LUNA is warranted and supported by these findings. Trial registration: Clinical trials registration: NCT05847023 (clinical trials.gov). [ABSTRACT FROM AUTHOR]

Thyroid disease classification plays a crucial role in early diagnosis and effective treatment of thyroid disorders. Machine learning (ML) techniques have demonstrated remarkable potential in this domain, offering accurate and efficient diagnostic tools. Most of the real-life datasets have imbalanced characteristics that hamper the overall performance of the classifiers. Existing data balancing techniques process the whole dataset at a time that sometimes causes overfitting and underfitting. However, the complexity of some ML models, often referred to as "black boxes," raises concerns about their interpretability and clinical applicability. This paper presents a comprehensive study focused on the analysis and interpretability of various ML models for classifying thyroid diseases. In our work, we first applied a new data-balancing mechanism using a clustering technique and then analyzed the performance of different ML algorithms. To address the interpretability challenge, we explored techniques for model explanation and feature importance analysis using eXplainable Artificial Intelligence (XAI) tools globally as well as locally. Finally, the XAI results are validated with the domain experts. Experimental results have shown that our proposed mechanism is efficient in diagnosing thyroid disease and can explain the models effectively. The findings can contribute to bridging the gap between adopting advanced ML techniques and the clinical requirements of transparency and accountability in diagnostic decision-making. [ABSTRACT FROM AUTHOR]

The amount of grey literature and 'softer' intelligence from social media or websites is vast. Given the long lead‐times of producing high‐quality peer‐reviewed health information, this is causing a demand for new ways to provide prompt input for secondary research. To our knowledge, this is the first review of automated data extraction methods or tools for health‐related grey literature and soft data, with a focus on (semi)automating horizon scans, health technology assessments (HTA), evidence maps, or other literature reviews. We searched six databases to cover both health‐ and computer‐science literature. After deduplication, 10% of the search results were screened by two reviewers, the remainder was single‐screened up to an estimated 95% sensitivity; screening was stopped early after screening an additional 1000 results with no new includes. All full texts were retrieved, screened, and extracted by a single reviewer and 10% were checked in duplicate. We included 84 papers covering automation for health‐related social media, internet fora, news, patents, government agencies and charities, or trial registers. From each paper, we extracted data about important functionalities for users of the tool or method; information about the level of support and reliability; and about practical challenges and research gaps. Poor availability of code, data, and usable tools leads to low transparency regarding performance and duplication of work. Financial implications, scalability, integration into downstream workflows, and meaningful evaluations should be carefully planned before starting to develop a tool, given the vast amounts of data and opportunities those tools offer to expedite research. [ABSTRACT FROM AUTHOR]

Background: Endometrial cancer (EC) is the most common gynecological malignancy in both Europe and the USA. Approximately 3–5% of cases occur in women of reproductive age. Fertility-sparing treatment (FST) options are available, but very limited evidence regarding grade 2 (G2) ECs exists in the current literature. This systematic review aimed to comprehensively evaluate reproductive and oncologic outcomes among young women diagnosed with stage IA or G2EC disease who underwent FST. Methods: A comprehensive search of the literature was carried out on the following databases: MEDLINE, EMBASE, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register), the Health Technology Assessment Database, and Web of Science. Only original studies that reported the oncologic and reproductive outcomes of patients with stage IA and G2EC tumors who underwent FST were considered eligible for inclusion in this systematic review (CRD42023484892). Studies describing only the FST for endometrial hyperplasia or G1 EC were excluded. Results: Twenty-two papers that met the abovementioned inclusion criteria were included in the present systematic review. Preliminary analysis suggested encouraging oncologic and reproductive outcomes after FST. Conclusions: The FST approach may represent a feasible and safe option for women of childbearing age diagnosed with G2EC. Despite these promising findings, cautious interpretation is warranted due to inherent limitations, including heterogeneity in study designs and potential biases. Further research with standardized methodologies and larger sample sizes is imperative for obtaining more robust conclusions. [ABSTRACT FROM AUTHOR]

Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022). [ABSTRACT FROM AUTHOR]

Background: Obesity and rapid weight gain are established risk factors for noncommunicable diseases and have emerged as independent risk factors for severe disease following Coronavirus Disease 2019 (COVID-19) infection. Restrictions imposed to reduce COVID-19 transmission resulted in profound societal changes that impacted many health behaviours, including physical activity and nutrition, associated with rate of weight gain. We investigated which clinical and sociodemographic characteristics were associated with rapid weight gain and the greatest acceleration in rate of weight gain during the pandemic among adults registered with an English National Health Service (NHS) general practitioner (GP) during the COVID-19 pandemic. Methods and findings: With the approval of NHS England, we used the OpenSAFELY platform inside TPP to conduct an observational cohort study of routinely collected electronic healthcare records. We investigated changes in body mass index (BMI) values recorded in English primary care between March 2015 and March 2022. We extracted data on 17,742,365 adults aged 18 to 90 years old (50.1% female, 76.1% white British) registered with an English primary care practice. We estimated individual rates of weight gain before (δ-prepandemic) and during (δ-pandemic) the pandemic and identified individuals with rapid weight gain (>0.5 kg/m2/year) in each period. We also estimated the change in rate of weight gain between the prepandemic and pandemic period (δ-change = δ-pandemic—δ-prepandemic) and defined extreme accelerators as the 10% of individuals with the greatest increase in their rate of weight gain (δ-change ≥1.84 kg/m2/year) between these periods. We estimated associations with these outcomes using multivariable logistic regression adjusted for age, sex, index of multiple deprivation (IMD), and ethnicity. P-values were generated in regression models. The median BMI of our study population was 27.8 kg/m2, interquartile range (IQR) [24.3, 32.1] in 2019 (March 2019 to February 2020) and 28.0 kg/m2, IQR [24.4, 32.6] in 2021. Rapid pandemic weight gain was associated with sex, age, and IMD. Male sex (male versus female: adjusted odds ratio (aOR) 0.76, 95% confidence interval (95% CI) [0.76, 0.76], p < 0.001), older age (e.g., 50 to 59 years versus 18 to 29 years: aOR 0.60, 95% CI [0.60, 0.61], p < 0.001]); and living in less deprived areas (least-deprived-IMD-quintile versus most-deprived: aOR 0.77, 95% CI [0.77, 0.78] p < 0.001) reduced the odds of rapid weight gain. Compared to white British individuals, all other ethnicities had lower odds of rapid pandemic weight gain (e.g., Indian versus white British: aOR 0.69, 95% CI [0.68, 0.70], p < 0.001). Long-term conditions (LTCs) increased the odds, with mental health conditions having the greatest effect (e.g., depression (aOR 1.18, 95% CI [1.17, 1.18], p < 0.001)). Similar characteristics increased odds of extreme acceleration in the rate of weight gain between the prepandemic and pandemic periods. However, changes in healthcare activity during the pandemic may have introduced new bias to the data. Conclusions: We found female sex, younger age, deprivation, white British ethnicity, and mental health conditions were associated with rapid pandemic weight gain and extreme acceleration in rate of weight gain between the prepandemic and pandemic periods. Our findings highlight the need to incorporate sociodemographic, physical, and mental health characteristics when formulating research, policies, and interventions targeting BMI in the period of post pandemic service restoration and in future pandemic planning. Miriam Samuel and team analyzed health records of 17 million adults in England, examining patterns of weight change before and during COVID-19 and identifying groups most prone to rapid weight gain. Author summary: Why was this study done?: Restrictions imposed during the Coronavirus Disease 2019 (COVID-19) pandemic may have led to lifestyle changes that are associated with weight gain. Some studies have suggested that women, younger adults (18 to 29 years), and those living in more deprived areas were at greatest risk of weight gain during the pandemic, but these were limited by small sample size. There are currently no large-scale analyses of how the pandemic impacted preexisting patterns of weight gain, and how this varied by sociodemographic and clinical characteristics. What did the researchers do and find?: We used data from the routinely collected health records of 17 million adults living in England to investigate patterns of weight change before and during the pandemic and describe which groups were most likely to have experienced unhealthy patterns of weight gain. We found that, among adults with measures of weight recorded in their healthcare records, women, younger adults (18 to 29 years), those living in the most deprived areas, and those of white British ethnicity were most likely to have gained weight rapidly before and during the pandemic. The same groups were also most likely to have experienced extreme acceleration in their rate of weight gain during the pandemic. Almost all the long-term conditions (LTCs) increased the risk of unhealthy patterns of weight gain, with mental health conditions, such as depression, having the greatest estimated effect. What do these findings mean?: The COVID-19 pandemic appears to have had the greatest impact on women, young adults, and those living in the most deprived areas in terms of unhealthy patterns of weight gain. We present, to our knowledge, new evidence that people with mental health conditions were more likely to have unhealthy patterns of weight gain during the pandemic, highlighting the need to consider sociodemographic, physical, and mental health characteristics in research, policies, and interventions around weight. We recommend that future pandemic planning should consider how to mitigate the unequal indirect impact of a pandemic on patterns of weight gain to prevent preexisting health inequalities being further exacerbated. Changes in healthcare activity during the pandemic affected patterns of weight monitoring in primary care, which may have introduced new bias to the analyses. [ABSTRACT FROM AUTHOR]

Gastroesophageal reflux disease (GERD) is a common concern following laparoscopic sleeve gastrectomy (LSG). This paper aimed to assess the incidence of reflux disease following these bariatric procedures. A literature search was conducted to identify observational studies and clinical trials reporting patients developed GERD disease after LSG. Twenty-two studies included in the analysis, involve 20,495 participants, indicated that the estimated proportion of patients who developed post-surgery GERD was 0.35 (95% CI 0.30–0.41). Subgroup analysis revealed a proportion of 0.33 (95% CI 0.27–0.38) in observational studies and 0.58 (95% CI 0.39–0.75) in clinical trials. High heterogeneity was noted across studies (I2 = 98%). Sensitivity analyses and publication bias assessments were performed to enhance the robustness of the results. Our findings highlight a moderate to high risk of developing GERD following LSG surgery. [ABSTRACT FROM AUTHOR]

Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the impact of removable partial dentures (RPDs) on masticatory performance (MP) of partially edentulous subjects. Materials and Methods: Electronic database and hand searches were conducted to explore clinical trials reporting the evidence of the effect of metal- and acrylic-based RPDs on mastication. The validated objective and subjective measures of assessment of mastication were included. The article selection, data extraction, and assessment of risk of bias were conducted by two reviewers independently. Results: Out of 11,200 studies, 1 randomized controlled trial and 23 clinical trials met the inclusion criteria. Positive impact on different parameters of masticatory function after RPD treatment was reported in 14 studies. Subjective evaluation of chewing ability (CA) displayed an improvement in 83.3% of studies, while improvement was evidenced only in 69.5% of studies upon objective evaluation. Most studies reported data on free-end saddles. Of the 13 studies associated with bilateral free-end saddle dentures, 9 studies showed a positive effect on masticatory efficiency. Various factors were found to have an impact on the MP of RPDs. Conclusions: Subjective evaluation displays higher positive impact of RPDs in MP than objective evaluation. Assessment of patients' perspectives is important in clinical decision-making. Multiple factors affect the MP with RPD treatment. [ABSTRACT FROM AUTHOR]

Background: The integration of Virtual Reality (VR) with Case-Based Learning (CBL) has the potential to revolutionise undergraduate medical education, particularly in complex subjects such as the anatomy and rehabilitation of the shoulder joint. This study aimed to explore the effectiveness of this innovative approach in enhancing learning outcomes and knowledge retention. Methods: This study employed a parallel-group, assessor-blinded randomised controlled trial (RCT) design. A comprehensive five-week educational programme was developed, combining traditional lecture-based learning with VR-enhanced CBL. The study involved 82 undergraduate students from China Medical University, who were divided into groups receiving different combinations of VR and CBL. Student performance was evaluated through tests and questionnaires. Results: In the anatomy-related courses, the integration of VR technology with CBL yielded significantly higher results (87.71 ± 5.60) compared to traditional methods (82.59 ± 6.64), with a statistically significant difference (P < 0.05). This provides compelling evidence of VR's potential to enhance student engagement and knowledge retention. In the context of physiotherapy-related courses, however, while the test scores of the VR-combined CBL group (81.85 ± 5.99) were marginally higher than those of the traditional CBL group (79.02 ± 7.57), this difference was not statistically significant (P > 0.05). Conclusion: The present study provides preliminary evidence for the benefits of incorporating VR into medical education, particularly in anatomy. While the results are promising, further research is needed to explore the optimal integration of VR and CBL in rehabilitation studies and to assess their long-term impact on student learning and clinical performance. Trial registration: The study was registered with Chinese Clinical Trials Registry (Registration Number: ChiCTR2400089295) on 05/09/2024. [ABSTRACT FROM AUTHOR]

Background and Objectives: Sound is an important environmental factor that influences the expression of behavioral and psychological symptoms of dementia. Recent research on the effect of soundscape has shown promising results in improving environmental impact on people with dementia. However, no controlled studies have aimed to quantify the effects of soundscape intervention on resident outcomes. The aim of this study was to assess the feasibility and impact of a soundscape intervention on people with dementia and behavioral symptoms. Research Design and Methods: Pilot single-blind repeated-measures randomized controlled trial of an augmented soundscape intervention. Participants were people with dementia in a hospital-based specialized dementia unit. Participants were randomized to an augmented soundscape intervention delivered in their room in the morning and evening or treatment as usual, with 2 baseline weeks and 4 weekly post-randomization assessments of the primary and secondary behavioral outcomes. Results: The soundscape intervention was feasible in terms of recruitment, retention, and delivery of the intervention. There were improvements in the neuropsychiatric inventory total scores over time in both groups (−5.89, 95%CI −8.45 to −3.28, p < .001), but no differences between groups. There were no significant group, time, or group × time differences for the Pittsburgh Agitation Scale (PAS) total score. For the PAS-resisting care subscale, there was a significant group × time difference, with a greater reduction in the soundscape group over the study period (−0.81, 95% CI −1.59 to −0.03, p = .042). Discussion and Implications: In this pilot study, soundscape augmentation was a feasible and effective nonpharmacological approach to reducing resistance to care in people with dementia, although it did not improve neuropsychiatric symptoms more globally. Further studies with larger samples and of longer duration are needed to investigate the long-term effects of augmented sonic environments on people with dementia. Clinical Trials Registration Number: NCT04809545 [ABSTRACT FROM AUTHOR]

The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers' capacity and enhance the quality and efficiency of human reviews of the research proposals by REC. [ABSTRACT FROM AUTHOR]

The Cairo Consensus Statement on Research Integrity of Randomised Clinical Trials is a document that emphasizes the importance of ethical and professional principles in clinical trials. It provides guidelines for various stakeholders involved in clinical research, including trialists, ethics committees, journal editors, and peer-reviewers. The statement addresses issues related to trial approval, data integrity, reporting guidelines, and conflict of interest disclosures. It also highlights the need for transparent reporting of errors and deviations, as well as the use of data monitoring committees and translations in patient reported outcomes. The text calls for support and protection for both complainants and trialists and suggests areas for future research and development. [Extracted from the article]

Background: This study addresses the need for improved transparency and reproducibility in randomized clinical trials (RCTs) within the field of physical activity (PA) interventions. Despite efforts to promote these practices, there is limited evidence on the adherence to established reporting and methodological standards in published RCTs. The research, part of the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative) in 2020, assessed the methodological standards and reporting quality of RCTs focusing on PA interventions. Methods: RCTs of PA advice or exercise interventions published in 2020 were selected. Monthly searches were conducted on PubMed/MEDLINE targeting six top-tier exercise science journals. Assessments were conducted by two independent authors, based on 44 items originally from CONSORT and TIDieR reporting guidelines. These items were divided into seven domains: transparency, completeness, participants, intervention, rigor methodology, outcomes and critical analysis. Descriptive analysis was performed using absolute and relative frequencies, and exploratory analysis was done by comparing proportions using the χ2 test (α = 0.05). Results: Out of 1,766 RCTs evaluated for eligibility, 53 were included. The median adherence to recommended items across the studies was 30 (18–44) items in individual assessments. Notably, items demonstrating full adherence were related to intervention description, justification, outcome measurement, effect sizes, and statistical analysis. Conversely, the least reported item pertained to mentioning unplanned modifications during trials, appearing in only 11.3% of studies. Among the 53 RCTs, 67.9% reported having a registration, and these registered studies showed higher adherence to assessed items compared to non-registered ones. Conclusions: In summary, while critical analysis aspects were more comprehensively described, aspects associated with transparency, such as protocol registrations/modifications and intervention descriptions, were reported suboptimally. The findings underscore the importance of promoting resources related to reporting quality and transparent research practices for investigators and editors in the exercise sciences discipline. [ABSTRACT FROM AUTHOR]

Introduction: Global inequality in clinical research capacity and service delivery can be indicated simply by the proportion of clinical trials that a country or region has registered in clinical trial registry databases. The proportion of clinical trials registered in Africa is very low at 0.02%, even though the region accounts for approximately 15% of the world's population. Despite the economic challenges in most African countries, they have shown potential for growth and change in recent years. Methods: We conducted desk reviews on the interventional clinical trials done in Kenya, Ethiopia, and Nigeria between 2015 to May 2023. The search was done in clinical trials repositories, and journal repositories. The search focused on intervention clinical trials. Data was extracted by screening through the publications and clinical trial platforms. The data extracted from the publications included the type of clinical trial, clinical trial phase, diseases, etc. The data extracted from the reports included: challenges in conducting clinical trials, capacity-building efforts, and the impact of the clinical trial. Results: The number of clinical trial studies identified in Kenya was 113 (28 were on infant clinical trials). The study identified 97 clinical trials in Nigeria, of which 11 studies were on infant clinical trials. In Ethiopia, there were 28 clinical trials and only five were on infant clinical trials. The landscape review also expanded to capacity and gaps in clinical trials in the three countries. The largest proportion of clinical trials carried out in Kenya was on injury, occupational disease, and poisoning, 30.5% (n = 18) and the smallest proportion was on kidney disease, neonatal disease, obstetrics, and gynecology. Most Infant clinical trials were carried out in the area of infections and infestations 33.3% (n=7). Most of the challenges faced by clinical trials in the three countries include a lack of infrastructure, a lack of human resources, and a lack of financial resources. Implications: There is a need to map clinical trials done by African researchers based in Africa to exclude the trials done by non-African researchers based in Africa. Opportunities for clinical trials should be supported and challenges addressed. [ABSTRACT FROM AUTHOR]

Background: Despite the availability of treatments such as surgery and hormonal therapy, women with endometriosis often endure chronic problems. This review aims to evaluate the effectiveness and safety of neuropelveology. Methods: In a systematic review with a meta-analysis, we searched three electronic databases: MEDLINE (PubMed), Scopus, Embase, and Web of Science (WOS). The search was conducted in January 2024 with no date or language restrictions using a carefully curated set of keywords. We conducted a comprehensive review, including all observational and clinical trials reporting data on neuropelveology approaches in the management of endometriosis, irrespective of geographical location. The studies included in our review were required to be published in peer-reviewed journals and be available in any language, with at least an abstract in English. The data of all included studies were summarized in excel (version 19) and were analyzed by Comprehensive Meta-analysis v3.3 (Biostat) and STATA (version 17). A multilevel meta-analysis was performed on studies with two arms (intervention and control) to evaluate the efficacy of neuropelveology in managing women with endometriosis. Results: After screening 476 records, 30 studies, published from 1952 to 2021, were included in this review, each employing various methodologies. The studies were divided into the following three categories: (a) efficacy of neurectomy or nerve resection (n = 20), (b) efficacy of neurolysis (nerve blocks) (n = 4), and (c) efficacy of neuromodulation (n = 6) in the management of endometriosis. Among the studies evaluating the efficacy of neurectomy or nerve resection, 10 studies (with 18 group comparisons) were included in the random-effects meta-analysis. Treatment success (not occurrence of pain) was higher with neurectomy vs. controls (RR = 0.497, 95% CI = 0.236 to 1.04, p = 0.06 (for experimental studies) and RR = 0.248, 95% CI = 0.14 to 0.43, p < 0.001 (for observational studies)), representing a 50% and 75.2% risk reduction in the recurrence of pain in experimental and observational studies, respectively. Similarly, neurolysis, particularly superior hypogastric plexus blocks and uterine nerve ethanol neurolysis, demonstrated encouraging outcomes in pain reduction and an improved quality of life for women with endometriosis. The efficacy of neuromodulation in managing endometriosis symptoms appears promising but requires further investigation. Conclusions: In conclusion, neuropelveology approaches, such as neurectomy, neurolysis, and neuromodulation, offer significant potential for pain reduction in endometriosis patients, albeit with risks of complications and high recurrence rates, necessitating careful patient selection and long-term monitoring. [ABSTRACT FROM AUTHOR]

Background: Modern housing has been shown to reduce the risk of malaria infections compared to traditional houses; however, it is unclear if the effects differ in different malaria transmission settings. This study evaluated the effects of modern housing on malaria among different endemic areas. Methods: Electronic databases, clinical trial registries and grey literature were searched for randomized controlled trials, cohort studies, case–control studies, and cross-sectional surveys on housing done between 1987 and 2022. Forest plots were done, and the quality of evidence was assessed using the Grading of Recommendations, Assessments, Development and Evaluation Framework. Results: Twenty-one studies were included; thirteen were cross-sectional, four were case–control and four were cohort studies. Cohort studies showed an adjusted risk ratio of 0.68 (95% CI 0.48–0.96), and cross-sectional studies indicated an adjusted odds ratio (aOR) of 0.79 (95%CI 0.75–0.83). By endemic transmission regions, the adjusted odds ratio in the high endemic settings was 0.80 (95%CI 0.76–085); in the moderate transmission regions, aOR = 0.76 (95%CI 0.67–0.85) and in the low transmission settings, aOR = 0.67 (95%CI 0.48–0.85). Conclusions: The evidence from observational studies suggests that there are no differences in the protective effects of modern houses compared to traditional houses on malaria by endemicity level. This implies that good quality modern housing protects against malaria regardless of the malaria transmission settings. [ABSTRACT FROM AUTHOR]

This letter to the editor responds to a study on the effectiveness of an Erector Spinae Plane Block (ESPB) in reducing opioid consumption and pain in patients undergoing minimally invasive posterior stabilization. The authors of the letter raise concerns about the study's methodology, including the absence of study registration and the lack of adherence to reporting guidelines. They also question the accuracy and interpretation of the visual analogue scale (VAS) measurements used in the study. Ultimately, the authors disagree with the conclusions drawn by the original study and suggest a more valid conclusion would be that there were no statistically significant differences in opioid consumption and VAS for pain during the first 48 hours after surgery. [Extracted from the article]

Introduction: Pulmonary rehabilitation (PR) is an intervention aimed at the comprehensive care of individuals with chronic respiratory diseases. Patients with chronic obstructive pulmonary disease (COPD) and asthma present low levels of physical fitness because they avoid physical exercises due to the fear of triggering recurrent symptoms. Wearable devices have been integrated into behavioral modification interventions for physical activity in PR protocols. Therefore, this review aims to identify how wearable devices are being utilized for monitoring chronic respiratory diseases in pulmonary rehabilitation programs. Methods and analysis: Searches will be conducted on Medline, Cochrane Central Register of Controlled Trials, Embase (CENTRAL), CINAHL and PEDro electronic databases, as well as a search in the grey literature. We will include baseline data from randomized clinical trials reporting the use of wearable devices for monitoring physical activity in protocols for pulmonary rehabilitation programs for chronic respiratory diseases. Studies that discuss only the development of algorithms or applications for the assessment of diseases or unavailable full texts will be excluded. The main reviewer will conduct the initial search and exclusion of duplicates, while two independent reviewers will select studies, extract data, and assess the methodological quality using the PEDro tool. PROSPERO registration number: CRD42024504137. [ABSTRACT FROM AUTHOR]

Background: Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig´s disease, is a rare neurological condition and is the most common motor neurone disease. It is a fatal disease with specific loss of motor neurons in the spinal cord, brain stem, and motor cortex leading to progressive paralysis and usually death within five years of diagnosis. There remains no cure for ALS, and management is focused on a combination of neuroprotective medication, respiratory support, and management by multidisciplinary clinics. Patients and methods: This prospective, single-arm, open-label phase II clinical trial of sustained weekly administration of 2 mg/kg ILB® (a low-molecular weight dextran sulphate) was conducted in a single UK hospital. Eligible patients were at least 18 years and had a definite diagnosis of ALS according to El Escorial Criteria. The co-primary outcomes were safety, tolerability, and quantity of ILB® administered. EudraCT number. 2018-000668-28 Findings: Between 18-Apr-2019 and 27-Mar-2020, 11 patients were recruited and treated for up to 38 weeks. There were no treatment terminations or withdrawals. One serious adverse event was reported, which was not related to ILB® and resolved without sequalae. 270 mild/moderate adverse events were reported with no intolerable events occurring during the trial. The total number of ILB® treatments administered per patient ranged from 4 to 38, with a cumulative dose ranging from 745 to 6668 mg. As a result of the COVID-19 pandemic and the high-risk status of study participants, recruitment and treatment was suspended early in Mar-2020. At the long-term follow-up, three patients had died after the trial was halted, between 53 and 62 weeks after their final ILB® injection. Interpretation: Long-term weekly ILB® injections of 2 mg/kg was well tolerated and had an acceptable safety profile in patients with ALS. Trial registration: EudraCT: 2018-000668-28. clinicaltrials.gov: NCT03705390. This trial adheres to the principles of GCP in the design, conduct, recording and reporting of clinical trials as listed in part 2, "Conditions and Principles which apply to all Clinical Trials" under the header "Principles based on Articles 2 to 5 of the EU GCP Directive" in the Medicines for Human Use Clinical Trials Regulations (as amended in SI 2006/1928). For clarity, the study did not conform to all aspects of the International Conference on Harmonisation (ICH) E6 R2 Guidelines for GCP (also known as 'ICH GCP'). Of note, we did not use an external database, perform 100% source data verification, and only primary outcome data were analysed in parallel by a second, independent statistician. [ABSTRACT FROM AUTHOR]

Background: Policymakers, health insurers, and health care providers are becoming increasingly interested in cost-effectiveness analyses (CEA's) when choosing between possible treatment alternatives, as costs for mental health care have been increasing in recent years. Objective: The current study compared the cost-effectiveness and cost-utility of a phased-based treatment approach that included a preparatory stabilization phase with direct trauma-focused treatment in patients with PTSD and a history of childhood abuse. Methods: A cost-effectiveness analysis was conducted based on data from a randomized controlled trial of 121 patients with PTSD due to childhood abuse. A phase-based treatment (Eye Movement Desensitization and Reprocessing [EMDR] therapy preceded by Skills Training in Affect and Interpersonal Regulation [STAIR]; n = 57) was compared with a direct trauma-focused treatment (EMDR therapy only; n = 64). The primary outcome of cost-effectiveness was the proportion of patients with remitted PTSD. Quality-adjusted life years (QALY) were used as the primary outcome measure for cost-utility analysis. Results: Although the results of the cost-effectiveness analyses yielded no statistically significant differences between the two groups, the mean societal costs per patient differed significantly between the STAIR-EMDR and EMDR therapy groups (€19.599 vs. €13.501; M cost differences = €6.098, CI (95%) = [€117; €12.644]). Conclusion: STAIR-EMDR is not cost-effective compared with EMDR-only therapy. Since trauma-focused treatment is less time-consuming, non-traumafocused phase-based, treatment does not seem to be a viable alternative for the treatment of PTSD due to adverse childhood events. Clinical trial registration: https://onderzoekmetmensen.nl/nl/trial/22074, identifier NL5836. [ABSTRACT FROM AUTHOR]

This study describes decentralized recruitment and enrollment for a COVID-19 treatment trial, while comparing 5 primary recruitment methods: search engine ads, paid advertising within a national testing company, paid advertising within a regional testing company, electronic health record messages, and word of mouth. These are compared across patient demographics, efficiency, and cost. Clinical Trials Registration NCT04510194. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to evaluate the discoverability of supporting research materials, including supporting documents, individual participant data (IPD), and associated publications, in US federally funded COVID-19 clinical study records in ClinicalTrials.gov (CTG). Methods: Study registration records were evaluated for (1) links to supporting documents, including protocols, informed consent forms, and statistical analysis plans; (2) information on how unaffiliated researchers may access IPD and, when applicable, the linking of the IPD record back to the CTG record; and (3) links to associated publications and, when applicable, the linking of the publication record back to the CTG record. Results: 206 CTG study records were included in the analysis. Few records shared supporting documents, with only 4% of records sharing all 3 document types. 27% of records indicated they intended to share IPD, with 45% of these providing sufficient information to request access to the IPD. Only 1 dataset record was located, which linked back to its corresponding CTG record. The majority of CTG records did not have links to publications (61%), and only 21% linked out to at least 1 results publication. All publication records linked back to their corresponding CTG records. Conclusion: With only 4% of records sharing all supporting document types, 12% sufficient information to access IPD, and 21% results publications, improvements can be made to the discoverability of research materials in federally funded, COVID-19 CTG records. Sharing these materials on CTG can increase their discoverability, therefore increasing the validity, transparency, and reusability of clinical research. [ABSTRACT FROM AUTHOR]

Background: Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation. Methods: The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation. Conclusions: The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection. Trial registration: ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. Protocol version: April 27, 2020, v2. [ABSTRACT FROM AUTHOR]

Background: Non-invasive brain stimulation (NIBS) is a promising intervention for treatment-resistant schizophrenia. However, there are multiple available techniques and a comprehensive synthesis of evidence is lacking. Thus, we will conduct a systematic review and network meta-analysis to investigate the comparative efficacy and safety of NIBS techniques as an add-on to antipsychotics for treatment-resistant schizophrenia. Methods: We will include single- and double-blind randomized-controlled trials (RCT) comparing any NIBS technique with each other or with a control intervention as an add-on to antipsychotics in adult patients with treatment-resistant schizophrenia. We will exclude studies focusing on predominant negative symptoms, maintenance treatment, and single sessions. The primary outcome will be a change in overall symptoms, and secondary outcomes will be a change in symptom domains, cognitive performance, quality of life, functioning, response, dropouts, and side effects. We will search for eligible studies in previous reviews, multiple electronic databases and clinical trial registries from inception onwards. At least two independent reviewers will perform the study selection, data extraction, and risk of bias assessment. We will measure the treatment differences using standardized mean difference (SMD) and odds ratio (OR) for continuous and dichotomous outcomes, respectively. We will conduct pairwise and network meta-analysis within a frequentist framework using a random-effects model, except for rare event outcomes where we will use a fixed-effects Mantel–Haenszel method. We will investigate potential sources of heterogeneity in subgroup analyses. Reporting bias will be assessed with funnel plots and the Risk of Bias due to Missing Evidence in Network meta-analysis (ROB-MEN) tool. The certainty in the evidence will be evaluated using the Confidence in Network Meta-analysis (CINeMA) approach. Discussion: Our network meta-analysis would provide an up-to-date synthesis of the evidence from all available RCTs on the comparative efficacy and safety of NIBS for treatment-resistant schizophrenia. This information could guide evidence-based clinical practice and improve the outcomes of patients. Systematic review registration: PROSPERO-ID CRD42023410645. [ABSTRACT FROM AUTHOR]

Background: Hearing impairments are a rising burden in our aging society. Hearing loss is associated with reduced cognitive performance as well as decrements in balance and gait. Therefore, impaired hearing affects also dual tasking (DT). The aim of this review is to summarize the evidence for DT performance decrements of older adults with hearing impairments during maintaining balance or walking. Methods: The systematic literature research according to PRISMA guidelines was conducted using MEDLINE, APA Psych-Info, and Web of Science. Inclusion criteria were: Independent living older people ≥ 60 years with hearing impairments, use of a DT paradigm to test hearing impaired older adults within a balance or walking condition. Results: N = 57 studies were found within the databases. Eight studies were included (N = 456 participants (58% women), including n = 200 older hearing-impaired persons with different levels of hearing loss). Most of the included studies oriented their inclusion criteria for hearing-impairments at thresholds for mild hearing loss with Pure Tone Average (0.5-4 kHz) ≥ 25 and < 40 dB. Three of the studies focused on DT balance performance and five used DT walking comparing participants with and without hearing loss. For DT balance and gait performance, higher decrements for the hearing-impaired group were observed compared to healthy older adults. Performance decrements were accompanied by reduced compensatory strategies in balance performance. Conclusion: More pronounced decrements in DT performance were observed for participants with hearing impairments compared to those without. This implies that hearing-impaired older adults might need specific interventions to reduce the cognitive-motor interference (CMI) to maintain balance control or walking stability in daily situations that require managing of cognitive and motor tasks simultaneously. However, taking all results into account the underlying mechanisms of CMI for this target group needs to be further examined. Trial registration: This review was registered at Prospero with the ID CRD42022340232. [ABSTRACT FROM AUTHOR]

Objective: Our objective was to create a machine learning architecture capable of identifying obstructive sleep apnea (OSA) patterns in single-lead electrocardiography (ECG) signals, exhibiting exceptional performance when utilized in clinical data sets. Methods: We conducted our research using a data set consisting of 1656 patients, representing a diverse demographic, from the sleep center of China Medical University Hospital. To detect apnea ECG segments and extract apnea features, we utilized the EfficientNet and some of its layers, respectively. Furthermore, we compared various training and data preprocessing techniques to enhance the model's prediction, such as setting class and sample weights or employing overlapping and regular slicing. Finally, we tested our approach against other literature on the Apnea-ECG database. Results: Our research found that the EfficientNet model achieved the best apnea segment detection using overlapping slicing and sample-weight settings, with an AUC of 0.917 and an accuracy of 0.855. For patient screening with AHI > 30, we combined the trained model with XGBoost, leading to an AUC of 0.975 and an accuracy of 0.928. Additional tests using PhysioNet data showed that our model is comparable in performance to existing models regarding its ability to screen OSA levels. Conclusions: Our suggested architecture, coupled with training and preprocessing techniques, showed admirable performance with a diverse demographic dataset, bringing us closer to practical implementation in OSA diagnosis. Trial registration The data for this study were collected retrospectively from the China Medical University Hospital in Taiwan with approval from the institutional review board CMUH109-REC3-018. [ABSTRACT FROM AUTHOR]

Noise-induced hearing loss (NIHL) is a major cause of hearing impairment and is linked to dementia and mental health conditions, yet no FDA-approved drugs exist to prevent it. Downregulating the mitogen-activated protein kinase (MAPK) cellular pathway has emerged as a promising approach to attenuate NIHL, but the molecular targets and the mechanism of protection are not fully understood. Here, we tested specifically the role of the kinases ERK1/2 in noise otoprotection using a newly developed, highly specific ERK1/2 inhibitor, tizaterkib, in preclinical animal models. Tizaterkib is currently being tested in phase 1 clinical trials for cancer treatment and has high oral bioavailability and low predicted systemic toxicity in mice and humans. In this study, we performed dose–response measurements of tizaterkib's efficacy against permanent NIHL in adult FVB/NJ mice, and its minimum effective dose (0.5 mg/kg/bw), therapeutic index (>50), and window of opportunity (<48 h) were determined. The drug, administered orally twice daily for 3 days, 24 h after 2 h of 100 dB or 106 dB SPL noise exposure, at a dose equivalent to what is prescribed currently for humans in clinical trials, conferred an average protection of 20–25 dB SPL in both female and male mice. The drug shielded mice from the noise-induced synaptic damage which occurs following loud noise exposure. Equally interesting, tizaterkib was shown to decrease the number of CD45- and CD68-positive immune cells in the mouse cochlea following noise exposure. This study suggests that repurposing tizaterkib and the ERK1/2 kinases' inhibition could be a promising strategy for the treatment of NIHL. [ABSTRACT FROM AUTHOR]

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Due to growing interest in the investigation of exercise induced sweat biomarkers to assess an individual's health and the increasing prevalence of tattoos in the world's population, investigators sought to determine whether local sweat concentrations and excretion rates of epidermal growth factor (EGF), interleukin (IL) -1α, IL-6, IL-8, cortisol, glucose, blood urea nitrogen (BUN), and lactate differ between tattooed and contralateral non-tattooed skin during exercise. Sixteen recreational exercisers [female (50%)] (age = 25–48 years) with ≥ 1 unilateral permanent tattoo [median tattoo age = 6 years, IQR = 5] on the arm/torso completed an outdoor group fitness session. There were no significant differences between tattooed and non-tattooed skin for sweat EGF, IL-1α, IL-8, cortisol, glucose, BUN, or lactate concentrations. There were no significant differences between tattooed and non-tattooed skin for sweat EGF, IL-1α, IL-8, cortisol, glucose, BUN, or lactate excretion rate. Findings suggest that permanent tattoos older than 1 year may not impact local sweat EGF, IL-1α, IL-8, cortisol, glucose, BUN, and lactate concentrations or excretion rates during exercise. Clinical trial identifier NCT04920266 was registered on June 9, 2021. [ABSTRACT FROM AUTHOR]

Importance: Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. Objective: Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. Evidence review: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. Findings: Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. Conclusion and relevance: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials (RCTs) are usually the basis of evidence-based medicine, but whether the results of RCTs can be correctly translated into clinical practice depends on the quality of the literature reported. In this study, we evaluated the general characteristics and quality of paediatric RCTs published in China to provide evidence for the reporting of paediatric RCTs and their application in clinical practice. Methods: We conducted a cross-sectional observational study of paediatric RCTs published in paediatric journals in China between January 1, 1999, and December 30, 2022. All RCTs that included children (younger than 18 years old) were retrieved, and the general characteristics of the RCTs were extracted and analysed. The quality of the RCTs was assessed by the Cochrane quality assessment protocol. Results: After screening 20 available paediatric journals, 3545 RCTs were included for analysis. The average annual growth rate of the number of published paediatric RCTs from 1999 to 2022 was 7.8% (P = 0.005, R2 = 0.311). Most of the studies were carried out in East China [1148 (32.4%]; the centres of the RCTs were mainly single-centre [3453 (97.4%], and the interventions were mainly medication [2442 (68.9%)]. Comparing RCTs published in 2017–2022 with RCTs published in 1999–2004, the quality of RCTs significantly improved in terms of random sequence generation, allocation concealment, blinding participants and personnel, incomplete outcome data and selective outcome reporting. RCTs published in multiple centres from the Chinese Science Citation Database were identified, and the approval of the ethics committee was of better quality for all the analysed risk of bias items. Conclusion: The number and quality of paediatric RCTs reported in China have improved in recent years, but the overall quality was relatively low. Special attention should be given to allocation concealment and blinding outcome assessment, and dropouts, adverse effects and sample size calculations should be reported. Promoting government policies, strengthening the standardization of journal publishing and advancing the registration of clinical trials are feasible measures. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depression are highly prevalent and often comorbid mental disorders that are encompassed within the broad category of emotional disorders. The frequent comorbidity of anxiety and depression can pose challenges for accurate diagnosis and treatment which, in turn, highlights the need for reliable measurements that are simultaneously responsive to change and prevent non-response bias. Brief measures of anxiety and depression can potentially increase response rates due to their brevity and ease of administration. This study evaluates the psychometric characteristics, discriminative accuracy, and sensitivity to change of the Generalized Anxiety Disorder 2-item scale (GAD-2) and the Patient Health Questionnaire 2-item scale (PHQ-2) within a clinical population. Method: The sample comprised treatment-seeking participants (n = 3,411), screened (n = 2,477) to receive an internet-based psychotherapeutic intervention (cognitive-behavioral, psychodynamic, or waitlist). Results: Brief measures can effectively detect individuals who may be eligible for a diagnosis of depression and anxiety, not only prior to but also during and following the completion of psychological treatment. The discriminative ability of the GAD-2 was significantly greater during active treatment and at post-assessment compared with pre-treatment screening, although no such differences were found for the PHQ-2. Finally, endorsing the most severe response option on the GAD-2 and PHQ-2 was associated with a high probability of presenting with clinically relevant anxiety and depressive symptoms. Conclusion: Brief measures of anxiety and depression are viable instruments to screen for and monitor anxiety and depressive symptoms. Clinical trial registration: ClinicalTrials.gov, identifier NCT05016843. [ABSTRACT FROM AUTHOR]

Background: Acute Coronary Syndrome is the most common heart disease and the most significant cause of death and disability-adjusted life years worldwide. Teaching a healthy eating style is one preventive measure to prevent the disease's recurrence. This study aimed to determine the effect of healthy nutrition education with the help of traffic light labels on food selection, preference, and consumption in patients with acute coronary syndrome. Methods: This randomized, single-blinded clinical trial was conducted with 139 participants (66 in the intervention group and 73 in the control group) from January 2021 to August 2021 in Shaheed Rajaie Hospital, Tehran, Iran. The control group received standard training. The intervention group, besides this, received additional bedside training with an educational poster on traffic light labels from the research team during their final hospitalization days. Data were collected using a researcher-made questionnaire on food selection, preference, and consumption. Results: The Brunner-Munzel test showed no significant difference between the two groups in terms of selection (P = 0.127), preference (P = 0.852), and food consumption (P = 0.846) in the baseline, while after the intervention, there were significant differences in selection (P > 0.001), preference (P > 0.001), and consumption (p < 0.004). Comparing the difference between the two groups in the difference between the before and after scores for selection (p < 0.001), preference (p < 0.001), and food consumption (p = 0.011) with the Brunner-Munzel test indicated a significant difference in all outcome variables. Conclusions: Teaching healthy eating styles with the help of traffic light labels affected food selection, preference, and consumption and led to healthier diets in these patients. Clinical trial registration number: Clinical trial registration: It was prospectively registered in the Iran Clinical Trials Registration Center on this date 30/10/2020 (IRCT20200927048857N1). [ABSTRACT FROM AUTHOR]

Background: Oral mucositis is a common and distressing side effect of head and neck oncology treatment. Photobiomodulation therapy can be utilized to prevent and treat oral mucositis. Its impact on salivary cytokines has yet to be thoroughly investigated. This is the first systematic review aiming to evaluate the effect of photobiomodulation on salivary cytokines in patients undergoing anticancer treatment. Methods: Numerous data resources, from the Web of Science, Embase, ScienceDirect, PubMed, Cochrane Library, and Scopus were sought. Articles published up until February 2024 were included if they met the following inclusion criteria: clinical trials reporting the effect on salivary cytokines in patients undergoing anticancer therapy. The methodological quality was assessed using several appraisal tools. Results: Four studies were deemed eligible for inclusion. All the studies were conducted in Brazil and used an InGaAlP diode laser with a wavelength of 660 nm. The included studies had a relatively low risk of bias. The head and neck cancer patients' salivary cytokines that were assessed by the studies, along with photobiomodulation therapy, included IL-12p70, TNF-α, IL-6, IL-8, IL-10, CXCL8, and IL-1β. The results varied among the studies. Conclusions: Our results show that photobiomodulation demonstrated positive results for reducing the severity of OM in all the included studies. Among the examined salivary cytokines, IL-6 is the most relevant cytokine for oral mucositis development and severity. A variation in the cytokine levels between the studies was noted due to differences in the type of anticancer treatment and saliva sampling. [ABSTRACT FROM AUTHOR]

Background Coronary microvascular dysfunction (CMD) could be a potential underlying mechanism for myocardial disease in HIV. Methods Comparisons of coronary flow reserve corrected for heart rate-blood pressure product (CFRCOR) were made among people with HIV (PWH) with no known history of cardiovascular disease (CVD) or diabetes mellitus, persons without HIV (PWOH), and persons with diabetes (PWDM) and no known history of CVD or HIV. Results PWH (n = 39, 74% male, age 55 [7] years, body mass index [BMI] 32.3 (26.8-34.9) kg/m2, duration of antiretroviral therapy 13 [5] years, CD4+ count 754 [598-961] cells/μL) were similar to PWOH (n = 69, 74% male, age 55 [8] years, BMI 32.2[25.6-36.5] kg/m2) and PWDM (n = 63, 63% male, age 55 [8] years, BMI 31.5 [28.6-35.6] kg/m2). CFRCOR was different among groups: PWOH 2.76 (2.37-3.36), PWH 2.47 (1.92-2.93), and PWDM 2.31 (1.98-2.84); overall P =.003. CFRCOR was reduced comparing PWH to PWOH (P =.04) and PWDM to PWOH (P =.007) but did not differ when comparing PWH to PWDM (P =.98). A total 31% of PWH had CFRCOR < 2.0, a critical cutoff for CMD, compared to 14% of PWOH and 27% with PWDM. A total 40% of women with HIV had a CFRCOR < 2.0 compared to 6% of women without HIV (P =.02). Conclusions Subclinical CMD is present among chronically infected and well-treated, asymptomatic PWH who are immunologically controlled. This study demonstrates CFR is reduced in PWH compared to PWOH and comparable to PWDM, further highlighting that well-treated HIV infection is a CVD-risk enhancing factor for CMD similar to diabetes. Clinical Trials Registration: NCT02740179 [ABSTRACT FROM AUTHOR]

Background More than half of childhood tuberculosis cases remain undiagnosed yearly. The World Health Organization recommends the Xpert-Ultra assay as a first pediatric diagnosis test, but microbiological confirmation remains low. We aimed to determine the diagnostic performance of Xpert-Ultra with stool and urine samples in presumptive pediatric tuberculosis cases in 2 high-tuberculosis-burden settings. Methods This Médecins Sans Frontières cross-sectional multicentric study took place at Simão Mendes Hospital, Guinea-Bissau (July 2019 to April 2020) and in Malakal Hospital, South Sudan (April 2021 to June 2023). Children aged 6 months to 15 years with presumptive tuberculosis underwent clinical and laboratory assessment, with 1 respiratory and/or extrapulmonary sample (reference standard [RS]), 1 stool, and 1 urine specimen analyzed with Xpert-Ultra. Results A total of 563 children were enrolled in the study, 133 from Bissau and 400 from Malakal; 30 were excluded. Confirmation of tuberculosis was achieved in 75 (14.1%), while 248 (46.5%) had unconfirmed tuberculosis. Of 553 with an RS specimen, the overall diagnostic yield was 12.4% (66 of 533). A total of 493 stool and 524 urine samples were used to evaluate the performance of Xpert-Ultra with these samples. Compared with the RS, the sensitivity and specificity of Xpert-Ultra were 62.5% (95% confidence interval, 49.4%–74%) and 98.3% (96.7%–99.2%), respectively, with stool samples, and 13.9% (7.5%–24.3%) and 99.4% (98.1%–99.8%) with urine samples. Nine patients were positive with stool and/or urine samples but negative with the RS. Conclusions Xpert-Ultra in stool samples showed moderate to high sensitivity and high specificity compared with the RS and an added diagnostic yield when RS results were negative. Xpert-Ultra in stool samples was useful in extrapulmonary cases. Xpert-Ultra in urine samples showed low test performance. Clinical Trials Registration NCT06239337 [ABSTRACT FROM AUTHOR]

Background: Endodontic therapy in pediatric dentistry is a challenging procedure, especially for special needs, uncooperative, and very young patients. A new conservative approach which is the non-instrumental endodontic treatment (NIET) has been developed to simplify the management of primary teeth requiring pulpectomy. This review aimed to compare the efficiency of NIET and conventional endodontic treatment in primary teeth. Methods: Electronic databases including MEDLINE (via PubMed), Cochrane Library (CENTRAL), and Scopus without restrictions on publication year or publication language were searched. Only randomized clinical trials reporting clinical and radiographical outcomes of NIET and conventional pulpectomy on primary teeth were considered eligible. Two reviewers extracted the data according to the PRISMA statement and assessed the bias risk using the revised Cochrane risk-of-bias tool and a meta-analysis was performed. Results: From 3322 screened articles, seven articles meeting the inclusion criteria were included. The selected studies included 283 primary molars, of 213 children aged between 3 and 9 years, treated by NIET and conventional pulpectomy, and had follow-up periods ranging from 1 month to tooth exfoliation. Two studies reported good success rates for both the NIET technique and endodontic therapy with no statistically significant difference while three studies showed radiographical significant differences with a low success rate for the NIET technique. Only one study reported better outcomes in the pulpectomy group with statistically significant differences. The quantitative grouping of the included studies showed no significant differences between NIET and conventional endodontic therapy regarding clinical and radiographical success (p value > 0.05). Conclusion: No difference between the NIET technique and the conventional endodontic therapy in primary molars requiring pulpectomy could be confirmed. Results of the present review need to be interpreted with caution since the quality of evidence according to the GRADE was considered as moderate to very low. Therefore, additional clinical trials on the NIET technique are recommended. [ABSTRACT FROM AUTHOR]

The aim of this split-mouth randomized clinical trial was to evaluate the clinical outcomes (operative time, edema, trismus, and pain), the immediate histological effects, the alveolar repair (2 and 4 months), and the quality of life after the extraction of impacted third molars using high-speed pneumatic and electrical rotation. Sixteen patients underwent extraction of the two mandibular third molars with a minimum interval of 15 days. On one side of the participant's mouth, high-speed pneumatic rotation was used (Control Group—CG) while for the other side, high-speed electrical rotation was used (Study Group—SG). Statistical analysis included ANOVA repeated measures and Pearson correlations. SG group showed: shorter operative time (p = 0.019), less pain (p = 0.034), swelling (p < 0.001) and trismus (p = 0.025) on the 1st postoperative day; less pain (p = 0.034) and trismus (p = 0.010) on the 3rd postoperative day; less trismus (p = 0.032) on the 7th postoperative day; and better quality of life (p = 0.007). No differences were observed for peripheral bone damage or bone density of alveolar repair at 2 and 4 months between groups. Electric high-speed rotation provided better postoperative clinical parameters of pain, edema and trismus when compared with pneumatic high-speed rotation for mandibular third molar surgery. Trial registration: Brazilian Registry of Clinical Trials registration number RBR-4xyqhqm (https://ensaiosclinicos.gov.br/rg/RBR-4xyqhqm). [ABSTRACT FROM AUTHOR]

Background: Cystic fibrosis is a chronic genetic disease that can affect the function of the respiratory system. Previous reviews of the effects of respiratory muscle training in people with cystic fibrosis are uncertain and do not consider the effect of age on disease progression. This systematic review aims to determine the effectiveness of respiratory muscle training in the clinical outcomes of children and adolescents with cystic fibrosis. Methods: Up to July 2023, electronic databases and clinical trial registries were searched. Controlled clinical trials comparing respiratory muscle training with sham intervention or no intervention in children and adolescents with cystic fibrosis. The primary outcomes were respiratory muscle strength, respiratory muscle endurance, lung function, and cough. Secondary outcomes included exercise capacity, quality of life and adverse events. Two review authors independently extracted data and assessed study quality using the Cochrane Risk of Bias Tool 2. The certainty of the evidence was assessed according to the GRADE approach. Meta-analyses where possible; otherwise, take a qualitative approach. Results: Six studies with a total of 151 participants met the inclusion criteria for this review. Two of the six included studies were published in abstract form only, limiting the available information. Four studies were parallel studies and two were cross-over designs. There were significant differences in the methods and quality of the methodology included in the studies. The pooled data showed no difference in respiratory muscle strength, lung function, and exercise capacity between the treatment and control groups. However, subgroup analyses suggest that inspiratory muscle training is beneficial in increasing maximal inspiratory pressure, and qualitative analyses suggest that respiratory muscle training may benefit respiratory muscle endurance without any adverse effects. Conclusions: This systematic review and meta-analysis indicate that although the level of evidence indicating the benefits of respiratory muscle training is low, its clinical significance suggests that we further study the methodological quality to determine the effectiveness of training. Trial registration: The protocol for this review was recorded in the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD42023441829. [ABSTRACT FROM AUTHOR]

Background: n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in rare conditions where fewer patients are available to take part in research. This review describes the characteristics of randomised n-of-1 trials conducted over the span of 12 years, including how the n-of-1 design has been employed to study both rare and non-rare conditions. Methods: Databases and clinical trials registries were searched for articles including "n-of-1" in the title between 2011 and 2023. The reference lists of reviews identified by the searches were searched for any additional eligible articles. Randomised n-of-1 trials were selected for inclusion and data were extracted on a range of design, population, and analysis characteristics. Descriptive statistics were produced for all variables. Results: We identified 74 studies meeting our eligibility criteria, 13 of which (17.6%) were conducted in rare conditions. They were conducted in a range of clinical areas with the most common being neurological conditions (n = 16, 21.6%). The median (Q1, Q3) number of participants randomised was 9 (4, 20) and 12 trials (16.2%) involved a single patient only. Forty-six (62.2%) trials evaluated pharmaceutical interventions and 49 (66.2%) trials were placebo controlled. Trials had a median (Q1, Q3) of six (4, 8) periods and 61 (82.4%) compared two health technologies. Fifty-seven (77.0%) trials incorporated blinding and 32 (43.2%) had a washout period. Forty-nine trials (66.2%) used patient-reported outcome measures (PROMs) to assess the primary outcome. Trials used a range of approaches to analysis and 48 (64.9%) combined data from multiple patients. The characteristics of the n-of-1 trials conducted in rare conditions were generally consistent with those in non-rare conditions. Conclusions: n-of-1 trials are still underused and the application of the n-of-1 design for the evaluation of health technologies for rare diseases has been particularly limited. We have summarised the characteristics of randomised n-of-1 trials in rare and non-rare conditions. We hope that it can inform researchers in the design of future n-of-1 studies. Further work is required to provide guidance on specific design considerations, implementation, and statistical analysis of these studies. Trial registration: Not applicable. [ABSTRACT FROM AUTHOR]

Background: Premenstrual syndrome (PMS) is prevalent among women of reproductive age, but most do not seek medical advice. We hypothesized that building PMS awareness could promote medical help-seeking for PMS and thus reduce menstrual symptoms and improve work productivity. Methods: In January 2020, women aged between 25 and 44 years, having paid work, and not currently consulting with an obstetrics and gynecology doctor (n = 3090) responded to the Menstrual Distress Questionnaire (MDQ), the Premenstrual Symptoms screening tool, and the World Health Organisation Health and Work Performance Questionnaire. In addition, they received checklist-based online education for PMS. Of 3090 participants, 2487 (80.5%) participated in a follow-up survey in September 2020. We conducted multiple logistic regression analyses and text analyses to explore factors that encouraged and discouraged medical help-seeking. We also evaluated changes in menstrual symptoms and work productivity, using generalized estimating equations with interactions between the severity of PMS, help-seeking, and time. Results: During the follow-up period, 4.9% of the participants (121/2487) sought medical help. Those having high annual income (adjusted odds ratio [aOR] = 2.07, 95% confidence interval [CI]: 1.21–3.53) and moderate-to-severe PMS (aOR = 2.27, 95% CI: 1.49–3.46) were more likely to have sought medical help. Those who did not seek medical help despite their moderate-to-severe PMS reported normalization of their symptoms (36%), time constraints (33%), and other reasons for not seeking medical help. Participants with moderate-to-severe PMS who had sought medical help showed a significant improvement of − 8.44 points (95% CI: − 14.73 to − 2.15 points) in intermenstrual MDQ scores during the follow-up period. However, there were no significant improvements in premenstrual and menstrual MDQ scores or absolute presenteeism. Conclusion: Medical help-seeking alleviated intermenstrual symptoms in women with moderate-to-severe PMS, but only a small proportion of them sought medical help after PMS education. Further research should be conducted to benefit the majority of women who are reluctant to seek medical help, including the provision of self-care information. Trial registration: UMIN Clinical Trials Registry number: UMIN000038917. [ABSTRACT FROM AUTHOR]

Background Observing medication ingestion through self-recorded videos (video directly observed therapy [VDOT]) has been shown to be a cost-effective alternative to in-person directly observed therapy (DOT) for monitoring adherence to treatment for tuberculosis disease. VDOT could be a useful tool to monitor short-course latent tuberculosis infection (LTBI) treatment. Methods We conducted a prospective randomized controlled trial comparing VDOT (intervention) and clinic-based DOT (control) among patients newly diagnosed with LTBI who agreed to a once-weekly 3-month treatment regimen of isoniazid and rifapentine. Study outcomes were treatment completion and patient satisfaction. We also assessed costs. Pre- and posttreatment interviews were conducted. Results Between March 2016 and December 2019, 130 participants were assigned to VDOT (n = 68) or DOT (n = 62). Treatment completion (73.5% vs 69.4%, P =.70) and satisfaction with treatment monitoring (92.1% vs 86.7%, P =.39) were slightly higher in the intervention group than the control group, but neither was statistically significant. VDOT cost less per patient (median, $230; range, $182−$393) vs DOT (median, $312; range, $246−$592) if participants used their own smartphone. Conclusions While both groups reported high treatment satisfaction, VDOT was not associated with higher LTBI treatment completion. However, VDOT cost less than DOT. Volunteer bias might have reduced the observed effect since patients opposed to any treatment monitoring could have opted for alternative unobserved regimens. Given similar outcomes and lower cost, VDOT may be useful for treatment monitoring when in-person observation is prohibited or unavailable (eg, during a respiratory disease outbreak). The trial was registered at the National Institutes of Health (ClinicalTrials.gov NTC02641106). Clinical Trials Registration ClinicalTrials.gov NTC02641106; registered 24 October 2016. [ABSTRACT FROM AUTHOR]