#Protocol

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Remote Monitoring for Rheumatoid Arthritis Flare During Drug Tapering: #Protocol for a Prospective Observational Cohort #Study

Background: Rheumatoid arthritis (RA) disease activity during disease-modifying antirheumatic drug (DMARD) tapering is commonly monitored using in-person clinical assessment and the 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP). Although effective, this approach is resource intensive and may be inconvenient for patients. Remote monitoring with patient-reported outcomes and ##Wearable sensors may enable earlier flare detection and support safer, more personalized tapering pathways. Prior pilot work suggests that accelerometry-derived physical activity, mobility, and sleep metrics correlate with RA disease activity and are acceptable to patients. Objective: This #Protocol aims to evaluate the feasibility and diagnostic accuracy of remote monitoring for detecting RA flare during DMARD tapering. The #Study will (1) continuously measure physical activity and quality metrics using wrist-worn accelerometers, (2) collect weekly Rheumatoid Arthritis Flare Questionnaire (RA-FQ) scores, (3) develop and evaluate dynamic risk prediction models using longitudinal accelerometry-derived measurements to estimate the risk of clinically confirmed flare, (4) retrospectively assess prediction accuracy against patient-reported flare, and (5) develop and evaluate a combined dynamic prediction model incorporating longitudinal accelerometry-derived measurements and total RA-FQ scores to assess whether the addition of the RA-FQ improves the prediction of clinically confirmed flare. Methods: This prospective, single-center observational cohort #Study is embedded within the Rheumatoid Arthritis DMARD Tapering (ROADMAP) clinic at Freeman Hospital, Newcastle upon Tyne, United Kingdom. Adults with clinician-confirmed RA in remission who are undergoing or are about to begin DMARD tapering will be recruited, with a target sample of 100 participants. Participants will be followed for 12 months, with clinical assessments aligned with routine ROADMAP visits at baseline and approximately months 3, 6, 9, and 12 together with ad hoc visits for suspected flare. Continuous wrist-worn accelerometry and weekly RA-FQ responses will be collected throughout follow-up. Clinical assessments will include tender and swollen joint counts, patient and physician visual analog scales, C-reactive protein, the DAS28-CRP, and Health Assessment Questionnaire Disability Index scores. The primary outcome is time to first clinically confirmed flare, defined as DAS28-CRP≥2.4 and/or at least 1 swollen joint attributable to inflammatory RA activity. Dynamic risk prediction methods, such as landmarking models, will use longitudinal accelerometry-derived physical activity, mobility, gait, and sleep measures to estimate flare risk over prespecified prediction horizons. Model performance will be assessed using time-dependent discrimination, calibration, predictive values, and lead time before clinically confirmed flare. Results: The first participant was recruited in October 2025. As of July 2026, 16 participants had been recruited. This #Protocol reports the #Study design and planned analyses; outcome analyses will be conducted after recruitment and 12-month follow-up are complete. Conclusions: This #Study will provide pilot evidence on the feasibility and accuracy of multimodal remote monitoring for RA flare detection during DMARD tapering in routine care. Findings will inform model refinement, external validation, and future larger multicenter studies evaluating clinical utility and service impact. International Registered Report Identifier (IRRID): DERR1-10.2196/99594

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Correction: #Protocol for a Sequential Multiple Assignment Randomized Trial to Improve Physical Activity and Diet Quality in Survivors of #Cancer

This is a correction of "#Protocol for a Sequential Multiple Assignment Randomized Trial to Improve Physical Activity and Diet Quality in Survivors of #Cancer"

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##Wearable-Based Assessment for Relapse Prediction Following Repetitive Transcranial Magnetic Stimulation for Depression: #Protocol for a Feasibility #Study (WARN-D #Study)

Background: A significant proportion of patients with major depressive disorder do not achieve remission after 2 antidepressant trials and are considered to have treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for TRD. However, relapse rates among remitters within the first year post treatment are significant, and there are no validated markers of relapse. ##Wearable devices have shown positive results for longitudinal monitoring of health metrics, and may be a promising tool for early detection of relapse following rTMS treatment. Objective: This #Study aims to evaluate the feasibility of a ##Wearable device (Oura Ring) to monitor individuals receiving rTMS treatment for depression. We will also explore the utility of ##Wearable-derived data as preliminary markers of treatment response and depressive relapse in a 6-month follow-up period. Methods: This single-arm pilot #Study will recruit 25 outpatients with a major depressive episode receiving rTMS at 2 tertiary hospitals in Ontario, Canada. Participants will be required to use a smart ring throughout the treatment course and during the 6-month follow-up. Clinical assessments including the Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Insomnia Severity Index (ISI), Posttraumatic Stress Disorder Checklist for (PCL-5), and World Health Organization-Five Well-Being Index (WHO-5) will be collected at baseline, treatment end, and 3- and 6-month follow-ups, alongside biweekly PHQ-9 and GAD-7 scores. The primary outcomes will be defined by feasibility measures (ie, recruitment, adherence, retention, missing data, and usability). Exploratory outcomes will include the assessment of preliminary associations between ##Wearable-derived features and clinical outcomes and depressive relapse. Results: The #Study was funded in December 2025, and data collection will commence following #Research ethics approval. At the time of manuscript submission, the #Study #Protocol was under review at the #Research Ethics Board of the participating institutions, and no #Study-related activities, including participant recruitment, had started. Data analysis and dissemination of findings will occur following completion of data collection. Conclusions: This #Study will provide initial evidence on the feasibility and utility of ##Wearable-based #Digital phenotyping in individuals receiving rTMS for TRD. Our findings will inform the design of future large-scale studies aimed at ##Wearable-supported relapse prevention and precision monitoring in depression care. International Registered Report Identifier (IRRID): PRR1-10.2196/89466

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Development and Validation of the Professional Readiness in Diversity and Equity Scale: #Protocol for a Scale Validation #Study

Background: Lesbian, gay, bisexual, #Transgender, queer, and intersex (LGBTQI+) patients continue to experience stigma, discrimination, and inadequate knowledge among mental health and medical professionals. These barriers can negatively impact health care outcomes, leading to delayed treatment, mistrust, and unmet medical needs within LGBTQI+ communities. Providing culturally competent care to LGBTQI+ people remains a critical challenge within health and social care. The development and use of reliable and valid assessments examining LGBTQI+ health care professional competency continue to be important in understanding and ameliorating LGBTQI+ health inequalities. Objective: The aim of the #Study is to develop and psychometrically validate a new multinational instrument designed to assess health care professionals’ LGBTQI+ attitudes, awareness, general skills, and knowledge, as well as to examine LGBTQI+ workplace affirmative policies, support, and climate. Methods: An initial pool of 100 new scale items was developed by reviewing existing LGBTQI+ health care scales and consulting with LGBTQI+ health care experts in the summer of 2023. Leading experts in LGBTQI+ health care were then asked to participate in the Delphi method to provide numeric and qualitative feedback on the 100 items. This process yielded a final primary survey comprising 39 test items. A cross-sectional multicenter, multicountry scale validation #Study using a web-based survey was administered to health care professionals and trainees in Italy, the United States, and the United Kingdom between October 2024 and December 2025 using a convenience sampling approach complemented by snowball recruitment. #Research participants were asked to complete a demographic and professional survey, the 39 new test items, the 18-item Lesbian, Gay, Bisexual, and #Transgender Development of Clinical Skills Scale (LGBT-DOCSS), and the 12-item Workplace Support subscale of the LGBT Climate Inventory (LGBTCI). Results: Funding commenced in May 2023, and data collection was conducted from October 2024 to December 2025. A total of 1339 eligible people completed the survey. Data analysis has started, and results will be reported in theautumn of 2026. It is anticipated that the Professional Readiness in Diversity and Equity (PRIDE) scale will emerge as a reliable and valid tool for assessing health care professionals’ LGBTQI+ attitudes, awareness, general skills, and knowledge, as well as examining LGBTQI+ workplace affirmative policies, support, and climate. The instrument may also serve as a useful outcome measure in #Research evaluating professional practice and development. Conclusions: The development and validation of the new PRIDE scale represent a significant advancement toward improved cultural competence among health care professionals. Validating the scale in both English- and Italian-speaking populations will support the development of international interventions and, ultimately, treatment outcomes for LGBTQI+ people. The PRIDE scale has the potential to exert a far-reaching impact on the delivery of clinical care and public health services worldwide. International Registered Report Identifier (IRRID): DERR1-10.2196/95456

journals.plos.org

De novo assembly and authentication of ancient DNA metagenomes with nf-core/mag

Author summary Advancements in genomic sequencing analyses are increasingly allowing researchers to reconstruct the genomes of microbial ‘dark matter’—those microbial species that are difficult to…

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Ayurvedic Treatment for Lumbar Disc Herniation With Radiculopathy: #Protocol for a #RCT #ClinicalTrial

Background: The leading cause of disability worldwide is low back pain. The incidence of herniated disc is approximately 5 to 20 cases per 1000 adults per year, and herniated disc is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, the condition grudhrasi is considered analogous to radiculopathy. In conventional medicine, the first line of treatment includes conservative management, such as patient education, manual therapy, and nonsteroidal anti-inflammatory drugs. Ayurvedic treatments are used to manage lumbar radiculopathy. Objective: This clinical #Study aims to compare the safety and efficacy of an Ayurvedic treatment #Protocol with standard care in patients with lumbar disc herniation with radiculopathy. Methods: This is an open-label, randomized, controlled, parallel group clinical trial with a sample size of 80 participants who will be randomly allocated to 2 groups. The intervention group will receive an Ayurvedic treatment #Protocol, and the control group will be treated with conventional care, including physiotherapy, for a period of 60 days. The changes in the numeric pain rating scale and visual analog scale score and the Oswestry Disability Index (version 2.0) score will be considered the primary outcome measures and will be recorded at baseline (day 1) and on day 8 (after completing inpatient [IP] treatment), day 30, and day 60. The secondary outcome, quality of life, will be recorded at baseline (day 1) and on day 8 (after completing IP treatment), day 30, and day 60. The occurrence of adverse events and the need for rescue analgesic medications will be considered other secondary outcome measures and will be recorded on day 8 (after completing IP treatment), day 30, and day 60. Results: The #Study was funded in March 2023, and the #Study period is 36 months. Participant enrollment began in November 2023. A total of 136 participants were screened, of whom 80 were enrolled in the #Study. Data analysis is in progress, and the #Study outcomes are expected to be published by December 2026. Conclusions: The outcome of this trial may provide scientific evidence regarding the safety and efficacy of Ayurvedic treatment for lumbar disc herniation with radiculopathy. The #Study may also contribute to the development of evidence-based integrative management strategies and standardized treatment #Protocols for this condition. Trial Registration: Clinical Trial Registry of India CTRI/2023/05/052859; https://tinyurl.com/y6h4b5kb

youtube.com

Protocol Radio 736

YouTube video by Nicky Romero

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The Effect of Integrated Aerobic and Cognitive Training (Activ4Brain) on Cognition and Neurophysiology in Older Adults: #Protocol for a Controlled Trial

Background: There is a need for efficient and engaging strategies that will mitigate the effects of aging on cognitive and physical functions while keeping users motivated for long-term adherence. Objective: This #Study #Protocol is designed to investigate, in older adults, the advantage of integrating cognitive training with aerobic exercise (AE) in fun group sessions to potentiate the effect of training on cognition while improving physical function. The #Protocol explores the effects of a novel intervention, the Activ4Brain program, on cognition and physical function as well as the underlying neurobiological mechanisms. Methods: The program consists of group AE classes that include computerized games designed to train cognition during exercise, taking advantage of exercise-induced arousal. Cognitive training task difficulty is adapted throughout the intervention as users improve their performance. Importantly, the setup allows for simultaneous body movements to maintain aerobic activation. This is a 3-arm controlled trial, using a parallel design with a 1:1:1 allocation to an experimental group that is engaged in the Activ4Brain program (24 sessions, twice a week), an active control group that is engaged in AE sessions, and a passive control group. Participants are tested at baseline and after the intervention. The main #Study outcome is changes in cognition. Additional outcomes include changes in brain and autonomic function, levels of inflammation and neuroprotective markers, cardiovascular and physical functional fitness, and body composition. Results: Data collection started in January 2024 and finished in April 2025. Seventy-three individuals (40 women and 33 men) were enrolled in the #Study and assigned to the 3 groups. The average age was 66 (SD 6) years. Data analyses are ongoing, with the publication of the results estimated for 2026 and 2027. Conclusions: This #Study will produce knowledge important for the development of efficient strategies to fight age-related decline. Trial Registration: ClinicalTrials.gov NCT07108413; https://clinicaltrials.gov/#Study/NCT07108413 International Registered Report Identifier (IRRID): DERR1-10.2196/92631

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Effects of a Nutritionally Balanced Between-Meal Food Product on Brain Function in Older Adults: #Protocol for a #RCT #ClinicalTrial (the MiniMeal #Study)

Background: Increasing evidence suggests that diet influences gut microbiota composition and systemic inflammation, which in turn may affect brain health, cognitive function, and mood regulation. Elevated levels of systemic inflammation have been associated with reduced resting-state functional connectivity within the default mode network, a pattern linked to poorer cognitive performance in older adults. Dietary interventions incorporating anti-inflammatory foods, such as oat bran and chickpeas, may help attenuate low-grade inflammation and promote healthier dietary behaviors in aging populations. Objective: This #Study #Protocol describes a #RCT #ClinicalTrial designed to investigate the effect of healthy between-meal products on brain activity in older adults. Methods: The MiniMeal #Study is a 9-week, 3-arm #RCT #ClinicalTrial comprising a blinded, 2-arm intervention and a nonblinded, no-intervention comparison group. A total of 114 community-dwelling men and women aged ≥70 years (38 per group) will be randomized to 1 of 3 #Study arms. Participants in the intervention group will consume the MiniMeal products, while those in the reference or control group will receive reference or control products. In both intervention arms, products will be consumed twice daily, either replacing or supplementing habitual morning, afternoon, or evening between-meal occasions. All other dietary habits will remain unchanged. Participants in the no-intervention group will maintain their habitual diet throughout the #Study period. The primary outcome is functional brain activity, assessed using functional magnetic resonance imaging during the n-back task, comparing the intervention and reference groups. Secondary outcomes include comparisons with the no-intervention group and assessment of other neural measures, biomarkers in blood, body composition, physical function, and self-reported well-being. Results: Ethics approval was obtained from the Swedish Ethical Review Authority (Etikprövningsmyndigheten) on February 20, 2024. Participant recruitment was completed on December 18, 2025. Data collection was completed by February 27, 2026. Data analysis is ongoing since January 7, 2026. A total of 114 participants were enrolled, of whom, 106 completed all 6 #Study visits. Conclusions: This #Study will provide insights into whether nutritious between-meal products influence brain function in older adults and will explore potential underlying biological mechanisms. The findings are expected to contribute to a better understanding of the relationship between dietary habits and cognitive health in older adults and may inform future #Research on diet-based strategies to support in healthy aging. Trial Registration: ClinicalTrials.gov NCT06353984; https://clinicaltrials.gov/#Study/NCT06353984

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Risk Alert System to Facilitate Universal Suicide Risk Screening in Emergency Care: #Protocol for a Prediction Model and Software Development #Study Using a Co-Design Approach

Background: Suicide is a leading cause of preventable mortality and a major contributor to years of life lost. Many people who later die by suicide present to emergency departments in the months before death, often for reasons not explicitly related to self-harm and without receiving a risk assessment. Universal suicide risk screening in emergency care can improve detection but is difficult to implement because of time constraints, workflow disruption, and limited capacity to respond to increased identification. Objective: The Clinical Risk Alert System for Suicide Risk Screening in Emergency Settings (CARES) project aims to lower the practical threshold for universal screening by developing a risk alert system software prototype for use among patients presenting to emergency care, prompting a brief, validated suicide risk screening and clinician-led assessment. Methods: CARES will develop machine learning–based prediction models for subsequent nonlethal intentional self-harm and suicide within 1, 6, and 12 months after discharge from an index emergency department visit, using linked, population-based electronic registries from Catalonia (Spain), including Electronic Health Record #ehrs, mortality data, administrative sociodemographic variables, and a specific self-harm register. Index visits will include emergency department contacts in individuals aged 6 years or older without self-harm–related chief complaints, with predictors defined from information recorded in the prior 12 months. Models will be trained with approaches addressing rare outcomes and unequal sampling probabilities, and evaluated using an independent test set and temporal validation. The risk alert system software prototype will be designed as a web-based application with a backend hosting trained models and a frontend that allows data entry and displays risk as descriptive text and visualizations in absolute and relative terms compared with same-age and same-sex peers. Implementation #Research will use a co-design process with a user advisory group (UAG; clinicians, people with lived experience, caregivers, and stakeholder organizations), guided by the Medical #Research Council framework for complex interventions, to define alert thresholds, response pathways, usability requirements, and training needs. Results: The CARES project was funded in March 2023. The project uses linked electronic registry data from Catalonia covering 2014-2019, including 2,982,736 eligible emergency department index visits from 603,098 patients. The first UAG meeting was held in December 2024. As of May 2026, the project is developing the initial prediction models and software backend, while iteratively refining the frontend through UAG meetings. Data analysis is ongoing, and the main results are expected to be published in spring 2027. Conclusions: CARES will deliver an experimental proof-of-concept risk alert system designed to support future targeted suicide risk assessment within emergency workflows while keeping clinical decision-making with clinicians and patients. If feasible and acceptable, this approach could improve detection of otherwise unrecognized risk and inform future real-time integration and evaluation within routine emergency care.