JMIR Research Protocols最新文献

{"title":"A Conversational Agent for Providing Personalized Preexposure Prophylaxis (PrEP) Support: Protocol for Chatbot Implementation and Evaluation.","authors":"Fatima Sayed, Albert Park, Patrick Sean Sullivan, Yaorong Ge","doi":"10.2196/79966","DOIUrl":"https://doi.org/10.2196/79966","url":null,"abstract":"<p><strong>Background: </strong>Chatbots have the potential to reduce barriers to preexposure prophylaxis (PrEP), including lack of awareness, misconceptions, and stigma, by providing anonymous and continuous support. However, in the context of PrEP, chatbots are still nascent; they lack personalized informational expertise, peer experiential expertise, and human-like emotional support to facilitate future PrEP uptake. These personalized and relatable forms of support are crucial for increasing engagement, influencing health decisions, and fostering resilience and well-being.</p><p><strong>Objective: </strong>In this paper, we describe the iterative development and evaluation plans of a retrieval-augmented generation (RAG) chatbot for providing personalized information, peer experiential expertise, and human-like emotional support to PrEP candidates.</p><p><strong>Methods: </strong>We used an iterative design process consisting of 2 phases: prototype conceptualization and iterative chatbot development. In the conceptualization phase, we identified real-world PrEP needs and designed a functional dialogue flow diagram for PrEP support. Chatbot development included developing 2 components: a query preprocessor and a RAG module. The preprocessor uses the Segment Any Text (SAT) tool (developed by Markus Frohmann, Igor Sterner, Ivan Vulić, Benjamin Minixhofer, and Markus Schedl) for query segmentation and a Gemma 2 fine-tuned support classifier to identify informational, emotional, and contextual data from real-world queries. To implement the RAG module, we used Sentence-Bidirectional Encoder Representations from Transformers (SBERT) embeddings with cosine similarity, and performed topic matching to identify topically relevant documents based on the query topic to support document retrieval. Extensive prompt engineering was used to guide the large language model (LLM), Gemini-2.0-flash, in generating tailored responses. We conducted 10 rounds of internal evaluations to assess and improve the chatbot responses based on 10 criteria: clarity, accuracy, actionability, relevancy, information detail, tailored information, comprehensiveness, language suitability, tone, and empathy. Finally, we conducted a blinded comparative study and used a linear mixed model to validate the chatbot against a general LLM and real-world user responses.</p><p><strong>Results: </strong>We developed a RAG chatbot and iteratively refined it based on the internal evaluation feedback. Prompt engineering is essential in guiding the LLM to generate responses tailored to information, experiential, and emotional user needs. We found that prompt effectiveness varied with task complexity; this was likely due to LLM sensitivity to the structure of prompts and to linguistic variability. Prompt decomposition and segmenting prompt instructions helped improve comprehensiveness and relevancy for complex and long queries. The linear mixed model analysis revealed that while both the general LLM ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e79966"},"PeriodicalIF":1.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13630282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[¹⁷⁷Lu]Lu-DOTATATE Molecular Radiotherapy During Induction Chemotherapy for First-Line Stage 4 High-Risk Neuroblastoma in South African Children: Protocol for a Phase 1 Randomized Controlled Trial (LuDO-SA Trial).","authors":"Jaques van Heerden, Mariana Kruger, Kershinee Reddy, Anel van Zyl, James Warwick, Celeste Burger, Tumelo Moalosi, Christoffel van Reenen, Alan Davidson, Khanyisile Hlongwa, Daniella Violante, Nanette Bruwer, Gita Naidu, Biance Rowe, Lizette Louw, Bronwin van Wyk, Mariza Vorster, Thokozani Mkhize, Anita Brink","doi":"10.2196/93547","DOIUrl":"https://doi.org/10.2196/93547","url":null,"abstract":"<p><strong>Background: </strong>In South Africa, the metastatic response rate for stage 4 high-risk neuroblastoma (HR-NB) to induction chemotherapy is lower than that of similar regimens in well-resourced settings. Augmenting current induction chemotherapy regimens with molecular radiotherapy, without increasing toxicity, is an attractive systemic treatment in radioisotope-avid tumors, especially in a resource-limited setting where stem cell transplantation and immunotherapy are unavailable and costly. Clinical trials of [<sup>177</sup>Lu]Lutetium DOTATATE ([<sup>177</sup>Lu]Lu-DOTATATE) have primarily focused on refractory or relapsed HR-NB, with disappointing results. This study evaluates the feasibility and dose-limiting toxicity grading of adding a single dose of [<sup>177</sup>Lu]Lu-DOTATATE to induction chemotherapy in achieving metastatic remission rates.</p><p><strong>Objective: </strong>The aim of the proof-of-concept, open-label study is to evaluate the safety and efficacy of induction [<sup>177</sup>Lu]Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) on postinduction response rate in children diagnosed with HR-NB. The primary objectives are to evaluate the dose-limiting toxicity profile of participants treated with induction [<sup>177</sup>Lu]Lu-DOTATATE PRRT in conjunction with standard induction chemotherapy; to evaluate the dosimetry in South African patients receiving induction [<sup>177</sup>Lu]Lu-DOTATATE PRRT; and to evaluate the feasibility related to resources in patients treated with induction [<sup>177</sup>Lu]Lu-DOTATATE PRRT in conjunction with standard induction chemotherapy. The secondary objective is to determine the postinduction metastatic response rate in patients diagnosed with HR-NB after receiving induction [<sup>177</sup>Lu]Lu-DOTATATE PRRT in conjunction with standard induction chemotherapy.</p><p><strong>Methods: </strong>The LuDO-SA trial is a phase 1, open-label, multicenter, 2-arm, randomized controlled clinical trial. Children aged 18 months to 18 years are eligible. The experimental arm, consisting of a single dose of [<sup>177</sup>Lu]Lu-DOTATATE after cycle 1 of OJEC (vincristine, carboplatin, etoposide, and cyclophosphamide) and OPEC (vincristine, cisplatin, etoposide, and cyclophosphamide) chemotherapy, will be compared to the standard arm of OJEC and OPEC chemotherapy. The postinduction metastatic response rate is based on the International Neuroblastoma Response Criteria (INRC). The statistical analysis will be descriptive. The Fisher exact test will be used to evaluate the significance of end-of-trial outcomes.</p><p><strong>Results: </strong>The trial received institutional ethics approval from 4 South African universities in 2022 and SAHPRA (South African Health Products Regulatory Authority) regulatory approval. The trial, funded by Kinderkankerfonds vzw and the UZA Foundation, commenced recruitment in January 2023. As of July 2026, a total of 15 patients have been enrolled across 4 acade","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93547"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dosing and Safety of Once-Weekly Rifapentine and Isoniazid for 12 Weeks for Tuberculosis Preventive Therapy in Children With and Without HIV: Protocol for a Phase I/II Open-Label, Exposure-Controlled, Dose-Finding, and Safety Study (Tuberculosis Trials Consortium Study 35).","authors":"Ingrid Courtney, Meredith G Dixon, Louvina van der Laan, Rada Savic, Belen Solans, Kelly Dooley, Deron Burton, Shaun Barnabas, Avy Violari, Kia Bryant, Nigel Scott, Patrick Phillips, Erin Sizemore, Wendy Carr, Susan Purchase, Elri Nortier, Joh-Nell van der Westhuizen, Anne-Marie Demers, Anneke Hesseling, Rosanna Boyd","doi":"10.2196/103274","DOIUrl":"https://doi.org/10.2196/103274","url":null,"abstract":"<p><strong>Background: </strong>Young children with exposure to or infection with <i>Mycobacterium tuberculosis</i> are at high risk of developing tuberculosis disease, and postexposure tuberculosis preventive treatment decreases this risk. Evidence is limited regarding the dosing and safety of the 12-dose once-weekly rifapentine and isoniazid regimen (3HP) for tuberculosis preventive treatment in children younger than 2 years and in children living with HIV.</p><p><strong>Objective: </strong>This protocol describes Tuberculosis Trials Consortium (TBTC) Study 35, which aims to establish practical age- and weight-banded rifapentine doses for 3HP in children aged 0 to 12 years, including children younger than 2 years, and children living with HIV, while assessing safety, tolerability, palatability, and acceptability.</p><p><strong>Methods: </strong>TBTC Study 35 was a phase I/II, open-label, multisite, single-arm, exposure-controlled dose-finding and safety study of 3HP in children aged 0 to 12 years, including children living with HIV. Novel water-dispersible rifapentine and isoniazid formulations were used. Building on TBTC Study 26 data, initial rifapentine doses were selected, and nonlinear mixed-effects modeling was used to analyze the pharmacokinetic data and evaluate subsequent rifapentine doses. Safety was monitored throughout the 12-week treatment period and 12-week posttreatment follow-up.</p><p><strong>Results: </strong>Data collection began with the first recruitment in November 2019. The last participant was enrolled in December 2023, and participant follow-up and data collection were completed in May 2024. As of now, 69 participants were enrolled. The trial was funded throughout this time period. Data analysis is ongoing, and trial results are expected to be disseminated in 2026.</p><p><strong>Conclusions: </strong>TBTC Study 35 is expected to provide pharmacokinetic and safety data to inform practical pediatric 3HP dosing recommendations, including for children younger than 2 years and children living with HIV.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e103274"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cocreation of a Digital Psychological Intervention to Improve Mental Health Among Survivors of Breast Cancer (SerenApp): Protocol for a Usability and Pilot Randomized Controlled Trial.","authors":"Irene Zarcos-Pedrinaci, Vanesa Ramos-García, María Padilla-Ruíz, Francisco Rivas-Ruíz, Antoni Baena, Santiago Galán, Andrea Duarte-Díaz, Lilisbeth Perestelo-Pérez, Yolanda Álvarez Pérez, Cristina Valcárcel-Nazco, Maximino Redondo Bautista, Esperanza Varela-Moreno","doi":"10.2196/87151","DOIUrl":"10.2196/87151","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Survivors of breast cancer frequently experience anxiety, stress, and depression during the follow-up and survivorship phases, when access to psychosocial support is often limited. Although psychological interventions have demonstrated effectiveness, their implementation in routine clinical practice remains challenging. Digital mental health interventions offer a promising alternative. However, many existing solutions show limited personalization, engagement, and long-term adherence, partly due to insufficient involvement of end users in their design.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to develop and pilot-test a cocreated digital psychological intervention (SerenApp) aimed at improving psychological well-being among women during breast cancer follow-up and to evaluate its feasibility, usability, and preliminary effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This mixed methods study adopts a participatory cocreation approach structured into 3 phases. Phase 1 focuses on identifying unmet psychosocial needs and co-designing the app's content and functionalities through workshops involving patients and health care professionals, applying design thinking principles and the Cocre-Ar-E (cocreate, assemble, and evaluate) framework. Phase 2 involves the technical development of the intervention using an agile scrum framework methodology, followed by usability and technical validation (alpha testing). Phase 3 consists of a pilot randomized controlled trial (n=90; 45 participants in each of the intervention and control groups) conducted in Andalusia and the Canary Islands, Spain. Outcomes include acceptability, usability, adherence, psychological well-being, and cost-effectiveness. Validated instruments include the Cancer Patients' Stress Coping Questionnaire (CAEPO), Patient Health Questionnaire-9 (PHQ-9), Hospital Anxiety and Depression Scale (HADS), EQ-5D-5L, System Usability Scale (SUS), Client Satisfaction Questionnaire-8 (CSQ-8), Client Service Receipt Inventory (CSRI), and Mobile App Rating Scale (MARS). Quantitative analyses will include ANOVA, multilevel regression models, and cost-effectiveness analyses (incremental cost-effectiveness ratio and incremental cost-utility ratio), whereas qualitative data will be analyzed using reflexive thematic analysis supported by NVivo software.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Funding was awarded by the Instituto de Salud Carlos III (PI24/01193) in 2024. The SerenApp project began in January 2025 with an exploratory phase and a comprehensive literature review. The cocreation phase was conducted between September 2025 and May 2026, involving 24 breast cancer survivors and 15 multidisciplinary health care professionals. Development and alpha testing are ongoing, with recruitment expected to begin in 2027. Data analysis has not yet started, and the main study findings are expected to be published in 2028.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol describes the ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e87151"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Role of Human Leukocyte Antigen (HLA) Allele Patterns in the Incidence of End-Stage Renal Disease and HLA Antibody Production: Protocol for a Case-Control Study.","authors":"Ira Puspitawati, Nyoman Kertia, Teguh Triyono","doi":"10.2196/107508","DOIUrl":"https://doi.org/10.2196/107508","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The incidence of end-stage renal disease (ESRD) continues to increase globally, including in Indonesia, representing a significant public health burden. Genetic factors, particularly variations in human leukocyte antigen (HLA) alleles, have been suggested to contribute to ESRD susceptibility, either indirectly through their association with underlying immune-mediated diseases or directly through their involvement in immune regulation and renal injury pathways. Studies have shown varying results due to HLA polymorphisms, ethnicity, and environmental influences. HLA polymorphisms are suspected of influencing HLA antibody production, which in turn impacts kidney transplant outcomes. Although ethnicity is one of the factors that determine HLA allele variation in the population, research on HLA alleles has not been widely conducted in Indonesia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to analyze the role HLA alleles play in the occurrence of ESRD and their association with HLA antibody production.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This observational case-control study incorporates both retrospective and prospective data collection at Dr Sardjito General Hospital, Yogyakarta. Retrospective HLA typing and HLA antibody data were obtained from the medical records of patients with ESRD and healthy controls between January 2020 and May 2026. Additional participants in both groups are being prospectively recruited between June and December 2026 according to predefined eligibility criteria. The case group will comprise participants aged 18 years or older with ESRD, complete HLA typing data for 8 loci, and available HLA antibody results, excluding those who have undergone kidney transplantation. The control group will comprise individuals aged 18 years or older with normal kidney function. HLA allele typing will be performed using a molecular method, namely, polymerase chain reaction sequence-specific oligonucleotide probes. HLA antibody testing will be performed using a solid-phase assay-based technology, specifically a Luminex single-antigen bead assay (DiaSorin), and both the HLA allele typing and HLA antibody testing will be analyzed using a LABScan3D analyzer (One Lambda Inc). The HLA antibody results will be subsequently categorized into positive and negative calculated panel reactive antibody (cPRA) statuses. Statistical analysis using odds ratio (OR) calculation will be performed to determine the association between specific HLA alleles and the occurrence of ESRD as well as HLA antibody production, with a 95% CI.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participant recruitment and data collection began after approval of ethical considerations and are anticipated to be completed by December 2026. Dissemination of the study findings is planned for mid-2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will evaluate the role of HLA class I and class II allele patterns in the development of ESRD and anti-HLA antibody produc","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e107508"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intersectionality in AI and Machine Learning for Health Care: Protocol for a Scoping Review.","authors":"Duy A Dinh, Julia St Louis, Erin Ziegler, Patricia Gongal, Katie L Bain, Ani Orchanian-Cheff, Sandra Holdsworth, Shilpa Raju, Divya Sharma, Mamatha Bhat, Kathleen A Sheehan, Suze Berkhout","doi":"10.2196/103601","DOIUrl":"10.2196/103601","url":null,"abstract":"<p><strong>Background: </strong>AI and machine learning (ML) are increasingly being used in health care settings but may reproduce or exacerbate systemic biases. The integration of intersectionality and equity-related concepts offers an analytical framework to guide more reflexive, equity-oriented AI and ML design and implementation, particularly when paired with a coproduction philosophy that meaningfully includes community-based collaborators and knowledge users. However, there is limited synthesis on how intersectionality is conceptualized and operationalized in this context, and the extent to which interdisciplinary collaborators and patient partners are involved in such undertakings is unknown.</p><p><strong>Objective: </strong>This study aims to synthesize how intersectionality is conceptualized and operationalized, including frameworks, pedagogical tools, and methods, in AI and ML for health care, as well as the extent to which such projects use participatory or coproduction frameworks.</p><p><strong>Methods: </strong>The proposed scoping review will be conducted in accordance with the scoping review framework developed by the Joanna Briggs Institute. With the assistance of a research librarian, the following databases will be searched for published articles with primary data: MEDLINE, Embase, Emcare Nursing, APA PsycInfo, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials. Eligible studies will include any primary article that applies intersectionality in guiding the design and implementation of AI and ML in health care. This review will only include studies written in English. Two independent reviewers will screen the title and abstracts of articles, followed by its full-text review, for eligibility against a priori inclusion criteria. Conflicts regarding inclusion or exclusion will be resolved through consensus. Data will be extracted from the included studies and summarized narratively, supplemented by tables and charts. Patient or family partners will be engaged throughout the review process to refine the scope of the review, interpret findings, and support knowledge translation efforts, ensuring outputs are equity oriented and responsive to community priorities.</p><p><strong>Results: </strong>Preliminary searches yielded a total of 4191 records across 6 databases. The scoping review will be completed by October 2026.</p><p><strong>Conclusions: </strong>This scoping review will map how intersectionality is used in AI and ML research in health care, with a particular focus on how the term is conceptualized, operationalized, and used in the context of community participatory practice. Findings from the review will identify key gaps in the literature and provide community-relevant recommendations on how to meaningfully integrate intersectionality into the development of AI and ML for health care.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/103601.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e103601"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Testing the Implementation of the PAIN-CPG-EIT: Protocol for a Randomized Clinical Trial.","authors":"Barbara Resnick, Elizabeth Galik, Rachel McPherson, Nayeon Kim, Shijun Zhu","doi":"10.2196/72985","DOIUrl":"https://doi.org/10.2196/72985","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pain is a common symptom among older adults in nursing home settings, affecting 30% to 80% of residents living with dementia. Pain is not assessed; the underlying cause is not identified, and treatment is not initiated for a large percentage of residents. Untreated or overtreated pain can lower quality of life, negatively impact function, impair sleep, and increase behavioral and psychological symptoms associated with dementia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The purpose of this National Institute of Aging-funded study is to use our theoretically based approach that includes the social ecological model, social cognitive theory, and the evidence integration triangle to translate the use of the Pain Management Clinical Practice Guideline (Pain Management CPG) into nursing home settings and improve the assessment, diagnosis, and management of pain among residents living with dementia. Our theoretically based approach, combined with the Pain Management CPG, is referred to as PAIN-CPG-EIT (Pain-Clinical Practice Guideline-Using the Evidence Integration Triangle).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study is a cluster-randomized clinical trial, with communities assigned to receive treatment with the PAIN-CPG-EIT vs pain education only (EO). The nursing homes have been randomized equally into intervention and control groups. The goal is to recruit a total of 300 residents from 12 nursing homes (25 residents from each community). Implementation of the study is being done via 3 cohorts, with 4 communities included in each cohort. The PAIN-CPG-EIT is implemented by a research nurse facilitator and includes 4 components, namely, component I: establishing and meeting with a stakeholder team; component II: education of the staff; component III: mentoring and motivating the staff to address pain; and component IV: ongoing monitoring of pain management in the community. The EO intervention is also implemented by a research nurse facilitator and consists of component II only, which is education of the staff.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Study activities began in September 2023, and recruitment of residents and intervention activities started with cohort 1 in January 2024. Cohort 2 was initiated in February 2025, and cohort 3 was initiated in June 2026 and is currently ongoing. A total of 208 residents have been recruited from the first 10 study sites. All intervention activities have been implemented as intended. The study is expected to be completed by December 2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Outcomes are evaluated at baseline, 4 months, and 12 months after implementation of the intervention, and include improvement in the assessment, diagnosis, and management of pain; a decrease in pain; and evidence of more appropriate use of opioids. The findings from this study will provide evidence of the effectiveness of our implementation approach and use of the Pain Management CPG. The theoretically based approach may be us","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e72985"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating the Effects of Paralinguistic Configuration in Background Human Speech on Attention: Protocol for a Within-Subject Study.","authors":"Zilu Liang, Carl Daniel Karlsson","doi":"10.2196/93525","DOIUrl":"https://doi.org/10.2196/93525","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Background noise is common in everyday environments; yet, its effects on attention vary according to task demands, individual characteristics, and properties of the noise itself. Previous research has largely focused on music, nonspeech noise, or intelligible speech, leaving the effects of paralinguistic components of human speech (eg, tone, pitch, and rhythm) difficult to disentangle from linguistic content.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to investigate whether paralinguistic characteristics of semantically inaccessible background speech influence attentional performance. Specifically, it will compare focused and diffused vocal stimuli that differ in paralinguistic configuration, with silence included as a reference condition, while also examining physiological responses and individual differences.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Adults aged 18 years or older (target n=60) will complete one 120-minute laboratory session. In a counterbalanced within-subject design, participants will perform attention-related tasks under 3 auditory conditions: silence, focused vocal stimuli, and diffused vocal stimuli. The primary outcome will be the concentration performance (CP) score of the d2 Test of Attention, and reading comprehension accuracy will be a secondary behavioral outcome. Pupillometry, electrodermal activity (EDA), and blood volume pulse (BVP) will be recorded continuously, with mean pupil diameter, phasic EDA response rate, and the root-mean-square of successive differences (RMSSD) designated as prespecified secondary physiological outcomes. Individual differences in working memory capacity, noise sensitivity, attention-deficit hyperactivity disorder (ADHD) symptomatology, sleep quality, and mood will be assessed as potential moderators. The primary confirmatory analysis will use a linear mixed-effects model with auditory condition as a fixed effect, block position as a covariate, and participant as a random intercept. The prespecified primary contrast will compare the focused and diffused vocal conditions at α=.05. Focused versus silence and diffused versus silence will be examined as secondary contrasts with Holm adjustment for multiple comparisons. The Holm procedure will be used to adjust for multiple testing across the prespecified physiological outcomes, while moderation analyses will be considered exploratory. The protocol was refined following a formative pilot with 9 participants using an abbreviated 2-block procedure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ethics approval was granted in June 2026. No participants have been recruited for the full study described in this protocol. Recruitment is scheduled to begin in September 2027, with data collection projected to conclude in September 2029, and data analysis expected to be completed by September 2030. Dissemination of the results is anticipated by September 2031.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol provides a reproducible approa","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93525"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Translation Validation, Software Adaptation, and Usability Testing of a Spanish Contraception Decision Tool: Protocol for a Mixed Methods Pilot Study.","authors":"Minji Michelle Kang, Analay Perez, Alicia Brooks-Greisen, Daniela Burgos, Raphaela Barrios, Desiree Virginia Fermin Olivares, Andrea Perez Mukdsi, Mikel Llanes, Murphy Van Sparrentak, Cynthia Wynn, Justine P Wu","doi":"10.2196/101800","DOIUrl":"https://doi.org/10.2196/101800","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Contraceptive care is complex, especially for individuals with health conditions (eg, diabetes, depression, and cardiovascular disease) who must consider how and to what extent their condition may be affected by contraception or vice versa. My Health, My Choice (MHMC) is a novel, web-based contraceptive decision support tool designed in English for patients with health conditions and is currently being tested in a cluster randomized controlled trial in the United States. MHMC is not available in Spanish, creating linguistic barriers to trial participation for those who prefer to read and learn in Spanish.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol describes a 3-stage process to create a medically accurate, linguistically and culturally acceptable Spanish version of MHMC called &lt;i&gt;Mi salud, mi decisión&lt;/i&gt;.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The pilot study combines an iterative, convergent mixed methods design with an innovative translation process and user experience methodology. In stage 1 (translation validation), a bilingual 8-person translation team will conduct the Team-Driven, Person-Centered Translation Process, a 7-step innovative process developed for this study: (1) resource and team preparation; (2) forward translations; (3) synthesis of translations; (4) back translation; (5) consensus (harmonizing) of translations; (6) review and proofreading; and (7) pretest or pilot of the translated adaptation. In stage 2 (software adaptation), we will work with a professional software team to internationalize MHMC (prepare it to technically support multiple languages) and then localize MHMC (prepare it for a specific language or region) for use in Spanish. In stage 3, we will conduct usability testing with a nonprobability sample of 12 to 20 Spanish-speaking individuals (aged 18-49, who can get pregnant and want contraceptive decision support) who vary in reading levels and Spanish dialects. Quantitative usability data will be collected via electronic survey with an adapted version of the Spanish System Usability Scale (SUS). Qualitative data will be collected via \"think aloud\" cognitive interviews during which participants navigate the tool in real-time. We will conduct iterative cycles of rapid qualitative analysis and software revisions to identify and resolve user-interface problems and improve the Spanish text for medical accuracy, linguistic acceptability, and cultural acceptability. Usability testing will stop when data no longer yield substantive feedback.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of September 7, 2026, we have enrolled 5 participants to date and anticipate completion of the pilot by November 1, 2026. We anticipate completion of qualitative analysis by December 2026 and publication of results in 2027. The final product, &lt;i&gt;Mi salud, mi decisión&lt;/i&gt;, will be a contraceptive decision tool in Spanish with semantic equivalence (similar meanings of words) and conceptual equivalence (similar meanings ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e101800"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149109737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Digital System to Assess Mental Health in People With Intellectual Disability (MENTALSED): Protocol for a Development and Pilot Study.","authors":"Jairo Rodríguez-Medina, Clara Gonzalez Sanguino, Elena Betegón, Alba Ayuso-Lanchares, Teresa Boemo","doi":"10.2196/106072","DOIUrl":"https://doi.org/10.2196/106072","url":null,"abstract":"<p><strong>Background: </strong>People with intellectual disabilities have a high prevalence of mental health problems, which are often underdiagnosed and treated late due to difficulties in assessment. The limited availability of validated instruments, communication barriers, and reliance on external informants hinder the early detection of symptoms and the monitoring of their progression.</p><p><strong>Objective: </strong>This study describes the protocol for the development and piloting of MENTALSED, a digital assessment system designed for the continuous monitoring of mental health and emotional well-being in people with intellectual disability through ecological momentary assessment using traditional questionnaires supplemented with psychophysiological measures.</p><p><strong>Methods: </strong>The study uses a mixed methods design, combining quantitative and qualitative procedures. Following a literature review, a survey assessed the needs of direct care professionals. On the basis of these findings, self-report and proxy-report EMA questionnaires were developed. The professional version was evaluated by university experts and direct care professionals. The self-report version was adapted into an easy-to-read format with the support of a focus group of people with intellectual disabilities and subsequently evaluated by individuals with intellectual disabilities and professionals. The questionnaires were implemented on the Avicenna Research platform. Objective psychophysiological measures (heart rate variability via a chest strap and sleep quality and heart rate via a smartwatch) were included. All data are integrated into a custom application displaying 4 well-being dimensions. The subsequent pilot study will involve individuals with intellectual disability and support professionals over a 2-week period in natural settings.</p><p><strong>Results: </strong>The project was funded by the Ministry of Science, Innovation and Universities, the State Research Agency, and the European Regional Development Fund/European Union (grant PID2023-150190OA-I00/MENTAL-SED). The needs assessment and validation phases were conducted between January and May 2025. As of manuscript submission, a total of 91 participants (71 professionals and experts and 20 individuals with intellectual disability) have been recruited and have participated in the development and validation stages. The 2-week pilot study is currently concluding data collection. Data analysis for the pilot phase is expected to begin in October 2026, and the final results are expected to be published in 2027.</p><p><strong>Conclusions: </strong>MENTALSED is expected to facilitate the early detection of emotional and behavioral changes, improve diagnostic accuracy, and enable the development of evidence-based preventive interventions. The integration of multiple sources of information is expected to help overcome traditional limitations in mental health assessment in this population.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e106072"},"PeriodicalIF":1.6,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13626399/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149110014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}