JMIR Research Protocols最新文献

{"title":"Treatment of Erythematotelangiectatic Rosacea With Collateral Puncture Therapy: Protocol for a Randomized Controlled Trial.","authors":"Aolin Song, Bingnan Cui, Xuemin Wang, Jianing Bi, Xiaohong Wu, Liu Yang, Li Liu, Shengyuan Qu, Zhu Fan, Jiao Yang, Yuhe Yan","doi":"10.2196/59682","DOIUrl":"10.2196/59682","url":null,"abstract":"<p><strong>Background: </strong>Erythematotelangiectatic rosacea (ETR) is the most common subtype of rosacea, characterized by persistent facial erythema and telangiectasia of varying calibers. It causes significant aesthetic impairment and is often accompanied by uncomfortable symptoms, such as burning, stinging, dryness, and itching, profoundly affecting patients' quality of life. Intense pulsed light (IPL) therapy demonstrates notable improvement in persistent erythema and telangiectasia; however, it is associated with issues such as a prolonged treatment course and high costs. Collateral puncture therapy involves rapid puncturing of specific acupuncture points followed by gentle squeezing around the needle holes to induce minor bleeding. Previous studies have shown that collateral puncture therapy for ETR offers advantages such as rapid onset of effect, a simple procedure, and low cost. Nevertheless, more high-quality clinical research data are needed to confirm these findings.</p><p><strong>Objective: </strong>This study aims to observe the clinical efficacy and safety of collateral puncture therapy in treating ETR.</p><p><strong>Methods: </strong>This study enrolled 60 patients diagnosed with ETR. The patients were randomly divided into 2 groups: one group underwent 4 sessions of collateral puncture therapy with 1-week intervals between treatments, and the other group received a single session of IPL therapy. The primary efficacy end points were the clinician's erythema assessment and the clinician's telangiectasia assessment. The secondary efficacy end points included the investigator's global assessment, patient's self-assessment, Flushing Assessment Tool results, Dermatology Life Quality Index, and Rosacea-specific Quality-of-Life instrument. The evaluation points were before treatment, immediately after treatment, and during follow-up. The data were statistically analyzed using SPSS (version 25.0; IBM Corp) to compare intragroup and intergroup differences between the 2 sets of data before and after treatment, with a significance level of α=.05 for hypothesis testing.</p><p><strong>Results: </strong>Recruitment began on June 1, 2023. All participants have been recruited. Data analysis will be complete by the end of August 2025, with study findings available by December 2025.</p><p><strong>Conclusions: </strong>This study has the potential to verify the clinical efficacy and safety of collateral puncture therapy in the treatment of ETR, supplement rosacea treatment methods, standardize treatment protocols, and fill a current clinical gap in treating rosacea.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2200062639; https://www.chictr.org.cn/showproj.html?proj=177100.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/59682.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59682"},"PeriodicalIF":1.4,"publicationDate":"2025-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12214693/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316886","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":"Assessing the Efficacy of Current Histopathological Tumor Reporting Systems for Evaluating the Response to Neoadjuvant Chemotherapy for Breast Carcinoma: Protocol for an Observational Study.","authors":"Anita Sajjanar, Sunita Vagha","doi":"10.2196/56825","DOIUrl":"10.2196/56825","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;With a predicted 2 million new cases identified globally in 2018, breast carcinomas are the most common cancer in women and the primary cause of cancer-associated mortality. In the management of breast cancer, neoadjuvant chemotherapy treatment (NACT) has become a mainstay, particularly for patients with inflammatory and locally advanced breast cancer. It increases the possibility of breast-conserving surgery, facilitates tumor downstaging, and gives early indications of the effectiveness of treatment. Evaluating the histopathological response after NACT is crucial for prognosis and guiding subsequent treatment decisions. This study explores the various histopathological assessment systems used in breast carcinoma patients after NACT, focusing on the residual cancer burden (RCB) score, Miller-Payne system, Chevallier classification, Sataloff classification, National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 system, and the American Joint Committee on Cancer residual tumor size (R) categories. We compare their methodologies, strengths, limitations, and clinical significance, providing a detailed analysis of their roles in improving patient outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to confirm the diagnosis of breast carcinoma based on histopathology, to evaluate various scoring systems through assessments of histomorphological features affecting post-NACT patients with breast carcinoma, to compare the various systems regarding the response to therapy and forming prognoses, and to develop an ideal histomorphological assessment system for breast carcinoma in post-NACT patients. The study also focused on how breast tumors respond to NACT and how this response can guide treatment decisions and improve the formulation of prognoses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This observational study will be retrospective and prospective; it will include 128 patients diagnosed with breast carcinomas who have undergone NACT and were referred to a tertiary care hospital between January 2019 and December 2024. Following chemotherapy, a thorough examination of the histopathological specimens will be conducted to assess any changes in histomorphology.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection started in September 2021 and will be completed by December 2025. Data analysis began in January 2025, and the results are expected to be published in December 2025. Institutional ethics committee clearance was obtained prior to commencement of the study. This is a nonfunded academic study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This project aims to evaluate and compare histopathological assessment systems in patients with breast carcinoma after NACT. Various histopathological systems, such as the RCB score, the Miller-Payne grading system, and other systems, each provide valuable insights into how well tumors respond to chemotherapy. The aim is to reveal essential histopathological parameters, lead","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e56825"},"PeriodicalIF":1.4,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12209717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309937","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":"Effects of Selective Head-and-Neck Cooling on Brain Injury-Related Biomarker Levels and Symptom Rating Following a Boxing Bout: Protocol for an Exploratory Randomized Trial.","authors":"Ali Al-Husseini, Yelverton Tegner, Kaj Blennow, Henrik Zetterberg, Niklas Marklund","doi":"10.2196/68954","DOIUrl":"10.2196/68954","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Head impacts are common in contact sports such as boxing and occur at times of elevated core body and brain temperatures induced by the exercise. Following impact, elevated brain temperature may lead to the development of exacerbated brain injury that can be monitored by blood biomarkers. Blood-brain biomarkers S100B and glial fibrillary acidic protein (GFAP) reflect glial injury; neurofilament light (NFL), axonal injury; and Neuron-Specific Enolase (NSE) and Tubulin-associated unit (tau), neuronal injury. Time to peak levels post injury for these biomarkers varies. Levels of S100B l peak early post injury, while NSE, GFAP, and tau are regarded as subacute markers, and NFL shows prolonged increases. We attempt to cover a large spectrum of first week postfight alterations in blood-brain biomarkers and their response to head-neck cooling.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We hypothesized that acute head-and-neck cooling, recently shown to shorten return-to-play in concussed ice hockey players, applied acutely following a boxing bout, is associated with an attenuated concentration of blood biomarkers and improved symptom rating.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The trial is academically driven and funded by external and hospital research funds. Young, healthy elite boxers aged ≥18 years are recruited. Before, and immediately after a competitive boxing bout consisting of 2 or 3 rounds of 2 minutes each, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation before baseline testing. After the initial postfight blood sample is drawn and symptom rating using the Sports Concussion Assessment Tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 minutes or routine postfight management. The number of head impacts is counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial postbout blood sample, as well as 3 and 6 days post fight. At all blood sampling time points, the number of symptoms (NOS) and symptom severity score (SSS) are assessed using the symptom rating part of the SCAT-5. The primary endpoint is the difference in biomarker levels (GFAP, NFL, tau, UCH-L1, neuronal-specific enolase) immediately post fight and preintervention, to those obtained at 6 days post fight. The postfight SCAT-5 NOS and SSS are secondary endpoints.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment started in November 2021 and is ongoing. So far, 41 boxers have been included: 20 controls and 21 cooled. Data collection started in October 2024 following the completion of blood sample analysis. We expect to recruit more boxers before the middle of 2025, but challenges with recruitment may limit this.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;There is no treatment available for boxing-induced brain injury. Biomarkers are surrogate yet objective markers of brain injury, and the head-and-neck cooling tre","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68954"},"PeriodicalIF":1.4,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12209727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309938","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":"Identifying and Taking Action on the Protective and Risk Factors of Black Maternal Mental Health: Protocol for Community-Based Participatory Study.","authors":"Priscilla N Boakye, Kenneth Fung, Mawuko Setordzi, Egbe B Etowa, Rosanra Yoon, Josephine Etowa, Feven Desta, Nana Ama Tiwaa-Boateng, Modupe Tunde-Byass, Janet Yamada, Karline Wilson-Mitchell, Cynthia Maxwell, Crystal T Clark, Josephine Pui-Hing Wong","doi":"10.2196/70076","DOIUrl":"10.2196/70076","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Maternal mental health disorders are associated with adverse maternal and infant health outcomes. Despite advances in screening and treatment, disparities in maternal mental health disorders continue to disproportionately affect Black mothers and birthing persons. While there are studies that have examined maternal mental health, a gap in research remains in understanding the protective and risk factors of Black maternal mental health in Canada. Identifying the risks and protective factors is critical for advancing equitable and inclusive policies and practices that promote maternal well-being and optimal outcomes for Black perinatal populations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This paper presents an outline of a study protocol that seeks to identify the protective and risk factors of Black maternal mental health and to engage Black mothers and birthing persons from the Greater Toronto Area in codesigning a culturally safe and inclusive best practices model to inform policy and interventions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The proposed study will use an exploratory 3-phase sequential mixed methods approach underpinned by the principles of health equity and community-based participatory research. Phase 1 will involve engaging Black mothers and birth persons (n=300) in a survey to examine the psychosocial determinants of Black maternal mental health, including depression, anxiety, discrimination, strong Black women trope, attitude toward seeking mental health, support, and stigma. In phase 2, we will conduct 6 focus groups and individual interviews (n=60) to explore the stressors in the context of Black mothers and birth persons' everyday lives, psychosocial and support needs, and conditions that promote their resilience. Finally, phase 3 will engage Black women and birthing persons (n=30) in a codesign session using the concept mapping method to identify priority areas for action to inform policy and programming. We will use SPSS version 26 (IBM Corp) to analyze the survey data, drawing on both descriptive and inferential statistics. NVivo (Lumivero), a qualitative data analysis software, will be used to organize the data from phase 2 into meaningful themes informed by Braun and Clarke's thematic analysis approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Ethics approval was granted in July 2024. Data collection for phase 1 started in December 2024 and will be completed in April 2025. Findings from phase 1 will inform phases 2 and 3 of this study, which will be conducted in the third quarter of 2025. We will disseminate the results of this study in the second and third quarters of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The findings will generate the much-needed knowledge to shift policy, practice, and research and support capacity building among Black mothers and birthing persons. In addition, the proposed study will contribute to informing policy initiatives and interventions at the health system and community level t","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70076"},"PeriodicalIF":1.4,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12209720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309939","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":"Sexual Health Determinants During the Life Course and Migration of Haitian-Origin People in French Guiana: Protocol for the Parcours d'Haïti Biographical and Transdisciplinary Study.","authors":"Leslie Alcouffe, Marc-Alexandre Tareau, Gabriel Brun Rambaud, Aude Lucarelli, Mathilde Boutrou, Camille Thorey, Greta Cantalupi, Karl Kpossou, Florence Huber, Sébastien Rabier, Dévi Rita Rochemont, Théo Blaise, Estelle Thomas, Guerline Jean, Ruth Pierre Louis, Annette Zephirin, Célia Basurko, Félix Djossou, Hawa Cissé, William Faurous, Quentin Drouaud, Mayka Mergeay-Fabre, Antoine Adenis, Mathieu Nacher, Nicolas Vignier","doi":"10.2196/63586","DOIUrl":"10.2196/63586","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;French Guiana, an overseas territory located in the Guiana Shield in South America, faces unique social and demographic challenges, particularly in relation to migration. Haitians represent 1 of the 3 largest foreign communities in the region and face specific barriers to health care access and prevention. They are also a population exposed to HIV infection.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This Parcours d'Haïti study aims to update knowledge on the health of the Haitian population residing in French Guiana. From a quantitative standpoint, the primary objective of this study was to assess the frequency of sexual behaviors that expose Haitian individuals to HIV risk after arriving in French Guiana and explore the association of this risk with their living conditions. This study adopts a transdisciplinary approach to understand the broader determinants of health and the processes underlying HIV transmission.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This mixed methods study involves a quantitative epidemiological and biographical analysis of Haitian individuals aged 18 to 60 years who have lived in French Guiana for more than 3 months. The biographical component uses a detailed grid that tracks key life events since birth. The qualitative component includes 3 substudies based on semistructured interviews and focus groups with Haitian people and health care professionals. These aim to deepen understanding of health care access, use of traditional and biomedical care, and mental health among Haitians. A phylogenetic component describes the distribution of clades of the Pol gene in the viruses of people living with HIV. The study materials were cocreated with local stakeholders. Recruitment of this partially hidden population used an innovative method involving all local actors and targeting key locations frequented by the Haitian community. Data collection and recruitment were carried out by Haitian Creole-speaking peer investigators (community health mediators).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Over 20 months between 2021 and 2023, the Parcours d'Haïti study was implemented in French Guiana. Anticipated results suggest that the main reasons for migration include insecurity and fleeing violence. Upon arrival, Haitian people likely experience significant economic hardship and social isolation. Mental health deterioration is expected, with high rates of posttraumatic stress disorder. People living with HIV are expected to face heightened vulnerability compared to HIV-negative individuals even though they already struggle with precarious living conditions. The qualitative findings regarding health care use indicate that Haitian people encounter numerous barriers to accessing health care, such as administrative complexity, language, and financial and mobility issues. The anthropological results are expected to emphasize the magical-religious origins of HIV and the use of plants and traditional medicine for its treatment. Phylogeneti","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63586"},"PeriodicalIF":1.4,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144284422","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":"Home Monitoring in Interstitial Lung Disease: Protocol for a Real-World Observational Study.","authors":"Marium Naqvi, Rebecca Borton, Sarah Lines, Joanne Dallas, Jessica Mandizha, Howard Almond, Colin Edwards, Wendy Adams, Michael Gibbons, Anne-Marie Russell, Alex West","doi":"10.2196/65339","DOIUrl":"10.2196/65339","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Interstitial lung diseases (ILDs), a group of parenchymal lung disorders, present with varying degrees of inflammation and fibrosis, which lead to symptoms such as progressive breathlessness, impaired quality of life (QoL), and reduced life expectancy. Patients with ILD can experience a sudden worsening of their condition, known as an acute exacerbation, which is associated with inappropriate hospital admissions, concomitant National Health Service (NHS) costs, impaired QoL, and high mortality. The heterogeneity of ILDs, the unpredictability of acute exacerbations, and significant variation in disease progression and response to treatment present numerous management challenges. Standard care typically involves 3-6 monthly hospital outpatient visits to monitor disease and assess response to treatment. Home monitoring with remote review of spirometry, pulse oximetry, and patient-reported measures offers an alternative approach to in-person clinic review and laboratory-based physiological measurements. Clinical trials indicate home monitoring of patients with ILD is acceptable, and results correlate with laboratory-based pulmonary function tests (PFTs). The impact of implementing home monitoring for patients with ILD in a real-world setting is not well understood.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aim to evaluate the safety, effectiveness, and acceptability of home monitoring with standard care in the management of patients with ILD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study has been registered as a quality improvement project at Guy's and St Thomas' NHS Foundation Trust (reference 13660) and Royal Devon University Healthcare NHS Foundation Trust (reference 24-1378). The project has been co-designed by the steering group, including clinicians, researchers, technology partners, a patient advocacy charity, and patients diagnosed with ILD. Patients who meet the inclusion criteria will be provided a handheld spirometer, pulse oximeter, and access to patientMpower, an electronic health app, on their smart devices and followed up for 12 months. All participants will be asked to complete at least once weekly home spirometry and pulse oximetry measurements and 3 monthly patient-reported measures, including outcome, engagement, and experience measures, using the patientMpower app. Results will be available to the clinicians in real time and used to monitor disease progression, symptoms, and QoL, and to assess treatment response.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded by NHS Digital in September 2021. Patient recruitment and data collection started in March 2022. By January 2024, 186 patients were enrolled. All patients will have home monitoring for at least 12 months. Results are expected to be published at the end of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We hypothesize home monitoring will be safe, effective and acceptable for patients with ILD and result in a 50% reduction in routine laboratory-based p","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65339"},"PeriodicalIF":1.4,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274930","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":"Implementation and Evaluation of a Therapeutic Communication Educational Program for Nurses: Protocol for a Mixed Methods Study.","authors":"Krista Hoek, Louise Suur, Monique van Velzen, Elise Y Sarton","doi":"10.2196/65795","DOIUrl":"10.2196/65795","url":null,"abstract":"<p><strong>Background: </strong>Admission to a hospital can be a very stressful and anxiety-provoking experience, as patients face many unknowns that can compromise their physical and psychological well-being. Patient-centered care necessitates that health care organizations and professionals actively comprehend patients' experiences and values, for which effective training in communication skills is essential.</p><p><strong>Objective: </strong>This study will contribute to this field of research by evaluating a blended therapeutic communication training program.</p><p><strong>Methods: </strong>The training consists of online e-learning that provides insights into important concepts of therapeutic communication, followed by a virtual reality patient-embodied experience shown to help nurses feel what it is like to be a patient themselves during a 1-day didactic training with experiential small groups. Theory on therapeutic communication is taught, focusing on how to use rapid rapport techniques and hypnotic and suggestive language to facilitate empathy. This is combined with practical exercises, ensuring an active learning process. By integrating these diverse blended learning training methods, the program aims to enhance nurses' communication skills, ultimately improving patient care. Applying the Kirkpatrick model for training evaluation, this prospective study will use a convergent mixed methods study design, integrating both qualitative and quantitative data. Qualitative data will include fieldwork, as well as individual and focus group interviews with the participating nurses. Quantitative data will include questionnaires that include the first two levels of the Kirkpatrick model and that are validated for this purpose. Inclusion started in April 2024, and the therapeutic communication training was scheduled for the first half of 2024.</p><p><strong>Results: </strong>On February 8, 2024, we received permission from the authorizing body (Institutional Science Committee and NWMO Committee) to start our study. Data collection started in April 2024 and was completed by the end of 2024.</p><p><strong>Conclusions: </strong>This study will systematically evaluate the effectiveness of therapeutic communication training in the acute admission ward for patients who require emergency treatment. The results will yield insights into the feasibility and acceptance of the implementation of therapeutic communication training among nurses in an acute admission ward in the Netherlands.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/65795.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65795"},"PeriodicalIF":1.4,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274931","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":"Correction: ENABLE-App-Based Digital Capture and Intervention of Patient-Reported Quality of Life, Adverse Events, and Treatment Satisfaction in Breast Cancer: Protocol for a Randomized Controlled Trial.","authors":"Thomas M Deutsch, Léa L Volmer, Manuel Feisst, Laura Bodenbeck, Kathrin Hassdenteufel, Lara Tretschock, Christiane Breit, Stefan Stefanovic, Armin Bauer, Carolin Anders, Lina Weinert, Tobias Engler, Andreas D Hartkopf, Nico Pfeifer, Pascal Escher, Marc Mausch, Oliver Heinze, Marc Suetterlin, Sara Y Brucker, Andreas Schneeweiss, Markus Wallwiener","doi":"10.2196/78781","DOIUrl":"10.2196/78781","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2196/69855.].</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e78781"},"PeriodicalIF":1.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12198690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274929","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":"Efficacy and Safety of Haidebao Body Lotion in Patients With Mild Atopic Dermatitis: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.","authors":"Zhen Duan, Yuning Ding, Ruiping Wang","doi":"10.2196/71255","DOIUrl":"10.2196/71255","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD) is a chronic, relapsing skin condition that significantly impacts patients' quality of life. In clinical practice, AD is commonly managed through the use of emollients and topical corticosteroids. Haidebao Body Lotion (HBL) incorporated with calcium-based antimicrobial peptide compounds (CAPCS) has demonstrated clinical benefits for patients with mild AD, but there is a lack of high-quality clinical trial evidence.</p><p><strong>Objective: </strong>In this study, we will implement a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of HBL incorporated with CAPCS as an adjunctive therapy in ameliorating mild AD.</p><p><strong>Methods: </strong>This multicenter, double blind, randomized, placebo-controlled trial will recruit 200 eligible participants from 10 hospitals in China from October 2023 to October 2025. In this study, AD will be confirmed in accordance with Williams diagnostic criteria, and patients with mild AD, aged 18-55 years, who provide signed informed consent will be enrolled. However, patients who are pregnant, have serious underlying diseases, have communication barriers, and violate medication regulations will be excluded. The 200 patients will be randomly assigned (1:1) to a treatment group (HBL with CAPCS; n=100, 50%) and a control group (HBL without CAPCS, placebo; n=100, 50%), and each participant will receive 3 sessions of treatments per day for 4 weeks. The primary outcome is the proportion of patients who achieve at least 60% improvement in the Eczema Area and Severity Index (EASI) score from baseline to week 2. The secondary outcomes include the Numeric Rating Scale (NRS), EASI50, EASI60, and Dermatology Life Quality Index (DLQI) scores at weeks 2 and 4, as well as adherence and adverse events. The full analysis set (FAS) and the per protocol set (PPS) will be analyzed using SAS 9.3 software, and missing data will be processed using the multiple imputation method. In this study, P<.05 is considered statistically significant.</p><p><strong>Results: </strong>Participant recruitment began in January 2024. As of May 2025, we enrolled 180 patients, with 160 (88.9%) completing the 2-week follow-up. Data collection and management are still ongoing, and data analysis has not yet been performed.</p><p><strong>Conclusions: </strong>This study will evaluate the clinical efficacy and safety of HBL incorporated with CAPCS in the treatment of patients with mild AD. If treatment efficacy is proven, HBL incorporated with CAPCS could be clinically used as an adjunctive therapy in ameliorating mild AD.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/71255.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71255"},"PeriodicalIF":1.4,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12188137/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144266267","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":"Implementation of Medication Disposal Programs and Availability of Same-Day Naloxone at Community Pharmacies: Protocol for a Secret Shopper Caller Approach.","authors":"Kathleen L Egan, Briana Lewis, Kayleigh Fields, James McMillian Iii, Rachel L Graves, David M Kline, Lori Ann Eldridge","doi":"10.2196/64344","DOIUrl":"10.2196/64344","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pharmacies can implement multiple strategies, including medication disposal programs (eg, disposal boxes, deactivation products, and mail-back envelopes) and offering over-the-counter naloxone, to prevent nonmedical opioid use and overdose. The quantity of opioid prescriptions dispensed in the United States is so high that every other adult could receive one opioid prescription per year. Many of these opioids go unused and are kept in homes rather than disposed of after ceasing use. The primary source of prescription opioids for nonmedical use is relatives or friends, which suggests that the diversion of excess and retained prescription opioids contributes significantly to nonmedical use. Naloxone is a life-saving medication that works as an opioid antagonist to reverse the effects of opioids and restore normal breathing to a person experiencing an overdose. All 50 US states have passed laws (eg, statewide standing orders) that allow pharmacists to distribute naloxone without an individual patient prescription, and the US Food and Drug Administration approved the first over-the-counter naloxone medication in March 2023. Individual and neighborhood characteristics are associated with nonmedical opioid use and overdose. It is essential to ensure that pharmacy-based overdose prevention practices are widely available to all individuals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;: This study aims to assess the extent to which disposal programs and same-day naloxone have been implemented in pharmacies across the United States and examine neighborhood characteristics in implementation. We hypothesize that as neighborhood disadvantage and the proportion of Black or African American residents in a neighborhood increase, the likelihood of a pharmacy having a disposal program or same-day naloxone decreases. We also hypothesize differences in medication disposal programs and same-day naloxone availability by retailer chain and type of pharmacy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A secret shopper caller protocol will be used to identify pharmacies that have implemented a medication disposal program and have naloxone available on the same day without a prescription. We will conduct disproportionate stratified random sampling with the strata being pharmacy chains to maximize the likelihood of sampling corporations and independent pharmacies. The goal is to obtain a final sample of 1000 pharmacies. Neighborhood characteristics will be appended to the secret shopper data. To explore neighborhood and pharmacy characteristics associated with the availability of medication disposal programs and same-day naloxone, we will use logistic regression. This protocol represents the entire structure of the secret shopper caller approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection was completed in the spring of 2024. The expected results will be published in 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This will be the first study to examine national es","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64344"},"PeriodicalIF":1.4,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12188141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144258084","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}