JMIR Research Protocols最新文献

Background: Data collection is an essential aspect of clinical trials because it forms the basis of the scientific analysis that evaluates the performance and safety of interventions. With the wide variety of digital data collection tools available, decision-makers responsible for choosing the appropriate tools for clinical trials must exercise caution. There are numerous challenges that could impact data collection, and a careful selection of tools is necessary to ensure that they effectively support the trial. Therefore, an evidence-based framework is needed to support the selection of an appropriate digital data collection tool in clinical trials.

Objective: This systematic review aims to develop an evidence-based framework for the selection of digital data collection tools for clinical trials.

Methods: Bibliographic databases including IEEE Xplore, eAIS, PubMed, CINAHL, MEDLINE, Embase, ClinicalTrials.gov, Scopus, and Web of Science will be searched for published articles. Additionally, searches will be performed for publicly available gray literature from reputable institutions such as the United States Food and Drug Administration and World Health Organization. Studies should include a framework that is relevant to selecting digital data collection tools for clinical trials. Two reviewers will independently use Covidence to screen and review the articles to be included. Data related to the selection of digital data collection tools will be extracted. Thematic synthesis will be conducted to develop a new evidence-based framework to select digital data collection tools for clinical trials.

Results: The review started in May 2025 and is expected to be completed in December 2025. The searches yielded 9151 studies, which were reduced to 4333 after the removal of duplicates using Covidence.

Conclusions: There is a dearth of established frameworks to guide the selection of digital data collection tools for clinical trials. This review aims to develop an evidence-based framework to support technology decision-makers in identifying and selecting tools that are fit-for-purpose, ensuring they meet the specific needs of clinical research settings.

Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are widely used in the treatment of non-small cell lung cancer due to their precision, efficiency, and ease of use. However, skin rashes induced by EGFR-TKIs are the most common and earliest form of skin toxicity, often affecting the quality of life and treatment compliance of patients and leading to early discontinuation of therapy. These skin reactions may even impact cancer outcomes. In clinical practice, traditional Chinese medicine detoxification granules have shown effectiveness in relieving skin discomforts such as itching, pain, and burning caused by EGFR-TKI therapy. A prior single-arm trial investigating the treatment of targeted drug-induced rashes demonstrated a sustained improvement in rash symptoms with an effectiveness rate of 80.77% and was well tolerated by patients.

Objective: As an exploratory clinical study, this randomized controlled trial will preliminarily evaluate the potential efficacy and safety of jiedu xiaozhen (JDXZ) granules in managing EGFR-TKI-related skin toxicities.

Methods: This randomized controlled trial will be conducted at Shanxi Provincial Hospital of Traditional Chinese Medicine. A total of 94 patients with confirmed epidermal growth factor receptor gene-mutated non-small cell lung cancer who developed rashes after EGFR-TKI treatment will be enrolled. Patients will be randomly assigned to either a JDXZ traditional Chinese medicine group (group J) or a urea ointment group (group U). The primary outcome will be the severity of the rash as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events grading. Secondary outcomes will include the WoMo (Wollenberg and Moosmann) score, numerical rating scale, Dermatology Life Quality Index scale, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 score, median progression-free survival, and changes in the levels of fibroblast growth factor 7 and hepatocyte growth factor in the blood. Adverse reactions will be recorded throughout the study. Data will be analyzed using SPSS.

Results: The clinical trial registration was completed in October 2024. This study is currently underway. As of December 1, 2025, a total of 81 eligible participants had been enrolled, all of whom were assigned to groups following the randomization principle. Among them, 42 participants were allocated to the JDXZ group (with an additional 2 participants pending enrollment), and 39 to the control group. Based on the current progress, the estimated trial completion date has been extended to January 31, 2026.

Conclusions: The results of this study may help develop an effective treatment for EGFR-TKI-mediated rashes. The findings will be published in academic journals upon the completion of the trial.

Background: Currently, head and neck cancer (HNC) associated with pesticide exposure represents a global public health concern. However, there is no consensus regarding the specific determinants involved in this association. Moreover, there is a lack of scientific evidence to support the development of systematic reviews on this topic.

Objective: This study aims to synthesize the methodology for conducting a systematic review to explore the current scientific evidence on the determinants of HNC associated with pesticides.

Methods: The review will follow the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines to ensure methodological rigor. The protocol includes detailed steps for constructing a robust search strategy using relevant databases such as PubMed, Embase, Scopus, Web of Science, CINAHL, LILACS, and AGRICOLA. Keywords and Medical Subject Headings terms related to "pesticides," "exposure," "head and neck neoplasms," and related concepts will be used to capture the most relevant studies. Eligibility criteria will be clearly defined, including study design (eg, cohort, case-control, and cross-sectional), population characteristics, exposure assessment, and cancer outcomes. Studies published in any language that involve human participants will be included. The studies will be screened in 2 phases: first by title and abstract and then by full-text review. Two independent reviewers will assess the quality of each study and extract key data, such as exposure levels, cancer subtypes, and effect sizes. Any disagreements will be resolved through discussion or by a third reviewer.

Results: This systematic review was initiated in February 2025 after protocol registration. The literature search and review process is ongoing at the time of submission of this paper. Data extraction and quality assessment have not yet been completed. Final results of the review, including a synthesis of determinants associated with pesticide exposure in patients with HNC, are expected to be completed and submitted for publication in June 2026.

Conclusions: The necessary steps to conduct a systematic review must be concise and publicly available to ensure replicability within the scientific community.

Background: Physical activity (PA) interventions can increase levels of PA to help participants meet recommended levels. The impact of PA interventions may be affected by an individual's neighborhood environment, including attributes such as walkability, crime rates, or greenspace availability, but research to date has lacked the power and geographic spread to adequately assess the role of the environment.

Objective: The Interventions Supporting Physical Activity and the Environment (InSPACE) study used the Automatic Context Measurement Tool (ACMT) to gather environmental measures for participants around their home address in completed lifestyle intervention trials across the United States, then pooled and harmonized demographic and device-based activity data, creating a dataset for use in assessing the moderation effect of neighborhood attributes on interventions to increase PA.

Methods: PA intervention trials were recruited from across the United States, and trialists were instructed in the use of the ACMT to geocode and collect prespecified environmental measures. The InSPACE research team gathered deidentified data from trialists, including demographics, raw accelerometry data, and ACMT-generated environmental measures and harmonized data to create a pooled dataset of PA intervention trial participants.

Results: As of August 2025, a total of 39 PA intervention trials have been recruited and data from 31 of these trials have been processed and harmonized, creating a current pooled dataset of 4471 participants with any harmonized data, of whom 4360 (97.5%) have linked environmental data and 2208 (49.4%) have specified (3 days of at least 8 hours per day) accelerometry data for both baseline and postintervention. Results from the primary analysis for the InSPACE project are expected to be published in late 2026.

Conclusions: InSPACE will contribute to understanding the role of the environment in moderating the effect of interventions to increase PA. The protocols and processes of InSPACE can inform future projects in pooled data harmonization and analysis.

Background: Primary insomnia often corresponds to the syndrome of liver depression and spleen deficiency in traditional Chinese medicine. This study evaluates a new acupuncture protocol derived from the "Jing Bie" theory. Tianrong (TE16) and Tianyou (SI17) were selected to regulate the Shaoyang meridian, soothe the liver, regulate qi (the basic life energy or life force to maintain the physiological function of the body according to traditional Chinese medicine), strengthen the spleen, and tranquilize the mind, so as to restore sleep.

Objective: The objective of this study is to evaluate the clinical efficacy of this regimen and to explore its effects on autonomic nervous system function and central nervous system chemistry.

Methods: This is a single-blind randomized controlled trial. A total of 96 patients with primary insomnia (liver depression and spleen deficiency pattern) will be recruited and randomly assigned to the treatment group or the control group. At the same time, 48 healthy volunteers will be recruited as the healthy control group.

Results: This study was funded in November 2023. Recruitment and data collection began in January 2024 and are currently underway. As of December 2025, a total of 40 participants have been enrolled, of whom 4 have withdrawn. Recruitment is projected to conclude by December 2026. Data analysis will be performed after the completion of recruitment. The results are expected to be published in summer 2027.

Conclusions: This study integrates a traditional Chinese medicine framework with modern physiological measurements. The aim is to provide evidence for targeted acupuncture strategies by linking clinical improvement to autonomic nervous system balance and neurochemical changes and to elucidate potential mechanisms to provide a nondrug treatment option for insomnia.

Background: Pericoronitis is a common pathological condition associated with mandibular third molars that may cause pain and discomfort. This condition may be chronic, exhibiting episodic symptoms that last for a few days to weeks and recurring multiple times in less than a year. The operculum covering the erupting mandibular third molars may become obscured by the eruption of maxillary third molars. Such recurrent traumas might exacerbate the symptoms and lead to ulcerations. With clinical monitoring at regular intervals and with the help of radiographic examinations, clinicians can develop the most effective treatment plan.

Objective: This study aims to determine the association between mandibular third molar position and recurrent pericoronitis.

Methods: This cross-sectional study will include 200 patients having partially impacted mandibular third molar with recurrent pericoronitis. Patients aged 18-40 years with occurrence of pericoronitis will be included in this study. The impacted tooth's side and the symptoms associated with pericoronitis will be recorded during clinical examination. All these patients will be evaluated using panoramic radiographs to assess the position of the unerupted/impacted mandibular third molar.

Results: The duration of this study will be 6 months from October 2025 to April 2026. Approval for this study has been granted by the institutional ethics committee of Datta Meghe Institute of Higher Education and Research (deemed to be university), Sawangi, Wardha (DMIHER (DU)/IEC/2024/53). In panoramic radiographs, the impaction status of the mandibular third molar will be evaluated based on Winter's and Pell and Gregory classification systems. Patients' data will be recorded and analyzed for statistical significance.

Conclusions: The detection of the position and intervention at the early stage for pericoronitis in individuals with impacted third molars is vital.

International registered report identifier (irrid): PRR1-10.2196/72682.

Background: Shared decision-making (SDM) is a collaborative process that integrates patients' values and preferences into health care decisions. In intensive care units, patients who are critically ill often lack the capacity to make decisions, necessitating surrogates to make complex choices regarding life-sustaining treatments (LSTs).

Objective: This scoping review aims to assess the range of research conducted on surrogate SDM for LSTs among patients who are critically ill over the past decade and highlight areas where current research remains limited.

Methods: This scoping review will follow the Joanna Briggs Institute methodology and adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) reporting guidelines. Studies will be included if they examine SDM involving surrogates of adult patients who are critically ill in relation to LST decisions within intensive care unit settings. SDM is defined using 4 criteria: participation of both health care professionals and surrogates, mutual information sharing, consensus building, and agreement on treatment based on the patient's values and preferences. A comprehensive search will be performed across PubMed, CINAHL, PsycInfo, CENTRAL, and Ichushi-Web for English- and Japanese-language studies published between 2016 and 2025. Eligible study designs will include quantitative, qualitative, and mixed methods research. Title and abstract screening, as well as full-text selection, will be conducted independently by 2 reviewers using Rayyan. Data will be extracted on study characteristics, SDM definitions, participant roles, and key findings. Results will be synthesized descriptively and presented in tables and narrative summaries to identify research gaps and inform future investigations.

Results: As of June 13, 2025, the literature search has been completed. A total of 2899 citations were identified through the specified database searches, and 527 (18.2%) duplicates were removed. Title and abstract screening are currently in progress, and full-text review is expected to be completed by September 2025.

Conclusions: This scoping review will systematically map recent evidence on surrogate SDM in the context of LST decisions for patients who are critically ill. By synthesizing diverse studies, it will identify challenges faced by surrogates and summarize existing interventions that aim to improve SDM processes. The findings are expected to inform future interventions and policies and advance patient- and family-centered care in critical care settings.

Background: Conventional amblyopia treatment involves the occlusion of the fellow eye using an eye patch. However, this approach imposes a substantial psychological and physical burden on pediatric patients with amblyopia, resulting in low adherence and suboptimal visual outcomes. As responsiveness to therapy declines beyond early childhood, treatments that can enhance adherence and improve efficacy are needed. We developed a virtual reality dichoptic training app (VR app) that integrates gamification and hand-eye coordination training in pediatric patients with amblyopia.

Objective: This study investigated the effect of a VR app on visual acuity improvement in pediatric patients with amblyopia compared with conventional occlusion therapy using an eye patch.

Methods: This is a multicenter, open-label, prospective, randomized controlled trial that will be conducted at 3 centers in Tokyo, Japan. Pediatric patients aged 3-10 years with anisometropic, strabismic, or refractive amblyopia will be enrolled. Participants will be assigned 1:1 to a VR app group or a control group. The VR app group will use the VR app at home for 1 hour per day for 6 months. The control group will undergo conventional occlusion therapy with an eye patch for 6 months. Each group will comprise 15 participants (30 participants in total). Ophthalmologic examinations will be performed at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary endpoint will be the change in the best-corrected visual acuity in the amblyopic eye from baseline to week 12. Secondary endpoints will include changes in best-corrected visual acuity, stereopsis, and ocular deviation through week 24. We will also assess treatment adherence, defined as the ratio of the cumulative actual treatment time to the cumulative prescribed time; record adverse events, and evaluate usability in the VR app group. Longitudinal changes in outcome measures will be analyzed using a mixed-effects model.

Results: Participant enrollment will start from January 1, 2026, to September 30, 2026. The data analysis will begin on October 1, 2026, and the results will be reported by March 31, 2027.

Conclusions: This study will clarify the effectiveness of the newly developed VR app in improving treatment outcomes and adherence among pediatric patients with amblyopia. By addressing the limitations of conventional occlusion therapy and providing a potentially more efficacious and acceptable treatment option, the VR app may enhance clinical outcomes and represent a paradigm shift in the treatment of pediatric amblyopia.