JMIR Research Protocols最新文献

Background: Chronic obstructive pulmonary disease (COPD) is a debilitating respiratory disease that is highly associated with smoking. Despite widespread knowledge of the health risks of smoking, many patients with COPD continue to smoke. Growing evidence suggests that alternatives to combustible cigarettes (CIG), such as heated tobacco products (HTP), may be less harmful.

Objective: To evaluate the impact of switching from CIG to HTP on the time to subsequent COPD exacerbations in patients who have had a COPD-related hospitalization.

Methods: This retrospective cohort study will be conducted in Japan using electronic health data and tobacco exposure data from questionnaires and consumer databases. The study will invite approximately 30,000 patients who had a COPD-related hospitalization between May 2016 and December 2022. The first of these hospitalizations will be considered a patient's study Index Event. The primary outcome is the time from Index Event to subsequent COPD exacerbation (a composite outcome of subsequent COPD-related hospitalization and all-cause mortality); patients will be observed until March 2025. The primary exposure groups are HTP use and CIG use, respectively, pre- and post-index. We will use weighted Cox proportional hazard models, with propensity score weighting to balance potential confounders, to compare the primary outcome between the primary exposure groups. We will also compare the primary outcome between exclusive HTP users and ancillary exposure groups of dual users of CIG and HTP and former CIG smokers. Secondary outcomes include all-cause mortality, pneumonia-related hospitalization, COPD-related hospitalizations, and all-cause hospitalizations and will be assessed in primary and ancillary exposure groups.

Results: The study described in this protocol intends to assess whether there is a longer time to subsequent COPD hospitalizations and all-cause mortality for HTP users compared to CIG smokers.

Conclusions: This protocol describes the first large-scale study that will identify patients with COPD from a nationally representative healthcare database and evaluate the history of tobacco product usage from multiple sources. Additionally, this study protocol is the first in the tobacco medical literature that embraces real-world data providing information on HTP use from various tobacco product exposure sources. This will also be the first study to assess the relationship between HTP use and mortality in this patient population. Given the limited evidence on the health effects of HTP in COPD, the results of this study will provide real-world insights into the effects of switching to HTP use compared to continued CIG smoking in patients with COPD.

Clinicaltrial: Not applicable.

Background: Smoking is a known risk factor for cardiovascular diseases (CVD). Despite widespread knowledge of the health risks of combustible cigarettes (CIG), many smokers continue to smoke. There have been efforts to provide alternatives, such as heated tobacco products (HTP), that may be less harmful than CIG.

Objective: To evaluate the impact of switching from CIG to HTP on the time to first subsequent major adverse cardiovascular event (MACE) compared with continued CIG smoking.

Methods: This retrospective cohort study will use health data from the Tokushukai Medical Database and tobacco exposure data from questionnaires and consumer databases in Japan. The study will include patients with a first cardiovascular event of non-fatal myocardial infarction (MI), unstable angina, or urgent coronary revascularization between May 2016 and December 2020 (Index Event); patients will be observed until March 2025. The primary exposure of interest is HTP use, while the primary comparator is continued CIG smoking pre- and post-index. The primary outcome is first post-index MACE (a composite outcome of any of the following: non-fatal MI, non-fatal stroke, hospitalization for angina, hospitalization for heart failure, urgent revascularization for angina, or all-cause mortality). After accounting for potential confounding factors with a propensity score weighting method, weighted log-rank tests and a weighted non-proportional Cox model will be used to compare the primary outcome between the exposure groups. Dual use of CIG and HTP, quitting CIG, and never smoking will also be analyzed as ancillary exposure groups to address secondary objectives.

Results: The study described in this protocol intends to assess whether there is a longer time to first MACE in HTP users as compared to CIG smokers.

Conclusions: This protocol describes a large-scale study that intends to identify patients with CVD from a nationally representative healthcare database and utilizes multiple data sources to evaluate their history of tobacco product usage. This will be the first study to assess the effect of HTP use on CVD outcomes by sex. Given the limited evidence on the health impacts of HTP in relation to CVD, the results of this study will provide insights into the effect of switching to HTP use compared to continued CIG smoking in patients with a prior cardiovascular event.

Background: Contactless monitoring of vital signs, especially the breathing of children, in the hospital is performed on a priority basis because their organs and immune system are immature. Therefore, continuous monitoring of their vital signs with a sensor that is directly attached to their body is not possible, as it irritates the sensitive newborn skin and causes discomfort. A contactless frequency-modulated continuous-wave (FMCW) radar-based device can wirelessly monitor the breathing rate and pattern of a child in the hospital or at home. Signal-processing capability can be added to this device to process breathing data and analyze the apnea condition arising due to irregular breathing patterns.

Objective: This study will develop a contactless FMCW radar-based system to accurately monitor the breathing rate and pattern of neonates and infants in hospitals and at home in order to provide a noninvasive, nonintrusive and contactless alternative to conventional sensor-based methods and address a critical need in neonatal care, potentially improving health outcomes for vulnerable infants.

Methods: The radar transmits a signal toward the body, and the time taken by the signal received to travel from the body to the receiving antenna is analyzed. This time is proportional to the distance between the radar and the body, and the breathing pattern is recognized as a slight, periodic variation in this distance. We will use this concept with multiple antenna systems to monitor the breathing of neonates with improved sensitivity. The radar-based device will be installed, in addition to conventional breathing monitors, in the neonatal intensive care unit. The signals received at the radar and the respiration signals from conventional monitors will be recorded in a database. Signal-processing techniques will be applied to extract breathing signals from the signals received at the radar.

Results: This study was funded in January 2023 by the Science and Engineering Research Board (SERB) of India. The device was designed by May 2024, and a working proof-of concept was verified in the Indian Institute of Technology (IIT) Ropar laboratory. Implementation of the proposed method for initial study began in December 2024. Results are expected to be published in the first quarter of 2025.

Conclusions: The contactless FMCW radar-based system will provide reliable estimation of the breathing rate and pattern, which is close to the conventional reference device values most of the time. Our device will also provide a seamless breathing-monitoring system to be used both in hospitals and at home for newborns and premature babies until they are fully healthy and fit.

International registered report identifier (irrid): PRR1-10.2196/59532.

Background: Educational technology (EdTech) has been instrumental in the last few decades in promoting inclusive education by overcoming various learning barriers and offering tools and opportunities to all students, including those with special educational needs and disabilities (SEND). However, there is limited understanding of current classroom practices and policies and of the effects of the COVID-19 pandemic on EdTech use in the inclusive classroom.

Objective: This systematic review aims to outline the current knowledge on the use of EdTech to support the learning of students with SEND in inclusive primary schools in high-income countries.

Methods: We followed the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) and the Generalized Systematic Review Registration Form in reporting the details of this protocol. The inclusion criteria for the systematic review require that studies focus on students with SEND who are attending the primary stage of school in high-income countries. The studies can be qualitative or quantitative and should explore the design and use of EdTech with these students. Eligible studies must be published between 2016 and 2024, be peer-reviewed, and be available in English. We systematically searched the ACM, Directory of Open Access Journals, British Educational Index, ERIC, Google Scholar (first 100 records), IEEE, PsycINFO, Scopus, and Web of Science databases. The titles and abstracts of all records will be screened for relevance according to the inclusion criteria. Following this, the full text of the articles will be screened. To ensure the reliability of the screening process, an independent reviewer will screen a percentage of the records for the first screening round. The data extraction process for this systematic review will start with a pilot stage to validate and eventually update the list of entities to be extracted. Following the pilot stage, the final data extraction will be undertaken. An independent reviewer will extract data from a subsample of the records to ensure the reliability of the data extraction process.

Results: The database search was conducted in July 2024. The database search identified a total of 547 records. It is anticipated that the study findings will be submitted for publication in a peer-reviewed journal by the end of January 2025.

Conclusions: This study will provide up-to-date evidence of the use of EdTech in inclusive primary school settings in high-income countries and will describe the impact of the COVID-19 pandemic on the use of EdTech with students with SEND.

International registered report identifier (irrid): DERR1-10.2196/65045.

Background: Misuse of prescription opioids remains a public health problem. Appropriate short-term use of these medications in opioid-naïve patients is indicated in selected settings, but can result in unintended prolonged opioid use (UPOU), defined as the continuation of opioid therapy beyond the period by which acute pain would have been expected to resolve. Clinical strategies aimed at preventing UPOU are lacking due, in part, to the absence of information about how this poorly-understood clinical phenomenon actually develops.

Objective: In this research project, three Clinical and Translational Science Awards (CTSA) programs (Mayo Clinic, University of Michigan, and Yale University) leveraged the conceptual framework for UPOU to investigate how the patient characteristics, practice environment characteristics, and opioid prescriber characteristics facilitate or impede UPOU. All data management and analyses were conducted at a fourth CTSA program (University of Minnesota). This work was accomplished by pursuing three specific aims.

Methods: In aim 1, opioid-naïve adults receiving an initial opioid prescription were recruited for study participation. Opioid prescriptions were identified longitudinally and patterns of use were categorized as short-term, episodic or long-term utilizing established criteria. Using a prospective case-control design, patients progressing to UPOU were matched 1:1 with patients who did not develop UPOU and differences in patient characteristics were assessed. In aim 2, clinicians who prescribed opioids to patients in aim 1 were identified and recruited for prospective assessments. Institutional and individual practice environments were assessed using a validated self-report survey. In aim 3, structural equation modeling was utilized to evaluate data collected in aims 1 and 2 and identified interactions were further evaluated in a large national administrative claims database.

Results: Patient recruitment began August 1, 2019. However, due to the coronavirus disease of 2019 (COVID-19) pandemic, patient recruitment was slowed and intermittently interrupted over the ensuing 3 year period. As a result of regional variations in the impact of the COVID-19 pandemic on research activities, the majority of patient and clinician recruitment occurred at the Mayo Clinic site.

Conclusions: Following complete data analyses, it is anticipated that electronic health record systems will be leveraged to help clinicians identify at risk patients and to develop direct-to-patient educational materials to raise awareness of the risk factors for developing UPOU.

Clinicaltrial: Trial registration (clinicaltrials.gov): NCT04024397.

Background: The increase in average life expectancy, aging, and the rise in the number of people living with dementia contribute to growing interest from the scientific community. As the disease progresses, people with dementia may need help with most daily activities and need to be supervised by their carer to ensure their safety. With the help of technology, health care provides new means of self-managing health that support active aging, allowing older people and people with dementia to live independently in their homes for a longer period of time. Although some systematic reviews have revealed some of the impacts of using digital interventions in this area, a broad systematic review that examines the overall results of the effect of this intervention type is mandatory.

Objective: The aim of this review is to further investigate and understand the acceptability and barriers to using technology to monitor and manage health conditions of people living with dementia and their caregivers.

Methods: A review of systematic reviews on acceptability factors and barriers for people with dementia and caregivers was carried out. Interventions that assessed acceptability factors and barriers to the use of technology by people with dementia or their carers were included. Each potentially relevant systematic review was assessed in full text by a member of a team of external experts.

Results: The analysis of the results will be presented in the form of a detailed table of the characteristics of the reviews included. It will also describe the technologies used and factors of acceptability and barriers to their use. The search and preliminary analysis were carried out between May 5, 2023, and August 1, 2024.

Conclusions: This review will play an important role as a comprehensive, evidence-based summary of the barriers and facilitators to the use of digital interventions. This review may help to establish effective policy and clinical guideline recommendations.