JMIR Research Protocols最新文献_第3页

Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries - Protocol for a Systematic Review and Meta-Analysis. 中危国家进行胃癌内镜筛查的有效性--系统回顾和元分析协议》（Effectiveness of Gastric Cancer Endoscopic Screening in Intermediate-Risk Countries - Protocol for a Systematic Review and Meta-Analysis）。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-14 DOI: 10.2196/56791

Maria Beatriz Mourato, Nuno Pratas, Andreia Branco Pereira, Filipa Taré, Raphael Chança, Inês Fronteira, Rui Dinis, Miguel Areia

Background: Gastric Cancer (GC) is the fifth neoplasia with the highest incidence worldwide and the fourth with the highest mortality and its geographical distribution isn't homogeneous with high risk, intermediate-risk (IR) and low-risk areas. Advanced stage at diagnosis is related with high mortality of GC, but early detection greatly increases the chances of successful treatment. Upper endoscopy with biopsy is the gold-standard for diagnosis of GC. In IR countries, several studies have been developed to determine the relevance of endoscopic screening and how it could be developed. However most Western Societies continue to recommend screen only in selected populations with high-risk factors for GC. Furthermore, there are no systematic reviews on GC endoscopic screening in IR countries.Objective: This review aims to determine the effectiveness and economic viability of endoscopic GC screening in IR countries, that will answer the research question: What is the effectiveness of endoscopic screening for GC in IR countries?Methods: We will include randomized controlled trials, non-randomized controlled trials, cohort studies, case-control studies, cross-sectional studies and economic studies focusing on endoscopic screening of GC in asymptomatic population of IR countries. The search will be conducted in MEDLINE, SCOPUS, EMBASE and Web of Science. Other grey literature sources will be additionally searched. Studies published in English, Portuguese or Spanish published until September 2024 be included. Two independent reviewers screen the titles and abstracts of all search results. The selected studies will then be fully analyzed and the data will be collected and coded in a database. To minimize the risk of bias, the included studies will undergo a quality analysis according to Cochrane risk of bias tools, RoB 2 of randomized trials and ROBINS-I for non-randomized trials, QUADAS-2 for diagnostic test accuracy and the National Heart, Lung and Blood Institute study quality assessment tools for observational cohort, cross-sectional and case-control studies. The data collected will be catalogued in 2 categories: efficacy/effectiveness data and economic data, and separate meta-analyses will be performed for each category.Results: This systematic review is expected to provide results on the efficacy, effectiveness and cost-effectiveness of endoscopic screening in an IR population. It is expected that the presentation of these results will shed light on the relevance of endoscopic GC screening in IR countries. The review is currently in the full-text screening stage and will be published in the first quarter of 2025.Conclusions: To our knowledge, this review will be the first to provide evidence on the effectiveness of endoscopic GC screening in IR countries. In doing so, we believe we will help guide future research, inform health care dec

背景：胃癌（GC）是全球发病率最高的第五大肿瘤，死亡率最高的第四大肿瘤，其地理分布并不均匀，有高风险区、中风险区（IR）和低风险区。晚期诊断与 GC 的高死亡率有关，但早期发现可大大增加治疗成功的几率。上消化道内窥镜检查和活检是诊断 GC 的黄金标准。在红外国家，已经开展了多项研究，以确定内镜筛查的相关性以及如何发展内镜筛查。然而，大多数西方学会仍然建议只对具有 GC 高危因素的特定人群进行筛查。此外，目前还没有关于红外国家 GC 内镜筛查的系统性综述：本综述旨在确定内镜 GC 筛查在红外国家的有效性和经济可行性，从而回答研究问题：内镜筛查 GC 在 IR 国家的有效性如何？我们将纳入随机对照试验、非随机对照试验、队列研究、病例对照研究、横断面研究和经济学研究，重点关注在 IR 国家无症状人群中进行 GC 内窥镜筛查的情况。检索将在 MEDLINE、SCOPUS、EMBASE 和 Web of Science 中进行。此外，还将检索其他灰色文献来源。包括 2024 年 9 月之前以英语、葡萄牙语或西班牙语发表的研究。两名独立审稿人将对所有检索结果的标题和摘要进行筛选。然后将对所选研究进行全面分析，并在数据库中收集和编码数据。为了最大限度地降低偏倚风险，纳入的研究将根据科克伦偏倚风险工具、随机试验的 RoB 2 和非随机试验的 ROBINS-I、诊断测试准确性的 QUADAS-2 以及美国国家心肺血液研究所对观察性队列研究、横断面研究和病例对照研究的研究质量评估工具进行质量分析。收集到的数据将分为两类：疗效/效果数据和经济数据，并对每类数据分别进行荟萃分析：本系统综述预计将提供有关内窥镜筛查在红外人群中的疗效、有效性和成本效益的结果。预计这些结果的介绍将阐明在红外国家进行内镜下胆管癌筛查的意义。该综述目前正处于全文筛选阶段，将于 2025 年第一季度发表：据我们所知，这篇综述将是第一篇为内镜下胆管癌筛查在印度河沿岸国家的有效性提供证据的文章。我们相信，我们这样做将有助于指导未来的研究，为这一领域的医疗决策和政策制定者提供信息，并支持未来在这类人群中实施胃癌筛查计划的决策：临床试验：Prospero：CRD42024502174。

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引用次数: 0

Neighborhoods, Networks, and HIV Care Among Men Who Have Sex With Men: Proposal for a Longitudinal Study. 男男性行为者中的邻里、网络和 HIV 护理：纵向研究提案》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-13 DOI: 10.2196/64358

Hong Van Tieu, Vijay Nandi, José E Diaz, Emily Greene, Melonie Walcott, Frank Curriero, Michael R Desjardins, Cara Wychgram, Carl Latkin, Andrew G Rundle, Victoria A Frye

Background: The majority of people living with HIV in the United States are men who have sex with men (MSM), with race- and ethnicity-based disparities in HIV rates and care continuum. In order to uncover the neighborhood- and network-involved pathways that produce HIV care outcome disparities, systematic, theory-based investigation of the specific and intersecting neighborhood and social network characteristics that relate to the HIV care continuum must be engaged.Objective: Using socioecological and intersectional conceptual frameworks, we aim to identify individual-, neighborhood-, and network-level characteristics associated with HIV care continuum outcomes (viral suppression, retention in care, and antiretroviral adherence) among MSM living with HIV in New York City.Methods: In the longitudinal cohort study, we assess 3 neighborhoods of potential influence (residential, social, and health care access activity spaces) using Google Earth. We investigate the influence of neighborhood composition (eg, concentrated poverty and racial segregation) and four neighborhood-level characteristics domains: (1) community violence, physical disorder, and social disorganization (eg, crime rates and housing vacancy); (2) alcohol and other drug use; (3) social norms (eg, homophobia and HIV stigma); and (4) community resources (eg, social services and public transit access). We test theoretical pathways of influence, including stress or coping, stigma or resilience, and access to resources, across the different neighborhoods in which MSM live, socialize, and receive HIV care. At each visit, we locate each participant's reported activity spaces (ie, neighborhoods of potential influence) and collect individual-level data on relevant covariates (including perceptions of or exposure to neighborhoods) and social network inventory data on the composition, social support, and perceived social norms. The outcomes are HIV viral suppression, retention in care, and antiretroviral adherence. These data are combined with an existing, extensive geospatial database of relevant area characteristics. Spatial analysis and multilevel modeling are used to test the main theory-driven hypotheses and capture independent neighborhood-level and network-level effects and changes over time.Results: The study began enrollment in March 2019 and concluded visits in December 2023, with a total of 327 participants enrolled. The median age was 44.1 (SD 11.5) years. Almost all participants self-identified as cisgender men (n=313, 98.1%) and as gay, homosexual, or bisexual (n=301, 94.4%). Overall, 192 (60.1%) participants identified as non-Hispanic Black, and 81 (25.3%) identified as Hispanic. Most (n=201, 63%) reported at least occasional difficulty in meeting basic needs (eg, rent and food) in the past 6 months. The mean number of years living with HIV was 15.4 (SD 10.1).Conclusions: </s

背景：在美国，大多数艾滋病毒感染者是男男性行为者（MSM），在艾滋病毒感染率和持续护理方面存在种族和民族差异。为了揭示产生艾滋病护理结果差异的邻里和网络途径，必须对与艾滋病护理连续性相关的具体和交叉的邻里和社会网络特征进行系统的、基于理论的调查：利用社会生态学和交叉概念框架，我们旨在确定纽约市感染 HIV 的男男性行为者中与 HIV 护理持续结果（病毒抑制、持续护理和坚持抗逆转录病毒治疗）相关的个人、邻里和网络层面的特征：在纵向队列研究中，我们使用谷歌地球评估了 3 个具有潜在影响的社区（居住、社交和医疗保健活动空间）。我们调查了邻里构成（如集中贫困和种族隔离）和四个邻里层面特征领域的影响：（1）社区暴力、身体失调和社会混乱（如犯罪率和住房空置率）；（2）酒精和其他药物的使用；（3）社会规范（如仇视同性恋和艾滋病耻辱化）；以及（4）社区资源（如社会服务和公共交通）。我们将在男男性行为者生活、社交和接受 HIV 护理的不同社区测试理论上的影响途径，包括压力或应对、污名化或复原力，以及获取资源的途径。在每次访问时，我们都会找到每位参与者报告的活动空间（即具有潜在影响的社区），并收集个人层面的相关协变量数据（包括对社区的看法或接触社区的情况），以及有关组成、社会支持和感知社会规范的社会网络清单数据。研究结果包括艾滋病病毒抑制率、护理保留率和抗逆转录病毒治疗依从性。这些数据与相关地区特征的现有广泛地理空间数据库相结合。利用空间分析和多层次建模来检验主要理论驱动的假设，并捕捉独立的邻里级和网络级效应以及随时间的变化：研究于 2019 年 3 月开始注册，2023 年 12 月结束访问，共有 327 名参与者注册。年龄中位数为 44.1 岁（SD 11.5）。几乎所有参与者都自我认定为顺性男性（人数=313，98.1%）和同性恋、双性恋（人数=301，94.4%）。总体而言，192 名参与者（60.1%）被认定为非西班牙裔黑人，81 名参与者（25.3%）被认定为西班牙裔。大多数参与者（n=201，63%）表示在过去 6 个月中至少偶尔在满足基本需求（如房租和食物）方面遇到过困难。感染艾滋病毒的平均年数为 15.4 年（标准差 10.1）：本研究将对多层次干预措施的设计产生直接影响，解决邻里、网络和个人层面的因素。研究结果可为城市规划和项目设计提供参考，以改善男男性行为者，尤其是生活在城市地区的黑人和拉丁裔男男性行为者的艾滋病护理效果：PRR1-10.2196/64358。

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引用次数: 0

Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial. 改善创伤后癫痫患者焦虑和抑郁生活质量的协作护理（CoCarePTE）：随机混合疗效实施试验方案》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-13 DOI: 10.2196/59329

Heidi M Munger Clary, Beverly M Snively, Christian Cagle, Richard Kennerly, James N Kimball, Halley B Alexander, Gretchen A Brenes, Justin B Moore, Robin A Hurley

Background: Anxiety and depression in people with epilepsy are common and associated with poor outcomes; yet, they often go untreated due to poor mental health specialist access. Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Evaluating implementation outcomes when translating evidence-based interventions to new clinical settings to inform future scaling and incorporation into real-world practice is important.Objective: The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety or depressive symptoms and posttraumatic epilepsy.Methods: CoCarePTE is a 2-site, randomized, single-blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to receive either neurology-based collaborative care or usual care. Adults receiving neurological care at participating centers with anxiety or depressive symptoms and a history of at least mild traumatic brain injury before epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with video or telephone calls every 2 weeks by a care manager for measurement-based anxiety and depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by antidepressant prescribing recommendations by psychiatrists for neurologists via case conferences and care manager-facilitated team communication. In step 2 of the intervention, individuals with <50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life. As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group compared to control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes, including fidelity, acceptability, feasibility, and appropriateness, are evaluated before implementation and at 3 months. The primary effectiveness analysis will compare changes in emotional quality of life scores from baseline to 6 months between the intervention and control arms using multiple linear regression modeling, adjusting for study site and using an intent-to-treat approach.Results: Enrollment commenced in 2023, with modifications in the inclusion and exclusion made after the first 6 enrollees due to slow recruitment. Enrollment is expected to continue at least into early 2025.Conclusions: The CoCarePTE trial is novel in its use of a hybrid effectiveness-implementation

背景：癫痫患者的焦虑和抑郁很常见，并与不良后果相关；然而，由于精神健康专科就诊率低，这些患者往往得不到治疗。协作护理是一种综合护理模式，在初级保健和医疗机构中具有坚实的证据基础，但尚未在神经病学诊所中进行过评估。在将循证干预措施转化到新的临床环境时，对其实施结果进行评估非常重要，以便为今后的推广和融入现实世界的实践提供依据：创伤后癫痫协作护理（CoCarePTE）试验旨在评估针对焦虑或抑郁症状和创伤后癫痫患者的协作护理干预措施的有效性（生活情绪质量的改善）和实施情况：CoCarePTE 是一项两地、随机、单盲、混合型 1 类有效性实施试验，将随机抽取 60 名成人，让他们接受神经科协作护理或常规护理。在参与试验的中心接受神经病学治疗的成人将被纳入试验，他们都有焦虑或抑郁症状，并且在癫痫发病前至少有过轻度脑外伤病史。协作护理干预是一种为期 24 周的阶梯式护理模式，护理经理每两周会通过视频或电话对患者进行焦虑和抑郁护理测量、癫痫发作护理监测以及简短治疗干预。此外，精神科医生还通过病例会议和护理经理主持的团队交流为神经科医生提供抗抑郁药物处方建议。在干预措施的第 2 步中，有结果的个人将接受治疗：2023 年开始招募，由于招募速度缓慢，在招募了前 6 名患者后，对纳入和排除范围进行了修改。预计招募至少会持续到 2025 年初：CoCarePTE试验的新颖之处在于它采用了混合效果-实施设计来评估癫痫患者的循证心理健康干预措施，并将癫痫护理纳入合作护理模式。如果干预组的生活质量与常规护理相比有明显改善，这将有助于下一步的推广或临床实施：试验注册：ClinicalTrials.gov NCT05353452；https://www.clinicaltrials.gov/study/NCT05353452.International 注册报告标识符 (irrid)：DERR1-10.2196/59329。

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引用次数: 0

Bystander Response and Out-of-Hospital Cardiac Arrest Outcomes (Bro. Study) in 3 Gulf Countries: Protocol for a Prospective, Observational, International Collaboration Study. 3 个海湾国家的旁观者反应和院外心脏骤停结果（兄弟研究）：前瞻性、观察性、国际合作研究协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-12 DOI: 10.2196/58780

Munawar Farooq, Mahmood Al Jufaili, Faisal K Hanjra, Shabbir Ahmad, Emad Hanna Dababneh, Omar Al Nahhas, Khalid Bashir

Background: : Globally, there is significant variation in the out-of-hospital cardiac arrest (OHCA) survival rate. Early links in the chain of survival, including bystander cardiopulmonary resuscitation (CPR) and the use of an automated external defibrillator at the scene, are known to be of crucial importance, with strong evidence of increased survival rate with good neurological outcomes. The data from the Middle East are limited and report variable rates of bystander CPR and survival. It is crucial to get prospective, reliable data on bystander response in these regions to help plan interventions to improve bystander response and outcomes.

Objective: This international collaborative study aims to describe the characteristics, including bystander interventions and outcomes, of OHCAs brought to hospitals enrolled in the study from Abu Dhabi, United Arab Emirates; Doha, Qatar; and Muscat, Oman. It also aims to describe the strength of the association between bystander response and OHCA outcomes, including the return of spontaneous circulation, survival to hospital admission, survival to discharge, and good neurological outcome at discharge in the local context of low bystander CPR rates.

Methods: This multicenter, prospective, noninterventional observational study (Bro. Study) will be conducted at the emergency departments of 4 participating tertiary care hospitals in 3 countries. The data will be collected prospectively according to the Utstein style (a set of internationally accepted guidelines for uniform reporting of cardiac arrests) on demographic variables (age, sex, nationality, country, participating center, and comorbidities), peri-cardiac arrest variables (location, witnessed or not, bystander CPR, use of automated external defibrillator, time of emergency medical services arrival, initial rhythm, number of shocks, and time of prehospital CPR), and outcome variables (return of spontaneous circulation, survival to discharge, and neurological outcome at discharge and 3 months). Univariate and multivariate analysis with logistic regression models will be used to measure the strength of the association of bystander interventions with outcomes using SPSS (version 22).

Results: Data collection began in November 2023 and will continue for 2 years, with publication expected by early 2026.

Conclusions: Bystander response to an OHCA is critical to a favorable outcome. The reliable, baseline bystander CPR data will be a cornerstone in the team's next planned projects, which are to qualitatively identify the barriers to bystander CPR, conduct a scoping review of community interventions in the Gulf and other Asian countries, and design and implement strategies to help improve the bystander CPR rate in the community.

International registered report identifier (irrid): DERR1-10.2196/58780.

背景：：在全球范围内，院外心脏骤停（OHCA）的存活率差异很大。众所周知，生存链的早期环节，包括旁观者心肺复苏术（CPR）和在现场使用自动体外除颤器至关重要，有确凿证据表明，这能提高存活率，并带来良好的神经功能预后。中东地区的数据有限，报告的旁观者心肺复苏率和存活率也不尽相同。在这些地区获得有关旁观者反应的前瞻性可靠数据至关重要，有助于规划干预措施，改善旁观者反应和结果：这项国际合作研究旨在描述阿拉伯联合酋长国阿布扎比、卡塔尔多哈和阿曼马斯喀特参与研究的医院所收治的 OHCAs 患者的特征，包括旁观者干预和结果。本研究还旨在描述旁观者反应与 OHCA 结果之间的关联强度，包括在当地旁观者心肺复苏率较低的情况下，自发循环恢复、入院存活、出院存活以及出院时良好的神经功能结果：这项多中心、前瞻性、非干预性观察研究（Bro. Study）将在 3 个国家 4 家参与研究的三级医院急诊科进行。数据将根据 Utstein 风格（一套国际公认的统一报告心脏骤停的指南）进行前瞻性收集，包括人口统计学变量（年龄、性别、国籍、国家、参与中心和合并症）、心脏骤停周围变量（位置、有无目击者、旁观者心肺复苏术）、心肺复苏术后处理变量（心肺复苏术后处理、心肺复苏术后处理、心肺复苏术后处理、心肺复苏术后处理、心肺复苏术后处理等）、有无目击、旁观者心肺复苏、自动体外除颤器的使用、急救医疗服务到达时间、初始心律、电击次数和院前心肺复苏时间），以及结果变量（自发性循环恢复、出院后存活率、出院和 3 个月后的神经功能预后）。将使用 SPSS（22 版）利用逻辑回归模型进行单变量和多变量分析，以衡量旁观者干预与结果之间的关联强度：数据收集工作于 2023 年 11 月开始，将持续两年，预计于 2026 年初发表：结论：旁观者对 OHCA 的反应对获得良好的预后至关重要。可靠的旁观者心肺复苏基线数据将成为该团队下一步计划项目的基石，这些项目将从质量上确定旁观者心肺复苏的障碍，对海湾地区和其他亚洲国家的社区干预措施进行范围审查，并设计和实施有助于提高社区旁观者心肺复苏率的策略：DERR1-10.2196/58780。

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引用次数: 0

Clinical and Biochemical Outcomes in Transgender Individuals Undergoing Hormone Therapy: Protocol for a Systematic Review. 接受激素治疗的变性人的临床和生化结果：系统综述协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-12 DOI: 10.2196/57931

Emily Sattora, Karen Teelin, Christopher Prendergast, Abigail Smith, James Evans, Aamer Imdad

Background: Monitoring of various clinical outcomes and parameters, such as lipid levels, is recommended in transgender individuals undergoing hormone therapies. However, comprehensive data to inform these recommendations is scarce.

Objective: This study aims to conduct a systematic review and meta-analysis to synthesize evidence from existing literature on the effect of exogenous hormone therapy on clinical and biochemical outcomes for transgender adolescents and adults.

Methods: We will search multiple electronic databases and will include prospective and retrospective observational studies with and without a control group. The study population will include transgender individuals undergoing hormone therapy with testosterone or estrogen. Comparisons will include age-matched, cisgender individuals and changes from baseline. Primary outcomes include changes in or the development of abnormal lipid parameters. Secondary outcomes include BMI, weight, height, and blood pressure for age, serum testosterone or estrogen levels, and development of disease including hypertension, diabetes, fatty liver disease, obesity, adverse cardiac events, as well as all-cause mortality. The meta-analysis will pool the studies where applicable, and meta-regressions will be conducted to evaluate effect modifiers. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach will be used to evaluate the overall certainty of evidence.

Results: We will summarize the selection of the eligible studies using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart. The results will be presented in a table summarizing the evidence. Data collection is ongoing, and the paper is expected to be published in Spring 2025.

Conclusions: This systematic review will summarize and evaluate the evidence of the clinical and biochemical outcomes associated with hormone therapies for transgender individuals.

Trial registration: PROSPERO CRD42024483138; https://tinyurl.com/yc4sfvnb.

International registered report identifier (irrid): PRR1-10.2196/57931.

背景：建议对接受激素治疗的变性人进行各种临床结果和参数（如血脂水平）的监测。然而，为这些建议提供依据的综合数据却很少：本研究旨在开展一项系统性回顾和荟萃分析，从现有文献中总结有关外源性激素治疗对变性青少年和成人的临床和生化结果影响的证据：方法：我们将搜索多个电子数据库，包括有对照组和无对照组的前瞻性和回顾性观察研究。研究人群将包括接受睾酮或雌激素激素治疗的变性人。比较对象将包括年龄匹配的顺性别者以及与基线相比的变化。主要结果包括血脂参数的变化或异常发展。次要结果包括体重指数、体重、身高、年龄血压、血清睾酮或雌激素水平，以及包括高血压、糖尿病、脂肪肝、肥胖症、不良心脏事件和全因死亡率在内的疾病发展情况。荟萃分析将对适用的研究进行汇总，并进行荟萃回归以评估效应调节因子。将采用 GRADE（建议评估、制定和评价分级）方法评估证据的总体确定性：我们将使用 PRISMA（系统综述和 Meta 分析首选报告项目）流程图对符合条件的研究进行筛选。结果将以证据汇总表的形式呈现。数据收集工作正在进行中，论文预计将于 2025 年春季发表：本系统综述将总结和评估变性人激素疗法相关临床和生化结果的证据：PROSPERO CRD42024483138; https://tinyurl.com/yc4sfvnb.International 注册报告标识符 (irrid)：PRR1-10.2196/57931。

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引用次数: 0

Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial. 为医疗补助计划下的严重精神疾病患者提供过渡性护理支持：I 型混合效果-实施阶梯-楔形集群随机对照试验方案》（Protocol for a Type I Hybrid Effectiveness-Implementation Stepped-Wedge Cluster Randomized Controlled Trial）。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-12 DOI: 10.2196/64575

J Margo Brooks Carthon, Heather Brom, Kelvin Eyram Amenyedor, Michael O Harhay, Marsha Grantham-Murillo, Jacqueline Nikpour, Karen B Lasater, Daniela Golinelli, Pamela Z Cacchione, Amanda P Bettencourt

Background: People diagnosed with a co-occurring serious mental illness (SMI; ie, major depressive disorder, bipolar disorder, or schizophrenia) but hospitalized for a nonpsychiatric condition experience higher rates of readmissions and other adverse outcomes, in part due to poorly coordinated care transitions. Current hospital-to-home transitional care programs lack a focus on the integrated social, medical, and mental health needs of these patients. The Thrive clinical pathway provides transitional care support for patients insured by Medicaid with multiple chronic conditions by focusing on posthospitalization medical concerns and the social determinants of health. This study seeks to evaluate an adapted version of Thrive that also meets the needs of patients with co-occurring SMI discharged from a nonpsychiatric hospitalization.Objective: This study aimed to (1) engage staff and community advisors in participatory implementation processes to adapt the Thrive clinical pathway for all Medicaid-insured patients, including those with SMI; (2) examine utilization outcomes (ie, Thrive referral, readmission, emergency department [ED], primary, and specialty care visits) for Medicaid-insured individuals with and without SMI who receive Thrive compared with usual care; and (3) evaluate the acceptability, appropriateness, feasibility, and cost-benefit of an adapted Thrive clinical pathway that is tailored for Medicaid-insured patients with co-occurring SMI.Methods: This study will use a prospective, type I hybrid effectiveness-implementation, stepped-wedge, cluster randomized controlled trial design. We will randomize the initiation of Thrive referrals at the unit level. Data collection will occur over 24 months. Inclusion criteria for Thrive referral include individuals who (1) are Medicaid insured, dually enrolled in Medicaid and Medicare, or Medicaid eligible; (2) reside in Philadelphia; (3) are admitted for a medical diagnosis for over 24 hours at the study hospital; (4) are planned for discharge to home; (5) agree to receive home care services; and (6) are aged ≥18 years. Primary analyses will use a mixed-effects negative binomial regression model to evaluate readmission and ED utilization, comparing those with and without SMI who receive Thrive to those with and without SMI who receive usual care. Using a convergent parallel mixed methods design, analyses will be conducted simultaneously for the survey and interview data of patients, clinicians, and health care system leaders. The cost of Thrive will be calculated from budget monitoring data for the research budget, the cost of staff time, and average Medicaid facility fee payments.Results: This research project was funded in October 2023. Data collection will occur from April 2024 through December 2025. Results are anticipated to be published in 2025-2027.Conclusions: We anticipate

背景：被诊断出同时患有严重精神疾病（SMI，即重度抑郁障碍、双相情感障碍或精神分裂症）但因非精神疾病住院的患者，其再入院率和其他不良后果较高，部分原因是护理过渡的协调性较差。目前从医院到家庭的过渡性护理计划缺乏对这些患者的社会、医疗和心理健康综合需求的关注。Thrive 临床路径通过关注入院后的医疗问题和健康的社会决定因素，为有多种慢性病的医疗保险患者提供过渡性护理支持。本研究旨在评估 Thrive 的调整版本，该版本也能满足从非精神病院出院的并发 SMI 患者的需求：本研究旨在：（1）让员工和社区顾问参与实施过程，以调整 Thrive 临床路径，使其适用于所有医疗补助保险患者，包括患有 SMI 的患者；(2) 与常规护理相比，检查有或没有 SMI 的医疗补助保险患者在接受 Thrive 护理后的使用结果（即 Thrive 转诊、再入院、急诊科 [ED]、初级和专科护理就诊）；以及 (3) 评估为有并发 SMI 的医疗补助保险患者量身定制的 Thrive 临床路径的可接受性、适当性、可行性和成本效益。研究方法：本研究将采用前瞻性、I 型混合有效性实施、阶梯式楔形、群组随机对照试验设计。我们将在单位层面随机启动茁壮成长转介。数据收集将持续 24 个月。Thrive 转介的纳入标准包括以下人员：（1）医疗补助保险、医疗补助和医疗保险双重参保或符合医疗补助资格；（2）居住在费城；（3）因医疗诊断在研究医院住院超过 24 小时；（4）计划出院回家；（5）同意接受家庭护理服务；（6）年龄≥18 岁。主要分析将使用混合效应负二项回归模型来评估再入院和急诊室使用情况，并将接受 Thrive 治疗的 SMI 患者和非 SMI 患者与接受常规护理的 SMI 患者和非 SMI 患者进行比较。采用会聚平行混合方法设计，将同时对患者、临床医生和医疗保健系统领导者的调查和访谈数据进行分析。茁壮成长项目的成本将根据研究预算的预算监测数据、工作人员的时间成本以及医疗补助设施的平均费用来计算：该研究项目于 2023 年 10 月获得资助。数据收集时间为 2024 年 4 月至 2025 年 12 月。预计将于 2025-2027 年公布结果：我们预计，合并或不合并 SMI 的患者都将受益于经过调整的 Thrive 临床路径。我们还预计，经过调整的 Thrive 临床路径将被患者、临床医生和医疗系统领导者认为是可行、可接受和适当的：ClinicalTrials.gov NCT06203509; https://clinicaltrials.gov/ct2/show/NCT06203509.International 注册报告标识符 (irrid)：DERR1-10.2196/64575。

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引用次数: 0

Influence of Psychological Stress on the Response to Periodontal Treatment: Protocol for a Systematic Review. 心理压力对牙周治疗反应的影响：系统综述协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-12 DOI: 10.2196/56765

Kelly R Vargas Villafuerte, Luiz H Palucci Vieira, Karina Oliveira Santos

Background: The interaction between stress and periodontal treatment is a topic of growing interest. It stands out as a field of research that sheds light on the complexity of oral health in individuals subjected to high levels of emotional stress.

Objective: This paper aims to provide a protocol for a systematic review to examine the scientific evidence related to the influence of psychological stress on the response to periodontal treatment.

Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines will be followed, and the study is based on a formulation of PECO (Participants, Exposure, Comparators, and Outcomes) questions. This systematic review will involve a literature search covering studies published from January 2000 to May 2024. It will include searching the PubMed, Web of Science, EBSCOHost, Scopus, and ProQuest databases to identify relevant studies. After selection, data extraction and quality assessment (using the Ottawa-Newcastle Scale) of the included studies will be carried out. The objective is to integrate high-quality evidence on how psychological stress impacts the outcomes of periodontal treatment. Depending on the number and methodological consistency of included studies, the results may be presented by meta-analysis or qualitative synthesis.

Results: The current stage of the study consists of selecting studies for the systematic review as outlined by this protocol. The search, screening, and data extraction began in January 2024. The final results are expected by July 2024, with final manuscript submission planned for November 2024.

Conclusions: This review will help clarify how psychological factors, such as stress, influence the results of periodontal treatment, providing valuable guidelines for future research and helping clinicians make decisions about the best treatment options for patients.

Trial registration: Open Science Framework (OSF) Registries qfs6p; https://osf.io/qfs6p.

International registered report identifier (irrid): PRR1-10.2196/56765.

背景：压力与牙周治疗之间的相互作用是一个日益受到关注的话题。它是一个突出的研究领域，揭示了受到高度情绪压力的人的口腔健康的复杂性：本文旨在提供一个系统性综述的方案，以研究与心理压力对牙周治疗反应的影响有关的科学证据：方法：将遵循系统综述和荟萃分析首选报告项目（PRISMA）指南，研究基于 PECO（参与者、暴露、比较者和结果）问题的制定。本系统综述将对 2000 年 1 月至 2024 年 5 月期间发表的研究进行文献检索。其中包括搜索 PubMed、Web of Science、EBSCOHost、Scopus 和 ProQuest 数据库，以确定相关研究。筛选后，将对纳入的研究进行数据提取和质量评估（采用渥太华-纽卡斯尔量表）。目的是整合有关心理压力如何影响牙周治疗效果的高质量证据。根据纳入研究的数量和方法的一致性，研究结果可能会通过荟萃分析或定性综合来呈现：本研究的现阶段工作包括按照本方案的规定，为系统综述挑选研究。搜索、筛选和数据提取工作于 2024 年 1 月开始。预计在 2024 年 7 月得出最终结果，并计划在 2024 年 11 月提交最终稿件：本综述将有助于阐明压力等心理因素如何影响牙周治疗效果，为未来研究提供有价值的指导，并帮助临床医生为患者做出最佳治疗方案的决策：Open Science Framework (OSF) Registries qfs6p; https://osf.io/qfs6p.International registered report identifier (irrid)：PRR1-10.2196/56765。

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引用次数: 0

Using a Device-Free Wi-Fi Sensing System to Assess Daily Activities and Mobility in Low-Income Older Adults: Protocol for a Feasibility Study. 使用无设备 Wi-Fi 传感系统评估低收入老年人的日常活动和行动能力：可行性研究协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-12 DOI: 10.2196/53447

Jane Chung, Ingrid Pretzer-Aboff, Pamela Parsons, Katherine Falls, Eyuphan Bulut

Background: Older adults belonging to racial or ethnic minorities with low socioeconomic status are at an elevated risk of developing dementia, but resources for assessing functional decline and detecting cognitive impairment are limited. Cognitive impairment affects the ability to perform daily activities and mobility behaviors. Traditional assessment methods have drawbacks, so smart home technologies (SmHT) have emerged to offer objective, high-frequency, and remote monitoring. However, these technologies usually rely on motion sensors that cannot identify specific activity types. This group often lacks access to these technologies due to limited resources and technology experience. There is a need to develop new sensing technology that is discreet, affordable, and requires minimal user engagement to characterize and quantify various in-home activities. Furthermore, it is essential to explore the feasibility of developing machine learning (ML) algorithms for SmHT through collaborations between clinical researchers and engineers and involving minority, low-income older adults for novel sensor development.Objective: This study aims to examine the feasibility of developing a novel channel state information-based device-free, low-cost Wi-Fi sensing system, and associated ML algorithms for localizing and recognizing different patterns of in-home activities and mobility in residents of low-income senior housing with and without mild cognitive impairment.Methods: This feasibility study was conducted in collaboration with a wellness care group, which serves the healthy aging needs of low-income housing residents. Prior to this feasibility study, we conducted a pilot study to collect channel state information data from several activity scenarios (eg, sitting, walking, and preparing meals) using the proposed Wi-Fi sensing system continuously over a week in apartments of low-income housing residents. These activities were videotaped to generate ground truth annotations to test the accuracy of the ML algorithms derived from the proposed system. Using qualitative individual interviews, we explored the acceptability of the Wi-Fi sensing system and implementation barriers in the low-income housing setting. We use the same study protocol for the proposed feasibility study.Results: The Wi-Fi sensing system deployment began in November 2022, with participant recruitment starting in July 2023. Preliminary results will be available in the summer of 2025. Preliminary results are focused on the feasibility of developing ML models for Wi-Fi sensing-based activity and mobility assessment, community-based recruitment and data collection, ground truth, and older adults' Wi-Fi sensing technology acceptance.Conclusions: This feasibility study can make a contribution to SmHT science and ML capabilities for early detection of cognitive decline among socially v

背景：社会经济地位低下的少数种族或少数族裔老年人患痴呆症的风险较高，但用于评估功能衰退和检测认知障碍的资源却很有限。认知障碍会影响日常活动能力和行动行为。传统的评估方法存在缺陷，因此智能家居技术（SmHT）应运而生，可提供客观、高频率的远程监控。然而，这些技术通常依赖于运动传感器，无法识别特定的活动类型。由于资源和技术经验有限，这一群体往往无法获得这些技术。有必要开发新的传感技术，这种技术要隐蔽、经济实惠，而且只需用户极少的参与，就能对各种居家活动进行特征描述和量化。此外，还必须通过临床研究人员和工程师之间的合作，探索为 SmHT 开发机器学习（ML）算法的可行性，并让少数民族、低收入老年人参与新型传感器的开发：本研究旨在探讨开发基于信道状态信息的新型无设备、低成本 Wi-Fi 传感系统和相关 ML 算法的可行性，以定位和识别低收入老年住宅中患有或未患有轻度认知障碍的居民的不同居家活动和移动模式：这项可行性研究是与一家健康护理集团合作进行的，该集团为低收入住房居民的健康老龄化需求提供服务。在进行这项可行性研究之前，我们进行了一项试点研究，在低收入住房居民的公寓中使用拟议的 Wi-Fi 传感系统连续一周收集几种活动场景（如坐着、行走和准备饭菜）的通道状态信息数据。我们对这些活动进行了录像，以生成地面实况注释，从而测试拟议系统衍生的 ML 算法的准确性。通过定性个人访谈，我们探讨了 Wi-Fi 传感系统的可接受性以及在低收入住房环境中的实施障碍。我们在拟议的可行性研究中使用了相同的研究协议：Wi-Fi 传感系统于 2022 年 11 月开始部署，并于 2023 年 7 月开始招募参与者。初步结果将于 2025 年夏季公布。初步结果主要集中在为基于Wi-Fi传感的活动和流动性评估开发ML模型的可行性、基于社区的招募和数据收集、地面实况以及老年人对Wi-Fi传感技术的接受程度：这项可行性研究可以为早期检测社会弱势老年人认知能力下降的 SmHT 科学和 ML 能力做出贡献。目前，由于成本和信息方面的障碍，传感设备并不容易为这些人群所用。我们的传感设备有可能通过跟踪老年人的居家活动和行动行为，评估他们的身体功能水平，从而以较低的成本识别出有认知能力下降风险的人群：DERR1-10.2196/53447。

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引用次数: 0

Assistive Technology to Support Dementia Management: Protocol for a Scoping Review of Reviews. 支持痴呆症管理的辅助技术：范围界定审查协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-11 DOI: 10.2196/57036

Chaitali Desai, Erica Dove, Jarshini Nanthakumar, Emilia Main, Heather Colquhoun, Arlene Astell, Alex Mihailidis, Natasha Layton, Amer M Burhan, Brian Chan, Rosalie H Wang

Background: In Canada, more than 60% of persons living with dementia reside in their own homes, and over 25% rely heavily on their care partners (ie, family members or friends) for assistance with daily activities such as personal hygiene, eating, and walking. Assistive technology (AT) is a key dementia management strategy, helping to maintain health and social support in home and community settings. AT comprises assistive products and services required for safe and effective use. Persons living with dementia and their care partners often require multiple types of AT to maintain their needs, dignity, and autonomy. AT for dementia management is rapidly developing with abundant scientific literature, which can present a challenge to efficiently navigate and extract insights for policy and personal decision-making.Objective: This scoping review aims to synthesize review-level evidence from published scientific literature on AT to support dementia management for persons living with dementia and their care partners in their homes and communities. Research gaps in knowledge and areas for further investigation into the use and access of AT will be identified. This review will provide an overview of AT types and characteristics and chart the outcomes and conclusions in review-level evidence.Methods: This review will follow the Joanna Briggs Institute's framework for conducting scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. In total, 6 electronic databases will be searched. Articles will be screened according to the "Population-Concept-Context (PCC)" framework for eligible studies. Population includes persons living with dementia, their care partners, and health care professionals (eg, therapists or others who recommend AT). Concept includes AT and self-help devices of many types. Context includes homes and communities. A data charting template will guide data extraction, charting, and summarization. A descriptive numerical summary and an overview of the findings will be presented. Data, such as (1) article information (eg, author and year), (2) article characteristics (eg, review type), (3) AT types and characteristics, (4) setting and population characteristics, and (5) key review outcomes and conclusions, will be extracted.Results: A total of 10,978 unique citations were identified across the 6 electronic databases. This review is in the full-text screening stage, which is expected to be completed by October 2024.Conclusions: This review will provide a comprehensive understanding and documentation of the published scientific literature on AT to support dementia management. Findings from this review are expected to provide evidence-based insights on the complexities of AT types, uses, availability, and access. The author group's diverse natio

背景：在加拿大，超过 60% 的痴呆症患者居住在自己家中，超过 25% 的患者在很大程度上依赖护理伙伴（即家人或朋友）的帮助来进行日常活动，如个人卫生、进食和行走。辅助技术（AT）是一项重要的痴呆症管理策略，有助于在家庭和社区环境中保持健康和社会支持。辅助技术包括安全有效使用所需的辅助产品和服务。痴呆症患者及其护理伙伴通常需要多种类型的辅助器具来维持他们的需求、尊严和自主性。用于痴呆症管理的辅助器具发展迅速，科学文献丰富，但如何有效浏览并从中汲取启示，为政策制定和个人决策提供参考，是一项挑战：本范围综述旨在从已发表的科学文献中归纳出有关支持痴呆症患者及其护理伙伴在家中和社区进行痴呆症管理的辅助器具的综述级证据。本综述将指出在使用和获取辅助器具方面存在的知识空白和有待进一步调查的领域。本综述将概述智能辅助工具的类型和特点，并在综述层面的证据中列出结果和结论：本综述将遵循乔安娜-布里格斯研究所（Joanna Briggs Institute）的范围界定综述框架和 PRISMA-ScR（范围界定综述扩展的系统综述和元分析首选报告项目）指南。总共将检索 6 个电子数据库。将根据 "人群-概念-背景 (PCC) "框架筛选符合条件的研究文章。人群包括痴呆症患者、他们的护理伙伴和医护人员（例如，治疗师或其他推荐使用辅助器具的人员）。概念包括各种类型的辅助器具和自助设备。环境包括家庭和社区。数据图表模板将指导数据提取、图表绘制和总结。将提供描述性数字摘要和研究结果概述。提取的数据包括：（1）文章信息（如作者和年份）；（2）文章特征（如综述类型）；（3）AT 类型和特征；（4）环境和人群特征；（5）主要综述结果和结论：结果：在 6 个电子数据库中共识别出 10,978 条独特的引文。本综述正处于全文筛选阶段，预计将于 2024 年 10 月完成：本综述将全面了解和记录已发表的关于支持痴呆症管理的辅助治疗科学文献。本综述的研究结果有望就辅助器具类型、用途、可用性和可及性的复杂性提供以证据为基础的见解。作者小组的不同国家和国际视角可促进知识交流并影响标准，从而改善痴呆症患者的日常功能、安全性和福祉：开放科学框架 DKSM9；https://osf.io/dksm9.International 注册报告标识符 (irrid)：PRR1-10.2196/57036。

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引用次数: 0

Effectiveness of Ayush Rasayana A and B on the Quality of Life of Older Adults: Protocol for a Cluster Randomized Controlled Trial. Ayush Rasayana A 和 B 对老年人生活质量的影响：群组随机对照试验方案》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES

JMIR Research Protocols

Pub Date : 2024-11-11 DOI: 10.2196/58186

Pallavi Mundada, Deepa Makhija, Sunita Mata, Kalpana Kachare, Aparna Manathottathil, Abha Sharma, Bhogavalli Chandra Sekhara Rao, Rakesh Rana, Arunabh Tripathi, Kiran Rana, Vandana Joshi, Ashish Raturi, Anukampa Singh, N Srikanth, Rabinarayan Acharya

Background: With advancing age among older adults, the associated debilities increase, indicating a deteriorating health status as there is a gradual loss of muscle mass, strength, and functionality. Ayush Rasayana A and B are coded Ayurvedic medicines developed from herbal extracts. This study has been planned to prevent debilitating conditions and improve the quality of life (QOL) in older adults.

Objective: This study aimed to assess the effectiveness of Ayush Rasayana A and B on the QOL, quality of sleep, and functionality of older adults, along with the tolerability of the intervention.

Methods: This was a multicenter, open-label, cluster randomized controlled trial conducted with 720 participants aged 60 to 75 years. The participants were divided into 2 groups (intervention and control), with both receiving Ayurvedic ancillary treatment for 3 months. The intervention group additionally received 10 g of Ayush Rasayana A orally once daily at bedtime for 6 days, followed by 1.5 g of Ayush Rasayana B orally twice daily before food for the remaining 84 days. The assessment criteria included the Older People's Quality of Life Questionnaire Brief, Katz Index of Independence in Activities of Daily Living, Pittsburgh Sleep Quality Index, Five Times Sit-to-Stand Test, and shoulder and scapular movements. Any change in hematological and biochemical parameters and occurrence of treatment-emergent adverse events were also assessed during the study period.

Results: The recruitment of the participants started in December 2023, and the final follow-up was completed in April 2024. Out of the total 720 enrolled participants, 686 (95.3%) completed the study up to the last follow-up.

Conclusions: This study may provide evidence-based data to establish preventive treatment protocols for enhancing the QOL and functionality among older adults. The study results may also be helpful for the planning of interdisciplinary health policies for improving the health conditions of different populations.

International registered report identifier (irrid): DERR1-10.2196/58186.

背景：随着老年人年龄的增长，相关的衰弱症状也会增加，这表明随着肌肉质量、力量和功能的逐渐丧失，健康状况也会恶化。Ayush Rasayana A 和 B 是由草药提取物研制而成的阿育吠陀编码药物。本研究旨在预防老年人出现衰弱状况，并改善其生活质量（QOL）：本研究旨在评估 Ayush Rasayana A 和 B 对老年人生活质量、睡眠质量和功能的影响，以及干预措施的耐受性：这是一项多中心、开放标签、分组随机对照试验，共有 720 名 60 至 75 岁的参与者参加。参与者被分为两组（干预组和对照组），均接受为期 3 个月的阿育吠陀辅助治疗。干预组每天睡前口服一次 Ayush Rasayana A，每次 10 克，持续 6 天，然后在剩余的 84 天里，每天饭前口服两次 Ayush Rasayana B，每次 1.5 克。评估标准包括老年人生活质量问卷简表、卡茨日常生活活动独立性指数、匹兹堡睡眠质量指数、五次坐立测试以及肩部和肩胛骨运动。研究期间还评估了血液和生化指标的任何变化以及治疗引发的不良反应：参与者招募始于 2023 年 12 月，最终随访于 2024 年 4 月完成。在总共 720 名注册参与者中，有 686 人（95.3%）完成了最后一次随访：这项研究可为制定预防性治疗方案提供循证数据，从而提高老年人的生活质量和功能。研究结果还有助于规划跨学科卫生政策，改善不同人群的健康状况：DERR1-10.2196/58186。

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引用次数: 0