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Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. 结合无创脑刺激和物理治疗改善退伍军人慢性腰痛的管理:一项多臂随机对照试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-26 DOI: 10.2196/78952
Frederique Dupuis, Yannick Tousignant-Laflamme, Pascale Marier Deschênes, Philippe Fournier, Ildephonse Nduwimana, Orlane Ballot, Loris Loisel, Anne Marie Pinard, Luc Lacombe, Pierre Langevin, Alain Gaumond, Jean-Sébastien Roy, Hugo Massé-Alarie
<p><strong>Background: </strong>Low back pain (LBP) is the most common chronic pain condition in veterans, but the effectiveness of standard management approaches is modest. Addressing the psychological risk factors of chronic pain that are often observed in this population (eg, anxiety, depression, stress and mood disorders) may be important to enhance outcomes. Psychologically informed physiotherapy (PiP) identifies and mitigates the negative impacts of emotional and cognitive factors alongside the biomedical aspects of chronic LBP to improve physical functioning and has shown promising results in this population. However, residual pain and disability often persist in veterans. The combination of PiP with repetitive transcranial magnetic stimulation (rTMS) to the prefrontal cortex may enhance its effectiveness by modulating cognition, emotion, and pain perception.</p><p><strong>Objective: </strong>The aim of this study is to compare the effects of (1) combining active rTMS with PiP, (2) combining sham rTMS with PiP, and (3) usual physiotherapy (UP) on physical functioning in veterans with chronic LBP and comorbid psychological risk factors. Secondary objectives include comparing their effect on pain intensity, quality of life, depression symptoms, pain catastrophizing, movement pain-related fear, self-efficacy, medication use, and posttraumatic stress disorder symptoms.</p><p><strong>Methods: </strong>Ninety-six veterans with chronic LBP and comorbid psychological risks factors of pain will be enrolled in this 3-arm parallel randomized controlled trial. Individuals will be allocated to receive an 8-week intervention of (1) active rTMS + PiP, (2) sham rTMS + PiP, or (3) UP. Online self-administered questionnaires will be completed at baseline, 2, 8, and 26 weeks after the first treatment session. A linear mixed model will be used to assess the treatment effects by using intention-to-treat analyses. We hypothesize that active rTMS + PiP will be more effective than sham rTMS + PiP and that active PiP + rTMS or sham rTMS will be more effective than UP.</p><p><strong>Results: </strong>Ethics approval was obtained in January 2025, and participating physiotherapists completed the 2-day PiP training in May 2025. Participants have been recruited since June 2025. As of December 2025, 28 participants have been included, and recruitment is expected to continue up to June 2027, targeting the inclusion of approximately 4 new participants per month. Follow-up should be completed by December 2027, and results will be analyzed. The results of this randomized controlled trial should be published and available in June 2028.</p><p><strong>Conclusions: </strong>It is paramount to identify innovative and effective interventions for the management of chronic LBP in veterans. This study will provide new evidence on the effectiveness of two innovative interventions targeting cognitive and emotional factors of pain (ie, PiP and rTMS). If our hypothesis is confirmed, it
背景:腰痛(LBP)是退伍军人中最常见的慢性疼痛,但标准管理方法的有效性是适度的。解决在这一人群中经常观察到的慢性疼痛的心理风险因素(例如,焦虑、抑郁、压力和情绪障碍)可能对提高结果很重要。心理知情物理疗法(PiP)识别和减轻情绪和认知因素的负面影响,以及慢性腰痛的生物医学方面,以改善身体功能,并在这一人群中显示出有希望的结果。然而,残余的疼痛和残疾往往在退伍军人中持续存在。PiP联合前额皮质重复经颅磁刺激(rTMS)可能通过调节认知、情绪和疼痛感知来增强其有效性。目的:本研究旨在比较(1)主动rTMS联合PiP、(2)假rTMS联合PiP、(3)常规物理治疗(UP)对慢性腰痛退伍军人身体功能及共病心理危险因素的影响。次要目标包括比较它们对疼痛强度、生活质量、抑郁症状、疼痛灾难化、运动疼痛相关恐惧、自我效能、药物使用和创伤后应激障碍症状的影响。方法:96名患有慢性腰痛并伴有疼痛共病心理危险因素的退伍军人进行三组平行随机对照试验。个体将被分配接受为期8周的干预(1)激活rTMS + PiP,(2)假rTMS + PiP,或(3)UP。在线自我管理问卷将在第一次治疗后的基线、2周、8周和26周完成。将使用一个线性混合模型,通过意向-治疗分析来评估治疗效果。我们假设主动rTMS + PiP比假rTMS + PiP更有效,主动PiP + rTMS或假rTMS比UP更有效。结果:2025年1月获得伦理批准,参与的物理治疗师于2025年5月完成为期2天的PiP培训。参与者从2025年6月开始招募。截至2025年12月,已纳入28名参与者,预计招募将持续到2027年6月,目标是每月纳入约4名新参与者。随访应在2027年12月之前完成,并对结果进行分析。这项随机对照试验的结果将于2028年6月公布。结论:在退伍军人慢性腰痛的治疗中,寻找创新和有效的干预措施至关重要。本研究将为两种针对疼痛认知和情绪因素的创新干预措施(即PiP和rTMS)的有效性提供新的证据。如果我们的假设被证实,它可以激励临床实践的改变,并改善退伍军人慢性腰痛的生活质量。试验注册:ClinicalTrials.gov NCT06999772;https://clinicaltrials.gov/study/NCT06999772.International注册报表标识符(irrid): PRR1-10.2196/78952。
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引用次数: 0
Acceptance and Commitment to Empowerment Intervention to Reduce HIV Stigma and Promote Community Resilience: Protocol for an Implementation Study. 接受和承诺授权干预,以减少艾滋病毒耻辱和促进社区复原力:实施研究的协议。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-26 DOI: 10.2196/80669
Josephine Pui-Hing Wong, Alan Tai-Wai Li, Carla T Hilario, Mandana Vahabi, Egbe Etowa, Isaac Luginaah, Aniela M Dela Cruz, Miya Narushima, Kenneth Po-Lun Fung
<p><strong>Background: </strong>Racialized immigrants are disproportionately impacted by HIV in Canada. In 2022, 69.5% of first-time HIV cases, where race and/or ethnicity was reported, were among racialized individuals: Indigenous (22.6%), Black (18.0%), Asian and Arab (16.3%), and Latinx (10.1%). HIV vulnerability in racialized communities is reinforced by HIV stigma intersecting with prejudice and discrimination associated with racism, gendered oppression, homophobia, and economic marginalization. Stigma and discrimination impede public health efforts in HIV prevention, testing, treatment, and care.</p><p><strong>Objective: </strong>The goal of the study is to reduce HIV-related stigma in racialized immigrant communities in 6 Canadian cities in Alberta (Calgary, Edmonton) and Ontario (London, Niagara, Ottawa, Toronto). We will implement an evidence-based 6-session online intervention, Acceptance and Commitment to Empowerment (ACE), to promote skills for psychological flexibility (mindfulness, acceptance, cognitive defusion, values clarification, and committed action) and collective empowerment (critical reflection, dialogue, interconnectedness, and collective action). The objectives are to (1) assess community contexts and needs to inform the refinement of ACE; (2) build community capacity in stigma reduction; (3) evaluate the facilitators and barriers of implementing stigma reduction programs; and (4) disseminate knowledge to advance research, policy, and practice.</p><p><strong>Methods: </strong>Guided by the principles of social justice and health equity, we will apply the context-based PRISM (Practical Robust Implementation and Sustainability Model) and outcome-based RE-AIM (reach, effectiveness, adoption, implementation, maintenance) frameworks to inform the contextual adaptation, implementation, and evaluation of the ACE intervention. In phase 1 (year 1), we aim to survey 12 local organizations on their existing stigma reduction programs; engage 30 service providers and 60 community members to explore the local contexts and needs of stigma reduction. In phase 2 (year 2), phase 1 results will be used to refine the ACE intervention and apply a train-the-trainer (TTT) approach to engage 48 service providers or community leaders in the ACE training. ACE TTT graduates will be mentored to become ACE Community Facilitators. In phase 3 (years 3-4), project staff and ACE Community Facilitators will work in small 3-member teams to deliver the online ACE intervention to qualified participants (n=288) in 6 cities. Mixed methods will be used to examine the contextual factors on implementation processes and intervention effectiveness. Data analyses will include reflexive thematic analysis of qualitative data, inferential statistics, and analyses of variance to determine the effectiveness of the intervention over time.</p><p><strong>Results: </strong>The implementation of project ACE was delayed by 2 years due to the COVID-19 pandemic. The requirement
背景:在加拿大,种族化的移民受到艾滋病毒的影响不成比例。2022年,报告种族和/或民族的首次艾滋病毒病例中,有69.5%是种族化的个体:土著(22.6%),黑人(18.0%),亚洲和阿拉伯人(16.3%),拉丁裔(10.1%)。种族化社区的艾滋病毒易感性因艾滋病毒污名与与种族主义、性别压迫、同性恋恐惧症和经济边缘化相关的偏见和歧视交织在一起而加剧。污名化和歧视阻碍了艾滋病毒预防、检测、治疗和护理方面的公共卫生工作。目的:本研究的目的是减少阿尔伯塔省(卡尔加里、埃德蒙顿)和安大略省(伦敦、尼亚加拉、渥太华、多伦多)6个加拿大城市种族化移民社区中艾滋病毒相关的耻辱感。我们将实施基于证据的6期在线干预,接受和承诺赋权(ACE),以促进心理灵活性(正念、接受、认知融合、价值观澄清和承诺行动)和集体赋权(批判性反思、对话、相互联系和集体行动)的技能。目的是(1)评估社区的情况和需要,为改善社区教育提供信息;(2)建立社区减少污名的能力;(3)评估实施减少耻辱感项目的促进因素和障碍;(4)传播知识以推进研究、政策和实践。方法:在社会公正和健康公平原则的指导下,我们将应用基于情境的PRISM(实用稳健实施和可持续性模型)和基于结果的RE-AIM(覆盖范围、有效性、采用、实施、维护)框架,为ACE干预的情境适应、实施和评估提供信息。在第一阶段(第一年),我们的目标是调查12个当地组织现有的减少耻辱项目;与30个服务提供者和60个社区成员合作,探讨减少耻辱的当地情况和需求。在第二阶段(第二年),第一阶段的结果将用于完善ACE干预措施,并采用培训师培训(TTT)方法,让48家服务提供商或社区领导人参与ACE培训。ACE TTT毕业生将被指导成为ACE社区协调员。在第三阶段(第3-4年),项目工作人员和ACE社区协调员将以三人小组为单位,向6个城市的合格参与者(288人)提供在线ACE干预。混合方法将用于检查实施过程和干预有效性的背景因素。数据分析将包括对定性数据的反思性专题分析、推论统计和方差分析,以确定干预措施随时间的有效性。结果:由于COVID-19大流行,ACE项目的实施推迟了2年。获得所有附属大学(n=8)的研究伦理批准的要求进一步推迟了涉及参与者的研究活动的启动,直到2023年9月。在2023年10月至2024年8月期间,项目组从6个项目点招募了8位社区领导组成项目咨询委员会(PAC),并与PAC成员一起确定了第一阶段的外联和招募策略,并招募并确保了19个社区组织作为第二阶段的项目合作者。截至2025年3月,第一阶段数据收集已经完成,数据分析和知识转化正在进行中。结论:基于先前的研究结果,我们期望通过集体赋权,对ACE在减少内化和制定的耻辱方面的有效性,以及在现实环境中种族化移民中实施ACE的促进因素/障碍,产生关键的知识。
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引用次数: 0
Comparative Evaluation of Push-Out Bond Strength of Glass Fiber Posts and Carbon Fiber Posts in Root Canals Treated With Calcium Hydroxide-Based, Resin-Based, and Bioceramic-Based Root Canal Sealers: Protocol for an In Vitro Study. 玻璃纤维桩和碳纤维桩在氢氧化钙基、树脂基和生物陶瓷基根管密封剂治疗根管中推出结合强度的比较评估:一项体外研究方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-26 DOI: 10.2196/76621
Vinus Shivlani, Manoj Chandak, Sanika Damle

Background: For root canal procedures to be successful, adequate bond strength between endodontic sealer and post material is necessary. For postendodontic restorations, glass fiber posts and carbon fiber posts are frequently used. Depending on the type of root canal sealer used, such posts may work differently. The chemical composition and characteristics of calcium hydroxide-based, resin-based, and bioceramic-based sealers vary, which may have an impact on the posts' binding strength. Therefore, optimizing rehabilitative results requires an understanding of these connections.

Objective: This study aims to evaluate and compare the push-out bond strength of glass fiber posts and carbon fiber posts in root canals treated with calcium hydroxide-based, resin-based, and bioceramic-based endodontic sealers.

Methods: A total of 60 extracted human premolars will be used in this in vitro investigation. After canal preparation, specimens will be separated into 3 groups according to the type of sealer used (bioceramic-based, resin-based, and calcium hydroxide-based). The type of post (carbon fiber or glass fiber) will be used to further split each group into 2 subgroups. A universal testing machine will be used to exert a compressive force on each post to test its push-out bond strength. Bond strength data will be recorded in megapascals and analyzed using ANOVA and post hoc tests.

Results: The results are expected to demonstrate significant differences in push-out bond strength among different post and sealer combinations. Glass fiber posts are expected to have higher bond strength values than carbon fiber posts across all sealer groups, with the highest bond strength anticipated in the bioceramic-based sealer group. Resin-based sealers are expected to exhibit intermediate bond strength values, whereas calcium hydroxide-based sealers are expected to show the lowest bond strength values across both types of post.

Conclusions: Glass fiber posts are expected to offer superior push-out bond strength in comparison to carbon fiber posts, especially when used with bioceramic-based sealers. The type of root canal sealer significantly affects bond strength, with bioceramic-based sealers providing the most reliable bond. Findings are expected that will suggest that careful selection of both post material and sealer type is necessary to enhance the long-term success of root canal restorations.

International registered report identifier (irrid): DERR1-10.2196/76621.

背景:为了根管治疗的成功,根管密封剂和桩材料之间有足够的粘结强度是必要的。牙髓后修复多采用玻璃纤维桩和碳纤维桩。根据所使用的根管密封器的类型,这些桩的工作可能不同。氢氧化钙基密封剂、树脂基密封剂和生物陶瓷基密封剂的化学成分和特性各不相同,这可能会影响桩的结合强度。因此,优化康复效果需要了解这些联系。目的:比较氢氧化钙基根管密封剂、树脂基根管密封剂和生物陶瓷根管密封剂对玻璃纤维根管和碳纤维根管的推出强度。方法:用60颗提取的人前磨牙进行体外研究。根管预备完成后,根据使用的封闭剂类型将标本分为3组(生物陶瓷基、树脂基、氢氧化钙基)。柱子的类型(碳纤维或玻璃纤维)将用于进一步将每组分成2个子组。将使用万能试验机对每个桩施加压缩力,以测试其推出粘结强度。粘结强度数据将以兆帕斯卡为单位记录,并使用方差分析和事后测试进行分析。结果:结果预计将证明在推出粘结强度显著差异在不同的桩和封口剂组合。在所有密封剂组中,玻璃纤维桩的粘结强度值预计高于碳纤维桩,其中生物陶瓷基密封剂组的粘结强度预计最高。树脂基封口剂预计会表现出中等的结合强度值,而氢氧化钙基封口剂预计会在两种类型的桩中表现出最低的结合强度值。结论:与碳纤维桩相比,玻璃纤维桩有望提供更好的推出结合强度,特别是当与生物陶瓷基密封剂一起使用时。根管密封剂的类型会显著影响根管的粘结强度,生物陶瓷基密封剂提供最可靠的粘结。研究结果表明,为了提高根管修复的长期成功率,需要仔细选择桩材料和密封器类型。国际注册报告标识符(irrid): DERR1-10.2196/76621。
{"title":"Comparative Evaluation of Push-Out Bond Strength of Glass Fiber Posts and Carbon Fiber Posts in Root Canals Treated With Calcium Hydroxide-Based, Resin-Based, and Bioceramic-Based Root Canal Sealers: Protocol for an In Vitro Study.","authors":"Vinus Shivlani, Manoj Chandak, Sanika Damle","doi":"10.2196/76621","DOIUrl":"10.2196/76621","url":null,"abstract":"<p><strong>Background: </strong>For root canal procedures to be successful, adequate bond strength between endodontic sealer and post material is necessary. For postendodontic restorations, glass fiber posts and carbon fiber posts are frequently used. Depending on the type of root canal sealer used, such posts may work differently. The chemical composition and characteristics of calcium hydroxide-based, resin-based, and bioceramic-based sealers vary, which may have an impact on the posts' binding strength. Therefore, optimizing rehabilitative results requires an understanding of these connections.</p><p><strong>Objective: </strong>This study aims to evaluate and compare the push-out bond strength of glass fiber posts and carbon fiber posts in root canals treated with calcium hydroxide-based, resin-based, and bioceramic-based endodontic sealers.</p><p><strong>Methods: </strong>A total of 60 extracted human premolars will be used in this in vitro investigation. After canal preparation, specimens will be separated into 3 groups according to the type of sealer used (bioceramic-based, resin-based, and calcium hydroxide-based). The type of post (carbon fiber or glass fiber) will be used to further split each group into 2 subgroups. A universal testing machine will be used to exert a compressive force on each post to test its push-out bond strength. Bond strength data will be recorded in megapascals and analyzed using ANOVA and post hoc tests.</p><p><strong>Results: </strong>The results are expected to demonstrate significant differences in push-out bond strength among different post and sealer combinations. Glass fiber posts are expected to have higher bond strength values than carbon fiber posts across all sealer groups, with the highest bond strength anticipated in the bioceramic-based sealer group. Resin-based sealers are expected to exhibit intermediate bond strength values, whereas calcium hydroxide-based sealers are expected to show the lowest bond strength values across both types of post.</p><p><strong>Conclusions: </strong>Glass fiber posts are expected to offer superior push-out bond strength in comparison to carbon fiber posts, especially when used with bioceramic-based sealers. The type of root canal sealer significantly affects bond strength, with bioceramic-based sealers providing the most reliable bond. Findings are expected that will suggest that careful selection of both post material and sealer type is necessary to enhance the long-term success of root canal restorations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/76621.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e76621"},"PeriodicalIF":1.5,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12887557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052322","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}
引用次数: 0
Effectiveness and Safety of Kangjia Decoction Granules for the Treatment of Hashimoto Thyroiditis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Clinical Trial. 康佳汤颗粒治疗桥本甲状腺炎的有效性和安全性:一项随机、双盲、安慰剂对照、多中心临床试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-26 DOI: 10.2196/80993
Duanchun Zhang, Dan Zhang, Xiaoxiao Qu, Huihong Cao, Yanming He
<p><strong>Background: </strong>Hashimoto thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient's quality of life. At the time of this writing, there is a lack of effective clinical treatments for early-stage HT. Kangjia decoction granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs.</p><p><strong>Objective: </strong>This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients.</p><p><strong>Methods: </strong>This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1=n2=70). The intervention group will receive KDG treatment, whereas the control group will receive a placebo treatment. All participants will undergo treatment for 3 months. Changes in antithyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include antithyroglobulin antibodies (TGAb), thyrotropin, also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL17 mRNA and FOXP3 mRNA, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored.</p><p><strong>Results: </strong>The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities were scheduled for completion by October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.</p><p><strong>Conclusions: </strong>This study's findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs.</p><p><strong>Trial registration: </strong>China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showp
桥本甲状腺炎(桥本甲状腺炎)是一种由自身免疫性疾病介导的甲状腺慢性炎症,常导致甲状腺功能减退,并显著降低患者的生活质量。在撰写本文时,对早期HT缺乏有效的临床治疗。根据临床经验和结果分析,康佳汤颗粒(KDGs)在改善HT患者抗体水平和生活质量方面显示出良好的效果。然而,缺乏对kdg的有效性和安全性的进一步评价。目的:本先导研究旨在通过临床研究进一步了解和验证kdg治疗HT的有效性和安全性,全面评估该干预措施对患者的益处。方法:本研究为多中心、随机、双盲、安慰剂对照临床试验。符合HT诊断标准的参与者将被随机分配到干预组和对照组(n1=n2=70)。干预组将接受KDG治疗,而对照组将接受安慰剂治疗。所有参与者将接受为期3个月的治疗。抗甲状腺过氧化物酶抗体(TPOAb)水平的变化将是主要结果。次要结局包括抗甲状腺球蛋白抗体(TGAb)、促甲状腺素(又称促甲状腺激素(TSH))、三碘甲状腺原氨酸(T3)、甲状腺激素(T4)、血清游离三碘甲状腺原氨酸(FT3)、血清游离甲状腺素(FT4)、甲状腺超声检查、il - 17 mRNA和FOXP3 mRNA、中医证候疗效评分、生活质量量表评分。在整个治疗和随访期间,将监测安全指标,如血常规和尿常规、肝肾功能、心电图和主要不良反应。结果:研究方案和知情同意书于2022年12月14日获得上海中医药大学附属岳阳中西医结合医院临床研究伦理委员会批准(批准号:2022-123)。参与者招募于2023年6月开始。所有干预和同步数据收集活动计划于2025年10月完成。数据管理仍在进行中;因此,尚未进行数据分析。结论:本研究结果将为中药复方KDGs在调节HT患者外周免疫、降低自身免疫抗体水平、改善中医证候、提高生活质量等方面的疗效提供初步临床证据。这些结果将作为未来大规模试验设计的基础。试验注册:中国临床试验注册中心ChiCTR2300070184;https://www.chictr.org.cn/showprojEN.html?proj=189169.International注册报告标识符(irrid): DERR1-10.2196/80993。
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引用次数: 0
Development of a Mobile App (MyLepto App) to Improve Knowledge, Attitude, and Practice Regarding Leptospirosis Among Wet Market Workers in Selangor, Malaysia: Protocol for a Quasi-Experimental Study. 开发一款移动应用程序(MyLepto App),以提高马来西亚雪兰莪州菜市场工作人员对钩端螺旋体病的知识、态度和实践:一项准实验研究方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/75809
Mas Norehan Merican Aljunid Merican, Zaleha Md Isa, Rozita Hod, Roszita Ibrahim, Zamtira Seman, Rusdi Abd Rashid
<p><strong>Background: </strong>Leptospirosis is the most common zoonotic cause of mortality, with most of its burden occurring in tropical regions and low-income countries. It is endemic in Southeast and South Asian nations. Leptospirosis outbreaks occur after natural disasters. In Malaysia, the e-notification system of the Communicable Diseases Control Information System recorded 5217 leptospirosis cases in 2019 with 32 fatalities. The incidence rate was 15.61 per 100,000 people. Male individuals comprised 67% of leptospirosis cases, while people aged 25 to 55 years accounted for 45% of the cases. Information and perception are crucial in influencing positive behavior. Nonetheless, information on urban and rural people's knowledge, attitude, and practice (KAP) regarding the incidence of leptospirosis is limited.</p><p><strong>Objective: </strong>We aimed to develop a mobile app with information on leptospirosis and measure its effectiveness in improving KAP regarding leptospirosis among wet market workers in Selangor, Malaysia.</p><p><strong>Methods: </strong>A 3-phase study will be conducted and includes development of a mobile app containing information about leptospirosis, analysis of its acceptability, and application of the intervention. Participants will be recruited based on specific inclusion criteria by using purposive sampling. Four wet markets in Hulu Langat district, Selangor, will be selected according to a list provided by local municipal councils. The respondents from each selected wet market will be workers aged 18 years and older. Mobile app development will begin with an idea description, storyboard creation, and content approval through the nominal group technique. The mobile app content will be constructed using the Health Belief Model theory. Subsequently, the usability of the mobile app prototype will be evaluated using the validated Malay version of the System Usability Scale questionnaire for the evaluation of mobile apps. This protocol entails a 12-week intervention stage, in which the baseline assessment is regarded as a pretest evaluation and the follow-up assessment as a posttest evaluation. Participant selection will be based on the inclusion and exclusion criteria. This study will incorporate a set of validated questionnaires created by a group of leptospirosis experts. The validated questionnaire will comprise 9 sections with open-ended questions on sociodemographic data, KAP, and mobile app requirements.</p><p><strong>Results: </strong>Mobile app development and usability testing were completed between January 2024 and March 2025. Participant recruitment is scheduled in April to May 2025 after submission of this manuscript, with the 12-week intervention and data collection running from May to July 2025. As of manuscript submission, recruitment, data collection, and data analysis have not yet begun. Data analysis is expected to be completed by September 2025, and results are anticipated for publication in late 202
背景:钩端螺旋体病是最常见的人畜共患死亡原因,其负担大多发生在热带地区和低收入国家。它是东南亚和南亚国家的地方病。钩端螺旋体病发生在自然灾害之后。在马来西亚,传染病控制信息系统的电子通报系统在2019年记录了5217例钩端螺旋体病病例,其中32例死亡。发病率为每10万人15.61人。男性占钩端螺旋体病病例的67%,而年龄在25至55岁之间的人占45%。信息和感知是影响积极行为的关键。然而,关于城乡居民对钩端螺旋体病发病率的知识、态度和行为(KAP)的信息是有限的。目的:我们旨在开发一个带有钩端螺旋体病信息的移动应用程序,并衡量其在改善马来西亚雪兰莪州菜市场工作人员钩端螺旋体病的KAP方面的有效性。方法:将进行一项三期研究,包括开发包含钩端螺旋体病信息的移动应用程序,分析其可接受性和干预措施的应用。参与者将根据特定的纳入标准,采用有目的的抽样方法招募。雪兰莪州Hulu Langat区的四个菜市场将根据当地市政委员会提供的名单进行选择。每个选定菜市场的受访者都是年满18岁的工人。移动应用程序开发将从想法描述、故事板创建和通过名义上的小组技术的内容批准开始。使用健康信念模型理论构建移动应用程序内容。随后,将使用经过验证的马来语版本的系统可用性量表问卷来评估移动应用程序原型的可用性。该方案包括为期12周的干预阶段,其中基线评估被视为测试前评估,随访评估被视为测试后评估。参与者的选择将基于纳入和排除标准。这项研究将包括一组由钩端螺旋体病专家创建的有效问卷。经过验证的问卷将包括9个部分,其中包括关于社会人口统计数据、KAP和移动应用程序要求的开放式问题。结果:手机应用开发和可用性测试在2024年1月至2025年3月完成。本文提交后,计划于2025年4月至5月招募参与者,并于2025年5月至7月进行为期12周的干预和数据收集。截至稿件提交,招募、数据收集和数据分析尚未开始。数据分析预计将于2025年9月完成,结果预计将于2025年底公布。结论:由于雪兰莪州Hulu Langat地区报告的钩端螺旋体病病例较多,本干预研究将在那里进行。移动应用程序的开发可能有助于提高菜市场工作人员对钩端螺旋体病的认知。国际注册报告标识符(irrid): PRR1-10.2196/75809。
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引用次数: 0
Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study. 成人2型糖尿病合并代谢综合征的中医辨证:一项横断面研究方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/86217
Jialing Zhang, Hoi Ki Wong, Zhilin Lin, Shuyan Zhong, Minxia Ma, Xuejiao Wang

Background: The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce.

Objective: This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance.

Methods: This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression.

Results: This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025.

Conclusions: As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine.

Trial registration: ClinicalTrials.gov NCT06703684; https://clinicaltrials.gov/study/NCT06703684.

International registered report identifier (irrid): DERR1-10.2196/86217.

背景:2型糖尿病(T2DM)和代谢综合征(MetS)的全球负担持续上升,这些疾病显著增加了心血管疾病、残疾和死亡的风险。中医辨证论治是中医实践的基石,通过辨证论治来指导诊断和治疗。然而,关于T2DM合并MetS的中医证候模式的大规模研究仍然很少。目的:本横断面研究旨在描述T2DM和MetS人群的中医证候特征,并评估其诊断相关性。方法:这项横断面研究将招募470名诊断为T2DM和MetS的参与者。所有参与者都将接受全面的评估,包括T2DM和MetS的证候调查问卷、人口统计学和人体测量、生化分析(如空腹血糖、糖化血红蛋白和脂质面板)、饮食测量(食物频率调查问卷)、体育活动测量(国际体育活动问卷简表)、睡眠质量评估(匹兹堡睡眠质量指数)。生活质量评估(糖尿病依赖生活质量审计),卒中风险评估(Framingham卒中风险评分)和视网膜成像。潜在类分析将用于识别中医证型。采用因子分析方法识别核心中医证候因子。分层聚类分析将对中医证候要素进行分类,逻辑回归将检验辨证、代谢参数、生活方式因素和疾病进展之间的关系。结果:该试验于2024年11月17日注册。本研究的参与者招募于2024年11月开始。截至2025年10月,已招募了450多名符合条件的参与者并完成了数据收集。招聘计划于2025年12月31日结束。结论:作为第一个系统表征T2DM-MetS合并症中医辨证的大规模临床研究,本研究将建立与代谢参数、生活方式因素和疾病进展相关的证候谱。该研究结果有望为中医辨证纳入慢性病管理提供一个框架,最终有助于个性化治疗策略和改善中西医结合患者的预后。试验注册:ClinicalTrials.gov NCT06703684;https://clinicaltrials.gov/study/NCT06703684.International注册报告标识符(irrid): DERR1-10.2196/86217。
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引用次数: 0
Developing the Link-me+EMPHN Mental Health Model of Care to Improve General Practitioner Capacity for Mental Health Care in Australian Primary Care: Protocol for a Mixed Methods Formative Study. 发展Link-me+ empn心理健康护理模式以提高澳大利亚初级保健的全科医生心理健康护理能力:混合方法形成性研究的协议。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/79560
Amy Coe, Jane London, Anne-Marie Martin, Aaron van Ree, Kirsty Lembke, Caroline Johnson, Bridget Bassilios, Catherine Kaylor-Hughes
<p><strong>Background: </strong>The rising prevalence of mental health conditions continues to place significant pressure on general practitioners (GPs) and general practice. Despite their critical role in managing mental health conditions, GPs and practice staff face substantial barriers in providing effective mental health care, such as time and financial constraints. A new mental health model of care (Link-me+EMPHN) aimed at engaging and building capacity in GPs and practice staff for the provision of mental health services is being designed and implemented in a Primary Health region in Victoria, Australia.</p><p><strong>Objective: </strong>This protocol describes formative research that aims to support the implementation of the Link-me+EMPHN Mental Health Model of Care in general practice, focusing on identifying current gaps in GP mental health training, assessing barriers and facilitators to implementation, exploring stakeholder perceptions and experiences, and determining needs and priorities for successful integration into routine practice.</p><p><strong>Methods: </strong>The formative research involves a multimethod approach comprising (1) a desktop audit of currently available mental health training and guidelines for GPs; (2) up to 20 semistructured interviews with GPs and practice nurses; (3) an online survey exploring current mental health care practice of GPs and practice nurses; (4) two co-design workshops with people with lived experience of mental health care help-seeking in general practice and four expert working group workshops with a multidisciplinary primary-care team; and (5) testing of the model of care in a simulated practice setting with GPs, patients, and Care Navigators. The desktop audit, online survey, and interviews will be mapped to the Theoretical Domains Framework to systematically identify gaps in GP knowledge and skills in providing mental health care. Thematic analysis of the interviews will provide context for the gaps found in current mental health care and training so that we can begin to address these. Findings from each of the co-design, expert working group, and simulation sessions will be thematically analyzed and will include key themes, insights, and any practical implications.</p><p><strong>Results: </strong>The formative research received funding in May 2024, with the formative research components taking place from May 2024 to July 2025. As of June 24, 2025, a total of 5 people participated in co-design, 14 in semistructured interviews, 28 in simulation sessions, 30 completed the online survey, and 4 working groups have been held. The desktop audit yielded 270 results. The findings of the formative research are tentatively planned for publication in 2026.</p><p><strong>Conclusions: </strong>This formative research will generate a robust understanding of the factors influencing GP and practice engagement in mental health care and will provide practical solutions to improve implementation of the menta
背景:心理健康状况的患病率不断上升,继续给全科医生(gp)和全科实践带来巨大压力。尽管全科医生和执业人员在管理精神健康状况方面发挥着关键作用,但他们在提供有效的精神卫生保健方面面临着重大障碍,例如时间和资金限制。在澳大利亚维多利亚州的一个初级保健区,正在设计和实施一种新的精神卫生保健模式(Link-me+ epn),目的是使全科医生和执业人员参与并建立提供精神卫生服务的能力。目的:本协议描述了旨在支持在全科实践中实施Link-me+ empn心理健康护理模式的形成性研究,重点是确定全科医生心理健康培训的当前差距,评估实施的障碍和促进因素,探索利益相关者的看法和经验,并确定成功融入日常实践的需求和优先事项。方法:形成性研究涉及多方法方法,包括:(1)当前可用的心理健康培训和全科医生指南的桌面审计;(2)与全科医生和执业护士进行多达20次半结构化访谈;(3)开展全科医生和执业护士心理卫生服务现状在线调查;(4) 2次与有精神卫生保健全科求助生活经历的人共同设计工作坊,4次与多学科初级保健团队共同设计专家工作组工作坊;(5)在全科医生、患者和护理导航员的模拟实践环境中测试护理模型。桌面审计、在线调查和访谈将映射到理论领域框架,以系统地确定全科医生在提供精神卫生保健方面的知识和技能差距。对访谈进行专题分析将为当前精神卫生保健和培训中发现的差距提供背景,以便我们能够开始解决这些问题。每个共同设计、专家工作组和模拟会议的结果将进行主题分析,并将包括关键主题、见解和任何实际意义。结果:形成性研究于2024年5月获得资助,形成性研究组成部分在2024年5月至2025年7月进行。截至2025年6月24日,共5人参与协同设计,14人参与半结构化访谈,28人参与模拟会话,30人完成在线调查,4个工作组。桌面审计产生了270个结果。形成性研究的结果暂定于2026年发表。结论:这项形成性研究将对影响全科医生和精神卫生保健实践参与的因素产生强有力的理解,并将为改善精神卫生保健模式的实施提供切实可行的解决方案。这些发现将有助于创建一个可持续的、可扩展的模式,以改善患者的心理健康结果,并支持全科医生。国际注册报告标识符(irrid): DERR1-10.2196/79560。
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引用次数: 0
Developing a Culturally Adapted Digital Health Application for Older Hispanic Adults With Type 2 Diabetes: Protocol for a Qualitative and Pilot Study. 为老年西班牙裔2型糖尿病患者开发一种文化适应的数字健康应用程序:一项定性和试点研究的方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/76294
Joshua Caballero, Raymond L Ownby, Henry Nolan Young, Michelle B McElhannon, N M Mahmudul Alam Bhuiya, Kenny H Esho, Russ H Palmer
<p><strong>Background: </strong>Over 40% of Hispanic individuals have below basic health literacy levels, significantly impacting their ability to manage chronic conditions such as type 2 diabetes (T2D). Chronic disease self-management, essential for improving adherence, is often hindered by modifiable factors such as health literacy. Ambulatory care clinical (ACC) pharmacists, through comprehensive medication management (CMM), play a critical role in addressing these barriers; however, current methods for delivering CMM vary significantly, limiting effectiveness. Digital technology may offer significant potential for improving medication adherence, particularly among Hispanic individuals who use smartphones to seek health information.</p><p><strong>Objective: </strong>This study aims to revise, develop, and pilot test a culturally adapted, individually tailored digital health app designed to enhance health literacy and medication adherence among older Hispanic adults with T2D by integrating interactive educational modules into pharmacist-delivered CMM.</p><p><strong>Methods: </strong>Our team previously developed a prototype computer-delivered, culturally adapted intervention targeting health literacy and adherence among older Hispanic individuals. The proposed project involves transforming this intervention into a modernized digital health app. We will achieve 2 specific aims. The first aim is to refine and modernize previously developed content into an interactive digital health app suitable for older Hispanic adults with T2D and ACC pharmacists. A total of 20 patients and 10 ACC pharmacists will review and provide feedback on the app modules. Usability and acceptability will be measured using validated tools, including the System Usability Scale, Adjectival Ease of Use Scale, and the technology acceptance model. The second aim is to conduct a pilot test with 40 Hispanic adults (aged ≥50 years) diagnosed with T2D. Participants will be recruited from a local Federally Qualified Health Center where ACC pharmacists manage diabetes care. Patients will complete a baseline CMM session, interact with the app modules, and return for 1 or 2 CMM follow-up visits. We will assess medication adherence, hemoglobin A1c, and fasting glucose levels as primary outcomes.</p><p><strong>Results: </strong>The digital app has been modernized and completed for acceptability and usability testing. We will begin testing the hypothesis that the app will have above-average usability and acceptability (System Usability Scale: mean score ≥71 and Adjectival Ease of Use Scale: mean score ≥5), with an overall goal that the digital app will be acceptable (via the technology acceptance model) by ≥90% of the patient participants and ACC pharmacists. In addition, anticipated health outcomes for aim 2 include improvements in medication adherence (>80%), hemoglobin A1c (≥0.75% reduction), and fasting glucose (≥25% reduction) from baseline.</p><p><strong>Conclusions: </strong>When t
背景:超过40%的西班牙裔人的基本健康素养水平低于基本水平,这严重影响了他们管理2型糖尿病(T2D)等慢性疾病的能力。慢性病自我管理对于改善依从性至关重要,但往往受到卫生素养等可改变因素的阻碍。门诊临床(ACC)药师通过综合用药管理(CMM)在解决这些障碍方面发挥着关键作用;然而,目前提供CMM的方法差异很大,限制了有效性。数字技术可能为提高药物依从性提供巨大潜力,特别是在使用智能手机寻求健康信息的西班牙裔人群中。目的:本研究旨在修订、开发和试点测试一种适合文化的、个性化定制的数字健康应用程序,旨在通过将互动教育模块整合到药剂师提供的CMM中,提高西班牙裔老年T2D患者的健康素养和药物依从性。方法:我们的团队先前开发了一种计算机交付的原型,针对西班牙裔老年人的健康素养和依从性进行文化适应干预。拟议的项目涉及将这种干预转变为现代化的数字健康应用程序。我们将实现两个具体目标。第一个目标是将先前开发的内容完善和现代化,使其成为适合患有T2D和ACC药剂师的西班牙裔老年人的交互式数字健康应用程序。共有20名患者和10名ACC药剂师将对应用程序模块进行审查并提供反馈。可用性和可接受性将使用经过验证的工具进行测量,包括系统可用性量表、形容词易用性量表和技术接受模型。第二个目标是对40名诊断为T2D的西班牙裔成年人(年龄≥50岁)进行试点试验。参与者将从当地的联邦合格健康中心招募,ACC药剂师管理糖尿病护理。患者将完成基线CMM会话,与应用程序模块进行交互,并返回进行1或2次CMM随访。我们将评估药物依从性、糖化血红蛋白和空腹血糖水平作为主要结局。结果:数字化app已现代化并完成可接受性和可用性测试。我们将开始测试应用程序具有高于平均水平的可用性和可接受性的假设(系统可用性量表:平均分≥71分,形容词易用性量表:平均分≥5分),总体目标是数字应用程序将被≥90%的患者参与者和ACC药剂师接受(通过技术接受模型)。此外,目标2的预期健康结果包括药物依从性(>80%)、血红蛋白A1c(降低≥0.75%)和空腹血糖(降低≥25%)较基线的改善。结论:研究完成后,预计该文化适应性的数字健康应用程序将被患者和药剂师接受和使用。成功的结果将使改进后的应用程序得到更广泛的传播,并建立一个适用于其他慢性疾病、不同语言、文化和卫生保健环境的框架。
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引用次数: 0
Retrieving Transgender and Gender Diverse Literature: Protocol for the Development and Validation of 2 Search Hedges. 检索跨性别和性别多样性文献:2个搜索限制的开发和验证方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/76055
Chi Dinh, Zack Marshall, Scott Marsalis, Ryn Gagen, Preet Kang, Avery Everhart

Background: Searching for transgender and gender diverse (TGD) references within large academic databases can be a challenging process, partly due to the dynamic and diverse definitions of words and terminologies used by multiple interest holders. Search hedges are preestablished search strings that aid in the efficacy of identifying and screening relevant articles. Validated search hedges focused on TGD people and topics will aid in identifying relevant literature.

Objective: This study aims to develop and validate the sensitivity and precision of 2 interdisciplinary and cross-cultural TGD search hedges designed for retrieving references from MEDLINE and APA PsycInfo, both on the Ovid platform.

Methods: Searches were conducted using the finalized search hedges via Ovid on June 7, 2024, yielding 31,055 references from MEDLINE and 22,924 references from APA PsycInfo. A random sample of 2330 records from MEDLINE and 2293 records from APA PsycInfo will be independently screened by at least 2 team members. At the title and abstract screening stage, references will be excluded if they (1) use solely binary terminology to describe gender, (2) focus on psychometric measurement of gender, or (3) focus on intersex or differences of sex development (DSD) topics. References will be included if they (1) report on transgender or gender diverse people, or both, in their sample; or (2) specifically discuss TGD communities or TGD topics. References without an abstract will be categorized as No_Abstract. References in which the TGD population is unclear will be categorized as LGB_Maybe_T or Mixed_Topics. Only references in the No_Abstract, LGB_Maybe_T, or Mixed_Topics categories will proceed to the full-text screening phase. In the full-text screening phase, references will be categorized as included if they (1) clearly distinguish between sexual identity and gender identity, (2) mention or discuss TGD topics or experiences in the Methods or Results sections, (3) communicate consideration for participants' gender self-identification and experiences, or (4) consider TGD populations as a distinct subpopulation. The results of the screening process will be used to calculate precision and sensitivity, with a targeted sensitivity of 100% and a targeted precision of 76% for each search hedge.

Results: Validation and data analysis are projected to be finished by December 2025, with results expected to be published in 2026.

Conclusions: Rigorous and transparent knowledge synthesis processes, starting with a high-quality search hedge, can help inform and equip community members, clinicians, policymakers, and other key decision-makers with scientifically sound evidence.

International registered report identifier (irrid): DERR1-10.2196/76055.

背景:在大型学术数据库中搜索跨性别和性别多样性(TGD)参考文献可能是一个具有挑战性的过程,部分原因是多个兴趣持有人使用的单词和术语的动态和多样化定义。搜索对冲是预先建立的搜索字符串,有助于识别和筛选相关文章的功效。针对TGD人员和主题的有效搜索限制将有助于识别相关文献。目的:本研究旨在开发和验证两种跨学科和跨文化的TGD搜索限制语,用于检索Ovid平台上的MEDLINE和APA PsycInfo的文献。方法:于2024年6月7日在Ovid上使用最终的搜索对冲进行检索,从MEDLINE中获得31,055篇文献,从APA PsycInfo中获得22,924篇文献。随机抽取来自MEDLINE的2330条记录和来自APA PsycInfo的2293条记录,由至少2名团队成员独立筛选。在标题和摘要筛选阶段,如果参考文献(1)仅使用二元术语来描述性别,(2)专注于性别的心理测量,或(3)专注于双性人或性别发展差异(DSD)主题,则将被排除。如果他们(1)在他们的样本中报告了跨性别者或性别多样化者,或两者兼而有之,则将包括参考文献;或(2)专门讨论TGD社区或TGD主题。没有摘要的参考文献将被归类为No_Abstract。不清楚TGD人群的参考文献将被归类为LGB_Maybe_T或Mixed_Topics。只有No_Abstract、LGB_Maybe_T或Mixed_Topics类别中的引用才会进入全文筛选阶段。在全文筛选阶段,如果参考文献(1)明确区分性别认同和性别认同,(2)在方法或结果部分提及或讨论TGD主题或经验,(3)传达对参与者性别自我认同和经验的考虑,或(4)将TGD人群视为一个独特的亚群体,则将其归类为纳入。筛选过程的结果将用于计算精度和灵敏度,每个搜索对冲的目标灵敏度为100%,目标精度为76%。结果:预计2025年12月完成验证和数据分析,预计2026年公布结果。结论:严格和透明的知识合成过程,从高质量的搜索对冲开始,可以帮助社区成员、临床医生、政策制定者和其他关键决策者了解并掌握科学可靠的证据。国际注册报告标识符(irrid): DERR1-10.2196/76055。
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引用次数: 0
Interventions for Students' Well-Being at the University of Helsinki (INSIGHT): Protocol and Preliminary Descriptive Results for a Quasi-Experimental Controlled Trial of a Social Identity Intervention and Two Active Comparators. 赫尔辛基大学学生幸福感的干预措施(INSIGHT):社会认同干预和两个积极比较者的准实验对照试验的方案和初步描述性结果。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-23 DOI: 10.2196/79319
Silja Martikainen, Oona Karhunen, Iiris Mankki, Vera Gergov, Päivi Berg, Satu Venäläinen, Elisa Rissanen, Johanna Lammintakanen, Erkki Heinonen, Anu Lehtinen, Janna Pöntinen, Henna Asikainen, Nina Katajavuori, Outi Linnaranta, Milla Räisänen, Samuli Salminen, Jari Lahti

Background: University students' mental health problems are prevalent globally, which underlines the need for accessible and cost-effective mental health services in universities. Loneliness is a key risk factor for mental health problems, and it disproportionately affects students from minority backgrounds. Therefore, addressing loneliness and fostering inclusion and equality can be crucial strategies for enhancing students' well-being.

Objective: The aim of this study is to investigate a social-identity group intervention called Groups 4 Health (G4H) for university students' well-being using both quantitative and qualitative methods. Here, we present the research protocol and report preliminary descriptive findings from the study cohort.

Methods: The quantitative part of the study is a 4 parallel-arm nonrandomized controlled trial aiming to recruit 600 student participants from the University of Helsinki. The experimental group, which receives the G4H intervention, includes 5 group meetings held over a 7-week period. The experimental group will be compared with 2 active comparators: groups organized by the University of Helsinki study psychologists and a 7-week online intervention course focused on well-being and study skills, and to a no-intervention control group. The primary quantitative outcomes of the study are loneliness and depression; secondary outcomes include several measures of students' well-being, academic performance, and cost-effectiveness of the intervention. Quantitative data are collected before the intervention, during the intervention (at week 3), immediately post intervention (at week 7 after baseline), and at 1- and 3-month follow-ups. The qualitative part of the study explores the challenges and opportunities related to inclusion and equality identified in the G4H intervention using observations, interviews, and focus group discussions.

Results: In the preliminary findings based on the first data freeze in March 2025, we observed differences in the background characteristics between the trial arms, highlighting the need to address group selection bias. First results from the study are expected in 2026.

Conclusions: If proven effective, these interventions have significant potential to improve students' well-being in both short and long term, fostering mental health and supporting academic success and future career paths.

背景:大学生心理健康问题在全球普遍存在,这突出表明需要在大学提供可获得和具有成本效益的心理健康服务。孤独是心理健康问题的一个关键风险因素,对少数族裔学生的影响尤为严重。因此,解决孤独感、促进包容和平等是提高学生幸福感的关键战略。目的:本研究旨在运用定量和定性两种方法,探讨社会认同群体对大学生幸福感的干预——第四群体健康(G4H)。在这里,我们提出了研究方案,并报告了研究队列的初步描述性发现。方法:研究的定量部分是一个4平行组的非随机对照试验,旨在从赫尔辛基大学招募600名学生参与者。实验组接受G4H干预,包括在7周内举行的5次小组会议。实验组将与两个积极的比较组进行比较:由赫尔辛基大学研究心理学家组织的小组和一个为期7周的专注于幸福感和学习技能的在线干预课程,以及一个无干预的对照组。该研究的主要定量结果是孤独和抑郁;次要结果包括学生幸福感、学业成绩和干预的成本效益等几个指标。定量数据在干预前、干预期间(第3周)、干预后立即(基线后第7周)以及1个月和3个月随访时收集。本研究的定性部分通过观察、访谈和焦点小组讨论,探讨了与G4H干预措施中确定的包容和平等相关的挑战和机遇。在基于2025年3月第一次数据冻结的初步发现中,我们观察到试验组之间背景特征的差异,突出了解决群体选择偏倚的必要性。该研究的第一批结果预计将于2026年公布。结论:如果证明有效,这些干预措施在短期和长期内都有显著的潜力改善学生的幸福感,促进心理健康,支持学业成功和未来的职业道路。
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引用次数: 0
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