Pub Date : 2025-12-11DOI: 10.1002/14651858.CD016162
Dennis Vaidakis, Anastasia Bagiasta, Vasileios Sioulas, Dimitrios Giannakidis, Athanasios Saitis, Melina Nikolakea, Angeliki C Syristatidi, Michail Papapanou
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of pelvic floor muscle therapy for sexual dysfunction in gynaecological cancer survivors.
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Pub Date : 2025-12-11DOI: 10.1002/14651858.CD000512.pub3
Chad Andersen, Michael J Stark, Tara Crawford, Robin K Whyte, Axel R Franz, Roger F Soll, Haresh Kirpalani
<p><strong>Background: </strong>Infants of very low birthweight frequently receive red blood cell transfusions during their primary hospital stay. Generally, this is guided by predetermined haemoglobin or haematocrit thresholds according to a protocol or as prompted by clinical situations, including critical illness or surgery. Recommendations advocate maintaining higher thresholds in the early weeks when the risk of major morbidity is highest, while permitting lower thresholds after this time. In truth, clinicians worry about the potential effect of chronic anaemia on neurodevelopmental outcomes, as well as the risk of transfusion-related complications in the immature host. Clinical trials have reflected this practice by comparing haemoglobin levels adjusted for critical illness, comparing transfusion algorithms that use fixed differences between haemoglobin thresholds, with both thresholds progressively lowered across postnatal age. This is an update of a review first published in 2011.</p><p><strong>Objectives: </strong>To evaluate the effect of lower (restrictive) compared with higher (liberal) haemoglobin thresholds for transfusion, with or without adjustment for age and critical illness with either fixed or variable transfusion volume, on mortality or later neurodevelopmental outcomes assessed in later infancy at approximately two years postmenstrual age, or the number of transfusions in very low birthweight infants.</p><p><strong>Search methods: </strong>Searches were conducted in January 2024 in CENTRAL, MEDLINE, Embase, CINAHL, Epistemonikos, and trial registries. We searched the reference lists of related systematic reviews and trials.</p><p><strong>Selection criteria: </strong>We selected randomised controlled trials (RCTs) of lower or restrictive haemoglobin/haematocrit thresholds compared with liberal or higher haemoglobin/haematocrit thresholds for transfusion in low birthweight infants within three days of birth.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our main outcomes were a combined outcome of death or neurodevelopmental impairment, all-cause mortality, and the number of transfusions per infant. We expressed our results using mean difference (MD), standardised mean difference (SMD), risk ratio (RR), and risk difference (RD) with 95% confidence intervals (CIs). We used GRADE to assess the certainty of evidence.</p><p><strong>Main results: </strong>Six trials, enrolling 3451 infants, compared transfusion strategies utilising a lower (restrictive) haemoglobin threshold compared to a higher (liberal) haemoglobin threshold. The transfusion thresholds used in these trials reflected prevailing clinical practice at the time of study design. For comparative purposes, they have been labelled as 'restrictive' and 'liberal'. The trials were similar in design, although each used slightly different transfusion algorithms and intervention thresholds. The three larger trials also conducted later n
背景:出生体重极低的婴儿在初级住院期间经常接受红细胞输注。一般来说,这是由预先确定的血红蛋白或红细胞压积阈值根据协议或提示临床情况,包括危重疾病或手术。建议主张在主要发病风险最高的最初几周保持较高的阈值,而在此之后允许降低阈值。事实上,临床医生担心慢性贫血对神经发育结果的潜在影响,以及未成熟宿主输注相关并发症的风险。临床试验反映了这种做法,通过比较针对危重疾病调整的血红蛋白水平,比较使用血红蛋白阈值固定差异的输血算法,两种阈值随着出生年龄逐渐降低。这是对2011年首次发表的一篇综述的更新。目的:评价输血时较低(限制性)血红蛋白阈值与较高(自由)血红蛋白阈值的影响,无论是否调整年龄和固定或可变输血量的危重疾病,对大约2岁后婴儿的死亡率或后期神经发育结局评估,或对极低出生体重婴儿的输血次数评估。检索方法:检索于2024年1月在CENTRAL、MEDLINE、Embase、CINAHL、Epistemonikos和试验注册中心进行。我们检索了相关系统综述和试验的参考文献列表。选择标准:我们选择了低出生体重婴儿出生3天内输血时较低或限制性血红蛋白/红细胞压积阈值与自由或较高血红蛋白/红细胞压积阈值的随机对照试验(rct)。资料收集与分析:采用标准Cochrane方法。我们的主要结局是死亡或神经发育障碍、全因死亡率和每个婴儿输血次数的综合结局。我们使用95%置信区间(ci)的平均差(MD)、标准化平均差(SMD)、风险比(RR)和风险差(RD)来表达我们的结果。我们使用GRADE来评估证据的确定性。主要结果:6项试验,纳入3451名婴儿,比较了使用较低(限制性)血红蛋白阈值与较高(自由)血红蛋白阈值的输血策略。这些试验中使用的输血阈值反映了研究设计时的主流临床实践。出于比较的目的,他们被贴上了“限制性”和“自由”的标签。这些试验在设计上是相似的,尽管每个试验使用的输血算法和干预阈值略有不同。三个更大的试验还进行了后来的神经感觉评估。纳入结果计算的婴儿数量因住院与出院后结果、评估方法和排除标准而异,我们的分析使用了原始出版物中报告的分母。总的来说,使用较低的血红蛋白输血阈值与较高的血红蛋白输血阈值相比,在月经后18至26个月的死亡或神经发育障碍的综合结局方面几乎没有差异(RR 1.02, 95% CI 0.95至1.09;I2 = 55%; RD 0.01, 95% CI -0.03至0.04;3项研究,3041名婴儿;高确定性证据)。18至26个月的死亡率也无差异(RR 0.99, 95% CI 0.83至1.17;I2 = 0%; RD -0.00, 95% CI -0.03至0.02;I2 = 0%; 3项研究,3186名婴儿;高确定性证据)。分配到限制性阈值的婴儿可能在初级住院期间接受较少的输血(每个婴儿输血次数的平均差异为-1.05,95% CI为-1.26至-0.84;I2 = 84%; 6项研究,3451名婴儿;低确定性证据)。作者的结论是:比较输血时较低或限制性血红蛋白阈值与较高或自由血红蛋白阈值的试验显示,出院时和后来神经发育随访时的重要结果几乎没有差异。在这些试验中,与自由输血相比,在极低出生体重婴儿中使用限制性血红蛋白或红细胞压度输血阈值可导致输血暴露和血红蛋白水平的适度降低。血红蛋白水平低于这些下限的安全性尚未得到评估,仅应在随机对照试验的背景下考虑。
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Pub Date : 2025-12-11DOI: 10.1002/14651858.CD014794.pub2
Elizabeth Kristjansson, Michael Dignam, Anita Rizvi, Muna Osman, Olivia Magwood, Deborah Olarte, Juliana Fw Cohen, Julia Krasevec, Tanya Grover, Patrick R Labelle, Jennifer A Garner, Laura Janzen, Sydney Rossiter, Omar Dewidar, Beverley Shea, Vivian Welch, George A Wells
<p><strong>Rationale: </strong>School feeding aims to alleviate hunger and enhance child outcomes. Since the first Cochrane systematic review of school meals, there has been a marked increase in studies and reviews of school feeding programs. However, most systematic reviews are geographically limited and use qualitative analysis. We reviewed worldwide papers and performed several meta-analyses, providing a more comprehensive picture of the effectiveness of school feeding.</p><p><strong>Objectives: </strong>1. To assess effectiveness of school feeding programs for improving the physical and psychological health of children experiencing socioeconomic disadvantage worldwide. 2. To assess effectiveness of school feeding programs for improving the health of children experiencing socioeconomic disadvantage compared with children who are more advantaged.</p><p><strong>Search methods: </strong>We searched 17 subject-specific and multidisciplinary databases and registries up to November 2023. In November 2024, two Information Specialists ran a top-up search for randomized controlled trials (RCTs). We handsearched references of included studies and relevant reviews.</p><p><strong>Eligibility criteria: </strong>We included individually randomized, cluster-randomized, and cross-over trials, as well as longitudinal non-randomized studies of interventions (NRSIs). Studies had to compare the provision of free or reduced-price food in schools versus no school feeding, focusing on socioeconomically disadvantaged children. The food had to contain at least 3% of the daily energy requirement and at least 10% of the daily protein requirement for the specified age group(s). Eligible participants were primary or secondary school students aged five to 19 years.</p><p><strong>Outcomes: </strong>Our critical outcomes were change in: math achievement, reading achievement, attendance, enrollment, height-for-age z-score (HAZ), weight-for-age z-score (WAZ), and overweight/obesity. Our important outcomes were change in: overall academic achievement, fluid intelligence, working memory, behavioral/emotional outcomes, height, weight, and anemia. We planned to study changes between baseline and final outcomes. In one study with extreme contamination, we used the first follow-up.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias for RCTs by outcome using the appropriate version of the Cochrane risk of bias tool (RoB 2): RoB 2 for individually randomized trials, for cluster-RCTs, and for cross-over trials. We evaluated the quality of NRSIs using the School-based Measurement & Assessment of Results Tool (SMART), which is adapted from the Newcastle Ottawa Scale.</p><p><strong>Synthesis methods: </strong>We used standardized mean differences (SMDs) with 95% confidence intervals (CIs) for educational and cognitive outcomes. We used mean differences (MDs), odds ratios (ORs), or incidence rate ratios (IRRs) for others. All meta-analyses used random-effects generic inverse
理由:学校供餐旨在减轻饥饿和提高儿童的学业成绩。自从Cochrane首次对学校膳食进行系统评估以来,对学校供餐计划的研究和评估显著增加。然而,大多数系统综述在地理上是有限的,并且使用定性分析。我们回顾了世界各地的论文,并进行了几项荟萃分析,为学校供餐的有效性提供了更全面的图景。目的:1。评估学校供餐计划在改善全球处于社会经济劣势的儿童身心健康方面的有效性。2. 评估学校供餐计划在改善社会经济劣势儿童与社会经济优势儿童健康方面的有效性。检索方法:我们检索了截至2023年11月的17个特定学科和多学科数据库和注册库。2024年11月,两位信息专家对随机对照试验(rct)进行了补充搜索。我们手工检索了纳入研究的参考文献和相关综述。入选标准:我们纳入了单独随机、集群随机和交叉试验,以及纵向非随机干预研究(NRSIs)。研究必须比较学校提供免费或减价食品与不提供学校供餐的情况,重点关注社会经济上处于不利地位的儿童。食物必须含有指定年龄组每日所需能量的至少3%及每日所需蛋白质的至少10%。合资格的参与者为5至19岁的小学生或中学生。结果:我们的关键结果是:数学成绩、阅读成绩、出勤、入学、身高年龄z分数(HAZ)、体重年龄z分数(WAZ)和超重/肥胖的变化。我们的重要结果是:总体学业成绩、流体智力、工作记忆、行为/情绪结果、身高、体重和贫血。我们计划研究基线和最终结果之间的变化。在一项严重污染的研究中,我们使用了第一次随访。偏倚风险:我们使用适当版本的Cochrane偏倚风险工具(RoB 2)通过结果评估rct的偏倚风险:单独随机试验、集群rct和交叉试验的RoB 2。我们使用基于学校的结果测量和评估工具(SMART)来评估nsis的质量,该工具改编自纽卡斯尔渥太华量表。综合方法:我们使用标准化平均差异(SMDs)和95%置信区间(ci)来衡量教育和认知结果。我们使用平均差异(md)、优势比(ORs)或发病率比(IRRs)来分析其他指标。所有荟萃分析均采用随机效应一般逆方差。我们按性别和社会经济地位进行了公平亚组分析。我们使用GRADE来评估我们对随机对照试验中报告的关键结局证据的信心。纳入的研究:我们纳入了40项研究和83份报告。共有13项随机对照试验(12项集群随机试验和1项单独随机试验)和27项nrsi。大多数研究(34项)来自低收入和中等收入国家。总共有超过91,885名学生(有四项研究没有报告样本量)。其中一项研究涉及59,613名学生,而其他研究涉及60至6038名学生。这些研究包括48个结果;我们荟萃分析或报道了14例。结果综合:低收入和中等收入国家(LMICs)学校供餐与没有学校供餐相比,数学成绩略有提高(SMD 0.14, 95% CI 0.06至0.23;P = 0.001; I²= 68%;6个集群rct, 5587名参与者;高确定性证据),但对阅读成绩可能几乎没有影响(SMD 0.02, 95% CI -0.06至0.11;P = 0.61; I2 = 54%; 3个集群rct, 3417名参与者;低确定性证据)。学校供餐计划导致入学率略有增加(MD增加3.44%,95% CI 0.83至6.04;P = 0.01; I²= 0%;2组随机对照试验,5200名参与者,高确定性证据),但可能对出勤率几乎没有影响(MD 0.17%, 95% CI -2.64%至2.97%;P = 0.91; I2 = 81%; 3组随机对照试验,3566名参与者,低确定性证据)。学校供餐计划可能导致HAZ (MD 0.06, 95% CI 0.03至0.09;P < 0.001; I2 = 0%; 2组随机对照试验,3678名参与者;中等确定性证据)和WAZ (MD 0.08, 95% CI 0.05至0.12;P < 0.001; I2 = 0%; 3组随机对照试验,2132名参与者;中等确定性证据)略有增加。两组随机对照试验评估了肥胖/超重的变化。一项为期10个月的研究发现,与对照组青少年相比,接受校餐的青少年超重/肥胖的几率低53% (OR 0.47, 95% CI 0.30至0.72)。另一项研究发现,在干预前后没有超重/肥胖病例。这些发现的确定性很低。 一些研究人员遇到了他们无法控制的实施问题,包括冲突、延误和官僚决策。背景、结果、儿童群体和统计数据的异质性是本综述的局限性。高收入国家(HICs)一个NRSI发现了非常不确定的证据,即与对照组的儿童相比,被分配到早餐俱乐部的儿童平均出勤率提高了1.6%以上。性别和社会经济地位的公平性(亚组)分析均不显著。每个亚组分析中只有两项研究;他们可能动力不足。作者的结论是:在中低收入国家,学校供餐计划导致数学成绩略有提高,但可能对阅读成绩几乎没有影响。学校供餐计划导致入学人数略有增加,但可能对出勤率几乎没有影响。他们可能会导致HAZ和WAZ的轻微增加。学校供餐和超重/肥胖之间可能几乎没有联系,但证据非常不确定。我们建议研究人员和决策者将研究视为实施过程的一个组成部分。为了减少结果的异质性,我们建议加强研究的协调,研究人员和利益相关者共同努力确定一组核心结果。资助:作者要感谢以下捐助方的慷慨支持,使本次审查成为可能:迪拜关怀,世界粮食计划署的学校膳食和社会保护服务,以及学校健康和营养研究联盟。注册:议定书(2022):https://doi.org/10.1002/14651858.CD014794原始审查(2007):https://doi.org/10.1002/14651858.CD004676.pub2原始坎贝尔议定书(2006):doi.org/10.1002/CL2.12。
{"title":"School feeding programs for improving the physical and psychological health of school children experiencing socioeconomic disadvantage.","authors":"Elizabeth Kristjansson, Michael Dignam, Anita Rizvi, Muna Osman, Olivia Magwood, Deborah Olarte, Juliana Fw Cohen, Julia Krasevec, Tanya Grover, Patrick R Labelle, Jennifer A Garner, Laura Janzen, Sydney Rossiter, Omar Dewidar, Beverley Shea, Vivian Welch, George A Wells","doi":"10.1002/14651858.CD014794.pub2","DOIUrl":"10.1002/14651858.CD014794.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>School feeding aims to alleviate hunger and enhance child outcomes. Since the first Cochrane systematic review of school meals, there has been a marked increase in studies and reviews of school feeding programs. However, most systematic reviews are geographically limited and use qualitative analysis. We reviewed worldwide papers and performed several meta-analyses, providing a more comprehensive picture of the effectiveness of school feeding.</p><p><strong>Objectives: </strong>1. To assess effectiveness of school feeding programs for improving the physical and psychological health of children experiencing socioeconomic disadvantage worldwide. 2. To assess effectiveness of school feeding programs for improving the health of children experiencing socioeconomic disadvantage compared with children who are more advantaged.</p><p><strong>Search methods: </strong>We searched 17 subject-specific and multidisciplinary databases and registries up to November 2023. In November 2024, two Information Specialists ran a top-up search for randomized controlled trials (RCTs). We handsearched references of included studies and relevant reviews.</p><p><strong>Eligibility criteria: </strong>We included individually randomized, cluster-randomized, and cross-over trials, as well as longitudinal non-randomized studies of interventions (NRSIs). Studies had to compare the provision of free or reduced-price food in schools versus no school feeding, focusing on socioeconomically disadvantaged children. The food had to contain at least 3% of the daily energy requirement and at least 10% of the daily protein requirement for the specified age group(s). Eligible participants were primary or secondary school students aged five to 19 years.</p><p><strong>Outcomes: </strong>Our critical outcomes were change in: math achievement, reading achievement, attendance, enrollment, height-for-age z-score (HAZ), weight-for-age z-score (WAZ), and overweight/obesity. Our important outcomes were change in: overall academic achievement, fluid intelligence, working memory, behavioral/emotional outcomes, height, weight, and anemia. We planned to study changes between baseline and final outcomes. In one study with extreme contamination, we used the first follow-up.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias for RCTs by outcome using the appropriate version of the Cochrane risk of bias tool (RoB 2): RoB 2 for individually randomized trials, for cluster-RCTs, and for cross-over trials. We evaluated the quality of NRSIs using the School-based Measurement & Assessment of Results Tool (SMART), which is adapted from the Newcastle Ottawa Scale.</p><p><strong>Synthesis methods: </strong>We used standardized mean differences (SMDs) with 95% confidence intervals (CIs) for educational and cognitive outcomes. We used mean differences (MDs), odds ratios (ORs), or incidence rate ratios (IRRs) for others. All meta-analyses used random-effects generic inverse","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD014794"},"PeriodicalIF":8.8,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12695400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145721454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-10DOI: 10.1002/14651858.CD016277
Diego Ivaldi, Mariana Andrea Burgos, Sabrina Rico, Lucia B Varela, Samanta Díaz Menai, Camila Micaela Escobar Liquitay, Luis I Garegnani
Objectives: This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the accuracy of Evan's blue dye test (EBDT) and modified Evan's blue dye test (MEBDT) for detecting respiratory aspiration in tracheostomized patients. This could be useful for detecting patients ready to undergo decannulation and for deciding the feeding mode for patients in low-resource settings. Secondary objectives To investigate potential sources of heterogeneity due to different dyeing sources and reference standards.
{"title":"Evan's blue dye test for detection of aspiration in tracheostomized patients.","authors":"Diego Ivaldi, Mariana Andrea Burgos, Sabrina Rico, Lucia B Varela, Samanta Díaz Menai, Camila Micaela Escobar Liquitay, Luis I Garegnani","doi":"10.1002/14651858.CD016277","DOIUrl":"10.1002/14651858.CD016277","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the accuracy of Evan's blue dye test (EBDT) and modified Evan's blue dye test (MEBDT) for detecting respiratory aspiration in tracheostomized patients. This could be useful for detecting patients ready to undergo decannulation and for deciding the feeding mode for patients in low-resource settings. Secondary objectives To investigate potential sources of heterogeneity due to different dyeing sources and reference standards.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD016277"},"PeriodicalIF":8.8,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12690626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145713551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Background: </strong>Glaucoma is the leading cause of irreversible blindness globally, and the second leading cause of blindness in high-income countries. It is a chronic optic nerve disease that can lead to loss of vision, although it is usually asymptomatic until it progresses (worsens) to an advanced stage. Primary open angle glaucoma (POAG) is the most common type of glaucoma, and it is recognized as a multifactorial disorder. Pseudoexfoliative glaucoma (PXFG) is a common form of secondary open-angle glaucoma and has a higher rate of progression. The understanding of prognostic factors is useful for clinicians to estimate the risk of disease progression and to identify those who are at risk of losing sight early.</p><p><strong>Objectives: </strong>To identify risk factors associated with disease progression, defined as worsening or deterioration of functional visual outcomes and/or structural outcomes, amongst adults with POAG and PXFG.</p><p><strong>Search methods: </strong>We searched CENTRAL, Ovid MEDLINE, Ovid Embase, and two trial registries on 15 August 2024. The search was supplemented by checking reference lists of eligible articles. We did not apply any restrictions on language or year of publication.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials, cohort, and case-control study designs. We excluded any study with less than two years of follow-up and a sample size of < 200. The targeted population consisted of adults ≥ 18 years of age of any sex with glaucoma type restricted to POAG, normal-tension glaucoma (NTG), and PXFG and no previous glaucoma surgery. Two review authors independently screened titles and abstracts, and full-text articles, to determine eligibility. The discrepancies were resolved through discussion with a third reviewer. The time points for the evaluation of outcomes were at a minimum of two years of follow-up.</p><p><strong>Data collection and analysis: </strong>Two review authors independently extracted data from included studies using pre-piloted data extraction forms in Covidence, SRDR+ and Microsoft Excel. We used the Quality in Prognosis Studies (QUIPS) tool to assess the risk of bias in Covidence. We conducted meta-analyses where homogeneous outcomes were reported, using a random-effects, generic inverse variance model. We reported hazard ratios (HR), odds ratio (OR), and risk ratios (RR) separately for each available prognostic factor and outcome, stratified by different time points and multivariable or univariable prognostic estimates, where possible. We evaluated and reported the certainty of evidence using the GRADE guidelines.</p><p><strong>Main results: </strong>We screened 16,188 titles and abstracts and retrieved 487 full-text reports from 239 studies for assessment. After full-text screening, we included 123 reports of 22 studies in this review. The 22 studies included 6082 participants. The mean ages of participants ranged from 50 to 78 years across
背景:青光眼是全球不可逆失明的主要原因,也是高收入国家第二大致盲原因。这是一种慢性视神经疾病,可导致视力丧失,尽管在进展(恶化)到晚期之前通常无症状。原发性开角型青光眼(POAG)是最常见的青光眼类型,被认为是一种多因素疾病。假剥脱性青光眼(PXFG)是继发性开角型青光眼的一种常见形式,具有较高的进展率。对预后因素的了解有助于临床医生估计疾病进展的风险,并识别那些有早期失明风险的人。目的:在成年POAG和PXFG患者中,确定与疾病进展相关的危险因素,定义为功能性视觉结果和/或结构结果的恶化或恶化。检索方法:我们于2024年8月15日检索了CENTRAL、Ovid MEDLINE、Ovid Embase和两个试验注册中心。通过检查符合条件的文章的参考文献列表来补充搜索。我们没有对语言或出版年份施加任何限制。选择标准:我们包括随机对照试验、队列和病例对照研究设计。我们排除了任何随访时间少于2年且样本量< 200人的研究。目标人群包括年龄≥18岁的成年人,任何性别,青光眼类型仅限于POAG,正常眼压青光眼(NTG)和PXFG,并且没有青光眼手术史。两位综述作者独立筛选标题和摘要,以及全文文章,以确定合格性。通过与第三位审稿人的讨论解决了这些差异。评估结果的时间点至少为两年的随访。数据收集和分析:两位综述作者使用covid - ence、SRDR+和Microsoft Excel中的预先导数据提取表格独立地从纳入的研究中提取数据。我们使用预后质量研究(QUIPS)工具来评估冠状病毒的偏倚风险。我们使用随机效应、通用逆方差模型进行了荟萃分析,报告了均质结果。我们分别报告了每个可用预后因素和结果的风险比(HR)、优势比(OR)和风险比(RR),并尽可能按不同时间点和多变量或单变量预后估计进行分层。我们使用GRADE指南评估并报告了证据的确定性。主要结果:我们筛选了16188篇标题和摘要,从239篇研究中检索了487篇全文报告进行评估。经过全文筛选,我们纳入了22项研究的123篇报道。这22项研究包括6082名参与者。研究参与者的平均年龄从50岁到78岁不等。其中16项研究仅使用视野(VF)恶化来检测和测量青光眼的进展。在六项研究中,通过功能和结构结果评估疾病进展(例如,通过光谱域光学相干断层扫描检测视网膜神经纤维层厚度变化)。我们判断22项纳入研究中的19项(86%)总体上具有高偏倚风险。我们发现一些预后因素与进展有一致的关系。具体来说,椎间盘出血的存在(校正HR 2.03, 95% CI 1.55至2.67,1068名受试者,3项研究;未校正HR 1.51, 95% CI 1.12至2.02,961名受试者,3项研究;低确定性),双侧疾病的存在(校正HR 1.77, 95% CI 1.35至2.32,771名受试者,2项研究;中等确定性),以及青光眼的治疗(校正HR 0.44, 95% CI 0.31至0.61,961名受试者,3项研究;未校正HR 0.56, 95% CI 0.44至0.72,771,2项研究,低确定性)。其余因素与青光眼进展的预后相关性证据不一,其中包括一些根据其他文献预计很重要的因素。关于基线时的眼压(IOP),我们对HR的荟萃分析有足够的证据表明有影响(调整后的HR为1.08,95% CI为1.03至1.13,913名参与者,3项研究,低确定性),而OR没有(调整后的OR为0.96,95% CI为0.84至1.10,458名参与者,2项研究,低确定性),超过一半的报告IOP的研究没有发现影响的证据。同样,基线年龄每增加1年的合并调整风险比为1.01 (95% CI 0.97 - 1.05; 865名参与者,4项研究),证据的确定性非常低,研究对其与进展的关联得出了不同的结果。关于性别,两项研究的合并调整分析表明,女性的进展风险可能比男性高64% (HR 1.64, 95% CI 1.15至2.34;961,3项研究;低确定性)。然而,其他对性别的研究估计在影响方向上是混合的。 我们没有发现一致的证据表明角膜中央厚度(调整后的风险比1.13,95% CI 0.85至1.51,425名受试者,2项研究;未调整的风险比1.00,95% CI 1.00至1.00,706名受试者,2项研究,非常低的确定性)、全体性高血压(调整后的风险比1.33,95% CI 0.68至2.60,731名受试者,3项研究;未调整的风险比0.89,95% CI 0.67至1.17,771名受试者,2项研究;极低确定性)、心血管疾病(调整后的相对危险度1.06,95% CI 0.75至1.49,771名受试者,2项研究;低确定性)、偏头痛(未调整的相对危险度1.06,95% CI 0.75至1.49,961名受试者,3项研究;极低确定性)或雷诺综合征(未调整的相对危险度1.21,95% CI 0.85至1.73,961名受试者,3项研究;极低确定性)对视野进展有影响。作者的结论:有中等确定性的证据支持双侧疾病是与青光眼患者VF进展相关的预后因素。有低确定性证据表明,女性和椎间盘出血的存在与进展有关,而药物治疗对进展有保护作用。证据不确定进展与我们确定的所有其他预后因素之间的关系。未来需要适当设计预后因素的研究。资助:NIH (NEI: UG1EY020522), USA;HRB、爱尔兰;HSC PHA (CBES-2018-001),爱尔兰注册:协议可在doi.org/10.1002/14651858.CD015436获得。
{"title":"Prognostic factors associated with progression of open-angle glaucoma in adults.","authors":"Mapa Prabhath Piyasena, Qëndresë Daka, Riaz Qureshi, Gloria Roberti, Manuele Michelessi, Su-Hsun Liu, Tianjing Li, Yemisi Takwoingi, Augusto Azuara-Blanco, Gianni Virgili","doi":"10.1002/14651858.CD015436.pub2","DOIUrl":"10.1002/14651858.CD015436.pub2","url":null,"abstract":"<p><strong>Background: </strong>Glaucoma is the leading cause of irreversible blindness globally, and the second leading cause of blindness in high-income countries. It is a chronic optic nerve disease that can lead to loss of vision, although it is usually asymptomatic until it progresses (worsens) to an advanced stage. Primary open angle glaucoma (POAG) is the most common type of glaucoma, and it is recognized as a multifactorial disorder. Pseudoexfoliative glaucoma (PXFG) is a common form of secondary open-angle glaucoma and has a higher rate of progression. The understanding of prognostic factors is useful for clinicians to estimate the risk of disease progression and to identify those who are at risk of losing sight early.</p><p><strong>Objectives: </strong>To identify risk factors associated with disease progression, defined as worsening or deterioration of functional visual outcomes and/or structural outcomes, amongst adults with POAG and PXFG.</p><p><strong>Search methods: </strong>We searched CENTRAL, Ovid MEDLINE, Ovid Embase, and two trial registries on 15 August 2024. The search was supplemented by checking reference lists of eligible articles. We did not apply any restrictions on language or year of publication.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials, cohort, and case-control study designs. We excluded any study with less than two years of follow-up and a sample size of < 200. The targeted population consisted of adults ≥ 18 years of age of any sex with glaucoma type restricted to POAG, normal-tension glaucoma (NTG), and PXFG and no previous glaucoma surgery. Two review authors independently screened titles and abstracts, and full-text articles, to determine eligibility. The discrepancies were resolved through discussion with a third reviewer. The time points for the evaluation of outcomes were at a minimum of two years of follow-up.</p><p><strong>Data collection and analysis: </strong>Two review authors independently extracted data from included studies using pre-piloted data extraction forms in Covidence, SRDR+ and Microsoft Excel. We used the Quality in Prognosis Studies (QUIPS) tool to assess the risk of bias in Covidence. We conducted meta-analyses where homogeneous outcomes were reported, using a random-effects, generic inverse variance model. We reported hazard ratios (HR), odds ratio (OR), and risk ratios (RR) separately for each available prognostic factor and outcome, stratified by different time points and multivariable or univariable prognostic estimates, where possible. We evaluated and reported the certainty of evidence using the GRADE guidelines.</p><p><strong>Main results: </strong>We screened 16,188 titles and abstracts and retrieved 487 full-text reports from 239 studies for assessment. After full-text screening, we included 123 reports of 22 studies in this review. The 22 studies included 6082 participants. The mean ages of participants ranged from 50 to 78 years across ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015436"},"PeriodicalIF":8.8,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12694756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145721471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-10DOI: 10.1002/14651858.CD013733.pub3
Rebecca Calthorpe, Sherie Smith, Nikki Jahnke, Alan R Smyth
<p><strong>Rationale: </strong>Improved understanding and treatment of cystic fibrosis (CF) has led to longer life expectancy, which is accompanied by an increasingly complex regimen of treatments. Suboptimal adherence to the treatment plan, in the context of respiratory disease, is associated with poorer health outcomes. With digital technology being more accessible, it can be used to monitor adherence to inhaled therapies via chipped nebulisers, mobile phone applications and web-based platforms. This technology can allow monitoring of adherence, as well as clinical outcomes, and allow feedback to both the person with CF and their healthcare team.</p><p><strong>Objectives: </strong>To assess the effects of using digital technology to monitor adherence to inhaled therapies and health status in adults and children with CF.</p><p><strong>Search methods: </strong>We searched the Cochrane CF Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched Embase and three clinical trial registries, and checked the references of included studies. The date of last search was 27 February 2025.</p><p><strong>Eligibility criteria: </strong>We searched for randomised controlled trials (RCTs) looking at the effects of digital technology for monitoring adherence to inhaled therapies of children and adults with CF.</p><p><strong>Outcomes: </strong>We assessed available data (at up to three months in one study, and up to 12 months in the second) for adherence to the inhaled treatment, treatment burden, quality of life (QoL) and the change from baseline in forced expiratory volume in one second (FEV<sub>1</sub>). We assessed the number of pulmonary exacerbations by the end of each study.</p><p><strong>Risk of bias: </strong>Using Cochrane's Risk of Bias 2 tool, we assessed the risk of bias within each of the included trials and for each outcome from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome and selection of the reported result.</p><p><strong>Synthesis methods: </strong>Two review authors screened the search results for studies eligible for inclusion in the review and extracted their data. Due to the difference in the studies' interventions, we analysed the data separately. We assessed the overall certainty of the evidence using GRADE.</p><p><strong>Included studies: </strong>We included two studies with 628 participants aged five to 41 years. There was one study in each of two different comparisons.</p><p><strong>Synthesis of results: </strong>Nebuliser target inhalation mode versus standard inhalation mode One parallel study was carried out over 10 weeks after a run-in period of four to six weeks. The study compared the effects of a digitally enhanced inhalation mode (target inhalation mode) for nebulised antibiotics compared to standard mode in children attending a regional CF clinic in the UK. The primary outcome
理由:对囊性纤维化(CF)的理解和治疗的提高导致了预期寿命的延长,这伴随着越来越复杂的治疗方案。在呼吸系统疾病的情况下,对治疗计划的不理想依从性与较差的健康结果相关。随着数字技术更容易获得,它可以通过芯片雾化器、手机应用程序和网络平台来监测吸入疗法的依从性。这项技术可以监测依从性和临床结果,并允许向CF患者及其医疗团队提供反馈。目的:评估使用数字技术监测成人和儿童CF患者吸入治疗依从性和健康状况的效果。检索方法:我们检索了Cochrane CF试验注册表,该注册表由电子数据库检索和手工检索期刊和会议摘要书籍汇编而成。我们还检索了Embase和三个临床试验注册库,并检查了纳入研究的参考文献。最后一次搜索日期是2025年2月27日。入选标准:我们检索了随机对照试验(RCTs),研究数字技术对监测儿童和成人慢性阻塞性肺病患者吸入治疗依从性的影响。结果:我们评估了吸入治疗依从性、治疗负担、生活质量(QoL)和一秒钟用力呼气量(FEV1)从基线变化的可用数据(一项研究长达3个月,另一项研究长达12个月)。在每项研究结束时,我们评估了肺恶化的数量。偏倚风险:使用Cochrane's Risk of bias 2工具,我们评估了每个纳入的试验和随机化过程的每个结果的偏倚风险、预期干预的偏差、缺失的结果数据、结果的测量和报告结果的选择。综合方法:两位综述作者筛选符合纳入综述的研究的搜索结果并提取其数据。由于研究干预的差异,我们对数据进行了单独分析。我们使用GRADE评估证据的总体确定性。纳入的研究:我们纳入了两项研究,共有628名参与者,年龄在5至41岁之间。在两种不同的比较中,每一种都有一项研究。一项平行研究在4至6周的磨合期后进行,为期10周。该研究比较了数字增强吸入模式(目标吸入模式)对雾化抗生素的效果,与在英国参加区域性CF诊所的儿童的标准模式相比。主要结果是完成吸入治疗所需的时间,但研究作者也报告了治疗的依从性。结果显示,采用目标吸入模式可改善依从性(平均差值(MD) 24.0%, 95%可信区间(CI) 2.95 ~ 45.05;1项研究,20名参与者;确定性的证据)。目标吸入方式可能对预测的FEV1 %影响很小或没有影响(MD 1.00%, 95% CI -9.37至11.37;1项研究,20名受试者;低确定性证据)。该研究未报告治疗负担、生活质量或肺恶化。由于样本量小,我们降低了证据的确定性,因为不精确,而且由于研究是在儿童中进行的,结果可能不适用于成人,因此我们降低了证据的间接性。一项大型多中心随机对照试验通过数据跟踪雾化器监测了12个月的依从性。干预组还可以访问基于网络的在线平台CFHealthHub,该平台提供研究作者量身定制的灵活支持,以及他们的依从性数据、教育和解决问题的信息。与常规治疗相比,数字干预可能提高吸入治疗的依从性(MD 18%, 95% CI 12.90至23.10;1项研究,588名参与者;中等确定性证据);可能导致治疗负担轻微减轻(MD 5.10, 95% CI 1.79 - 8.41; 1项研究,539名受试者;中等确定性证据);并可能导致FEV1 %的预测略有改善(MD 3.70%, 95% CI -0.23至7.63;1项研究,556名参与者;低确定性证据)。两组间肺恶化的发生率或生活质量可能几乎没有差异。我们降低了间接证据的确定性,因为干预措施仅在成人人群中进行评估,因此可能不适用于儿童。作者的结论是:数字监测加上通过在线平台的量身定制支持可能在中期提高吸入治疗的依从性并减轻治疗负担(但没有相应的生活质量变化)(低和中等确定性证据)。 在较短的时间内,吸入抗生素的技术增强可能会提高对治疗的依从性(低确定性证据)。两种干预措施对肺功能的影响可能很小或没有影响,在线监测可能对肺恶化没有影响。未来的研究应评估数字技术对儿童和成人吸入治疗依从性的影响。考虑对整个治疗方案的依从性也很重要,因为对吸入疗法的改善依从性可能以对治疗方案其他部分的依从性为代价。资助:原综述由Cochrane基础设施基金支持,该基金来自美国国立卫生研究院(NIHR)。本综述由CF基金会和英国CF信托基金资助的Cochrane CF进行更新。注册:协议(2020)DOI: 10.1002/14651858。CD013733原综述(2023)DOI: 10.1002/14651858.CD013733.pub2。
{"title":"Digital technology for monitoring adherence to inhaled therapies in people with cystic fibrosis.","authors":"Rebecca Calthorpe, Sherie Smith, Nikki Jahnke, Alan R Smyth","doi":"10.1002/14651858.CD013733.pub3","DOIUrl":"10.1002/14651858.CD013733.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Improved understanding and treatment of cystic fibrosis (CF) has led to longer life expectancy, which is accompanied by an increasingly complex regimen of treatments. Suboptimal adherence to the treatment plan, in the context of respiratory disease, is associated with poorer health outcomes. With digital technology being more accessible, it can be used to monitor adherence to inhaled therapies via chipped nebulisers, mobile phone applications and web-based platforms. This technology can allow monitoring of adherence, as well as clinical outcomes, and allow feedback to both the person with CF and their healthcare team.</p><p><strong>Objectives: </strong>To assess the effects of using digital technology to monitor adherence to inhaled therapies and health status in adults and children with CF.</p><p><strong>Search methods: </strong>We searched the Cochrane CF Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched Embase and three clinical trial registries, and checked the references of included studies. The date of last search was 27 February 2025.</p><p><strong>Eligibility criteria: </strong>We searched for randomised controlled trials (RCTs) looking at the effects of digital technology for monitoring adherence to inhaled therapies of children and adults with CF.</p><p><strong>Outcomes: </strong>We assessed available data (at up to three months in one study, and up to 12 months in the second) for adherence to the inhaled treatment, treatment burden, quality of life (QoL) and the change from baseline in forced expiratory volume in one second (FEV<sub>1</sub>). We assessed the number of pulmonary exacerbations by the end of each study.</p><p><strong>Risk of bias: </strong>Using Cochrane's Risk of Bias 2 tool, we assessed the risk of bias within each of the included trials and for each outcome from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome and selection of the reported result.</p><p><strong>Synthesis methods: </strong>Two review authors screened the search results for studies eligible for inclusion in the review and extracted their data. Due to the difference in the studies' interventions, we analysed the data separately. We assessed the overall certainty of the evidence using GRADE.</p><p><strong>Included studies: </strong>We included two studies with 628 participants aged five to 41 years. There was one study in each of two different comparisons.</p><p><strong>Synthesis of results: </strong>Nebuliser target inhalation mode versus standard inhalation mode One parallel study was carried out over 10 weeks after a run-in period of four to six weeks. The study compared the effects of a digitally enhanced inhalation mode (target inhalation mode) for nebulised antibiotics compared to standard mode in children attending a regional CF clinic in the UK. The primary outcome ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD013733"},"PeriodicalIF":8.8,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12690627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145713518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the clinical effectiveness and safety of high-flow nasal cannula (HFNC) oxygen therapy compared with conventional oxygen therapy for the management of asthma exacerbations in children and adults. We will also explore potential equity implications, including differences in access to and outcomes of HFNC oxygen therapy across diverse healthcare settings and populations.
{"title":"High-flow nasal cannula oxygen therapy for asthma exacerbation.","authors":"Aiko Honda, Yoshitaka Watanabe, Yoshifusa Abe, Sojiro Kusumoto, Takeshi Hasegawa, Hisashi Noma, Erika Ota, Takanori Imai, Noyuri Yamaji, Edward Barroga","doi":"10.1002/14651858.CD016205","DOIUrl":"10.1002/14651858.CD016205","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the clinical effectiveness and safety of high-flow nasal cannula (HFNC) oxygen therapy compared with conventional oxygen therapy for the management of asthma exacerbations in children and adults. We will also explore potential equity implications, including differences in access to and outcomes of HFNC oxygen therapy across diverse healthcare settings and populations.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD016205"},"PeriodicalIF":8.8,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12687409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1002/14651858.CD015151.pub2
Jae Won Yang, Patrizia Natale, Sukyeong Kim, Minjy Kim, Min Soo Jeon, Daeho Yi, Yu Ah Hong, Sungjin Chung, Woo Yeong Park, Young Youl Hyun, Soon Hyo Kwon, Sung Joon Shin, Dong Ah Park, Jimin Kim, Jae Hung Jung, Giovanni Fm Strippoli, Jun Young Lee
<p><strong>Rationale: </strong>The prevalence of kidney failure in people aged 65 years and above is gradually increasing. However, there is insufficient evidence to determine which treatment is better for people with kidney failure, conservative kidney management (CKM) or dialysis.</p><p><strong>Objectives: </strong>We aimed to assess the effects of CKM and dialysis in older people with kidney failure.</p><p><strong>Search methods: </strong>We searched the Cochrane Kidney and Transplant Register of Studies, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and regional databases (LILACS, KoreaMed, CADTH), as well as grey literature repositories up to 22 September 2025.</p><p><strong>Eligibility criteria: </strong>Randomised and non-randomised studies evaluated CKM compared to dialysis in people aged 65 years and above with kidney failure.</p><p><strong>Outcomes: </strong>The critical outcomes included death (any cause), cardiovascular death, cardiovascular events, and health-related quality of life (HRQoL). The important outcomes included overall adverse events, hospitalisation, malnutrition, sarcopenia, and residual kidney function.</p><p><strong>Risk of bias: </strong>Two authors independently performed the risk of bias analysis. We used the 'Risk Of Bias In Non-randomised Studies of Interventions' (ROBINS-I) tool to assess the risk of bias in the included studies.</p><p><strong>Synthesis methods: </strong>Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR), mean difference (MD), or standard mean difference (SMD) with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.</p><p><strong>Included studies: </strong>We included 24 non-randomised studies that involved 26,127 people with kidney failure. These studies compared CKM to dialysis.</p><p><strong>Synthesis of results: </strong>Compared to dialysis, CKM had uncertain effects on death (any cause) (23 studies, 24,628 participants: 813 per 1000 with CKM versus 630 per 1000 with dialysis) (RR 1.28, 95% CI 1.17 to 1.41; I² = 89%; very low-certainty evidence) and cardiovascular death (3 studies, 262 participants: 114 per 1000 with CKM versus 66 per 1000 with dialysis) (RR 1.72, 95% CI 0.68 to 4.34; I² = 0%; very low-certainty evidence). For HRQoL, the Physical Component Summary (PCS) score (2 studies, 186 participants) was on average about 1.46 points lower with CKM compared with dialysis (MD -1.46, 95% CI -12.08 to 9.16; I² = 77%; very low-certainty evidence). The Mental Component Summary (MCS) score (2 studies, 186 participants) was about 2.5 points lower with CKM (MD -2.50, 95% CI -7.82 to 2.82; I² = 19%; very low-certainty evidence). We found no randomised controlled trials. The certainty of evidence from non-randomised studies was very low due to a high risk of bias, because of significant imbalances in prognostic factors that could not be
理由:65岁及以上人群肾衰竭的患病率逐渐增加。然而,没有足够的证据来确定哪种治疗对肾衰竭患者更好,保守肾管理(CKM)或透析。目的:我们旨在评估CKM和透析对老年肾衰竭患者的影响。检索方法:我们检索了Cochrane肾脏和移植研究注册、MEDLINE、Embase、WHO国际临床试验注册平台(ICTRP)、ClinicalTrials.gov和区域数据库(LILACS、KoreaMed、CADTH),以及截至2025年9月22日的灰色文献库。资格标准:随机和非随机研究评估了65岁及以上肾衰竭患者CKM与透析的比较。结局:关键结局包括死亡(任何原因)、心血管死亡、心血管事件和健康相关生活质量(HRQoL)。重要结局包括总体不良事件、住院、营养不良、肌肉减少症和残余肾功能。偏倚风险:两位作者独立进行了偏倚风险分析。我们使用“非随机干预研究的偏倚风险”(ROBINS-I)工具来评估纳入研究的偏倚风险。综合方法:使用随机效应两两荟萃分析总结治疗估计,并以相对危险度(RR)、平均差异(MD)或标准平均差异(SMD)表示,并给出相应的95%置信区间(CI)。证据确定性采用GRADE评估。纳入的研究:我们纳入了24项非随机研究,涉及26127名肾衰竭患者。这些研究比较了CKM和透析。综合结果:与透析相比,CKM对死亡(任何原因)有不确定的影响(23项研究,24,628名参与者:CKM组813 / 1000,透析组630 / 1000)(RR 1.28, 95% CI 1.17 - 1.41; I²= 89%;极低确定性证据)和心血管死亡(3项研究,262名参与者:CKM组114 / 1000,透析组66 / 1000)(RR 1.72, 95% CI 0.68 - 4.34; I²= 0%;极低确定性证据)。对于HRQoL,与透析相比,CKM的物理成分总结(PCS)评分(2项研究,186名参与者)平均低约1.46分(MD -1.46, 95% CI -12.08至9.16;I²= 77%;非常低确定性证据)。CKM患者的心理成分总结(MCS)评分(2项研究,186名受试者)约低2.5分(MD -2.50, 95% CI -7.82至2.82;I²= 19%;非常低确定性证据)。我们没有发现随机对照试验。来自非随机研究的证据的确定性非常低,因为有很高的偏倚风险,因为预后因素的显著不平衡无法完全解决。纳入的研究均未报告心血管事件、营养不良、肌肉减少症、残留肾功能或不良事件。作者的结论是:与透析相比,CKM对死亡(任何原因)、心血管死亡、住院和HRQoL有不确定的影响。资助:由国家循证医疗合作机构(NA21 - 001)支持。注册:协议可通过https://doi.org/10.1002/14651858.CD015151获得。
{"title":"Conservative kidney management versus dialysis for stage 5 chronic kidney disease in older people.","authors":"Jae Won Yang, Patrizia Natale, Sukyeong Kim, Minjy Kim, Min Soo Jeon, Daeho Yi, Yu Ah Hong, Sungjin Chung, Woo Yeong Park, Young Youl Hyun, Soon Hyo Kwon, Sung Joon Shin, Dong Ah Park, Jimin Kim, Jae Hung Jung, Giovanni Fm Strippoli, Jun Young Lee","doi":"10.1002/14651858.CD015151.pub2","DOIUrl":"10.1002/14651858.CD015151.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>The prevalence of kidney failure in people aged 65 years and above is gradually increasing. However, there is insufficient evidence to determine which treatment is better for people with kidney failure, conservative kidney management (CKM) or dialysis.</p><p><strong>Objectives: </strong>We aimed to assess the effects of CKM and dialysis in older people with kidney failure.</p><p><strong>Search methods: </strong>We searched the Cochrane Kidney and Transplant Register of Studies, MEDLINE, Embase, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and regional databases (LILACS, KoreaMed, CADTH), as well as grey literature repositories up to 22 September 2025.</p><p><strong>Eligibility criteria: </strong>Randomised and non-randomised studies evaluated CKM compared to dialysis in people aged 65 years and above with kidney failure.</p><p><strong>Outcomes: </strong>The critical outcomes included death (any cause), cardiovascular death, cardiovascular events, and health-related quality of life (HRQoL). The important outcomes included overall adverse events, hospitalisation, malnutrition, sarcopenia, and residual kidney function.</p><p><strong>Risk of bias: </strong>Two authors independently performed the risk of bias analysis. We used the 'Risk Of Bias In Non-randomised Studies of Interventions' (ROBINS-I) tool to assess the risk of bias in the included studies.</p><p><strong>Synthesis methods: </strong>Treatment estimates were summarised using random effects pair-wise meta-analysis and expressed as a relative risk (RR), mean difference (MD), or standard mean difference (SMD) with a corresponding 95% confidence interval (CI). Evidence certainty was assessed using GRADE.</p><p><strong>Included studies: </strong>We included 24 non-randomised studies that involved 26,127 people with kidney failure. These studies compared CKM to dialysis.</p><p><strong>Synthesis of results: </strong>Compared to dialysis, CKM had uncertain effects on death (any cause) (23 studies, 24,628 participants: 813 per 1000 with CKM versus 630 per 1000 with dialysis) (RR 1.28, 95% CI 1.17 to 1.41; I² = 89%; very low-certainty evidence) and cardiovascular death (3 studies, 262 participants: 114 per 1000 with CKM versus 66 per 1000 with dialysis) (RR 1.72, 95% CI 0.68 to 4.34; I² = 0%; very low-certainty evidence). For HRQoL, the Physical Component Summary (PCS) score (2 studies, 186 participants) was on average about 1.46 points lower with CKM compared with dialysis (MD -1.46, 95% CI -12.08 to 9.16; I² = 77%; very low-certainty evidence). The Mental Component Summary (MCS) score (2 studies, 186 participants) was about 2.5 points lower with CKM (MD -2.50, 95% CI -7.82 to 2.82; I² = 19%; very low-certainty evidence). We found no randomised controlled trials. The certainty of evidence from non-randomised studies was very low due to a high risk of bias, because of significant imbalances in prognostic factors that could not be ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015151"},"PeriodicalIF":8.8,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12687411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1002/14651858.CD011225.pub2
Nejin Chacko, Anita R Gross, Jordan Miller, Pasqualina L Santaguida, Stephen J Burnie, Geoffrey M Gelley, Jean-Philippe Paquin, Mujeeb-Rehman Duranai, Pierre Langevin, Neha Chopra-Tandon, Nga Ting Chak, Jan L Hoving, Pavlos Bobos
<p><strong>Rationale: </strong>Manual therapy and exercise are supported by evidence of effectiveness as single modal interventions for neck pain; however, their combined effect remains unclear.</p><p><strong>Objectives: </strong>To assess the benefits and harms of manual therapy with exercise versus placebo or no treatment for acute to chronic neck pain with or without radicular symptoms or cervicogenic headache in adults.</p><p><strong>Search methods: </strong>We searched multiple databases (CENTRAL, MEDLINE, Embase, CINAHL, Index to Chiropractic Literature, trial registries) together with reference checking and handsearching up to 5 March 2025.</p><p><strong>Eligibility criteria: </strong>We included parallel, cross-over, or cluster-randomised controlled trials (RCTs) in adults with neck pain, which compared manual therapy and exercise with placebo or no treatment. We excluded studies in people with myelopathy or headaches not of cervical origin.</p><p><strong>Outcomes: </strong>Our outcomes were pain intensity, function or disability, health-related quality of life, participant-reported treatment success, and serious or non-serious adverse events, measured at short-term and long-term follow-up.</p><p><strong>Risk of bias: </strong>We used RoB 1 plus an additional six items to assess bias in the included studies.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using meta-analysis or, when not possible, SWiM methods. We used random-effects models to calculate mean differences (MD) or standardised mean differences (SMD) and 95% confidence intervals (CI) for continuous outcomes, and risk ratios (RR) with 95% CI for adverse events. We used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>We included nine RCTs (seven parallel, two cross-over) with a total of 694 participants. Studies were conducted in outpatient settings across North America, Europe, Central Asia, East Asia, and the Pacific. Manual therapy with exercise was compared with placebo (two studies) or no treatment (seven studies). Participants were 76% female, with a mean age of 46 years and mean pain severity of 4.75 on a 0 to 10 scale. Six studies (67%) reported receiving institutional or government funding. The disorder classification included chronic (n = 8) and subacute (n = 1) neck pain.</p><p><strong>Synthesis of results: </strong>The main biases affecting our findings were selection (44%), performance (100%), detection (100%), and reporting bias (78%). Performance bias is an inherent limitation in manual therapy and exercise RCTs, while detection bias was unavoidable due to reliance on self-reported outcomes. All data reflect short-term follow-up (closest to four weeks). Manual therapy with exercise versus placebo (short-term) Manual therapy with exercise may result in: 1) little or no difference in pain, which was a mean of 3.35 with placebo and showed little to no improvement of 0.91 points (95% CI 1.85 better
理论基础:有证据支持手工疗法和运动作为颈部疼痛的单模态干预措施的有效性;然而,它们的综合影响尚不清楚。目的:评估在成人急性到慢性颈部疼痛伴有或不伴有神经根症状或颈源性头痛的情况下,手工运动疗法与安慰剂或不治疗相比的利与弊。检索方法:我们检索了多个数据库(CENTRAL, MEDLINE, Embase, CINAHL, Index to Chiropractic Literature, trial registry),并进行了参考文献检查和手工检索,检索时间截止到2025年3月5日。入选标准:我们纳入了平行、交叉或集群随机对照试验(rct),研究对象为患有颈部疼痛的成人,这些试验将手工治疗和运动与安慰剂或不治疗进行了比较。我们排除了脊髓病或非颈椎源性头痛患者的研究。结果:我们的结果是疼痛强度、功能或残疾、与健康相关的生活质量、参与者报告的治疗成功、严重或非严重不良事件,通过短期和长期随访进行测量。偏倚风险:我们使用RoB 1和另外6个项目来评估纳入研究的偏倚。综合方法:我们使用荟萃分析或在不可能的情况下使用SWiM方法综合每个结局的结果。我们使用随机效应模型来计算连续结局的平均差异(MD)或标准化平均差异(SMD)和95%置信区间(CI),以及不良事件的95% CI的风险比(RR)。我们使用GRADE来评估证据的确定性。纳入的研究:我们纳入了9项随机对照试验(7项平行试验,2项交叉试验),共694名受试者。研究在北美、欧洲、中亚、东亚和太平洋地区的门诊环境中进行。手工运动疗法与安慰剂(2项研究)或不治疗(7项研究)进行比较。参与者中76%为女性,平均年龄为46岁,平均疼痛严重程度为4.75分(0到10分)。六项研究(67%)报告得到了机构或政府的资助。疾病分类包括慢性(n = 8)和亚急性(n = 1)颈部疼痛。结果综合:影响我们研究结果的主要偏倚是选择偏倚(44%)、表现偏倚(100%)、检测偏倚(100%)和报告偏倚(78%)。表现偏倚是手工治疗和运动随机对照试验的固有局限性,而检测偏倚是不可避免的,因为依赖于自我报告的结果。所有数据均反映短期随访(最接近四周)。手工运动疗法与安慰剂(短期)手工运动疗法可能导致:1)疼痛的差异很小或没有差异,安慰剂组的平均值为3.35,在0到10的量表上几乎没有改善0.91点(95% CI 1.85好到0.04差),其中得分越低表明疼痛越少(I²= 0%;2项研究,114名参与者;由于不精确,性能和检测偏差导致的低确定性证据);2)功能适度增加,安慰剂组平均为21.50分,在0到100的量表上改善10.20分(95% CI 16.84更好至3.56更好),其中0表示最佳功能(I²= 0%;2项研究,115名参与者);这代表转换后的数据(SMD 0.77更好,95% CI 1.15更好至0.39更好;由于不精确、性能和检测偏差导致的低确定性证据);3)与健康相关的生活质量改善很少或没有改善,安慰剂组的平均值为52.10,在Short -12 0 - 100量表上略有改善2.00点(95% CI为5.78较好至1.78较差),其中0表示生活质量较好(1项研究,64名参与者;由于不精确、性能和检测偏差导致的低确定性证据)。没有参与者报告的治疗成功和不良反应的数据。手工治疗加运动与不治疗(短期)手工治疗加运动可能导致:1)疼痛大幅度减轻,在0到10的量表上,没有治疗的疼痛平均减轻4.01分,疼痛大幅度减轻2.44分(95% CI 3.23更好至1.65更好),分数越低表明疼痛越少(I²= 66%;7项研究,360名参与者;由于不精确、性能和检测偏差导致的低确定性证据);2)功能的中度改善,在0到100的量表上,未经治疗的平均值为22.38,改善了13.84点(95% CI 25.24 better至2.44 better),其中0表示最佳功能(I²= 92%;5项研究,303名参与者;由于不精确,性能和检测偏差导致的低确定性证据);3)健康相关生活质量的中度改善,在Short -36 0 - 100量表上,未治疗的健康相关生活质量平均为53.60,改善了24.80点(95% CI 31.38 better至18.22 better),其中0表示生活质量改善(1项研究,65名参与者;由于不精确、性能和检测偏差,证据的确定性较低);4)参与者报告的治疗成功(SMD)证据非常不确定。
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Pub Date : 2025-12-05DOI: 10.1002/14651858.CD015723.pub2
Zanna Kruoch, Adeline Ym Choo, Andrew Kemp, Marcus Gonzales, Tsz Wing Yim, Paul McCann, Su-Hsun Liu, Darren Shu Jeng Ting, Irene C Kuo
<p><strong>Rationale: </strong>Alterations to the corneal nerves can lead to neurotrophic keratopathy (NK), which is marked by breakdown of the corneal epithelium and impaired healing. If untreated, NK can cause severe corneal damage and significant visual impairment. Etiologies include infection, inflammation, chemical or mechanical trauma, systemic disease (e.g. diabetes mellitus), drug toxicity, contact lens overuse, and ophthalmic, neurosurgical, or otolaryngologic surgery. Treatments are often clinician-dependent and include an array of topical medications and surgical techniques to promote re-epithelialization and preserve vision. There is no consensus on the "gold standard" treatment.</p><p><strong>Objectives: </strong>To examine the efficacy and safety of medical and surgical interventions when compared with no treatment, placebo, standard care, or an alternative treatment, for people with neurotrophic keratopathy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PubMed, LILACS, and trial registries on 10 January 2025.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs) in which medical or surgical interventions were compared with no treatment, placebo (e.g. ophthalmic vehicle, normal saline), standard care (e.g. artificial tears, bandage contact lens (BCL)), or an alternative treatment.</p><p><strong>Outcomes: </strong>Our outcomes of interest were corneal re-epithelialization, visual acuity, corneal sensitivity, worsening or relapse of the disease, and adverse events as assessed by investigators. We analyzed most outcome data at one to three months post-intervention; we assessed disease progression at six months or longer, and non-serious and serious adverse events at the longest follow-up time point.</p><p><strong>Risk of bias: </strong>Using Cochrane's risk of bias tool RoB 2, we assessed the risk of bias for outcomes reported in our summary of findings table.</p><p><strong>Synthesis methods: </strong>We performed separate comparisons for medical and surgical interventions. In addition to the qualitative synthesis of included studies, where possible, we conducted fixed-effect meta-analyses, calculating risk ratios (RRs) with 95% confidence intervals (CI) for dichotomous outcomes and mean differences (MDs) and 95% CIs for continuous outcomes. We checked continuous data for skewness. We assessed the certainty of evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included seven parallel-group RCTs with a total of 494 participants (study sample size: 18 to 156 participants; mean age: 25 to 68 years; proportion of female participants: 60% to 77%). Follow-up duration in the studies ranged from 28 days to 18 months. Four studies (57.1%) were multicenter RCTs in the USA and Europe; three studies were conducted in Europe or Asia. Five studies (71.4%) that reported funding sources were industry-sponsored. Six studies compared medical interventions v
理由:角膜神经的改变可导致神经营养性角膜病变(NK),其特征是角膜上皮的破坏和愈合受损。如果不治疗,NK会造成严重的角膜损伤和严重的视力障碍。病因包括感染、炎症、化学或机械创伤、全身性疾病(如糖尿病)、药物毒性、隐形眼镜过度使用以及眼科、神经外科或耳鼻喉外科手术。治疗通常依赖于临床医生,包括一系列局部药物和手术技术,以促进再上皮化和保护视力。对于“金本位”的治疗方法,目前还没有达成共识。目的:研究与不治疗、安慰剂、标准治疗或替代治疗相比,药物和手术干预对神经营养性角膜病变患者的疗效和安全性。检索方法:我们检索了CENTRAL、MEDLINE、Embase、PubMed、LILACS和2025年1月10日的试验注册库。入选标准:我们纳入了随机对照试验(RCTs),其中将药物或手术干预与无治疗、安慰剂(如眼科载体、生理盐水)、标准护理(如人工泪液、绷带接触镜(BCL))或替代治疗进行比较。结果:我们感兴趣的结果是角膜再上皮化、视力、角膜敏感性、疾病恶化或复发以及研究者评估的不良事件。我们分析了干预后一到三个月的大多数结果数据;我们评估了6个月或更长时间的疾病进展,以及最长随访时间点的非严重和严重不良事件。偏倚风险:使用Cochrane的偏倚风险工具RoB 2,我们评估了结果摘要表中报告的结果的偏倚风险。综合方法:我们分别对内科和外科干预进行了比较。除了对纳入的研究进行定性综合外,在可能的情况下,我们进行了固定效应荟萃分析,以95%置信区间(CI)计算二分类结局的风险比(rr),以95%置信区间(CI)计算连续结局的平均差异(md)和95% CI。我们检查了连续数据的偏度。我们使用GRADE方法评估证据的确定性。纳入的研究:我们纳入了7个平行组随机对照试验,共494名参与者(研究样本量:18至156名参与者;平均年龄:25至68岁;女性参与者比例:60%至77%)。研究的随访时间从28天到18个月不等。4项研究(57.1%)为美国和欧洲的多中心随机对照试验;三项研究分别在欧洲和亚洲进行。5项研究(71.4%)报告的资金来源是行业赞助的。六项研究比较了医疗干预与眼载体或人工泪液;医学干预包括两种外用生物干预(20 μg/ml重组人神经生长因子(rhNGF; 2项研究)和重组牛碱性成纤维细胞生长因子(rb-bFGF)),以及三种非生物干预(0.1% RGN-259、外用胞胆碱和维生素B12 (Cit-B12)和CACICOL20 (T4020))。一项试验比较了羊膜移植与泪膜修补术或BCL治疗NK。综合结果:六项研究评估了药物干预与载体或人工泪液的对比。两项研究的荟萃分析显示,rhNGF可能略微改善角膜再上皮化(定义为角膜染色< 0.5 mm) (RR 1.88, 95% CI 1.37至2.58;I2 = 0%; 148名参与者;低确定性证据)。同样的两项研究评估了完全的角膜再上皮化(定义为角膜染色< 0.1 mm),发现了相似的结果,但在荟萃分析中存在很大的异质性(RR 2.75, 95% CI 1.82至4.16;I2 = 72%; 148名参与者;低确定性证据)。一项CACICOL20的试验发现,它可能不会增加角膜再上皮化的参与者比例(RR 0.89, 95% CI 0.66至1.19;148名参与者;低确定性证据),而一项0.1% RGN-259的试验发现了相同的结果(RR 9.00, 95% CI 0.57至141.88;18名参与者;低确定性证据)。两项研究的荟萃分析显示rhNGF可能不能改善视力(RR 0.07, 95% CI -0.58 ~ 0.71; I2 = 0%; 151名受试者;低确定性证据)。两项研究的荟萃分析表明,医疗干预,特别是rb-bFGF,可能改善角膜敏感性(MD 8.43, 95% CI 1.90至14.97;I2 = 0%; 60名受试者;极低确定性证据),但证据非常不确定。一项试验显示rhNGF可能不能改善角膜敏感性(MD 1.08, 95% CI -0.32 - 2.48; 33名受试者;极低确定性证据),但这一结果的证据也非常不确定。两项研究叙述性地报道了rhNGF与眼部载体相比较低的疾病复发率。 CACICOL20的一项试验发现,与对照组相比,它可能导致不良事件的风险几乎没有差异(RR 0.98, 95% CI 0.63至1.52;152名参与者;低确定性证据);在两项rhNGF研究的荟萃分析中也发现了类似的结果(RR 1.08, 95% CI 0.62 ~ 1.86; I2 = 0%; 151名受试者;低确定性证据)。只有一项试验评估了手术干预,比较了羊膜移植与泪膜修补术或BCL。羊膜可能对角膜再上皮化的受试者比例(RR 1.10, 95% CI 0.69至1.76;30名受试者;极低确定性证据)或视力改善的影响很小或没有影响(RR 1.40, 95% CI 0.57至3.43;30名受试者;极低确定性证据),但证据非常不确定。在该比较中未报告其他预先指定的结果。作者的结论:神经营养性角膜病变是一种罕见的疾病,其病因多种多样,这对研究设计、参与者招募和客观结果测量的共识提出了挑战。我们的综述发现,关于药物或手术干预对角膜再上皮化、视力和角膜敏感性的影响,证据的确定性很低或非常低。我们降低了证据的确定性,主要是因为不精确,其次是间接、偏倚风险和不一致。鉴于目前的证据和缺乏通用指南,临床医生应该根据临床判断和现有资源进行个体化治疗。我们预计,未来的研究将检验更广泛的干预措施,能够提供更高质量的证据,并产生更结论性的评估。经费:本综述没有内部支持来源。外部来源:美国国立卫生研究院国立眼科研究所;联合王国公共卫生署;英国贝尔法斯特女王大学;伯明翰健康伙伴,英国。注册:协议可通过doi.org/10.1002/14651858.CD015723获得。
{"title":"Medical and surgical interventions for neurotrophic keratopathy.","authors":"Zanna Kruoch, Adeline Ym Choo, Andrew Kemp, Marcus Gonzales, Tsz Wing Yim, Paul McCann, Su-Hsun Liu, Darren Shu Jeng Ting, Irene C Kuo","doi":"10.1002/14651858.CD015723.pub2","DOIUrl":"10.1002/14651858.CD015723.pub2","url":null,"abstract":"<p><strong>Rationale: </strong>Alterations to the corneal nerves can lead to neurotrophic keratopathy (NK), which is marked by breakdown of the corneal epithelium and impaired healing. If untreated, NK can cause severe corneal damage and significant visual impairment. Etiologies include infection, inflammation, chemical or mechanical trauma, systemic disease (e.g. diabetes mellitus), drug toxicity, contact lens overuse, and ophthalmic, neurosurgical, or otolaryngologic surgery. Treatments are often clinician-dependent and include an array of topical medications and surgical techniques to promote re-epithelialization and preserve vision. There is no consensus on the \"gold standard\" treatment.</p><p><strong>Objectives: </strong>To examine the efficacy and safety of medical and surgical interventions when compared with no treatment, placebo, standard care, or an alternative treatment, for people with neurotrophic keratopathy.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, PubMed, LILACS, and trial registries on 10 January 2025.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs) in which medical or surgical interventions were compared with no treatment, placebo (e.g. ophthalmic vehicle, normal saline), standard care (e.g. artificial tears, bandage contact lens (BCL)), or an alternative treatment.</p><p><strong>Outcomes: </strong>Our outcomes of interest were corneal re-epithelialization, visual acuity, corneal sensitivity, worsening or relapse of the disease, and adverse events as assessed by investigators. We analyzed most outcome data at one to three months post-intervention; we assessed disease progression at six months or longer, and non-serious and serious adverse events at the longest follow-up time point.</p><p><strong>Risk of bias: </strong>Using Cochrane's risk of bias tool RoB 2, we assessed the risk of bias for outcomes reported in our summary of findings table.</p><p><strong>Synthesis methods: </strong>We performed separate comparisons for medical and surgical interventions. In addition to the qualitative synthesis of included studies, where possible, we conducted fixed-effect meta-analyses, calculating risk ratios (RRs) with 95% confidence intervals (CI) for dichotomous outcomes and mean differences (MDs) and 95% CIs for continuous outcomes. We checked continuous data for skewness. We assessed the certainty of evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included seven parallel-group RCTs with a total of 494 participants (study sample size: 18 to 156 participants; mean age: 25 to 68 years; proportion of female participants: 60% to 77%). Follow-up duration in the studies ranged from 28 days to 18 months. Four studies (57.1%) were multicenter RCTs in the USA and Europe; three studies were conducted in Europe or Asia. Five studies (71.4%) that reported funding sources were industry-sponsored. Six studies compared medical interventions v","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"12 ","pages":"CD015723"},"PeriodicalIF":8.8,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12679690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}