Pub Date : 2026-02-17DOI: 10.1002/14651858.CD016327
Francesca Gimigliano, Sara Liguori, Chiara Arienti, Marco Paoletta, Olivier Butzbach, Giovanni Iolascon, Melissa Atkinson-Graham, Nora Bakaa, Irene Battel, Paolo Capodaglio, Claudio Cordani, Pierre Côté, Simon Décary, Wouter De Groote, Matteo Johann Del Furia, Antony Duttine, Eshetu Haileselassie Engeda, Walter R Frontera, Carlotte Kiekens, Theodore Konstantinidis, Silvia Minozzi, Qhayiya Mudau, Rebecca Ryan, Carla Sabariego, Dima Touhami, Stefano Negrini, Antimo Moretti
<p><strong>Background: </strong>Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview focuses on financial arrangements, which Cochrane EPOC defines as changes in how funds are collected, how insurance schemes are structured, how services are purchased, and the use of targeted financial incentives or disincentives.</p><p><strong>Objectives: </strong>This overview aimed to synthesize the current evidence on financial arrangements in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews, incorporating evidence on governance arrangements, delivery arrangements, financial arrangements, and implementation strategies, have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end-users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up-to-date systematic reviews currently exist.</p><p><strong>Methods: </strong>We searched the Epistemonikos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non-Cochrane systematic reviews of randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to financial arrangements as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR 2 to critically appraise the quality of the reviews. Reviews with ratings of high-to-moderate confidence are reported separately from low-confidence reviews.</p><p><strong>Main results: </strong>We identified two non-Cochrane systematic reviews relevant to rehabilitation and the EPOC category of financial arrangements. We excluded one review from the synthesis due to low methodological quality. The other review included 18 primary studies, but only one study reported data relevant to rehabilitation. This study, conducted in a single country (China), compared insured and uninsured children aged birth to 17 years with intellectual disabilities, focusing on the likeliho
{"title":"Financial arrangements for rehabilitation services in health systems: an overview of systematic reviews.","authors":"Francesca Gimigliano, Sara Liguori, Chiara Arienti, Marco Paoletta, Olivier Butzbach, Giovanni Iolascon, Melissa Atkinson-Graham, Nora Bakaa, Irene Battel, Paolo Capodaglio, Claudio Cordani, Pierre Côté, Simon Décary, Wouter De Groote, Matteo Johann Del Furia, Antony Duttine, Eshetu Haileselassie Engeda, Walter R Frontera, Carlotte Kiekens, Theodore Konstantinidis, Silvia Minozzi, Qhayiya Mudau, Rebecca Ryan, Carla Sabariego, Dima Touhami, Stefano Negrini, Antimo Moretti","doi":"10.1002/14651858.CD016327","DOIUrl":"10.1002/14651858.CD016327","url":null,"abstract":"<p><strong>Background: </strong>Cochrane Rehabilitation and the World Health Organization (WHO) Rehabilitation Programme have collaborated to produce four Cochrane overviews of systematic reviews that synthesize current available evidence from health policy and systems research (HPSR) in rehabilitation. Each overview focuses on one of the four pillars of HPSR as identified by the Cochrane Effective Practice and Organisation of Care (EPOC) taxonomy: delivery arrangements, financial arrangements, governance arrangements, and implementation strategies. This overview focuses on financial arrangements, which Cochrane EPOC defines as changes in how funds are collected, how insurance schemes are structured, how services are purchased, and the use of targeted financial incentives or disincentives.</p><p><strong>Objectives: </strong>This overview aimed to synthesize the current evidence on financial arrangements in rehabilitation from a health policy and systems research (HPSR) perspective. Our series of four overviews, incorporating evidence on governance arrangements, delivery arrangements, financial arrangements, and implementation strategies, have the following overarching objectives. • To offer a broad synthesis of the existing evidence on health policy and systems interventions' effects. • To direct end-users, including policymakers, towards systematic reviews that may address their health policy questions. • To identify current research gaps and set priorities for future primary HPSR. • To pinpoint the needs and priorities for new evidence syntheses where no reliable, up-to-date systematic reviews currently exist.</p><p><strong>Methods: </strong>We searched the Epistemonikos database, the Health Systems Evidence database, and EPOC Group systematic reviews to identify reviews published between 1 January 2015 and 17 November 2024. We applied no language limitations. We included Cochrane and non-Cochrane systematic reviews of randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) that evaluated the effectiveness of health policy and systems interventions for rehabilitation in health systems, specifically related to financial arrangements as defined in the EPOC taxonomy. All four overview teams collaborated to screen reviews and extract data. We used AMSTAR 2 to critically appraise the quality of the reviews. Reviews with ratings of high-to-moderate confidence are reported separately from low-confidence reviews.</p><p><strong>Main results: </strong>We identified two non-Cochrane systematic reviews relevant to rehabilitation and the EPOC category of financial arrangements. We excluded one review from the synthesis due to low methodological quality. The other review included 18 primary studies, but only one study reported data relevant to rehabilitation. This study, conducted in a single country (China), compared insured and uninsured children aged birth to 17 years with intellectual disabilities, focusing on the likeliho","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016327"},"PeriodicalIF":8.8,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12910665/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146212234","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 : 2026-02-16DOI: 10.1002/14651858.CD015610.pub2
Luis I Garegnani, Gisela Oltra, Diego Ivaldi, Mariana Andrea Burgos, Paola J Andrenacci, Sabrina Rico, Melinda Boyd, Diane Radler, Camila Micaela Escobar Liquitay, Eva Madrid
<p><strong>Rationale: </strong>Weight loss remains the primary strategy for reducing health risks and societal consequences associated with overweight and obesity. The most common dietary interventions are calorie-restricted diets, including various permutations of energy restriction, macronutrients, foods, and dietary intake patterns, which achieve initial but often unsustained weight loss. Intermittent fasting involves eating patterns during which individuals take little or no energy for extended time periods, alternated with periods of normal food intake. The mechanism for weight loss is related to caloric restriction, increased fat metabolism, enhanced insulin sensitivity, and improved glucose metabolism. Intermittent fasting has been publicised in blogs and news articles but studies show inconsistent effects on health, highlighting the uncertainty faced by physicians and people with overweight or obesity when considering intermittent fasting as a feasible approach for sustained weight loss.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of intermittent fasting versus regular dietary advice, no intervention or waiting list for adults with overweight or obesity.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE (Ovid), and two trials registers up to 5 November 2024, as well as reference checking, citation searching and contact with study authors to identify additional studies.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) and cluster-RCTs that compared intermittent fasting (including time-restricted feeding, periodic fasting, alternate-day fasting, and modified alternate-day fasting) with regular dietary advice, no intervention or waiting list in men and women with overweight or obesity, with or without associated comorbid conditions. The minimum duration of the intervention was four weeks, and the minimum duration of follow-up was six months. We excluded cross-over and quasi-RCTs.</p><p><strong>Outcomes: </strong>Our outcomes were weight loss, quality of life, participant satisfaction, diabetes status, and adverse events. We considered outcomes measured up to and including 12 months after randomisation as short-term, and longer than 12 months as long-term.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tool (RoB 2) and the RoB2 extension for cluster-RCTs.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using meta-analysis where possible, using random-effects models to calculate risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes, and mean differences (MD) or standardised mean differences (SMD) for continuous outcomes. Where this was not possible due to the nature of the data, we would have synthesised results using narrative synthesis, including the summary of effect estimates. We used GRADE to assess the certainty of evidence for each outcome.</p><p><strong>Included studies:
理由:减肥仍然是减少与超重和肥胖相关的健康风险和社会后果的主要策略。最常见的饮食干预是热量限制饮食,包括能量限制、常量营养素、食物和饮食摄入模式的各种组合,可以实现最初但往往无法持续的体重减轻。间歇性禁食指的是一种饮食模式,在这种模式下,人们在很长一段时间内摄入很少或不摄入能量,与正常食物摄入的时间交替进行。减肥的机制与热量限制、脂肪代谢增加、胰岛素敏感性增强和葡萄糖代谢改善有关。间歇性禁食已经在博客和新闻文章中进行了宣传,但研究显示间歇性禁食对健康的影响并不一致,这突显了医生和超重或肥胖人士在考虑间歇性禁食作为持续减肥的可行方法时所面临的不确定性。目的:评估间歇性禁食与常规饮食建议、无干预或等待名单的利弊,以帮助超重或肥胖的成年人。检索方法:截至2024年11月5日,我们检索了CENTRAL、MEDLINE (Ovid)和两个试验注册库,以及参考文献查询、引文检索和与研究作者联系以确定其他研究。入选标准:我们纳入了随机对照试验(rct)和集群rct,将间歇性禁食(包括限时喂养、周期性禁食、隔日禁食和改良隔日禁食)与常规饮食建议、无干预或等候名单进行比较,这些患者均为超重或肥胖,伴有或不伴有相关合并症。干预的最短时间为4周,随访的最短时间为6个月。我们排除了交叉和准随机对照试验。结果:我们的结果是体重减轻、生活质量、参与者满意度、糖尿病状况和不良事件。我们认为随机化后12个月以内的结果为短期,超过12个月的结果为长期。偏倚风险:我们使用Cochrane偏倚风险工具(RoB2)和集群随机对照试验的RoB2扩展。综合方法:我们尽可能使用荟萃分析对每个结果进行综合,使用随机效应模型计算二分类结果的风险比(RR)和95%置信区间(CI),以及连续结局的平均差异(MD)或标准化平均差异(SMD)。如果由于数据的性质而无法做到这一点,我们将使用叙述性综合来综合结果,包括效果估计的摘要。我们使用GRADE来评估每个结果证据的确定性。纳入的研究:我们纳入了22项研究,共有1995名参与者。所有研究均在北美、澳大利亚、中国、丹麦、德国、挪威和巴西的门诊环境中进行,并于2016年至2024年间发表。结果综合:与常规饮食建议相比,间歇性禁食可能导致与基线体重减轻百分比的差异很小或没有差异(MD -0.33, 95% CI -0.92至0.26;21项研究,1430名参与者;由于存在偏倚风险,证据的确定性较低)。间歇性禁食可能对体重减少5%几乎没有影响,但证据非常不确定(RR 0.98, 95% CI 0.82至1.18;4项研究,472名参与者;由于存在偏倚和不精确的风险,证据的确定性非常低)。间歇性禁食可能导致生活质量的差异很小或没有差异(SMD为0.11,95% CI为-0.27至0.49;3项研究,106名参与者;由于存在偏倚和不精确的风险,证据的确定性较低)。间歇性禁食可能对不良事件几乎没有影响,但证据非常不确定(RR 1.45, 95% CI 0.64至3.28;7项研究,619名参与者;由于存在偏倚、不一致和不精确的风险,证据的确定性非常低)。与不干预或等待名单相比,间歇性禁食可能导致与基线相比体重减轻百分比几乎没有差异(MD -3.42, 95% CI -4.95至-1.90;6项研究,427名参与者;由于存在偏倚风险,证据的确定性为中等)。间歇性禁食可能导致生活质量几乎没有差异,但证据非常不确定(MD 3.49, 95% CI -49.35至56.33,1项研究,60名参与者;由于极度担心不精确,证据的确定性非常低)。间歇性禁食可能导致不良事件的差异很小或没有差异,但证据非常不确定(RR 1.84, 95% CI 0.88至3.85;2项研究,189名参与者;由于存在偏倚和不精确的风险,证据的确定性非常低)。纳入的研究均未报告参与者满意度、糖尿病状况或合并症的总体测量。 作者的结论是:与常规饮食建议相比,间歇性禁食可能在减肥或生活质量方面几乎没有差别。间歇性禁食可能导致不良事件几乎没有差异,但证据非常不确定。这些方法在实现体重减轻方面没有差异,在本综述中考虑的大多数结果中没有产生有临床意义的改变。与不干预或等待名单相比,间歇性禁食可能在减肥方面几乎没有差异,可能在生活质量或不良事件方面几乎没有差异,但证据非常不确定。医生和患者可能需要根据个人的实用性和可持续性来评估实施间歇性禁食作为治疗策略的意愿和准备。纳入的研究侧重于干预的短期效果(长达12个月),限制了本综述中证据在较长时间内为决策提供信息的适用性。将随访期延长至12个月以上,为长期影响建立更有力的证据基础,将有利于今后的研究。需要进一步的研究来解决间歇性禁食对几个结果的影响,包括参与者满意度、糖尿病状态和合并症的总体测量。这些研究必须考虑不同的人群,其中肥胖和超重有不同的负担,比如来自低收入和中等收入国家和高收入国家的人群,分别是男性还是女性,以及不同的体重指数类别。资金来源:Cochrane综述没有专门的资金来源。注册:协议(2023):doi.org/10.1002/14651858.CD015610。
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Pub Date : 2026-02-13DOI: 10.1002/14651858.CD016286
Lauro Av Costa, Celso Gp Dias, Vinícius Y Moraes, Eliane Antonioli, Mário Lenza
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of robotic-assisted versus conventional total knee arthroplasty for the treatment of osteoarthritis.
{"title":"Robotic-assisted versus conventional total knee arthroplasty for treating osteoarthritis.","authors":"Lauro Av Costa, Celso Gp Dias, Vinícius Y Moraes, Eliane Antonioli, Mário Lenza","doi":"10.1002/14651858.CD016286","DOIUrl":"10.1002/14651858.CD016286","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of robotic-assisted versus conventional total knee arthroplasty for the treatment of osteoarthritis.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016286"},"PeriodicalIF":8.8,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12903641/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178026","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 : 2026-02-12DOI: 10.1002/14651858.CD000214.pub3
Kelsey J Sharrad, Kristin V Carson-Chahhoud, Marjolein Ea Verbiest, Sarah Greenslade, Thomas Parkhouse, Willem Jj Assendelft, Mathilde R Crone, Jonathan Livingstone-Banks
<p><strong>Rationale: </strong>Cigarette smoking is one of the leading causes of preventable death worldwide. There is good evidence that brief interventions by health professionals can increase smoking cessation attempts. However, as new studies become available, the effectiveness of these training programmes needs to be re-assessed to inform public policy, clinical care, and guideline recommendations. This is an update of a Cochrane review first published in 2000, and previously updated in 2012.</p><p><strong>Objectives: </strong>To assess the effectiveness of training healthcare professionals to deliver smoking cessation interventions to their patients, and to assess the effects of training characteristics (such as content, setting, delivery, and intensity).</p><p><strong>Search methods: </strong>We searched the following databases from inception to August 2024: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase; PsycINFO; ClinicalTrials.gov (through CENTRAL); and the World Health Organization International Clinical Trials Registry Platform (through CENTRAL). We also searched the references of eligible studies.</p><p><strong>Eligibility criteria: </strong>We included randomised trials in which the intervention was training of healthcare professionals in smoking cessation. We considered trials for inclusion if they reported outcomes for patient smoking at least six months after the intervention. Process outcomes needed to be reported. However, we excluded trials that reported effects only on process outcomes and not smoking behaviour.</p><p><strong>Outcomes: </strong>The critical outcome measure was abstinence from smoking six months or more after baseline, using the strictest measure of abstinence available at the longest follow-up. Prolonged or continuous abstinence was preferred over point prevalence. Our important outcome was the number of participants who made a quit attempt.</p><p><strong>Risk of bias: </strong>Working independently, two review authors evaluated the risk of bias using the Cochrane RoB 1 tool, following guidance from the Cochrane Tobacco Addiction Group.</p><p><strong>Synthesis methods: </strong>Working independently, two review authors extracted information about the characteristics of each included study (i.e. interventions, participants, outcomes, and methods). We pooled studies using random-effects meta-analysis where possible and otherwise summarised findings using narrative synthesis in text and tables. We used the GRADE framework to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>We included 29 studies in the review, published between 1989 and 2024. Together, the studies provided training for over 4030 health professionals, and data for 38,178 participants. We assessed 10 studies to have an overall low risk of bias, 17 an unclear risk, and two to have an overall high risk of bias.</p><p><strong>Synthesis of results: </strong>Sixteen studies compared training of h
理由:吸烟是全世界可预防死亡的主要原因之一。有充分的证据表明,卫生专业人员的短暂干预可以增加戒烟的尝试。然而,随着新的研究的出现,需要重新评估这些培训计划的有效性,以便为公共政策、临床护理和指南建议提供信息。这是对Cochrane综述的更新,该综述首次发表于2000年,之前更新于2012年。目的:评估培训医疗保健专业人员向患者提供戒烟干预措施的有效性,并评估培训特征(如内容、设置、交付和强度)的效果。检索方法:我们检索了以下数据库,从成立到2024年8月:Cochrane中央对照试验登记册(Central);MEDLINE;Embase;PsycINFO;ClinicalTrials.gov(通过CENTRAL);以及世界卫生组织国际临床试验注册平台(通过CENTRAL)。我们还检索了符合条件的文献。入选标准:我们纳入了随机试验,其中干预措施是对医疗保健专业人员进行戒烟培训。如果试验报告了干预后至少6个月患者吸烟的结果,我们将考虑纳入试验。需要报告过程结果。然而,我们排除了仅对过程结果有影响而对吸烟行为没有影响的试验。结果:关键的结果测量是在基线后6个月或更长时间内戒烟,在最长的随访中使用最严格的戒烟措施。长期或持续禁欲优于点流行。我们的重要结果是尝试戒烟的参与者的数量。偏倚风险:两位综述作者在Cochrane烟草成瘾小组的指导下,独立使用Cochrane RoB 1工具评估偏倚风险。综合方法:两位综述作者独立工作,提取每个纳入研究的特征信息(即干预措施、参与者、结果和方法)。我们在可能的情况下使用随机效应荟萃分析汇总研究,并在文本和表格中使用叙述性综合来总结研究结果。我们使用GRADE框架来评估证据的确定性。纳入的研究:我们纳入了1989年至2024年间发表的29项研究。这些研究总共为4030多名卫生专业人员提供了培训,并为38178名参与者提供了数据。我们评估了10项研究总体偏倚风险低,17项风险不明确,2项总体偏倚风险高。结果综合:16项研究比较了医疗保健专业人员在戒烟方面的培训与未培训,并评估了在最长随访期间对参与者人数的影响。高确定性证据表明,与未接受培训的患者相比,接受过戒烟培训的医护人员增加了患者的戒烟率(风险比(RR) 1.34, 95%可信区间(CI) 1.08 ~ 1.67;I2 = 48%;16项研究,16,513名参与者)。我们进行了三个亚组分析,以检验特定潜在异质性来源的影响:训练强度、接受培训的医疗保健专业人员类型和培训中推荐的治疗;没有发现组间异质性的证据。四项研究评估了与低强度训练相比,高强度训练对医疗保健专业人员在最长随访期间戒酒人数的影响。证据表明,与低强度训练相比,高强度训练可能会促进戒烟,尽管置信区间很宽,包括没有益处的可能性(RR 1.64, 95% CI 0.86至3.12;I2 = 54%; 4项研究,1151名参与者;低确定性证据)。三项研究评估了在最长的随访中,训练辅助对参与者禁欲人数的影响。我们发现低确定性证据表明,当医疗保健专业人员接受戒烟培训时,更多人在接受尼古丁替代疗法时可能会戒烟(RR 1.64, 95% CI 0.72至3.71;I2 = 69%; 2项研究,1892名参与者),极低确定性证据表明,除了戒烟培训外,向医疗保健专业人员提供提示可能有助于更多人戒烟(RR 1.37, 95% CI 0.69至2.70;I2 = 66%; 3项研究,2429名参与者)。然而,在这两种情况下,置信区间都很宽,并且包括了没有益处的可能性。作者的结论是:高确定性的证据支持对健康专业人员进行戒烟培训与不进行培训相比是有效的。 多成分调查结合新的药物干预戒烟(如伐尼克兰和安非他酮)或其他戒烟辅助与医生培训应考虑,以确定是否有任何额外的好处,长期戒烟可以获得。经费:本综述由阿德莱德大学博士奖学金资助,并由Houd研究小组共同资助,授予KS。注册:本综述于1994年首次在Cochrane之外发表,随后于2000年更新为Cochrane综述(DOI: 10.1002/14651858)。CD000214)和2012 (DOI: 10.002 /14651858.CD000214.pub2)。没有发布或注册任何协议。
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Pub Date : 2026-02-12DOI: 10.1002/14651858.CD013616.pub2
Michelle Butler, Marcia Kirwan, Vera Jc Mc Carthy, Judith A Cole, Timothy J Schultz
<p><strong>Rationale: </strong>The demand for health services to deliver hospital-based care has increased due to an ageing population, more complex healthcare needs, comorbidities, and increasing healthcare costs. Nurse-physician substitution can improve access to care for patients who may otherwise have a significant wait for review by a physician.</p><p><strong>Objectives: </strong>The main objective of this review was to examine the impact of substituting nurses for physicians in the hospital setting (hospital inpatient units and outpatient clinics) on patient outcomes, process of care outcomes, and economic outcomes. The secondary objectives of this review were to assess whether the effects of nurse-physician substitution differ according to healthcare setting (low- and middle-income countries (which included low-income, lower middle-income, and upper middle-income countries) versus high-income countries), patient type, patient disease, intervention type (inpatient care, nurse-led clinics, role substitution, and task substitution), nurse grade, additional training, level of responsibility, and mode of substitution for nurse-led clinics (telephone/telehealth, partial substitution, enhanced substitution, and full substitution).</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, NHSEED, CINAHL, ProQuest, two citation indexes, and two trial registries. We also conducted handsearches, reference checking, and contacted study authors to identify eligible studies. We searched five grey literature databases and contacted experts relevant to the review area. The evidence is current to 25 June 2024.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials of both individual and cluster design that compared the effects of care delivered by a nurse to that delivered by a physician on patient, process of care, and economic outcomes. We included care of inpatients or outpatients in hospital settings.</p><p><strong>Outcomes: </strong>Our critical outcomes were mortality, patient safety events, and clinical outcomes. Important outcomes were quality of life, self-efficacy, relative performance of practitioner, and direct costs.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias using the Cochrane RoB 2 tool.</p><p><strong>Synthesis methods: </strong>We synthesised results for six outcomes (70 studies) using meta-analysis. We calculated odds ratios (OR) or risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes, and standardised mean differences (SMD) or mean differences (MD) with 95% CI for continuous outcomes. Data for clinical outcomes and relative performance of practitioner were stratified, and direct costs were summarised narratively. We assessed the certainty of evidence using GRADE for all outcomes.</p><p><strong>Included studies: </strong>We included 80 parallel-group single or multi-site randomised studies and two cross-over single-site randomised studies. Ther
理由:由于人口老龄化、更复杂的卫生保健需求、合并症和不断增加的卫生保健费用,对提供医院护理的卫生服务的需求有所增加。护士-医生替代可以改善患者获得护理的机会,否则他们可能需要等待医生的检查。目的:本综述的主要目的是检查医院环境(医院住院和门诊)中护士替代医生对患者预后、护理结果过程和经济结果的影响。本综述的次要目标是评估护士-医生替代的效果是否因医疗环境(低收入和中等收入国家(包括低收入、中低收入和中高收入国家)与高收入国家)、患者类型、患者疾病、干预类型(住院护理、护士主导的诊所、角色替代和任务替代)、护士等级、额外培训、责任水平、护理人员和护理人员等因素而不同。以及护士主导诊所的替代模式(电话/远程医疗、部分替代、增强替代和完全替代)。检索方法:检索了CENTRAL、MEDLINE、Embase、NHSEED、CINAHL、ProQuest、两个引文索引和两个试验注册库。我们还进行了手工检索、参考资料核查,并联系了研究作者以确定符合条件的研究。我们检索了5个灰色文献数据库,并联系了与综述领域相关的专家。证据截止到2024年6月25日。资格标准:我们纳入了随机对照试验,包括个体设计和集群设计,比较护士和医生提供的护理对患者、护理过程和经济结果的影响。我们包括住院病人和门诊病人的护理。结局:我们的关键结局是死亡率、患者安全事件和临床结局。重要的结果是生活质量、自我效能、从业人员的相对表现和直接成本。偏倚风险:我们使用Cochrane RoB 2工具评估偏倚风险。综合方法:我们使用荟萃分析综合了6个结果(70项研究)的结果。我们用95%置信区间(CI)计算二分结局的优势比(OR)或风险比(RR),用95%置信区间(CI)计算连续结局的标准化平均差异(SMD)或平均差异(MD)。对临床结果和从业人员的相对表现进行了分层,并对直接成本进行了叙述总结。我们对所有结果使用GRADE来评估证据的确定性。纳入的研究:我们纳入了80项平行组单点或多点随机研究和2项交叉单点随机研究。共有28,041名参与者,研究样本量从7人到1907人不等。研究包括专科护士、高级执业护士和替代初级和高级医生的注册护士,涵盖一系列专业,包括:癌症、心脏病学、皮肤病学、内分泌学、胃肠病学、普通医学、新生儿学、神经病学、产科/妇科、眼科、风湿病学和呼吸学。护士自主执业或在医生的监督下执业,有时使用规程,有时为特定的患者群体提供护理。大多数研究持续了12个月,有两项研究持续了5年。这些研究是在世界范围内进行的,其中大多数是在英国进行的(39%)。在高收入国家进行了72项研究。我们判断34%的研究具有低偏倚风险,46%的研究存在一些担忧。综合结果:荟萃分析显示护士和医生护理在死亡率(RR 1.03, 95% CI 0.87至1.21;I²= 0%;19项研究,8239名受试者;中等确定性证据)、生活质量(SMD 0.10, 95% CI -0.04至0.23;I²= 65%;22项研究,5246名受试者;中等确定性证据)和自我效能(SMD 0.01, 95% CI -0.06至0.09;I²= 0%;11项研究,3022名受试者;中确定性证据),并且患者安全事件可能几乎没有差异(RR 0.92, 95% CI 0.84至1.01;I²= 9%;31项研究,14,437名受试者;低确定性证据)。我们没有汇总临床结果的总体结果(36项研究,5177名参与者),但发现在大多数临床结果中,护士-医生替代和医生主导的护理之间可能几乎没有差异。然而,对于少数结果,护士-医生替代可能导致临床结果的改善。 我们没有汇总医生总体相对表现的结果(22项研究,13,818名参与者),并发现一些结果可能倾向于护士-医生替代;有些人可能支持医生主导的护理;对于一些结果,两者之间可能几乎没有区别。就直接费用而言,证据的确定性很低。直接成本的叙述性综合(36项研究,15,230名参与者)显示,17项研究报告了当医生被护士取代时成本降低,9项研究报告由于更长时间的咨询、转诊和药物处方而成本增加。所有研究的偏倚风险普遍较低。作者的结论:在我们的综述中,我们发现护士-医生替代和医生主导护理之间几乎没有差异。虽然在某些情况下,护士-医生替代可能导致更好的结果,但证据是不确定的。在考虑将护士-医生替代作为医生短缺的解决方案时,我们还需要考虑其对护理人员的影响。经费:未收到任何财政支助。注册:协议(2020)DOI:10.1002/14651858.CD013616。
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Pub Date : 2026-02-11DOI: 10.1002/14651858.CD009733.pub4
Rita Champaneria, Lise J Estcourt, Louise Geneen, Susan J Brunskill, Carolyn Dorée, Simon J Stanworth, Michael Jr Desborough
<p><strong>Rationale: </strong>People with haematological disorders are frequently at risk of severe or life-threatening bleeding as a result of thrombocytopenia (reduced platelet count). This is despite the routine use of prophylactic platelet transfusions to prevent bleeding once the platelet count falls below a certain threshold. Platelet transfusions are not without risk and adverse events may be life-threatening. A possible adjunct to prophylactic platelet transfusions is the use of antifibrinolytics, specifically the lysine analogues tranexamic acid (TXA) and epsilon aminocaproic acid (EACA). This is an update of a Cochrane review last published in 2016 (with database searches conducted on 7 March 2016).</p><p><strong>Objectives: </strong>To determine the benefits and harms of antifibrinolytics (lysine analogues) in preventing bleeding in people with haematological disorders.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Transfusion Evidence Library, and ongoing trial databases on 21 January 2025. We handsearched the reference lists of all identified randomised controlled trials (RCTs). We contacted the authors of relevant studies, study groups, and experts worldwide known to be active in the field to request information about unpublished material or further information on ongoing studies.</p><p><strong>Eligibility criteria: </strong>We included RCTs in people with haematological disorders who required prophylactic platelet transfusions to prevent bleeding. We only included RCTs in which the interventions were the lysine analogues TXA or EACA.</p><p><strong>Outcomes: </strong>We assessed bleeding severity using the World Health Organization (WHO) bleeding scale (ordinal grades 0 to 4, with higher grades indicating more severe bleeding), which has been widely applied in thrombocytopenia studies. The outcomes prioritised for the summary of findings tables were: number of participants with grade 2 bleeding or higher; number of participants with grade 3 bleeding or higher; number of participants with any thromboembolism; all-cause mortality; and adverse events attributable to antifibrinolytic drugs. We provide results only for these outcomes below.</p><p><strong>Risk of bias: </strong>We used Cochrane's risk of bias 2 (RoB 2) tool. We used this tool to re-assess the previously included trials.</p><p><strong>Synthesis methods: </strong>For this update, two review authors independently selected trials for inclusion, assessed methodological quality and risk of bias, and extracted data. We used fixed-effect models for the meta-analysis. We analysed dichotomous outcomes using risk ratios (RRs) with 95% confidence intervals (CIs), and the Peto odds ratio (Peto OR) for outcomes with very low event rates (< 3% in both arms). We assessed the certainty of the evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included eight RC
理由:血液病患者由于血小板减少(血小板计数减少)而经常面临严重或危及生命的出血风险。这是尽管常规使用预防性血小板输注,以防止出血一旦血小板计数低于某一阈值。血小板输注并非没有风险,不良事件可能危及生命。预防性血小板输注的一种可能辅助手段是使用抗纤溶药物,特别是赖氨酸类似物氨甲环酸(TXA)和epsilon氨基己酸(EACA)。这是2016年Cochrane综述的更新(数据库检索于2016年3月7日进行)。目的:确定抗纤溶药物(赖氨酸类似物)在预防血液病患者出血方面的益处和危害。检索方法:我们于2025年1月21日检索了CENTRAL、MEDLINE、Embase、护理和相关健康文献累积索引(CINAHL)、输血证据库和正在进行的试验数据库。我们手工检索了所有确定的随机对照试验(rct)的参考文献列表。我们联系了相关研究的作者、研究组和世界范围内已知活跃在该领域的专家,以获取有关未发表材料的信息或正在进行的研究的进一步信息。入选标准:我们纳入了需要预防性血小板输注以预防出血的血液病患者的随机对照试验。我们只纳入了干预赖氨酸类似物TXA或EACA的随机对照试验。结果:我们使用世界卫生组织(WHO)出血量表评估出血严重程度(普通等级0至4,等级越高表明出血越严重),该量表已广泛应用于血小板减少症研究。结果总结表优先考虑的结果是:2级或以上出血的受试者人数;3级或以上出血的受试者人数;有任何血栓栓塞的参与者人数;全因死亡率;以及抗纤溶药物引起的不良事件。我们只提供以下结果的结果。偏倚风险:我们使用Cochrane的偏倚风险2 (RoB 2)工具。我们使用该工具重新评估先前纳入的试验。综合方法:在本次更新中,两位综述作者独立选择了纳入的试验,评估了方法学质量和偏倚风险,并提取了数据。我们使用固定效应模型进行meta分析。我们使用95%可信区间(ci)的风险比(rr)和极低事件发生率(两组均< 3%)的Peto优势比(Peto OR)分析二分类结局。我们使用GRADE方法评估证据的确定性。纳入的研究:我们在本次综述更新中纳入了8项随机对照试验(4项新纳入的研究加上4项来自先前版本的研究),共1041名受试者。6项试验比较了TXA与安慰剂,1项试验比较了EACA与无EACA, 1项试验比较了EACA与标准血小板输注。我们没有发现比较TXA和EACA的试验。七项试验招募成人,一项招募儿童。结果综合:氨甲环酸(TXA)与安慰剂在发生2级或以上出血、3级或以上出血、血栓栓塞、死亡和药物相关不良事件的风险方面,TXA与安慰剂之间可能没有差异,尽管这些结果的证据确定性从极低到中度不等:2级或以上出血:RR 0.89, 95% CI 0.75至1.05;I²= 7%;3项研究,894名参与者;moderate-certainty证据;3级或以上出血:RR 1.07, 95% CI 0.51 ~ 2.22;I²= 6%;3项研究,894名参与者;确定性的证据;任何血栓栓塞:Peto OR 0.85, 95% CI 0.39 - 1.86;I²= 0%;5项研究,984名参与者;确定性的证据;全因死亡率:Peto OR 1.50, 95% CI 0.62 ~ 3.63;I²= 37%;3项研究,930名参与者;非常低确定性的证据;和归因于抗纤溶药物的不良事件数量:Peto OR 2.24, 95% CI 0.64 - 7.78;I²= 0%;3项研究,949名受试者;非常低确定性的证据。Epsilon氨基自戊酸(EACA)与无EACA进行比较的单一研究没有以适合分析的形式报告出血严重程度,也没有报告任何血栓栓塞或全因死亡率的参与者数量。该研究报告没有患者死于血栓形成。没有足够的证据来分析抗纤溶药物引起的不良事件。作者的结论是:对于患有血小板减少症和血液恶性肿瘤的患者,TXA可能对临床显著出血(即2级或更高)几乎没有影响,对严重或危及生命的出血(即3级或更高)或任何血栓栓塞几乎没有影响。 证据表明抗纤溶药物引起的全因死亡率和严重不良事件的确定性非常低。与无EACA相比,EACA没有足够的数据来评估临床显著出血、危及生命的出血、任何血栓栓塞、全因死亡率和严重不良事件。那些决定给血小板减少症和血液恶性肿瘤患者预防性使用TXA的人应该考虑到,目前的证据并没有显示TXA在预防临床重大或危及生命的出血方面有什么好处或坏处。资金来源:Cochrane综述没有专门的资金来源。注册:协议(2012):DOI: 10.1002/14651858.CD009733。原评(2013):DOI: 10.002 /14651858. cd009733 .pub2。回顾更新(2016):DOI: 10.002 /14651858. cd009733 .pub3.kljkj。
{"title":"Antifibrinolytics (lysine analogues) for the prevention of bleeding in people with haematological disorders.","authors":"Rita Champaneria, Lise J Estcourt, Louise Geneen, Susan J Brunskill, Carolyn Dorée, Simon J Stanworth, Michael Jr Desborough","doi":"10.1002/14651858.CD009733.pub4","DOIUrl":"10.1002/14651858.CD009733.pub4","url":null,"abstract":"<p><strong>Rationale: </strong>People with haematological disorders are frequently at risk of severe or life-threatening bleeding as a result of thrombocytopenia (reduced platelet count). This is despite the routine use of prophylactic platelet transfusions to prevent bleeding once the platelet count falls below a certain threshold. Platelet transfusions are not without risk and adverse events may be life-threatening. A possible adjunct to prophylactic platelet transfusions is the use of antifibrinolytics, specifically the lysine analogues tranexamic acid (TXA) and epsilon aminocaproic acid (EACA). This is an update of a Cochrane review last published in 2016 (with database searches conducted on 7 March 2016).</p><p><strong>Objectives: </strong>To determine the benefits and harms of antifibrinolytics (lysine analogues) in preventing bleeding in people with haematological disorders.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Transfusion Evidence Library, and ongoing trial databases on 21 January 2025. We handsearched the reference lists of all identified randomised controlled trials (RCTs). We contacted the authors of relevant studies, study groups, and experts worldwide known to be active in the field to request information about unpublished material or further information on ongoing studies.</p><p><strong>Eligibility criteria: </strong>We included RCTs in people with haematological disorders who required prophylactic platelet transfusions to prevent bleeding. We only included RCTs in which the interventions were the lysine analogues TXA or EACA.</p><p><strong>Outcomes: </strong>We assessed bleeding severity using the World Health Organization (WHO) bleeding scale (ordinal grades 0 to 4, with higher grades indicating more severe bleeding), which has been widely applied in thrombocytopenia studies. The outcomes prioritised for the summary of findings tables were: number of participants with grade 2 bleeding or higher; number of participants with grade 3 bleeding or higher; number of participants with any thromboembolism; all-cause mortality; and adverse events attributable to antifibrinolytic drugs. We provide results only for these outcomes below.</p><p><strong>Risk of bias: </strong>We used Cochrane's risk of bias 2 (RoB 2) tool. We used this tool to re-assess the previously included trials.</p><p><strong>Synthesis methods: </strong>For this update, two review authors independently selected trials for inclusion, assessed methodological quality and risk of bias, and extracted data. We used fixed-effect models for the meta-analysis. We analysed dichotomous outcomes using risk ratios (RRs) with 95% confidence intervals (CIs), and the Peto odds ratio (Peto OR) for outcomes with very low event rates (< 3% in both arms). We assessed the certainty of the evidence using the GRADE approach.</p><p><strong>Included studies: </strong>We included eight RC","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD009733"},"PeriodicalIF":8.8,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-11DOI: 10.1002/14651858.CD016326
Stephanie Ball, Rhianydd Thomas, Adam M Galloway, Luke M Davies, Kelly Gray, Sue Brennan, Renea V Johnston, Nicole Williams, Craig F Munns, Verity Pacey
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To investigate the benefits and harms of surgical, non-surgical, and pharmacological interventions for paediatric primary lower limb avascular necrosis (AVN). This is a common review protocol, outlining the approach for four separate Cochrane reviews for paediatric primary lower limb AVN. To assess the benefit and harm of surgical interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the benefit and harm of non-surgical interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the benefit and harm of pharmacological interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the comparative effectiveness of surgical, non-surgical, and pharmacological interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. The secondary objective for all four of the reviews is to evaluate health equity by assessing the effects across different geographical regions, gender, and age groups.
{"title":"Treatment for primary avascular necrosis of the lower limb in childhood.","authors":"Stephanie Ball, Rhianydd Thomas, Adam M Galloway, Luke M Davies, Kelly Gray, Sue Brennan, Renea V Johnston, Nicole Williams, Craig F Munns, Verity Pacey","doi":"10.1002/14651858.CD016326","DOIUrl":"10.1002/14651858.CD016326","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To investigate the benefits and harms of surgical, non-surgical, and pharmacological interventions for paediatric primary lower limb avascular necrosis (AVN). This is a common review protocol, outlining the approach for four separate Cochrane reviews for paediatric primary lower limb AVN. To assess the benefit and harm of surgical interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the benefit and harm of non-surgical interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the benefit and harm of pharmacological interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. To assess the comparative effectiveness of surgical, non-surgical, and pharmacological interventions for paediatric primary lower limb AVN on function, pain, patient-reported outcomes, and radiological outcomes. The secondary objective for all four of the reviews is to evaluate health equity by assessing the effects across different geographical regions, gender, and age groups.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016326"},"PeriodicalIF":8.8,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12892395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156122","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 : 2026-02-11DOI: 10.1002/14651858.CD015072.pub2
Ya Gao, Ming Liu, Lun Li, Junhua Zhang, Fujian Song, Jinhui Tian
<p><strong>Background: </strong>Triple-negative breast cancer (TNBC), an aggressive subtype lacking oestrogen and progesterone receptors and amplification of HER2 receptors, accounts for 12% to 17% of breast cancers. Adjuvant and neoadjuvant chemotherapy improve survival; however, 30% to 40% of early-stage TNBC cases progress to metastatic disease. Recent evidence suggests that combining immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) with chemotherapy may improve pathological complete response and event-free survival.</p><p><strong>Objectives: </strong>To assess the benefits and harms of immune checkpoint inhibitors (PD-1 or PD-L1 inhibitors) plus chemotherapy compared with chemotherapy for people with early TNBC.</p><p><strong>Search methods: </strong>We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, the WHO ICTRP, and ClinicalTrials.gov up to 6 November 2024. We also searched the reference lists of identified relevant trials or reviews for potentially eligible studies.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs) comparing PD-1 or PD-L1 inhibitors plus chemotherapy with chemotherapy alone in participants with early TNBC.</p><p><strong>Data collection and analysis: </strong>Pairs of review authors independently identified studies for inclusion and performed data extraction and risk of bias assessment. Outcomes were pathological complete response, event-free survival (EFS), overall survival (OS), health-related quality of life (HRQoL), and overall rates of any adverse events and serious adverse events (SAEs). We calculated hazard ratios (HRs) for time-to-event data, risk ratios (RRs), odds ratios (ORs), or risk differences (RDs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes with corresponding 95% confidence intervals (CIs). We performed random-effects meta-analyses to summarise the evidence and evaluated the certainty of evidence using the GRADE approach.</p><p><strong>Main results: </strong>We included seven RCTs with a total of 4341 participants. Two trials investigated PD-1 inhibitors (i.e. pembrolizumab), and five investigated PD-L1 inhibitors (i.e. durvalumab, atezolizumab) in the intervention group. Six studies used neoadjuvant chemotherapy (NACT), and one study used adjuvant chemotherapy (ACT) in the control group. The studies cover a five-year follow-up period. Two studies were at low risk of bias for all reported outcomes. The main limitation of the other trials was lack of blinding. PD-1 or PD-L1 inhibitors plus chemotherapy versus chemotherapy alone beforebreast cancer surgery PD-1 or PD-L1 inhibitors plus chemotherapy probably increase pathological complete response rate (RR 1.47, 95% CI 1.15 to 1.86; 6 studies, 1564 participants; moderate-certainty evidence); improve EFS (HR 0.64, 95% CI 0.52 to 0.79; 4 studies, 1789 participants; high-certainty evidence); and probably improve OS (HR 0.56, 95% CI 0.34 to 0.93; 3 studies,
背景:三阴性乳腺癌(TNBC)是一种缺乏雌激素和孕激素受体以及HER2受体扩增的侵袭性亚型,占乳腺癌的12% - 17%。辅助和新辅助化疗可提高生存率;然而,30%至40%的早期TNBC病例进展为转移性疾病。最近的证据表明,免疫检查点抑制剂(PD-1/PD-L1抑制剂)联合化疗可以改善病理完全缓解和无事件生存期。目的:评估免疫检查点抑制剂(PD-1或PD-L1抑制剂)联合化疗与化疗对早期TNBC患者的益处和危害。检索方法:我们检索了截至2024年11月6日的Cochrane乳腺癌组专业注册、CENTRAL、MEDLINE、Embase、WHO ICTRP和ClinicalTrials.gov。我们还检索了已确定的相关试验或综述的参考文献列表,以寻找可能符合条件的研究。选择标准:比较早期TNBC患者PD-1或PD-L1抑制剂加化疗与单独化疗的随机对照试验(rct)。数据收集和分析:两组综述作者独立确定纳入的研究,并进行数据提取和偏倚风险评估。结果为病理完全缓解、无事件生存期(EFS)、总生存期(OS)、健康相关生活质量(HRQoL)以及任何不良事件和严重不良事件(SAEs)的总发生率。我们计算了时间到事件数据的风险比(hr),二分类结局的风险比(rr)、优势比(ORs)或风险差异(rd),以及具有相应95%置信区间(ci)的连续结局的平均差异(MDs)。我们进行了随机效应荟萃分析来总结证据,并使用GRADE方法评估证据的确定性。主要结果:纳入7项随机对照试验,共纳入4341名受试者。两项试验研究PD-1抑制剂(即派姆单抗),五项试验研究PD-L1抑制剂(即durvalumab, atezolizumab)在干预组。6项研究使用新辅助化疗(NACT), 1项研究使用辅助化疗(ACT)作为对照组。这些研究涵盖了五年的随访期。两项研究的所有报告结果均为低偏倚风险。其他试验的主要限制是缺乏盲法。乳腺癌手术前PD-1或PD-L1抑制剂加化疗与单独化疗相比,PD-1或PD-L1抑制剂加化疗可能增加病理完全缓解率(RR 1.47, 95% CI 1.15至1.86;6项研究,1564名受试者;中等确定性证据);改善EFS (HR 0.64, 95% CI 0.52 ~ 0.79; 4项研究,1789名受试者;高确定性证据);并可能改善OS (HR 0.56, 95% CI 0.34 - 0.93; 3项研究,1681名参与者;中等确定性证据)。PD-1或PD-L1抑制剂联合化疗与单独化疗在HRQoL方面可能差异不大或没有差异(MD -1.49, 95% CI -3.88 - 0.91; 2项研究,1395名受试者;低确定性证据)。与单独化疗相比,PD-1或PD-L1抑制剂加化疗可能对任何不良事件(or 0.26, 95% CI 0.05至1.24;3项研究,1781名受试者;中等确定性证据)和治疗相关死亡(RD 0.2%, 95% CI -0.4%至0.8%;4项研究,1761名受试者;中等确定性证据)影响很小或没有影响。与单独化疗相比,PD-1或PD-L1抑制剂加化疗可能增加免疫相关sae (or 1.75, 95% CI 1.15至2.67;5项研究,2016名受试者;中等确定性证据)。乳腺癌手术后PD-1或PD-L1抑制剂加化疗与单独化疗相比,PD-1或PD-L1抑制剂加化疗与单独化疗在EFS (HR 1.11, 95% CI 0.87 - 1.42, 1项研究,2199名受试者,低确定性证据)、OS (HR 1.23, 95% CI 0.87 - 1.73, 1项研究,2199名受试者,低确定性证据)、HRQoL (MD -1.02, 95% CI -2.71 - 0.67, 1项研究,2168名受试者;低确定性证据)、任何不良事件(OR 3.38, 95% CI 0.93 ~ 12.33; 1项研究,2177名受试者;低确定性证据)和治疗相关死亡(RD -0.1%, 95% CI -0.4% ~ 0.2%; 1项研究,2177名受试者;低确定性证据)。与单独化疗相比,PD-1或PD-L1抑制剂加化疗可能增加免疫相关sae (or 1.81, 95% CI 1.47 - 2.24; 1项研究,2177名受试者;中等确定性证据)。作者的结论是:与乳腺癌手术前单独化疗相比,联合PD-1或PD-L1抑制剂化疗可改善早期TNBC的病理反应、EFS和OS。相比之下,与单独化疗相比,乳腺癌手术后PD-1/PD-L1抑制剂联合化疗对早期TNBC患者EFS和OS的影响可能很小或没有影响。 添加PD-1或PD-L1抑制剂可能会增加免疫相关的sae。
{"title":"Immune checkpoint inhibitors and chemotherapy versus chemotherapy for early triple-negative breast cancer.","authors":"Ya Gao, Ming Liu, Lun Li, Junhua Zhang, Fujian Song, Jinhui Tian","doi":"10.1002/14651858.CD015072.pub2","DOIUrl":"10.1002/14651858.CD015072.pub2","url":null,"abstract":"<p><strong>Background: </strong>Triple-negative breast cancer (TNBC), an aggressive subtype lacking oestrogen and progesterone receptors and amplification of HER2 receptors, accounts for 12% to 17% of breast cancers. Adjuvant and neoadjuvant chemotherapy improve survival; however, 30% to 40% of early-stage TNBC cases progress to metastatic disease. Recent evidence suggests that combining immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) with chemotherapy may improve pathological complete response and event-free survival.</p><p><strong>Objectives: </strong>To assess the benefits and harms of immune checkpoint inhibitors (PD-1 or PD-L1 inhibitors) plus chemotherapy compared with chemotherapy for people with early TNBC.</p><p><strong>Search methods: </strong>We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, the WHO ICTRP, and ClinicalTrials.gov up to 6 November 2024. We also searched the reference lists of identified relevant trials or reviews for potentially eligible studies.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs) comparing PD-1 or PD-L1 inhibitors plus chemotherapy with chemotherapy alone in participants with early TNBC.</p><p><strong>Data collection and analysis: </strong>Pairs of review authors independently identified studies for inclusion and performed data extraction and risk of bias assessment. Outcomes were pathological complete response, event-free survival (EFS), overall survival (OS), health-related quality of life (HRQoL), and overall rates of any adverse events and serious adverse events (SAEs). We calculated hazard ratios (HRs) for time-to-event data, risk ratios (RRs), odds ratios (ORs), or risk differences (RDs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes with corresponding 95% confidence intervals (CIs). We performed random-effects meta-analyses to summarise the evidence and evaluated the certainty of evidence using the GRADE approach.</p><p><strong>Main results: </strong>We included seven RCTs with a total of 4341 participants. Two trials investigated PD-1 inhibitors (i.e. pembrolizumab), and five investigated PD-L1 inhibitors (i.e. durvalumab, atezolizumab) in the intervention group. Six studies used neoadjuvant chemotherapy (NACT), and one study used adjuvant chemotherapy (ACT) in the control group. The studies cover a five-year follow-up period. Two studies were at low risk of bias for all reported outcomes. The main limitation of the other trials was lack of blinding. PD-1 or PD-L1 inhibitors plus chemotherapy versus chemotherapy alone beforebreast cancer surgery PD-1 or PD-L1 inhibitors plus chemotherapy probably increase pathological complete response rate (RR 1.47, 95% CI 1.15 to 1.86; 6 studies, 1564 participants; moderate-certainty evidence); improve EFS (HR 0.64, 95% CI 0.52 to 0.79; 4 studies, 1789 participants; high-certainty evidence); and probably improve OS (HR 0.56, 95% CI 0.34 to 0.93; 3 studies, ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD015072"},"PeriodicalIF":8.8,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12892397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156066","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 : 2026-02-10DOI: 10.1002/14651858.CD016328
Xin Lu, Yanxia Gao, Chao Gong, Qin Zhou, Mubing Qin, Zengrui Song, Yi Li
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of clarithromycin for treating sepsis in adults versus standard care with or without placebo or with an alternative active intervention, or clarithromycin in combination with antibiotic therapy versus standard care.
{"title":"Clarithromycin for treating sepsis in adults.","authors":"Xin Lu, Yanxia Gao, Chao Gong, Qin Zhou, Mubing Qin, Zengrui Song, Yi Li","doi":"10.1002/14651858.CD016328","DOIUrl":"10.1002/14651858.CD016328","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of clarithromycin for treating sepsis in adults versus standard care with or without placebo or with an alternative active intervention, or clarithromycin in combination with antibiotic therapy versus standard care.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016328"},"PeriodicalIF":8.8,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888077/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149353","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 : 2026-02-10DOI: 10.1002/14651858.CD016149
Miya St John, Elizabeth Murray, Frederique J Liégeois, Angela T Morgan
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To examine the effectiveness of speech and language interventions for children and adolescents with Childhood Apraxia of Speech (CAS) as delivered by speech and language pathologists/therapists or by other personnel under the direction of a speech and language pathologist/therapist.
{"title":"Interventions for childhood apraxia of speech.","authors":"Miya St John, Elizabeth Murray, Frederique J Liégeois, Angela T Morgan","doi":"10.1002/14651858.CD016149","DOIUrl":"10.1002/14651858.CD016149","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To examine the effectiveness of speech and language interventions for children and adolescents with Childhood Apraxia of Speech (CAS) as delivered by speech and language pathologists/therapists or by other personnel under the direction of a speech and language pathologist/therapist.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"2 ","pages":"CD016149"},"PeriodicalIF":8.8,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149327","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}