Pub Date : 2026-01-09DOI: 10.1002/14651858.CD013524.pub2
Maria Grazia Celani, Massimiliano Orso, Marta Melis, Maria Vittoria Ercolani, Teresa Anna Cantisani
<p><strong>Rationale: </strong>Multiple sclerosis (MS) is a chronic, degenerative, autoimmune-mediated disease of the central nervous system (CNS). Although its pathogenesis is not fully understood, inflammation involving both T and B cells is considered an essential factor. Cladribine induces targeted lymphocyte depletion in the peripheral and central nervous system, potentially lowering inflammation and slowing disease progression.</p><p><strong>Objectives: </strong>To assess the short- and long-term benefits and harms of cladribine compared to no intervention, placebo, or any other disease-modifying drugs (DMDs) in people with any form of multiple sclerosis (MS).</p><p><strong>Search methods: </strong>We searched the Cochrane MS and Rare Diseases of the CNS Trials Register (part of CENTRAL), MEDLINE, Embase, CINAHL, LILACS, major trials registries, and conference abstracts up to 3 February 2025.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs), their open-label extension trials (OLEs), the first phase of cross-over trials, and non-randomised studies of interventions (NRSIs) that investigated cladribine, alone or in combination, at any dose or duration versus no intervention, placebo, or any other DMDs. Participants had a confirmed diagnosis of MS or clinically isolated syndrome according to accepted criteria. We excluded retrospective studies and studies without a comparison group.</p><p><strong>Outcomes: </strong>Critical outcomes Number of participants at the end of follow-up: with at least one serious adverse event (SAE), free from disability worsening, with no evidence of disease activity (NEDA), who withdrew from treatment, and with cognitive impairment; and quality of life. Important outcomes Number of participants at the end of follow-up with: at least one advert event, at least one new relapse, and new gadolinium-enhancing positive T1-weighted (Gd+ T1) or new/enlarging T2-weighted magnetic resonance imaging (MRI) lesions.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tools RoB 2 (for RCTs and OLEs) and ROBINS-I (for NRSIs).</p><p><strong>Synthesis methods: </strong>We conducted random-effects meta-analyses to calculate risk ratios (RRs) with 95% confidence intervals (CIs), assessing RCTs, OLEs, and NRSIs separately. We assessed the certainty of evidence using GRADE.</p><p><strong>Included studies: </strong>We included 15 studies: nine RCTs (follow-up 52-96 weeks; 2571 participants), two medium-term follow-up OLEs (24-96 weeks; 915 participants), two long-term follow-up OLEs (9.5-11.4 years), one NRSI with one year of follow-up (37 participants in cladribine group vs 599 in interferon beta [IFN-β], fingolimod, and natalizumab groups), and one NRSI with three years of follow-up (633 participants in cladribine group vs 2842 in fingolimod, dimethyl fumarate, and teriflunomide groups). Three reports assessed MRI outcomes. No studies reported quality of life or cognitive im
理由：多发性硬化症（MS）是一种慢性、退行性、自身免疫介导的中枢神经系统（CNS）疾病。尽管其发病机制尚不完全清楚，但涉及T细胞和B细胞的炎症被认为是必不可少的因素。Cladribine诱导外周和中枢神经系统的靶向淋巴细胞耗竭，可能降低炎症并减缓疾病进展。目的：评估与无干预、安慰剂或任何其他疾病改善药物（dmd）相比，克拉德滨对任何形式多发性硬化症（MS）患者的短期和长期益处和危害。检索方法：我们检索了截至2025年2月3日的Cochrane多发性硬化症和罕见病的中枢神经系统试验注册（CENTRAL的一部分）、MEDLINE、Embase、CINAHL、LILACS、主要试验注册和会议摘要。入选标准：我们纳入了随机对照试验（RCTs）、它们的开放标签扩展试验（ole）、第一阶段交叉试验和非随机干预研究（NRSIs），这些研究调查了单独或联合使用任何剂量或持续时间的克拉德里滨与不干预、安慰剂或任何其他dmd的对比。参与者根据公认的标准确诊为多发性硬化症或临床孤立综合征。我们排除了回顾性研究和没有对照组的研究。随访结束时的参与者人数：至少有一个严重不良事件（SAE），无残疾恶化，无疾病活动证据（NEDA），退出治疗，认知障碍；以及生活质量。随访结束时的参与者人数：至少有一个不良事件，至少有一个新的复发，新的钆增强T1加权阳性（Gd+ T1）或新的/扩大的t2加权磁共振成像（MRI）病变。偏倚风险：我们使用Cochrane偏倚风险工具RoB 2（用于rct和ole）和ROBINS-I（用于nrsi）。综合方法：我们进行随机效应荟萃分析，以95%置信区间（ci）计算风险比（RRs），分别评估rct、OLEs和nrsi。我们使用GRADE评估证据的确定性。纳入的研究：我们纳入了15项研究：9项随机对照试验（随访52-96周，2571名受试者），2项中期随访ole(24-96周；915例受试者)，2例长期随访ole（9.5-11.4年），1例NRSI随访1年（克拉德里滨组37例，干扰素β [IFN-β]、芬戈莫德和那他单抗组599例），1例NRSI随访3年（克拉德里滨组633例，芬戈莫德、富马酸二甲酯和特立氟米特组2842例）。三份报告评估了MRI结果。没有研究报告生活质量或认知障碍。结果综合：随机对照试验：与安慰剂相比，克拉宾可能对SAEs（相对危险度1.08,95% CI 0.80至1.45；8项研究，2495名受试者）和治疗停药（相对危险度1.43,95% CI 0.77至2.66;I²= 76%；8项研究，2503名受试者）的风险影响很小或没有影响，但这两个结果的证据都非常不确定。Cladribine可能对24个月内没有残疾恶化的人数几乎没有影响（RR 1.05, 95% CI 0.96至1.16；3项研究，1549名受试者；低确定性）。与安慰剂相比，克拉德滨可能增加任何不良事件的风险，但证据非常不确定（RR 1.14, 95% CI 1.02至1.28；8项研究，2405名受试者）。克拉德滨可能降低新发复发的风险（RR 0.53, 95% CI 0.45至0.62；2项研究，1498名受试者；中等确定性），它可能降低新发Gd+ T1 MRI病变的风险，尽管结果是异质的，证据是非常不确定的（RR 0.30, 95% CI 0.19至0.47;I²= 79%；4项研究，2153名受试者）。随访超过2年，与安慰剂相比，克拉德滨可能对SAEs （RR 0.89, 95% CI 0.60 - 1.33； 2项研究，915名受试者）、无残疾恶化风险（RR 1.02, 95% CI 0.93 - 1.11； 1项研究，806名受试者）和治疗停药（RR 0.93, 95% CI 0.81 - 1.08； 2项研究，915名受试者）的影响很小或没有影响，但这三个结果的证据都非常不确定。Cladribine可能增加4年时NEDA患者的比例（RR 1.63, 95% CI 1.23 - 2.16； 2项研究，662名受试者；低确定性）。与安慰剂相比，克拉宾可能对任何不良事件的风险几乎没有影响（RR 1.04, 95% CI 0.96至1.12；2项研究，916名受试者），并可能在长期随访中减少复发（RR 0.68, 95% CI 0.59至0.79；2项研究，662名受试者），但这两种结果的证据都非常不确定。在一项研究中，克拉德滨减少了新的Gd+ T1 MRI病变，但证据非常不确定（RR 0.68, 95% CI 0.52至0.88；806名参与者）。 干预措施的非随机研究观察性比较（1项研究）显示，与富马酸二甲酯相比，克拉德滨在三年内减少了复发率（RR 0.57, 95% CI 0.38至0.88；低确定性）；•特立氟米特（RR 0.30, 95% CI 0.20 - 0.47，中等确定性）；•fingolimod （RR 0.51, 95% CI 0.36 ~ 0.74；中等确定性）。然而，与芬戈莫德相比，克拉德里滨对12个月内复发的影响的证据非常不确定：•芬戈莫德（RR 1.05, 95% CI 0.52至2.10；非常低的确定性）；•natalizumab （RR 1.25, 95% CI 0.58 - 2.71，非常低的确定性）；干扰素β （RR 0.65, 95% CI 0.26 - 1.62；非常低的确定性）。作者的结论是：Cladribine是一种口服治疗成人多发性硬化症的药物，只需很少的监测访问和两年以上的短期疗程，从而减轻了治疗负担，基于非常低确定性的证据，其安全性似乎是可以接受的。来自随机对照试验的证据表明，克拉德滨可能减少新的复发，可能减少新的Gd+ T1 MRI病变（尽管证据非常不确定），但可能对减缓残疾进展几乎没有影响。ole的结果显示，克拉宾可能会增加4年时NEDA患者的比例。由于缺乏研究，亚组和一些关键结果的获益仍然不确定。需要进一步开展高质量的对照试验和以患者为中心的实用登记，以加强证据基础。资金来源：Cochrane综述没有专门的资金来源。注册：协议可通过https://doi.org/10.1002/14651858.CD013524获得。
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Pub Date : 2026-01-08DOI: 10.1002/14651858.CD004366.pub7
Andrew J Clegg, James E Hill, Donncha S Mullin, Catherine Harris, Chris J Smith, C Elizabeth Lightbody, Kerry Dwan, Gary M Cooney, Gillian E Mead, Caroline L Watkins
<p><strong>Rationale: </strong>Depression is a common cause of morbidity and mortality worldwide. Depression is often treated with antidepressants or psychological therapy, or both, but some people may prefer alternative approaches such as exercise. This review updates one first published in 2008 and last updated in 2013.</p><p><strong>Objectives: </strong>To determine the effectiveness of exercise in the treatment of depression in adults compared with no intervention, waiting list control or placebo, or where exercise is used as an adjunct to an established treatment that is received by both exercising and non-exercising groups. To determine the effectiveness of exercise compared with other active interventions for depression in adults (psychological therapies, pharmacological treatments or alternative interventions such as light therapy).</p><p><strong>Search methods: </strong>We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Controlled Trials Register (CCDANCTR) to November 2013. We searched MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials (CENTRAL) from 2013 to November 2023. No date or language restrictions were applied.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) in which exercise was compared to no treatment, inactive treatment or active treatment in adults (aged 18 years and over) with depression. We included trials that randomised individual participants or clusters. We excluded trials of postnatal depression. Two authors independently undertook study selection.</p><p><strong>Outcomes: </strong>The primary outcome we assessed was a measure of depression or mood at the end of treatment and at any longer-term follow-up. Other outcomes were treatment acceptability, quality of life, cost and adverse events.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias using the Cochrane risk of bias tool RoB 1. Two authors independently performed the risk of bias assessment.</p><p><strong>Synthesis methods: </strong>Two authors independently extracted data on outcomes at the end of the trial and end of follow-up (if available). We calculated effect sizes for each trial using Hedges' g method and a mean difference (MD) or standardised mean difference (SMD) for the overall pooled effect for continuous data, and risk ratios for dichotomous data. Where trials used a number of different tools to assess depression, we included only the main outcome measure in our meta-analyses. Where trials provided several 'doses' of exercise, we used data from the largest dose and performed sensitivity analysis using the lower dose. We performed subgroup analysis to explore the influence of diagnostic method, exercise intensity, number of exercise sessions, type of exercise and type of control (i.e. placebo, no treatment, waiting list, usual care and self monitoring). Through our sensitivity analyses, we explored the influence of study risk of bias.</p><p>
理由：抑郁症是全世界发病率和死亡率的常见原因。抑郁症通常用抗抑郁药或心理治疗来治疗，或者两者兼而有之，但有些人可能更喜欢其他方法，比如锻炼。这篇综述更新了2008年首次发表、2013年最后更新的一篇综述。目的：确定运动治疗成人抑郁症的有效性，与不干预、等候名单对照或安慰剂相比，或将运动作为既定治疗的辅助治疗，在运动组和非运动组中均接受。确定运动与其他积极干预措施（心理治疗、药物治疗或替代干预措施，如光疗）相比对成人抑郁症的有效性。检索方法：我们检索了Cochrane抑郁、焦虑和神经症回顾组的对照试验注册（CCDANCTR）至2013年11月。我们检索了2013年至2023年11月的MEDLINE、Embase、PsycINFO和Cochrane Central Register of Controlled Trials （Central）。没有日期或语言限制。入选标准：我们纳入了随机对照试验（RCTs），在这些试验中，对18岁及以上的成人抑郁症患者进行运动与不治疗、不积极治疗或积极治疗的比较。我们纳入了随机个体参与者或群体的试验。我们排除了产后抑郁症的试验。两位作者独立进行了研究选择。结果：我们评估的主要结果是治疗结束时和任何长期随访时的抑郁或情绪测量。其他结果包括治疗可接受性、生活质量、费用和不良事件。偏倚风险：我们使用Cochrane偏倚风险工具RoB 1评估偏倚风险。两位作者独立进行了偏倚风险评估。综合方法：两位作者独立提取试验结束和随访结束（如果有）的结果数据。我们使用Hedges' g方法计算每个试验的效应大小，并使用连续数据的总体汇总效应的平均差（MD）或标准化平均差（SMD）和二分类数据的风险比。在试验中使用了许多不同的工具来评估抑郁症，我们在meta分析中只包括了主要的结果测量。当试验提供了几个“剂量”的运动时，我们使用最大剂量的数据，并使用较低剂量进行敏感性分析。我们进行了亚组分析，以探讨诊断方法、运动强度、运动次数、运动类型和控制类型（即安慰剂、无治疗、等候名单、常规护理和自我监测）的影响。通过敏感性分析，我们探讨了研究偏倚风险的影响。纳入的研究：我们纳入了73项随机对照试验（至少4985名受试者），其中69项为我们的荟萃分析提供了数据。结果综合：57项试验（2189名受试者）比较运动与不治疗或对照干预，治疗结束时抑郁症状的综合SMD为-0.67(95%可信区间(CI) -0.82至-0.52；低确定性证据)，表明运动可能导致抑郁症状的减轻。当我们仅纳入7项试验（447名受试者），并进行适当的分配隐藏、意向治疗分析和盲法结果评估时，合并的SMD较小（SMD -0.46, 95% CI -0.88至-0.04）。9项试验（405名参与者）的长期随访汇总数据提供了关于运动对抑郁症状影响的非常不确定的证据（SMD -0.53, 95% CI -1.11至0.06；非常低确定性证据）。10项试验（414名参与者）比较了运动和心理治疗，发现它们在治疗结束时对抑郁症状的影响可能几乎没有差异（SMD为0.03,95% CI为-0.16至0.23；中等确定性证据）。在长期随访中也有类似的结果（SMD -0.11, 95% CI -0.48 - 0.26； 4项研究，114名受试者；低确定性证据）。五项试验（330名参与者）比较了运动与药物治疗，发现它们在治疗结束时对抑郁症状的影响可能几乎没有差异（SMD -0.11, 95% CI -0.33至0.10；低确定性证据）。在长期随访中，证据非常不确定（SMD -0.40, 95% CI -0.80 - 0.00； 1项研究，58名参与者；非常低确定性证据）。在治疗可接受性方面，运动和其他干预措施之间似乎没有差异，正如完成研究的参与者所测量的那样（中度到低确定性证据）。结果“生活质量”的结果不一致（低到非常低的确定性证据）。 不良事件在任何比较中都不常见，但包括肌肉骨骼损伤和运动患者的抑郁，以及服用舍曲林的患者报告的腹泻、性功能障碍和疲劳。许多试验受到多重偏倚来源的影响：只有22项研究充分掩盖了随机化，只有31项研究使用了意向治疗分析，只有23项研究使用了盲法结果评估。对接受和提供干预措施的人进行盲测本身就是困难的；我们判断所有的研究都有较高的表现偏倚风险。许多试验使用参与者自我报告评定量表，这有可能使研究结果产生偏倚。作者的结论是：在减轻抑郁症状方面，运动可能比对照干预更有效。运动似乎并不比心理或药物治疗更有效，尽管这个结论是基于一些小的试验。长期随访很少。在这一更新中增加了35项随机对照试验（至少2526名参与者），这对估计运动对抑郁症症状的益处几乎没有影响。如果要进行进一步的研究，它应该把重点放在提高试验质量上，评估运动的哪些特征对不同的人有效，并探索健康公平。经费：本综述更新没有经费资助。综述作者AC、JH、CH和CW由美国国家卫生与保健研究所西北海岸应用研究合作组织（NIHR ARC NWC）部分资助。所表达的观点是作者的观点，不一定是NHS、NIHR或卫生和社会保障部的观点。注册：协议和以前版本：DOI 10.1002/14651858.CD004366；DOI cd4366.pub2 10.1002/14651858.;DOI cd4366.pub3 10.1002/14651858.;DOI cd4366.pub4 10.1002/14651858.;DOI cd4366.pub5 10.1002/14651858.;DOI cd4366.pub6 10.1002/14651858.。
{"title":"Exercise for depression.","authors":"Andrew J Clegg, James E Hill, Donncha S Mullin, Catherine Harris, Chris J Smith, C Elizabeth Lightbody, Kerry Dwan, Gary M Cooney, Gillian E Mead, Caroline L Watkins","doi":"10.1002/14651858.CD004366.pub7","DOIUrl":"10.1002/14651858.CD004366.pub7","url":null,"abstract":"<p><strong>Rationale: </strong>Depression is a common cause of morbidity and mortality worldwide. Depression is often treated with antidepressants or psychological therapy, or both, but some people may prefer alternative approaches such as exercise. This review updates one first published in 2008 and last updated in 2013.</p><p><strong>Objectives: </strong>To determine the effectiveness of exercise in the treatment of depression in adults compared with no intervention, waiting list control or placebo, or where exercise is used as an adjunct to an established treatment that is received by both exercising and non-exercising groups. To determine the effectiveness of exercise compared with other active interventions for depression in adults (psychological therapies, pharmacological treatments or alternative interventions such as light therapy).</p><p><strong>Search methods: </strong>We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Controlled Trials Register (CCDANCTR) to November 2013. We searched MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials (CENTRAL) from 2013 to November 2023. No date or language restrictions were applied.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) in which exercise was compared to no treatment, inactive treatment or active treatment in adults (aged 18 years and over) with depression. We included trials that randomised individual participants or clusters. We excluded trials of postnatal depression. Two authors independently undertook study selection.</p><p><strong>Outcomes: </strong>The primary outcome we assessed was a measure of depression or mood at the end of treatment and at any longer-term follow-up. Other outcomes were treatment acceptability, quality of life, cost and adverse events.</p><p><strong>Risk of bias: </strong>We assessed the risk of bias using the Cochrane risk of bias tool RoB 1. Two authors independently performed the risk of bias assessment.</p><p><strong>Synthesis methods: </strong>Two authors independently extracted data on outcomes at the end of the trial and end of follow-up (if available). We calculated effect sizes for each trial using Hedges' g method and a mean difference (MD) or standardised mean difference (SMD) for the overall pooled effect for continuous data, and risk ratios for dichotomous data. Where trials used a number of different tools to assess depression, we included only the main outcome measure in our meta-analyses. Where trials provided several 'doses' of exercise, we used data from the largest dose and performed sensitivity analysis using the lower dose. We performed subgroup analysis to explore the influence of diagnostic method, exercise intensity, number of exercise sessions, type of exercise and type of control (i.e. placebo, no treatment, waiting list, usual care and self monitoring). Through our sensitivity analyses, we explored the influence of study risk of bias.</p><p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD004366"},"PeriodicalIF":8.8,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12779368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917186","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 : 2026-01-07DOI: 10.1002/14651858.CD016315
Angela Shahbazian, Mark Sherstinsky, Elysia M Ison, Genie Han, Zanna Kruoch, Kensington Hatcher, John G Lawrenson
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the effectiveness of telemedicine diabetic retinopathy screening versus traditional in-person eye exams in people with type 1 or 2 diabetes mellitus on screening uptake, screening adherence, and referral adherence.
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Pub Date : 2026-01-07DOI: 10.1002/14651858.CD011506.pub3
Enrico Bodrero, María Carolina Isaza-López, Michelle Fiander, Gorm Greisen, Christian Gluud, Matteo Bruschettini
<p><strong>Rationale: </strong>Very preterm infants (i.e. born before 32 weeks of gestation) are at risk of cerebral injury and long-term neurodevelopmental impairment. Cerebral near-infrared spectroscopy (NIRS) enables continuous monitoring of cerebral oxygenation to guide clinical management. Interest in NIRS has grown in recent years, highlighting the need for better evidence to support its clinical efficacy in improving brain development and reducing neurological sequelae. This is an update of a Cochrane review first published in 2017.</p><p><strong>Objectives: </strong>To evaluate the beneficial and harmful effects of cerebral near-infrared spectroscopy (NIRS) monitoring versus no NIRS or blinded NIRS monitoring in very preterm infants.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, three trial registries, and conference abstracts up to August 2025. We also checked reference lists of included studies and relevant systematic reviews.</p><p><strong>Eligibility criteria: </strong>We included randomised clinical trials (RCTs) comparing cerebral NIRS monitoring versus no NIRS or blinded NIRS monitoring (where the treating healthcare professionals were unaware of the oxygenation levels) in very preterm infants.</p><p><strong>Outcomes: </strong>Our critical outcomes included all-cause mortality at longest follow-up, major neurodevelopmental disability in children aged 18 to 24 months (a composite outcome including cerebral palsy, severe neurodevelopmental impairment, blindness, and profound hearing impairment), and major brain injury prior to discharge. Our important outcomes included chronic lung disease at 36 weeks' gestational age, proven necrotising enterocolitis prior to discharge, retinopathy of prematurity (stage ≥ III) prior to discharge, and severe adverse reactions prior to discharge.</p><p><strong>Risk of bias: </strong>We used Cochrane's original risk of bias tool (RoB 1).</p><p><strong>Synthesis methods: </strong>We conducted meta-analyses using fixed-effect models to calculate risk ratios (RRs) and 95% confidence intervals (CIs) for all outcomes. We summarised the certainty of the evidence according to GRADE methods.</p><p><strong>Included studies: </strong>We included five parallel-group RCTs published between 2016 and 2023 that enroled a total of 2415 infants, with sample sizes ranging from 23 to 1600 infants per trial. The mean gestational age ranged from 26.1 weeks to 33.1 weeks. Four trials were conducted in multiple hospitals in high-income countries across North America, Asia, and Europe. The remaining trial took place in a single hospital in Austria. The comparator was no NIRS in two trials and blinded NIRS in three trials. In all trials, infants in the NIRS group were treated according to brain oxygen saturation values with specific preset treatment regimens, while those in the control group received standard or usual care regardless of NIRS monitoring values. The trials involved infants w
理由：极早产儿（即在妊娠32周前出生）存在脑损伤和长期神经发育障碍的风险。脑近红外光谱（NIRS）可以连续监测脑氧合，指导临床管理。近年来，人们对近红外光谱的兴趣越来越大，需要更好的证据来支持其在改善大脑发育和减少神经系统后遗症方面的临床疗效。这是对2017年首次发表的Cochrane综述的更新。目的：评价脑近红外光谱（NIRS）监测与不进行NIRS或盲法NIRS监测对早产儿的有益和有害影响。检索方法：我们检索了截止到2025年8月的CENTRAL、MEDLINE、Embase、CINAHL、三个试验注册中心和会议摘要。我们还检查了纳入研究的参考文献和相关的系统评价。入选标准：我们纳入了随机临床试验（rct），比较极早产儿脑NIRS监测与无NIRS或盲法NIRS监测（治疗保健专业人员不知道氧合水平）。结果：我们的关键结果包括最长随访时的全因死亡率、18至24个月儿童的主要神经发育障碍（包括脑瘫、严重神经发育障碍、失明和深度听力障碍的复合结果）和出院前的主要脑损伤。我们的重要结局包括妊娠36周时的慢性肺病、出院前证实的坏死性小肠结肠炎、出院前的早产儿视网膜病变（≥III期）和出院前的严重不良反应。偏倚风险：我们使用Cochrane的原始偏倚风险工具（RoB 1）。综合方法：我们使用固定效应模型进行meta分析，计算所有结果的风险比（rr）和95%置信区间（ci）。我们根据GRADE方法总结证据的确定性。纳入的研究：我们纳入了2016年至2023年间发表的5项平行组随机对照试验，共纳入2415名婴儿，每项试验的样本量从23名到1600名不等。平均胎龄26.1 ~ 33.1周。四项试验在北美、亚洲和欧洲高收入国家的多家医院进行。其余的试验在奥地利的一家医院进行。比较者在两个试验中没有近红外光谱，在三个试验中盲法近红外光谱。在所有试验中，NIRS组的婴儿根据脑氧饱和度值和特定的预设治疗方案进行治疗，而对照组的婴儿无论NIRS监测值如何，都接受标准或常规护理。试验涉及不同开始时间和NIRS监测持续时间的婴儿。只有一项试验报告了主要的神经发育障碍，两项试验报告了早产儿视网膜病变（≥III期）。所有五项试验均为本综述的其他主要结局提供了数据。我们确定了五个正在进行的试验。综合结果：近红外光谱监测与无近红外光谱监测或盲法近红外光谱监测相比，最长随访期间的全因死亡率（RR 0.99, 95% CI 0.82至1.18;I²= 46%；5项研究，2415名受试者；中等确定性证据）和出院前脑超声诊断的严重脑损伤（RR 0.99, 95% CI 0.84至1.17;I²= 13%；5项研究，2415名受试者；中等确定性证据）几乎没有差异。与盲法NIRS监测相比，NIRS监测对18 - 24月龄儿童主要神经发育障碍的影响的证据非常不确定（RR 1.28, 95% CI 0.50 - 3.29； 1项研究，115名参与者；极低确定性证据）。近红外光谱监测与无近红外光谱监测或盲法近红外光谱监测相比，可能导致36孕周时慢性肺部疾病的差异很小或没有差异（RR 0.95, 95% CI 0.86至1.06;I²= 43%；5项研究，2415名受试者；中等确定性证据），证实出院前出现坏死性小肠结肠炎(RR 1.08, 95% CI 0.85至1.37;I²= 0%；5项研究，2415名受试者；中等确定性证据)，出院前早产儿视网膜病变（≥3期）（RR 1.15, 95% CI 0.86 ~ 1.54; I²= 0%；2项研究，1745名受试者；中等确定性证据），出院前严重不良反应（RR 9.41, 95% CI 0.51 ~ 174.44； I²不适用；5项研究，2415名受试者；中等确定性证据）。作者的结论是：总的来说，对极早产儿进行大脑近红外光谱监测可能对大多数测量结果几乎没有好处。 与常规监测相比，对极早产儿进行脑NIRS监测在最长随访期间的全因死亡率和出院前脑超声诊断的严重脑损伤方面可能几乎没有差异，我们不确定其对18至24个月儿童的主要神经发育障碍的影响。此外，NIRS监测可能导致36周胎龄的慢性肺部疾病、出院前证实的坏死性小肠结肠炎、出院前早产儿严重视网膜病变和出院前严重不良反应的风险几乎没有差异。未来针对极早产儿的随机试验应提供从出生到心肺稳定的连续NIRS监测，以更准确地评估干预的潜在益处。需要进一步的研究来了解和量化现有近红外光谱装置之间的性能差异，并评估其对长期临床结果的影响。在随机对照试验中，很少（如果有的话）生命体征监测方法显示出与患者相关的益处。对于早产儿的脑氧饱和度测定，由于样本量大，使用有临床意义的终点（例如，用贝利量表评估两岁时的神经发育）的试验可能不可行。在这种情况下，替代结果，如缺氧脑损伤的电生理标记，可能提供一个可行的替代方案，前提是它们严格验证了临床终点。资金来源：Cochrane综述没有专门的资金来源。注册：议定书（2015）：doi.org/10.1002/14651858.CD011506原始审查（2017）：doi.org/10.1002/14651858.CD011506.pub2审查更新（2025）：doi.org/10.1002/14651858.CD011506.pub3。
{"title":"Cerebral near-infrared spectroscopy monitoring for prevention of death or neurodevelopmental disability in very preterm infants.","authors":"Enrico Bodrero, María Carolina Isaza-López, Michelle Fiander, Gorm Greisen, Christian Gluud, Matteo Bruschettini","doi":"10.1002/14651858.CD011506.pub3","DOIUrl":"10.1002/14651858.CD011506.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Very preterm infants (i.e. born before 32 weeks of gestation) are at risk of cerebral injury and long-term neurodevelopmental impairment. Cerebral near-infrared spectroscopy (NIRS) enables continuous monitoring of cerebral oxygenation to guide clinical management. Interest in NIRS has grown in recent years, highlighting the need for better evidence to support its clinical efficacy in improving brain development and reducing neurological sequelae. This is an update of a Cochrane review first published in 2017.</p><p><strong>Objectives: </strong>To evaluate the beneficial and harmful effects of cerebral near-infrared spectroscopy (NIRS) monitoring versus no NIRS or blinded NIRS monitoring in very preterm infants.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, three trial registries, and conference abstracts up to August 2025. We also checked reference lists of included studies and relevant systematic reviews.</p><p><strong>Eligibility criteria: </strong>We included randomised clinical trials (RCTs) comparing cerebral NIRS monitoring versus no NIRS or blinded NIRS monitoring (where the treating healthcare professionals were unaware of the oxygenation levels) in very preterm infants.</p><p><strong>Outcomes: </strong>Our critical outcomes included all-cause mortality at longest follow-up, major neurodevelopmental disability in children aged 18 to 24 months (a composite outcome including cerebral palsy, severe neurodevelopmental impairment, blindness, and profound hearing impairment), and major brain injury prior to discharge. Our important outcomes included chronic lung disease at 36 weeks' gestational age, proven necrotising enterocolitis prior to discharge, retinopathy of prematurity (stage ≥ III) prior to discharge, and severe adverse reactions prior to discharge.</p><p><strong>Risk of bias: </strong>We used Cochrane's original risk of bias tool (RoB 1).</p><p><strong>Synthesis methods: </strong>We conducted meta-analyses using fixed-effect models to calculate risk ratios (RRs) and 95% confidence intervals (CIs) for all outcomes. We summarised the certainty of the evidence according to GRADE methods.</p><p><strong>Included studies: </strong>We included five parallel-group RCTs published between 2016 and 2023 that enroled a total of 2415 infants, with sample sizes ranging from 23 to 1600 infants per trial. The mean gestational age ranged from 26.1 weeks to 33.1 weeks. Four trials were conducted in multiple hospitals in high-income countries across North America, Asia, and Europe. The remaining trial took place in a single hospital in Austria. The comparator was no NIRS in two trials and blinded NIRS in three trials. In all trials, infants in the NIRS group were treated according to brain oxygen saturation values with specific preset treatment regimens, while those in the control group received standard or usual care regardless of NIRS monitoring values. The trials involved infants w","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD011506"},"PeriodicalIF":8.8,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12777921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910898","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 : 2026-01-07DOI: 10.1002/14651858.CD016153
Julian Hirt, Magdalena Vogt, Janine Vetsch, Martin N Dichter, Jasmin Eppel-Meichlinger, Hannah Ewald, Ralph Möhler, Martin Mueller, Anne C Rahn, Gabriele Meyer, Thomas Nordhausen
Objectives: This is a protocol for a Cochrane Review (methodology). The objectives are as follows: To evaluate the effects of educational interventions for improving health-related literature searching skills of health professionals and students.
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Pub Date : 2026-01-07DOI: 10.1002/14651858.CD015415.pub2
Luka Vranić, Tin Nadarević, Davor Štimac, Mirella Fraquelli, Cristina Manzotti, Giovanni Casazza, Agostino Colli
<p><strong>Background: </strong>Clinically significant portal hypertension (CSPH) in chronic liver disease (CLD) is a key driver of decompensation, with severe portal hypertension (SPH) leading to severe complications like oesophageal bleeding. Early detection is essential for timely treatment. The current gold standard for assessing portal pressure is hepatic venous pressure gradient (HVPG), an invasive and costly procedure with limited availability. Non-invasive alternatives are increasingly needed to estimate portal pressure (e.g. by liver and spleen stiffness measurement) and guide treatment. However, the diagnostic accuracy of vibration-controlled transient elastography (VCTE), point shear wave elastography (pSWE), two-dimensional shear wave elastography (2D-SWE), and magnetic resonance elastography (MRE) remains unknown.</p><p><strong>Objectives: </strong>Primary objectives: to assess the diagnostic accuracy of liver stiffness measurement (LSM) and spleen stiffness measurement (SSM), as well as in combination, measured by any elastography technique (VCTE, pSWE, 2D-SWE, or MRE) in the detection of CSPH in adults with CLD; and to compare the diagnostic accuracies between the individual tests. We will regard a combination of tests as positive when at least one is positive.</p><p><strong>Secondary objectives: </strong>to assess the diagnostic accuracy of LSM and SSM, as well as in combination, measured by any elastography technique (VCTE, pSWE, 2D-SWE, or MRE) in the detection of SPH in adults with CLD; and to investigate sources of heterogeneity in the results.</p><p><strong>Search methods: </strong>We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Hepato-Biliary Group Diagnostic Test of Accuracy Studies Register, CENTRAL, MEDLINE ALL Ovid, Embase Ovid, LILACS, Science Citation Index - Expanded (Web of Science), and Conference Proceedings Citation Index - Science (Web of Science) until 8 April 2024. We applied no restrictions on language or document type.</p><p><strong>Selection criteria: </strong>We included studies that evaluated the diagnostic accuracy of LSM and SSM either alone or in combination, as measured by different elastography techniques (VCTE, pSWE, 2D-SWE, or MRE), for the diagnosis of CSPH and SPH in adults with CLD. We only considered studies with cross-sectional design using HVPG measurement as the reference standard.</p><p><strong>Data collection and analysis: </strong>Two review authors independently screened studies, extracted data, and assessed the risk of bias and applicability concerns using the QUADAS-C tool. In the case of different cut-off values, we used the hierarchical summary receiver operating characteristic (HSROC) model to meta-analyse data (sensitivities and specificities) and to estimate a summary ROC (SROC) curve. In the case of common cut-off values, we used the bivariate model. We presented uncertainty of the accuracy estimates using 95% confidence intervals (CIs).</p><
背景：慢性肝病（CLD）的临床显著门脉高压（CSPH）是代偿失调的关键驱动因素，严重的门脉高压（SPH）可导致严重的并发症，如食管出血。早期发现对于及时治疗至关重要。目前评估门静脉压力的金标准是肝静脉压力梯度（HVPG），这是一种侵入性和昂贵的方法，可用性有限。越来越需要非侵入性替代方法来估计门静脉压力（例如，通过肝脏和脾脏刚度测量）并指导治疗。然而，振动控制瞬态弹性成像（VCTE）、点横波弹性成像（pSWE）、二维横波弹性成像（2D-SWE）和磁共振弹性成像（MRE）的诊断准确性仍然未知。主要目的：评估肝刚度测量（LSM）和脾刚度测量（SSM）的诊断准确性，以及任何弹性成像技术（VCTE, pSWE， 2D-SWE或MRE）测量的组合在CLD成人CSPH检测中的准确性；并比较各个测试之间的诊断准确性。当至少有一项检测结果为阳性时，我们将把一组检测结果视为阳性。次要目的：评估LSM和SSM的诊断准确性，以及通过任何弹性成像技术（VCTE, pSWE， 2D-SWE或MRE）检测成人CLD中SPH的准确性；并调查结果异质性的来源。检索方法：我们检索了Cochrane肝胆对照试验注册，Cochrane肝胆诊断试验准确性研究注册，CENTRAL, MEDLINE ALL Ovid, Embase Ovid， LILACS， Science引文索引-扩展（Web of Science）和会议记录引文索引-科学（Web of Science），直到2024年4月8日。我们对语言或文档类型没有任何限制。选择标准：我们纳入了评估LSM和SSM单独或联合诊断准确性的研究，通过不同的弹性成像技术（VCTE, pSWE， 2D-SWE或MRE）测量，用于诊断CLD成人CSPH和SPH。我们只考虑以HVPG测量作为参考标准的横断面设计研究。数据收集和分析：两位综述作者独立筛选研究，提取数据，并使用QUADAS-C工具评估偏倚风险和适用性问题。在不同截止值的情况下，我们使用分层汇总接收者工作特征（HSROC）模型对数据（敏感性和特异性）进行meta分析，并估计汇总ROC （SROC）曲线。在共同截止值的情况下，我们使用双变量模型。我们使用95%置信区间（ci）给出了准确度估计的不确定性。主要结果：纳入47项研究（7817名受试者）。评价最高的指标检验是VCTE对CSPH的LSM（27项研究，3818名受试者）。在所有领域中，我们只对两项低偏倚风险的研究进行了评判。由于缺乏预先设定的阈值和对患者选择适用性的高度关注，大多数在指标测试领域显示出较高的风险。总的来说，证据的确定性非常低。由于不同研究的阈值不同，我们使用HSROC模型来获得汇总估计。检测CSPH的主要发现如下。VCTE LSM（27项研究，3818名受试者）：在固定特异性为90%时，VCTE LSM的灵敏度为72.6% (95% CI 60.0%至82.5%)；在固定特异性为90%时，VCTE LSM的灵敏度为75.9% (95% CI 63.5%至85.1%)（6项研究，391名受试者）；在固定特异性为90%时，pSWE LSM固定敏感性为90%时，灵敏度为72.9% (95% CI 27.1%至95.1%)；2D-SWE在固定特异性为90%时的灵敏度为84.1% (95% CI 8.4%至99.7%)，在固定特异性为90%时的灵敏度为86.1% (95% CI 40.4%至98.3%)（10项研究，767名受试者）；在固定特异性为90%时的灵敏度为73.5% (95% CI 52.6%至87.4%)，2D-SWE在固定敏感性为80%时的灵敏度为83.4% (95% CI 68.2%至92.2%)（估计为90%不可行）：灵敏度为80.0% (95% CI 59.8% ~ 91.5%)，固定特异性为90%，固定敏感性下估计不可行，由于数据不足，HSROC分析对pSWE法LSM和MRE法LSM或SSM不可行。对于25 kPa的VCTE LSM（9项研究，1553名受试者），敏感性为62.3% (95% CI 53.0%至70.7%)，特异性为94.1% （95% CI 87.2%至97.3%）。我们探讨了异质性并观察到患病率效应：相对特异性0.90 （95% CI 0.83 ~ 0.97）。其他因素无法评估。对于次要目标SPH， VCTE的LSM是评价最多的测试（8项研究，637名参与者）。90%特异性对应的敏感性为67.2% （95% CI 48.8% ~ 81）。 4%)，而90%的敏感性对应的特异性无法通过HSROC模型计算出来。由于每个指标测试的参与者人数不一致，因此不可能对两个指标测试进行直接比较。由于各研究报告的截止值存在可变性，我们仅使用SROC曲线进行间接比较。因此，没有可靠的结果出现从比较或跨技术组合。作者的结论是：肝脏和脾脏硬度测量可以提供一种非侵入性的替代HVPG检测CSPH的方法。然而，个别技术的准确性仍然不确定，因为证据的确定性非常低，而且用于可靠比较的数据不足。没有一项测试的灵敏度和特异性均达到≥90%，限制了它们在确定是否患有CSPH的应用。对于通过VCTE进行的LSM（最常用的研究方法），基于使用不同阈值的研究，HSROC建模的灵敏度为72.6% (95% CI 60.0%至82.5%)，固定特异性为90%。在使用预先定义的25 kPa临界值的9个研究（1553名参与者）的亚组中，38%的CSPH患者将被遗漏，6%的无CSPH患者将被错误识别。证据的确定性非常低，主要是由于高偏倚、异质性和不精确的风险。高质量的研究需要有预定义的阈值、标准化的方法和改进的报告。未来的研究应针对关键亚群（如代偿性CLD、特定病因），并评估非侵入性工具的组合，以提高诊断准确性和临床实用性。资金：没有内部或外部的支持来源。注册:https://doi.org/10.1002/14651858.CD015415。
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Pub Date : 2026-01-07DOI: 10.1002/14651858.CD012589.pub2
Craig Zhao, James G Jefferies, Kanniraj Marimuthu, Venkatesan S Kumar, Darren Chen, Ian A Harris, Samuel J MacDessi
<p><strong>Background: </strong>Accurate alignment of components is considered important for improved outcomes when restoring lower limb alignment in total knee arthroplasty (TKA). Patient-specific guides were developed with the intention of improving surgical efficiency, accuracy of component positioning and overall limb alignment. Currently, the benefits of patient-specific guides in achieving these goals and whether this has an impact on clinical and functional outcomes remains unclear.</p><p><strong>Objectives: </strong>To assess the benefits and harms of patient-specific cutting guides versus conventional cutting guides or computer-assisted surgical navigation in people undergoing primary TKA.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid) and trial registers up to 21st January 2025, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing patient-specific cutting guides (PSGs) to conventional instrumentation (CON) or computer-assisted surgical navigation (NAV) in TKA. Major outcomes were survival of implant (risk of revision), function, radiographic lower limb alignment, pain, global assessment, total adverse events and re-operation rate.</p><p><strong>Data collection and analysis: </strong>We used standard methods recommended by Cochrane.</p><p><strong>Main results: </strong>Forty-four studies with 3664 participants were identified. Out of these, 40 studies with 3134 participants compared PSG to CON, two studies with 140 participants compared PSG to NAV and two studies with 390 participants compared PSG to NAV and CON. Regarding the imaging modality, 27 trials used magnetic resonance imaging (MRI)-based PSGs, 18 trials used computed tomographic (CT- based PSGs and 2 trials used both CT-based and MR-based PSGs). The mean age of participants ranged from 63 years to 74 years. Fifty-three per cent of participants were male, with more than 90% of participants having knee osteoarthritis. Most of the included trials were at risk of bias; 25/44 (56.8%) studies were at risk of selection bias, and 39/44 (88.6%) were at risk of performance and detection biases. 1. PSGs compared to conventional instrumentation Compared to conventional instrumentation, PSGs may result in little to no difference in survival of the implant. At 26 months, 7/347 participants (20 per 1000) in the conventional instrumentation group reported survival of implant (risk of revision) compared to 4/342 participants (16 per 1000) in the PSG group (RR 0.79 (95% CI 0.25 to 2.52); I² = 0%; 689 participants; 9 studies; low-certainty evidence downgraded for bias and imprecision). Compared to conventional instrumentation, PSGs may result in little to no improvement in function. Mean function (KSS, OKS, WOMAC, KOOS) was 15.1 points with conventional instrumentation and 13.44 points with PSG (SMD -0.11, 95% CI -0.25 to 0.03 ba
背景：在全膝关节置换术（TKA）中，部件的准确对齐被认为是改善恢复下肢对齐效果的重要因素。开发患者特异性指南的目的是提高手术效率，部件定位的准确性和整体肢体对齐。目前，患者特异性指南在实现这些目标方面的益处以及这是否对临床和功能结果产生影响尚不清楚。目的：评估患者特异性切割指南与传统切割指南或计算机辅助手术导航在原发性TKA患者中的利弊。检索方法：我们检索了截至2025年1月21日的Cochrane中央对照试验注册库（Central）、MEDLINE （Ovid）、Embase （Ovid）和试验注册库，不受语言限制。选择标准：我们纳入了随机对照试验（rct），比较TKA中患者特异性切割指南（psg）与传统仪器（CON）或计算机辅助手术导航（NAV）。主要结果是种植体的存活（翻修风险）、功能、x线下肢对中、疼痛、总体评估、总不良事件和再手术率。资料收集与分析：采用Cochrane推荐的标准方法。主要结果：确定了44项研究，3664名参与者。其中，40项研究有3134名参与者将PSG与CON进行比较，2项研究有140名参与者将PSG与NAV进行比较，2项研究有390名参与者将PSG与NAV和CON进行比较。关于成像方式，27项试验使用磁共振成像（MRI）为基础的PSG， 18项试验使用计算机断层扫描（CT为基础的PSG， 2项试验同时使用CT和MRI为基础的PSG）。参与者的平均年龄从63岁到74岁不等。53%的参与者是男性，超过90%的参与者患有膝关节骨关节炎。大多数纳入的试验存在偏倚风险；25/44（56.8%）的研究存在选择偏倚风险，39/44（88.6%）的研究存在表现偏倚和检测偏倚风险。1. 与传统器械相比，psg在种植体存活方面几乎没有差异。在26个月时，常规器械组中有7/347名参与者（每1000人中有20人）报告了种植体的存活（翻修风险），而PSG组中有4/342名参与者（每1000人中有16人）报告了种植体的存活(RR 0.79 (95% CI 0.25至2.52)；I²= 0%；689名参与者;9的研究;低确定性证据因偏见和不精确而降级)。与传统仪器相比，psg可能在功能上几乎没有改善。常规仪器的平均功能（KSS， OKS， WOMAC, kos）为15.1分，PSG为13.44分（SMD -0.11, 95% CI -0.25至0.03，反译为MD低1.66分（95% CI低3.77点，高0.45点；I²= 56%；23项研究，1913名参与者；低确定性证据因偏倚和间接性而降低））。通过股胫冠状角（FTCA）的异常值比例测量，psg可能导致下肢对齐精度的微小差异或没有差异。在长达两年的时间里，传统仪器组有266/1208名参与者（220 / 1000）报告了放射学异常事件，而PSG组有234/1204名参与者（189 / 1000）报告了放射学异常事件（RR 0.86, 95% CI 0.68至1.10,I²= 49%；29项研究，2412名参与者；低确定性证据因偏倚和不精确而降级）。低确定性证据（因偏倚和间接性而降级）表明，psg可能导致疼痛几乎没有差异。平均疼痛（0至100分，0无疼痛）在常规仪器中为17.4分，在PSG中为15.8分（SMD -0.09, 95% CI -0.23至0.06，反译为MD低1.52分（95% CI 3.88低，1.01高；I²= 0%，10项研究，715名参与者））。纳入的研究均未提供关于全球评估的数据。低确定性证据（因偏倚和不精确而降级）表明，psg可能导致不良事件的差异很小或没有差异。常规器械组报告的总不良事件（感染、血栓）发生率为60/590(102 / 1000)，而PSG组为61/579 (99 / 1000)（RR 0.97, 95% CI 0.68 ~ 1.39, I²= 5%，14项研究，1169名参与者）。低确定性证据（因偏倚和不精确而降级）表明，psg可能导致再手术率几乎没有差异。常规器械组有21/424例（50 / 1000）再手术，而PSG组有16/419例（44 / 1000）再手术（RR 0.87, 95% CI 0.45 ~ 1.68, I²= 0%，10项研究，843例）。2. 低确定性证据（因偏见和不精确而降级）表明，与计算机辅助导航相比，psg可能导致很少或没有功能差异。计算机辅助导航的平均功能（0到100,100个最佳功能）在短期（不到两年）为52.5分，psg为57.5分：MD高5.00分（95% CI 1.31低至11.31高，I²= 0%，2项研究，120名参与者）。低确定性证据（因偏差和不精确而降级）表明，与计算机辅助导航相比，使用psg可能导致下肢对齐的精度更差。在短期内（不到两年），计算机辅助导航组中13/135名参与者（96 / 1000）报告了放射异常事件，而PSG组中28/135名参与者（196 / 1000）报告了放射异常事件（RR 2.04, 95% CI 0.87至4.82,I²= 44%，3项研究，270名参与者）。纳入的研究均未提供植入物存活、总体评估、疼痛、再手术或不良事件的数据。作者的结论是：低确定性证据表明，在全膝关节置换术中，将患者特异性切割指南与传统器械或计算机辅助导航进行比较时，在植入物的存活率、再手术率、不良事件、功能、疼痛和整体评估方面没有显著差异。
{"title":"Patient-specific cutting guides for total knee arthroplasty.","authors":"Craig Zhao, James G Jefferies, Kanniraj Marimuthu, Venkatesan S Kumar, Darren Chen, Ian A Harris, Samuel J MacDessi","doi":"10.1002/14651858.CD012589.pub2","DOIUrl":"10.1002/14651858.CD012589.pub2","url":null,"abstract":"<p><strong>Background: </strong>Accurate alignment of components is considered important for improved outcomes when restoring lower limb alignment in total knee arthroplasty (TKA). Patient-specific guides were developed with the intention of improving surgical efficiency, accuracy of component positioning and overall limb alignment. Currently, the benefits of patient-specific guides in achieving these goals and whether this has an impact on clinical and functional outcomes remains unclear.</p><p><strong>Objectives: </strong>To assess the benefits and harms of patient-specific cutting guides versus conventional cutting guides or computer-assisted surgical navigation in people undergoing primary TKA.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid), Embase (Ovid) and trial registers up to 21st January 2025, unrestricted by language.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) comparing patient-specific cutting guides (PSGs) to conventional instrumentation (CON) or computer-assisted surgical navigation (NAV) in TKA. Major outcomes were survival of implant (risk of revision), function, radiographic lower limb alignment, pain, global assessment, total adverse events and re-operation rate.</p><p><strong>Data collection and analysis: </strong>We used standard methods recommended by Cochrane.</p><p><strong>Main results: </strong>Forty-four studies with 3664 participants were identified. Out of these, 40 studies with 3134 participants compared PSG to CON, two studies with 140 participants compared PSG to NAV and two studies with 390 participants compared PSG to NAV and CON. Regarding the imaging modality, 27 trials used magnetic resonance imaging (MRI)-based PSGs, 18 trials used computed tomographic (CT- based PSGs and 2 trials used both CT-based and MR-based PSGs). The mean age of participants ranged from 63 years to 74 years. Fifty-three per cent of participants were male, with more than 90% of participants having knee osteoarthritis. Most of the included trials were at risk of bias; 25/44 (56.8%) studies were at risk of selection bias, and 39/44 (88.6%) were at risk of performance and detection biases. 1. PSGs compared to conventional instrumentation Compared to conventional instrumentation, PSGs may result in little to no difference in survival of the implant. At 26 months, 7/347 participants (20 per 1000) in the conventional instrumentation group reported survival of implant (risk of revision) compared to 4/342 participants (16 per 1000) in the PSG group (RR 0.79 (95% CI 0.25 to 2.52); I² = 0%; 689 participants; 9 studies; low-certainty evidence downgraded for bias and imprecision). Compared to conventional instrumentation, PSGs may result in little to no improvement in function. Mean function (KSS, OKS, WOMAC, KOOS) was 15.1 points with conventional instrumentation and 13.44 points with PSG (SMD -0.11, 95% CI -0.25 to 0.03 ba","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD012589"},"PeriodicalIF":8.8,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12777925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910894","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 : 2026-01-06DOI: 10.1002/14651858.CD008112.pub3
Annemarie de Zoete, Tiziano Innocenti, M John Petrozzi, Marienke van Middelkoop, Willem Jj Assendelft, Michiel R de Boer, Maurits W van Tulder, Sidney M Rubinstein
<p><strong>Rationale: </strong>Many therapies exist for the treatment of chronic low back pain (LBP), including spinal manipulative therapy (SMT), which is a worldwide, extensively practised intervention. The effectiveness of SMT for chronic LBP is not without dispute. This Cochrane review is an update of a Cochrane systematic review published in 2011.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of SMT compared to (1) sham SMT/placebo intervention, (2) no treatment, and (3) other conservative interventions in people with chronic LBP (18+ years old).</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, two other databases, and two trial registers up to 18 October 2024, unrestricted by language. We also screened the reference lists of all included studies and relevant systematic reviews, and approached content experts to identify potentially missing studies.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that examined the effect of spinal manipulation or mobilisation in adults with chronic LBP compared to sham SMT/placebo, no treatment, and other conservative interventions. We placed no restrictions on the setting. We excluded studies that exclusively examined sciatica.</p><p><strong>Outcomes: </strong>Our critical outcomes were pain, functional status, and adverse events. The primary time point was one month for pain and functional status. We evaluated adverse events at the end of the intervention.</p><p><strong>Risk of bias: </strong>We assessed bias in the included studies using the original Cochrane risk of bias tool (RoB 1).</p><p><strong>Synthesis methods: </strong>Where possible, we synthesised results using meta-analysis with a generic inverse-variance approach and random-effects models; otherwise, we used narrative synthesis. We assessed the certainty of evidence using the GRADE approach. Our main comparisons were SMT versus (1) sham SMT/placebo treatment, (2) no treatment, and (3) other conservative interventions at one month. We converted all pain scales to a 100-point scale.</p><p><strong>Included studies: </strong>Seventy-six RCTs (11,866 participants) met our inclusion criteria, 50 (66%) of which were not included in the previous version of this review. Seventeen trials (2021 participants) compared SMT to sham SMT/placebo, and four trials (435 participants) compared SMT to no treatment. Most trials (43, including 8291 participants) examined the effect of SMT compared to other conservative interventions. The remaining trials examined other comparisons. Treatment allocation was appropriately conducted in just four sham SMT/placebo-controlled trials (24%), while only six trials 'blinded' participants to the intervention (35%), indicating a high risk of selection and performance bias. Similarly, the no-treatment controlled trials were as susceptible to selection bias (50%) and performance bia
{"title":"Spinal manipulative therapy for adults with chronic low back pain.","authors":"Annemarie de Zoete, Tiziano Innocenti, M John Petrozzi, Marienke van Middelkoop, Willem Jj Assendelft, Michiel R de Boer, Maurits W van Tulder, Sidney M Rubinstein","doi":"10.1002/14651858.CD008112.pub3","DOIUrl":"10.1002/14651858.CD008112.pub3","url":null,"abstract":"<p><strong>Rationale: </strong>Many therapies exist for the treatment of chronic low back pain (LBP), including spinal manipulative therapy (SMT), which is a worldwide, extensively practised intervention. The effectiveness of SMT for chronic LBP is not without dispute. This Cochrane review is an update of a Cochrane systematic review published in 2011.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of SMT compared to (1) sham SMT/placebo intervention, (2) no treatment, and (3) other conservative interventions in people with chronic LBP (18+ years old).</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, two other databases, and two trial registers up to 18 October 2024, unrestricted by language. We also screened the reference lists of all included studies and relevant systematic reviews, and approached content experts to identify potentially missing studies.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) that examined the effect of spinal manipulation or mobilisation in adults with chronic LBP compared to sham SMT/placebo, no treatment, and other conservative interventions. We placed no restrictions on the setting. We excluded studies that exclusively examined sciatica.</p><p><strong>Outcomes: </strong>Our critical outcomes were pain, functional status, and adverse events. The primary time point was one month for pain and functional status. We evaluated adverse events at the end of the intervention.</p><p><strong>Risk of bias: </strong>We assessed bias in the included studies using the original Cochrane risk of bias tool (RoB 1).</p><p><strong>Synthesis methods: </strong>Where possible, we synthesised results using meta-analysis with a generic inverse-variance approach and random-effects models; otherwise, we used narrative synthesis. We assessed the certainty of evidence using the GRADE approach. Our main comparisons were SMT versus (1) sham SMT/placebo treatment, (2) no treatment, and (3) other conservative interventions at one month. We converted all pain scales to a 100-point scale.</p><p><strong>Included studies: </strong>Seventy-six RCTs (11,866 participants) met our inclusion criteria, 50 (66%) of which were not included in the previous version of this review. Seventeen trials (2021 participants) compared SMT to sham SMT/placebo, and four trials (435 participants) compared SMT to no treatment. Most trials (43, including 8291 participants) examined the effect of SMT compared to other conservative interventions. The remaining trials examined other comparisons. Treatment allocation was appropriately conducted in just four sham SMT/placebo-controlled trials (24%), while only six trials 'blinded' participants to the intervention (35%), indicating a high risk of selection and performance bias. Similarly, the no-treatment controlled trials were as susceptible to selection bias (50%) and performance bia","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD008112"},"PeriodicalIF":8.8,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12774432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910890","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 : 2026-01-06DOI: 10.1002/14651858.CD006680.pub4
Siddhant Pherwani, Ahmed Gendia, Shampa Sen, Graeme K Ambler, Robert J Hinchliffe, Christopher P Twine
<p><strong>Rationale: </strong>Peripheral arterial disease (PAD) is a condition most commonly caused by atherosclerotic narrowing of lower limb arteries, resulting in intermittent claudication, chronic limb-threatening ischaemia or acute limb ischaemia. There are various treatment strategies, including atherectomy, a technique used during endovascular surgery where the atheroma is cut or ground away within the artery. Another procedure, such as balloon angioplasty, is often performed at the same time. The studies investigating atherectomy for PAD have all been small-scale, with varying methodologies and, as a result, it is unclear if atherectomy is a more effective treatment for PAD compared to more conventional treatments. Despite this, rates of atherectomy use are increasing, especially in the United States. This review focuses on randomised controlled trials and is the second update of a Cochrane review, following the original publication in 2014 and the first update in 2020.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of atherectomy as a treatment for peripheral arterial disease compared to other treatments.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from 13 August 2019 to 28 January 2025.</p><p><strong>Eligibility criteria: </strong>We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or chronic limb-threatening ischaemia and evidence of atherosclerotic lower limb arterial disease.</p><p><strong>Outcomes: </strong>Outcomes of interest were: primary patency, all-cause mortality, fatal and non-fatal cardiovascular events, target vessel revascularisation rates and complication rates.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tool (RoB 1) to assess the risk of bias in the studies. We judged all included studies to have a high risk of overall bias.</p><p><strong>Synthesis methods: </strong>Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used the GRADE criteria to assess the certainty of the evidence. Any disagreements were resolved through discussion. We synthesised results for each outcome using meta-analysis where possible (random-effects model, dichotomous outcomes assessed using the Mantel-Haenszel method, continuous outcomes assessed using the inverse variance method).</p><p><strong>Included studies: </strong>We included 11 studies, with a total of 814 participants and 872 treated lesions.</p><p><strong>Synthesis of results: </strong>We found two comparisons: atherectomy versus balloon angioplasty (atherec
{"title":"Atherectomy for peripheral arterial disease.","authors":"Siddhant Pherwani, Ahmed Gendia, Shampa Sen, Graeme K Ambler, Robert J Hinchliffe, Christopher P Twine","doi":"10.1002/14651858.CD006680.pub4","DOIUrl":"10.1002/14651858.CD006680.pub4","url":null,"abstract":"<p><strong>Rationale: </strong>Peripheral arterial disease (PAD) is a condition most commonly caused by atherosclerotic narrowing of lower limb arteries, resulting in intermittent claudication, chronic limb-threatening ischaemia or acute limb ischaemia. There are various treatment strategies, including atherectomy, a technique used during endovascular surgery where the atheroma is cut or ground away within the artery. Another procedure, such as balloon angioplasty, is often performed at the same time. The studies investigating atherectomy for PAD have all been small-scale, with varying methodologies and, as a result, it is unclear if atherectomy is a more effective treatment for PAD compared to more conventional treatments. Despite this, rates of atherectomy use are increasing, especially in the United States. This review focuses on randomised controlled trials and is the second update of a Cochrane review, following the original publication in 2014 and the first update in 2020.</p><p><strong>Objectives: </strong>To evaluate the benefits and harms of atherectomy as a treatment for peripheral arterial disease compared to other treatments.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from 13 August 2019 to 28 January 2025.</p><p><strong>Eligibility criteria: </strong>We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or chronic limb-threatening ischaemia and evidence of atherosclerotic lower limb arterial disease.</p><p><strong>Outcomes: </strong>Outcomes of interest were: primary patency, all-cause mortality, fatal and non-fatal cardiovascular events, target vessel revascularisation rates and complication rates.</p><p><strong>Risk of bias: </strong>We used the Cochrane risk of bias tool (RoB 1) to assess the risk of bias in the studies. We judged all included studies to have a high risk of overall bias.</p><p><strong>Synthesis methods: </strong>Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used the GRADE criteria to assess the certainty of the evidence. Any disagreements were resolved through discussion. We synthesised results for each outcome using meta-analysis where possible (random-effects model, dichotomous outcomes assessed using the Mantel-Haenszel method, continuous outcomes assessed using the inverse variance method).</p><p><strong>Included studies: </strong>We included 11 studies, with a total of 814 participants and 872 treated lesions.</p><p><strong>Synthesis of results: </strong>We found two comparisons: atherectomy versus balloon angioplasty (atherec","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"1 ","pages":"CD006680"},"PeriodicalIF":8.8,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12774431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910841","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 : 2026-01-06DOI: 10.1002/14651858.CD015378.pub2
Lissa Pacheco-Brousseau, Said Abdelrazeq, Shannon E Kelly, Jordi Pardo Pardo, Geoff Dervin, Dawn Stacey, George A Wells
<p><strong>Rationale: </strong>Total and partial knee arthroplasty (TKA, PKA) are common treatments for moderate to severe knee osteoarthritis. While effective in symptom management, these surgeries carry potential risks, necessitating careful evaluation of benefits and harms. High-quality evidence comparing TKA/PKA to placebo, sham, or non-surgical interventions is essential to support informed decision-making.</p><p><strong>Objectives: </strong>To assess the benefits and harms of TKA and PKA for people with moderate to severe knee osteoarthritis compared to placebo, sham (efficacy), or non-surgical interventions for the knee (effectiveness).</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, and two trial registers from 2010 to January 2025. We also performed reference and citation checks. Two reviewers independently screened studies, extracted data, and assessed risk of bias and the certainty of evidence.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials of adults with moderate to severe osteoarthritis receiving TKA/PKA compared to placebo, sham, or non-surgical treatments including physiotherapy, weight loss, pharmacotherapy, braces, insoles, and any intraarticular injection. We excluded studies including participants with other joint conditions or having TKA/PKA because of trauma (e.g. fracture), infection, or revision.</p><p><strong>Outcomes: </strong>We reported on pain, physical function, knee surgery, patient satisfaction with treatment outcomes, health-related quality of life, serious adverse events, and withdrawals due to adverse events. We measured outcomes at short-term (≤ 6 months), intermediate-term (6 to 12 months), and long-term (≥ 1 year) follow-up.</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 1 tool to assess risk of bias.</p><p><strong>Synthesis methods: </strong>We conducted a narrative synthesis, reported on risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data with a 95% confidence interval (CI), and used GRADE to assess the certainty of evidence.</p><p><strong>Included studies: </strong>One randomised controlled trial conducted in Denmark met the inclusion criteria. The study enrolled 100 adults with primary mild to severe knee osteoarthritis (Kellgren-Lawrence score ≥ 2 to 4) and compared TKA followed by a non-surgical programme (exercise, osteoarthritis education, dietary advice, insoles, pain medication) to the same non-surgical programme alone.</p><p><strong>Synthesis of results: </strong>Pain Compared to a non-surgical programme, unilateral TKA may reduce pain at a level that is clinically important at one year (MD 17.60, 95% CI 8.25 to 26.95; 1 study, 100 participants; low-certainty evidence). The certainty of evidence was low given the imprecision of results and risk of bias. Physical function Compared to a non-surgical programme, unilateral TKA may improve physical function at one year, but the improvement
理由：全膝关节置换术和部分膝关节置换术（TKA， PKA）是中重度膝关节骨关节炎的常用治疗方法。虽然在症状管理方面有效，但这些手术有潜在的风险，需要仔细评估利弊。比较TKA/PKA与安慰剂、假干预或非手术干预的高质量证据对于支持知情决策至关重要。目的：评估TKA和PKA与安慰剂、假治疗（疗效）或非手术治疗（疗效）相比对中度至重度膝关节骨性关节炎患者的利与弊。检索方法：检索了2010年至2025年1月的CENTRAL、MEDLINE、Embase和两个试验注册库。我们还进行了参考文献和引用检查。两位审稿人独立筛选研究，提取数据，评估偏倚风险和证据的确定性。入选标准：我们纳入了接受TKA/PKA与安慰剂、假手术或非手术治疗（包括物理治疗、减肥、药物治疗、牙套、鞋垫和任何关节内注射）比较的中度至重度骨关节炎成人的随机对照试验。我们排除了有其他关节疾病或因创伤（如骨折）、感染或翻修而发生TKA/PKA的研究。结果：我们报告了疼痛、身体功能、膝关节手术、患者对治疗结果的满意度、与健康相关的生活质量、严重不良事件和因不良事件而退出治疗。我们测量了短期（≤6个月）、中期（6至12个月）和长期（≥1年）随访的结果。偏倚风险：我们使用Cochrane RoB 1工具评估偏倚风险。综合方法：我们进行了叙述性综合，报告了二分数据的风险比（rr）和连续数据的平均差异（MDs），置信区间为95%，并使用GRADE评估证据的确定性。纳入研究：在丹麦进行的一项随机对照试验符合纳入标准。该研究招募了100名患有原发性轻度至重度膝关节骨关节炎（kelgren - lawrence评分≥2 - 4）的成年人，并将TKA后的非手术方案（运动、骨关节炎教育、饮食建议、鞋垫、止痛药）与单独的相同非手术方案进行了比较。与非手术方案相比，单侧TKA可以在一年内将疼痛减轻到临床上重要的水平（MD 17.60, 95% CI 8.25至26.95；1项研究，100名参与者；低确定性证据）。考虑到结果的不精确性和偏倚风险，证据的确定性较低。与非手术方案相比，单侧TKA可能在一年内改善身体功能，但改善可能在临床上并不重要（MD 12.40, 95% CI 3.06至21.74；1项研究，100名参与者；低确定性证据）。考虑到结果的不精确性和偏倚风险，证据的确定性较低。与非手术方案相比，单侧全膝关节置换术可以减少随访一年的膝关节手术（翻修或随后的膝关节手术和初始膝关节手术）的需要（RR 0.04, 95% CI 0.00至0.62；1项研究，99名参与者；低确定性证据）。考虑到结果的不精确性和偏倚风险，证据的确定性较低。患者对治疗结果的满意度纳入的试验没有评估患者对治疗结果的满意度。与健康相关的生活质量在单侧TKA和非手术治疗一年内可能没有临床上重要的差异（MD为0.09,95% CI为0.01至0.18；1项研究，100名受试者；中等确定性证据）。由于存在偏倚风险，证据的确定性为中等，由于效应估计和CI没有跨越最小临床重要差异线，因此没有因不精确而降低证据的确定性。与非手术方案相比，单侧TKA可能增加严重不良事件，但证据非常不确定（RR 4.00, 95% CI 1.79至8.94；1项研究，100名参与者；非常低确定性证据）。考虑到结果的不精确性、间接性和偏倚风险，证据的确定性非常低。单侧TKA与非手术治疗在因不良事件而停药方面可能没有差异，但证据非常不确定（两组n = 0，不可估计；1项研究，100名参与者；证据的确定性非常低）。由于结果不精确，证据的确定性很低。作者的结论是：与单独的非手术方案相比，TKA后的非手术方案可以在临床上重要的程度上减轻疼痛；可能在临床上不重要的水平上改善身体机能；并可能减少后续膝关节手术的需要。 与健康相关的生活质量在TKA之后的非手术方案和单独的非手术方案之间可能没有临床上重要的差异。TKA后非手术方案可能增加严重不良事件的风险，但证据非常不确定。由于不良事件引起的停药在两组之间可能没有差异，但证据非常不确定。由于以下几点限制，本研究的结论应谨慎解释：证据是基于在丹麦进行的一项研究；外科医生使用TKA的资格标准没有明确报道；12%的成年人患有轻度骨关节炎；在前一周报告剧烈疼痛的成年人被排除在外；纳入的研究采用了对严重不良事件的广泛定义。这些因素可能会影响研究结果的可靠性和普遍性。资助：LPB由关节炎协会博士奖（#21-0000000085）、渥太华大学和共同导师的研究基金、安大略省研究生奖学金和渥太华大学入学奖学金资助。在过去的五年中，LPB还获得了Hans K. Uhthoff MD FRCSC研究生奖学金（#712240301930），女王伊丽莎白二世科学和技术研究生奖学金，渥太华大学优秀奖学金，安大略省物理治疗协会东区（#712140302327,#712200305332）和l'Ordre Professionnel de la physiothacrapie du quacimade)的支持。注册：协议（2023）10.1002/14651858.CD015378。
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