Pub Date : 2024-11-06DOI: 10.1002/14651858.CD014834
Kazufumi Yoshida, Hissei Imai, Ethan Sahker, Yan Luo, Shino Kikuchi, Yasushi Tsujimoto, Ioannis Michopoulos, Toshi A Furukawa, Norio Watanabe
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of antipsychotic drugs (both first- and second-generation antipsychotics) compared to placebo on body weight gain, psychological symptoms, acceptability, and adverse events for people with anorexia nervosa.
{"title":"Antipsychotic drugs for anorexia nervosa.","authors":"Kazufumi Yoshida, Hissei Imai, Ethan Sahker, Yan Luo, Shino Kikuchi, Yasushi Tsujimoto, Ioannis Michopoulos, Toshi A Furukawa, Norio Watanabe","doi":"10.1002/14651858.CD014834","DOIUrl":"10.1002/14651858.CD014834","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of antipsychotic drugs (both first- and second-generation antipsychotics) compared to placebo on body weight gain, psychological symptoms, acceptability, and adverse events for people with anorexia nervosa.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582455","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 : 2024-11-05DOI: 10.1002/14651858.CD001747.pub4
Amanda Wei Yin Lim, Lon Schneider, Clement Loy
<p><strong>Background: </strong>Dementia leads to progressive cognitive decline, and represents a significant health and societal burden. Its prevalence is growing, with Alzheimer's disease as the leading cause. There is no cure for Alzheimer's disease, but there are regulatory-approved pharmacological interventions, such as galantamine, for symptomatic relief. This review updates the 2006 version.</p><p><strong>Objectives: </strong>To assess the clinical effects, including adverse effects, of galantamine in people with probable or possible Alzheimer's disease or mild cognitive impairment, and to investigate potential moderators of effect.</p><p><strong>Search methods: </strong>We systematically searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 14 December 2022 using the term 'galantamine'. The Register contains records of clinical trials identified from major electronic databases (including CENTRAL, MEDLINE, and Embase), trial registries, grey literature sources, and conference proceedings. We manually searched reference lists and collected information from US Food and Drug Administration documents and unpublished trial reports. We imposed no language restrictions.</p><p><strong>Selection criteria: </strong>We included double-blind, parallel-group, randomised controlled trials comparing oral galantamine with placebo for a treatment duration exceeding four weeks in people with dementia due to Alzheimer's disease or with mild cognitive impairment.</p><p><strong>Data collection and analysis: </strong>Working independently, two review authors selected studies for inclusion, assessed their quality, and extracted data. Outcomes of interest included cognitive function, change in global function, activities of daily living, functional disability, behavioural function, and adverse events. We used a fixed-effect model for meta-analytic synthesis, and presented results as Peto odds ratios (OR) or weighted mean differences (MD) with 95% confidence intervals. We used Cochrane's original risk of bias tool (RoB 1) to assess the risk of bias in the included studies.</p><p><strong>Main results: </strong>We included 21 studies with a total of 10,990 participants. The average age of participants was 74 years, and 37% were male. The studies' durations ranged from eight weeks to two years, with 24 weeks being the most common duration. One newly included study assessed the effects of galantamine at two years, and another newly included study involved participants with severe Alzheimer's disease. Nineteen studies with 10,497 participants contributed data to the meta-analysis. All studies had low to unclear risk of bias for randomisation, allocation concealment, and blinding. We judged four studies to be at high risk of bias due to attrition and two due to selective outcome reporting. Galantamine for dementia due to Alzheimer's disease We summarise only the results for galantamine given at 8 to 12 mg twice daily (total galantamine
背景:痴呆症会导致认知能力逐步下降,给健康和社会造成沉重负担。痴呆症的发病率越来越高,阿尔茨海默病是其主要病因。阿尔茨海默病目前尚无根治方法,但有经监管部门批准的药物干预措施,如加兰他敏,可缓解症状。本综述更新了 2006 年版本:评估加兰他敏对可能或可能患有阿尔茨海默病或轻度认知障碍患者的临床效果,包括不良反应,并研究潜在的效果调节因素:我们于2022年12月14日使用 "加兰他敏 "一词系统地检索了Cochrane痴呆症与认知改善小组的专门登记册。该登记册包含从主要电子数据库(包括 CENTRAL、MEDLINE 和 Embase)、试验登记册、灰色文献来源和会议论文集中确定的临床试验记录。我们人工检索了参考文献列表,并从美国食品药品管理局的文件和未发表的试验报告中收集了信息。我们对语言没有限制:我们纳入了双盲、平行组、随机对照试验,这些试验比较了口服加兰他敏与安慰剂在阿尔茨海默病痴呆患者或轻度认知障碍患者中的疗程,疗程超过四周:两位综述作者独立工作,选择纳入研究、评估研究质量并提取数据。研究结果包括认知功能、整体功能变化、日常生活活动、功能障碍、行为功能和不良事件。我们采用固定效应模型进行荟萃分析综合,并将结果显示为佩托几率比(OR)或加权平均差(MD)及 95% 置信区间。我们使用 Cochrane 最初的偏倚风险工具(RoB 1)来评估纳入研究的偏倚风险:我们纳入了 21 项研究,共有 10,990 名参与者。参与者的平均年龄为 74 岁,37% 为男性。研究持续时间从 8 周到 2 年不等,其中 24 周是最常见的持续时间。一项新纳入的研究评估了加兰他敏两年后的疗效,另一项新纳入的研究涉及严重阿尔茨海默氏症患者。19项研究共10497名参与者为荟萃分析提供了数据。所有研究在随机化、分配隐藏和盲法方面的偏倚风险都较低或不明确。我们判定四项研究因自然减员而存在高偏倚风险,两项研究因选择性结果报告而存在高偏倚风险。治疗阿尔茨海默病所致痴呆症的加兰他敏 我们仅总结了加兰他敏的治疗结果,剂量为8至12毫克,每天两次(加兰他敏总量为16至24毫克/天),评估时间为6个月。有关其他给药方案和评估时间点的结果,请参阅完整综述。有高度确定性的证据表明,与安慰剂相比,加兰他敏能改善:阿尔茨海默病评估量表--认知分量表(ADAS-cog)评估的认知功能(MD-2.86,95% CI -3.29至-2.43;6项研究,3049名参与者;最小临床重要效应(MCID)= 2.6至4分的变化);功能障碍,采用痴呆残疾评估量表(DAD)进行评估(MD为2.12,95% CI为0.75至3.49;3项研究,1275名参与者);行为功能,采用神经精神量表(NPI)进行评估(MD为-1.63,95% CI为-3.07至-0.20;2项研究,1043名参与者)。根据基于临床医生访谈的变化印象加护理人员输入(CIBIC-plus)评估,加兰他敏可在6个月后改善整体功能(OR 1.58,95% CI 1.36至1.84;6项研究,3002名参与者;低确定性证据)。接受加兰他敏治疗的参试者比接受安慰剂治疗的参试者更有可能过早停药(22.7%对17.2%)(OR 1.41,95% CI 1.19对1.68;6项研究,3336名参试者;高确定性证据),并在研究期间出现恶心(20.9%对8.4%)(OR 2.89,95% CI 2.40对3.49;7项研究,3616名参试者;高确定性证据)。加兰他敏降低了六个月的死亡率:加兰他敏组的死亡率为1.3%,而安慰剂组的死亡率为2.3%(OR为0.56,95% CI为0.33至0.96;6项研究,3493名参与者;高确定性证据)。治疗轻度认知障碍的加兰他敏 我们总结了两项研究在两年后进行评估的结果,这两项研究为参与者提供了加兰他敏,剂量为8至12毫克,每天两次(加兰他敏总量为16至24毫克/天)。与安慰剂相比,加兰他敏可能无法改善认知功能,根据轻度认知障碍的扩展 ADAS-cog 评估(MD -0.21, 95% CI -0.78 to 0.00)。
{"title":"Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment.","authors":"Amanda Wei Yin Lim, Lon Schneider, Clement Loy","doi":"10.1002/14651858.CD001747.pub4","DOIUrl":"10.1002/14651858.CD001747.pub4","url":null,"abstract":"<p><strong>Background: </strong>Dementia leads to progressive cognitive decline, and represents a significant health and societal burden. Its prevalence is growing, with Alzheimer's disease as the leading cause. There is no cure for Alzheimer's disease, but there are regulatory-approved pharmacological interventions, such as galantamine, for symptomatic relief. This review updates the 2006 version.</p><p><strong>Objectives: </strong>To assess the clinical effects, including adverse effects, of galantamine in people with probable or possible Alzheimer's disease or mild cognitive impairment, and to investigate potential moderators of effect.</p><p><strong>Search methods: </strong>We systematically searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 14 December 2022 using the term 'galantamine'. The Register contains records of clinical trials identified from major electronic databases (including CENTRAL, MEDLINE, and Embase), trial registries, grey literature sources, and conference proceedings. We manually searched reference lists and collected information from US Food and Drug Administration documents and unpublished trial reports. We imposed no language restrictions.</p><p><strong>Selection criteria: </strong>We included double-blind, parallel-group, randomised controlled trials comparing oral galantamine with placebo for a treatment duration exceeding four weeks in people with dementia due to Alzheimer's disease or with mild cognitive impairment.</p><p><strong>Data collection and analysis: </strong>Working independently, two review authors selected studies for inclusion, assessed their quality, and extracted data. Outcomes of interest included cognitive function, change in global function, activities of daily living, functional disability, behavioural function, and adverse events. We used a fixed-effect model for meta-analytic synthesis, and presented results as Peto odds ratios (OR) or weighted mean differences (MD) with 95% confidence intervals. We used Cochrane's original risk of bias tool (RoB 1) to assess the risk of bias in the included studies.</p><p><strong>Main results: </strong>We included 21 studies with a total of 10,990 participants. The average age of participants was 74 years, and 37% were male. The studies' durations ranged from eight weeks to two years, with 24 weeks being the most common duration. One newly included study assessed the effects of galantamine at two years, and another newly included study involved participants with severe Alzheimer's disease. Nineteen studies with 10,497 participants contributed data to the meta-analysis. All studies had low to unclear risk of bias for randomisation, allocation concealment, and blinding. We judged four studies to be at high risk of bias due to attrition and two due to selective outcome reporting. Galantamine for dementia due to Alzheimer's disease We summarise only the results for galantamine given at 8 to 12 mg twice daily (total galantamine","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582457","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 : 2024-11-05DOI: 10.1002/14651858.CD011204.pub3
Mark R Marshall, Millie Yue Wang, Alain C Vandal, Joanna L Dunlop
<p><strong>Background: </strong>Cardiovascular (CV) disease is the leading cause of death in dialysis patients and is strongly associated with fluid overload and hypertension. It is plausible that low dialysate sodium ion concentration [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension and ultimately reducing CV morbidity and death. This is an update of a review first published in 2019.</p><p><strong>Objectives: </strong>This review evaluated the harms and benefits of using a low (< 138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients.</p><p><strong>Search methods: </strong>We searched the Cochrane Kidney and Transplant Register of Studies up to 1 October 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs), both parallel and cross-over, of low (< 138 mM) versus neutral (138 to 140 mM) or high (> 140 mM) dialysate [Na+] for maintenance HD patients were included.</p><p><strong>Data collection and analysis: </strong>Two authors independently screened studies for inclusion and extracted data. Statistical analyses were performed using the random-effects model, and results expressed as risk ratios (RR) for dichotomous outcomes, and mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI). Confidence in the evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE).</p><p><strong>Main results: </strong>We included 17 studies randomising 509 patients, with data available for 452 patients after dropouts. All but three studies evaluated a fixed concentration of low dialysate [Na+], with one using profiled dialysate [Na+] and two using individualised dialysate [Na+]. Five were parallel group studies, and 12 were cross-over studies. Of the latter, only six used a washout between intervention and control periods. Most studies were short-term with a median (interquartile range) follow-up of 4 (4 to 16) weeks. Two were of a single HD session and two of a single week's HD. Seven studies were conducted prior to 2000, and six reported the use of obsolete HD practices. Other than for indirectness arising from older studies, risks of bias in the included studies were generally low. Compared to neutral or high dialysate [Na+] (≥ 138 mM), low dialysate [Na+] (< 138 mM) reduces interdialytic weight gain (14 studies, 515 participants: MD -0.36 kg, 95% CI -0.50 to -0.22; high certainty evidence) and antihypertensive medication use (5 studies, 241 participants: SMD -0.37, 95% CI -0.64 to -0.1; high certainty evidence), and probably reduces left ventricular mass index (2 studies, 143 participants
{"title":"Low dialysate sodium levels for chronic haemodialysis.","authors":"Mark R Marshall, Millie Yue Wang, Alain C Vandal, Joanna L Dunlop","doi":"10.1002/14651858.CD011204.pub3","DOIUrl":"10.1002/14651858.CD011204.pub3","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular (CV) disease is the leading cause of death in dialysis patients and is strongly associated with fluid overload and hypertension. It is plausible that low dialysate sodium ion concentration [Na+] may decrease total body sodium content, thereby reducing fluid overload and hypertension and ultimately reducing CV morbidity and death. This is an update of a review first published in 2019.</p><p><strong>Objectives: </strong>This review evaluated the harms and benefits of using a low (< 138 mM) dialysate [Na+] for maintenance haemodialysis (HD) patients.</p><p><strong>Search methods: </strong>We searched the Cochrane Kidney and Transplant Register of Studies up to 1 October 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.</p><p><strong>Selection criteria: </strong>Randomised controlled trials (RCTs), both parallel and cross-over, of low (< 138 mM) versus neutral (138 to 140 mM) or high (> 140 mM) dialysate [Na+] for maintenance HD patients were included.</p><p><strong>Data collection and analysis: </strong>Two authors independently screened studies for inclusion and extracted data. Statistical analyses were performed using the random-effects model, and results expressed as risk ratios (RR) for dichotomous outcomes, and mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI). Confidence in the evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE).</p><p><strong>Main results: </strong>We included 17 studies randomising 509 patients, with data available for 452 patients after dropouts. All but three studies evaluated a fixed concentration of low dialysate [Na+], with one using profiled dialysate [Na+] and two using individualised dialysate [Na+]. Five were parallel group studies, and 12 were cross-over studies. Of the latter, only six used a washout between intervention and control periods. Most studies were short-term with a median (interquartile range) follow-up of 4 (4 to 16) weeks. Two were of a single HD session and two of a single week's HD. Seven studies were conducted prior to 2000, and six reported the use of obsolete HD practices. Other than for indirectness arising from older studies, risks of bias in the included studies were generally low. Compared to neutral or high dialysate [Na+] (≥ 138 mM), low dialysate [Na+] (< 138 mM) reduces interdialytic weight gain (14 studies, 515 participants: MD -0.36 kg, 95% CI -0.50 to -0.22; high certainty evidence) and antihypertensive medication use (5 studies, 241 participants: SMD -0.37, 95% CI -0.64 to -0.1; high certainty evidence), and probably reduces left ventricular mass index (2 studies, 143 participants","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Background: </strong>Venous thromboembolism (VTE) involves the formation of a blood clot in a vein, and includes deep venous thrombosis (DVT) or pulmonary embolism (PE). The annual incidence for VTE varies from 0.75 to 2.69 per 1000 individuals, with about 40 million people worldwide impacted by VTE. Statins, 3-hydroxy-3-methylglutaryl (HMG)-coenzyme A (CoA) reductase inhibitors, inhibit cholesterol biosynthesis and display several vascular-protective effects, including antithrombotic properties. However, the potential role of statins in the primary prevention of VTE is still not clear.</p><p><strong>Objectives: </strong>To evaluate the benefits and risks of statins in preventing venous thromboembolism (VTE) in individuals with no prior history of VTE.</p><p><strong>Search methods: </strong>We used standard Cochrane search methods. The search was last updated on 13 March 2023.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) comparing statins with any control intervention (including placebo and usual care) in healthy individuals or participants with conditions other than VTE. There were no restrictions on the dose, duration, route, or timing of statins.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were VTE, DVT, and PE. Our secondary outcomes were serious adverse events, adverse events, and mortality. We used the trial sequential analysis (TSA) method to judge whether the evidence was sufficient, and we used the GRADE approach to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>We included 27 RCTs involving 122,601 adults (aged 18 years and above) who were healthy, had various medical conditions (e.g. hypercholesterolemia), or were at risk for cardiovascular disease. Both males and females were included in all studies. Two studies focused solely on participants over 60 years of age. We deemed four studies to have a low risk of bias overall, while 19 were at high risk of bias, and four were unclear. The 27 studies compared use of statins versus placebo or usual care in individuals who had never experienced VTE. The statins used in the studies were atorvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, and simvastatin. Twenty-three studies followed up participants for over a year, with six of those extending follow-ups for over five years. Twenty-five studies were based in hospitals, and 24 studies were funded by industry. Only one study used VTE as a primary endpoint. The median incidence of VTE in the statins group was 0.72% (ranging from 0% to 10.53%), and in the control group it was 0.89% (ranging from 0% to 6.83%). Our pooled analysis of the 27 studies showed that, relative to control groups, statins may slightly reduce the overall incidence of VTE (odds ratio (OR) 0.86, 95% confidence intervals (CI) 0.76 to 0.98; 27 studies, 122,601 participants; low-certainty evidence). Of
{"title":"Statins for the primary prevention of venous thromboembolism.","authors":"Zixin Wang, Peng Zhang, Jinhui Tian, Peizhen Zhang, Kehu Yang, Lun Li","doi":"10.1002/14651858.CD014769.pub2","DOIUrl":"10.1002/14651858.CD014769.pub2","url":null,"abstract":"<p><strong>Background: </strong>Venous thromboembolism (VTE) involves the formation of a blood clot in a vein, and includes deep venous thrombosis (DVT) or pulmonary embolism (PE). The annual incidence for VTE varies from 0.75 to 2.69 per 1000 individuals, with about 40 million people worldwide impacted by VTE. Statins, 3-hydroxy-3-methylglutaryl (HMG)-coenzyme A (CoA) reductase inhibitors, inhibit cholesterol biosynthesis and display several vascular-protective effects, including antithrombotic properties. However, the potential role of statins in the primary prevention of VTE is still not clear.</p><p><strong>Objectives: </strong>To evaluate the benefits and risks of statins in preventing venous thromboembolism (VTE) in individuals with no prior history of VTE.</p><p><strong>Search methods: </strong>We used standard Cochrane search methods. The search was last updated on 13 March 2023.</p><p><strong>Selection criteria: </strong>We included randomized controlled trials (RCTs) comparing statins with any control intervention (including placebo and usual care) in healthy individuals or participants with conditions other than VTE. There were no restrictions on the dose, duration, route, or timing of statins.</p><p><strong>Data collection and analysis: </strong>We used standard Cochrane methods. Our primary outcomes were VTE, DVT, and PE. Our secondary outcomes were serious adverse events, adverse events, and mortality. We used the trial sequential analysis (TSA) method to judge whether the evidence was sufficient, and we used the GRADE approach to assess the certainty of the evidence for each outcome.</p><p><strong>Main results: </strong>We included 27 RCTs involving 122,601 adults (aged 18 years and above) who were healthy, had various medical conditions (e.g. hypercholesterolemia), or were at risk for cardiovascular disease. Both males and females were included in all studies. Two studies focused solely on participants over 60 years of age. We deemed four studies to have a low risk of bias overall, while 19 were at high risk of bias, and four were unclear. The 27 studies compared use of statins versus placebo or usual care in individuals who had never experienced VTE. The statins used in the studies were atorvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, and simvastatin. Twenty-three studies followed up participants for over a year, with six of those extending follow-ups for over five years. Twenty-five studies were based in hospitals, and 24 studies were funded by industry. Only one study used VTE as a primary endpoint. The median incidence of VTE in the statins group was 0.72% (ranging from 0% to 10.53%), and in the control group it was 0.89% (ranging from 0% to 6.83%). Our pooled analysis of the 27 studies showed that, relative to control groups, statins may slightly reduce the overall incidence of VTE (odds ratio (OR) 0.86, 95% confidence intervals (CI) 0.76 to 0.98; 27 studies, 122,601 participants; low-certainty evidence). Of ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582471","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 : 2024-11-05DOI: 10.1002/14651858.CD015898
Nadia Roumeliotis, George Sabbagh, Philippe Dodin, Genevieve Du Pont-Thibodeau, Jeannie Callum, Marisa Tucci, François Martin Carrier, Jacques Lacroix
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: The objective of this review is to compare the effectiveness and safety of larger versus smaller RBC volume per transfusion for anemia in hospitalized adults, children, and preterm neonates.
{"title":"Larger versus smaller red blood cell volume per transfusion in hospitalized adults, children, and preterm neonates.","authors":"Nadia Roumeliotis, George Sabbagh, Philippe Dodin, Genevieve Du Pont-Thibodeau, Jeannie Callum, Marisa Tucci, François Martin Carrier, Jacques Lacroix","doi":"10.1002/14651858.CD015898","DOIUrl":"10.1002/14651858.CD015898","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: The objective of this review is to compare the effectiveness and safety of larger versus smaller RBC volume per transfusion for anemia in hospitalized adults, children, and preterm neonates.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582460","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 : 2024-11-05DOI: 10.1002/14651858.CD009022.pub3
Ahmer Irfan, Ahsan Rao, Irfan Ahmed
<p><strong>Background: </strong>Appendicectomy is a well-established surgical procedure to manage acute appendicitis. The operation was historically performed as an open procedure and is currently performed using minimally invasive surgical techniques. A recent development in appendicectomy technique is the introduction of single-incision laparoscopic surgery. This incorporates all working ports (either one multi-luminal port or multiple mono-luminal ports) through a single skin incision; the procedure is known as single-incision laparoscopic appendicectomy or SILA. Unanswered questions remain regarding the efficacy of this novel technique, including its effects on patient benefit and satisfaction, complications, and long-term outcomes, when compared to multi-incision conventional laparoscopy (CLA). This is an update of a review published in 2011.</p><p><strong>Objectives: </strong>To assess the effects of single-incision laparoscopic appendicectomy compared with multi-incision laparoscopic appendicectomy, on benefits, complications, and short-term outcomes, in patients with acute appendicitis.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled trials (CENTRAL, the Cochrane Library 2018 Issue 2), Ovid MEDLINE (1983 to January 2024), Ovid Embase (1983 to January 2024), the WHO International Clinical Trial Register (January 2024), and Clinicaltrials.gov (January 2024). We also searched reference lists of relevant articles and reviews, conference proceedings, and ongoing trial databases. The searches were carried out on 20 January 2024.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) that compared the single-incision procedure SILA against CLA for patients (male and female) over the age of 10 years, diagnosed with appendicitis, or symptoms of appendicitis, and undergoing laparoscopic appendicectomy.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion, extracted data into a standardised form, and assessed the risk of bias in the studies. We extracted data relevant to the predetermined outcome measures. Where appropriate, we calculated a summary statistic: odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous data and mean difference (MD) with 95% CI for continuous data. We used Review Manager Web for our statistical analysis.</p><p><strong>Main results: </strong>This review was first published in 2011, when there was no RCT evidence available. For this update, we identified 11 RCTs involving 1373 participants (689 in the SILA groups and 684 in the CLA groups). The participants were similar at baseline in terms of age (mean 31.7 (SILA) versus 30.9 years (CLA)) and sex (female: 53.0% (SILA) versus 50.3% (CLA)). Diagnosis of appendicitis was based on clinical assessment; none of the studies used a diagnosis confirmed by imaging as part of their inclusion criteria. The certainty of the evide
SILA 的缺点可能是转换率较高,但 SILA 可能与患者较高的美容满意度有关。
{"title":"Single-incision versus conventional multi-incision laparoscopic appendicectomy for suspected uncomplicated appendicitis.","authors":"Ahmer Irfan, Ahsan Rao, Irfan Ahmed","doi":"10.1002/14651858.CD009022.pub3","DOIUrl":"10.1002/14651858.CD009022.pub3","url":null,"abstract":"<p><strong>Background: </strong>Appendicectomy is a well-established surgical procedure to manage acute appendicitis. The operation was historically performed as an open procedure and is currently performed using minimally invasive surgical techniques. A recent development in appendicectomy technique is the introduction of single-incision laparoscopic surgery. This incorporates all working ports (either one multi-luminal port or multiple mono-luminal ports) through a single skin incision; the procedure is known as single-incision laparoscopic appendicectomy or SILA. Unanswered questions remain regarding the efficacy of this novel technique, including its effects on patient benefit and satisfaction, complications, and long-term outcomes, when compared to multi-incision conventional laparoscopy (CLA). This is an update of a review published in 2011.</p><p><strong>Objectives: </strong>To assess the effects of single-incision laparoscopic appendicectomy compared with multi-incision laparoscopic appendicectomy, on benefits, complications, and short-term outcomes, in patients with acute appendicitis.</p><p><strong>Search methods: </strong>We searched the Cochrane Central Register of Controlled trials (CENTRAL, the Cochrane Library 2018 Issue 2), Ovid MEDLINE (1983 to January 2024), Ovid Embase (1983 to January 2024), the WHO International Clinical Trial Register (January 2024), and Clinicaltrials.gov (January 2024). We also searched reference lists of relevant articles and reviews, conference proceedings, and ongoing trial databases. The searches were carried out on 20 January 2024.</p><p><strong>Selection criteria: </strong>We included randomised controlled trials (RCTs) that compared the single-incision procedure SILA against CLA for patients (male and female) over the age of 10 years, diagnosed with appendicitis, or symptoms of appendicitis, and undergoing laparoscopic appendicectomy.</p><p><strong>Data collection and analysis: </strong>Two review authors independently selected studies for inclusion, extracted data into a standardised form, and assessed the risk of bias in the studies. We extracted data relevant to the predetermined outcome measures. Where appropriate, we calculated a summary statistic: odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous data and mean difference (MD) with 95% CI for continuous data. We used Review Manager Web for our statistical analysis.</p><p><strong>Main results: </strong>This review was first published in 2011, when there was no RCT evidence available. For this update, we identified 11 RCTs involving 1373 participants (689 in the SILA groups and 684 in the CLA groups). The participants were similar at baseline in terms of age (mean 31.7 (SILA) versus 30.9 years (CLA)) and sex (female: 53.0% (SILA) versus 50.3% (CLA)). Diagnosis of appendicitis was based on clinical assessment; none of the studies used a diagnosis confirmed by imaging as part of their inclusion criteria. The certainty of the evide","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536430/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582466","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 : 2024-10-31DOI: 10.1002/14651858.CD013821.pub2
Nicola Rocco, Giuseppe F Catanuto, Giuseppe Accardo, Nunzio Velotti, Paolo Chiodini, Michela Cinquini, Francesca Privitera, Corrado Rispoli, Maurizio B Nava
<p><strong>Background: </strong>Women who have a mastectomy for breast cancer treatment or risk reduction may be offered different options for breast reconstruction, including use of implants or the woman's own tissue (autologous tissue flaps). The choice of technique depends on factors such as the woman's preferences, breast characteristics, preoperative imaging, comorbidities, smoking habits, prior chest or breast irradiation, and planned adjuvant therapies.</p><p><strong>Objectives: </strong>To assess the effects of implants versus autologous tissue flaps for postmastectomy breast reconstruction on women's quality of life, satisfaction, and short- and long-term surgical complications.</p><p><strong>Search methods: </strong>We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registries in July 2022.</p><p><strong>Selection criteria: </strong>We included studies that compared implant-based reconstruction with autologous tissue-based reconstruction following mastectomy for breast cancer treatment or risk reduction. The minimum eligible sample size was 100 participants.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed risk of bias and extracted data using standard Cochrane procedures. We used GRADE to assess the certainty of the evidence.</p><p><strong>Main results: </strong>Thirty-five non-randomised studies with 57,555 participants met our inclusion criteria. There were nine prospective cohort studies and 26 retrospective cohort studies. We judged 26 studies at serious overall risk of bias and the remaining studies at moderate overall risk of bias. Some studies measured quality of life and satisfaction using the BREAST-Q (scale of 0 to 100, higher is better). Implants may reduce postoperative psychosocial well-being compared with autologous tissue flaps (mean difference (MD) -4.26 points, 95% confidence interval (CI) -4.91 to -3.61; I² = 0%; 6 studies, 3335 participants; low-certainty evidence). Implants may reduce or have little to no effect on postoperative physical well-being compared with autologous tissue flaps, but the evidence is very uncertain (MD -1.92 points, 95% CI -4.44 to 0.60; I² = 87%; 6 studies, 3335 participants; very low-certainty evidence). Implants may reduce postoperative sexual well-being compared with autologous reconstruction (MD -6.63 points, 95% CI -7.55 to -5.72; I² = 0; 6 studies, 3335 participants; low-certainty evidence). Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the breast, but the evidence is very uncertain (MD -8.17 points, 95% CI -11.41 to -4.92; I² = 90%; 6 studies, 3335 participants; very low-certainty evidence). This outcome refers to a woman's satisfaction with breast size, bra fit, appearance in the mirror (clothed or unclothed), and how the breast feels to touch. Women who undergo breast reconstruction with implants versus autologous t
{"title":"Implants versus autologous tissue flaps for breast reconstruction following mastectomy.","authors":"Nicola Rocco, Giuseppe F Catanuto, Giuseppe Accardo, Nunzio Velotti, Paolo Chiodini, Michela Cinquini, Francesca Privitera, Corrado Rispoli, Maurizio B Nava","doi":"10.1002/14651858.CD013821.pub2","DOIUrl":"10.1002/14651858.CD013821.pub2","url":null,"abstract":"<p><strong>Background: </strong>Women who have a mastectomy for breast cancer treatment or risk reduction may be offered different options for breast reconstruction, including use of implants or the woman's own tissue (autologous tissue flaps). The choice of technique depends on factors such as the woman's preferences, breast characteristics, preoperative imaging, comorbidities, smoking habits, prior chest or breast irradiation, and planned adjuvant therapies.</p><p><strong>Objectives: </strong>To assess the effects of implants versus autologous tissue flaps for postmastectomy breast reconstruction on women's quality of life, satisfaction, and short- and long-term surgical complications.</p><p><strong>Search methods: </strong>We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registries in July 2022.</p><p><strong>Selection criteria: </strong>We included studies that compared implant-based reconstruction with autologous tissue-based reconstruction following mastectomy for breast cancer treatment or risk reduction. The minimum eligible sample size was 100 participants.</p><p><strong>Data collection and analysis: </strong>Two review authors independently assessed risk of bias and extracted data using standard Cochrane procedures. We used GRADE to assess the certainty of the evidence.</p><p><strong>Main results: </strong>Thirty-five non-randomised studies with 57,555 participants met our inclusion criteria. There were nine prospective cohort studies and 26 retrospective cohort studies. We judged 26 studies at serious overall risk of bias and the remaining studies at moderate overall risk of bias. Some studies measured quality of life and satisfaction using the BREAST-Q (scale of 0 to 100, higher is better). Implants may reduce postoperative psychosocial well-being compared with autologous tissue flaps (mean difference (MD) -4.26 points, 95% confidence interval (CI) -4.91 to -3.61; I² = 0%; 6 studies, 3335 participants; low-certainty evidence). Implants may reduce or have little to no effect on postoperative physical well-being compared with autologous tissue flaps, but the evidence is very uncertain (MD -1.92 points, 95% CI -4.44 to 0.60; I² = 87%; 6 studies, 3335 participants; very low-certainty evidence). Implants may reduce postoperative sexual well-being compared with autologous reconstruction (MD -6.63 points, 95% CI -7.55 to -5.72; I² = 0; 6 studies, 3335 participants; low-certainty evidence). Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the breast, but the evidence is very uncertain (MD -8.17 points, 95% CI -11.41 to -4.92; I² = 90%; 6 studies, 3335 participants; very low-certainty evidence). This outcome refers to a woman's satisfaction with breast size, bra fit, appearance in the mirror (clothed or unclothed), and how the breast feels to touch. Women who undergo breast reconstruction with implants versus autologous t","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11526434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Primary objective: to assess the benefits and harms of currently recommended regimens as the first-line therapy in high-risk people with chronic lymphocytic leukemia, using network meta-analysis Secondary objectives: to assess whether the benefits and harms of the recommended regimens differ according to sex, Rai stage, or genetic mutation status to estimate the ranking of treatments for overall survival, progression-free survival, objective response rate, complete response rate, minimal residual disease, and serious adverse events to estimate the overall rate of adverse events and serious adverse events.
{"title":"First-line therapy for high-risk people with chronic lymphocytic leukemia: a network meta-analysis.","authors":"Kenichi Miyamoto, Akihiro Ohmoto, Daisuke Yoneoka, Md Obaidur Rahman, Erika Ota","doi":"10.1002/14651858.CD015169","DOIUrl":"10.1002/14651858.CD015169","url":null,"abstract":"<p><strong>Objectives: </strong>This is a protocol for a Cochrane Review (intervention). The objectives are as follows: Primary objective: to assess the benefits and harms of currently recommended regimens as the first-line therapy in high-risk people with chronic lymphocytic leukemia, using network meta-analysis Secondary objectives: to assess whether the benefits and harms of the recommended regimens differ according to sex, Rai stage, or genetic mutation status to estimate the ranking of treatments for overall survival, progression-free survival, objective response rate, complete response rate, minimal residual disease, and serious adverse events to estimate the overall rate of adverse events and serious adverse events.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Rationale: </strong>Retained placenta is a potentially life-threatening condition because of its association with postpartum haemorrhage. Manual removal of the placenta increases the likelihood of infectious complications of the uterine cavity. So, prophylactic antibiotics are recommended by some experts, and commonly administered to reduce these risks. However, the evidence supporting this decision is limited. This review aims to assess the effectiveness of prophylactic antibiotics for manual removal of retained placenta after vaginal birth.</p><p><strong>Objectives: </strong>To compare the effectiveness and adverse effects of routine prophylactic antibiotics for the manual removal of placenta after vaginal birth. To identify appropriate prophylactic antibiotic regimens.</p><p><strong>Search methods: </strong>For this update, we searched CENTRAL, MEDLINE, Embase, CINAHL, and two trials registries, in addition to screening the reference lists of retrieved studies and systematic reviews. The last search was 14 May 2024.</p><p><strong>Eligibility criteria: </strong>All randomised controlled trials and non-randomised studies comparing prophylactic antibiotics to no treatment or to another prophylactic antibiotic to prevent postpartum endometritis after manual removal of placenta after vaginal birth.</p><p><strong>Outcomes: </strong>The critical outcome in our review was postpartum endometritis. Other important outcomes were puerperal morbidity, perineal infection, duration of hospital stay, sepsis, any infection, blood loss, postpartum haemorrhage, secondary postpartum haemorrhage, readmission to hospital, adverse effects of the drugs, women's satisfaction, and neonatal outcomes, such as jaundice, sepsis, neonatal intensive care unit admission, et cetera.</p><p><strong>Risk of bias: </strong>The risk of bias was assessed at the outcome level. We used the Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool to assess the risk of bias in non-randomised studies.</p><p><strong>Synthesis methods: </strong>We carried out statistical analysis using Review Manager. We used a fixed-effect meta-analysis to synthesise the results, and GRADE to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>We included four retrospective cohort studies with a total of 974 participants. Studies were conducted in Germany, Bulgaria, Norway, and Israel, between 1983 and 2017.</p><p><strong>Synthesis of results: </strong>Prophylactic antibiotics versus no antibiotics was the only comparison in our analysis. Postpartum endometritis We do not know whether prophylactic antibiotics have an impact on postpartum endometritis (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.48 to 1.85; 4 studies, 974 participants; very low-certainty evidence). Postpartum haemorrhage The evidence suggests that prophylactic antibiotics may result in little to no difference in postpartum haemorrhage (RR 1.00, 95% CI 0.78 to 1.29; 1 study, 325
{"title":"Prophylactic antibiotics for manual removal of retained placenta in vaginal birth.","authors":"Kiattisak Kongwattanakul, Porjai Pattanittum, Apiwat Jongjakapun, Jen Sothornwit, Chetta Ngamjarus, Nampet Jampathong, Termtem Waidee, Pisake Lumbiganon","doi":"10.1002/14651858.CD004904.pub4","DOIUrl":"10.1002/14651858.CD004904.pub4","url":null,"abstract":"<p><strong>Rationale: </strong>Retained placenta is a potentially life-threatening condition because of its association with postpartum haemorrhage. Manual removal of the placenta increases the likelihood of infectious complications of the uterine cavity. So, prophylactic antibiotics are recommended by some experts, and commonly administered to reduce these risks. However, the evidence supporting this decision is limited. This review aims to assess the effectiveness of prophylactic antibiotics for manual removal of retained placenta after vaginal birth.</p><p><strong>Objectives: </strong>To compare the effectiveness and adverse effects of routine prophylactic antibiotics for the manual removal of placenta after vaginal birth. To identify appropriate prophylactic antibiotic regimens.</p><p><strong>Search methods: </strong>For this update, we searched CENTRAL, MEDLINE, Embase, CINAHL, and two trials registries, in addition to screening the reference lists of retrieved studies and systematic reviews. The last search was 14 May 2024.</p><p><strong>Eligibility criteria: </strong>All randomised controlled trials and non-randomised studies comparing prophylactic antibiotics to no treatment or to another prophylactic antibiotic to prevent postpartum endometritis after manual removal of placenta after vaginal birth.</p><p><strong>Outcomes: </strong>The critical outcome in our review was postpartum endometritis. Other important outcomes were puerperal morbidity, perineal infection, duration of hospital stay, sepsis, any infection, blood loss, postpartum haemorrhage, secondary postpartum haemorrhage, readmission to hospital, adverse effects of the drugs, women's satisfaction, and neonatal outcomes, such as jaundice, sepsis, neonatal intensive care unit admission, et cetera.</p><p><strong>Risk of bias: </strong>The risk of bias was assessed at the outcome level. We used the Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool to assess the risk of bias in non-randomised studies.</p><p><strong>Synthesis methods: </strong>We carried out statistical analysis using Review Manager. We used a fixed-effect meta-analysis to synthesise the results, and GRADE to assess the certainty of the evidence.</p><p><strong>Included studies: </strong>We included four retrospective cohort studies with a total of 974 participants. Studies were conducted in Germany, Bulgaria, Norway, and Israel, between 1983 and 2017.</p><p><strong>Synthesis of results: </strong>Prophylactic antibiotics versus no antibiotics was the only comparison in our analysis. Postpartum endometritis We do not know whether prophylactic antibiotics have an impact on postpartum endometritis (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.48 to 1.85; 4 studies, 974 participants; very low-certainty evidence). Postpartum haemorrhage The evidence suggests that prophylactic antibiotics may result in little to no difference in postpartum haemorrhage (RR 1.00, 95% CI 0.78 to 1.29; 1 study, 325 ","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544142","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 : 2024-10-30DOI: 10.1002/14651858.CD013783.pub2
Peta E Tehan, Joseph Mills, Sarah Leask, Christopher Oldmeadow, Benjamin Peterson, Mathew Sebastian, Viv Chuter
<p><strong>Background: </strong>Peripheral arterial disease (PAD) of the lower limbs is caused by atherosclerotic occlusive disease in which narrowing of arteries reduces blood flow to the lower limbs. PAD is common; it is estimated to affect 236 million individuals worldwide. Advanced age, smoking, hypertension, diabetes and concomitant cardiovascular disease are common factors associated with increased risk of PAD. Complications of PAD can include claudication pain, rest pain, wounds, gangrene, amputation and increased cardiovascular morbidity and mortality. It is therefore clinically important to use diagnostic tests that accurately identify PAD. Accurate and timely detection of PAD allows clinicians to implement appropriate risk management strategies to prevent complications, slow progression or intervene when indicated. Toe-brachial index (TBI) and toe systolic blood pressure (TSBP) are amongst a suite of non-invasive bedside tests used to detect PAD. Both TBI and TSBP are commonly utilised by a variety of clinicians in different settings, therefore a systematic review and meta-analysis of their diagnostic accuracy is warranted and highly relevant to inform clinical practice.</p><p><strong>Objectives: </strong>To (1) estimate the accuracy of TSBP and TBI for the diagnosis of PAD in the lower extremities at different cut-off values for test positivity in populations at risk of PAD, and (2) compare the accuracy of TBI and TSBP for the diagnosis of PAD in the lower extremities. Secondary objectives were to investigate several possible sources of heterogeneity in test accuracy, including the following: patient group tested (people with type 1 or type 2 diabetes, people with renal disease and general population), type of equipment used, positivity threshold and type of reference standard.</p><p><strong>Search methods: </strong>The Cochrane Vascular Information Specialist searched the MEDLINE, Embase, CINAHL, Web of Science, LILACS, Zetoc and DARE databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 27 February 2024.</p><p><strong>Selection criteria: </strong>We included diagnostic case-control, cross-sectional, prospective and retrospective studies in which all participants had either a TSBP or TBI measurement plus a validated method of vascular diagnostic imaging for PAD. We needed to be able to cross-tabulate (2 x 2 table) results of the index test and the reference standard to include a study. To be included, study populations had to be adults aged 18 years and over. We included studies of symptomatic and asymptomatic participants. Studies had to use TSBP and TBI (also called toe-brachial pressure index (TBPI)), either individually, or in addition to other non-invasive tests as index tests to diagnose PAD in individuals with suspected disease. We included data collected by photoplethysmography, laser Doppler, continuous wave Doppler, sphygmomanometers (both manua
背景:下肢外周动脉疾病(PAD)是由动脉粥样硬化性闭塞症引起的,动脉狭窄导致下肢血流量减少。下肢动脉粥样硬化症很常见,估计全球有 2.36 亿人患有此病。高龄、吸烟、高血压、糖尿病和合并心血管疾病是导致 PAD 风险增加的常见因素。PAD 的并发症包括跛行疼痛、静息痛、伤口、坏疽、截肢以及心血管疾病发病率和死亡率增加。因此,使用能准确识别 PAD 的诊断测试具有重要的临床意义。及时准确地检测出 PAD 可使临床医生实施适当的风险管理战略,以预防并发症、延缓病情发展或在必要时进行干预。脚趾肱动脉指数(TBI)和脚趾收缩压(TSBP)是用于检测 PAD 的一系列无创床边检测方法之一。TBI和TSBP通常被不同环境下的各种临床医生所使用,因此有必要对它们的诊断准确性进行系统回顾和荟萃分析,并为临床实践提供参考:目的:(1) 估计在有 PAD 风险的人群中,不同检测阳性临界值下 TSBP 和 TBI 诊断下肢 PAD 的准确性;(2) 比较 TBI 和 TSBP 诊断下肢 PAD 的准确性。次要目标是调查测试准确性异质性的几种可能来源,包括:受测患者群体(1型或2型糖尿病患者、肾病患者和普通人群)、所用设备类型、阳性阈值和参考标准类型:Cochrane血管信息专家检索了MEDLINE、Embase、CINAHL、Web of Science、LILACS、Zetoc和DARE数据库,以及世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册表(截至2024年2月27日):我们纳入了诊断性病例对照研究、横断面研究、前瞻性研究和回顾性研究,在这些研究中,所有参与者都进行了 TSBP 或 TBI 测量,并采用了有效的 PAD 血管诊断成像方法。我们需要将指标检测结果与参考标准交叉列表(2 x 2 表),才能纳入一项研究。研究对象必须是 18 岁及以上的成年人。我们纳入了对有症状和无症状参与者的研究。研究必须单独使用 TSBP 和 TBI(也称为趾肱压指数 (TBPI)),或将其作为诊断疑似患者 PAD 的指标测试,或与其他非侵入性测试一起使用。我们纳入了通过光电血压计、激光多普勒、连续波多普勒、血压计(手动和无创)以及手动或自动数字设备收集的数据:两位综述作者使用标准化表格独立完成数据提取。如果有数据(真阳性、真阴性、假阳性、假阴性),我们将提取数据填入 2 x 2 或然表。如果数据无法进行统计分析,我们会直接联系研究作者。两位独立工作的综述作者使用 QUADAS-2 进行质量评估,出现分歧时由第三位综述作者解决。我们在质量评估中增加了两个问题,以帮助我们了解研究的开展情况,并对偏倚风险和适用性做出适当的判断:18 项研究符合纳入标准;其中 13 项仅评估了 TBI,1 项仅评估了 TSBP,4 项同时评估了 TBI 和 TSBP。其中 13 项研究使用彩色双相超声(CDU)作为参考标准,2 项研究使用计算机断层扫描血管造影(CTA),1 项研究使用多载体行计算机断层扫描(MDCT),1 项研究使用血管造影,1 项研究结合使用 CDU、CTA 和血管造影。对 1927 名参与者和 2550 条肢体进行了创伤性脑损伤调查。对 701 名参与者的 TSBP 进行了调查,其中对 701 个肢体的 TSBP 进行了测量。这些研究的方法学质量普遍较低,对参与者招募的连续或随机抽样的报告较差,对指数测试和参考标准之间的盲法以及指数测试和参考标准之间的时间安排的报告较差。根据 GRADE,大多数研究的证据确定性很低:虽然针对 TBI 和 TSBP 识别 PAD 完成了少量诊断测试准确性研究,但总体方法学质量较低,大多数研究提供的证据确定性很低。因此,支持使用 TBI 和 TSBP 识别 PAD 的证据基础非常有限。虽然 TBI 和 TSBP 在临床上被广泛使用,但这些检查的总体诊断效果仍不确定。
{"title":"Toe-brachial index and toe systolic blood pressure for the diagnosis of peripheral arterial disease.","authors":"Peta E Tehan, Joseph Mills, Sarah Leask, Christopher Oldmeadow, Benjamin Peterson, Mathew Sebastian, Viv Chuter","doi":"10.1002/14651858.CD013783.pub2","DOIUrl":"10.1002/14651858.CD013783.pub2","url":null,"abstract":"<p><strong>Background: </strong>Peripheral arterial disease (PAD) of the lower limbs is caused by atherosclerotic occlusive disease in which narrowing of arteries reduces blood flow to the lower limbs. PAD is common; it is estimated to affect 236 million individuals worldwide. Advanced age, smoking, hypertension, diabetes and concomitant cardiovascular disease are common factors associated with increased risk of PAD. Complications of PAD can include claudication pain, rest pain, wounds, gangrene, amputation and increased cardiovascular morbidity and mortality. It is therefore clinically important to use diagnostic tests that accurately identify PAD. Accurate and timely detection of PAD allows clinicians to implement appropriate risk management strategies to prevent complications, slow progression or intervene when indicated. Toe-brachial index (TBI) and toe systolic blood pressure (TSBP) are amongst a suite of non-invasive bedside tests used to detect PAD. Both TBI and TSBP are commonly utilised by a variety of clinicians in different settings, therefore a systematic review and meta-analysis of their diagnostic accuracy is warranted and highly relevant to inform clinical practice.</p><p><strong>Objectives: </strong>To (1) estimate the accuracy of TSBP and TBI for the diagnosis of PAD in the lower extremities at different cut-off values for test positivity in populations at risk of PAD, and (2) compare the accuracy of TBI and TSBP for the diagnosis of PAD in the lower extremities. Secondary objectives were to investigate several possible sources of heterogeneity in test accuracy, including the following: patient group tested (people with type 1 or type 2 diabetes, people with renal disease and general population), type of equipment used, positivity threshold and type of reference standard.</p><p><strong>Search methods: </strong>The Cochrane Vascular Information Specialist searched the MEDLINE, Embase, CINAHL, Web of Science, LILACS, Zetoc and DARE databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 27 February 2024.</p><p><strong>Selection criteria: </strong>We included diagnostic case-control, cross-sectional, prospective and retrospective studies in which all participants had either a TSBP or TBI measurement plus a validated method of vascular diagnostic imaging for PAD. We needed to be able to cross-tabulate (2 x 2 table) results of the index test and the reference standard to include a study. To be included, study populations had to be adults aged 18 years and over. We included studies of symptomatic and asymptomatic participants. Studies had to use TSBP and TBI (also called toe-brachial pressure index (TBPI)), either individually, or in addition to other non-invasive tests as index tests to diagnose PAD in individuals with suspected disease. We included data collected by photoplethysmography, laser Doppler, continuous wave Doppler, sphygmomanometers (both manua","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523229/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544143","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}