Peta E Tehan, Joseph Mills, Sarah Leask, Christopher Oldmeadow, Benjamin Peterson, Mathew Sebastian, Viv Chuter
{"title":"用于诊断外周动脉疾病的脚趾肱动脉指数和脚趾收缩压。","authors":"Peta E Tehan, Joseph Mills, Sarah Leask, Christopher Oldmeadow, Benjamin Peterson, Mathew Sebastian, Viv Chuter","doi":"10.1002/14651858.CD013783.pub2","DOIUrl":null,"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 manual and aneroid) and manual or automated digital equipment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently completed data extraction using a standardised form. We extracted data to populate 2 x 2 contingency tables when available (true positives, true negatives, false positives, false negatives). Where data were not available to enable statistical analysis, we contacted study authors directly. Two review authors working independently undertook quality assessment using QUADAS-2, with disagreements resolved by a third review author. We incorporated two additional questions into the quality appraisal to aid our understanding of the conduct of studies and make appropriate judgements about risk of bias and applicability.</p><p><strong>Main results: </strong>Eighteen studies met the inclusion criteria; 13 evaluated TBI only, one evaluated TSBP only and four evaluated both TBI and TSBP. Thirteen of the studies used colour duplex ultrasound (CDU) as a reference standard, two used computed tomography angiography (CTA), one used multi-detector row tomography (MDCT), one used angiography and one used a combination of CDU, CTA and angiography. TBI was investigated in 1927 participants and 2550 limbs. TSBP was investigated in 701 participants, of which 701 limbs had TSBP measured. Studies were generally of low methodological quality, with poor reporting of participant recruitment in regard to consecutive or random sampling, and poor reporting of blinding between index test and reference standard, as well as timing between index test and reference standard. The certainty of evidence according to GRADE for most studies was very low.</p><p><strong>Authors' conclusions: </strong>Whilst a small number of diagnostic test accuracy studies have been completed for TBI and TSBP to identify PAD, the overall methodological quality was low, with most studies providing a very low certainty of evidence. The evidence base to support the use of TBI and TSBP to identify PAD is therefore limited. Whilst both TBI and TSBP are used extensively clinically, the overall diagnostic performance of these tests remains uncertain. Future research using robust methods and clear reporting is warranted to comprehensively determine the diagnostic test accuracy of the TBI and TSBP for identification of PAD with greater certainty. However, conducting such research where some of the reference tests are invasive and only clinically indicated in populations with known PAD is challenging.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":null,"pages":null},"PeriodicalIF":8.8000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523229/pdf/","citationCount":"0","resultStr":"{\"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\":null,\"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. 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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 manual and aneroid) and manual or automated digital equipment.</p><p><strong>Data collection and analysis: </strong>Two review authors independently completed data extraction using a standardised form. We extracted data to populate 2 x 2 contingency tables when available (true positives, true negatives, false positives, false negatives). Where data were not available to enable statistical analysis, we contacted study authors directly. Two review authors working independently undertook quality assessment using QUADAS-2, with disagreements resolved by a third review author. We incorporated two additional questions into the quality appraisal to aid our understanding of the conduct of studies and make appropriate judgements about risk of bias and applicability.</p><p><strong>Main results: </strong>Eighteen studies met the inclusion criteria; 13 evaluated TBI only, one evaluated TSBP only and four evaluated both TBI and TSBP. Thirteen of the studies used colour duplex ultrasound (CDU) as a reference standard, two used computed tomography angiography (CTA), one used multi-detector row tomography (MDCT), one used angiography and one used a combination of CDU, CTA and angiography. TBI was investigated in 1927 participants and 2550 limbs. TSBP was investigated in 701 participants, of which 701 limbs had TSBP measured. 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Future research using robust methods and clear reporting is warranted to comprehensively determine the diagnostic test accuracy of the TBI and TSBP for identification of PAD with greater certainty. 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引用次数: 0
摘要
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。
Toe-brachial index and toe systolic blood pressure for the diagnosis of peripheral arterial disease.
Background: 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.
Objectives: 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.
Search methods: 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.
Selection criteria: 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 manual and aneroid) and manual or automated digital equipment.
Data collection and analysis: Two review authors independently completed data extraction using a standardised form. We extracted data to populate 2 x 2 contingency tables when available (true positives, true negatives, false positives, false negatives). Where data were not available to enable statistical analysis, we contacted study authors directly. Two review authors working independently undertook quality assessment using QUADAS-2, with disagreements resolved by a third review author. We incorporated two additional questions into the quality appraisal to aid our understanding of the conduct of studies and make appropriate judgements about risk of bias and applicability.
Main results: Eighteen studies met the inclusion criteria; 13 evaluated TBI only, one evaluated TSBP only and four evaluated both TBI and TSBP. Thirteen of the studies used colour duplex ultrasound (CDU) as a reference standard, two used computed tomography angiography (CTA), one used multi-detector row tomography (MDCT), one used angiography and one used a combination of CDU, CTA and angiography. TBI was investigated in 1927 participants and 2550 limbs. TSBP was investigated in 701 participants, of which 701 limbs had TSBP measured. Studies were generally of low methodological quality, with poor reporting of participant recruitment in regard to consecutive or random sampling, and poor reporting of blinding between index test and reference standard, as well as timing between index test and reference standard. The certainty of evidence according to GRADE for most studies was very low.
Authors' conclusions: Whilst a small number of diagnostic test accuracy studies have been completed for TBI and TSBP to identify PAD, the overall methodological quality was low, with most studies providing a very low certainty of evidence. The evidence base to support the use of TBI and TSBP to identify PAD is therefore limited. Whilst both TBI and TSBP are used extensively clinically, the overall diagnostic performance of these tests remains uncertain. Future research using robust methods and clear reporting is warranted to comprehensively determine the diagnostic test accuracy of the TBI and TSBP for identification of PAD with greater certainty. However, conducting such research where some of the reference tests are invasive and only clinically indicated in populations with known PAD is challenging.
期刊介绍:
The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.