Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.
Department of Health Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.
Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD014461. doi: 10.1002/14651858.CD014461.pub2.
BACKGROUND: Low back pain is a common presentation across different healthcare settings. Clinicians need to confidently be able to screen and identify people presenting with low back pain with a high suspicion of serious or specific pathology (e.g. vertebral fracture). Patients identified with an increased likelihood of having a serious pathology will likely require additional investigations and specific treatment. Guidelines recommend a thorough history and clinical assessment to screen for serious pathology as a cause of low back pain. However, the diagnostic accuracy of recommended red flags (e.g. older age, trauma, corticosteroid use) remains unclear, particularly those used to screen for vertebral fracture. OBJECTIVES: To assess the diagnostic accuracy of red flags used to screen for vertebral fracture in people presenting with low back pain. Where possible, we reported results of red flags separately for different types of vertebral fracture (i.e. acute osteoporotic vertebral compression fracture, vertebral traumatic fracture, vertebral stress fracture, unspecified vertebral fracture). SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 26 July 2022. SELECTION CRITERIA: We considered primary diagnostic studies if they compared results of history taking or physical examination (or both) findings (index test) with a reference standard test (e.g. X-ray, magnetic resonance imaging (MRI), computed tomography (CT), single-photon emission computerised tomography (SPECT)) for the identification of vertebral fracture in people presenting with low back pain. We included index tests that were presented individually or as part of a combination of tests. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data for diagnostic two-by-two tables from the publications or reconstructed them using information from relevant parameters to calculate sensitivity, specificity, and positive (+LR) and negative (-LR) likelihood ratios with 95% confidence intervals (CIs). We extracted aspects of study design, characteristics of the population, index test, reference standard, and type of vertebral fracture. Meta-analysis was not possible due to heterogeneity of studies and index tests, therefore the analysis was descriptive. We calculated sensitivity, specificity, and LRs for each test and used these as an indication of clinical usefulness. Two review authors independently conducted risk of bias and applicability assessment using the QUADAS-2 tool. MAIN RESULTS: This review is an update of a previous Cochrane Review of red flags to screen for vertebral fracture in people with low back pain. We included 14 studies in this review, six based in primary care, five in secondary care, and three in tertiary care. Four studies reported on 'osteoporotic vertebral fractures', two studies reported on 'vertebral compression fracture', one study reported on 'osteoporotic and traumatic vertebral fracture', two studies reported on 'vertebral stress fracture', and five studies reported on 'unspecified vertebral fracture'. Risk of bias was only rated as low in one study for the domains reference standard and flow and timing. The domain patient selection had three studies and the domain index test had six studies rated at low risk of bias. Meta-analysis was not possible due to heterogeneity of the data. Results from single studies suggest only a small number of the red flags investigated may be informative. In the primary healthcare setting, results from single studies suggest 'trauma' demonstrated informative +LRs (range: 1.93 to 12.85) for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture' (+LR: 6.42, 95% CI 2.94 to 14.02). Results from single studies suggest 'older age' demonstrated informative +LRs for studies in primary care for 'unspecified vertebral fracture' (older age greater than 70 years: 11.19, 95% CI 5.33 to 23.51). Results from single studies suggest 'corticosteroid use' may be an informative red flag in primary care for 'unspecified vertebral fracture' (+LR range: 3.97, 95% CI 0.20 to 79.15 to 48.50, 95% CI 11.48 to 204.98) and 'osteoporotic vertebral fracture' (+LR: 2.46, 95% CI 1.13 to 5.34); however, diagnostic values varied and CIs were imprecise. Results from a single study suggest red flags as part of a combination of index tests such as 'older age and female gender' in primary care demonstrated informative +LRs for 'unspecified vertebral fracture' (16.17, 95% CI 4.47 to 58.43). In the secondary healthcare setting, results from a single study suggest 'trauma' demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 2.18, 95% CI 1.86 to 2.54) and 'older age' demonstrated informative +LRs for 'osteoporotic vertebral fracture' (older age greater than 75 years: 2.51, 95% CI 1.48 to 4.27). Results from a single study suggest red flags as part of a combination of index tests such as 'older age and trauma' in secondary care demonstrated informative +LRs for 'unspecified vertebral fracture' (+LR: 4.35, 95% CI 2.92 to 6.48). Results from a single study suggest when '4 of 5 tests' were positive in secondary care, they demonstrated informative +LRs for 'osteoporotic vertebral fracture' (+LR: 9.62, 95% CI 5.88 to 15.73). In the tertiary care setting, results from a single study suggest 'presence of contusion/abrasion' was informative for 'vertebral compression fracture' (+LR: 31.09, 95% CI 18.25 to 52.96). AUTHORS' CONCLUSIONS: The available evidence suggests that only a few red flags are potentially useful in guiding clinical decisions to further investigate people suspected to have a vertebral fracture. Most red flags were not useful as screening tools to identify vertebral fracture in people with low back pain. In primary care, 'older age' was informative for 'unspecified vertebral fracture', and 'trauma' and 'corticosteroid use' were both informative for 'unspecified vertebral fracture' and 'osteoporotic vertebral fracture'. In secondary care, 'older age' was informative for 'osteoporotic vertebral fracture' and 'trauma' was informative for 'unspecified vertebral fracture'. In tertiary care, 'presence of contusion/abrasion' was informative for 'vertebral compression fracture'. Combinations of red flags were also informative and may be more useful than individual tests alone. Unfortunately, the challenge to provide clear guidance on which red flags should be used routinely in clinical practice remains. Further research with primary studies is needed to improve and consolidate our current recommendations for screening for vertebral fractures to guide clinical care.
背景:下腰痛是不同医疗保健环境中常见的表现。临床医生需要有信心能够筛选并识别出患有高度怀疑有严重或特定病理(如椎体骨折)的下腰痛患者。被识别出患有严重病理可能性增加的患者可能需要进一步的检查和特定的治疗。指南建议进行全面的病史和临床评估,以筛选出导致下腰痛的严重病理。然而,推荐的警示标志(如年龄较大、创伤、使用皮质类固醇)的诊断准确性仍然不清楚,特别是那些用于筛查椎体骨折的警示标志。
目的:评估用于筛选下腰痛患者椎体骨折的警示标志的诊断准确性。在可能的情况下,我们分别报告了不同类型椎体骨折(即急性骨质疏松性椎体压缩性骨折、椎体外伤性骨折、椎体应力性骨折、未特指的椎体骨折)的警示标志的结果。
检索策略:我们使用了标准的、广泛的 Cochrane 检索方法。最新的检索日期是 2022 年 7 月 26 日。
纳入标准:如果研究比较了病史采集或体格检查(或两者)结果(指标测试)与参考标准测试(如 X 射线、磁共振成像(MRI)、计算机断层扫描(CT)、单光子发射计算机化断层扫描(SPECT))用于识别下腰痛患者的椎体骨折,则我们将其视为主要诊断研究。我们纳入了单独呈现或作为组合测试一部分呈现的指标测试。
数据收集和分析:两名综述作者独立从出版物中提取或使用相关参数重建诊断性 2×2 表格数据,以计算灵敏度、特异性、阳性(+LR)和阴性(-LR)似然比及其 95%置信区间(CI)。我们提取了研究设计、人群特征、指标测试、参考标准和椎体骨折类型等方面的信息。由于研究和指标测试的异质性,无法进行荟萃分析,因此分析是描述性的。我们计算了每个测试的灵敏度、特异性和 LR,并将其作为临床有用性的指示。两名综述作者独立使用 QUADAS-2 工具进行了偏倚和适用性评估。
主要结果:这是一篇对以前的下腰痛椎体骨折筛查警示标志的 Cochrane 综述的更新。我们在本次综述中纳入了 14 项研究,其中 6 项来自初级保健,5 项来自二级保健,3 项来自三级保健。四项研究报告了“骨质疏松性椎体骨折”,两项研究报告了“椎体压缩性骨折”,一项研究报告了“骨质疏松性和外伤性椎体骨折”,两项研究报告了“椎体应力性骨折”,五项研究报告了“未特指的椎体骨折”。只有一项研究在参考标准和流程与时间两个领域被评为低偏倚风险。在患者选择领域有三项研究,在指标测试领域有六项研究被评为低偏倚风险。由于数据的异质性,无法进行荟萃分析。来自单一研究的结果表明,所调查的警示标志中只有少数可能具有信息性。在初级医疗保健环境中,来自单一研究的结果表明,“创伤”对于“未特指的椎体骨折”和“骨质疏松性椎体骨折”表现出有信息性的+LR(范围:1.93 至 12.85)。来自单一研究的结果表明,“年龄较大”对于初级保健中“未特指的椎体骨折”的研究表现出有信息性的+LR(年龄大于 70 岁:11.19,95%CI 5.33 至 23.51)。来自单一研究的结果表明,“皮质类固醇使用”可能是初级保健中“未特指的椎体骨折”的一个有信息性的警示标志(+LR 范围:3.97,95%CI 0.20 至 79.15 至 48.50,95%CI 11.48 至 204.98)和“骨质疏松性椎体骨折”(+LR:2.46,95%CI 1.13 至 5.34);然而,诊断值各不相同,CI 不精确。来自单一研究的结果表明,警示标志作为指标测试组合的一部分,例如初级保健中的“年龄较大和女性”,对于“未特指的椎体骨折”表现出有信息性的+LR(16.17,95%CI 4.47 至 58.43)。在二级保健环境中,来自单一研究的结果表明,“创伤”对于“未特指的椎体骨折”表现出有信息性的+LR(+LR:2.18,95%CI 1.86 至 2.54),“年龄较大”对于“骨质疏松性椎体骨折”表现出有信息性的+LR(年龄大于 75 岁:2.51,95%CI 1.48 至 4.27)。来自单一研究的结果表明,警示标志作为指标测试组合的一部分,例如二级保健中的“年龄较大和创伤”,对于“未特指的椎体骨折”表现出有信息性的+LR(+LR:4.35,95%CI 2.92 至 6.48)。来自单一研究的结果表明,当二级保健中“4 项中的 5 项为阳性”时,它们对于“骨质疏松性椎体骨折”表现出有信息性的+LR(+LR:9.62,95%CI 5.88 至 15.73)。在三级保健环境中,来自单一研究的结果表明,“存在瘀伤/擦伤”对于“椎体压缩性骨折”具有信息性(+LR:31.09,95%CI 18.25 至 52.96)。
结论:现有证据表明,只有少数警示标志可能对指导临床决策以进一步调查疑似椎体骨折的患者具有指导意义。大多数警示标志都不是筛查工具,不能用于识别患有下腰痛的患者的椎体骨折。在初级保健中,“年龄较大”对于“未特指的椎体骨折”具有信息性,而“创伤”和“皮质类固醇使用”对于“未特指的椎体骨折”和“骨质疏松性椎体骨折”都具有信息性。在二级保健中,“年龄较大”对于“骨质疏松性椎体骨折”具有信息性,而“创伤”对于“未特指的椎体骨折”具有信息性。在三级保健中,“存在瘀伤/擦伤”对于“椎体压缩性骨折”具有信息性。组合的警示标志也具有信息性,可能比单独的测试更有用。不幸的是,为临床实践提供明确的指导,确定哪些警示标志应该常规用于筛选椎体骨折以指导临床护理,仍然是一个挑战。需要进一步的原始研究来改进和巩固我们目前对筛查椎体骨折以指导临床护理的建议。
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