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J Athl Train. 2011 Jan-Feb;46(1):99-102. doi: 10.4085/1062-6050-46.1.99.
Chou R, Fu R, Carrino JA, Deyo RA. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009;373(9662):463-472.
In patients with low back pain (LBP) who do not have indications of a serious underlying condition, does routine, immediate lumbar imaging result in improved patient outcomes when compared with clinical care without immediate imaging?
Studies were identified by searching MEDLINE (1966 through first week of August 2008) and the Cochrane Central Register of Controlled Trials (third quarter of 2008). The reference lists of identified studies were manually reviewed for additional citations. The search terms spine, low-back pain, diagnostic imaging, and randomized controlled trials were used in both databases. The complete search strategy was made available as an online supplement.
The search criteria were applied to the articles obtained from the electronic searches and the subsequent manual searches with no language restrictions. This systematic review and meta-analysis included randomized, controlled trials that compared immediate, routine lumbar imaging (or routine provision of imaging findings) with usual clinical care without immediate lumbar imaging (or not routinely providing results of imaging) for LBP without indications of serious underlying conditions.
Data extraction and assessment of study quality were well described. The trials assessed one or more of the following outcomes: pain, function, mental health, quality of life, patient satisfaction, and overall patient-reported improvement. Two reviewers independently appraised citations considered potentially relevant, with disagreements between reviewers resolved by consensus. Two independent reviewers abstracted data from the trials and assessed quality with modified Cochrane Back Review Group criteria. The criterion for blinding of patients and providers was excluded because of lack of applicability to imaging studies. In addition, the criterion of co-intervention similarity was excluded because a potential effect of different imaging strategies is to alter subsequent treatment decisions. As a result of excluding these criteria, quality ratings were based on the remaining 8 criteria. The authors resolved disagreements about quality ratings through discussion and consensus. Trials that met 4 or more of the 8 criteria were classified as higher quality, whereas those that met 3 or fewer of the 8 criteria were classified as lower quality. In addition, the authors categorized duration of symptoms as acute (<4 weeks), subacute (4-12 weeks), or chronic (>12 weeks). The investigators also contacted the study authors for additional data if included outcomes were not published or if median (rather than mean) outcomes were reported. Statistical analysis was conducted on the primary outcomes of improvement in pain or function. Secondary outcomes of improvement in mental health, quality of life, patient satisfaction, and overall improvement were also analyzed. Outcomes were categorized as short term (≤ 3 months), long term (>6 months to ≤ 1 year), or extended (>1 year). For continuous outcomes, standardized mean differences (SMDs) of interventions for change between baseline and follow-up measurements were calculated. In studies reporting the same pain (visual analog scale [VAS] or Short Form-36 bodily pain score) or function (Roland-Morris Disability Questionnaire [RDQ]) outcomes, weighted mean differences (WMDs) were calculated. In all analyses, lower pain and function scores indicated better outcomes. For quality-of-life and mental health outcomes, higher scores indicated improved outcomes. All statistical analyses were performed with Stata 10.0. For outcomes in which SMDs were calculated, values of 0.2 to 0.5 were considered small, 0.5 to 0.8 were considered moderate, and values greater than 0.8 were considered large. For WMDs, mean improvements of 5 to 10 points on a 100-point scale (or equivalent) were considered small, 10-point to 20-point changes were considered moderate, and changes greater than 20 points were considered large. For the RDQ, mean improvements of 1 to 2 points were termed small, and improvements of 2 to 5 points were termed moderate.
The total number of citations identified using the search criteria was 479 articles and abstracts. Of these, 466 were excluded because either they were not randomized trials or they did not use imaging strategies for LBP. At this step, 13 articles were retrieved for further analysis. This analysis resulted in 3 additional articles being excluded (1 was not a randomized trial and the other 2 compared 2 imaging techniques rather than immediate imaging versus no imaging). The final step resulted in the inclusion of 6 trials reported in 10 publications for the meta-analysis. In the studies meeting the inclusion criteria, 4 assessed lumbar radiography and 2 assessed magnetic resonance imaging (MRI) or computed tomography (CT) scans. In these 6 trials, 1804 patients were randomly assigned to the intervention group. The duration of patient follow-up ranged from 3 weeks to 2 years. In addition, 1 trial excluded patients with sciatica or other radiculopathy symptoms, whereas another did not report the proportion of patients with these symptoms. In the other 4 studies, the proportion of patients with sciatica or radiculopathy ranged from 24% to 44%. Of the included trials, 3 compared immediate lumbar radiography with usual clinical care without immediate radiography, and a fourth study compared immediate lumbar radiography and a brief educational intervention with lumbar radiography if no improvement was seen by 3 weeks. The final 2 studies assessed advanced imaging modalities. Specifically, one group compared immediate MRI or CT with usual clinical care without advanced imaging in patients with primarily chronic LBP (82% with LBP for >3 months) who were referred to a surgeon. In the other advanced imaging study, all patients with LBP for <3 weeks underwent MRI and were then randomized to routine notification of results or to notification of results only if clinically indicated. With respect to study quality, 5 trials met at least 4 of the 8 predetermined quality criteria, leading to a classification of higher quality. In addition, 5 trials were included in the primary meta-analysis on pain or function improvement at 1 or more follow-up periods. With regard to short-term and long-term improvements in pain, no differences were noted between routine, immediate lumbar imaging and usual clinical care without immediate imaging ( Table 1 ). In studies using the VAS pain score, the WMD (0.62, 95% confidence interval [CI] = 0.03, 1.21) at short-term follow-up slightly favored no immediate imaging. No differences in outcome were seen in studies using the Short Form-36 bodily pain score. No improvements in function at short-term or long-term follow-up were noted between imaging strategies. Specifically, short-term function measured with the RDQ in 3 studies showed a WMD of 0.48 points (95% CI = -1.39, 2.35) between imaging strategies, whereas long-term function in 3 studies, also measured with the RDQ, showed a WMD of 0.33 points (95% CI = -0.65, 1.32). One included trial reported pain outcomes at extended (2-year) follow-up and found no differences between imaging strategies for pain (Short Form-36 bodily pain or Aberdeen pain score), with SMDs of -2.7 (95% CI = -6.17, 0.79) and -1.6 (-4.04, 0.84), respectively. The outcomes between immediate imaging and usual clinical care without immediate imaging did not differ for short-term follow-up in those studies reporting quality of life (SMD = -0.10, 95% CI = -0.53, 0.34), mental health (SMD = 0.12, 95% CI = -0.37, 0.62), or overall improvement (mean risk ratio = 0.83, 95% CI = 0.65, 1.06). In those studies reporting long-term follow-up periods, similar results can be seen for quality of life (SMD = -0.15, 95% CI = -0.33, 0.04) and mental health (SMD = 0.01, 95% CI = -0.32, 0.34). In the study reporting extended follow-up, immediate imaging was not better in terms of improving quality of life (SMD = 0.02, 95% CI = -0.02, 0.07) or mental health (SMD = -1.50, 95% CI = -4.09, 1.09) when compared with usual clinical care without immediate imaging. In the included studies, no cases of cancer, infection, cauda equina syndrome, or other serious diagnoses were reported in patients randomly assigned to either imaging strategy.
Available evidence indicates that immediate, routine lumbar spine imaging in patients with LBP and without features indicating a serious underlying condition did not improve outcomes compared with usual clinical care without immediate imaging. Clinical care without immediate imaging seems to result in no increased odds of failure in identifying serious underlying conditions in patients without risk factors for these conditions. In addition to lacking clinical benefit, routine lumbar imaging is associated with radiation exposure (radiography and CT) and increased direct expenses for patients and may lead to unnecessary procedures. This evidence confirms that clinicians should refrain from routine, immediate lumbar imaging in primary care patients with nonspecific, acute or subacute LBP and no indications of underlying serious conditions. Specific consideration of patient expectations about the value of imaging was not addressed here; however, this aspect must be considered to avoid unnecessary imaging while also meeting patient expectations and increasing patient satisfaction.
Chou R, Fu R, Carrino JA, Deyo RA. 影像学策略在治疗下腰痛中的应用:系统评价和荟萃分析。柳叶刀。2009;373(9662):463-472.
对于没有严重潜在疾病的下腰痛(LBP)患者,如果不进行即刻的影像学检查,而是采用常规的临床护理,是否会改善患者的预后?
研究人员通过检索 MEDLINE(1966 年至 2008 年 8 月第一周)和 Cochrane 中心对照试验注册库(2008 年第三季度),对符合纳入标准的研究进行了评估。此外,还对已纳入研究的参考文献进行了手工检索,以获取额外的参考文献。搜索词包括 spine(脊柱)、low-back pain(下腰痛)、diagnostic imaging(诊断影像学)和 randomized controlled trials(随机对照试验)。这两个数据库都使用了完整的搜索策略,并且可以作为在线补充材料获取。
搜索策略应用于从电子搜索和随后的手动搜索中获得的文章,且不受语言限制。本系统评价和荟萃分析纳入了随机对照试验,这些试验比较了即刻、常规的腰椎影像学检查(或常规提供影像学结果)与没有严重潜在疾病的下腰痛患者的常规临床护理(或不常规提供影像学结果),纳入研究的患者具有以下一个或多个特征:疼痛、功能、心理健康、生活质量、患者满意度和整体患者报告的改善。两名审查员独立评估了被认为可能相关的引文,对意见不一致的地方通过协商达成一致。两名独立的审查员从试验中提取数据,并使用改良的 Cochrane 腰背综述组标准对数据进行评估。由于影像学研究中缺乏患者和提供者的盲法,因此排除了患者和提供者盲法的标准。此外,由于不同影像学策略的潜在作用是改变后续治疗决策,因此也排除了类似干预措施的标准。由于排除了这些标准,因此质量评价是基于其余的 8 个标准进行的。对于质量评价不一致的试验,通过讨论和协商达成一致。如果符合纳入标准的试验达到或超过 4 个标准,则将其归类为高质量试验,而符合纳入标准的试验达到或低于 3 个标准,则将其归类为低质量试验。此外,作者还根据症状持续时间(急性,<4 周;亚急性,4-12 周;慢性,>12 周)对患者进行分类。作者还通过联系研究作者获取纳入结局未发表或仅报告中位数(而非均值)结局的额外数据。如果主要结局(疼痛或功能改善)改善,则进行统计分析。次要结局(心理健康、生活质量、患者满意度和整体改善)也进行了分析。结局分为短期(≤3 个月)、长期(>6 个月至≤1 年)和扩展(>1 年)。对于连续结局,采用基线与随访测量之间的变化来计算标准化均数差异(SMD)。对于报告相同疼痛(视觉模拟评分 [VAS] 或短期表单-36 身体疼痛评分)或功能(Roland-Morris 残疾问卷 [RDQ])结局的研究,采用加权均数差(WMD)进行计算。所有分析中,较低的疼痛和功能评分表明改善的结局。对于生活质量和心理健康结局,较高的评分表明改善的结局。所有统计学分析均使用 Stata 10.0 进行。对于计算 SMD 的结局,0.2 到 0.5 的值被认为是小的,0.5 到 0.8 的值被认为是中等的,而大于 0.8 的值被认为是大的。对于 WMD,100 分制的 5 到 10 分的改善被认为是小的,10 到 20 分的改善被认为是中等的,而大于 20 分的改善被认为是大的。对于 RDQ,1 到 2 分的改善被称为小的,而 2 到 5 分的改善被称为中等的。
使用搜索标准确定的总引文数为 479 篇文章和摘要。其中,466 篇因不是随机对照试验或未使用影像学策略治疗下腰痛而被排除。在这一步骤中,又有 13 篇文章被纳入进一步分析。这进一步分析导致 3 篇额外的文章被排除(1 篇不是随机对照试验,另 2 篇比较了 2 种影像学技术,而不是即刻影像学与无影像学)。最后一步纳入了 10 篇出版物中 6 项随机对照试验的 10 篇文献进行荟萃分析。在符合纳入标准的研究中,4 项研究评估了腰椎 X 线摄影,2 项研究评估了磁共振成像(MRI)或计算机断层扫描(CT)扫描。在这些纳入的试验中,1804 名患者被随机分配到干预组。患者的随访时间范围从 3 周到 2 年。此外,1 项试验排除了有坐骨神经痛或其他根性症状的患者,而另一项试验没有报告这些症状的比例。在其他 4 项研究中,坐骨神经痛或根性症状的患者比例为 24%至 44%。在纳入的试验中,3 项比较了即刻腰椎 X 线摄影与无即刻 X 线摄影的常规临床护理,第四项研究比较了即刻腰椎 X 线摄影和腰椎 X 线摄影如果在 3 周内未见改善的情况下进行简短的教育干预。最后 2 项研究评估了高级影像学方法。具体来说,一组将立即 MRI 或 CT 与主要为慢性下腰痛(82%的腰痛持续时间>3 个月)患者的常规临床护理进行比较,这些患者被转诊给外科医生。在另一项高级影像学研究中,所有腰痛持续时间<3 周的患者均接受 MRI 检查,然后随机分为常规通知结果组或仅在临床指征时通知结果组。关于研究质量,5 项试验至少符合 8 项预定质量标准中的 4 项,因此被归类为高质量试验。此外,5 项试验都被纳入了对至少 1 个随访期疼痛或功能改善的主要 meta 分析。对于短期和长期的疼痛改善,常规、即刻腰椎影像学检查与无即刻影像学检查之间没有差异(表 1)。在使用视觉模拟评分(VAS)疼痛评分的研究中,在短期随访时,WMD(0.62,95%置信区间 [CI] 0.03,1.21)略微倾向于无即刻影像学检查。使用短期表单-36 身体疼痛评分的研究中未见疼痛改善。在短期和长期随访中,影像学策略对功能均无改善。具体来说,3 项研究中使用 RDQ 测量的短期功能的 WMD 为 0.48 分(95% CI -1.39,2.35),3 项研究中使用 RDQ 测量的长期功能的 WMD 为 0.33 分(95% CI -0.65,1.32)。一项纳入的试验报告了 2 年的延长(扩展)随访期的疼痛结局,发现影像学策略之间的疼痛(短期表单-36 身体疼痛或阿伯丁疼痛评分)没有差异,SMD 分别为 -2.7(95% CI -6.17,0.79)和 -1.6(95% CI -4.04,0.84)。在那些报告短期随访时生活质量(SMD -0.10,95% CI -0.53,0.34)、心理健康(SMD 0.12,95% CI -0.37,0.62)或整体改善(平均风险比 0.83,95% CI 0.65,1.06)的研究中,即刻影像学与常规临床护理无即刻影像学之间的结局没有差异。在那些报告长期随访期的研究中,也可以看到生活质量(SMD -0.15,95% CI -0.33,0.04)和心理健康(SMD 0.01,95% CI -0.32,