Bagnall A-M, Jones L, Richardson G, Duffy S, Riemsma R
NHS Centre for Reviews and Dissemination, University of York, UK.
Health Technol Assess. 2003;7(19):iii, 1-92. doi: 10.3310/hta7190.
To examine four key areas: (1) the effectiveness and cost-effectiveness of spinal fixation surgery, (2) the consequences of immediate versus delayed referral to a spinal injuries unit (SIU), (3) the number of people with a new spinal cord injury (SCI) who are discharged from hospital without ever being transferred to an SIU, and (4) the effectiveness and cost-effectiveness of steroids for people with SCI.
Searches were carried out on several databases and also on the Internet. Specialist SCI and spinal injury related websites were searched, specifically the Spinal Injuries Association, the British Association of Spinal Cord Injury Specialists and the National Spinal Cord Injury Association.
Three separate search strategies were devised to find studies relating to the four key areas. Two reviewers independently screened all study citations for inclusion. The lists of all retrieved studies were scanned for additional studies. Quality of studies was assessed and data were extracted by one reviewer then checked by the second. Data from included studies were summarised within each key area. For dichotomous data, relative risks were calculated with 95% confidence intervals. Pooled relative risks were calculated as appropriate. For continuous data, mean differences with 95% confidence intervals were calculated and, if data were pooled, weighted mean differences were calculated. Searches were carried out to identify economic evaluations, details of these together with a critical appraisal of quality are presented in structured tables. Quality was assessed using a checklist supplemented with additional comments on the adequacy of methodology where appropriate.
For spinal fixation versus no fixation, 68 retrospective observational studies were found that suggested some benefits of fixation surgery. Only four studies were found on fixation surgery in SIUs compared with non-SIU hospitals and no significant differences were seen. All 28 studies concerning delayed referral to a SIU were retrospective observational studies. In most, study details were poorly reported and there was doubt over the comparability of groups at baseline and on confounding factors. Times of referral and transfer were not reported separately. Evidence suggested an effect in favour of the SIU group for neurological improvement. No relevant published studies of any design were found regarding how many people with a new SCI are discharged from hospital without ever being transferred to an SIU. Two systematic reviews were found that assessed the effectiveness of steroids. No studies were identified that considered both costs and the impact on patient outcomes of a given intervention.
Although there was evidence to suggest some benefits of fixation surgery and also a benefit of immediate referral to SIUs compared with delayed or no referral, owing to the limitations of the data these should be interpreted with caution. Not enough data were found to assess whether surgery is more beneficial when carried out in SIUs and further research is required in this area. Well-designed prospective observational studies with appropriately matched controls are needed. High-dose methylprednisolone steroid therapy may be effective in promoting some degree of neurological recovery if given within 8 hours of injury. There is a need for more randomised controlled trials (RCTs) of pharmacological therapy for acute SCI. No published studies of any design were found to answer the question of how many people with acute SCI are discharged from hospital without ever being transferred to an SIU. Primary research involving audit of selected hospital records should be commissioned and published. The search strategy did not identify any full economic evaluations. Future research should include full economic evaluations, possibly alongside a large RCT, which fully consider the costs and consequences of implementing interventions.
研究四个关键领域：（1）脊柱固定手术的有效性和成本效益；（2）立即转诊与延迟转诊至脊髓损伤治疗单位（SIU）的后果；（3）新发生脊髓损伤（SCI）但未转诊至SIU就出院的人数；（4）类固醇对SCI患者的有效性和成本效益。
在多个数据库以及互联网上进行了检索。检索了与SCI和脊柱损伤相关的专业网站，特别是脊髓损伤协会、英国脊髓损伤专家协会和美国国家脊髓损伤协会。
设计了三种独立的检索策略，以查找与四个关键领域相关的研究。两名评审员独立筛选所有研究引文以确定是否纳入。扫描所有检索到的研究列表以查找其他研究。由一名评审员评估研究质量并提取数据，然后由第二名评审员进行核对。纳入研究的数据在每个关键领域内进行总结。对于二分数据，计算相对风险并给出95%置信区间。酌情计算合并相对风险。对于连续数据，计算95%置信区间的平均差值，若合并数据，则计算加权平均差值。进行检索以识别经济评估，这些评估的详细信息以及质量的批判性评价以结构化表格形式呈现。使用清单评估质量，并在适当情况下对方法的充分性添加额外评论。
对于脊柱固定与不固定，发现68项回顾性观察性研究表明固定手术有一些益处。与非SIU医院相比，仅发现4项关于SIU中固定手术的研究，未发现显著差异。所有28项关于延迟转诊至SIU的研究均为回顾性观察性研究。在大多数研究中，研究细节报告不佳，且对基线时各组的可比性以及混杂因素存在疑问。转诊和转移时间未分别报告。有证据表明SIU组在神经功能改善方面有效果。未找到关于有多少新发生SCI的患者未转诊至SIU就出院的任何设计的相关已发表研究。发现两项系统综述评估了类固醇的有效性。未识别出考虑给定干预措施的成本及其对患者结局影响的研究。
尽管有证据表明固定手术有一些益处，且与延迟转诊或不转诊相比，立即转诊至SIU有益，但由于数据的局限性，应谨慎解读这些结果。未找到足够数据来评估在SIU进行手术是否更有益，该领域需要进一步研究。需要设计良好的前瞻性观察性研究并设置适当匹配的对照组。如果在损伤后8小时内给予高剂量甲基强的松龙类固醇治疗，可能有效地促进一定程度的神经功能恢复。对于急性SCI的药物治疗，需要更多的随机对照试验（RCT）。未找到任何设计的已发表研究来回答有多少急性SCI患者未转诊至SIU就出院的问题。应委托并发表涉及对选定医院记录进行审核的初步研究。检索策略未识别出任何全面的经济评估。未来的研究应包括全面的经济评估，可能与大型RCT一起，充分考虑实施干预措施的成本和后果。
