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磁共振成像用于膝关节检查的成本效益

The cost-effectiveness of magnetic resonance imaging for investigation of the knee joint.

作者信息

Bryan S, Weatherburn G, Bungay H, Hatrick C, Salas C, Parry D, Field S, Heatley F

机构信息

Health Economics Facility, University of Birmingham, UK.

出版信息

Health Technol Assess. 2001;5(27):1-95. doi: 10.3310/hta5270.

Abstract

This study considered the role of magnetic resonance imaging (MRI) in the diagnosis of knee injuries in a district general hospital (DGH) setting. The principal objective was to identify whether the use of MRI had a major impact on the clinical management of patients presenting with chronic knee problems, in whom surgery was being considered, whether it reduced overall costs and whether it improved patient outcome. In addition, the research: (1) explored the 'diagnostic accuracy' of initial clinical investigation of the knee by an orthopaedic trainee, consultant knee specialist and consultant radiologist; (2) considered the variability and diagnostic accuracy of interpretations of knee MRI investigations between radiologists; (3) measured the strength of preference for the potential diagnostic/therapeutic impact of knee MRI (i.e. the avoidance of surgery). METHODS - RANDOMISED CONTROLLED TRIAL: The research was based on a single-centre randomised controlled trial conducted at Kent and Canterbury Hospital. Patients attending with knee problems in whom surgery was being considered were recruited from routine orthopaedic clinics. Most patients had been referred by their general practitioner. Patients were randomised to either investigation using an MRI scan (MRI trial arm) or investigation using arthroscopy (no-MRI trial arm). The study investigated the benefits of knee MRI at two levels: diagnostic/therapeutic impact (i.e. avoidance of surgery) and patient outcome (using the Short Form with 36 items and EQ-5D quality-of-life measurement instruments). Quality of life was assessed at baseline and at 6 and 12 months. Costs were assessed from the perspectives of the NHS and patients. All analyses were by intention to treat. METHODS - SUBSTUDIES (INVESTIGATION OF DIAGNOSTIC ACCURACY): For the investigation of diagnostic accuracy of initial clinical investigation, the sample comprised 114 patients recruited in a separate study conducted at St Thomas' Hospital. The sample was drawn from patients presenting at the Accident and Emergency Department with an acute knee injury. All study patients received an MRI scan, but initial diagnosis was made without access to the scan or the radiologist's report. After 12 months, all clinical notes and MRI scans of study patients were reviewed and a final 'reference standard' diagnosis for each patient was reached. Comparison was made between the diagnosis recorded by each clinician (i.e. orthopaedic trainee, knee specialist and consultant radiologist) and the reference diagnosis. METHODS - SUBSTUDIES (INVESTIGATION OF THE GENERALISABILITY OF RESULTS): For this substudy, the MRI images from 80 patients (recruited at St Thomas' Hospital) were interpreted independently by seven consultant radiologists at DGHs and the St Thomas' Hospital MRI radiologist. For each area of the knee, the level of agreement (measured using weighted kappa) between the responses of the eight radiologists and the reference standard diagnosis was assessed. METHODS - SUBSTUDIES (INVESTIGATION OF PREFERENCES): The investigation of potential patient preferences for the diagnostic/therapeutic impact of MRI was explored using a discrete choice conjoint measurement research design. Choices involved selecting between two alternative scenarios described using four attributes, and data were collected from 585 undergraduate sports science students and analysed using a random-effects probit model. RESULTS - RANDOMISED CONTROLLED TRIAL: The trial recruited 118 patients (59 randomly allocated to each arm). The two groups were similar in important respects at baseline. The central finding was of no statistically significant differences between groups in all measures of health outcome, although a trend in favour of the no-MRI group was observed. However, the use of MRI was found to be associated with a positive diagnostic/therapeutic impact: a significantly smaller proportion of patients in the MRI group underwent surgery (MRI = 0.41, no-MRI = 0.71; p = 0.001). There was a similar mean overall NHS cost for both groups. RESULTS - SUBSTUDIES (INVESTIGATION OF DIAGNOSTIC ACCURACY): The exploration of diagnostic accuracy found that, when compared to orthopaedic trainees (44% correct diagnoses) or to radiologists reporting an MRI scan (68% correct diagnoses), the accuracy rate was higher for knee specialists (72% correct diagnoses). RESULTS - SUBSTUDIES (INVESTIGATION OF THE GENERALISABILITY OF RESULTS): This generalisability study indicated that, in general terms, radiologists in DGHs provide accurate interpretations of knee MRI images that are similar to a radiologist at a specialist centre. The one area of the knee for which this did not hold was the lateral collateral ligament. RESULTS - SUBSTUDIES (INVESTIGATION OF PREFERENCES): The central finding for this substudy was that, on average and within the range specified, choices in this group of potential patients were not significantly influenced by variation in the chance of avoiding surgery. CONCLUSIONS - IMPLICATIONS FOR HEALTHCARE: The evidence presented in this report supports the conclusions that the use of MRI in patients presenting at DGHs with chronic knee problems in whom arthroscopy was being considered did not increase NHS costs overall, was not associated with significantly worse outcomes and avoided surgery in a significant proportion of patients. CONCLUSIONS - RECOMMENDATIONS FOR FURTHER RESEARCH (IN PRIORITY ORDER): (1) The trial data demonstrated that the use of MRI in patients with chronic knee problems reduced the need for surgery. However, the link between diagnostic processes and changes in health outcome is indirect and the finding of no-MRI-related effect on health outcome may, therefore, be a consequence of the limited power of the trial. Further research to confirm (or contradict) these findings would be valuable. (2) The investigation of diagnostic accuracy involved comparison with a reference diagnosis established by a panel of two clinical members of the research team. It would be interesting to explore the extent to which the results would differ using an external panel. (3) The result from the preference study, indicating that the potential diagnostic/therapeutic impact of knee MRI was not highly valued, is a surprising finding that would be important to explore in general public or patient populations. (4) The focus for the trial-based aspects of this research was the DGH and patients presenting with chronic knee problems who were being considered for surgery. Care should be taken in generalising from these results to other patient groups (e.g. acute knee injuries) or to other settings (e.g. specialist centres). Further clinical trials would be required in order to answer such questions.

摘要

本研究探讨了磁共振成像(MRI)在地区综合医院(DGH)环境下对膝关节损伤诊断的作用。主要目的是确定MRI的使用是否对考虑手术治疗的慢性膝关节问题患者的临床管理产生重大影响,是否降低总体成本,以及是否改善患者预后。此外,该研究:(1)探讨了骨科实习医生、膝关节专科顾问医生和放射科顾问医生对膝关节进行初步临床检查的“诊断准确性”;(2)考虑了放射科医生对膝关节MRI检查解读的变异性和诊断准确性;(3)衡量了对膝关节MRI潜在诊断/治疗影响(即避免手术)的偏好强度。方法——随机对照试验:该研究基于在肯特郡坎特伯雷医院进行的单中心随机对照试验。从常规骨科门诊招募考虑进行手术治疗的膝关节问题患者。大多数患者由其全科医生转诊。患者被随机分为使用MRI扫描进行检查(MRI试验组)或使用关节镜检查进行检查(无MRI试验组)。该研究在两个层面上调查了膝关节MRI的益处:诊断/治疗影响(即避免手术)和患者预后(使用36项简短问卷和EQ - 5D生活质量测量工具)。在基线以及6个月和12个月时评估生活质量。从英国国家医疗服务体系(NHS)和患者的角度评估成本。所有分析均按意向性分析进行。方法——子研究(诊断准确性调查):为了调查初步临床检查的诊断准确性,样本包括在圣托马斯医院进行的另一项研究中招募的114名患者。样本取自因急性膝关节损伤到急诊部就诊的患者。所有研究患者均接受了MRI扫描,但在未获取扫描结果或放射科医生报告的情况下进行了初步诊断。12个月后,对研究患者的所有临床记录和MRI扫描进行了复查,并为每位患者得出了最终的“参考标准”诊断。比较了每位临床医生(即骨科实习医生、膝关节专科医生和放射科顾问医生)记录的诊断与参考诊断。方法——子研究(结果可推广性调查):对于该子研究,来自圣托马斯医院的80名患者的MRI图像由DGHs的7名放射科顾问医生和圣托马斯医院的MRI放射科医生独立解读。对于膝关节的每个区域,评估了8名放射科医生的反应与参考标准诊断之间的一致性水平(使用加权kappa测量)。方法——子研究(偏好调查):使用离散选择联合测量研究设计探讨了患者对MRI诊断/治疗影响潜在偏好的调查。选择涉及在使用四个属性描述的两种替代方案之间进行选择,数据收集自585名本科运动科学学生,并使用随机效应概率模型进行分析。结果——随机对照试验:该试验招募了118名患者(每组随机分配59名)。两组在基线的重要方面相似。主要发现是,在所有健康结局指标上,两组之间没有统计学上的显著差异,尽管观察到有利于无MRI组的趋势。然而,发现使用MRI与积极的诊断/治疗影响相关:MRI组接受手术的患者比例明显较小(MRI = 0.41,无MRI = = 0.71;p = 0.001)。两组的NHS总体平均成本相似。结果——子研究(诊断准确性调查):对诊断准确性的探索发现,与骨科实习医生(正确诊断率44%)或报告MRI扫描结果的放射科医生(正确诊断率68%)相比,膝关节专科医生的准确率更高(正确诊断率72%)。结果——子研究(结果可推广性调查):这项可推广性研究表明,一般而言,DGHs的放射科医生对膝关节MRI图像的解读与专科中心的放射科医生相似。膝关节中不适用这一情况的一个区域是外侧副韧带。结果——子研究(偏好调查):该子研究的主要发现是,在平均水平以及指定范围内,这组潜在患者的选择没有受到避免手术可能性变化的显著影响。结论——对医疗保健的影响:本报告提供的证据支持以下结论:在DGHs中,对于考虑进行关节镜检查的慢性膝关节问题患者,使用MRI不会增加NHS的总体成本,与明显更差的结局无关,并且在很大一部分患者中避免了手术。结论——进一步研究的建议(按优先顺序排列):(1)试验数据表明,在慢性膝关节问题患者中使用MRI减少了手术需求。然而,诊断过程与健康结局变化之间的联系是间接的,因此,未发现与MRI相关的对健康结局的影响可能是试验效力有限的结果。进一步研究以证实(或反驳)这些发现将是有价值的。(2)诊断准确性调查涉及与由研究团队的两名临床成员组成的小组确定的参考诊断进行比较。使用外部小组探讨结果在多大程度上会有所不同将是有趣的。(3)偏好研究的结果表明,膝关节MRI的潜在诊断/治疗影响未得到高度重视,这是一个令人惊讶的发现,在普通公众或患者群体中进行探索将很重要。(4)本研究基于试验的方面重点关注DGH和考虑进行手术的慢性膝关节问题患者。在将这些结果推广到其他患者群体(如急性膝关节损伤)或其他环境(如专科中心)时应谨慎。需要进一步的临床试验来回答此类问题。

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