Ont Health Technol Assess Ser. 2024 Nov 12;24(9):1-76. eCollection 2024.
In medicine, x-rays are used to generate images of tissues and structures inside the body. X-rays are emitted by a source device and, after passing through the body, strike a detector, which forms an image of the tissues and structures the x-rays passed through. Dual-energy subtraction (DES) x-ray systems use radiation of different energy spectra (energy levels) and the principle of differential absorption characteristics of bone and soft tissue to produce separate bone and soft tissue x-ray images, in addition to a conventional x-ray image. The aim is to minimize potential issues with anatomical overlap with conventional x-ray that may obscure some findings. Single-exposure, DES flat panel x-ray detectors produce a conventional x-ray image in addition to DES bone and soft tissue x-ray images using a single x-ray exposure. We conducted a health technology assessment of single-exposure, DES digital flat panel x-ray detectors in adults for indications such as pneumonia, pneumothorax, and pulmonary nodules, and for visualizing lines and tubes, compared with conventional x-ray. Our assessment included an evaluation of the diagnostic accuracy, the impact on diagnostic confidence, patient management and clinical outcomes, the budget impact of publicly funding the technology, and the experiences, preferences, and values of health care providers.
We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the QUADAS-C tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search on the economic evidence of single-exposure, DES flat panel x-ray detectors. We did not conduct a primary economic evaluation because of limited evidence on the implications of this technology. We analyzed the budget impact of publicly funding single-exposure, DES flat panel detectors in Ontario hospitals. To contextualize the potential value of single-exposure, DES flat panel x-ray detectors, we spoke with people with expertise in diagnostic imaging, including radiologists and other health care practitioners.
The clinical evidence review identified 2 eligible observational studies that assessed the use of single-exposure, DES flat panel x-ray detectors to generate DES bone and soft tissue x-ray images and a conventional x-ray image. The findings of 1 study suggest an improvement in the sensitivity and specificity for the detection of pulmonary nodule calcification with the use of single-exposure, DES soft tissue and conventional x-ray images compared with using a conventional x-ray image alone (results were statistically significant for 2 out of 5 reviewers; GRADE: Low). In one study, x-ray image reviewers reported an improvement in the visibility of the tips of lines and tubes (although these were visualized with the conventional x-ray image alone) in all patients and an improvement in the diagnostic confidence in 16 (57.1%) patients, with no difference in the time to review the images with the use of single-exposure, DES bone and soft tissue x-ray images plus the conventional x-ray image compared with using the conventional x-ray image alone, but the evidence is very uncertain (GRADE: Very low).The economic evidence review identified 1 costing study in the US setting. This analysis suggested adoption of single-exposure, DES x-ray detectors may lead to cost savings. However, this study was deemed not directly applicable to the Ontario setting. The cost-effectiveness of single-exposure, DES flat panel x-ray detectors is therefore unknown. Owing to the limited evidence on the impact of these detectors on short-term outcomes such as diagnostic accuracy and workflow, and long-term costs and health outcomes, we did not conduct a primary economic evaluation. Our budget impact analysis estimated that, for a typical community hospital, purchasing 3 detectors to retrofit existing x-ray machines would lead to an additional cost of $12,137 per institution. However, there is a large degree of uncertainty around the downstream costs and benefits of this technology.We interviewed 20 health care providers who had expertise with x-ray systems. Those who had the opportunity to interpret the x-ray images produced by a single-exposure, DES detector in a clinical setting were supportive of this technology and perceived an increase in confidence with diagnosing patients. Retrofitting existing x-ray systems to be compatible with the single-exposure, DES detector posed a challenge for operators as it was not a seamless process. Those who operated the retrofitted x-ray systems using the single-exposure, DES detector commented on issues related to workflow, including the physical specifications, connectivity, battery life, and maneuverability as barriers to use. Participants who did not have experience using the DES detector technology expressed uncertainty regarding the benefits compared to the alternative options currently in use in Ontario, such as image enhancing software, emerging artificial intelligence technology, and low-dose CT scanning. None of the users had experience with a fully integrated mobile x-ray system (i.e., a mobile x-ray system that did not require retrofitting to be compatible with the single-exposure, DES detector).
The use of single-exposure, DES flat panel x-ray detectors may lead to an improvement in the sensitivity and specificity to detect pulmonary nodule calcification compared with conventional x-ray, but the evidence is very uncertain for its effect on the visibility of the tips of lines and tubes, diagnostic confidence, and time to review the x-ray images compared with conventional x-ray. Evidence gaps include lack of evidence for the use of the technology for most populations and outcomes that we sought to evaluate. Due to limited clinical and economic evidence, the cost-effectiveness of single-exposure, DES flat panel x-ray detectors is currently unknown. We estimate that purchasing 3 detectors to retrofit with existing x-ray machines may lead to an additional cost of $12,137 per institution. Users of single-exposure, DES x-ray detectors who viewed and interpreted the images produced spoke positively about their experience with the technology and expressed an increase in confidence when making a diagnosis. Participants who operated the retrofitted single-exposure, DES x-ray detector commented on issues that negatively impacted their workflow. The experiences of providers with a fully integrated system are unknown at this time.
在医学中，X射线用于生成人体内部组织和结构的图像。X射线由源设备发出，穿过人体后撞击探测器，探测器形成X射线穿过的组织和结构的图像。双能减影（DES）X射线系统利用不同能谱（能级）的辐射以及骨骼和软组织的差异吸收特性原理，除了生成传统X射线图像外，还能产生单独的骨骼和软组织X射线图像。目的是尽量减少传统X射线中可能掩盖某些发现的解剖结构重叠问题。单曝光DES平板X射线探测器通过一次X射线曝光，除了生成DES骨骼和软组织X射线图像外，还能生成传统X射线图像。我们对单曝光DES数字平板X射线探测器在成人中的应用进行了卫生技术评估，评估其在肺炎、气胸和肺结节等病症以及可视化导管方面的应用，并与传统X射线进行比较。我们的评估包括对诊断准确性、对诊断信心的影响、患者管理和临床结果、该技术公共资金投入的预算影响以及医疗保健提供者的经验、偏好和价值观的评估。
我们对临床证据进行了系统的文献检索。我们使用QUADAS - C工具评估每项纳入研究的偏倚风险，并根据推荐分级评估、制定和评价（GRADE）工作组标准评估证据的质量。我们对单曝光DES平板X射线探测器的经济证据进行了系统的文献检索。由于关于该技术影响的证据有限，我们未进行初步经济评估。我们分析了安大略省医院为单曝光DES平板探测器提供公共资金的预算影响。为了解单曝光DES平板X射线探测器的潜在价值，我们与诊断成像领域的专家进行了交流，包括放射科医生和其他医疗从业者。
临床证据审查确定了2项符合条件的观察性研究，这些研究评估了使用单曝光DES平板X射线探测器生成DES骨骼和软组织X射线图像以及传统X射线图像的情况。1项研究的结果表明，与仅使用传统X射线图像相比，使用单曝光DES软组织和传统X射线图像检测肺结节钙化的敏感性和特异性有所提高（5名评审员中有2名的结果具有统计学意义；GRADE：低）。在一项研究中，X射线图像评审员报告称，所有患者的导管尖端可见性均有所改善（尽管仅通过传统X射线图像即可看到），16名（57.1%）患者的诊断信心有所提高，与仅使用传统X射线图像相比，使用单曝光DES骨骼和软组织X射线图像加传统X射线图像进行图像审查的时间没有差异，但证据非常不确定（GRADE：极低）。经济证据审查确定了1项美国背景下的成本研究。该分析表明采用单曝光DES X射线探测器可能会节省成本。然而，这项研究被认为不适用于安大略省的情况。因此，单曝光DES平板X射线探测器的成本效益尚不清楚。由于关于这些探测器对诊断准确性和工作流程等短期结果以及长期成本和健康结果影响的证据有限，我们未进行初步经济评估。我们的预算影响分析估计，对于一家典型的社区医院，购买3台探测器对现有X射线机进行改造，每个机构将导致额外成本12,137美元。然而，这项技术的下游成本和效益存在很大的不确定性。我们采访了20名具有X射线系统专业知识的医疗保健提供者。那些有机会在临床环境中解读单曝光DES探测器产生的X射线图像的人支持这项技术，并认为在诊断患者时信心有所增强。将现有X射线系统改造为与单曝光DES探测器兼容对操作人员来说是一项挑战，因为这不是一个无缝的过程。那些使用改造后的单曝光DES探测器操作X射线系统的人提到了与工作流程相关的问题，包括物理规格、连接性、电池寿命和可操作性等使用障碍。没有使用DES探测器技术经验的参与者对与安大略省目前使用的替代选项（如图像增强软件、新兴人工智能技术和低剂量CT扫描）相比的益处表示不确定。没有用户使用过完全集成的移动X射线系统（即不需要改造即可与单曝光DES探测器兼容的移动X射线系统）。
与传统X射线相比，使用单曝光DES平板X射线探测器可能会提高检测肺结节钙化的敏感性和特异性，但关于其对导管尖端可见性、诊断信心以及与传统X射线相比审查X射线图像时间的影响，证据非常不确定。证据差距包括缺乏针对我们试图评估的大多数人群和结果使用该技术的证据。由于临床和经济证据有限，单曝光DES平板X射线探测器的成本效益目前尚不清楚。我们估计购买3台探测器对现有X射线机进行改造，每个机构可能会导致额外成本12,137美元。查看和解读所产生图像的单曝光DES X射线探测器用户对他们的技术体验给予了积极评价，并表示在诊断时信心有所增强。操作改造后的单曝光DES X射线探测器的参与者提到了对其工作流程产生负面影响的问题。目前尚不清楚提供者使用完全集成系统的经验。
