Centre for Cancer Imaging, Peter MacCallum Cancer Centre, East Melbourne, Australia.
J Nucl Med. 2011 Dec;52 Suppl 2:64S-73S. doi: 10.2967/jnumed.110.086611.
Health technology assessment (HTA) has the objective of providing individual patients, clinicians, and funding bodies with the highest-quality information on the net patient benefits and cost effectiveness of medical interventions. Founded on systematic reviews of the available evidence, HTA aims to reduce bias and thereby provide a more valid evaluation of the benefits of new medical interventions than the primary studies themselves. Competing with the traditional role of medical experts, HTA agencies have gained considerable influence over public opinion and policy. The fundamental tenets of evidence-based medicine mandate that this influence should be used first and foremost for the benefit of patients. Over nearly 2 decades, multiple HTA systematic reviews in many countries have discredited most or all of the evidence pertaining to the ability of PET to improve patient-important outcomes. These determinations have delayed, restricted, and, in many cases, prevented access to this technology, especially by cancer patients. HTA systematic review findings are very much at variance with the opinion of clinicians. Our scrutiny of these reviews, benchmarking them against the core values of science and evidence-based medicine, has revealed errors of fact, inappropriate exclusion of pertinent data, and injudicious appraisal of the clinical relevance of evidence, potentially introducing bias into these reviews and compromising the validity of their conclusions about the net patient benefits of PET. We believe that our findings mandate that the molecular imaging community actively engage institutionalized HTA agencies to ensure appropriate representation of our primary data and adherence to the highest principles of evidence-based medicine.
健康技术评估(HTA)的目标是为个体患者、临床医生和资金机构提供有关医疗干预措施净患者获益和成本效益的最高质量信息。HTA 建立在对现有证据的系统评价基础上,旨在减少偏倚,从而对新医疗干预措施的获益提供比原始研究本身更有效的评估。HTA 机构与医学专家的传统角色相竞争,已经获得了对公众舆论和政策的相当大的影响力。循证医学的基本原则要求,首先应该将这种影响力用于患者的利益。近 20 年来,许多国家的多项 HTA 系统评价对与 PET 改善患者重要结局的能力相关的大多数或所有证据提出了质疑。这些决策延迟、限制了,并且在许多情况下,阻止了对这项技术的应用,尤其是癌症患者。HTA 系统评价的结果与临床医生的意见非常不一致。我们对这些综述进行了审查,将它们与科学和循证医学的核心价值观进行了基准比较,发现了事实错误、不适当地排除了相关数据以及对证据的临床相关性的不当评价,这些可能会给这些综述带来偏见,并影响其对 PET 净患者获益的结论的有效性。我们认为,我们的发现要求分子成像界积极与制度化的 HTA 机构合作,以确保我们的原始数据得到适当的代表,并遵守循证医学的最高原则。