A Flexible, Multifaceted Approach Is Needed in Health Technology Assessment of PET

Dahabreh, Issa J; Gatsonis, Constantine

doi:10.2967/jnumed.114.142331

Cited by 4 publications

(2 citation statements)

References 29 publications

(27 reference statements)

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“…Lack of data, however, precluded reliable assessment on how 18 F-FDG PET or 18 F-FDG PET/CT affects estimates of the probability of particular FUO cases or how it alters diagnostic or therapeutic management decisions. Arguably, these outcomes are more relevant to clinical practice than test performance, suggesting that more research, ideally comparative studies of alternative testing strategies incorporating nuclear imaging tests, is needed to assess clinical outcomes beyond test performance (51).…”

Section: Discussionmentioning

confidence: 99%

Nuclear Imaging for Classic Fever of Unknown Origin: Meta-Analysis

et al. 2016

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Several studies have assessed nuclear imaging tests for localizing the source of fever in patients with classic fever of unknown origin (FUO); however, the role of these tests in clinical practice remains unclear. We systematically reviewed the test performance, diagnostic yield, and management decision impact of nuclear imaging tests in patients with classic FUO. Methods: We searched PubMed, Scopus, and other databases through October 31, 2015, to identify studies reporting on the diagnostic accuracy or impact on diagnosis and management decisions of 18 F-FDG PET alone or integrated with CT ( 18 F-FDG PET/CT), gallium scintigraphy, or leukocyte scintigraphy. Two reviewers extracted data. We quantitatively synthesized test performance and diagnostic yield and descriptively analyzed evidence about the impact on management decisions. Results: We included 42 studies with 2,058 patients. Studies were heterogeneous and had methodologic limitations. Diagnostic yield was higher in studies with higher prevalence of neoplasms and infections. Nonneoplastic causes, such as adult-onset Still's disease and polymyalgia rheumatica, were less successfully localized. Indirect evidence suggested that 18 F-FDG PET/CT had the best test performance and diagnostic yield among the 4 imaging tests; summary sensitivity was 0.86 (95% confidence interval [CI], 0.81-0.90), specificity 0.52 (95% CI, 0.36-0.67), and diagnostic yield 0.58 (95% CI, 0.51-0.64). Evidence on direct comparisons of alternative imaging modalities or on the impact of tests on management decisions was limited. Conclusion: Nuclear imaging tests, particularly 18 F-FDG PET/CT, can be useful in identifying the source of fever in patients with classic FUO. The contribution of nuclear imaging may be limited in clinical settings in which infective and neoplastic causes are less common. Studies using standardized diagnostic algorithms are needed to determine the optimal timing for testing and to assess the impact of tests on management decisions and patient-relevant outcomes.

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Section: Discussionmentioning

confidence: 99%

Nuclear Imaging for Classic Fever of Unknown Origin: Meta-Analysis

et al. 2016

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“…Patients could be managed for a disease with and without the new imaging technology, to see if it improves outcomes [ 50 ]. These studies are difficult to conduct, however, and have not been widely used [ 51 , 52 ].…”

Section: Cms Coverage Of Petmentioning

confidence: 99%

Regulatory Agencies and PET/CT Imaging in the Clinic

Herscovitch

2022

Curr Cardiol Rep

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Purpose of Review The regulatory steps necessary to bring new PET radiopharmaceuticals to the clinic will be reviewed. The US Food and Drug Administration (FDA) provides approval to manufacture and use diagnostic radiopharmaceuticals, including those for cardiovascular PET/CT. Medicare not only provides insurance reimbursement for imaging procedures for its beneficiaries but also sets an example for third-party insurers to cover these procedures. Recent Findings FDA provides extensive guidance for performing studies to obtain the safety and efficacy data needed to approve PET radiopharmaceuticals, and the pace of approval has recently increased. There also has been considerable progress in insurance coverage for PET by Medicare. Several promising agents for cardiovascular PET imaging are in the development pipeline. Challenges remain, however, including low levels of reimbursement and the application of appropriate use criteria for imaging procedures. Summary It is important for cardiologists to understand the regulatory steps involved in translating PET radiopharmaceuticals to the clinic. Recent progress in both FDA approvals and Medicare coverage should facilitate the clinical use of new PET agents for molecular imaging of the heart.

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