Rationale and Objectives
The aim of this study was to systematically review the reporting of the value of imaging unrelated to treatment consequences and test characteristics in all imaging-related published cost-utility analyses (CUAs) in the medical literature.
Materials and Methods
All CUAs published between 1976 and 2008 evaluating diagnostic imaging technologies contained in the CEA Registry, a publicly available comprehensive database of health related CUAs, were screened. Publication characteristics, imaging modality, and the inclusion of test characteristics including accuracy, costs, risks, and the potential value unrelated to treatment consequences (eg, reassurance or anxiety) were assessed.
Results
Ninety-six published CUAs evaluating 155 different imaging technologies were included in the final sample; 27 studies were published in imaging-specialized journals. Fifty-two studies (54%) evaluated the performance of a single imaging modality, while 44 studies (46%) compared two or more different imaging modalities. The most common areas of interest were cardiovascular (45%) and neuroradiology (17%). Forty-two technologies (27%) concerned ultrasound, while 34 (22%) concerned magnetic resonance. Seventy-nine (51%) technologies used ionizing radiation. Test accuracy was reported or calculated for 90% ( n = 133 and n = 5, respectively) and assumed perfect (reference test or gold-standard test without alternative testing strategy to capture false-negatives and false-positives) for 8% ( n = 12) of technologies. Only 22 studies (23%) assessing 40 imaging technologies (26%) considered inconclusive or indeterminate results. The risk of testing was reported for 32 imaging technologies (21%). Fifteen studies (16%) considered the value of diagnostic imaging unrelated to treatment. Four studies incorporated it as quality-of-life adjustments, while 10 studies mentioned it only in their discussions or as a limitation.
Conclusions
The intrinsic value of imaging (the value of imaging unrelated to treatment) has not been appropriately defined or incorporated in the existing cost-utility literature, which could be due to a lack of evidence on the issue. Thus, more research is needed on metrics for a more comprehensive evaluation of diagnostic imaging. Similarly, the incorporation of variations in imaging tests accuracy, inconclusive results and associated risks has lacked uniformity in the cost-utility literature. Acknowledgment of these characteristics in future cost-utility publications will enhance their value and provide results that more closely resemble routine clinical practice.
The use of diagnostic imaging has increased exponentially, growing more rapidly than any other physician-ordered services, driven by technological advances, increased clinical reliance on noninvasive imaging, wider availability, patient preference, and at least in part by compelling financial interest of physicians . This has translated to higher costs and consequently closer scrutiny by payers, including a recent report by the US Government Accountability Office examining Medicare expenses on medical imaging , also encouraging public and professional organizations to provide evidence for the value of imaging . The demand to prove the value of imaging has also translated into a rising number of published cost-utility analyses (CUAs) . CUAs are a subtype of cost-effectiveness analyses that incorporates patient preferences and summarize the impact of interventions using a single common unit of cost per quality-adjusted life-year (QALY). CUAs allow the comparison of different medical interventions and are the preferred method for conducting economic analyses of health care interventions . However, limitations remain regarding which QALY comparisons are considered appropriate and meaningful .
Traditionally, the value of diagnostic imaging in CUAs follows a hierarchical model in which increased technical efficacy necessitates generating increased accuracy, and the information obtained must then be use to improve therapeutic efficacy, which is ultimately measured as a patient outcome . In this model, value is measured only in terms of how imaging influences patient survival or morbidity . However, few imaging interventions can be definitively measured using standard measures of patient outcomes such as life-years saved or QALYs .
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Materials and methods
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Results
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Table 1
Basic Publication Characteristics and Distribution of Studies and Technologies According to Clinical Area of Interest, Modality Under Study, and Reported Accuracy
Variable_n_ (%) Publication year 1990–1994 2 (2) 1995–1999 22 (23) 2000–2004 35 (37) 2005–2008 37 (39) Total 96 Journal_Radiology_ 12 (13)Annals of Internal Medicine 6 (6)American Journal of Roentgenology 4 (4)Stroke 4 (4)Academic Radiology 3 (3)Cancer 3 (3)JAMA 3 (3)Academic Emergency Medicine 3 (3)Journal of General Internal Medicine 3 (3) Others ∗ 55 (55) Total 96 Journal’s target audience Imaging 27 (28) Other clinical specialty 41 (43) General medicine or surgery 21 (22) Health services or pharmacoeconomics 7 (7) Total 96 Country of analysis United States 66 (69) United Kingdom 11 (11) The Netherlands 8 (8) Japan 3 (3) Australia 2 (2) Others 6 (6) Total 96 Authors’ affiliation Academic 91 (95) Health care organization 33 (34) Government 15 (16) Consultant 2 (2) Total † 141 Funding source Government 51 (53) Foundation 12 (13) Professional society 3 (3) Health care 4 (4) Pharmaceutical or manufacturer 4 (4) None 3 (3) Could not be determined 30 (31) Total † 107 Perspective of the analysis Society 69 (72) Health care payer 24 (25) Not determined 3 (3) Total 96 Area of clinical application Cardiovascular 43 (45) Neuroradiology or ear, nose, and throat 16 (17) Gastrointestinal or genitourinary 13 (14) Breast and obstetric imaging 6 (6) Thoracic imaging 6 (6) Oncoradiology 6 (6) Musculoskeletal 5 (5) Pediatric imaging 1 (1) Total 96 Imaging modality Ultrasound 42 (27) Magnetic resonance 34 (22) Computed tomography 29 (19) Conventional radiography 19 (12) Nuclear medicine 13 (8) Angiography 10 (7) Positron emission tomography ‡ 8 (5) Total 155 Test accuracy Not reported 5 (3) Assumed perfect § 12 (8) Reported 133 (86) Calculated 5 (3) Total 155
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Table 2
Distribution of Consideration of Inconclusive or Indeterminate Results and Risk of Imaging Testing
Variable_n_ (%) Inconclusive or indeterminate results proceed to Additional noninvasive imaging 28 (70) Additional invasive imaging (catheter-based angiography) 5 (12.5) Tissue sampling (pathology confirmation) 4 (10) Consider the results as negative 2 (5) Treatment (consider inconclusive results as positives) 1 (2.5) Total 40 Additional risk of imaging testing related to Radiation 7 (22) Hemorrhage 6 (19) Discomfort from invasive angiography 4 (13) CT contrast agents 3 (9) Angiography contrast agents 3 (9) MR contrast agents 2 (6) Esophageal perforation 3 (9) Others (including cardiac arrhythmia on TEE and complications of sedation in pediatric patients undergoing MR imaging) 4 (13) Total 32
CT, computed tomographic; MR, magnetic resonance; TEE, transesophageal echocardiography.
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Table 3
Cost-utility Analyses That Acknowledge the Added Value of Diagnostic Imaging in the Absence of Treatment Changes
Study Year Article Title Intrinsic Value Section Relevant Quotation Eckman et al 1995 “Foot infections in diabetic patients. Decision and cost-effectiveness analyses” Diagnostic reassurance Discussion “Although strategies that decrease uncertainty are intuitively more comfortable for physicians, they might expose patients to additional risk and may engender unnecessary costs.” Mushlin et al 1997 “The cost-effectiveness of magnetic resonance imaging for patients with equivocal neurological symptoms” Ambiguity avoidance Discussion “[In low risk patients] neither CT nor MRI is cost-effective when looked at from the standpoint of survival benefit. However, if there is a clear need for reassurance, then its use can be quite appropriate from a cost-effectiveness viewpoint.” McMahon et al 2000 “Cost-effectiveness of functional imaging tests in the diagnosis of Alzheimer disease” Ambiguity avoidance (planning of disability) Limitations “We did not attempt to quantify the benefits of diagnosis of early Alzheimer disease to the patient or family; the ability to plan for the eventual decline in cognition, such as by preparing estate plans or caretaker arrangements, could be of great value.” Kievit and Haak 2000 “Diagnosis and treatment of adrenal incidentaloma. A cost-effectiveness analysis” Ambiguity avoidance/decreased fear of liability Discussion “Most physicians hesitate to leave such a diagnosis [adrenal metastasis] unmade, fearing accusations of neglect.…Likewise, patient may demand adrenalectomy not because of expected gains in LY but because of the certainty this treatment provides. Generally, patients and physicians are more aggressive in their pursue of diagnosis than a strict cost-per-QALY approach would advise.” Keen et al 2001 “Proximity arteriography: Cost-effectiveness in asymptomatic penetrating extremity trauma” Liability avoidance Discussion “Perhaps the wild card in the analysis is the potential for civil liability associated with missed injury, including pain and suffering and economic losses.” Gould et al 2003 “Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules” Ambiguity avoidance Sensitivity analysis “Some patients might be uncomfortable not knowing whether a nodule was benign or malignant.” Hollingworth et al 2003 “Rapid magnetic resonance imaging for diagnosing cancer-related low back pain” Diagnostic reassurance Discussion “Rapid MRI increased physician’s diagnostic confidence and provided greater reassurance about the absence of serious disease that did plain films.” Stout et al 2006 “Retrospective cost-effectiveness analysis of screening mammography” Increased anxiety from false-positive results QALY “The QALY weight captures potential short term decrements in quality of life (e.g., anxiety) that may occur as the result of a false positive screening mammogram.” Guadagnolo et al 2006 “Cost-effectiveness analysis of computerized tomography in the routine follow-up of patients after primary treatment for Hodgkin’s disease” Increased anxiety from false-positive results QALY “False-positive CT −0.02” Wong et al 2007 “Cost effectiveness of mammography screening for Chinese women” Increased anxiety from false-positive results Discussion/limitations “[Mass mammography] would cause unnecessary distress to many women because since ∼4/5 women enrolled in the program would end up with 1 positive screen during their lifetime and most would turn out to be a false alarm.…The anxiety and psychological trauma associated with [confirmatory tests], unaccounted for in the current analysis, can be considerable albeit transient in nature.” Norman et al 2007 “The cost-utility of magnetic resonance imaging for breast cancer in BRCA1 mutation carriers aged 30-49” Increased anxiety from false-positive results Methods/limitations “There is also likely to be a disutility associated with being a false positive (through anxiety). However, the model did not include this issue due to lack of evidence amenable to a CEA.” Hernández and Vale 2007 “The value of myocardial perfusion scintigraphy in the diagnosis and management of angina and myocardial infarction: A probabilistic economic analysis” Decreased anxiety of waiting for treatment Discussion “The increased use of SPECT in rapid access clinics could reduce the distress associated with the wait [for angiography/angioplasty].” Wermer et al 2008 “Effectiveness and costs of screening for aneurysms every 5 years after subarachnoid hemorrhage” Ambiguity avoidance QALY/discussion “Utility of known but untreated 0.8. Little is known about the health utility in patients who are aware of an increased risk but are not offered screening.” Takao et al 2008 “Screening for familial intracranial aneurysms: Decision and cost-effectiveness analysis” Ambiguity avoidance QALY “We assigned a utility of 0.95 to knowingly living with an untreated, unruptured intracranial aneurysm.” Ladapo et al 2008 “Cost-effectiveness of coronary MDCT in the triage of patients with acute chest pain” Reassurance from negative results Discussion “Negative CCTA exams may provide clinicians and patients with reassurance and extinguish any intentions of performing further CAD diagnostic studies in an outpatient setting.”
CAD, coronary artery disease; CCTA, cardiac computed tomographic angiography; CEA, cost-effectiveness analysis; CT, computed tomography; LY, life-year; MDCT, multidetector computed tomography; MRI, magnetic resonance imaging; QALY, quality-adjusted life-year; SA, sensitivity analysis; SPECT, single-photon emission computed tomography.
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Discussion
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Conclusion
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