Highlights
Standardizing diagnostic test-related benefits and risks may improve decision making.
Benefit-risk assessment (BRA) in diagnostic radiology involves multiple criteria.
We propose a framework and process based on using standardized benefit-risk criteria (BRC).
Multi-disciplinary teams of radiologists and imaging-ordering providers may improve decisions.
Rationale and Objectives
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Materials and Methods
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Results
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Conclusion
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Introduction
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Methods
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Literature Search
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Creation and Design of Survey
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Selection of Clinical Scenarios
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Survey Respondent Identification and Recruitment
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Selection of BRC for Clinical Scenarios
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A patient seeks diagnosis for non-specific, subacute low back pain. The patient has had non-specific pain for more than 3 months but has no history of structural problems or trauma, leg pain or red flags. You are asked to weigh the benefits and harms of two diagnostic approaches: Approach A: magnetic resonance imaging (MRI) Approach B: no additional diagnostic or therapeutic action (No Test) For each reason listed below select MRI if MRI offers an advantage over No Test, select No Test if No Test offers an advantage over MRI and select N/A if comparison is not possible or there is no meaningful difference between approaches.
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Results
Literature Search
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Online Survey Responses
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TABLE 1
Description of Clinical Conditions Presented in the Survey
ACR AC Clinical Scenarios Survey Description of Case Comparators Clinical Specialties Recruited Low back pain (NGC-8863) variant 1 A patient seeks diagnosis for nonspecific, subacute lower back pain. The patient has had nonspecific pain for more than 3 months but has no history of structural problems or trauma, leg pain, or red flags. Magnetic resonance imaging (MRI) compared to no testing Neuroradiology and primary care Chronic headache, no new features (NGC-7779) variant 1 A patient seeks diagnosis for chronic uncomplicated headache. The patient is not experiencing new headache features, focal neurologic deficits, or red flags. Magnetic resonance imaging (MRI) compared to no testing Neuroradiology and primary care Lower quadrant pain-suspected appendicitis (NGC-10146) variant 1 A patient arrives complaining of lower quadrant pain. Fever, leukocytosis, and other signs point to a classic case of clinical appendicitis. Ultrasound (US) compared to computed tomography (CT) Emergency medicine and emergency radiology Acute-onset flank pain suspicion of stone disease (NGC-008476) variant 2 A patient arrives complaining of acute-onset flank pain. The patient is having recurrent symptoms of stone disease. Ultrasound (US) compared to computed tomography (CT) Emergency medicine and emergency radiology
AC, Appropriateness Criteria; ACR, American College of Radiology; NGC, National Guideline Clearinghouse.
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The Finalized BRC Domains and Criteria
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TABLE 2
Test-specific Features Domain BRC
Criteria Brief Description Missed cases Type II error or as 1-NPV (the chance of having the condition among those who test negative) False diagnoses Type I error or 1-PPV (the chance of not having the condition among those who test positive) Diagnostic accuracy consistency Existence/extent of influence of patient characteristics on diagnostic accuracy Interobserver reading agreement Proxy measure of image clarity and quality Depth/breadth of anatomy visualization Categorization of extent of anomaly characterization (eg, size, shape, vascularization, shape) Invasiveness/risk of adverse events The number or categorization of probabilities and/or severity of adverse events Contrast reaction potential Probability or categorization of probability and/or severity of contrast reaction Ionizing radiation dose Measure of millisievert dose or categorization of dose Patient-specific exclusions Measure of existence/extent categorization of exclusions (eg, metal implants, BMI, age) Failure/malfunction rate Failure rate or categorization of the rate/manufacturer reputation Patient preparation requirements Number of minutes or categorization of relative wait times Examination time Number of minutes or categorization of relative wait times Posttest observation time Number of minutes or categorization of relative wait times Decision support Existence/extent of automated interpretation or characterization of function Portability Existence/extent of device portability Ease of use Categorization of dependence on skilled operator Reimbursement potential Categorization of relative potential for reimbursement
BMI, body mass index; BRC, benefit-risk criteria; NPV, negative predictive value; PPV, positive predictive value.
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Test-specific Features ( N = 17)
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Patient Management and Provider Intrinsic Value ( N = 12)
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TABLE 3
Patient Management and Provider Intrinsic Value BRC
Criteria Brief Description Therapeutic/procedural success Net counts/probability and severity/categorization of complications of medical treatment with/without test Potential for additional confirmatory testing (inconclusive/false-positive results) Existence/extent of confirmatory testing Potential for incidental finding management Existence/extent of repeat follow-up Net unnecessary treatment (test prescribed or averted treatment) Net counts/probability and severity/categorization of unnecessary treatments performed or averted based on test information Access to test Perceived relative access to test Time to diagnosis Net hours/days/weeks to diagnosis or extent of delay with/without test Inpatient/outpatient healthcare visits Net number of healthcare visits or extent of utilization with/without test Time to discharge Net hours/days/weeks to discharge with/without test Provider utility Extent of confidence in test usefulness Liability protections Existence/extent of protection from liability afforded by test Financial incentives Existence/extent associated with test Contribution of information to prognosis Existence/extent of test information contributing to prognosis
BRC, benefit-risk criteria.
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Patient Intrinsic Value and Outcomes ( N = 7)
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TABLE 4
Patient Outcomes and Intrinsic Value Domain BRC
Criteria Brief Description Value of knowing Value of knowing true test results; decrease in perceived uncertainty (eg, peace of mind, reassurance) Disvalue of knowing Disvalue of knowing false test results or learning of insignificant incidental findings; increase in perceived uncertainty (eg, anxiety, confusion, distrust) Burden (time and money) to patient Out-of-pocket travel costs and work absenteeism: direct time and money costs of test Patient comfort Claustrophobia, fasting, physical discomfort, and pain from test Patient future compliance and behavior Changes in behavior: measures of uptake or attrition of health visits/programs Radiation-induced cancers Count of expected cases/QALYs lost Length/quality of life Net incremental survival attributable to test/net QALYs
BRC, benefit-risk criteria; QALYs, quality-adjusted life-years.
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Additional Considerations
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Clinical Scenarios
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TABLE 5
Survey Results by Clinical Scenario and Specialty
Domain Initial List of Benefit-risk Criteria Low Back Pain Chronic Headache Suspected Appendicitis Suspicion of Stone Disease PCP NRAD PCP NRAD ED MD ED RAD ED MD ED RAD TSF Manufacturer reputation ◐ ◐ ◐ ○ ○ ○ ○ ○Missed cases ● ● ● ● ● ● ● ● False diagnoses ● ● ● ● ◕ ● ◕ ◕ Patient preparation requirements ● ● ● ◕ ◐ ◐ ◐ ○ Diagnostic accuracy consistency ◕ ● ◕ ● ● ● ● ● Invasiveness/risk of adverse events ● ◕ ● ◕ ● ◕ ◕ ◐ Contrast reaction potential ● ◕ ● ◕ ● ● ◕ ● Ionizing radiation dose ○ ◐ ◐ ○ ● ● ● ● Failure/malfunction rate ◕ ● ● ● ○ ◐ ○ ○ Decision support features ◕ ● ● ◕ ◐ ○ ◐ ○ Portability of the device ◕ ◕ ◐ ◕ ● ● ● ● Reimbursement potential ● ● ◕ ● ○ ○ ○ ○ PMPV Therapeutic/procedural success ● ● ◐ ◕ ○ ◕ ◐ ◐Potential for additional confirmatory testing ● ● ● ● ● ● ● ●Provider utility ● ● ● ● ● ● ● ● Potential for incidental findings management ● ● ● ◕ ● ● ● ● Net unnecessary treatment ● ● ● ◕ ◕ ◕ ◕ ◐ Time to diagnosis ● ● ● ◕ ◕ ◕ ◕ ● Inpatient/outpatient healthcare visits ● ◕ ● ◕ ○ ◐ ◐ ○ Time to discharge ◕ ◕ ◐ ◕ ◐ ◐ ○ ○ Liability protections ● ◕ ● ● ● ◕ ◕ ◐ Financial incentives ◐ ● ◕ ◕ ○ ○ ○ ◐ Contribution of information to prognosis ◕ ● ◕ ● ● ● ● ● POIV Value of knowing ◕ ● ◕ ● ◐ ◕ ● ◕ Disvalue of knowing ● ● ● ● ◐ ○ ◐ ○ Burden (time and money) to patient ● ● ● ● ◕ ◕ ◕ ● Patient future compliance and behavior ◐ ○ ○ ◐ ○ ○ ○ ○ Radiation-induced cancers ◐ ◐ ◐ ○ ● ● ● ● Quality of life ◐ ◕ ◐ ◐ ○ ○ ○ ○ Length of life ◐ ◐ ○ ◐ ◐ ○ ○ ○ Consensus percentages indicating respondents believed there were differences between testing strategies (MRI vs no testing or CT vs US), stratified by clinical scenario and specialty <25% 25%–50% 51%–75% >75% ○ ◐ ◕ ●
CT, computed tomography; ED MD, emergency department medical doctor; ED RAD, emergency radiologist; MRI, magnetic resonance imaging; NRAD, neuroradiologist; PCP, primary care provider; PMPV, patient management and provider intrinsic value; POIV, patient outcomes and intrinsic value; TSF, test-specific features; US, ultrasound.
Patient comfort, interobserver reading agreement, depth/breadth of anatomy visualization, patient-specific exclusions, patient preparation requirements, examination time, posttest observation time, ease of use, access to test, and time to diagnosis were added to the final list based on short answer responses on the survey. Manufacturer reputation removed from the final list.
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The Proposed Framework: Consensus-based Selection of Relevant BRC
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Step 1: Pairwise Comparisons Based on Individual Beliefs
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Step 2: Consensus Selection of Relevant Criteria
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Step 3: Group Review of the Aggregated List
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Discussion
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Acknowledgments
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Appendix
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TABLE A1
Literature Search Results Mapped to the Fryback and Thornbury Hierarchical Model of Efficacy
Technical efficacy
The design and technical performance of test
Resolution of line pairs
Modulation of transfer function change
Gray scale range
Amount of mottle
Sharpness
Reliability of image quality and performance
Performance dependencies (multiple tests relying on one another for effectiveness)
Patient wait/preparation time for test
Length of examination
Post-test observation time
Inconclusive results Diagnostic accuracy efficacy
Yield of abnormal or normal diagnoses in case series
Diagnostic accuracy
Positive and negative predictive value
Sensitivity and specificity in a clinical case
ROC Positive and negative predictive values (47 references)
Positive likelihood ratio
Diagnostic odds ratio
Detection percentage
Accuracy in subpopulations Diagnostic thinking efficacy
Impact on pretest probability
Probability of learning incidental information Provider confidence
Liability avoidance
Risk stratification
Probability of learning incidental information
Pre-test probability Therapeutic efficacy
How helpful an imaging test is to patient management
Unnecessary procedures avoided
Pre-test/post-test therapy changes Procedural success
Number of healthcare visits
Need for additional follow-up
Downstream procedures from incidental findings
Radiation exposure dose
Extent and severity of harms associated with unnecessary procedures Patient outcome efficacy
Morbidity (procedures) avoided in QALYs
Patient improvement with vs. without test
Survival measured in QALYs
Value of test information to patient (future planning and psychological impact)
Cost per QALY saved with image information Pain and other physical discomfort such as tight quarters
Psychological impact (e.g. anxiety, reassurance or peace of mind)
Future planning based on test information
Tolerability
Sequelae from contrast reagent reactions
Invasiveness
Patient compliance (downstream)
Morbidity and mortality benefit from improved treatment plan
Radiation-associated cancers
Non-institutionalized days alive
Quality of life
ROC, receiver operating characteristic; QALYs, quality-adjusted life-years.
Societal efficacy, the last tier of the hierarchy, is not represented, as costs are not typically considered in benefit-risk analyses.
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