Economic Considerations for Radiation Protection in Medical Settings-Is It Time for a New Paradigm?

ABSTRACT: The full ALARA principle includes "as low as reasonably achievable" taking social and economic factors into consideration. The International Commission on Radiological Protection advises a conventional cost benefit approach (e.g., cost per monetized averted stochastic effects or years of life saved) to consider economic factors. Given small incremental radiation dose reductions to patients, workers, or the public that may be realized in medical settings and the correspondingly small changes to theoretical stochastic effects, a conventional cost benefit approach is less than ideal. This is illustrated in the case studies presented in this paper. Alternate approaches, such as cost per unit of radiation dose averted (e.g., $/µSv averted), cancer induction/fatality probabilistic thresholds, or thresholds relative to natural background radiation may be alternate options. However, the decision regarding what is a "safe" level of radiation and what are reasonable costs to make it "safer" are driven by societal values and may vary from jurisdiction to jurisdiction.

Cost-risk-benefit analysis in diagnostic radiology with special reference to the application of referral guidelines.

Cost-risk-benefit analysis has been applied to protection of the patient in diagnostic radiology with special reference to the application of referral guidelines. The analysis presented has extended previous work in this field to provide a theoretical framework that encompasses key factors that need to be considered in the optimisation of patient protection from both diagnostic and radiation risks. The fraction of patients whose symptoms do not meet criteria contained in the referral guidelines and, therefore, for whom an X-ray examination is not indicated has been termed the selectivity of the guidelines. Also included are the detriments arising from rejected or repeated examinations as well as the levels of patient dose employed in order to achieve given levels of true and false diagnostic outcomes. A comprehensive framework for optimisation is outlined and its relationship to justification discussed.

Evaluating the Cost-Effectiveness of Hydrogel Rectal Spacer in Prostate Cancer Radiation Therapy.

PURPOSE: A hydrogel rectal spacer (HRS) is a medical device that is approved by the U.S. Food and Drug Administration to increase the separation between the prostate and rectum. We conducted a cost-effectiveness analysis of HRS use for reduction in radiation therapy (RT) toxicities in patients with prostate cancer (PC) undergoing external beam RT (EBRT). METHODS AND MATERIALS: A multistate Markov model was constructed from the U.S. payer perspective to examine the cost-effectiveness of HRS in men with localized PC receiving EBRT (EBRT alone vs EBRT + HRS). The subgroups analyzed included site of HRS placement (hospital outpatient, physician office, ambulatory surgery center) and proportion of patients with good baseline erectile function (EF). Data on EF, gastrointestinal and genitourinary toxicities incidence, and potential risks associated with HRS implantation were obtained from a recently published randomized clinical trial. Health utilities and costs were derived from the literature and the 2018 Physician Fee Schedule and were discounted 3% annually. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis and value-based threshold analyses were conducted. RESULTS: The per-patient 5-year incremental cost for spacers administered in a hospital outpatient setting was $3578, and the incremental effectiveness was 0.0371 QALYs. The incremental cost-effectiveness ratio was $96,440/QALY for patients with PC undergoing HRS insertion in a hospital and $39,286/QALY for patients undergoing HRS insertion in an ambulatory facility. For men with good baseline EF, the incremental cost-effectiveness ratio was $35,548/QALY and $9627/QALY in hospital outpatient and ambulatory facility settings, respectively. CONCLUSIONS: Based on the current Medicare Physician Fee Schedule, HRS is cost-effective at a willingness to pay threshold of $100,000. These results contain substantial uncertainty, suggesting more evidence is needed to refine future decision-making.

Decreasing the Toxicity of Radiation Therapy: Radioprotectors and Radiomitigators Being Developed by the National Cancer Institute Through Small Business Innovation Research Contracts.

PURPOSE: The use of radioprotectors and radiomitigators could improve the therapeutic index of radiation therapy. With the intention of accelerating translation of radiation-effect modulators (radioprotectors and mitigators), the Radiation Research Program and SBIR (Small Business Innovation Research) Development Center within the National Cancer Institute issued 4 Requests for Proposals (RFPs) from 2010 to 2013. Twelve SBIR contract awards in total were made in response to the 4 RFPs from September 2011 through September 2014. Here, we provide an update on the status of SBIR contract projects for the development of radiation-effect modulators. METHODS AND MATERIALS: To assess the status of research and development efforts under the 4 RFPs on radiation-effect modulators, we searched PubMed for research articles, google.com for published abstracts, clinicaltrials.gov for ongoing or completed clinical trials, and company websites for press releases and other news. All information obtained and reported here is publicly available and thus protects the intellectual property of the investigators and companies. RESULTS: Of the 12 SBIR projects funded, 5 (42%) transitioned successfully from phase 1 to phase 2 SBIR funding, and among the Fast-Track contracts, this rate was 100% (3 of 3). The Internet search identified 3 abstracts and 6 publications related to the aims of the SBIR contracts. One-third of the companies (4 of 12) have successfully launched a total of 8 clinical trials to demonstrate the safety and efficacy of their investigational agents. Two drugs are in clinical trials for their indication as a radioprotector, and 2 drugs are under evaluation for their anticancer properties (an immunomodulator and a small molecule inhibitor). CONCLUSIONS: The National Cancer Institute's SBIR has provided pivotal funding to small businesses for the development of radioprotectors and radiomitigators, which resulted in multiple early-phase clinical trials. Longer follow-up is needed to determine the full impact of these novel therapeutics that enter clinical practice.

COST-RISK-BENEFIT ANALYSIS IN DIAGNOSTIC RADIOLOGY: A THEORETICAL AND ECONOMIC BASIS FOR RADIATION PROTECTION OF THE PATIENT.

In 1973, International Commission on Radiological Protection Publication 22 recommended that the acceptability of radiation exposure levels for a given activity should be determined by a process of cost-benefit analysis. It was felt that this approach could be used to underpin both the principle of ALARA as well for justification purposes. The net benefit, B, of an operation involving irradiation was regarded as equal to the difference between its gross benefit, V, and the sum of three components; the basic production cost associated with the operation, P; the cost of achieving the selected level of protection, X; and the cost Y of the detriment involved in the operation: [Formula: see text] This article presents a theoretical cost-risk-benefit analysis that is applicable to the diagnostic accuracy (Levels 1 and 2) of the hierarchical efficacy model presented by National Council on Radiation Protection and Measurements in 1992. This enables the costs of an examination to be related to the sensitivity and specificity of an X-ray examination within a defined clinical problem setting and introduces both false-positive/false-negative diagnostic outcomes into the patient radiation protection framework.

Reducing an already low dental diagnostic X-ray dose: does it make sense? Comparison of three cost-utility analysis methods used to assess two dental dose-reduction measures.

OBJECTIVES: To find a method that is suitable for providing an objective assessment of the cost effectiveness of a dose-reducing measure used for diagnostic dental X-ray exposures. METHODS: Three cost-utility analysis (CUA) methods were evaluated by comparing their assessments of two dose-reduction measures, a rectangular collimator and the combination of two devices that reduce the radiation dose received during orthodontic lateral cephalography. The following CUA methods were used: (1) the alpha value (AV), a monetary valuation of dose reduction used in the nuclear industry; (2) the value of a statistical life for valuation of the reduction in stochastic adverse effects; and (3) the time-for-time method, based on the postulate that risk reduction is effective when the number of years of life gained is more than the years that an average worker must work to earn the costs of the risk-reducing measure. The CUA methods were used to determine the minimum number of uses that was required for the dose-reducing device to be cost effective. The methods were assessed for coherence (are comparable results achieved for comparable countries?) and adaptability (can the method be adjusted for age and gender of specific patient groups?). RESULTS: The performance of the time-for-time method was superior to the other methods. Both types of dose-reduction devices tested were assessed as cost effective after a realistic number of uses with all three methods except low AVs. CONCLUSIONS: CUA for the methods of X-ray dose reduction can be performed to determine if investment in low dose reduction is cost effective. The time-for-time method proved to be a coherent and versatile method for performing CUA.

Dose rate in brachytherapy using after-loading machine: pulsed or high-dose rate?

Since February 2014, it is no longer possible to use low-dose rate 192 iridium wires due to the end of industrial production of IRF1 and IRF2 sources. The Brachytherapy Group of the French society of radiation oncology (GC-SFRO) has recommended switching from iridium wires to after-loading machines. Two types of after-loading machines are currently available, based on the dose rate used: pulsed-dose rate or high-dose rate. In this article, we propose a comparative analysis between pulsed-dose rate and high-dose rate brachytherapy, based on biological, technological, organizational and financial considerations.

Use of health economics in the development of a national radon control strategy in Ireland.

A health economics evaluation of different radon intervention strategies was undertaken including the incorporation of prevention into new buildings, the incorporation of potential remedial measures into new buildings and remediation of existing buildings. The analysis shows that (1) the incorporation of prevention into new houses at the time of construction is generally more cost effective than remediation of existing houses and (2) that the cost effectiveness of programmes aimed at encouraging householders to test and remediate their houses may be poor if they are not undertaken within the context of coherent radon reduction strategy. The results of this evaluation were used to identify the most cost-effective radon interventions in an Irish context in support of the development of a National Radon Control Strategy.

Cost-effectiveness analysis of cochlear dose reduction by proton beam therapy for medulloblastoma in childhood.

BACKGROUND: The aim of this study is to evaluate the cost-effectiveness of proton beam therapy with cochlear dose reduction compared with conventional X-ray radiotherapy for medulloblastoma in childhood. METHODS: We developed a Markov model to describe health states of 6-year-old children with medulloblastoma after treatment with proton or X-ray radiotherapy. The risks of hearing loss were calculated on cochlear dose for each treatment. Three types of health-related quality of life (HRQOL) of EQ-5D, HUI3 and SF-6D were used for estimation of quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) for proton beam therapy compared with X-ray radiotherapy was calculated for each HRQOL. Sensitivity analyses were performed to model uncertainty in these parameters. RESULTS: The ICER for EQ-5D, HUI3 and SF-6D were $21 716/QALY, $11 773/QALY, and $20 150/QALY, respectively. One-way sensitivity analyses found that the results were sensitive to discount rate, the risk of hearing loss after proton therapy, and costs of proton irradiation. Cost-effectiveness acceptability curve analysis revealed a 99% probability of proton therapy being cost effective at a societal willingness-to-pay value. CONCLUSIONS: Proton beam therapy with cochlear dose reduction improves health outcomes at a cost that is within the acceptable cost-effectiveness range from the payer's standpoint.

Cost and radiation savings of partial substitution of ultrasound for CT in appendicitis evaluation: a national projection.

OBJECTIVE: The costs of an ultrasound-CT protocol and a CT-only protocol for an appendicitis evaluation are compared. For the ultrasound-CT protocol, patients with right lower quadrant abdominal pain undergo an ultrasound examination. If it is positive for appendicitis, they are sent directly to surgery, avoiding CT. MATERIALS AND METHODS: A comparative effectiveness research study was conducted. The costs of imaging tests, excess surgeries, and excess surgical deaths for the ultrasound-CT protocol and the costs of imaging tests and excess cancer deaths in the CT-only protocol were estimated. Data sources were Centers for Medicare & Medicaid Services (CMS) datasets, national hospital discharge surveys, radiology information system cases, and U.S. Census Bureau life tables. A meta-analysis and sensitivity analyses were also conducted. RESULTS: The meta-analysis showed a positive predictive value of 92.5% for CT and 91.0% for ultrasound. Analysis of CMS files showed that utilization of CT was almost exactly 2.0 examinations (one abdominal and one pelvic) per patient and for ultrasound was almost nil. The cost of this imaging protocol was $547 per patient, whereas the cost of a limited ultrasound study would be $88 per patient. For the total U.S. population, the cost savings in imaging minus the cost of extra surgeries and extra surgical deaths is $24.9 million per year. Following model VII proposed by the Committee on the Biological Effects of Ionizing Radiation (BEIR), which is known as "BEIR VII," the avoidance of a 12.4-mSv exposure for 262,500 persons would prevent 180 excess cancer deaths. The value of the years of life lost would be $339.5 million. The sensitivity analyses indicate that the cost savings are robust. CONCLUSION: An ultrasound-CT protocol for appendicitis evaluation offers potentially large savings over the standard CT-only protocol. There are moderate savings from using a less expensive imaging technique despite extra surgeries and large savings from radiation exposure avoided.

Insertion of PICCs with minimum number of lumens reduces complications and costs.

BACKGROUND: Inappropriate catheter requests at the McGill University Health Centre (MUHC) led to significantly increased costs and early catheter malfunction or infection. Dual-lumen catheters were often requested and inserted when only a single lumen was required, and inappropriate catheter care on the wards led to early infection or thrombosis. METHODS: A full-time registered nurse was hired to analyze and transform the vascular access program of the MUHC. Catheter selection was streamlined on the basis of clinical unit need. Clinical and cost data were collected between May 2011 and January 2012. RESULTS: Requests for vascular access at the MUHC have been standardized and centralized. Single-lumen catheters are inserted unless a specific indication for a dual-lumen catheter is provided. To date, data have been collected on >4,000 catheter insertions, both before and after the switch to the single-lumen program. Dual-lumen catheters have been required in only 50% of cases. Reinsertion rates have decreased, leading to the first year-over-year reduction in peripherally inserted central venous catheter insertion since data collection began in 2002. The program has also resulted in significant reductions in central line-associated bloodstream infection and catheter-related thrombosis. Decreased maintenance and reinsertion costs have led to overall savings for the MUHC of approximately $1.1 million.

Practical advice on calculating confidence intervals for radioprotection effects and reducing animal numbers in radiation countermeasure experiments.

The dose of a substance that causes death in P% of a population is called an LDP, where LD stands for lethal dose. In radiation research, a common LDP of interest is the radiation dose that kills 50% of the population by a specified time, i.e., lethal dose 50 or LD50. When comparing LD50 between two populations, relative potency is the parameter of interest. In radiation research, this is commonly known as the dose reduction factor (DRF). Unfortunately, statistical inference on dose reduction factor is seldom reported. We illustrate how to calculate confidence intervals for dose reduction factor, which may then be used for statistical inference. Further, most dose reduction factor experiments use hundreds, rather than tens of animals. Through better dosing strategies and the use of a recently available sample size formula, we also show how animal numbers may be reduced while maintaining high statistical power. The illustrations center on realistic examples comparing LD50 values between a radiation countermeasure group and a radiation-only control. We also provide easy-to-use spreadsheets for sample size calculations and confidence interval calculations, as well as SAS® and R code for the latter.

The EOS 2D/3D X-ray imaging system: a cost-effectiveness analysis quantifying the health benefits from reduced radiation exposure.

OBJECTIVES: To evaluate the cost-effectiveness of the EOS(®) 2D/3D X-ray imaging system compared with standard X-ray for the diagnosis and monitoring of orthopaedic conditions. MATERIALS AND METHODS: A decision analytic model was developed to quantify the long-term costs and health outcomes, expressed as quality-adjusted life years (QALYs) from the UK health service perspective. Input parameters were obtained from medical literature, previously developed cancer models and expert advice. Threshold analysis was used to quantify the additional health benefits required, over and above those associated with radiation-induced cancers, for EOS(®) to be considered cost-effective. RESULTS: Standard X-ray is associated with a maximum health loss of 0.001 QALYs, approximately 0.4 of a day in full health, while the loss with EOS(®) is a maximum of 0.00015 QALYs, or 0.05 of a day in full health. On a per patient basis, EOS(®) is more expensive than standard X-ray by between £10.66 and £224.74 depending on the assumptions employed. The results suggest that EOS(®) is not cost-effective for any indication. Health benefits over and above those obtained from lower radiation would need to double for EOS to be considered cost-effective. CONCLUSION: No evidence currently exists on whether there are health benefits associated with imaging improvements from the use of EOS(®). The health benefits from radiation dose reductions are very small. Unless EOS(®) can generate additional health benefits as a consequence of the nature and quality of the image, comparative patient throughput with X-ray will be the major determinant of cost-effectiveness.

Radiology stewardship and quality improvement: the process and costs of implementing a CT radiation dose optimization committee in a medium-sized community hospital system.

PURPOSE: The aims of this study were to measure the effectiveness of a multidisciplinary CT dose optimization committee and estimate its costs and to describe a radiation stewardship quality improvement initiative in one CT department at a medium-sized community hospital system that used a participatory design committee methodology. METHODS: A CT dose optimization committee was conceived, funded, and formed, consisting of the following stakeholders: radiologists, technologists, consultant medical physicists, and an administrator. Volume CT dose index (CTDIvol) and repeat rate were monitored for 1 month, for one scan type, during which iterative protocol adjustments were made through committee interaction. Effects on repeat rate and CTDIvol were quantified and benchmarked against national diagnostic reference levels after retrospective medical record review of 100 consecutive patients before and after the intervention. Labor hours were reported and wage resources estimated. RESULTS: Over 3 months, the committee met in person twice and exchanged 128 e-mails in establishing a process for protocol improvement and measurement of success. Repeat rate was reduced from 13% (13 of 100) to 0% (0 of 100). Scans meeting the ACR reference level for CTDIvol (75 mGy) improved by 34% (38 of 100 before, 51 of 100 after; Fisher's exact 2-tailed P = .09), and those meeting ACR pass/fail criterion (80 mGy) improved by 29% (58 of 100 before, 75 of 100 after; Fisher's exact 2-tailed P = .01). Committee evolution and work, and protocol development and implementation, required 57 person-hours, at an estimated labor cost of $12,488. CONCLUSIONS: An efficient process was established as a proof of concept for the use of a multidisciplinary committee to reduce patient radiation dose, repeat rate, and variability in image quality. The committee and process ultimately improved the quality of patient care, fostered a culture of safety and ongoing quality improvement, and calculated costs for such an endeavor.

Comparison of radiation dose, workflow, patient comfort and financial break-even of standard digital radiography and a novel biplanar low-dose X-ray system for upright full-length lower limb and whole spine radiography.

OBJECTIVE: To compare the radiation dose, workflow, patient comfort, and financial break-even of a standard digital radiography and a biplanar low-dose X-ray system. MATERIALS AND METHODS: A standard digital radiography system (Ysio, Siemens Healthcare, Erlangen, Germany) was compared with a biplanar X-ray unit (EOS, EOS imaging, Paris, France) consisting of two X-ray tubes and slot-scanning detectors, arranged at an angle of 90° allowing simultaneous vertical biplanar linear scanning in the upright patient position. We compared data of standing full-length lower limb radiographs and whole spine radiographs of both X-ray systems. RESULTS: Dose-area product was significantly lower for radiographs of the biplanar X-ray system than for the standard digital radiography system (e.g. whole spine radiographs; standard digital radiography system: 392.2 ± 231.7 cGy*cm(2) versus biplanar X-ray system: 158.4 ± 103.8 cGy*cm(2)). The mean examination time was significantly shorter for biplanar radiographs compared with standard digital radiographs (e.g. whole spine radiographs: 449 s vs 248 s). Patients' comfort regarding noise was significantly higher for the standard digital radiography system. The financial break-even point was 2,602 radiographs/year for the standard digital radiography system compared with 4,077 radiographs/year for the biplanar X-ray unit. CONCLUSION: The biplanar X-ray unit reduces radiation exposure and increases subjective noise exposure to patients. The biplanar X-ray unit demands a higher number of examinations per year for the financial break-even point, despite the lower labour cost per examination due to the shorter examination time.

CT coronary angiography at an ultra-low radiation dose (<0.1 mSv): feasible and viable in times of constraint on healthcare costs.

Computed tomography coronary angiography (CTCA) has reached very high standards both in terms of diagnostic performance and radiation dose reduction. This commentary follows a report on CTCA using less than 0.1 mSv in selected patients. This is an extraordinary accomplishment, both for technology and for medicine. The difficult task is now to implement this tool in clinical practice so it can play the best possible role. CTCA can improve diagnostic pathways, can save money for healthcare systems and could even improve pharmacological therapy. All of this may happen, but it will require the combined effort of all the experienced operators in this field, including the referring clinicians. In times of financial constraint, CTCA may also help to restrict ineffective medical expenses.

The monetary value of the man-mSv for Korean NPP radiation workers assessed by the radiation aversion factor.

The monetary value of the man-mSv for operators of Korean nuclear power plants (NPPs) was calculated using a radiation aversion factor based on a survey of NPP workers. Initially, the life expectancy in the population is 79.4 y, the average age of cancer occurrence is 60 y, the average annual wage for an electric worker is 56 000 $ y(-1) and the nominal risk coefficient induced by radiation is 4.2E(-5) mSv were used to evaluate the basic monetary value (α(base)) resulting in 45.6 $ mSv(-1). To investigate the degree of radiation aversion, the subject of the investigation was selected as the working radiation workers in 10 NPPs in Korea (Kori 1-2, Yeonggwang 1-3, Ulchin 1-3 and Wolseong 1-2). In August 2010, with the cooperation of KHNP and partner companies, a total of 2500 survey questionnaires to 10 NPPs (or 250 surveys to each NPP) were distributed to currently employed radiation workers. From these, 2157 responses were obtained between August and October 2010. The assessed radiation aversion factor and the monetary value of the man-mSv from the calculated radiation aversion factor were 1.26 and ∼50 $ in the 0-1 mSv range, 1.38 and ∼200 $ in the 1-5 mSv range, 1.52 and ∼1000 $ in the 5-10 mSv range, 1.65 and ∼4000 $ in the 10-20 mSv range and 1.74 and ∼8500 $ >20 mSv.