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.

Promoting the Appropriate Use of Advanced Radiation Technologies in Oncology: Summary of a National Cancer Policy Forum Workshop.

PURPOSE: Leaders in the oncology community are sounding a clarion call to promote "value" in cancer care decisions. Value in cancer care considers the clinical effectiveness, along with the costs, when selecting a treatment. To discuss possible solutions to the current obstacles to achieving value in the use of advanced technologies in oncology, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop, "Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology" in July 2015. The present report summarizes the discussions related to radiation oncology. METHODS AND MATERIALS: The workshop convened stakeholders, including oncologists, researchers, payers, policymakers, and patients. Speakers presented on key themes, including the rationale for a value discussion on advanced technology use in radiation oncology, the generation of scientific evidence for value of advanced radiation technologies, the effect of both scientific evidence and "marketplace" (or economic) factors on the adoption of technologies, and newer approaches to improving value in the practice of radiation oncology. The presentations were followed by a panel discussion with dialogue among the stakeholders. RESULTS: Challenges to generating evidence for the value of advanced technologies include obtaining contemporary, prospective, randomized, and representative comparative effectiveness data. Proposed solutions include the use of prospective registry data; integrating radiation oncology treatment, outcomes, and quality benchmark data; and encouraging insurance coverage with evidence development. Challenges to improving value in practice include the slow adoption of higher value and the de-adoption of lower value treatments. The proposed solutions focused on engaging stakeholders in iterative, collaborative, and evidence-based efforts to define value and promote change in radiation oncology practice. Recent examples of ongoing or successful responses to the discussed challenges were provided. CONCLUSIONS: Discussions of "value" have increased as a priority in the radiation oncology community. Practitioners in the radiation oncology community can play a critical role in promoting a value-oriented framework to approach radiation oncology treatment.

Variations in Medicare Reimbursement in Radiation Oncology: An Analysis of the Medicare Provider Utilization and Payment Data Set.

PURPOSE: The purposes of this study were to summarize recently published data on Medicare reimbursement to individual radiation oncologists and to identify the causes of variation in Medicare reimbursement in radiation oncology. METHODS AND MATERIALS: The Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (POSPUF), which details nearly all services provided by radiation oncologists in 2012, was used for this study. The data were filtered and analyzed by physician and by billing code. Statistical analysis was performed to identify differences in reimbursements based on sex, rurality, billing of technical services, or location in a certificate of need (CON) state. RESULTS: There were 4135 radiation oncologists who received a total of $1,499,625,803 in payments from Medicare in 2012. Seventy-five percent of radiation oncologists were male. The median reimbursement was $146,453. The code with the highest total reimbursement was 77418 (radiation treatment delivery intensity modulated radiation therapy [IMRT]). The most commonly billed evaluation and management (E/M) code for new visits was 99205 (49%). The most commonly billed E/M code for established visits was 99213 (54%). Forty percent of providers billed none of their new office visits using 99205 (the highest E/M billing code), whereas 34% of providers billed all of their new office visits using 99205. For the 1510 radiation oncologists (37%) who billed technical services, median Medicare reimbursement was $606,008, compared with $93,921 for all other radiation oncologists (P<.001). On multivariate analysis, technical services billing (P<.001), male sex (P<.001), and rural location (P=.007) were predictive of higher Medicare reimbursement. CONCLUSIONS: The billing of technical services, with their high capital and labor overhead requirements, limits any comparison in reimbursement between individual radiation oncologists or between radiation oncologists and other specialists. Male sex and rural practice location are independent predictors of higher total Medicare reimbursements.

Cost of care in a paediatric intensive care unit of a tertiary-care university hospital of Pakistan.

OBJECTIVE: To assess the cost of treatment for families of children hospitalised in paediatric intensive care unit of a tertiary care teaching hospital. METHODS: The retrospective cohort study was conducted in Aga Khan University Hospital, Karachi, and comprised record of all children admitted to the paediatric intensive care unit from January 1 to June 30, 2013. Demographic data, diagnosis at the time of admission, co-morbidity, length of stay in intensive care and outcome were recorded. The record of all hospital charges for each day the patient was cared for were also recorded. The finance department itemised the cost into major categories like pharmacy, radiology, laboratory, etc. SPSS 19 was used for statistical analysis. RESULTS: Record of 148 patients represented the study sample. Of them, 98(66%) were males. Overall median age was 2.7 yrs (interquartile range: 1 month to 16 years) and 93(62.8%) were below 5 years of age. Median length of stay was 3.5 days (range: 2-5 days) and total patient days in intensive care were 622. The median cost per admission was PKR 217,238 (range: (114,550-368,808) and mean cost per day was PKR 57,535 (43,911-85,527). The major cost distributions were bed charges PKR 8,092,080 (18.02%), physician charges PKR 6,398653(14.25%), medical-surgical supplies PKR 8,000772(17.8%), laboratory charges PKR 8,403,615(18.9%) and pharmacy charges PKR 5,852.226(13.03%). CONCLUSIONS: The cost of paediatric intensive care unit was expensive. Cost distribution was almost evenly distributed. Hence, a better admission policy is needed for resource utilisation and cost-effectiveness.

Does a too risk-averse approach to the implementation of new radiotherapy technologies delay their clinical use?

Radiotherapy is a generally safe treatment modality in practice; nevertheless, recent well-reported accidents also confirm its potential risks. However, this may obstruct or delay the introduction of new technologies and treatment strategies/techniques into clinical practice. Risks must be addressed and judged in a realistic context: risks must be assessed realistically. Introducing new technology may introduce new possibilities of errors. However, delaying the introduction of such new technology therefore means that patients are denied the potentially better treatment opportunities. Despite the difficulty in quantitatively assessing the risks on both sides of the possible choice of actions, including the "lost opportunity", the best estimates should be included in the overall risk-benefit and cost-benefit analysis. Radiotherapy requires a sufficiently high level of support for the safety, precision and accuracy required: radiotherapy development and implementation is exciting. However, it has been anxious with a constant awareness of the consequences of mistakes or misunderstandings. Recent history can be used to show that for introduction of advanced radiotherapy, the risk-averse medical physicist can act as an electrical fuse in a complex circuit. The lack of sufficient medical physics resource or expertise can short out this fuse and leave systems unsafe. Future technological developments will continue to present further safety and risk challenges. The important evolution of radiotherapy brings different management opinions and strategies. Advanced radiotherapy technologies can and should be safely implemented in as timely a manner as possible for the patient groups where clinical benefit is indicated.

A low-cost scalable solution for digitizing analog X-rays with applications to rural healthcare.

In this paper, we present a low-cost scalable solution for digitizing analog X-ray images with the goal of improving diagnostics in rural and remote areas, in addition to having potential applications in disaster healthcare. Our solution attempts to capitalize on the rapid gains made in cellular communication and mobile technologies. The proposed mobile application lets the user digitally acquire the analog X-ray image and apply enhancement operations to it. A novel nonlinear technique for X-ray image enhancement has been proposed and implemented in the application. Additionally, several standard enhancement techniques have also been implemented. A proof-of-concept of the proposed solution is demonstrated with an Android application running on a smartphone. Results from real-world data collected at a semi-urban hospital in India are presented. The Android application has been made available online at the fifth authors' homepage.

Level of accessibility of radiological diagnostic tools of high technology and its effect on human health: study of ultrasonography, CT scan and MRI in different perspective.

The study was conducted at JNMC, Aligarh, India, to discern the obstacles/hurdles that stood in the way of the patients and the high technology diagnostic tool. For this purpose several parameters were taken eg, education/literacy, occupation and income group, etc. From the study 97% chose to undergo USG and only 3% were defaulters; 86% chose to undergo CT scan and only 14% were defaulters; 79% chose to undergo MRI and 21% were defaulters. Low cost investigations ie, USG and CT scan were more prescribed to IVth social class but MRI was mostly prescribed to IInd. Most of the defaulters were from IVth social class and showed financial problem for getting investigation. Taking into consideration the cost and sensitivity of procedure, it was found in this study that mainly cost determines the outcome. Sensitivity did not matter in patient's perspective. This was the reason that maximum defaulters were found in MRI, followed by CT scan and least in USG. Financial constraint was primary reason declared by defaulters followed by distance. Additional parameters like literacy, occupation and social standing were also found significant in the study in the sense of prescription of investigation and being defaulter.

A clinical approach to technology assessment: how do we and how should we choose the right treatment?

The evidence required to support the use of new technology in medicine differs from that required for new drugs. On one extreme, very little may be required for small devices, but on the other strong evidence is required to support the use of truly novel, potentially dangerous, and high-cost machines. The randomized controlled trial is built into the evaluation of drugs and suits them well. It is not so well suited to the evaluation of major devices in which installation costs and return on investment are important. We discuss where the randomized controlled trial may still play a role and what alternatives may exist when this is not possible. We also discuss the role that independent bodies may have in determining whether or not a new device is not only safe but also adds to the medical landscape in a way that justifies its cost.

Stability and infrequency of radiologic technologist malpractice payments: an analysis of the National Practitioner Data Bank.

PURPOSE: The aim of this study was to describe characteristics and trends of radiologic technologist (RT) malpractice payments. METHODS: National Practitioner Data Bank data files were analyzed for details of RT malpractice payments from 1991 through 2008. Payment amounts, sources, and allegations were all identified and summarized, along with geographic and demographic data. RESULTS: Between 1991 and 2008, a total of 155 RT malpractice payments were reported nationally, ranging from $750 to $11.5 million (median, $57,500; mean, $293,655 +/- $1,305,091), with 153 (99%) <$1 million. Adjusting for outliers and inflation, payments changed little over the 18-year interval. More than half of all cases originated in 8 states, with per capita payments most common in Louisiana and New Jersey. Alleged errors in diagnosis accounted for one third of all cases. CONCLUSION: Malpractice payments on behalf of RTs are very infrequent (on average, <9 nationally each year) and usually relatively small (almost half <$50,000). Frequency and mean adjusted payment have remained stable over nearly two decades, likely related in part to "deep pocket" shielding by hospitals and radiologists.