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BACKGROUND: Systematic coding systems are used to define clinically meaningful outcomes when leveraging administrative claims data for research. How and when these codes are applied within a research study can have implications for the study validity and their specificity can vary significantly depending on treatment received. SUBJECTS: Data are from the Surveillance, Epidemiology, and End Results-Medicare linked dataset. STUDY DESIGN: We use propensity score methods in a retrospective cohort of prostate cancer patients first examined in a recently published radiation oncology comparative effectiveness study. RESULTS: With the narrowly defined outcome definition, the toxicity event outcome rate ratio was 0.88 per 100 person-years (95% confidence interval, 0.71-1.08). With the broadly defined outcome, the rate ratio was comparable, with 0.89 per 100 person-years (95% confidence interval, 0.76-1.04), although individual event rates were doubled. Some evidence of surveillance bias was suggested by a higher rate of endoscopic procedures the first year of follow-up in patients who received proton therapy compared with those receiving intensity-modulated radiation treatment (11.15 vs. 8.90, respectively). CONCLUSIONS: This study demonstrates the risk of introducing bias through subjective application of procedure codes. Careful consideration is required when using procedure codes to define outcomes in administrative data.

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PURPOSE: Arc-modulated cone beam therapy (AMCBT) is a fast treatment technique deliverable in a single rotation with a conventional C-arm shaped linac. In this planning study, the authors assess the dosimetric properties of single-arc therapy in comparison to helical tomotherapy for three different tumor types. METHODS: Treatment plans for three patients with prostate carcinoma, three patients with anal cancer, and three patients with head and neck cancer were optimized for helical tomotherapy and AMCBT. The dosimetric comparison of the two techniques is based on physical quantities derived from dose-volume histograms. RESULTS: For prostate cancer, the quality of dose distributions calculated for AMCBT was of equal quality as that generated for tomotherapy with the additional benefits of a faster delivery and a lower integral dose. For highly complex geometries, the plan quality achievable with helical tomotherapy could not be achieved with arc-modulated cone beam therapy. CONCLUSIONS: Rotation therapy with a conventional linac in a single arc is capable to deliver a high and homogeneous dose to the target and spare organs at risk. Advantages of this technique are a fast treatment time and a lower integral dose in comparison to helical tomotherapy. For highly complex cases, e.g., with several target regions, the dose shaping capabilities of AMCBT are inferior to those of tomotherapy. However, treatment plans for AMCBT were also clinically acceptable.

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A growing number of advanced intensity modulated treatment techniques is becoming available. In this study, the specific strengths and weaknesses of four techniques, static and dynamic multileaf collimator (MLC), conventional linac-based IMRT, helical tomotherapy (HT), and spot-scanning proton therapy (IMPT) are investigated in the framework of biological, EUD-based dose optimization. All techniques were implemented in the same in-house dose optimization tool. Monte Carlo dose computation was used in all cases. All dose-limiting, normal tissue objectives were treated as hard constraints so as to facilitate comparability. Five patient cases were selected to offer each technique a chance to show its strengths: a deep-seated prostate case (for 15 MV linac-based IMRT), a pediatric case (for IMPT), an extensive head-and-neck case (for HT), a lung tumor (for HT), and an optical neurinoma (for noncoplanar linac-based IMRT with a miniMLC). The plans were compared by dose statistics and equivalent uniform dose metrics. All techniques delivered results that were comparable with respect to target coverage and the most dose-limiting normal tissues. Static MLC IMRT struggled to achieve sufficient target coverage at the same level of dose homogeneity in the lung case. IMPT gained the greatest advantage when lung sparing was important, but did not significantly reduce the risk of nearby organs. Tomotherapy and dynamic MLC IMRT showed mostly the same performance. Despite the apparent conceptual differences, all four techniques fare equally well for standard patient cases. The absence of relevant differences is in part due to biological optimization, which offers more freedom to shape the dose than do, e.g., dose volume histogram constraints. Each technique excels for certain classes of highly complex cases, and hence the various modalities should be viewed as complementary, rather than competing.

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For a new treatment technology to become widely accepted in today's healthcare environment, the technology must not only be effective but also financially viable. Intensity modulated radiation therapy (IMRT), a technology that enables radiation oncologists to precisely target and attack cancerous tumors with higher doses of radiation using strategically positioned beams while minimizing collateral damage to healthy cells, now meets both criteria. With IMRT, radiation oncologists for the first time have obtained the ability to divide the treatment field covered by each beam angle into hundreds of segments as small as 2.5 mm by 5 mm. Using the adjustable leaves of an MLC to shape the beam and by controlling exposure times, physicians can deliver a different dose to each segment and therefore modulate dose intensity across the entire treatment field. Development of optimal IMRT plans using conventional manual treatment planning methods would take days. To be clinically practical, IMRT required the development of "inverse treatment planning" software. With this software, a radiation oncologist can prescribe the ideal radiation dose for a specific tumor as well as maximum dose limits for surrounding healthy tissue. These numbers are entered into the treatment planning program which then calculates the optimal delivery approach that will best fit the oncologist's requirements. The radiation oncologist then reviews and approves the proposed treatment plan before it is initiated. The most recent advance in IMRT technology offers a "dynamic" mode or "sliding window" technique. In this more rapid delivery method, the beam remains on while the leaves of the collimator continually re-shape and move the beam aperture over the planned treatment area. This creates a moving beam that saturates the tumor volume with the desired radiation dose while leaving the surrounding healthy tissue in a protective shadow created by the leaves of the collimator. In the dynamic mode, an IMRT treatment session generally can be initiated and completed within the traditional 15-minute appointment window for radiation oncology clinics. In addition to being comforting for the patient, this rapid treatment delivery mode satisfies a key financial issue for hospitals and clinics by giving them the ability to handle high patient loads and achieve a more rapid return on their investment in an IMRT system. New IMRT reimbursement codes have been issued under the pass-through provisions of Medicare's Outpatient Prospective Payment System (OPPS), which authorize special or increased reimbursement levels for promising new developments in healthcare technology that previous reimbursement procedures did not address. These pass-through payments are generally applicable for defined periods during a promising new technology's early stage of adoption. In the case of codes G0174 and G0178, the effective period has been left open-ended. While the CMS adoption of these new IMRT reimbursement codes certainly paves the economic road for the diffusion of this technology by flattening out some of the economic obstacles, there are still bumps to overcome. The most obvious one is the investment in hardware and software that may be required. However, the added demands on staff and the cost of training cannot be ignored. IMRT is a treatment process involving FDA-approved medical devices, offering the hope of improved treatment outcomes with fewer complications for patients and higher reimbursement rates for hospital providers. By the end of the year 2001, there will probably be more than 75 hospitals with IMRT capabilities in place.

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'Conformal radiotherapy' is the name fixed by usage and given to a new form of radiotherapy resulting from the technological improvements observed during, the last ten years. While this terminology is now widely used, no precise definition can be found in the literature. Conformal radiotherapy refers to an approach in which the dose distribution is more closely 'conformed' or adapted to the actual shape of the target volume. However, the achievement of a consensus on a more specific definition is hampered by various difficulties, namely in characterizing the degree of 'conformality'. We have therefore suggested a classification scheme be established on the basis of the tools and the procedures actually used for all steps of the process, i.e., from prescription to treatment completion. Our classification consists of four levels: schematically, at level 0, there is no conformation (rectangular fields); at level 1, a simple conformation takes place, on the basis of conventional 2D imaging; at level 2, a 3D reconstruction of the structures is used for a more accurate conformation; and level 3 includes research and advanced dynamic techniques. We have used our personal experience, contacts with colleagues and data from the literature to analyze all the steps of the planning process, and to define the tools and procedures relevant to a given level. The corresponding tables have been discussed and approved at the European level within the Dynarad concerted action. It is proposed that the term 'conformal radiotherapy' be restricted to procedures where all steps are at least at level 2.

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