Controlled CMS Data Demonstrates a Cost and Clinical Advantage for Hyperbaric Oxygen for Radiation Cystitis.

Introduction: Increasing cancer survivorship, in part due to new radiation treatments, has created a larger population at risk for delayed complications of treatment. Radiation cystitis continues to occur despite targeted radiation techniques. Materials and Methods: To investigate value-based care applying hyperbaric oxygen (HBO2) to treat delayed radiation cystitis, we reviewed public-access Medicare data from 3,309 patients from Oct 1, 2014, through Dec 31, 2019. Using novel statistical modeling, we compared cost and clinical effectiveness in a hyperbaric oxygen group to a control group receiving conventional therapies. Results: Treatment in the hyperbaric group provided a 36% reduction in urinary bleeding, a 78% reduced frequency of blood transfusion for hematuria, a 31% reduction in endoscopic procedures, and fewer hospitalizations when study patients were compared to control. There was a 53% reduction in mortality and reduced unadjusted Medicare costs of $5,059 per patient within the first year after completion of HBO2 treatment per patient. When at least 40 treatments were provided, cost savings per patient increased to $11,548 for the HBO2 study group compared to the control group. This represents a 37% reduction in Medicare spending for the HBO2-treated group. We also validate a dose-response curve effect with a complete course of 40 or more HBO2 treatments having better clinical outcomes than those treated with fewer treatments. Conclusion: These data support previous studies that demonstrate clinical benefits now with cost- effectiveness when adjunctive HBO2 treatments are added to routine interventions. The methodology provides a comparative group selected without bias. It also provides validation of statistical modeling techniques that may be valuable in future analysis, complementary to more traditional methods.

National Trends of Inpatient Radiation Cystitis: 2016-2019.

INTRODUCTION: Radiation cystitis with hematuria (RCH) is a potentially devastating complication after pelvic radiation. The cumulative incidence of RCH is debated, and certain severe manifestations may require hospital admission. We aimed to evaluate demographics and outcomes of patients hospitalized for RCH. METHODS: We performed a retrospective review of hospitalized patients with a primary or secondary diagnosis of RCH from 2016 to 2019 using the National Inpatient Sample. Our unit of analysis was inpatient encounters. Our primary outcome was inpatient mortality. Secondary outcomes included need for inpatient procedures, transfusion, length of stay (LOS), and cost of admission. We then performed multivariate analysis using either a logistic or linear regression to identify predictors of mortality and LOS. Cost was analyzed using a generalized linear model controlling for LOS. RESULTS: We identified 21,320 weighted cases of hospitalized patients with RCH. The average patient age was 75.4 years, with 84.7% male and 69.3% White. The median LOS was 4 days, and the median cost was $8767. The inpatient mortality rate was 1.3%. The only significant predictor for mortality was older age. The only significant predictor of both higher cost and longer LOS was an Elixhauser Comorbidity Score ≥ 3. CONCLUSIONS: RCH represents a significant burden to patients and the health care system, and we observed an increasing number of hospitalized patients over time. Additional research is needed to identify underlying causes of RCH and effective treatments for this sometimes-severe complication of pelvic radiation.

A no-fault risk compensation approach for radiation risks incurred in space travel.

In this paper we recommend an appropriate compensation approach should be established for fatality and disabilities that may occur due to space radiation exposures of government or industry workers. A brief review of compensation approaches for nuclear energy and nuclear weapons development workers in the United States and other countries is described. We then summarize issues in the application of probability of causation calculation and provide examples of probability of causation (PC) calculations for missions to the International Space Station and Earth's moon or for Mars exploration. The main focus of this paper follows with a recommendation of a no-fault approach to compensation with the creation of appropriate insurance policies funded by employers to cover all disabilities or fatality, without requiring proof of causation or restriction to conditions that imply causation. Importantly we propose that the compensation described should be managed by recourse to private insurers.

Review of the Accident Compensation Corporation's radiation therapy injury claims, 1 July 2009-30 June 2019.

AIM: The aim of this study was to review and report on radiation therapy injury claims lodged with the Accident Compensation Corporation (ACC) in New Zealand in the last decade. METHODS: ACC's treatment injury database was used to identify injury claims decided between 1 July 2009 and 30 June 2019. The associated structured and unstructured data, including claim lodgement information and medical records, were reviewed. RESULTS: Of 121,168 treatment injuries, only 975 (0.8%) were radiation therapy injury claims, with 519 claims accepted for cover. Most declined claims were considered "ordinary consequences of treatment" rather than treatment injuries. Of the 519 accepted claims, ACC classified 21 as fatal and eight as serious, which indicates a need for lifelong ACC support. Injuries correlated with the age and gender of the most common cancers treated with radiation therapy in New Zealand. More treatment injury claims were submitted and accepted for New Zealand European patients compared with Maori and Pasifika patients. CONCLUSION: Radiation therapy injury claims make up a very small proportion of the total number of ACC treatment injury claims. A better understanding of the claim process may assist injured individuals better by improving appropriate claim lodgement and claim acceptance rates.

[Compensation of damage in cancerology]. / Réparation du dommage en cancérologie.

In a few situations, the consequences secondary to a carcinological pathology require an assessment of damages for compensatory purposes. This is particularly the case when liable parties have been found to be at cause of the disease: occupational pathologies in the case of inexcusable employer's fault, exposure to a radioactive risk, for example in the context of full compensation for damages suffered by the victims of nuclear experiments performed by France, or lastly, in the after-effects of late diagnosis. This article does not discuss the imputability of cancer pathologies to an event, but it proposes an adaptation of methods for assessing damages, in an attempt to provide full compensation for damages.

Photobiomodulation in oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis followed by a cost-effectiveness analysis.

BACKGROUND: Oral mucositis (OM) is an oral toxicity caused by cancer treatment, found often in patients with head and neck cancer. Low-intensity laser therapy for OM has anti-inflammatory, analgesic, and tissue reparative properties. OBJECTIVE: The objective of this work is to perform a systematic review and meta-analysis of the randomized clinical trials of OM laser therapy in patients undergoing treatment for head and neck cancers, followed by a cost-effectiveness analysis of the therapy. METHOD: The search terms, mucositis and phototherapy, laser therapy and mucositis, photobiomodulation and mucositis, and low-level laser therapy and mucositis, were used to search the databases of PubMed, Web of Science, and MEDLINE. Randomized clinical trials were divided into two groups: one treated with laser therapy and the other given a placebo. Only 13 studies were included in the systematic review, and 6 studies in the meta-analysis. RESULTS: The results of the systematic review and meta-analysis show that the laser therapy presented good results in clinical improvement and pain reduction, decreasing the patients' likelihood of developing OM, with degrees of debilitating lesions, to 64% (RR = 0.36 [95% CI = 0.29-0.44]). The cost-effectiveness analysis revealed an incremental cost of R$ 3687.53 for the laser group, with an incremental effectiveness of 132.2. The incremental cost-effectiveness ratio (ICER) was 27.89, for the severe OM cases that were avoided. CONCLUSION: It was concluded, therefore, that photobiomodulation for OM in patients receiving head and neck cancer treatment was clinically effective and cost-effective.

Costing Urologic Complications Following Pelvic Radiation Therapy.

OBJECTIVES: To describe patients presenting with urologic complications following pelvic radiation therapy and estimate the financial costs incurred in their treatment. PATIENTS AND METHODS: In the year ending June 2018, all urology admissions at Royal Newcastle Centre were reviewed for diagnostic codes pertaining to urethral or ureteric strictures, cystitis, and haematuria. Presentations were complications following radiotherapy if a diagnosis of radiation cystitis or stricture was recorded, and there was relevant prior radiotherapy. The Independent Hospital Pricing Authority's National Weighted Activity Unit (NWAU) 2018 calculators, admission data and the National Efficient Price were used to estimate costs of care. HNELHD HREC granted ethics approval (AU201808-10). RESULTS: Complications following radiotherapy accounted for 65 admissions in 53 discrete patients, accounting for 206 bed days and 3.7% of the 1748 total urology admissions in 1 year. The majority (86%) of admissions had at least 1 operation. Mean time since radiotherapy was 7 years (range 1-30). Mean number of operations related to complications following radiotherapy was 3 (range 0-11). Readmissions were more frequent (mean 1.9 admissions/year) than other urology inpatients (mean 1.3 admissions/year, P < .001). Mean NWAU18 value was 4.12 (range 2-8.3). Admission and procedure costs were AUD $1,346,700, secondary malignancies were $9,000 and emergency department costs were $45,864 for a combined total of $1,401,591. CONCLUSION: Patients requiring urological admission with complications following radiotherapy use more resources, stay for longer, have more operations and return more frequently than other urology patients. Conservative estimates of cost $25,900 per patient in the study year alone.

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.

Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial.

BACKGROUND: Oral mucositis (OM) is the most frequent and debilitating acute side effect associated with head and neck cancer (HNC) treatment. When present, severe OM negatively impacts the quality of life of patients undergoing HNC treatment. Photobiomodulation is a well-consolidated and effective therapy for the treatment and prevention of severe OM, and is associated with a cost reduction of the cancer treatment. Although an increase in the quality of life and a reduction in the severity of OM are well described, there is no study on cost-effectiveness for this approach considering the quality of life as a primary outcome. In addition, little is known about the photobiomodulation effects on salivary inflammatory mediators. Thus, this study aimed to assess the cost-effectiveness of the photobiomodulation therapy for the prevention and control of severe OM and its influence on the salivary inflammatory mediators. METHODS/DESIGN: This randomized, double-blind clinical trial will include 50 HNC patients undergoing radiotherapy or chemoradiotherapy. The participants will be randomized into two groups: intervention group (photobiomodulation) and control group (preventive oral care protocol). OM (clinical assessment), saliva (assessment of collected samples) and quality of life (Oral Health Impact Profile-14 and Patient-Reported Oral Mucositis Symptoms questionnaires) will be assessed at the 1st, 7th, 14th, 21st and 30th radiotherapy sessions. Oxidative stress and inflammatory cytokine levels will be measured in the saliva samples of all participants. The costs are identified, measured and evaluated considering the radiotherapy time interval. The incremental cost-effectiveness ratio will be estimated. The study will be conducted according to the Brazilian public health system perspective. DISCUSSION: Photobiomodulation is an effective therapy that reduces the cost associated with OM treatment. However, little is known about its cost-effectiveness, mainly when quality of life is the effectiveness measure. Additionally, this therapy is not supported by the Brazilian public health system. Therefore, this study widens the knowledge about the safety of and strengthens evidence for the use of photobiomodulation therapy, providing information for public policy-makers and also for dental care professionals. This study is strongly encouraged due to its clinical relevance and the possibility of incorporating new technology into public health systems. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials-ReBEC, RBR-5h4y4n . Registered on 13 June 2017.

Finding Value for Protons: The Case of Prostate Cancer?

The standard radiotherapy treatment for prostate cancer is intensity-modulated radiotherapy (IMRT). An alternative option is proton beam therapy (PBT). PBT is a safe and effective treatment, but does it add value over IMRT? We explore this controversial question by examining the available dosimetric and clinical evidence.

Resource requirements and reduction in cardiac mortality from deep inspiration breath hold (DIBH) radiation therapy for left sided breast cancer patients: A prospective service development analysis.

INTRODUCTION: Use of deep inspiration breath hold (DIBH) radiation therapy may reduce long-term cardiac mortality. The resource and time commitments associated with DIBH are impediments to its widespread adoption. We report the dosimetric benefits, workforce requirements, and potential reduction in cardiac mortality when DIBH is used for left-sided breast cancers. METHODS AND MATERIALS: Data regarding the time consumed for planning and treating 50 patients with left-sided breast cancer with DIBH and 20 patients treated with free breathing (FB) radiation therapy were compiled prospectively for all personnel (regarding person-hours [PH]). A second plan was generated for all DIBH patients in the FB planning scan, which was then compared with the DIBH plan. Mortality reduction from use of DIBH was calculated using the years of life lost resulting from ischemic heart disease for Indians and the postulated reduction in risk of major cardiac events resulting from reduced cardiac dose. RESULTS: The median reduction in mean heart dose between the DIBH and FB plans was 166.7 cGy (interquartile range, 62.7-257.4). An extra 6.76 PH were required when implementing DIBH as compared with FB treatments. Approximately 3.57 PH were necessary per Gy of reduction in mean heart dose. The excess years of life lost from ischemic heart disease if DIBH was not done in was 0.95 per 100 patients, which translates into a saving of 12.8 hours of life saved per PH of work required for implementing DIBH. DIBH was cost effective with cost for implementation of DIBH for all left-sided breast cancers at 2.3 times the annual per capita gross domestic product. CONCLUSION: Although routine implementation of DIBH requires significant resource commitments, it seems to be worthwhile regarding the projected reductions in cardiac mortality.

Hospital burden of long-term genitourinary and gastrointestinal toxicity after radical radiotherapy for prostate cancer.

INTRODUCTION: Treatment options for prostate cancer (PCa) include radical radiotherapy (RT) and radical prostatectomy, both of which have comparable oncological outcomes. The aim of this study was to investigate the hospital burden of long-term genitourinary and gastrointestinal toxicity among patients with PCa who were treated with radiotherapy at our institution. METHODS: The radiotherapy department database was used retrospectively to identify all patients who underwent radiotherapy for PCa from January 2006 to January 2008. The patient administration system from each public hospital in the region was interrogated and all patient points of contact were recorded. Minimum follow up was 5 years. Individual patient charts were reviewed and factors that might influence outcomes were documented. RESULTS: We identified 112 patients. The mean age at diagnosis was 66 (44-76) and the median PSA was 12.1 (3.2-38). The mean duration of follow-up was 7.8 yrs. Twenty-three patients (20%) presented to the Emergency Department (ED) with late onset toxicity. Nine patients had more than 2 ED attendances. Twenty-five patients (22%) were investigated for genitourinary toxicity. Forty-seven patients (42%) underwent investigation for gastrointestinal side-effects and 45% of these required argon therapy (21/47). CONCLUSION: We found a significant hospital burden related to the management of gastrointestinal and genitourinary toxicity post radical radiotherapy for prostate cancer. As health care reforms gain momentum, policy makers must take into account the considerable longitudinal health care cost related to radiotherapy. It is also important that patients are counselled carefully in relation to potential long-term side-effects.

Socioeconomic status as an independent risk factor for severe late bowel toxicity after primary radiotherapy for cervical cancer.

OBJECTIVE: To evaluate the frequency of and risk factors for severe late bowel toxicity after curative radiotherapy in women treated for locally advanced cervical cancer. METHODS: Included were 515 women treated for locally advanced cervical cancer with primary radiotherapy with curative intent from 1992 to 2013. Bowel toxicity was graded according to the Common Terminology Criteria for Adverse Events. Associations between risk factors and severe late bowel toxicity were assessed using Cox proportional hazards regression models. RESULTS: Median follow-up was 78months. Fifty-nine patients developed severe late bowel toxicity. The actuarial 3-year and 5-year severe late bowel toxicity rates were both 13%. In the multivariable analysis, factors significantly associated with severe late bowel toxicity were: smoking (HR 2.59 [1.48-4.55]), severe acute bowel toxicity (HR 2.46 [1.24-4.49]), previous major abdominal surgery (HR 2.35 [1.20-4.60]), hypertension (HR 2.33 [1.23-4.40]), parametrial boost (HR 2.18 [1.10-4.33]), low socioeconomic status (HR 2.05 [1.17-3.59]) and low BMI (HR 0.93 [0.88-0.99]). First symptoms of severe late bowel toxicity were reported after a median follow-up of 9months, but occurred up to 10years after end of treatment. Only one third of the patients with severe late bowel toxicity were referred to a gastroenterologist. CONCLUSIONS: Severe late bowel toxicity is a frequent complication of definitive radiotherapy for cervical cancer. Several independent risk factors were found which warrant further research. A standardized and structured approach in the early diagnostics and management of bowel toxicity is needed.

Nature of Medical Malpractice Claims Against Radiation Oncologists.

PURPOSE: To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period. METHODS AND MATERIALS: Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression. RESULTS: There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included "improper performance" (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), "errors in diagnosis" (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and "no medical misadventure" (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. "Improper performance" was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment. CONCLUSIONS: Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against radiation oncologists may help direct efforts to improve quality of care and minimize the risk of being sued.

Cost-effectiveness of Stereotactic Body Radiation Therapy versus Radiofrequency Ablation for Hepatocellular Carcinoma: A Markov Modeling Study.

Purpose To assess the cost-effectiveness of stereotactic body radiation therapy (SBRT) versus radiofrequency ablation (RFA) for patients with inoperable localized hepatocellular carcinoma (HCC) who are eligible for both SBRT and RFA. Materials and Methods A decision-analytic Markov model was developed for patients with inoperable, localized HCC who were eligible for both RFA and SBRT to evaluate the cost-effectiveness of the following treatment strategies: (a) SBRT as initial treatment followed by SBRT for local progression (SBRT-SBRT), (b) RFA followed by RFA for local progression (RFA-RFA), (c) SBRT followed by RFA for local progression (SBRT-RFA), and (d) RFA followed by SBRT for local progression (RFA-SBRT). Probabilities of disease progression, treatment characteristics, and mortality were derived from published studies. Outcomes included health benefits expressed as discounted quality-adjusted life years (QALYs), costs in U.S. dollars, and cost-effectiveness expressed as an incremental cost-effectiveness ratio. Deterministic and probabilistic sensitivity analysis was performed to assess the robustness of the findings. Results In the base case, SBRT-SBRT yielded the most QALYs (1.565) and cost $197 557. RFA-SBRT yielded 1.558 QALYs and cost $193 288. SBRT-SBRT was not cost-effective, at $558 679 per QALY gained relative to RFA-SBRT. RFA-SBRT was the preferred strategy, because RFA-RFA and SBRT-RFA were less effective and more costly. In all evaluated scenarios, SBRT was preferred as salvage therapy for local progression after RFA. Probabilistic sensitivity analysis showed that at a willingness-to-pay threshold of $100 000 per QALY gained, RFA-SBRT was preferred in 65.8% of simulations. Conclusion SBRT for initial treatment of localized, inoperable HCC is not cost-effective. However, SBRT is the preferred salvage therapy for local progression after RFA. © RSNA, 2017 Online supplemental material is available for this article.

Cost-Effectiveness Analysis of Intensity Modulated Radiation Therapy Versus 3-Dimensional Conformal Radiation Therapy for Preoperative Treatment of Extremity Soft Tissue Sarcomas.

PURPOSE: Create a cost-effectiveness model comparing preoperative intensity modulated radiation therapy (IMRT) versus 3-dimensional conformal radiation therapy (3DCRT) for extremity soft tissue sarcomas. METHODS AND MATERIALS: Input parameters included 5-year local recurrence rates, rates of acute wound adverse events, and chronic toxicities (edema, fracture, joint stiffness, and fibrosis). Health-state utilities were used to calculate quality-adjusted life years (QALYs). Overall treatment costs per QALY or incremental cost-effectiveness ratio (ICER) were calculated. Roll-back analysis was performed using average costs and utilities to determine the baseline preferred radiation technique. One-way, 2-way, and probabilistic sensitivity analyses (PSA) were performed for input parameters with the largest impact on the ICER. RESULTS: Overall treatment costs were $17,515.58 for 3DCRT compared with $22,920.51 for IMRT. The effectiveness was higher for IMRT (3.68 QALYs) than for 3DCRT (3.35 QALYs). The baseline ICER for IMRT was $16,842.75/QALY, making it the preferable treatment. The ICER was most sensitive to the probability of local recurrence, upfront radiation costs, local recurrence costs, certain utilities (no toxicity/no recurrence, grade 1 toxicity/no local recurrence, grade 4 toxicity/no local recurrence), and life expectancy. Dominance patterns emerged when the cost of 3DCRT exceeded $15,532.05 (IMRT dominates) or the life expectancy was under 1.68 years (3DCRT dominates). Furthermore, preference patterns changed based on the rate of local recurrence (threshold: 13%). The PSA results demonstrated that IMRT was the preferred cost-effective technique for 64% of trials compared with 36% for 3DCRT. CONCLUSIONS: Based on our model, IMRT is the preferred technique by lowering rates of local recurrence, severe toxicities, and improving QALYs. From a third-party payer perspective, IMRT should be a supported approach for extremity soft tissue sarcomas.

[Economic Short-Term Cost Model for Stereotactic Radiotherapy of Neovascular AMD]. / Ökonomisches Kostenmodell zur Radiotherapie der neovaskulären AMD.

OBJECTIVES: Stereotactic radiation therapy (Oraya, OT) is available as a second line therapy for patients who, despite intensive anti-VEGF therapy for neovascular AMD, do not show an improvement in CNV. As OT is expensive (5,308 €), the short term economics for starting this therapy were investigated. METHODS: A short-term cost model was set up in MS Excel with a two year time horizon. On the basis of the data of the randomised, controlled INTREPID pivotal trial and current treatment practice in Germany, the costs were compared of conventional anti-VEGF therapy, with or without a single OT treatment. Patients with an active lesion after initial anti-VEGF therapy and a maximum lesion diameter ≤ 4 mm were included. Modeled cost components/aspects were direct savings from injection number, control follow-up examinations and aids, as well as anti-VEGF switches. Costs for Germany were employed and a univariate sensitivity analysis was performed to address the existing uncertainty. RESULTS: For the patients with a maximum AMD lesion diameter ≤ 4 mm and a macula volume > 7.4 mm(3), the INTREPID trial showed a mean reduction of 3.68 intravitreal injections for 16 Gy radiation versus sham over a time period of 2 years. These 3.68 IVM result in ~ 4,500 € direct cost savings. Moreover, due to the higher response rate with 16 Gy radiation, the number of follow-up visits and aids can be reduced, which results in savings between 207 € and 1,224 € over 2 years. After radiation, fewer anti-VEGF switches for low or non-responders are expected, which is modeled to result in ~ 1.7 fewer injections over 2 years. Due to overall fewer injections, fewer endophthalmitis cases would be expected. However, endophthalmitis and microvascular abnormalities, which can be observed in a few cases, are associated with low or non-quantifiable costs in this cost-cost comparison model. In summary, cost reductions of between 6,400 and 8,500 € are predicted in the model over two years, which have to be compared to the costs of a single application of OT. CONCLUSIONS: The short-term economic analysis shows that anti-VEGF therapy combined with OT results in savings above the costs for OT itself over a 2 year time horizon. Overall, the approach gives potential cost reductions, if the appropriate indication is followed.

[Brachytherapy for Prostate Cancer: Potentials and Limitations of Social Health Insurance Data for Benefit Assessment]. / Brachytherapie beim Prostata-Ca: Möglichkeiten und Limitationen von GKV-Routinedaten für eine Nutzenbewertung.

BACKGROUND: Due to the insufficient data base the Federal Joint Committee (G-BA) had in 2009 after 7 years of deliberation decided to initiate consultation regarding ambulatory brachytherapy for localised prostate cancer for 10 years from social health insurance (SHI) benefits. The aim is to gain more findings by means of comparative studies. PROBLEM: Based on the non-availability of clinical primary data of a methodologically acceptable level, it was analysed to what extent secondary data of the SHI may be used in order to arrive at valid conclusions for benefit aspects. METHODS: As base approx. 8 million insured of TK with their data of cost reimbursement between 2006 and 2011 were considered. In SHI secondary data no clinical information regarding tumour stage and other prognostic factors are available. Therefore, a novel method with therapy-specific multisectoral inclusion and exclusion criteria, respectively, was developed in order to differentiate between localised and advanced tumours of the prostate. Overall survival, relapse-free survival, event-free survival and side-effects associated to prostate cancer were analysed. RESULTS: Out of 87 822 insured persons with the diagnosis prostate cancer, 795 with PBT, 10 936 with RP and 1 925 with EBRT were investigated in detail. The 4-year event-free survival rate was 73% for RP, 77% for PBT and 71% for EBRT. Many prostate cancer-specific side effects appeared already before intervention. Side effects of the intestinal tract (23.8%) and sexual impairments (26.5%) were more frequent for EBRT than for RP (17.1%/14.8%) and PBT (16.4%/13.2%). CONCLUSION: By means of SHI secondary data and adequate operationalisation important findings regarding relevant aspects of prostate cancer in healthcare research can be generated. However, these hold methodological limitations and are not suited to draw valid conclusions for benefit assessment. Based solely on SHI routine data valid statements regarding comparative benefit assessment are limited. Limitations could be reduced by applying a record linkage with clinical data. Such primary data should include information on tumour stages as well as therapy assignment and observation of survival time.