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Background: Quality assurance (QA) of clinical practice is important for any medical specialty. Programs based on the Patterns of Care Study (PCS) have been developed to compare the quality of radiotherapeutic care at individual institutions, with the national average representing the process and outcome of radiotherapy. The feasibility of these programs was analyzed., Methods: Calculation programs for the national average and standard score were developed to evaluate quantitatively the process and outcome of radiotherapy at individual institutions as well as at the national level. The programs were used to evaluate the quality of radiotherapy for 561 esophageal carcinoma patients surveyed in the Japanese PCS., Results: As a representative example of QA measurement, the national average for the 5-year survival rate for these patients in the nonsurgery group was 5%. The regional averages for those in academic and nonacademic institutions were 9% and 1%, respectively (P = 0.0142), showing a significant difference between these two institutional strata. The standard score compared with the national average for institution No.105, for example, was 16.3 (P < 0.0001), with the positive value indicating that the outcome at this institution was significantly higher than the national average. The corresponding figure compared with the regional average was -0.3 (P = 0.7391), with the negative value indicating the outcome is not superior to the regional average of academic institutions., Conclusions: These programs make it possible to compare quantitatively the quality of radiation therapy at individual institutions with the national and regional averages. They should also be useful for nationwide QA projects in radiation oncology as well as in other medical specialities., (Copyright 2002 American Cancer Society.)

Background: The Patterns of Care Study (PCS) was imported to Japan from the United States in July 1996. A preliminary outcome analysis of the PCS for esophageal cancer patients in Japan was made with special reference to age, because the elderly population is rapidly increasing in Japan., Patients and Methods: From July 1996 to February 1998, external PCS audits were performed for 37 institutions nationwide and detailed information of 561 esophageal cancer patients treated during the period 1992-1994 was collected by using the fifth PCS data format developed in the United States. This format was provided courtesy of the American College of Radiology. For this study, patients who had not undergone surgery (n = 336) were selected. The patients were classified into three age groups: < 65 years old (n = 119), between 65 and 74 years (n = 93), and 75 years or older (n =123). Cox's proportional hazards model was used for the statistical analysis, with survival, acute/subacute complication and late complication of grade 3 or more based on RTOG criteria, as the endpoints., Results: Significant prognostic factors for the entire non-surgery group were Karnofsky Performance Status (KPS) (p = 0.0007), stage (p = 0.0001), and external irradiation dose (p = 0.0001). For the younger group, KPS (p = 0.0004), stage (p = 0.0197), and utilization of brachytherapy (p = 0.0010) were significant, while for the intermediate age group it was KPS (p = 0. 0027), history of pulmonary disease (p = 0.0339), stage (p = 0.0001), and external dose (p = 0.0001), and for the elderly group, stage (p = 0.0001) and external irradiation dose (p = 0.0224) were significant. Significant risk factors for complications for the entire group were stage (p = 0.0411), external dose (p = 0.0163), and stratification of institution (academic vs. nonacademic) (p = 0. 0114). Significant risk factors for the younger group were history of pulmonary disease (p = 0.0495) and external dose (p = 0.0037), and the other age groups showed no significant risk factors., Conclusion: Age was not a significant prognostic or risk factor for esophageal cancer patients in the non-surgery group treated with radiation therapy. Therefore, radiation therapy represented an important treatment modality for the elderly as well as for the younger esophageal cancer patients. External dose was a treatment-related prognostic factor for the elderly as well as for the intermediate age group.

Background: A nationwide effort is in progress to establish the actual state of radiotherapy and its quality assurance (QA) in Japan by using the Patterns of Care Study (PCS). In this study, national averages are calculated with a limited number of patients. A calculation program for national averages was prepared and applied to the radiotherapeutic processes used for esophageal cancer patients entered in the PCS., Methods: The calculation program for national averages, which were revised on the basis of differences between individual facilities and institutional strata, was developed in accordance with Sedransk's equation for the original PCS in the USA. National averages for several aspects concerning the sampled patients who had esophageal cancer between 1992 and 1994 were calculated with these procedures. Data for facilities and stratification of institution were simulated from a national structure survey of radiation oncology in 1990., Results: Values of the national average by Sedransk's equation were different from those of the simple sample average. There were significant differences in radiotherapeutic processes among stratification of institutions. For esophageal cancer, national averages were 0.129 for applications of endoscopic ultrasound, 0.599 for 'all fields treated each day' and 0.088 for application of brachytherapy., Conclusion: National averages for radiotherapy could be calculated. The values obtained in this PCS will be a useful measure for future QA in radiation oncology and in other specialties in Japan.