Failure mode and effects analysis: A community practice perspective.

PURPOSE: To report our early experiences with failure mode and effects analysis (FMEA) in a community practice setting. METHODS: The FMEA facilitator received extensive training at the AAPM Summer School. Early efforts focused on department education and emphasized the need for process evaluation in the context of high profile radiation therapy accidents. A multidisciplinary team was assembled with representation from each of the major department disciplines. Stereotactic radiosurgery (SRS) was identified as the most appropriate treatment technique for the first FMEA evaluation, as it is largely self-contained and has the potential to produce high impact failure modes. Process mapping was completed using breakout sessions, and then compiled into a simple electronic format. Weekly sessions were used to complete the FMEA evaluation. Risk priority number (RPN) values > 100 or severity scores of 9 or 10 were considered high risk. The overall time commitment was also tracked. RESULTS: The final SRS process map contained 15 major process steps and 183 subprocess steps. Splitting the process map into individual assignments was a successful strategy for our group. The process map was designed to contain enough detail such that another radiation oncology team would be able to perform our procedures. Continuous facilitator involvement helped maintain consistent scoring during FMEA. Practice changes were made responding to the highest RPN scores, and new resulting RPN scores were below our high-risk threshold. The estimated person-hour equivalent for project completion was 258 hr. CONCLUSIONS: This report provides important details on the initial steps we took to complete our first FMEA, providing guidance for community practices seeking to incorporate this process into their quality assurance (QA) program. Determining the feasibility of implementing complex QA processes into different practice settings will take on increasing significance as the field of radiation oncology transitions into the new TG-100 QA paradigm.

Current perceptions regarding surgical margin status after breast-conserving therapy: results of a survey.

OBJECTIVE: The surgical margin status after breast-conserving surgery is considered the strongest predictor for local failure. The purpose of this study is to survey how radiation oncologists in North America (NA) and Europe define negative or close surgical margins after lumpectomy and to determine the factors that govern the decision to recommend reexcision based on the margins status. METHODS: A questionnaire was sent to active members of the European Society of Therapeutic Radiation Oncology and the American Society for Therapeutic Radiology and Oncology who had completed training in radiation oncology. Respondents were asked whether they would characterize margins to be negative or close for a variety of scenarios. A second survey was sent to 500 randomly selected radiation oncologists in the United States to assess when a reexcision would be recommended based on surgical margins. RESULTS: A total of 702 responses were obtained from NA and 431 from Europe to the initial survey. An additional 130 responses were obtained from the United States to the second survey regarding reexcision recommendations. Nearly 46% of the North American respondents required only that there be "no tumor cells on the ink" to deem a margin negative (National Surgical Adjuvant Breast and Bowel Project definition). A total of 7.4% and 21.8% required no tumor cells seen at <1 mm and <2 mm, respectively. The corresponding numbers from European respondents were 27.6%, 11.2%, and 8.8%, respectively (P <0.001). Europeans more frequently required a larger distance (>5 mm) between tumor cells and the inked edges before considering a margin to be negative. CONCLUSION: This study revealed significant variation in the perception of negative and close margins among radiation oncologists in NA and Europe. Given these findings, a universal definition of negative margins and consistent recommendations for reexcision are needed.

Radiotherapy for invasive breast cancer in North America and Europe: results of a survey.

PURPOSE: To document and explain the current radiotherapeutic management of invasive breast cancer in North America and Europe. We also identified a number of areas of agreement, as well as controversy, toward which additional clinical research should be directed. METHODS AND MATERIALS: An original survey questionnaire was developed to assess radiation oncologists' self-reported management of breast cancer. The questionnaire was administered to physician members of the American Society for Therapeutic Radiology and Oncology and the European Society for Therapeutic Radiology and Oncology. We present the results of the comparative analysis of 702 responses from North America and 435 responses from Europe. RESULTS: Several areas of national and international controversy were identified, including the selection of appropriate candidates for postmastectomy radiation therapy (RT) and the appropriate management of the regional lymph nodes after mastectomy, as well as after lumpectomy. Only 40.7% and 36.1% of respondents would use postmastectomy RT in patients with 1-3 positive lymph nodes in North America and Europe, respectively. Sentinel lymph node biopsy was offered more frequently by North American than European respondents (p <0.0001) and more frequently by academic than nonacademic respondents in North America (p < 0.05). The average radiation fraction size was larger in Europe than in North America (p < 0.01). European respondents offered RT to the internal mammary chain more often than did the North American respondents (p < 0.001). North American respondents were more likely to offer RT to the supraclavicular fossa (p < 0.001) and axilla (p < 0.01). CONCLUSION: Marked differences were found in physician opinions regarding the management of breast cancer, with statistically significant international differences in patterns of care. This survey highlighted areas of controversy, providing support for international randomized trials to optimize the RT management of invasive breast cancer.

Results of a survey regarding irradiation of internal mammary chain in patients with breast cancer: practice is culture driven rather than evidence based.

PURPOSE: To examine the self-reported practice patterns of radiation oncologists in North America and Europe regarding radiotherapy to the internal mammary lymph node chain (IMC) in breast cancer patients. METHODS AND MATERIALS: A survey questionnaire was sent in 2001 to physician members of the American Society for Therapeutic Radiology and Oncology and European Society for Therapeutic Radiology and Oncology regarding their management of breast cancer. Respondents were asked whether they would treat the IMC in several clinical scenarios. RESULTS: A total of 435 responses were obtained from European and 702 responses from North American radiation oncologists. Respondents were increasingly likely to report IMC irradiation in scenarios with greater axillary involvement. Responses varied widely among different European regions, the United States, and Canada (p < 0.01). European respondents were more likely to treat the IMC (p < 0.01) than their North American counterparts. Academic physicians were more likely to treat the IMC than those in nonacademic positions (p < 0.01). CONCLUSION: The results of this study revealed significant international variation in attitudes regarding treatment of the IMC. The international patterns of variation mirror the divergent conclusions of studies conducted in the different regions, indicating that physicians may rely preferentially on evidence from local studies when making difficult treatment decisions. These variations in self-reported practice patterns indicate the need for greater data in this area, particularly from international cooperative trials. The cultural predispositions documented in this study are important to recognize, because they may continue to affect physician attitudes and practices, even as greater evidence accumulates.

The management of ductal carcinoma in situ in North America and Europe. Results of a survey.

BACKGROUND: The goal of the current study was to understand and document contemporary treatment approaches in the management of ductal carcinoma in situ (DCIS). METHODS: An original questionnaire was designed to assess radiation oncologists' management of breast carcinoma, including 26 questions specifically addressing DCIS. A postal survey was conducted of members of the American and European Societies of Therapeutic Radiology and Oncology. The results of 702 responses from North America were compared with 435 responses from Europe, to determine treatment recommendations and variability by type of institution and geographic region. RESULTS: There were strong correlations between the grade of DCIS and/or the margin status and the use of radiotherapy (RT; P < 0.0001). For Grade 3 DCIS, RT was recommended regardless of the margin status. Opinions were split in the treatment of low-grade DCIS with 10-mm margins. North American respondents were more likely to recommend RT for low-grade DCIS than their European counterparts (P < 0.0001). Within the United States, there were significant regional variations in physician recommendations for tamoxifen (P < 0.001), but not in the tendency to recommend RT. North American academic physicians were less likely to recommend RT for favorable DCIS than nonacademic physicians (P < 0.01). CONCLUSIONS: There were marked differences in physician opinions regarding the management of DCIS, with significant international differences in patterns of care. The survey quantified and highlighted areas of agreement and controversy regarding the use of RT and tamoxifen in the management of DCIS. It provided support for large international trials to evaluate the optimal management of DCIS in the areas identified as most controversial.