Skip Navigation


Japanese Journal of Clinical Oncology Advance Access originally published online on August 24, 2005
Japanese Journal of Clinical Oncology 2005 35(9):497-506; doi:10.1093/jjco/hyi142
This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
35/9/497    most recent
hyi142v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (15)
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Teshima, T.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Teshima, T.
Social Bookmarking
 Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?


© 2005 Foundation for Promotion of Cancer Research


Review Article

Patterns of Care Study in Japan

Teruki Teshima Japanese PCS Working Group

Department of Medical Physics and Engineering, Osaka University Graduate School of Medicine, Suita, Osaka, Japan

For reprints and all correspondence: Teruki Teshima, 1-7 Yamadaoka, Suita, Osaka 565-0871, Japan. E-mail: teshima{at}sahs.med.osaka-u.ac.jp

Received May 24, 2005; accepted June 30, 2005


    Abstract
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
Background: The Patterns of Care Study (PCS), started in the 1970's, is a well-known study used for clinical quality assurance (QA) in radiation oncology in the United States. PCS has been introduced in Japan since 1996.

Methods: Three national PCS surveys have been performed by means of external audit to evaluate patterns of care for the patients with carcinoma of any of esophagus and cervix treated with radiation between 1992 and 1994, for those with carcinoma of any of esophagus, cervix, breast, lung and prostate between 1995 and 1997, and for those with any of the five disease sites between 1999 and 2001. In the first PCS, feasibility of the study was confirmed. In the second PCS, two-stage cluster sampling of institutions and patients was performed and national averages for the survey items were calculated as QA measures. In the third PCS, additional imaging data were collected. The Japan/USA PCS workshops were held at San Francisco in 2001 and at Tokyo in 2003.

Results: Significant variations in process and structure were observed according to institutional stratification. In academic institutions, external beam energy ≥6 MV for deep-seated tumors of esophagus, lung, prostate and cervix, and brachytherapy for those of cervix and esophagus were used more frequently. There was an average of less than one full-time equivalent radiation oncologist in most non-academic institutions. These variations influenced the outcomes. There were also significant differences between USA and Japan in various aspects, e.g. a difference in radiation dose of 20% for uterine cervix cancer patients. It is higher in the USA. The number of new cancer patients requiring radiation is increasing steeply (120 000 in 2000 and 170 000 in 2005). Based on PCS data, structural guidelines were published and distributed throughout Japan.

Conclusion: PCS is useful for establishing the clinical QA for radiation oncology as well as other specialties through detailed monitoring and evaluation of their structures, processes and outcomes.

Key Words: Patterns of Care Study • process • radiation oncology • structure • outcome


    INTRODUCTION
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
The idea of the Patterns of Care Study (PCS) for use in radiation oncology was developed in 1969 by Kramer and Herring (1). The National Cancer Institute funded the American College of Radiology (ACR) to perform PCS in 1974 (2). They applied Donabedian's model of quality assessment to PCS as shown in Fig. 1 (3). In this model, quality of care was evaluated by monitoring the structure, process and outcome of the actual treatment of patients and understanding the relationships among these three factors. Structure of all radiotherapy facilities in the United States was monitored by questionnaire in terms of size, equipment, personnel and location, resulting in the establishment of a facility master list (FML) that have been updated every 5 years. The process comprises actions to evaluate and treat patients. The items included in the process surveys were determined by adapting best current management practices and decision trees for target disease sites, in which radiation therapy plays an important role. Outcome includes results for patients such as survival or complication rates. PCS was performed every 4 or 5 years for the patients treated with radiation in 1974, 1978, 1983, 1989, 1994 and 1999. Outcome surveys were continually updated every 5 years for the same patients after the initial process and outcome surveys. Important evidence disclosed by the American PCS that even elementary radiotherapy techniques are important is shown in Table 1. For example, technical improvements resulting from changing anterior–posterior parallel opposed fields to other multiple fields for prostate cancer and from one field/day to >one field/day (4), and the utilization of brachytherapy for uterine cervix cancer (5) significantly reduced complication rates nationwide. In addition, appropriate dose selection for prostate cancer from 55 to 70 Gy (6) and beam selection from <6 to ≥6 MV (4) significantly reduced recurrence rates. Finally, the introduction of brachytherapy for uterine cervix cancer improved survival dramatically (5). For the improvement of nationwide outcomes for cancer patients, even these elementary and simple techniques must therefore be performed carefully and extraordinarily well. This is the basic concept of clinical quality assurance (QA) projects nationwide. PCS monitors accomplishments in terms of process and outcome within a specific time window.



View larger version (45K):
[in this window]
[in a new window]
 
Figure 1. Donabedian's model of quality assessment for PCS (3).

 

View this table:
[in this window]
[in a new window]
 
Table 1. Important evidence disclosed by the American PCS that even elementary radiotherapy techniques are important

 
When we introduced PCS in Japan, Dr G. E. Hanks, former chairman of the Department of Radiation Oncology at Fox Chase Cancer Center and Principal Investigator of the PCS and Dr J. B. Owen, Director of PCS, ACR, supported us in all technical and academic aspects and have continued to encourage us (79). In this review article, we summarize the methods and most important achievements of PCS in Japan as well as its significance and future goals.


    PROGRESS OF JAPANESE PCS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
FIRST PCS (PCS92–94)
In 1996, we introduced PCS in Japan with partial support from a Grant-in-Aid for Cancer Research Groups from the Ministry of Health, Labor and Welfare in Japan (nos 8–27 and 8–29). We selected esophagus and cervix cancers as target disease sites, because annual numbers of these patients exceeded 4000 for either cancer type according to a structure survey by the Japan Society of Therapeutic Radiology and Oncology (JASTRO). We used the same database as that of American PCS, courtesy of ACR, which was installed on a personal computer. Since an important characteristic of PCS is data collection by external audit, we selected 37 radiotherapy facilities nationwide for our PCS survey and the audit was performed from July 1996 to February 1998 by the author and detailed information was collected for 561 patients with esophageal cancer (7,8) and 490 patients with cervix cancer (9). However, we could not use the original two-stage cluster sampling employed for the American PCS because of budget limitations for the first trial.

SECOND PCS (PCS95–97)
In 1998, PCS was fully supported by a Grant-in-Aid from the Ministry of Health, Labor and Welfare in Japan (no. 10–17) (10). The PCS data format was determined and the relevant computer software was developed for five disease sites, i.e. breast, esophagus, cervix, lung and prostate, through consensus panel discussion to establish the best current management and guidelines. An external audit team of 23 radiation oncologists was recruited from 10 academic institutions. External audits were performed from September 1998 to January 2001 for 96 participating institutes. We stratified radiotherapy facilities nationwide into four categories according to the FML created by JASTRO in 1995. This stratification was based on the academic conditions and the annual number of patients treated with radiation in each institution, because academic institutions require and have access to more resources for education and training while the annual caseload also constitutes essential information related to structure. Patients with carcinoma of any of the five disease sites were randomly selected by means of two-stage cluster sampling consisting of sampling of institutions from the four institutional strata in the first stage and sampling of patients from these institutions in the second stage (Fig. 2). Detailed and accurate data for 4399 patients with carcinoma of any of the five sites were collected by audit. National averages (NAs) and regional averages of various survey items could be calculated from the collected PCS data (11,12). NAs were used as a criterion for the evaluation of the quality of individual institutions as shown in Fig. 3. Computer software of PCS format was improved continually by installing new logical checking function to eliminate erroneous data obtained during audits (13). The first USA/Japan PCS workshop, supported by the National Cancer Institute and Japan Society for the Promotion of Science, was held in San Francisco in November 2001 (10,14).



View larger version (33K):
[in this window]
[in a new window]
 
Figure 2. Two-stage cluster sampling in the PCS. Number of institutions audited was limited to ~80 out of 700 in Japan (11).

 


View larger version (37K):
[in this window]
[in a new window]
 
Figure 3. PCS quantitative evaluation of the quality of radiotherapy in Japan (12).

 
THIRD PCS (PCS99–01)
In 2002, new funding for PCS (no. 14–6) enabled us to conduct the third national survey, for which we used the same study design as for the second PCS. In addition, we collected image data obtained from, for example, treatment planning simulator films and portal films by using digital camera at audit. For browsing these images, we developed a novel image database linked with the original PCS databases. In this new trial, more detailed analysis of treatment planning was possible. The PCS data format became highly sophisticated as a result of the installation of new logical checking functions based on actual data of the second PCS to determine a reasonable range between minimum and maximum values and help functions to indicate criteria for the definition of each of the survey items. At the PCS data center, online supporting functions such as early checking of the accuracy of data entry and image capturing was developed for the auditors that produced a dramatic improvement in the accuracy of data entry compared to that of the second PCS. During this survey period, the Individual Information Protection Act (draft) was introduced, promoting us to prepare applications for approval for the PCS from the institutional review board of each of the participating institutes before the audit was conducted. External audits of the 76 institutes were performed from July 2002 to June 2004, and two-stage cluster sampling enabled us to collect detailed and accurate data for 3396 patients with carcinoma of any of the five sites and their 13 386 images (7.03 GB). The second Japan/USA PCS workshop was held in February 2003, at the National Cancer Center, Tokyo, supported by grants from the Japanese Foundation of Aging and Health, the Japanese Society for the Promotion of Science, the Japanese Foundation of Cancer Research, Siemens Medical Ltd, Toshiba Medical Ltd and CMS Japan Ltd. In this workshop, further comparisons based on the findings of the first workshop were made, especially with regard to the best current management, the outcome for the patients with any of the five diseases surveyed in PCS and radiation doses for patients with cancer of the cervix. Leading Japanese surgical oncologists, medical oncologists and members of the Korean PCS group also participated and discussed issues from a broader viewpoint (15).


    STRUCTURE OF RADIATION ONCOLOGY BY INSTITUTIONAL STRATIFICATION
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
PCS uses two-stage cluster sampling of institutions and patients according to institutional stratification. This is the basic mechanism that renders PCS data useful for the improvement of the nationwide structure. PCS's two-stage cluster sampling made it possible to analyse the structure in close correlation with process and outcome. Table 2 shows the structure of institutions in 2001 for which the third PCS survey was performed. Structural maturity, reflected by number of equipment and personnel, closely correlated with this stratification. In 62–78% of academic institutions such as university hospitals or cancer centers (A), 1.6–1.8 accelerators with dual energy function were installed, and computed tomography (CT) simulators and high-dose rate brachytherapy machines in nearly 70%. On the one hand, full-time equivalent (FTE) radiation oncologists and technologists in these institutions numbered ≥1 and ≥2, respectively. On the other hand, non-academic institutions such as national, prefectural or municipal hospitals (B) showed smaller numbers of both equipment and staff. However, figures for these structures in 2001 improved by more than 20% over those in 1995, except for the number of FTE radiation oncologists in larger academic institutions (A1). The number of cancer patients/year increased markedly in all institutional strata. These findings show that this stratification made appropriate differentiation of the structure possible for use in further PCS analysis.


View this table:
[in this window]
[in a new window]
 
Table 2. Structure of radiotherapy facilities in 2001 surveyed by PCS

 
Although the structure has been improving recently in terms of patient load, the increase in the number of radiation oncologist is still well below that of equipment.


    FUTURE DEMAND FOR RADIOTHERAPY IN JAPAN
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
We surveyed by questionnaire the number of cancer patients in the last 13 years in the institutions audited, and the total number of patients was estimated by adjusting the number of facilities in each stratum and the number of annual patients in each institution. JASTRO has performed structure surveys every 2 years, and by combining their and our data the future demand for radiotherapy was estimated as shown in Fig. 4. It is expected that ~170 000 patients in 2005 and 240 000 in 2010 will be treated with radiation. However, the dotted line in Fig. 4 shows the projected increase in 10 years, i.e. 2015, based on the assumption that half of all cancer patients will be treated with radiation as is the case in the United States. This curve is much steeper than the one for our prediction. Therefore, the number of cancer patients who require radiation is increasing rapidly in Japan.



View larger version (21K):
[in this window]
[in a new window]
 
Figure 4. Estimated number of cancer patients treated with radiation in Japan based on PCS and its future demand. Dotted line shows the increase based on the assumption that by 2015, a total of 50% of cancer patients will be treated with radiation as in the case in the United States.

 

    THE USA/JAPAN PCS WORKSHOP
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
In the first workshop, all aspects of the similarities and differences between the two countries were compared and discussed in terms of epidemiology of esophageal, lung and uterine cervix cancer that had been surveyed with the PCSs, as well as the respective staging systems, the medical care systems and the structures of radiation oncology. It was noted that the PCS results confirmed the existence of epidemiological differences, that two-stage cluster sampling used in the PCSs functioned normally, and that the surveyed data accurately reflected the national practice patterns. There was a significant difference in utilization of radiation between the USA and Japan, with Japan's use of radiotherapy being ~3.5 times lower (10,14).

One of the more remarkable results of the second workshop was the identification of a significant discrepancy in radiation dose for uterine cervix cancer patients between Japan and the United States, while US medical physicists concluded, after reviewing films from Japanese institutions, that there was no significant difference in dose calculation of HDR brachytherapy. Differences in dose specification method for HDR brachytherapy and anatomical dimensions, such as pelvic parameters, vaginal anatomy and uterine size were suggested as causative factors and will be further explored.

The National Cancer Database (NCDB) was introduced by Dr D. P. Winchester, medical director of the NCDB sector of the American College of Surgeons. The NCDB comprises a non-population based clinical data set, which collects information from ~1600 hospital cancer registries for all cancer sites in the 50 United States. The NCDB has been used as a clinical surveillance mechanism, monitoring changes and variations in patterns of cancer care and patient outcomes. It holds information on about 70% of all newly diagnosed cases of cancer nationwide, with 850 000 cases entered every year. While the number of survey items surveyed by the NCDB is lesser (<200) than that included in the PCS, both systems have played important and complementary roles in the nationwide QA project (15). While the NCDB's mission is ‘to decrease the morbidity and mortality of cancer through standard setting, education and the tracking of outcomes’, PCS is more of a modality-specific study and the number of survey items is more than three or four times of that of NCDB. NCDB and PCS have been sharing information since 1999. To improve the quality of care for cancer patients in Japan, both NCDB and PCS are necessary as monitoring and evaluation mechanisms for processes and outcomes.


    VARIATION OF PROCESS ACCORDING TO INSTITUTIONAL STRATIFICATION
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
Table 3 summarizes the evidence from the Japanese PCS that the process for the patients with breast, cervix, esophagus, lung and prostate cancer varies significantly according to institutional stratification (7,9,1623). In general, the larger academic institutions (A) provided better quality of care for their patients than did the smaller non-academic institutions (B).


View this table:
[in this window]
[in a new window]
 
Table 3. Important evidence observed by Japanese PCS that the structure significantly influenced the process of radiotherapy and surgery

 


View larger version (21K):
[in this window]
[in a new window]
 
Figure 5. The utilization of brachytherapy (%) for the patients with uterine cervix cancer by institutional stratification (9).

 


View larger version (29K):
[in this window]
[in a new window]
 
Figure 6. Proportion of external beam energy for the treatment of esophageal cancer patients by institutional stratification (19).

 
BREAST PCS
As for post-mastectomy radiotherapy for breast cancer patients more advanced and appropriate techniques, such as use of a cast or shell, simulation with CT and multileaf collimator, were used frequently in A institutions. Beam energy >6 MV, which is no longer considered suitable for breast cancer patients, was still being used in 17% of B institutions.

CERVIX PCS
A daily fraction dose ≤180 cGy, which is safer for elderly patients, was used more frequently in B institutions. Beam energy ≥10 MV, which is appropriate for deep-seated tumors, such as cancer of the uterine cervix, esophagus, lung and prostate, was used for 85% of the patients in A institutions.

PCS92–94 showed a significant difference in utilization of brachytherapy between A and B institutions, and this discrepancy in process was also observed in PCS95–97 and PCS99–01. Figure 5 shows significant differences in the utilization of brachytherapy according to stratification of institutions. In smaller institutions the utilization rate was lower, especially in B2, but PCS99–01 showed improved rates for A2, B1 and B2 institutions.

ESOPHAGUS PCS
Radiotherapy was combined with surgery more frequently in A institutions, where more surgical oncologists are working. In addition, brachytherapy was used more frequently in A than in B institutions. The rule of ‘all fields treated a day’, which is considered a fundamental technique in routine radiotherapy as shown in Table 1, was observed for 76–86% of patients with esophagus, lung or prostate cancer in A institutions. The rates were significantly (20–30%) lower for B institutions. Higher external radiation doses (>60 Gy) were delivered to patients in A institutions, where treatment tends to be more aggressive. There were significant differences in the use of external beam energy among strata, for example, for esophageal cancer, as shown in Fig. 6. In smaller institutions, equipment with lower energy levels was more frequently used, although a recent survey indicated that these levels have markedly improved (PCS99–01). Nevertheless, 41% of the patients in the smallest institutions (B2) were still treated with energy levels ≤4 MV (19). In the surgery group, the extent of lymph node dissection, indicative of the aggressiveness of procedures, was significantly different, with D3 dominant in A institutions and D2 in B institutions.

LUNG PCS
As for the small cell lung cancer (SCLC) group, field reduction during radiotherapy, which requires careful application of technical skill, was more frequently performed in A institutions. As for non-small cell lung cancer (NSCLC) group, in addition, chemotherapy and radiotherapy for contralateral mediastinum, representative of more aggressive treatment, were more frequently used. Dose prescription was determined by means of isodose line for 25% of patients at A institutions, although the rate was still lower than that of the United States.

PROSTATE PCS
For prostate cancer, advanced technologies such as CT simulator, portal image and conformal therapy were used at significantly higher rates (20–30%) at A than at B institutions. Findings also differed according to disease site. For example, adoption of CT-simulation markedly differed for breast cancer and prostate cancer. For breast cancer patients, tangential beams constitute the standard technique for whole breast irradiation, which thus does not always require a CT simulator. For prostate cancer patients, on the other hands, 3D conformal radiotherapy, which makes use of CT simulator almost a necessary, is becoming increasingly popular. Therefore, these process data must be monitored carefully for individual disease sites.

These data confirmed that the structure of radiation oncology in Japan is immature, and this influences the process for cancer patients and possibly their outcome. American PCS has proved that the variations in process significantly affected outcome (46). The Japanese PCS also indicated that the stratum of institution or structure affected the outcome for esophagus cancer (19,20) or uterine cervix cancer patients.

Therefore, urgent structural improvement is considered an essential component of a nationwide QA project for cancer patients. To attain the ultimate goal of improvement in patient outcomes, the basic structure of radiation oncology must be established in accordance with appropriate institutional characteristics and patient load.


    AGE ANALYSIS RESULTS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
PCS92–94 featured age analysis for the non-surgery group esophageal cancer. There were significant differences in the backgrounds of patients, including history of cardiovascular disease, KPS, Stage/AJCC and process-like chemotherapy, as shown in Table 4 (23). The elderly, i.e. those ≥75 years showed higher frequency of cardiovascular disease, lower KPS, more Stage II and less Stage III. Chemotherapy was rarely performed for these patients. However, multivariate analysis showed that age did not affect outcome, while KPS, Stage/AJCC and external dose were identified as significant prognostic factors.


View this table:
[in this window]
[in a new window]
 
Table 4. Important evidence provided by Japanese PCS that the age also significantly affects the process and outcome of radiotherapy

 
The same analysis results for the SCLC group examined in PCS95–97 showed that use of chemotherapy, especially concurrent use of etoposide and cisplatin, and its cycles decreased significantly for the elderly (24). Age analysis also showed significant variations in patients' history of cardiovascular disease. Multivariate analysis using survival as the endpoint showed that age, chemotherapy and T-stage were significant prognostic factors.

PCS can provide important information to gain an understanding of actual nationwide practice, especially for the elderly, aged ≥75 years, which is sometimes difficult to survey because most of the elderly are generally not suitable candidates for prospective clinical studies. One important message obtained from the PCS is that radiation therapy can be used for elderly patients in almost the same manner as for younger age groups.


    BASIC STRUCTURE REQUIREMENTS FOR QA OF RADIOTHERAPY BASED ON PCS IN JAPAN
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
Based on the PCS data obtained during the three trials, we published guidelines for basic structure requirements for QA of radiotherapy and distributed them to all directors and chairpersons of radiotherapy facilities and medical schools throughout Japan (25).

Figure 7 shows the annual number of cancer patients treated per one external beam machine by institutional stratification. In half of the A2 and B1 institutions ≥250 patients were treated, and 300 or more patients in more than half of the A1 institutions. Therefore, we estimated an acceptable annual patient load as 250 on the assumption that four patients can be treated per hour and there are 7 working hours in a day. As a result, we based the guidelines for annual patient load/external beam machine on an annual patient load of 250–300. In more than one-quarter of the A1 institutions 450 or more patients were treated. The warning level of annual patient load/machine for institutions that urgently need structural improvement was set at 400. While the annual patient load/machine and the number of personnel in B2 institutions were below the guidelines, these institutions can be expected to play an important role in the treatment of rapidly growing numbers of cancer patients. Corresponding guidelines for annual patient load per FTE radiation oncologist and per FTE radiation technologist were set at 200 (warning level for improvement of structure: 300) and 120 (warning level: 200), respectively.



View larger version (19K):
[in this window]
[in a new window]
 
Figure 7. The distribution of annual number of cancer patients treated per one external machine by institutional stratification (25). Q1 includes four or five institutions in the lowest one-quarter (0–25%) for patient load/machine. Q2, 26–50%; Q3, 51–75%; and Q4, 76–100%.

 
We estimate on the basis of PCS data that the respective numbers of 1400 radiation oncologists, 830 medical physicists and 1400 radiotherapy technologists will be required in 2015 (25). Recruitment and education of such personnel are essential for a nationwide QA project in the field of radiation oncology. In particular, recent advances in radiotherapy technologies such as intensity modulated radiotherapy, image-guided radiotherapy and brachytherapy require large numbers of medical physicists, who already play an important role in QA and development of new treatment equipment or techniques in most western countries. However, there are few medical physicists in Japan, while significant variations according to institutional stratification in the use of accelerators were also observed. Overutilization of equipment with insufficient personnel constitutes a potential risk of malpractice. Therefore, we need a suitable and adequate structure of equipment and personnel to provide the best quality of care for our patients. To this end, we published structural guidelines for radiation oncology (25). We also confirmed that these requirements are justified for A1–B1 institutions in terms of a reasonable reimbursement from current medical insurance systems. The break-even point for patient load/machine is estimated at ~200 patients/year (25).


    IMAGE ANALYSIS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
Image data were collected for the third PCS. Figure 8 shows one example of image analysis for the distribution of the lower margin of the post-operative radiation field for patients with prostate cancer who underwent prostatectomy. Significant variations in radiation field patterns were observed. Nearly one-third of all patients were irradiated with inadequate or borderline field and with larger field in the craniocaudal direction.



View larger version (19K):
[in this window]
[in a new window]
 
Figure 8. Distribution of lower margin of radiation field for post-prostatectomy patients with prostate cancer evaluated by PCS image analysis.

 
PCS99–01 disclosed significant variations in position of the radiation field that could not be detected by text or numerical data only in the previous PCS database. For a multi-institutional prospective study, review of treatment film or condition is an essential component of the QA process. Image data of PCS can be used as criteria for the radiation field in a prospective study, while image analysis, which is part of PCS99–01, may represent a new frontier for a nationwide QA project and is both most promising and most challenging. We are currently developing an automatic image data capturing system to obtain data by means of the Radiation Therapy Oncology Group (RTOG) format or Digital Imaging and Communications in Medicine Radiation Therapy (DICOM-RT) from treatment planning computers. The feasibility of this system is now being tested.


    LIMITATION OF PCS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
While significant differences in patterns of care for the patients and structure were observed according to institutional stratification, there were also significant variations in follow-up rates for patients according to stratum. Figure 9 shows an example of survival curves for patients with NSCLC according to PCS and Osaka Cancer Registry (OCR) findings (26). It appears that survival curves of patients were overestimated by PCS, compared with those by OCR, since follow-up rates for PCS were ~65% but those for OCR 99% or more.



View larger version (31K):
[in this window]
[in a new window]
 
Figure 9. Survival curves for patients with NSCLC based on PCS and OCR data (26).

 
Therefore, the current PCS has shown some limitations in terms of outcome analysis, because there are significant variations according to institutional stratification in the follow-up information of surveyed patients (26). This indicates an urgent need for a new data capturing mechanism using an epidemiological approach by, for example, establishing in-house or regional cancer registries. PCS is a labor-intensive survey that requires more than 4000 h for data collection of 3000–4000 patients. The PCS method may therefore be unique, but is not at the leading edge.


    FUTURE GOALS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
Considering the current immaturity of the Japanese structure of radiation oncology, PCS still can perform an important function in monitoring structure, process and outcome, as well as providing essential information not only to medical staff and their patients but also to administrative policy makers. If the structure becomes mature in Japan, a more sophisticated data capturing system similar to the NCDB in the United States through the establishment of in-house cancer registries can take over the role of PCS. We have now started the development of a prototype of the Japanese National Cancer Database based on our PCS technology.

In the meantime, however, PCS can be expected to remain useful for improving the clinical QA of radiation oncology as well as other specialties through detailed monitoring and evaluation of their structure, process and outcome.


    CONCLUSIONS
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
The national data obtained with PCS confirmed the continuing existence of significant differences in structure of radiation oncology according to institutional stratification. PCS has been monitoring nationwide practice patterns of radiation oncology by means of external audit and reviewing medical charts of actually treated patients. PCS also confirmed that significant variations in the process remained according to stratification. PCS has thus provided overwhelming evidence of the influence of structure on the nationwide process of radiation oncology and of the existence of wide variations in both these factors.

PCS is useful for establishing the clinical QA for any of the specialties of oncology through monitoring of their structures, processes and outcomes nationwide.

‘Variation equals opportunity’ (G. E. Hanks)


    Acknowledgments
 
We thank all radiation oncologists who participated in this study. Their effort in providing information to us makes these surveys possible. The Japanese PCS working group currently includes the following members: Michihide Mitsumori, MD, Takashi Uno, MD, Katsumasa Nakamura, MD, Minako Sumi, MD, Masahiro Kenjo, MD, Naoto Shikama, MD, Takafumi Toita, MD, Kazuhiko Ogawa, MD, Masahiko Koizumi, MD, Hiroshi Onishi, MD, Yasuo Ashino, PhD, Masahiko Oguchi, MD, Chikako Yamauchi, MD, Yoshiharu Negoro, MD, Toshiyuki Gunbai, MD, Heitetsu Sai, MD, Keiji Nihei, MD, Yoshihide Sasaki, MD, Tomonari Sasaki, MD, Yoshiyuki Shioyama, MD, Yusuke Urashima, MD, Madoka Saku, MD, Tadamasa Yoshitake, MD, Shigeru Sasaki, MD, Atsushi Nishikawa, MD, Norio Mitsuhashi, MD, Katsuya Maebayashi, MD, Kaori Seki, MD, Yuji Murakami, MD, Koichi Domoto, MD, Hiroyuki Kawakami, MD, Shiho Tanaka, MD, Hiroshi Marino, MD, Takashi Komiyama, MD, Takeshi Kodaira, MD, Atunori Shinoda, MD, Yuko Ohno, PhD, Mitsuhiro Nakamura, MS, Hideki Takegawa, MS, Munenori Yoshioka, MS, Hodaka Numasaki, MS, Toshihiko Inoue, MD and Hiroshi Ikeda, MD. These studies were supported by Grant-in-Aid for Cancer Research (nos 8-27, 8-29, 10-17 and 14-6) from the Ministry of Health, Labor and Welfare of Japan.


    References
 TOP
 Abstract
 INTRODUCTION
 PROGRESS OF JAPANESE PCS
 STRUCTURE OF RADIATION ONCOLOGY...
 FUTURE DEMAND FOR RADIOTHERAPY...
 THE USA/JAPAN PCS WORKSHOP
 VARIATION OF PROCESS ACCORDING...
 AGE ANALYSIS RESULTS
 BASIC STRUCTURE REQUIREMENTS FOR...
 IMAGE ANALYSIS
 LIMITATION OF PCS
 FUTURE GOALS
 CONCLUSIONS
 References
 
1 Hanks GE, Coia LR, Curry J. Patterns of Care Studies: past, present, and future. Semin Radiat Oncol 1997;7:97–100.[CrossRef][Web of Science][Medline]

2 Kramer S. Patterns of Care Studies in Research Radiation Oncology. Grant Application CA 15978. Bethesda, MD: National Cancer Institute 1974.

3 Donabedian A. The quality of care. J Am Med Assoc 1988;260:1743–8.[Abstract/Free Full Text]

4 Hanks GE, Diamond JJ, Kramer S. The need for complex technology in radiation oncology. Correlations for facility characteristics and structure with outcome. Cancer 1985;55:2198–201.[CrossRef][Medline]

5 Lanciano RM, Won M, Coia LR, Hanks GE. Pretreatment and treatment factors associated with improved outcome in squamous cell carcinoma of the uterine cervix-A final report of the 1973 and 1978 Patterns of Care Studies. Int J Radiat Oncol Biol Phys 1991;20:667–76.[Medline]

6 Hanks GE. Optimizing the radiation treatment and outcome of prostate cancer. Int J Radiat Oncol Biol Phys 1985;11:1235–45.[Medline]

7 Teshima T, Abe M, Ikeda H, Hanks GE, Owen JB, Hiraoka M, et al. Patterns of Care Study for esophageal cancer in Japan: influence of the stratification on the process. Jpn J Clin Oncol 1998;28:308–13.[Abstract/Free Full Text]

8 Tanisada K, Teshima T, Ikeda H, Abe M, Owen JB, Hanks GE, et al. A preliminary outcome analysis of the Patterns of Care Study in Japan for esophageal cancer patients with special reference to age: non-surgery group. Int J Radiat Oncol Biol Phys 2000;46:1223–33.[CrossRef][Web of Science][Medline]

9 Teshima T, Abe M, Ikeda H, Hanks GE, Owen JB, Yamada S, et al. Patterns of Care Study for cervix cancer in Japan: influence of the stratification on the process. Jpn J Clin Oncol 1998;28:388–95.[Abstract/Free Full Text]

10 Inoue T. Quality assurance of radiotherapy and its clinical assessment. Jpn J Clin Oncol 2002;32:497–505.[Abstract/Free Full Text]

11 Tanisada K, Teshima T, Inoue T, Owen JB, Hanks GE, Abe M, et al. National average for the process of radiation therapy in Japan by Patterns of Care Study. Jpn J Clin Oncol 1999;29:209–13.[Abstract/Free Full Text]

12 Tanisada K, Teshima T, Ohno Y, Inoue T, Abe M, Ikeda H, et al. Patterns of Care Study quantitative evaluation of the quality of radiotherapy in Japan. Cancer 2002;95:164–71.[CrossRef][Web of Science][Medline]

13 Kinoshita K, Teshima T, Ohono Y, Inoue T, Yamashita T, Hiraoka M, et al. Logical checking function increases the accuracy of data entry in the Patterns of Care Study. Strahlenther Onkol 2003;179:107–12.[CrossRef][Web of Science][Medline]

14 Teshima T. Patterns of Care Study in radiotherapy and international information exchange. In: Furukawa Y, editor. The 30th Anniversary of Japan-U.S. Cooperative Cancer Research Program. The National Cancer Institute and Japan Society for the Promotion of Sciences 2004;80–2.

15 Teshima T, Frank J, Wilson, Ikeda H, Japanese PCS Working Group and PCS Group of American College of Radiology. The 2nd Japan/USA PCS Workshop at National Cancer Center, Tokyo: Meeting Report 2004;1–61.

16 Shikama N, Sasaki S, Mitsumori M, Hiraoka M, Yamauchi C, Yamamoto T, et al. Patterns of Care Study in Japan: analysis of patients subjected to mastectomy followed by radiotherapy. Jpn J Clin Oncol 2003;33:456–62.[Abstract/Free Full Text]

17 Toita T, Nakamura K, Uno T, Kodaira T, Shinoda A, Ogawa K, et al. Radiotherapy for uterine cervical cancer: results of the 1995–1997 patterns of care process survey in Japan. Jpn J Clin Oncol 2005;35:139–48.[Abstract/Free Full Text]

18 Toita T, Mitsuhashi N, Teshima T, Maebayashi K, Nakamura K, Takahashi Y, et al. Postoperative radiotherapy for uterine cervical cancer: results of the 1995–1997 patterns of care process survey in Japan. Jpn J Clin Oncol 2004;34:99–103.[Abstract/Free Full Text]

19 Kenjo M, Oguchi M, Gomi K, Yamashita T, Uno T, Hirokawa Y, et al. Radiation therapy for esophageal cancer: results of the Patterns of Care Study in Japan 1995–1997. Esophageal Cancer 2005;2:77–83.

20 Gomi K, Oguchi M, Hirokawa Y, Kenjo M, Ogata T, Takahashi Y, et al. Process and preliminary outcome of a Patterns of Care Study of esophageal cancer in Japan: patients treated with surgery and radiotherapy. Int J Radiat Oncol Biol Phys 2003;56:813–22.[CrossRef][Web of Science][Medline]

21 Uno T, Sumi M, Ikeda H, Teshima T, Yamashita M, Inoue T, et al. Radiation therapy for small-cell lung cancer: results of the 1995–1997 patterns of care process survey in Japan. Lung Cancer 2002;35:279–85.[CrossRef][Web of Science][Medline]

22 Ogawa K, Nakamura K, Sasaki T, Yamamoto T, Koizumi M, Teshima T, et al. Radical external beam radiotherapy for prostate cancer in Japan: preliminary results of the 1999–2001 patterns of care process survey. Jpn J Clin Oncol 2004;34:29–36.[Abstract/Free Full Text]

23 Tanisada K, Teshima T, Ikeda H, Abe M, Owen JB, Hanks GE, et al. A preliminary outcome analysis of the Patterns of Care Study in Japan for esophageal cancer patients with special reference to age: non-surgery group. Int J Radiat Oncol Biol Phys 2000;46:1223–33.[CrossRef][Web of Science][Medline]

24 Uno T, Sumi M, Sawa Y, Teshima T, Hara R, Ikeda H, et al. Process of care and preliminary outcome in limited-stage small-cell lung cancer: results of the 1995–1997 Patterns of Care Study in Japan. Int J Radiat Oncol Biol Phys 2003;55:626–32.[CrossRef][Web of Science][Medline]

25 Japanese PCS Working Group. Radiation oncology in multidisciplinary cancer therapy—basic structure requirement for quality assurance of radiotherapy based on Patterns of Care Study in Japan (in Japanese) Japanese PCS Working Group, 2005.

26 Sugiyama H, Teshima T, Ohno Y, Inoue T, Takahashi Y, Oshima A, et al. The Patterns of Care Study and regional cancer registry for non-small-cell lung cancer in Japan. Int J Radiat Oncol Biol Phys 2003;56:1005–12.[CrossRef][Medline]


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
Jpn J Clin OncolHome page
K. Nakamura, K. Ogawa, T. Sasaki, H. Onishi, M. Koizumi, M. Araya, N. Mukumoto, M. Mitsumori, T. Teshima, and Japanese Patterns of Care Study Working Subgroup o
Patterns of Radiation Treatment Planning for Localized Prostate Cancer in Japan: 2003-05 Patterns of Care Study Report
Jpn. J. Clin. Oncol., October 1, 2009; (2009) hyp115v1.
[Abstract] [Full Text] [PDF]


Home page
Jpn J Clin OncolHome page
T. Toita, T. Kodaira, T. Uno, A. Shinoda, Y. Akino, M. Mitsumori, and T. Teshima
Patterns of Pretreatment Diagnostic Assessment and Staging for Patients with Cervical Cancer (1999-2001): Patterns of Care Study in Japan
Jpn. J. Clin. Oncol., January 17, 2008; (2008) hym136v1.
[Abstract] [Full Text] [PDF]


Home page
Jpn J Clin OncolHome page
S. Jae Huh and on behalf of the Korean Society of Therapeutic Rad
Current Status of the Infrastructure and Characteristics of Radiation Oncology in Korea
Jpn. J. Clin. Oncol., August 4, 2007; (2007) hym073v2.
[Abstract] [Full Text] [PDF]


Home page
Jpn J Clin OncolHome page
K. Isobe, Y. Kagami, K. Higuchi, T. Kodaira, M. Hasegawa, N. Shikama, M. Nakazawa, I. Fukuda, K. Nihei, K. Ito, et al.
Initial Experience with the Quality Assurance Program of Radiation Therapy on behalf of Japan Radiation Oncology Group (JAROG)
Jpn. J. Clin. Oncol., February 1, 2007; 37(2): 135 - 139.
[Abstract] [Full Text] [PDF]


Home page
American Journal of Medical QualityHome page
C.-R. Chien and M.-S. Lai
Trends in the Pattern of Care for Lung Cancer and Their Correlation With New Clinical Evidence: Experiences in a University-Affiliated Medical Center
American Journal of Medical Quality, November 1, 2006; 21(6): 408 - 414.
[Abstract] [PDF]


Home page
Jpn J Clin OncolHome page
T. Sasaki, K. Nakamura, K. Ogawa, H. Onishi, Y. Otani, M. Koizumi, Y. Shioyama, T. Teshima, and The Japanese Patterns of Care Study Working Subgro
Postoperative Radiotherapy for Patients with Prostate Cancer in Japan; Changing Trends in National Practice between 1996-98 and 1999-2001: Patterns of Care Study for Prostate Cancer
Jpn. J. Clin. Oncol., October 1, 2006; 36(10): 649 - 654.
[Abstract] [Full Text] [PDF]


This Article
Right arrow Abstract Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
35/9/497    most recent
hyi142v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (15)
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Teshima, T.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Teshima, T.
Social Bookmarking
 Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?