Abstract
Objective
We aimed to propose a set of quality indicators (QIs) based on the clinical guidelines for cervical cancer treatment published by The Japan Society of Gynecologic Oncology, and to assess adherence to standard-of-care as an index of the quality of care for cervical cancer in Japan.
Methods
A panel of clinical experts devised the QIs using a modified Delphi method. Adherence to each QI was evaluated using data from a hospital-based cancer registry of patients diagnosed in 2013, and linked with insurance claims data, between October 1, 2012, and December 31, 2014. All patients who received first-line treatment at the participating facility were included. The QI scores were communicated to participating hospitals, and additional data about the reasons for non-adherence were collected.
Results
In total, 297 hospitals participated, and the care provided to 15,163 cervical cancer patients was examined using 10 measurable QIs. The adherence rate ranged from 50.0% for ‘cystoscope or proctoscope for stage IVA' to 98.8% for ‘chemotherapy using platinum for stage IVB'. Despite the variation in care, hospitals reported clinically valid reasons for more than half of the non-adherent cases. Clinically valid reasons accounted for 75%, 90.9%, 73.4%, 44.5%, and 88.1% of presented non-adherent cases respectively.
References
1. International Agency for Research on Cancer. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012 [Internet]. Lyon: International Agency for Research on Cancer;2012. [cited 2017 Jun 30]. Available from:. http://globocan.iarc.fr/old/FactSheets/cancers/cervix-new.asp.
2. National Institutes of Health Consensus Development Conference statement on cervical cancer. April 1–3, 1996. Gynecol Oncol. 1997; 66:351–61.
3. Hori M, Matsuda T, Shibata A, Katanoda K, Sobue T, Nishimoto H, et al. Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. Jpn J Clin Oncol. 2015; 45:884–91.
4. National Cancer Center. National database of hospital-based cancer registries: 5 year survival report 2008 [Internet]. Tokyo: National Cancer Center;2017. Aug [cited 2018 Jul 2]. Available from:. https://ganjoho.jp/data/reg_stat/statistics/brochure/hosp_c_reg_surv_2008.pdf.
5. Yamagami W, Nagase S, Takahashi F, Ino K, Hachisuga T, Aoki D, et al. Clinical statistics of gynecologic cancers in Japan. J Gynecol Oncol. 2017; 28:e32.
6. Fujikawa K, Miyamoto T, Ihara Y, Matsui Y, Takeuchi H. High incidence of severe urologic complications following radiotherapy for cervical cancer in Japanese women. Gynecol Oncol. 2001; 80:21–3.
7. Mabuchi S, Okazawa M, Isohashi F, Matsuo K, Ohta Y, Suzuki O, et al. Radical hysterectomy with adjuvant radiotherapy versus definitive radiotherapy alone for FIGO stage IIB cervical cancer. Gynecol Oncol. 2011; 123:241–7.
8. Institute of Medicine Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington, D.C.: National Academies Press (US);2001.
9. Ministry of Health, Labour and Welfare. Overview of the “Cancer Control Act” [Internet]. Tokyo: Ministry of Health, Labour and Welfare;2012. [cited 2017 Jun 20]. Available from:. http://www.mhlw.go.jp/english/wp/wp-hw3/dl/2-077.pdf. ;. http://www.mhlw.go.jp/bunya/kenkou/dl/gan_keikaku02.pdf.
10. Nagase S, Inoue Y, Umesaki N, Aoki D, Ueda M, Sakamoto H, et al. Evidence-based guidelines for treatment of cervical cancer in Japan: Japan Society of Gynecologic Oncology (JSGO) 2007 edition. Int J Clin Oncol. 2010; 15:117–24.
11. Ebina Y, Yaegashi N, Katabuchi H, Nagase S, Udagawa Y, Hachisuga T, et al. Japan Society of Gynecologic Oncology guidelines 2011 for the treatment of uterine cervical cancer. Int J Clin Oncol. 2015; 20:240–8.
12. Fitch K, Bernstein SJ, Aguilar MD, Burnand B, LaCalle JR, Lázaro P, et al. The RAND/UCLA appropriateness method user's manual [Internet]. Santa Monica, CA: RAND;2001. [cited 2017 Jun 20]. Available from:. https://www.rand.org/pubs/monograph_reports/MR1269.html.
13. Higashi T, Nakamura F, Shibata A, Emori Y, Nishimoto H. The national database of hospital-based cancer registries: a nationwide infrastructure to support evidence-based cancer care and cancer control policy in Japan. Jpn J Clin Oncol. 2014; 44:2–8.
14. Iwamoto M, Nakamura F, Higashi T. Monitoring and evaluating the quality of cancer care in Japan using administrative claims data. Cancer Sci. 2016; 107:68–75.
15. Trimble EL, Harlan LC, Gius D, Stevens J, Schwartz SM. Patterns of care for women with cervical cancer in the United States. Cancer. 2008; 113:743–9.
16. Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, et al. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999; 340:1154–61.
17. Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and paraaortic radiation for high-risk cervical cancer. N Engl J Med. 1999; 340:1137–43.
18. Ryu SY, Lee WM, Kim K, Park SI, Kim BJ, Kim MH, et al. Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2011; 81:e577–81.
19. Carlson JA, Rusthoven C, DeWitt PE, Davidson SA, Schefter TE, Fisher CM. Are we appropriately selecting therapy for patients with cervical cancer? Longitudinal patterns-of-care analysis for stage IB–IIB cervical cancer. Int J Radiat Oncol Biol Phys. 2014; 90:786–93.
20. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (cervical cancer) [Internet]. Fort Washington, PA: National Comprehensive Cancer Network; [cited 2017 Jun 30]. Available from:. https://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
21. Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, et al. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB–IVA carcinoma of the cervix with negative paraaortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999; 17:1339–48.
22. Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, et al. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999; 340:1144–53.
23. Japan Society of Obstetrics and Gynecology. The annual report of cervical cancer patients 2008 [Internet]. Tokyo: Japan Society of Obstetrics and Gynecology;2008. [cited 2017 Jun 30]. Available from:. http://plaza.umin.ac.jp/∼jsog-go/kanja_2008.pdf.
24. Ikeda Y, Furusawa A, Kitagawa R, Tokinaga A, Ito F, Ukita M, et al. Practice patterns of adjuvant therapy for intermediate/high recurrence risk cervical cancer patients in Japan. J Gynecol Oncol. 2016; 27:e29.
25. Matsuo K, Shimada M, Aoki Y, Sakamoto M, Takeshima N, Fujiwara H, et al. Comparison of adjuvant therapy for node-positive clinical stage IB–IIB cervical cancer: Systemic chemotherapy versus pelvic irradiation. Int J Cancer. 2017; 141:1042–51.
Table 1.
Variables | Values |
---|---|
Age, mean (SD) | 45.1 (15.0) |
<20 | 13 (0.1) |
20–29 | 1,528 (10.1) |
30–39 | 5,041 (33.2) |
40–49 | 4,113 (27.1) |
50–59 | 1,614 (10.6) |
≥60 | 2,854 (18.8) |
Histology type* | |
Squamous cell carcinoma | 13,314 (87.8) |
Squamous cell carcinoma in situ | 9,092 |
Adenocarcinoma | 1,371 (9.0) |
Adenocarcinoma in situ | 296 |
Other | 478 (3.1) |
FIGO stage | |
I | 2,288 (15.1) |
II | 1,314 (8.7) |
III | 552 (3.6) |
IV | 780 (5.1) |
Unknown† | 806 (5.3) |
Tis‡ | 9,423 (62.1) |
First-line treatment | |
Surgery | 10,129 (66.8) |
Radiotherapy | 743 (4.9) |
Chemotherapy | 167 (1.1) |
Surgery+chemotherapy | 672 (4.4) |
Radiotherapy+chemotherapy§ | 1,261 (8.3) |
Other | 2,191 (14.4) |
Values are presented as mean (SD) or number (%). CCRT, concurrent chemotherapy and radiation therapy; CIN3, cervical intraepithelial neoplasia 3; DPC, Diagnosis Procedure Combination; FIGO, International Federation of Gynecology and Obstetrics; HBCR, Hospital-Based Cancer Registry; ICD-O-3, International Classification of Diseases Oncology 3rd edition; SD, standard deviation.
Table 2.
QIs | Target patients (denominator) | Specified care (numerator) | No. | Adherence rate (95% CI) |
---|---|---|---|---|
QI1* | Conization for CIN3 | |||
CIN3 patients who are under age 43 years | Patients who had total hysterectomy without conization | 242/6,256 | 3.9% (3.4–4.4) | |
QI2 | Total hysterectomy for adenocarcinoma in situ | |||
Patients who had adenocarcinoma in situ over age 44 years | Patients who had total hysterectomy as the last treatment | 81/93 | 87.1% (78.5–93.2) | |
QI3 | Radical hysterectomy for stage II adenocarcinoma | |||
Stage II adenocarcinoma patients | Patients who had radical hysterectomy | 115/170 | 67.6% (60.1–74.6) | |
QI4 | CCRT as the first-line treatment for stage III or IVA | |||
Stage III or IVA patients | Patients who had CCRT as the first-line treatment | 397/720 | 55.1% (51.4–58.8) | |
QI5 | CCRT using cisplatin for stage III or IVA | |||
Stage III or IVA patients who had CCRT | Patients who had cisplatin-based regimen for CCRT | 333/417 | 79.9% (75.7–83.6) | |
QI6* | Chemotherapy for stage III or IVA | |||
Stage III or IVA patients who had curative radiation therapy | Patients who had chemotherapy before the main | 8/663 | 1.2% (0.5–2.4) | |
or CCRT as main treatment | treatment | |||
QI7 | Chemotherapy using platinum for stage IVB | |||
Stage IVB patients who had chemotherapy | Patients who had platinum-based chemotherapy | 422/426 | 99.1% (97.6–99.7) | |
QI8 | Cystoscope or proctoscope for stage IVA | |||
Stage IVA patients | Patients who had cystoscope or proctoscope before the treatment | 87/174 | 50.0% (42.3–57.7) | |
QI9 | Curative radiation therapy using brachytherapy | |||
Patients who had curative radiation therapy without surgery | Patients who had brachytherapy | 1,211/1,536 | 78.8% (76.7–80.9) | |
QI10* | * Post-treatment maintenance therapy using oral | |||
chemotherapy | ||||
Stage I or II patients who had surgery, radiation or CCRT for the first time. | Patients who used oral chemotherapy | 28/2,313 | 1.2% (0.8–1.7) |