Development and Validation of Ovarian Symptom Index-18 and Neurotoxicity-4 for Korean Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

다국어 초록 (Multilingual Abstract)

Purpose The purpose of this study was to develop Korean versions of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18) and FACT/Gynecologic Oncology Group (FACT-GOG) Neurotoxicity 4-item (NTX-4), evaluating their reliability and reproducibility.
Materials and Methods In converting NFOSI-18 and NTX-4, the following steps were performed: forward translation, backward translation, expert review, pretest of preliminary format, and finalization of Korean versions (K-NFOSI-18 and K-NTX-4). Patients were enrolled from six institutions where each had completed chemotherapy for ovarian, tubal, or peritoneal cancer at least 1 month earlier.
In addition to demographics obtained by questionnaire, all subjects were assessed via K-NFOSI-18, K-NTX-4, and a Korean version of the EuroQoL-5 Dimension. Internal structural validity and reliability were evaluated using item internal consistency, item discriminant validity, and Cronbach's . To evaluate test-retest reliability, K-NFOSI-18 and K-NTX-4 were readministered after 7-21 days, and intraclass correlation coefficients (ICCs) were calculated.
Results Of the 250 women enrolled during the 3-month recruitment period, 13 withdrew or did not respond, leaving 237 (94.8%) for the analyses. Mean patient age was 54.3±10.8 years.
Re-testing was performed in 190 patients (80.2%). The total K-NFOSI-18 and K-NTX-4 scores were 49 (range, 20 to 72) and 9 (range, 0 to 16), respectively, with high reliability (Cronbach's =0.84 and 0.89, respectively) and reproducibility (ICC=0.77 and 0.84, respectively) achieved in retesting.
Conclusion Both NFOSI-18 and NTX-4 were successfully developed in Korean with minimal modification.
Each Korean version showed high internal consistency and reproducibility.

참고문헌 (Reference)

1 Calhoun EA, "Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(Fact/GOG-Ntx)questionnaire for patients receiving systemic chemotherapy" 13 : 741-748, 2003

2 Dunne S, "Psychological variables associated with quality of life following primary treatment for head and neck cancer : a systematic review of the literature from 2004 to 2015" 26 : 149-160, 2017

3 Efficace F, "Patient-reported outcomes in randomised controlled trials of gynaecological cancers : investigating methodological quality and impact on clinical decision-making" 50 : 1925-1941, 2014

4 임명철, "Incidence of cervical, endometrial, and ovarian cancer in Korea, 1999-2010" 대한부인종양학회 24 (24): 298-302, 2013

5 Brundage M, "Health-related quality of life in recurrent platinum-sensitive ovarian cancer--results from the CALYPSO trial" 23 : 2020-2027, 2012

6 Basch E, "Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)" 106 : dju244-, 2014

7 Petersen MA, "Development of computerized adaptive testing(CAT)for the EORTC QLQ-C30 physical functioning dimension" 20 : 479-490, 2011

8 Kim MH, "Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with rheumatic diseases" 14 : 1401-1406, 2005

9 Liavaag AH, "Controlled study of fatigue, quality of life, and somatic and mental morbidity in epithelial ovarian cancer survivors: how lucky are the lucky ones?" 25 : 2049-2056, 2007

10 Jensen SE, "Content validity of the NCCN-FACT ovarian symptom index-18(NFOSI-18)" 136 : 317-322, 2015

11 Mirabeau-Beale KL, "Comparison of the quality of life of early and advanced stage ovarian cancer survivors" 114 : 353-359, 2009

12 Matei D, "Chronic physical effects and health care utilization in long-term ovarian germ cell tumor survivors : a Gynecologic Oncology Group study" 27 : 4142-4149, 2009

13 Ezendam NP, "Chemotherapy-induced peripheral neuropathy and its impact on health-related quality of life among ovarian cancer survivors : results from the population-based PROFILES registry" 135 : 510-517, 2014

14 Monahan PO, "Case-control comparison of quality of life in long-term ovarian germ cell tumor survivors : a gynecologic oncology group study" 26 : 19-42, 2008

15 Pignata S, "Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer(MITO-7) : a randomised, multicentre, open-label, phase 3trial" 15 : 396-405, 2014

16 Siegel RL, "Cancer statistics, 2016" 66 : 7-30, 2016

17 Cannistra SA, "Cancer of the ovary" 351 : 2519-2529, 2004

18 Jensen SE, "A new index of priority symptoms in advanced ovarian cancer" 120 : 214-219, 2011

19 Oronsky B, "A brief review of the management of platinum-resistantplatinum-refractory ovarian cancer" 34 : 103-, 2017