Tesis

Uji Keandalan dan Kesahihan European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Hepatocellular Carcinoma-18 di Indonesia = Reliability and Validity Test of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Hepatocellular Carcinoma-18 in Indonesia.

Latar Belakang: Meskipun berbagai kemajuan pengobatan dicapai selama lebih dari satu dekade terakhir, secara keseluruhan prognosis karsinoma sel hati tetap buruk. Efek samping terapi serta progresifitas penyakit itu sendiri sangat mempengaruhi kualitas hidup pasien. Selain kesembuhan dan survival rate, kualitas hidup menjadi poin akhir penting dalam pengobatan kanker. Kualitas hidup pada penderita karsinoma sel hati penting untuk diteliti, karena merupakan faktor prognostik penting dari survival time, selain dapat juga mengevaluasi keuntungan dan kerugian dari modalitas terapi yang dipilih. Sampai saat ini belum ada kuesioner yang andal dan sahih untuk menilai kualitas hidup pasien karsinoma sel hati secara akurat di Indonesia. Penelitian ini bertujuan untuk mendapatkan kuesioner European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Hepatocellular Carcinoma-18 (EORTC QLQ-HCC18) yang andal dan sahih untuk digunakan di Indonesia. Metode: Penelitian ini adalah studi potong lintang. Penelitian diawali dengan menerjemahkan EORTC QLQ-HCC18 ke dalam bahasa Indonesia dan kemudian diujicobakan pada 10 responden. Setelah itu, EORTC QLQ-HCC18 hasil terjemahan digunakan pada penelitian utama dengan jumlah sampel yang lebih besar. Keandalan dinilai dengan pendekatan tes ulang dan konsistensi internal. Tes ulang dinilai dengan intraclass correlation coefficient (ICC). Konsistensi internal dinilai dengan Cronbach Alpha. Kesahihan konstruksi dinilai dengan multi-trait scaling analysis. Kesahihan kriteria dinilai dengan melihat korelasi antara domain kuesioner EORTC QLQ-HCC18 dengan Short Form 36 (SF36). Hasil: Pengambilan data dilakukan terhadap 65 pasien karsinoma sel hati yang berobat ke Poli Hepatologi maupun yang sedang dirawat di RSUPN Cipto Mangunkusumo selama Oktober 2015 – Februari 2016. Nilai ICC (interval 1 jam) pada semua domain EORTC QLQ-HCC18 sangat baik (ICC > 0,8), kecuali domain ikterus yang termasuk dalam kategori baik (ICC 0,61-0,8). Nilai Cronbach Alpha > 0,7 pada separuh jumlah domain EORTC QLQ-HCC18 kecuali domain ikterus (0,137), nyeri (0,474), dan citra tubuh (0,599). Sedangkan nilai Cronbach Alpha yang diperoleh dari penggabungan seluruh domain tetap baik, yaitu 0,897. Multi-trait scaling analysis menunjukkan korelasi cukup tinggi antara skor butir pertanyaan dengan skor domainnya sendiri. Sedangkan hubungan butir pertanyaan dengan domain yang berbeda selalu mempunyai korelasi yang lebih rendah dibandingkan dengan domainnya sendiri. Pada uji kesahihan kriteria, didapatkan 43 korelasi (dari total 64 korelasi) dengan r ≥ 0,4 dan p < 0,05 antara domain EORTC QLQ-HCC18 dengan SF36. Simpulan: Kuesioner EORTC QLQ-HCC18 merupakan alat ukur yang andal dan sahih untuk menilai kualitas hidup pasien karsinoma sel hati di Indonesia.
Kata Kunci: EORTC QLQ-HCC18, Karsinoma Sel Hati, Kualitas Hidup, Keandalan, Kesahihan



Background: Despite various therapeutic progress has been achieved over the past decade, the overall prognosis of hepatocellular carcinoma remains poor. Each therapy undertaken certainly has side effects. Adverse effect of treatment and the progression of the disease itself greatly affect the patient’s quality of life. In addition to recovery and survival rate, quality of life becomes extra important end point in cancer treatment. Quality of life in hepatocellular carcinoma is important to investigate, because quality of life has become an important prognostic factor of survival time, whilst quality of life can also evaluate the cost and benefit of chosen therapeutic modalities. Currently there is no specific questionnaire that can assess the quality of life of hepatocellular carcinoma patients accurately in Indonesia. This study aims to get a reliable and valid EORTC QLQHCC18 questionnaire to assess the quality of life of patients with hepatocellular carcinoma in Indonesia. Methods: This is a cross-sectional study. The study began by translating the EORTC QLQ-HCC18 into Indonesian and then tested on 10 respondents. After that, the Indonesian version of EORTC QLQ-HCC18 is used in the main study with a larger sample size. The questionnaire reliability was assessed with test-retest and internal consistency approach. Test-retest was assessed with intraclass correlation coeficient (ICC). Internal consistency was assessed by Cronbach alpha. Construct validity was assessed by multi-trait scaling analysis. The criteria validity assessed by looking at the correlation between domains of EORTC QLQ-HCC18 with Short Form 36 (SF36). Results: Data was collected from 65 hepatocellular carcinoma patients who came to Hepatology Polyclinic or were hospitalized at Cipto Mangunkusumo National General Hospital from October 2015 to February 2016. ICC value (1 hour interval) in all domains of EORTC QLQ-HCC18 is very good (ICC> 0.8), except icterus domain which categorized as good value (ICC 0,61-0,8). Cronbach alpha values > 0.7 obtained in almost half of domains of EORTC QLQ-HCC18, except icterus (0,137), pain (0,474), dan body image domain (0,599). Whereas the Cronbach Alpha obtained from merging the entire domains was still good (0,897). Multi-trait scaling analysis showed a fairly high correlation between the scores of the questions with a score of his own domain. While the relationship of the questions with different domains always have a lower correlation than the domain itself. In criteria validity test, obtained 33 correlations with r ≥ 0,4 and p < 0,05 between domains of EORTC QLQ-HCC18 with SF36. Conclusion: EORTC QLQ-HCC18 is a reliable and valid instrument for assessing quality of life of hepatocellular carcinoma patients in Indonesia
Keywords: Quality of Life, EORTC QLQ-HCC18, Reliability, Validity, Hepatocellular Carcinoma