목적 : 본 연구는 베일리 영유아 발달검사 3판 대근육 운동척도를 한국판(Korean-Bayley-Ⅲ; K-Bayley-Ⅲ)으로 타당화하기 위하여 문항분석과 신뢰도 및 타당도를 검증하고자 하였다.
연구방법 : 본 연구의 참여자는 생후 16일에서 42개월 15일의 영유아 1,764명으로, 지역 및 성별, 모의 학력에 따라서 층화 표집되었다. 문항분석을 위하여 문항반응이론에 근거한 문항 난이도 분석과 고전검사이론을 통한 문항 통과율을 분석하였고, 신뢰도를 검증하기 위하여 반분신뢰도를 이용한 내적일관성, 검사-재검사 신뢰도, 평정자간 일치도를 살펴보았으며, 상호상관검증을 통해 수렴타당도와 변별타당도를 확인하였다.
결과 : 첫째, K-Bayley-Ⅲ 대근육 운동척도의 난이도를 조사한 결과, 총 72개의 문항은 원척도와 유사하게 쉬운 문항에서 어려운 문항까지 비교적 순차적으로 배치되어 있었다. 또한 시작점과 기저선 문항의 적절성을 알아보기 위하여 월령 단계별 문항 통과율을 확인한 결과, 대부분의 월령 단계에서 시작점과 기저선 문항이 적절한 것으로 나타났다. 둘째, 척도의 신뢰도 분석 결과, 대부분의 월령 단계에서 문항 내적일관성이 높은 것으로 나타났으며, 검사-재검사 신뢰도 및 평정자간 일치도도 높은 것으로 확인되었다. 마지막으로 타당도 검증 결과, 대근육 운동척도는 운동척도와는 높은 상호상관을 보인 반면 언어척도와는 중간 정도의 상호상관을 보여 수렴 및 변별타당도가 확보되었다.
결론 : 본 연구를 통해 K-Bayley-Ⅲ 대근육 운동척도가 한국 영유아의 대근육 운동발달을 평가하는데 타당하고 신뢰로운 척도임이 입증되었다.
Choline is an amine essential to maintenance of good health. Here, we modified the ion chromatographic method for measuring choline described by Laikhtman & Rohrer and validated by the ICH guideline and applied it to monitoring of choline content in infant formula in the Republic of Korea.
The Certified Reference Materials (CRM), NIST 1849a, were used for validation of the modified method. The parameters of validation were linearity, range, specificity, accuracy, precision, LOD, LOQ and recovery. The linearity, R2, was above 0.999 and the analytical range was 2.5 to 50 μg/mL. The specificity was confirmed by the retention time (RT) and positive tests with calibration standard and CRM. The accuracy, precision and recovery values were 99.6 ± 2.41 %, 2.42 % and 90.8 - 92.8 %. The LOD and LOQ values were 0.03 mg/kg and 0.17 mg/kg, respectively. Five livestock products inspection agencies voluntarily participated in the collaborative study. The result, HORRAT value was 0.8 which was within the reference value 0.5 – 2.0. The validated method was applied to the analysis of choline in infant formula in the Republic of Korea. The results also conformed to 'The Standard for Livestock Products Labeling'.
Vitamin K1 is a fat-soluble vitamin essential for human health. We used the Association of Official Analytical Chemists(AOAC) method 999.15, validated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) Guideline, to monitor vitamin K1 content in infant formula in the Republic of Korea. The Certified Reference Materials (CRM), NIST 1849a, were used for validation of the test method. The parameters of validation were linearity, range, specificity, accuracy, precision, LOD, LOQ and recovery. The linearity, R2 was above 0.999 and the analytical range was 0.001 to 0.22 μg/mL. The specificity was confirmed by the retention time (RT) and positive/negative sample test. The accuracy, precision and recovery values were 101.13 ± 0.13 %, 3.15 % and 81.60 % - 99.78 %. The LOD and LOQ values were 0.582 ng/mL and 1.76 ng/mL, respectively. Five livestock products inspection agencies voluntarily participated in the collaborative study. The HORRAT value was 0.6, which was within the reference value 0.5 – 2.0. The validated test method was applied for the monitoring of vitamin K1 in infant formula in the Republic of Korea. The results also conformed to 'The Standard for Livestock Products of Processing and Ingredient Specifications' and 'The Standard for Livestock Products Labeling'.