Effect of the Changing the Lower Limits of Normal and the Interpretative Strategies for Lung Function Tests

Background: To interpret lung function tests, it is necessary to determine the lower limits of normal (LLN) and to derive a consensus on the interpretative algorithm. '0.7 of LLN for the $FEV_1$/FVC' was suggested by the COPD International Guideline (GOLD) for defining obstructive disease. A consensus on a new interpretative algorithm was recently achieved by ATS/ERS in 2005. We evaluated the accuracy of '0.7 of LLN for the $FEV_1$/FVC' for diagnosing obstructive diseases, and we also determined the effect of the new algorithm on diagnosing ventilatory defects. Methods: We obtained the age, gender, height, weight, $FEV_1$, FVC, and $FEV_1$/FVC from 7362 subjects who underwent spirometry in 2005 at the Asan Medical Center, Korea. For diagnosing obstructive diseases, the accuracy of '0.7 of LLN for the $FEV_1$/FVC' was evaluated in reference to the $5^{th}$ percentile of the LLN. By applying the new algorithm, we determined how many more subjects should have lung volumes testing performed. Evaluation of 1611 patients who had lung volumes testing performed as well as spirometry during the period showed how many more subjects were diagnosed with obstructive diseases according to the new algorithm. Results: 1) The sensitivity of '0.7 of LLN for the $FEV_1$/FVC' for diagnosing obstructive diseases increased according to age, but the specificity was decreased according to age; the positive predictive value decreased, but the negative predictive value increased. 2) By applying the new algorithm, 34.5% (2540/7362) more subjects should have lung volumes testing performed. 3) By applying the new algorithm, 13% (205/1611) more subjects were diagnosed with obstructive diseases; these subjects corresponded to 30% (205/681) of the subjects who had been diagnosed with restrictive diseases by the old interpretative algorithm. Conclusion: The sensitivity and specificity of '0.7 of LLN for the $FEV_1$/FVC' for diagnosing obstructive diseases changes according to age. By applying the new interpretative algorithm, it was shown that more subjects should have lung volumes testing performed, and there was a higher probability of being diagnosed with obstructive diseases.

폐기능검사 해석에 정상하한치 변화와 새 해석흐름도가 미치는 영향

연구 배경: 폐기능검사를 해석하는데 정상하한치(lower limits of normal) 선정과 해석흐름도 합의가 필수적이다. COPD 국제지침은 $FEV_1$/FVC 정상하한치로 0.7을 사용하여 폐쇄성장애를 진단한다. 한편, 미국흉부학회(ATS)와 유럽호흡기학회(ERS) 공동으로 새 해석흐름도를 제시하였다. '$FEV_1$/FVC 정상하한치 0.7' 의 정확성과 새 해석흐름도가 실제 폐기능검사 해석에 어떤 영향을 미치는지 알아 보고자 하였다. 방 법: 서울 아산병원의 호흡기검사실에서 2005년 7월 1일부터 11월 30일까지 5개월간 폐활량측정법을 시행한 7362명을 대상으로 하여 '$FEV_1$/FVC 정상하한치 0.7' 의 정확성을 평가하였고 새로운 ATS/ERS 해석흐름도에 따르면 폐용적검사가 추가로 필요한 경우가 얼마나 증가하는지 평가하였다. 상기 기간 내에 같은 날 폐용적검사를 시행한 1611 명을 대상으로 과거 해석흐름도와 비교하여 새로운 ATS/ERS 해석흐름도를 적용하게 되면 폐쇄성장애로 진단되는 경우가 얼마나 증가하는지 알아보았다. 결 과: 1) '$FEV_1$/FVC < 0.7' 에 의한 폐쇄성장애 진단은 연령이 증가할수록 민감도는 증가하였으나 특이도는 감소하였고 양성예측도는 감소하였으나 음성예측도는 증가하였다. 2) 새 ATS/ERS 해석흐름도를 적용할 경우 34.5% (2540명/7362명)의 환자가 추가로 폐용적검사가 필요하였다. 3) 새 ATS/ERS 해석흐름도를 적용할 경우, 과거에 제한성질환으로 진단되었던 환자 중 30%(205명/681명)가 폐쇄성질환으로 진단되었고 이는 전체 환자의 13%(205명/1611명)에 해당하였다. 결 론: 폐쇄성질환 진단기준으로 '$FEV_1$/FVC < 0.7' 을 사용하였을 때 연령에 따라서 민감도와 특이도가 변한다. 또한, 새로운 ATS/ERS 해석흐름도를 실제 환자를 진료하는데 적용하면 폐용적검사를 시행해야 하는 경우가 증가하게 되고 폐쇄성장애로 진단되는 경우가 더 증가하게 된다.