LUNG HEALTH STUDY--LONG TERM FOLLOW-UP DATA COORD CTR

1986-1994年进行的肺健康研究（LHS）表明， 中年长期吸烟者的吸烟干预方案 吸烟者可以导致一个非常显着的有益影响的速度 FEV 1在五年内下降。然而，FEV 1只是一个替代指标， 呼吸系统发病率和死亡率的临床结局标志物。 本研究建议对前LHS进行长期的试验后随访 参与者评估发病率和死亡率， 呼吸道和心血管疾病及其他原因，如有记录的 医院诊所和死亡记录 肺功能检查11 进入LHS后12年，也建议确定长期- LHS吸烟干预计划对肺功能的长期影响。 研究的主要目的如下：1）确定，使用 意向治疗分析，LHS吸烟干预是否 显著降低临床上重要的呼吸道疾病的发生率 和心血管疾病在12至15年的研究后， 2）确定吸烟的有益效果是否 肺功能指标的干预计划持续到11 随访12年; 3）估计影响的程度 FEV 1和FVC对心血管和呼吸系统疾病发病风险的影响 控制吸烟史后的死亡率; 4）研究 其他因素的作用[性别、气道反应性、体重增加和共 发病率]确定肺功能下降率 以及心血管和呼吸系统发病率和死亡率的风险。 所有10个最初的LHS临床中心计划参与。到 最大限度地减少偏倚，肺部健康研究的所有存活受试者将 被邀请参加（潜在样本量，约5600）。 与之前的肺部健康研究一样，数据协调中心 将在生物统计学，公共卫生学院， 在明尼苏达大学，并将有充分的访问所有记录 和以前LHS项目的数据。

The Lung Health Study (LHS), conducted from 1986-1994, demonstrated that a smoking intervention program in middle-aged long-term cigarette smokers can result in a highly significant beneficial effect on the rate of FEV1 decline over five years. However, FEV1 is only a surrogate marker for clinical outcomes of respiratory morbidity and mortality. The present study proposes long-term post-trial follow-up of former LHS participants to assess the incidence of morbidity and mortality from respiratory and cardiovascular diseases and other causes, as documented by hospital, clinic, and death records. A pulmonary function test 11 to 12 years after entry into the LHS is also proposed to determine long- term effects of the LHS smoking intervention program on lung function. The main objectives of the study are as follows: 1) to determine, using an intent-to-treat analysis, whether the LHS smoking intervention significantly reduces the incidence of clinically important respiratory and cardiovascular disease over a 12- to 15-year period following study enrollment; 2) to determine whether the beneficial effect of the smoking intervention program on measures of lung function persists through 11 to 12 years of follow-up; 3) to estimate the magnitude of the effects of FEV1 and FVC on the risks of cardiovascular and respiratory morbidity and mortality, after controlling for smoking history; 4) to study the role of other factors [gender, airway reactivity, weight gain, and co- morbidities] in determining the rate of decline in pulmonary function and the risks of cardiovascular and respiratory morbidity and mortality. All ten of the original LHS clinical centers plan to participate. To minimize bias, all surviving participants of the Lung Health Study will be invited to participate (potential sample size, approximately 5600). As in the preceding Lung Health Studies, the Data Coordinating Center will be within the Diversion of Biostatistics, School of Public Health, at the University of Minnesota, and will have full access to all records and data from the previous LHS projects.