Wang E E, Law B J, Stephens D, Langley J M, MacDonald N E, Robinson J L, Dobson S, McDonald J, Boucher F D, de Carvalho V, Mitchell I
Department of Pediatrics and Clinical Epidermiology, University of Toronto, Ontario.
Pediatr Pulmonol. 1996 Jul;22(1):23-7. doi: 10.1002/(SICI)1099-0496(199607)22:1<23::AID-PPUL4>3.0.CO;2-L.
Randomized trials of ribavirin therapy have used clinical scores to assess illness severity. Little information on agreement for these findings between observers has been published. We decided to determine interobserver agreement for (1) a history for apnea or respiratory failure; (2) assessment of cyanosis, respiratory rate, retractions, and oximetry; and (3) determination of reason for hospitalization (requirement for medications, supportive care, underlying illness, poor home environment). At eight centers 137 RSV-infected patients were assessed by two observers blinded to the assessments by others with no interventions made between assessments. Observations were categorized, and agreement was summarized as percentage of observed agreement, Pearson correlation, or as a kappa statistic. Observed agreement for a history of either apnea or a respiratory arrest was at least 90% at all centers, with seven of the eight centers in total agreement. At all centers except one, the agreement on the reason why the patient remained in hospital was at least 80%. The observed agreement for assessing cyanosis was at least 94% at all eight centers. The correlation coefficient for respiratory rate varied from 0.42 to 0.97 across centers. The kappa values for agreement beyond chance for retractions varied from 0.05 to 1.00. The kappa values for oxygen saturation measures varied from 0.31 to 0.70. Although not statistically significant, there appeared to be more variation as the time between assessments increased. In conclusion, agreement for historical findings and assessment of cyanosis was high. However, there was wide variation in agreement in the other assessments. Training to ensure consistent and reproducible assessment by different examiners will be necessary if these findings are to be used as outcome variables in clinical trials.
利巴韦林治疗的随机试验使用临床评分来评估疾病严重程度。关于观察者之间这些发现的一致性的信息鲜有发表。我们决定确定观察者之间在以下方面的一致性:(1)呼吸暂停或呼吸衰竭病史;(2)对发绀、呼吸频率、吸气凹陷和血氧饱和度测定的评估;(3)确定住院原因(药物需求、支持治疗、基础疾病、家庭环境差)。在八个中心,137例呼吸道合胞病毒(RSV)感染患者由两名观察者进行评估,这两名观察者对其他人的评估不知情,且在评估之间未进行任何干预。观察结果进行分类,一致性总结为观察到的一致性百分比、皮尔逊相关性或kappa统计量。在所有中心,观察到的呼吸暂停或呼吸骤停病史的一致性至少为90%,八个中心中有七个完全一致。除一个中心外,在所有中心,关于患者住院原因的一致性至少为80%。在所有八个中心,评估发绀的观察到的一致性至少为94%。各中心呼吸频率的相关系数在0.42至0.97之间。吸气凹陷一致性超出偶然的kappa值在0.05至1.00之间。血氧饱和度测量的kappa值在0.31至0.70之间。尽管无统计学意义,但随着评估之间时间间隔的增加,似乎差异更大。总之,病史发现和发绀评估的一致性较高。然而,其他评估的一致性差异很大。如果要将这些发现用作临床试验的结果变量,就需要进行培训,以确保不同检查者进行一致且可重复的评估。