PDF(Pubmed)
Abstract：
UNASSIGNED: Composite measures, like the Disease Activity Score for 28 joints (DAS28), are key primary outcomes in rheumatoid arthritis (RA) trials. DAS28 combines four different components in a continuous measure. When one or more of these components are missing the overall composite score is also missing at intermediate or trial endpoint assessments.
UNASSIGNED: This study examined missing data patterns and mechanisms in a longitudinal RA trial to evaluate how best to handle missingness when analysing composite outcomes.
UNASSIGNED: The Tumour-Necrosis-Factor Inhibitors against Combination Intensive Therapy (TACIT) trial was an open label, pragmatic randomized multicentre two arm non-inferiority study. Patients were followed up for 12 months, with monthly measurement of the composite outcome and its components. Active RA patients were randomized to conventional disease modifying drugs (cDMARDs) or Tumour Necrosis Factor-α inhibitors (TNFis).
UNASSIGNED: The TACIT trial was used to explore the extent of missing data in the composite outcome, DAS28. Patterns of missing data in components and the composite outcome were examined graphically. Longitudinal multivariable logistic regression analysis assessed missing data mechanisms during follow-up.
UNASSIGNED: Two hundred and five patients were randomized: at 12 months 59/205 (29%) had unobserved composite outcome and 146/205 (71%) had an observed DAS28 outcome; however, 34/146 had one or more intermediate assessments missing. We observed mixed missing data patterns, especially for the missing composite outcome due to one component missing rather than patient not attending thier visit. Age and gender predicted missingness components, providing strong evidence the missing observations were unlikely to be Missing Completely at Random (MCAR).
UNASSIGNED: Researchers should undertake detailed evaluations of missing data patterns and mechanisms at the final and intermediate time points, whether or not the outcome variable is a composite outcome. In addition, the impact on treatment estimates in patients who only provide data at milestone assessments need to be assessed.
UNASSIGNED: 37438295.
UNASSIGNED: This study examined missing data patterns and mechanisms in a longitudinal RA trial to evaluate how best to handle missingness when analysing composite outcomes.
UNASSIGNED: The Tumour-Necrosis-Factor Inhibitors against Combination Intensive Therapy (TACIT) trial was an open label, pragmatic randomized multicentre two arm non-inferiority study. Patients were followed up for 12 months, with monthly measurement of the composite outcome and its components. Active RA patients were randomized to conventional disease modifying drugs (cDMARDs) or Tumour Necrosis Factor-α inhibitors (TNFis).
UNASSIGNED: The TACIT trial was used to explore the extent of missing data in the composite outcome, DAS28. Patterns of missing data in components and the composite outcome were examined graphically. Longitudinal multivariable logistic regression analysis assessed missing data mechanisms during follow-up.
UNASSIGNED: Two hundred and five patients were randomized: at 12 months 59/205 (29%) had unobserved composite outcome and 146/205 (71%) had an observed DAS28 outcome; however, 34/146 had one or more intermediate assessments missing. We observed mixed missing data patterns, especially for the missing composite outcome due to one component missing rather than patient not attending thier visit. Age and gender predicted missingness components, providing strong evidence the missing observations were unlikely to be Missing Completely at Random (MCAR).
UNASSIGNED: Researchers should undertake detailed evaluations of missing data patterns and mechanisms at the final and intermediate time points, whether or not the outcome variable is a composite outcome. In addition, the impact on treatment estimates in patients who only provide data at milestone assessments need to be assessed.
UNASSIGNED: 37438295.
摘要：
未经评估：综合措施，比如28个关节的疾病活动评分(DAS28)，是类风湿性关节炎（RA）试验的关键主要结局。DAS28在连续测量中组合了四个不同的组件。当这些组分中的一个或多个缺失时,在中间或试验终点评估中,总体综合评分也缺失。
UNASSIGNED：这项研究检查了纵向RA试验中缺失的数据模式和机制，以评估在分析综合结果时如何最好地处理错误。
未经批准：针对联合强化治疗（TACIT）的肿瘤坏死因子抑制剂试验是一个开放标签，实用随机多中心双臂非劣效性研究。患者随访12个月,每月测量综合结果及其组成部分。活动性RA患者随机接受常规疾病改善药物（cDMARDs）或肿瘤坏死因子-α抑制剂（TNFis）治疗。
UNASSIGNED：TACIT试验用于探索复合结局中缺失数据的程度，DAS28.以图形方式检查了组件中缺失数据的模式和复合结果。纵向多变量逻辑回归分析评估随访期间缺失的数据机制。
UNASSIGNED：二百零五名患者被随机分配：在12个月时，59/205（29％）有未观察到的复合结局，146/205（71％）有观察到的DAS28结局；然而，34/146缺少一个或多个中间评估。我们观察到混合的缺失数据模式，特别是对于由于一个成分缺失而不是患者没有参加他们的访问而导致的综合结局缺失。年龄和性别预测不良因素，提供强有力的证据，缺失的观察结果不太可能随机完全缺失（MCAR）。
UASSIGNED：研究人员应在最后和中间时间点对缺失的数据模式和机制进行详细评估，无论结果变量是否是复合结果。此外,需要评估仅在里程碑评估时提供数据的患者对治疗估计的影响.
UNASSIGNED：37438295。
UNASSIGNED：这项研究检查了纵向RA试验中缺失的数据模式和机制，以评估在分析综合结果时如何最好地处理错误。
未经批准：针对联合强化治疗（TACIT）的肿瘤坏死因子抑制剂试验是一个开放标签，实用随机多中心双臂非劣效性研究。患者随访12个月,每月测量综合结果及其组成部分。活动性RA患者随机接受常规疾病改善药物（cDMARDs）或肿瘤坏死因子-α抑制剂（TNFis）治疗。
UNASSIGNED：TACIT试验用于探索复合结局中缺失数据的程度，DAS28.以图形方式检查了组件中缺失数据的模式和复合结果。纵向多变量逻辑回归分析评估随访期间缺失的数据机制。
UNASSIGNED：二百零五名患者被随机分配：在12个月时，59/205（29％）有未观察到的复合结局，146/205（71％）有观察到的DAS28结局；然而，34/146缺少一个或多个中间评估。我们观察到混合的缺失数据模式，特别是对于由于一个成分缺失而不是患者没有参加他们的访问而导致的综合结局缺失。年龄和性别预测不良因素，提供强有力的证据，缺失的观察结果不太可能随机完全缺失（MCAR）。
UASSIGNED：研究人员应在最后和中间时间点对缺失的数据模式和机制进行详细评估，无论结果变量是否是复合结果。此外,需要评估仅在里程碑评估时提供数据的患者对治疗估计的影响.
UNASSIGNED：37438295。
