Statistics Department, Radiation Therapy Oncology Group, 1818 Market St. Suite 1600, Philadelphia, PA 19103, USA.
J Neurooncol. 2011 Nov;105(2):383-95. doi: 10.1007/s11060-011-0603-8. Epub 2011 May 21.
The Mini Mental Status Exam (MMSE) instrument has been commonly used in the Radiation Therapy Oncology Group (RTOG) to assess mental status in brain cancer patients. Evaluating patient factors in relation to patterns of incomplete MMSE assessments can provide insight into predictors of missingness and optimal MMSE collection schedules in brain cancer clinical trials. This study examined eight RTOG brain cancer trials with ten treatment arms and 1,957 eligible patients. Patient data compliance patterns were categorized as: (1) evaluated at all time points (Complete), (2) not evaluated from a given time point or any subsequent time points but evaluated at all the previous time points (Monotone drop-out), (3) not evaluated at any time point (All missing), and (4) all other patterns (Mixed). Patient characteristics and reasons for missingness were summarized and compared among the missing pattern groups. Baseline MMSE scores and change scores after radiation therapy (RT) were compared between these groups, adjusting for differences in other characteristics. There were significant differences in frequency of missing patterns by age, treatment type, education, and Zubrod performance status (ZPS; P < 0.001). Ninety-two percent of patients were evaluated at least once: seven percent of patients were complete pattern, 49% were Monotone pattern, and 36% were mixed pattern. Patients who received RT only regimens were evaluated at a higher rate than patients who received RT + other treatments (49-64% vs. 27-45%). Institutional error and request to not be contacted were the most frequent known reasons for missing data, but most often, reasons for missing MMSE was unspecified. Differences in baseline mean MMSE scores by missing pattern (Complete, Monotone dropout, Mixed) were statistically significant (P < 0.001) but differences were small (<1.5 points) and significance did not persist after adjustment for age, ZPS, and other factors related to missingness. Post-RT change scores did not differ significantly by missing pattern. While baseline and change scores did not differ widely by missing pattern for available measurements, incomplete data was common and of unknown reason, and has potential to substantially bias conclusions. Higher compliance rates may be achievable by addressing institutional compliance with assessment schedules and patient refusal issues, and further exploration of how educational and health status barriers influence compliance with MMSE and other tools used in modern neurocognitive batteries.
简易精神状态检查(MMSE)量表已被广泛应用于放射治疗肿瘤学组(RTOG),用于评估脑癌患者的精神状态。评估患者因素与不完整 MMSE 评估模式之间的关系,可以深入了解脑癌临床试验中缺失的预测因素和最佳 MMSE 采集方案。本研究对 8 项 RTOG 脑癌试验中的 10 个治疗臂和 1957 名合格患者进行了研究。患者数据的依从模式分为:(1)所有时间点均进行评估(完整);(2)未在给定时间点或任何后续时间点进行评估,但在所有先前时间点进行评估(单调缺失);(3)任何时间点均未进行评估(全部缺失);(4)所有其他模式(混合)。总结了缺失模式患者的特征和缺失原因,并对各组进行了比较。根据其他特征的差异,比较了这些组之间基线 MMSE 评分和放疗后变化评分。不同年龄、治疗类型、教育程度和 Zubrod 表现状态(ZPS;P<0.001)的缺失模式频率存在显著差异。92%的患者至少接受过一次评估:7%的患者为完整模式,49%为单调模式,36%为混合模式。仅接受放疗的患者比接受放疗+其他治疗的患者接受评估的比例更高(49-64%比 27-45%)。机构错误和要求不联系是数据缺失最常见的已知原因,但最常见的原因是未指定 MMSE 缺失。缺失模式(完整、单调缺失、混合)的基线平均 MMSE 评分差异具有统计学意义(P<0.001),但差异较小(<1.5 分),且在调整年龄、ZPS 和其他与缺失相关的因素后,差异不再显著。放疗后变化评分与缺失模式无显著差异。虽然可用测量值的缺失模式之间的基线和变化评分差异不大,但不完整的数据很常见且原因未知,并且有可能严重影响结论。通过解决机构对评估计划的依从性和患者拒绝问题,以及进一步探讨教育和健康状况障碍如何影响 MMSE 及现代神经认知测试中其他工具的依从性,可能可以提高依从率。