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Published in: Journal of Neuro-Oncology 2/2011

01-11-2011 | Clinical Study - Patient Study

Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials

Authors: K. Bae, D. W. Bruner, S. Baek, B. Movsas, B. W. Corn, J. J. Dignam

Published in: Journal of Neuro-Oncology | Issue 2/2011

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Abstract

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.
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Literature
1.
go back to reference Meyers CA, Hess KR (2003) Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. Neurooncology 5:89–95 Meyers CA, Hess KR (2003) Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. Neurooncology 5:89–95
2.
go back to reference Folstein MF, Folstein SE, McHugh PR (1975) “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189–198PubMedCrossRef Folstein MF, Folstein SE, McHugh PR (1975) “Mini-mental state”: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189–198PubMedCrossRef
3.
go back to reference Brown PD, Buckner JC, O’Fallon JR, Iturria NL, O’Neill BP, Brown CA, Scheithauer BW, Dinapoli RP, Arusell RM, Curran WJ, Abrams R, Shaw EG (2003) The effects of radiotherapy on cognitive function in patients with low-grade glioma as measured by the Folstein Mini-Mental State Examination. J Clin Oncol 21:2519–2524PubMedCrossRef Brown PD, Buckner JC, O’Fallon JR, Iturria NL, O’Neill BP, Brown CA, Scheithauer BW, Dinapoli RP, Arusell RM, Curran WJ, Abrams R, Shaw EG (2003) The effects of radiotherapy on cognitive function in patients with low-grade glioma as measured by the Folstein Mini-Mental State Examination. J Clin Oncol 21:2519–2524PubMedCrossRef
5.
go back to reference Heitjan DF (1997) What can be done about missing data? Approaches to Imputation. Am J Public Health 847(4):548–549CrossRef Heitjan DF (1997) What can be done about missing data? Approaches to Imputation. Am J Public Health 847(4):548–549CrossRef
6.
go back to reference Staquet M, Berzon R, Osoba D, Machin D (1996) Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 5:496–502PubMedCrossRef Staquet M, Berzon R, Osoba D, Machin D (1996) Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 5:496–502PubMedCrossRef
7.
go back to reference Bernhard J, Cella DF, Coates AS, Fallowpeld L, Ganz PA, Moinpour CM, Mosconi P, Osoba D, Simes J, Hurny C (1998) Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 17:517–532PubMedCrossRef Bernhard J, Cella DF, Coates AS, Fallowpeld L, Ganz PA, Moinpour CM, Mosconi P, Osoba D, Simes J, Hurny C (1998) Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 17:517–532PubMedCrossRef
8.
go back to reference Regine WF, Schmitt FA, Scott CB, Dearth C, Patchell RA, Nichols RC Jr, Gore EM, Franklin RL III, Suh JH, Mehta MP (2004) Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: results of Radiation Therapy Oncology Group trial BR-0018. Int J Radiat Oncol Biol Phys 58(5):1346–1352PubMedCrossRef Regine WF, Schmitt FA, Scott CB, Dearth C, Patchell RA, Nichols RC Jr, Gore EM, Franklin RL III, Suh JH, Mehta MP (2004) Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: results of Radiation Therapy Oncology Group trial BR-0018. Int J Radiat Oncol Biol Phys 58(5):1346–1352PubMedCrossRef
9.
go back to reference Little RJA, Rubin DB (2002) Statistical analysis with missing data, 2nd edn. John Wiley, New York Little RJA, Rubin DB (2002) Statistical analysis with missing data, 2nd edn. John Wiley, New York
10.
go back to reference Gunnes N, Seierstad TG, Aamdal S, Brunsvig PF, Jacobsen AB, Sundstrøm S, Aalen OO (2009) Assessing quality of life in a randomized clinical trial: correcting for missing data. BMC Med Res Methodol Apr 9:28CrossRef Gunnes N, Seierstad TG, Aamdal S, Brunsvig PF, Jacobsen AB, Sundstrøm S, Aalen OO (2009) Assessing quality of life in a randomized clinical trial: correcting for missing data. BMC Med Res Methodol Apr 9:28CrossRef
11.
go back to reference Troxel AB, Fairclough DL, Curran D, Hahn EA (1998) Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 17(5–7):653–666PubMedCrossRef Troxel AB, Fairclough DL, Curran D, Hahn EA (1998) Statistical analysis of quality of life with missing data in cancer clinical trials. Stat Med 17(5–7):653–666PubMedCrossRef
12.
go back to reference Robins JM, Rotnitzky A, Zhao LP (1995) Analysis of semiparametric regression models for repeated outcomes in the presence of missing data. J Am Stat Assoc 90:106–121CrossRef Robins JM, Rotnitzky A, Zhao LP (1995) Analysis of semiparametric regression models for repeated outcomes in the presence of missing data. J Am Stat Assoc 90:106–121CrossRef
13.
go back to reference Fitzmaurice GM, Laird NM (2000) Generalized linear mixture models for handling nonignorable dropouts in longitudinal studies. Biostatistics 1(2):141–156PubMedCrossRef Fitzmaurice GM, Laird NM (2000) Generalized linear mixture models for handling nonignorable dropouts in longitudinal studies. Biostatistics 1(2):141–156PubMedCrossRef
14.
go back to reference Little RJA (1993) Pattern-mixture models for multivariate incomplete data. J Am Stat Assoc 88:125–134CrossRef Little RJA (1993) Pattern-mixture models for multivariate incomplete data. J Am Stat Assoc 88:125–134CrossRef
15.
go back to reference Pauler DK, McCoy S, Moinpour C (2003) Pattern mixture models for longitudinal quality of life studies in advanced stage disease. Stat Med 22(5):795–809PubMedCrossRef Pauler DK, McCoy S, Moinpour C (2003) Pattern mixture models for longitudinal quality of life studies in advanced stage disease. Stat Med 22(5):795–809PubMedCrossRef
16.
go back to reference Troxel AB, Harrington DP, Lipsitz SR (1998) Analysis of longitudinal data with non-ignorable non-monotone missing values. Appl Statist 47:425–438 Troxel AB, Harrington DP, Lipsitz SR (1998) Analysis of longitudinal data with non-ignorable non-monotone missing values. Appl Statist 47:425–438
17.
go back to reference Guo X, Carlin BP (2004) Separate and joint modeling of longitudinal and event time data using standard computer packages. Am Stat 58(1):16–24CrossRef Guo X, Carlin BP (2004) Separate and joint modeling of longitudinal and event time data using standard computer packages. Am Stat 58(1):16–24CrossRef
Metadata
Title
Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials
Authors
K. Bae
D. W. Bruner
S. Baek
B. Movsas
B. W. Corn
J. J. Dignam
Publication date
01-11-2011
Publisher
Springer US
Published in
Journal of Neuro-Oncology / Issue 2/2011
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-011-0603-8

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