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Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database

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ClinicalTrials.gov Identifier: NCT01390909
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : February 14, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Epilepsy
Intervention Drug: Anti-epileptic drug (AED)
Enrollment 12386
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Well Controlled Private, Uncontrolled Private, Intermediate
Hide Arm/Group Description Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort. Database records for participants who are not classified as uncontrolled or well controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort. Database records for participants who are not classified as uncontrolled or well controlled
Period Title: Overall Study
Started 3454 3552 3552 602 613 613
Participants in Subgroup 0 3454 0 0 602 0
Completed 3454 3552 3552 602 613 613
Not Completed 0 0 0 0 0 0
Arm/Group Title Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Well Controlled Private, Uncontrolled Private, Intermediate Total
Hide Arm/Group Description Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort. Database records for participants who are not classified as uncontrolled or well controlled Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort. Database records for participants who are not classified as uncontrolled or well controlled Total of all reporting groups
Overall Number of Baseline Participants 3454 3552 3552 602 613 613 12386
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3454 participants 3552 participants 3552 participants 602 participants 613 participants 613 participants 12386 participants
Overall Study 41.5  (15.4) 41.3  (14.1) 41.2  (14.6) 54.2  (17.1) 54.1  (17.3) 54.6  (16.7) 43.2  (6.5)
Subgroup NA [2]   (NA) 41.4  (14.2) NA [2]   (NA) NA [2]   (NA) 54.0  (17.4) NA [2]   (NA) 43.3  (6.3)
[1]
Measure Description: For the total population and the subgroup total population, a weighted average of the individual study group means and number of participants was used. The standard deviation (SD) is the SD of the study group means.
[2]
There are no subgroup participants.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3454 participants 3552 participants 3552 participants 602 participants 613 participants 613 participants 12386 participants
Female, Overall Study 2106 2171 2159 341 351 332 7460
Male, Overall Study 1348 1381 1393 261 262 281 4926
Female, Subgroup NA [1]  2091 NA [1]  NA [1]  345 NA [1]  2436
Male, Subgroup NA [1]  345 NA [1]  NA [1]  257 NA [1]  602
[1]
There are no subgroup participants.
Number of Days of Observation   [1] 
Mean (Standard Deviation)
Unit of measure:  Days of observation
Number Analyzed 3454 participants 3552 participants 3552 participants 602 participants 613 participants 613 participants 12386 participants
Overall Study 2184  (1181) 2296  (1132) 2502  (1124) 1572  (847) 1478  (749) 1739  (792) 2221  (385)
Subgroup NA [2]   (NA) 2290  (1133) NA [2]   (NA) NA [2]   (NA) 1485  (751) NA [2]   (NA) 2170.5  (402.5)
[1]
Measure Description: For the total population and subgroups, a weighted average of the individual study group means and number of participants was used. The SDs reflect the SDs of the study group means.
[2]
There are no subgroup participants.
Charlson Comorbidity Index (CCI) Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 3454 participants 3552 participants 3552 participants 602 participants 613 participants 613 participants 12386 participants
Overall Study 0.98  (1.83) 1.09  (1.84) 1.00  (1.78) 1.13  (1.65) 1.32  (1.91) 1.20  (1.82) 1.05  (0.11)
Subgroup NA [2]   (NA) 1.08  (1.83) NA [2]   (NA) NA [2]   (NA) 1.29  (1.88) NA [2]   (NA) 1.11  (1.66)
[1]
Measure Description: The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival. For the total population and the subgroup, a weighted average of the study group means was used. The standard deviation (SD) is the SD of the study group means.
[2]
There are no subgroup participants.
Number of participant records with diagnosis codes for the indicated diseases or disorders  
Measure Type: Number
Unit of measure:  Participant records
Number Analyzed 3454 participants 3552 participants 3552 participants 602 participants 613 participants 613 participants 12386 participants
Alzheimer’s Disease, Overall Study 94 93 84 12 20 19 322
Alzheimer's Disease Subgroup NA [1]  93 NA [1]  NA [1]  20 NA [1]  113
Brain Tumor, Overall Study 53 63 40 38 50 43 287
Brain Tumor, Subgroup NA [1]  62 NA [1]  NA [1]  44 NA [1]  106
Meningitis, Overall Study 12 16 13 11 10 6 68
Meningitis, Subgroup NA [1]  15 NA [1]  NA [1]  9 NA [1]  24
Migraine, Overall Study 198 262 262 41 42 35 840
Migraine, Subgroup NA [1]  239 NA [1]  NA [1]  41 NA [1]  280
Stroke, Overall Study 267 303 264 123 134 154 1245
Stroke, Subgroup NA [1]  302 NA [1]  NA [1]  128 NA [1]  430
Anxiety Disorders, Overall Study 356 447 440 32 41 28 1344
Anxiety Disorders, Subgroup NA [1]  410 NA [1]  NA [1]  38 NA [1]  448
Bipolar Disorder, Overall Study 428 439 472 22 18 15 1394
Bipolar Disorder, Subgroup NA [1]  397 NA [1]  NA [1]  17 NA [1]  414
Depression, Overall Study 821 890 897 90 95 102 2895
Depression, Subgroup NA [1]  833 NA [1]  NA [1]  90 NA [1]  923
Psychosis, Overall Study 809 794 816 62 65 65 2611
Psychosis, Subgroup NA [1]  754 NA [1]  NA [1]  65 NA [1]  819
Personality Disorder, Overall Study 951 1062 1024 51 68 58 3214
Personality Disorder, Subgroup NA [1]  1001 NA [1]  NA [1]  67 NA [1]  1068
Mental Retardation, Overall Study 482 322 434 5 11 8 1262
Mental Retardation, Subgroup NA [1]  312 NA [1]  NA [1]  11 NA [1]  323
[1]
There are no subgroup participants.
1.Primary Outcome
Title Average Annualized Costs
Hide Description Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.
Arm/Group Title Medicaid, Uncontrolled, Subgroup Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Uncontrolled, Subgroup Private, Well Controlled Private, Uncontrolled Private, Intermediate
Hide Arm/Group Description:
Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
Database records for participants who are not classified as uncontrolled or well controlled
Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
Database records for participants who are not classified as uncontrolled or well controlled
Overall Number of Participants Analyzed 3454 3454 3552 3552 602 602 613 613
Mean (Standard Deviation)
Unit of Measure: United States dollars
AEDs 1352  (4580) 462  (2072) 1357  (4590) 1050  (4297) 1697  (3979) 639  (2248) 1713  (3989) 1299  (3949)
Non-AEDs 5615  (15730) 3657  (11702) 5725  (16016) 4801  (15357) 4497  (11374) 3096  (10692) 4587  (11972) 3883  (9436)
Hospitalizations; AMC 6902  (31181) 958  (9518) 7041  (31499) 3513  (22265) 11308  (62399) 1697  (12292) 12357  (84898) 5858  (37310)
ED Visits; AMC 400  (1496) 97  (731) 421  (1661) 242  (1371) 586  (4392) 76  (804) 603  (4422) 254  (2898)
Outpatient Visits; AMC 2416  (11759) 1258  (9953) 2466  (11829) 1804  (11649) 5757  (24888) 3061  (13353) 5771  (24883) 5780  (37154)
Neurology Visits; AMC 86  (850) 21  (425) 86  (839) 52  (666) 556  (4306) 175  (1593) 566  (4352) 442  (4263)
Other Healthcare Services; AMC 22022  (106033) 23202  (103595) 22113  (107291) 23428  (119218) 1008  (5428) 436  (4444) 1026  (5472) 645  (3910)
Hospitalizations; Ep Rel 4102  (19775) NA [1]   (NA) 4135  (19915) 1702  (13344) 6700  (48095) NA [1]   (NA) 7646  (70525) 2413  (23487)
ED Visits; Ep Rel 109  (610) NA [1]   (NA) 111  (616) 46  (540) 152  (972) NA [1]   (NA) 153  (968) 39  (635)
Outpatient Visits; Ep Rel 467  (2218) 68  (490) 469  (2239) 248  (1660) 703  (3072) 179  (1042) 702  (3082) 479  (6624)
Neurology Visits; Ep Rel 60  (712) 9  (143) 59  (703) 33  (472) 235  (1797) 68  (577) 237  (1845) 165  (1670)
Other Healthcare Costs; Ep Rel 1502  (14424) 754  (10724) 1475  (14265) 1273  (14072) 103  (752) 17  (204) 102  (746) 42  (472)
Total Healthcare Costs; AMC 38708  (114904) 29635  (105644) 39123  (116204) 34839  (123866) 24853  (81299) 9005  (28038) 26057  (100777) 17719  (69241)
[1]
None of the participants in this study arm incurred the indicated type of healthcare encounter during the study period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, AEDs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 849
Confidence Interval (2-Sided) 95%
786 to 921
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, nonAEDs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1879
Confidence Interval (2-Sided) 95%
1636 to 2112
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Hospitalizations, All Medical Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 5681
Confidence Interval (2-Sided) 95%
5257 to 6077
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Emergency Department Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 273
Confidence Interval (2-Sided) 95%
251 to 295
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Outpatient Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1021
Confidence Interval (2-Sided) 95%
819 to 1211
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Neurologist Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 60
Confidence Interval (2-Sided) 95%
48 to 72
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0080
Comments Adjusted Cost Differences in Other Healthcare Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2555
Confidence Interval (2-Sided) 95%
834 to 4281
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Hospitalizations
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4041
Confidence Interval (2-Sided) 95%
3776 to 4305
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 105
Confidence Interval (2-Sided) 95%
97 to 114
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Outpatient Services
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 384
Confidence Interval (2-Sided) 95%
358 to 413
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Neurologist Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 47
Confidence Interval (2-Sided) 95%
40 to 56
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 892
Confidence Interval (2-Sided) 95%
584 to 1192
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Subgroup, Medicaid, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Total Healthcare Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 12258
Confidence Interval (2-Sided) 95%
10482 to 14083
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 322
Confidence Interval (2-Sided) 95%
245 to 398
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, non-AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 841
Confidence Interval (2-Sided) 95%
556 to 1078
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Hospitalizations, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3248
Confidence Interval (2-Sided) 95%
2790 to 3714
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Emergency Department Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 164
Confidence Interval (2-Sided) 95%
138 to 190
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Outpatient Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 628
Confidence Interval (2-Sided) 95%
409 to 819
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Neurologist Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 29
Confidence Interval (2-Sided) 95%
18 to 42
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7628
Comments Adjusted Cost Differences in Other Healthcare Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 235
Confidence Interval (2-Sided) 95%
-1367 to 1798
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Hospitalizations
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2306
Confidence Interval (2-Sided) 95%
2016 to 2603
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 63
Confidence Interval (2-Sided) 95%
52 to 74
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Outpatient Services
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 211
Confidence Interval (2-Sided) 95%
179 to 245
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Neurologist Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23
Confidence Interval (2-Sided) 95%
15 to 33
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0581
Comments Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 277
Confidence Interval (2-Sided) 95%
-19 to 581
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Medicaid, Uncontrolled, Medicaid, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Total Healthcare Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5437
Confidence Interval (2-Sided) 95%
3672 to 7142
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1019
Confidence Interval (2-Sided) 95%
836 to 1191
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1047
Confidence Interval (2-Sided) 95%
564 to 1486
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Hospitalizations
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 9128
Confidence Interval (2-Sided) 95%
7346 to 11125
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Emergency Department Visits
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 459
Confidence Interval (2-Sided) 95%
326 to 622
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Outpatient Services
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2427
Confidence Interval (2-Sided) 95%
1587 to 3290
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Neurologists Visits
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 357
Confidence Interval (2-Sided) 95%
225 to 525
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Other Healthcare Services
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 502
Confidence Interval (2-Sided) 95%
234 to 768
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Hospitalizations
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6483
Confidence Interval (2-Sided) 95%
5329 to 7927
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 150
Confidence Interval (2-Sided) 95%
112 to 199
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Outpatient Services
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 516
Confidence Interval (2-Sided) 95%
401 to 645
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Epilepsy-Related Neurologist Visits
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 158
Confidence Interval (2-Sided) 95%
97 to 231
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs
Method Ordinary Least Squares Regression
Comments Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 83
Confidence Interval (2-Sided) 95%
58 to 113
Estimation Comments Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Subgroup, Private, Well Controlled
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Total Healthcare Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14582
Confidence Interval (2-Sided) 95%
12019 to 17097
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 420
Confidence Interval (2-Sided) 95%
210 to 630
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 658
Confidence Interval (2-Sided) 95%
217 to 1131
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Hospitalizations, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6040
Confidence Interval (2-Sided) 95%
3442 to 8795
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments Adjusted Cost Differences in Emergency Department Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 268
Confidence Interval (2-Sided) 95%
81 to 425
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9670
Comments Adjusted Cost Differences in Outpatient Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -40
Confidence Interval (2-Sided) 95%
-991 to 944
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2563
Comments Adjusted Cost Differences in Neurologist Visits, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 97
Confidence Interval (2-Sided) 95%
-77 to 302
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0100
Comments Adjusted Cost Differences in Other Healthcare Services, All Medical Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 328
Confidence Interval (2-Sided) 95%
90 to 588
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Hospitalizations, Epilepsy-Related
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4984
Confidence Interval (2-Sided) 95%
3168 to 7335
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 112
Confidence Interval (2-Sided) 95%
70 to 166
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments Adjusted Cost Differences in Outpatient Services, Epilepsy-Related
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 236
Confidence Interval (2-Sided) 95%
70 to 403
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1061
Comments Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 65
Confidence Interval (2-Sided) 95%
-22 to 145
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 58
Confidence Interval (2-Sided) 95%
28 to 93
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Private, Uncontrolled, Private, Intermediate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjusted Cost Differences in Total Healthcare Costs
Method Ordinary Least Squares Regression
Comments Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7673
Confidence Interval (2-Sided) 95%
4571 to 10989
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
 
Arm/Group Title Medicaid, Uncontrolled, Subgroup Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Uncontrolled, Subgroup Private, Well Controlled Private, Uncontrolled Private, Intermediate
Hide Arm/Group Description Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy Database records for participants who are not classified as uncontrolled or well controlled Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort. Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Database records for participants who are not classified as uncontrolled or well controlled
All-Cause Mortality
Medicaid, Uncontrolled, Subgroup Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Uncontrolled, Subgroup Private, Well Controlled Private, Uncontrolled Private, Intermediate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Medicaid, Uncontrolled, Subgroup Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Uncontrolled, Subgroup Private, Well Controlled Private, Uncontrolled Private, Intermediate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medicaid, Uncontrolled, Subgroup Medicaid, Well Controlled Medicaid, Uncontrolled Medicaid, Intermediate Private, Uncontrolled, Subgroup Private, Well Controlled Private, Uncontrolled Private, Intermediate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390909     History of Changes
Other Study ID Numbers: 113917
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: October 13, 2011
Results First Posted: February 14, 2012
Last Update Posted: October 8, 2012