Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Migraine Headache Index (MHI) at 1 Year |
MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00. |
1 year postoperatively |
|
Primary |
Migraine Headache Index (MHI) at 2 Years |
MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00. |
2 years postoperatively |
|
Primary |
Migraine Headache Index (MHI) at 2.5 Years |
MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00. |
2.5 years postoperatively |
|
Secondary |
Migraine Disability Assessment Test (MIDAS) Score at 1 Year |
MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00. |
1 year postoperatively |
|
Secondary |
Migraine Disability Assessment Test (MIDAS) Score at 2 Years |
MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00. |
2 years postoperatively |
|
Secondary |
Migraine Disability Assessment Test (MIDAS) Score at 2.5 Years |
MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00. |
2.5 years postoperatively |
|
Secondary |
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 1 Year |
MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00 |
1 year postoperatively |
|
Secondary |
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2 Years |
MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00 |
2 years postoperatively |
|
Secondary |
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2.5 Years |
MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00 |
2.5 years postoperatively |
|
Secondary |
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 1 Year |
MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00. |
1 year postoperatively |
|
Secondary |
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2 Years |
MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00. |
2 years postoperatively |
|
Secondary |
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2.5 Years |
MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00. |
2.5 years postoperatively |
|