NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
ECRI Health Technology Assessment Group. Treatment of Degenerative Lumbar Spinal Stenosis. Rockville (MD): Agency for Healthcare Research and Quality (US); 2001 Jun. (Evidence Reports/Technology Assessments, No. 32.)
This publication is provided for historical reference only and the information may be out of date.
Input Form for Trial Information Table
Lumbar Spinal Stenosis EPC Project
Record Entry Information
| Person Extracting and Entering Record: | Date When Record Was Entered: | Person Reviewing Record: | Date When Record Was Reviewed: |
| Trial Design and Identification | Unique ID Number for Trial Publication |
| 111111 |
| Last Name of First Author | Year of Publication | Study Design: | |
| Total Number of Patients in Trial | |||
| Purpose of Trial: | Diagnosis of Patient Condition | Year When Study Was Performed | |
| Country Where Study Was Performed | |||
| Clinical Setting Where Trial Was Performed | Centers | Institution of First Author: | Funding Source for Clinical Trial: |
| Confounding or Comments on Study Design and Patient Characteristics: | |||
| Diagnostic Imaging Method Used | Electromyography
or Somatosensory Diagnostics Used | ||
Patient Outcomes Measured
When describing the method of outcome measure include the number of levels on any scale used in the trial. Typically 3 to 5 levels are listed as Excellent, Good, Fair, Poor, and Very Poor, or the outcomes is considered Satisfactory or Unsatisfactory (2 levels).
| Method of Followup to Record Patient Outcomes | Individual Patient Data is Presented |
| Measured Back Pain | Person Reporting Back Pain: | Method Used to Measure Back Pain | |
| Measured Back Pain Relief | Person Reporting Back Pain Relief: | Method Used to Measure Back Pain Relief: | |
| Measured Leg Pain | Person Reporting Leg Pain: | Method Used to Measure Leg Pain | |
| Measured Leg Pain Relief: | Person Reporting Leg Pain Relief | Method Used to Measure Leg Pain Relief: | |
| Measured Walking | Person Reporting Walking: | Method Used to Measure Walkingm | |
| Measured Global Success | Person Reporting Global Success: | Method Used to Measure Global Success |
| Number of Levels Used in Global Success Rating System | 5 or more levels | 4 levels | 3 levels | 2 levels |
| Measured Ability to Work | Person Reporting Working: | Method Used to Measure Ability to Work | |
| Measured Quality of Life | Person Reporting Quality of Life: | Method Used to Measure Quality of Life | |
| Measured Mental Status | Person Reporting Mental Status: | Method Used to Measure Mental Status | |
| Measured Disability/Dependence | Person Reporting Disability or Dependency: | Method Used to Measure Disability/Dependency | |
| Measured Activities of Daily Living | Person Reporting Activities of Daily Living and Physical Function: | Method for Measuring Activities of Daily Living and Physical Function: |
Patient Inclusion and Exclusion Criteria
Months of Nonoperative Therapy Required Prior to Surgery:
Trial Inclusion Criteria
Trial Exclusion Criteria
Jadad Score
| Randomization | Method of Randomization | How to Determine the Jadad Score: |
| Jadad Score | ||
| Double Blinding | Method of Blinding Used in Trial | Give one point for each Check listed above for Randomization, Double Blinding, and Describing Withdrawals and Dropouts. Give one additional point each for describing an appropriate method of randomization and double blinding. Deduct one point each for describing an inappropriate method of randomization and double blinding. |
| Described Withdrawals and Dropouts | ||
Used in Meta-analysis
Trial was Excluded from Meta-analysis
Reason for Trial Exclusion from Meta-analysis
After entering the data in this form, go to the Patient Characteristics Input Form to enter Patient Characteristics for each arm of the trial. Then enter published data into the appropriate outcomes tables.
Input Form for Patient Characteristics Data for Each Disorder/Treatment Arm in a Trial
Lumbar Spinal Stenosis EPC Project
A separate record is entered for each Patient Group within a Trial (Arm of a Trial). Each Patient Group is distinguished by its Alexandria ID number (linked to Trial publication), Disorder, and Treatment, and Post Treatment Group. These four keys uniquely identifies each Patient Group within a Trial. Each Patient Group receives a unique ID Number
Patient Group Keys
The Patient Group Identification Number is composed of the Alexandria Number followed by a two digit number that uniquely identifies the patients in this arm of the trial
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-01 |
| Type of Lumbar Spinal Stenosis Disorder: | Type of Surgical or Conservative Treatment Received by Patient Group: |
Treatment Group Divided by Post Surgical Outcome:
Treatment Description
| Number of Patients with Single Level Surgery: | Method of Fusion | Name of Device Used for Instrumentation | Description of Conservative Therapy (Number of Treatments, Drug Dosage) |
| Number of Patients with Multiple Level Surgery: |
| Mean Number of Levels Surgically Removed: | Description of Any Concurrent Therapy |
Description of Patient Group Characteristics
| Number of Patients | Reported Number of Male and Female Patients | Number of Males | Number of Females |
| Mean Age | Standard Deviation of Mean Age | Age of Youngest Patient | Age of Oldest Patient | Total Number of Patients to Drop Out | Number of Drop Outs Due to Death Lost to Followup | Number of Drop Outs Recorded as |
| Mean or Median Number of Months For Duration of Condition Prior to Treatment | Standard Deviation of the Mean Number of months of Duration of Condition Prior to Treatment | Shortest Period in Months of Duration of Condition Prior to Treatment | Longest Period in Months of Duration of Condition Prior to Treatment | Number of Patients in Trial/Treatment Group with Prior Surgery |
Patient Signs and Symptoms Prior to Treatment
| Reported Back Pain | Number of Patients with Back Pain | Number of Patients with Unilateral Back Pain | Number of Patients with Bilateral Back Pain |
| Reported Leg Pain | Number of Patients with Leg Pain | Number of Patients with Unilateral Leg Pain | Number of Patients with Bilateral Leg Pain |
| Reported Back and Leg Pain | Number of Patients with Back and Leg Pain | Number of Patients with Unilateral Back and Leg Pain | Number of Patients with Bilateral Back and Leg Pain |
| Reported Leg Weakness | Number of Patients with Leg Weakness | Number of Patients with Unilateral Leg Weakness | Number of Patients with Bilateral Leg Weakness |
| Reported Claudication | Number of Patients with Neurogenic Claudication | Number of Patients with Unilateral Neurogenic Claudication | Number of Patients with Bilateral Neurogenic Claudication |
| Reported Sensory Dysfunction | Number of Patients with Sensory Dysfunction | Number of Patients with Unilateral Sensory Dysfunction | Number of Patients with Bilateral Sensory Dysfunction |
| Reported Flexion | Number of Patients in Which Pain is Relieved by Flexion | ||
| Reported Incontinence | Number of Patients with Bowel or Bladder Incontinence | ||
Extent of Disease in Each Patient Group Prior to Treatment
Extent of disease can be based on the diameter of the spinal canal
Reported Extent of Disease
| Number of Patients with Mild Disease Canal Diameter > 12 mm | Number of Patients with Moderate Disease Canal Diameter <12 | Number of Patients with Severe Disease Total or subtotal (partial) block |
Comorbidity in Each Patient Group
| Comorbidity Reported | Number of Patients With No Reported Comorbidity |
| Number of Patients with Heart or Cardiovascular Disease | Number of Patients with Kidney Disease |
| Number of Patients with Liver Disease | Number of Patients with Diabetes |
| Number of Patients with Hypertension | Number of Patients with Hip Disease |
| Number of Patients with Knee Disease | Number of Patients with Arthritis |
| Number of Patients with Herniated Disk | Number of Patients With Neurological Disease |
| Number of Patients With Pulmonary Disease | Number of Patients with Other Degenerative Spinal Disorders |
| Number of Patients with Other Comorbidity | Description of Other Comorbidity |
Ability to Work Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Ability to Work Outcome Measurements
| These Are Pretreatment/Baseline Outcomes Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Number of Patients Working | ||
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation of Mean Time When Outcome was Measured | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Baseline (Pretreatment) Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Ability to Work Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Back Pain Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Back Pain Outcome Measurements
| These Are Pretreatment/Baseline Outcomes Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean of Outcome Score | SD of Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation of Mean Time When Outcome was Measured | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Baseline (Pretreatment) Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Back Pain Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Back Pain Relief Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Back Pain Relief Outcome Measurements
| These Are Pretreatment/Baseline Outcomes Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Back Pain Relief Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Dependency/Disability Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Dependency/Disability Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Dependency/Disability Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Global Assessment Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Global Assessment Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Baseline/Pretreatment Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic to Compare Treatments or Pre-Post Outcomes
Global Assessment Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Leg Pain Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Leg Pain Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Leg Pain Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Leg Pain Relief Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Leg Pain Relief Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Leg Pain Relief Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Mental Status Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Mental Status Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Mental Status Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Physical Function and Activities of Daily Living Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Physical Function and Activities of Daily Living Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Physical Function and Activities of Daily Living Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Quality of Life Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Quality of Life Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Quality of Life Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Walking Capacity Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Walking Capacity Outcome Measurements
| These Are Baseline/Pretreatment Outcome Data | If these are pretreatment/baseline data, enter 0 in the Time Post Treatment box and make no entries in the Statistics boxes. If these are control group data, enter the appropriate number of months in the Time Post Treatment box and make no entries in the Statistics boxes. | ||
| Number of Patients | Mean Outcome Score | SD Outcome Score | |
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
| Statistical Approach | If the statistical comparison is reported as not significant, then enter 0.5 as the p value. If the p value is reported as less than 0.05 then enter 0.049 as the p value and so on for other less than p values. | ||
| P Value of Statistical Comparison to Pretreatment/Baseline Outcome | P Value of Statistical Comparison to Control Group Outcome | Control Group ID Number |
Statistic Used to Compare Outcomes
Walking Capacity Outcome Scale Measurements
| Number of Patients Rated as Excellent | Number of Patients Given Satisfactory Outcome |
| Number of Patients Rated as Good | Number of Patients Given Unsatisfactory Outcome |
| Number of Patients Rated as Fair | |
| Number of Patients Rated as Poor | |
| Number of Patients Rated as Very Poor | |
Treatment Complications Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
Complications
| Number of Patients | Total Complications | Number of Patients Who Died due to Treatment | |
| Number of Patients Reporting Nausea: | Number of Patients Reporting Headache: | Number of Patients Reporting Diarrhea: | Number of Patients Reporting a General Allergic Reaction: |
Number of Patients Reporting Allergic Reaction at the Injection Site:
| Number of Patients Experiencing Other Adverse Reaction | Description of Other Adverse Reactions | ||
| Number of Patients with Post-Operative Spinal Instability | Number of Patients with Post Operative Collapsed Fusion: | Number of Patients with Post-Operative Infection | Number of Patients with Post-Operative Thrombosis |
| Number of Patients with Post-Operative Neurological Disorder | Description of Post-Operative Neurological Disorder | ||
| Number of Patients with Post-Operative Dural Tears | Number of Patients with Post-Operative Fractures |
| Number of Patients with Post-Operative Paraplegia | Number of Patients with Post-Operative Incontinence |
Spinal Canal Measurement Table Input Form
Lumbar Spinal Stenosis EPC Project
These are preoperative measurements
| Unique ID Number | Patient Group Identification Number |
| 111111 | 111111-11 |
If these are control group data, make no entries in the Statistics boxes. If this is not control group data, enter the control group ID number for the statistical comparison group in the next box and enter the appropriate statistical data.
These Are Control Group Data
| Control Group ID Number | Number of Patients |
Spinal Canal Diameter Measurements
| Imaging Method Used to Obtain Diameter | Mean Lumbar Spinal Canal Diameter (mm) Diameter | Standard Deviation of Lumbar Spinal Canal Diameter | Minimum Lumbar Spinal Canal Diameter | Maximum Lumbar Spinal Canal |
| Statistics Used to Compare Patient Groups for Diameter | P Value of Statistical Comparison for Diameter |
Spinal Canal Cross-section Measurements
| Imaging Method Used to Obtain Cross-section | Mean Lumbar Spinal Canal Cross-section (mm2) | Standard Deviation of Lumbar Spinal Canal Cross-section | Minimum Lumbar Spinal Canal Cross-section | Maximum Lumbar Spinal Canal Cross-section |
| Statistics Used to Compare Patient Groups | P Value of Statistical Comparison for Cross-section |
Spinal Canal Ratio Measurements
| Imaging Method Used to Obtain Ratio | Mean Ratio of Canal Size to Vertebral Body Size | Standard Deviation of the Mean Ratio | Minimum Ratio of Canal Size to Vertebral Body Size | Maximum Ratio of Canal Size to Vertebral Body Size |
| Statistics Used to Compare Patient Groups for Diameter | P Value of Statistical Comparison for Diameter |
Spinal Canal Degeneration Measurements
Description of Method Used to Determine Spinal Degeneration Score
| Mean Spinal Degeneration Score | Standard Deviation of Mean Spinal Degeneration Score | Minimum Spinal Degeneration Score | Maximum Spinal Degeneration Score |
| Statistics Used to Compare Patient Groups for Spinal Degeneration Score | P Value of Statistical Comparison for Spinal Degeneration Score | ||
Spine Slip (Listhesis) Angle Measurements
Imaging Method Used to Obtain Slip Angle
| Mean Slip Angle | Standard Deviation of the Mean Slip Angle | Minimum Slip Angle | Maximum Slip Angle |
| Statistics Used to Compare Patient Groups | P Value of Statistical Comparison | ||
Spine Slip (Listhesis) Percentage Measurements
Imaging Method Used to Obtain Slip %
| Mean Slip % | Standard Deviation of the Mean Slip % | Minimum Slip % | Maximum Slip % |
| Statistics Used to Compare Patient Groups | P Value of Statistical Comparison | ||
Patients with Slip (Olisthesis)
| Imaging Method Used to Obtain Olisthesis | Definition of Olisthesis |
| Number of Patients with Olisthesis | Percentage of Patients with Olisthesis |
| Statistics Used to Compare Patient Groups | P Value of Statistical Comparison |
Surgical Outcomes Input Form
Lumbar Spinal Stenosis EPC Project
| Unique ID Number | Patient Group Identification |
| 111111 | 111111-11 |
If these are control group data, make no entries in the Statistics boxes. If this is not control group data, enter the control group ID number for the statistical comparison group in the next box and enter the appropriate statistical data.
These Are Control Group Data
| Control Group ID Number | Number of Patients | ||
| Time in Months Post Treatment When Outcome was Measured (Mean or Set) | Standard Deviation of Mean Time When Outcome was Measured | Minimum Time in Months Post Treatment When Outcome was Measured: | Maximum Time in Months Post Treatment When Outcome was Measured: |
Surgical Outcome Fusion Failure
| Number of Patients with Post Operative Fusion Failure | Percentage of Patients with Failed Fusion | P Value of Statistical Comparison to Control Group Fusion Outcome |
Surgical Outcome Instrumentation Failure
| Number of Patients with Post Operative Instrumentation Failure | Percentage of Patients with Failed Instrumentation | P Value of Statistical Comparison to Control Group Instrumentation Outcome |
Surgical Outcome Spondylolisthesis
| Number of Patients with Spondylolisthesis Progression | Rate or Percentage of Patients with Spondylolisthesis Progression | Extent of Olisthesis in Millimeters. | P Value for Comparison of Spondylolisthesis Progression |
| Description of Grading System for Spondylolisthesis Progression | |||
| Statistical Approach | Statistic Used to Compare Outcome | ||
- Input Form for Trial Information Table
- Input Form for Patient Characteristics Data for Each Disorder/Treatment Arm in a Trial
- Ability to Work Outcomes Input Form
- Back Pain Outcomes Input Form
- Back Pain Relief Outcomes Input Form
- Dependency/Disability Outcomes Input Form
- Global Assessment Outcomes Input Form
- Leg Pain Outcomes Input Form
- Leg Pain Relief Outcomes Input Form
- Mental Status Outcomes Input Form
- Physical Function and Activities of Daily Living Outcomes Input Form
- Quality of Life Outcomes Input Form
- Walking Capacity Outcomes Input Form
- Treatment Complications Input Form
- Spinal Canal Measurement Table Input Form
- Surgical Outcomes Input Form
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