Clinical Data Validation Procedure🔗
Validation procedures for Electronic Health Records (EHR) data are performed as follows:
- Load EHR data from the site into the Landing Zone within the Secure Computing Environment
- Run a script to validate that the Landing Zone data was loaded correctly that checks for the following issues and coordinate with the site to correct these issues:
- Dates only sent when expecting date / time
- Time only sent when expecting date / time
- Date / time format was unknown to import script so it was imported as a varchar (requires changes to import script)
- Headers not sent so the column names are based on the first row of the data
- Rows are all NULL values because the file had rows with no data
- Run the Landing Zone to OMOP mapping scripts for each site
- Correct any known site-specific issues that can be automatically corrected in the scripts
- Let the site know of any issues with their data preventing mapping of their data
- Move data that passes QA into the central HBCD Clinical Data Repository (versioned for each year)
- Generate two reports back to each site
[1] EHR data received by participant study ID
[2] Summary Table 1 for the site
| Characteristic | Total |
|---|---|
| N | 870 |
| Demographics | |
| Mean age (± SD) | 31.69 (5.69) |
| Sex|FEMALE | 870 (100.0) |
| Sex|MALE | 0 (0.0) |
| Sex|No matching concept | 0 (0.0) |
| Race|American Indian or Alaska Native | 10 (1.1) |
| Race|Asian | 39 (4.5) |
| Race|Black or African American | 197 (22.6) |
| Race|Native Hawaiian or Other Pacific Islander | < 10 |
| Race|No matching concept | 105 (12.1) |
| Race|White | 517 (59.4) |
| Ethnicity|Hispanic or Latino | 122 (14.0) |
| Ethnicity|Not Hispanic or Latino | 748 (86.0) |
| Ethnicity|No Matching Concept | 0 (0.0) |
| Conditions | |
| Major depression, single episode | < 10 |
| Second trimester pregnancy | 127 (14.6) |
| Third trimester pregnancy | 117 (13.4) |
| First trimester pregnancy | 88 (10.1) |
| Disorder of pregnancy | 87 (10.0) |
| Complication occurring during pregnancy | 66 (7.6) |
| Anxiety disorder | 66 (7.6) |
| Depressive disorder | 64 (7.4) |
| Fetal condition affecting obstetrical care of mother | 52 (6.0) |
| Gestation period, 36 weeks | 50 (5.7) |
| Anemia of pregnancy | 47 (5.4) |
| Mental disorders during pregnancy, childbirth and the puerperium | 46 (5.3) |
| Finding related to pregnancy | 34 (3.9) |
| Uncomplicated asthma | 28 (3.2) |
| Disease of the respiratory system complicating pregnancy, childbirth and/or the puerperium | 28 (3.2) |
| Poor fetal growth affecting management | 27 (3.1) |
| Maternal obesity complicating pregnancy, childbirth and the puerperium, antepartum | 24 (2.8) |
| Generalized anxiety disorder | 18 (2.1) |
| Posttraumatic stress disorder | 14 (1.6) |
| High risk pregnancy | 11 (1.3) |
| Lab Results | |
| Body temperature (degree Celsius) | 36.69 (0.18) |
| Systolic blood pressure (millimeter mercury column) | 119.48 (9.42) |
| Diastolic blood pressure (millimeter mercury column) | 72.49 (5.62) |
| Heart rate (counts per minute) | 91.58 (8.91) |
| No matching concept (nanogram per milliliter) | 358.33 (1243.37) |
| Pain severity - 0-10 verbal numeric rating [Score] - Reported | 1.77 (1.01) |
| Hematocrit [Volume Fraction] of Blood by Automated count (percent) | 34.81 (3.19) |
| MCV [Entitic volume] by Automated count (femtoliter) | 88.14 (6.84) |
| MCH [Entitic mass] by Automated count (picogram) | 29.53 (2.52) |
| Erythrocyte distribution width [Ratio] by Automated count (percent) | 13.65 (1.58) |
| Respiratory rate (counts per minute) | 17.35 (0.54) |
| Platelet mean volume [Entitic volume] in Blood by Automated count (femtoliter) | 10.52 (1.09) |
| Body temperature (degree Fahrenheit) | 97.87 (0.26) |
| Erythrocyte distribution width [Entitic volume] by Automated count (femtoliter) | 43.61 (8.49) |
| No matching concept (milligram per deciliter) | 98.85 (122.08) |
| Hemoglobin [Mass/volume] in Blood (gram per deciliter) | 11.64 (1.14) |
| Oxygen saturation in Arterial blood by Pulse oximetry (percent) | 97.99 (1.05) |
| Body weight (kilogram) | 83.74 (25.21) |
| Body height (centimeter) | 163.48 (6.62) |
| Procedures | |
| Ultrasound scan for fetal growth | < 10 |
| Antenatal screening | 12 (1.4) |
| Monitoring of Products of Conception, Cardiac Rate, External Approach | 10 (1.1) |
| Fetal biophysical profile | < 10 |
| Ultrasonography for antepartum monitoring of fetus | < 10 |
| Ultrasound scan - obstetric | < 10 |
| Ultrasound scan for fetal nuchal translucency | < 10 |
| Ultrasonography in first trimester | < 10 |
| Delivery of Products of Conception, External Approach | < 10 |
| Ultrasonography of Third Trimester, Single Fetus | < 10 |
| X-ray of chest anteroposterior view | < 10 |
| Extraction of Products of Conception, Low, Open Approach | < 10 |
| Drainage of Amniotic Fluid, Therapeutic from Products of Conception, Via Natural or Artificial Opening | < 10 |
| Ultrasonography of Second Trimester, Single Fetus | < 10 |
| Diagnostic radiography of chest, combined PA and lateral | < 10 |
| Counseling | < 10 |
| Ultrasonography of cervix uteri | < 10 |
| Insertion of Other Device into Products of Conception, Via Natural or Artificial Opening | < 10 |
| Repair Perineum Muscle, Open Approach | < 10 |
| Medications | |
| sodium chloride | 142 (16.3) |
| ibuprofen | 132 (15.2) |
| potassium chloride | 125 (14.4) |
| calcium chloride | 124 (14.3) |
| lactate | 124 (14.3) |
| acetaminophen | 85 (9.8) |
| ondansetron | 79 (9.1) |
| sennosides, USP | 63 (7.2) |
| oxycodone | 62 (7.1) |
| folic acid | 60 (6.9) |
| docusate | 57 (6.6) |
| ketorolac | 54 (6.2) |
| glucose | 53 (6.1) |
| oxytocin | 47 (5.4) |
| famotidine | 45 (5.2) |
| simethicone | 43 (4.9) |
| gabapentin | 25 (2.9) |
| buprenorphine | 11 (1.3) |