ZODIAC Medical Record Abstraction Form

Form Approved

OMB No.0920-XXXX

Exp. Date xx/xx/20xx

Zika Outcomes and Development in Infants and Children (ZODIAC) Medical Record Abstraction Form These data are considered confidential and will be stored in a secure database at the University of Brasilia.
Please refer to your Standard Operating Procedures #X for abstraction instructions. Completed abstraction forms are to be sent to XXX.
Section 1: Introduction and Demographics
Child Identification Number: ________________________________	Name of Abstractor: _____________________________ Date of Abstraction: ______________________
Child Date of Birth: ____/_____/_____ Child Place of Birth: _________________________ Child Death:  No  Yes, date: _____/_____/____ Cause of Death: _______________________________ Child Sex:  Male  Female  Ambiguous Child Race:  White  Black  Mulatto  Asian  Indigenous  Other, specify ____________________ Child State of Residence:  Paraíba  Ceará
Section 2: Growth
ENTRY 1, SECTION 2 2.1. Date assessed Date: ____/_____/_____ 2.2. Information source  Medical record  Baby book  Other 2.3. Head Circumference ________centimeters 2.4.  Normal  Abnormal (by physician report) 2.5. Microcephaly (head circumference <3%ile)  No  Yes 2.6. Length ________centimeters 2.7. Weight ________ kilograms 2.8. Notes:
ENTRY 2, SECTION 2 2.9. Date assessed Date: ____/_____/_____ 2.10. Information source  Medical record  Baby book  Other 2.11. Head Circumference ________centimeters 2.12.  Normal  Abnormal (by physician report) 2.13. Microcephaly (head circumference <3%ile)  No  Yes 2.14. Length ________centimeters 2.15. Weight ________ kilograms 2.16. Notes:
Section 3: Immunizations
ENTRY 1, SECTION 3 3.1. Hepatitis B (HB)  Yes  No  Unknown 3.2 Information source  Medical record  Baby book  Other 3.3. Dates received Date 1: ____/_____/_____
ENTRY 2, SECTION 3 3.4. Intradermal tuberculosis vaccine (BCGid)  Yes  No  Unknown 3.5 Information source  Medical record  Baby book  Other 3.6. Date received Date 1: ____/_____/_____
ENTRY 3, SECTION 3 3.7. Pentavalent (DTP+HB+Hib)  Yes  No  Unknown 3.8. Information source  Medical record  Baby book  Other 3.9. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____ Date 3: ____/_____/_____ Date 4: ____/_____/_____
ENTRY 4, SECTION 3 3.10. Inactivated injectable polio vaccine (IPV)  Yes  No  Unknown 3.11. Information source  Medical record  Baby book  Other 3.12. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____ Date 3: ____/_____/_____ Date 4: ____/_____/_____
ENTRY 5, SECTION 3 3.13. Pneumococcal conjugate vaccine with 7 serotypes (PnC7V)  Yes  No  Unknown 3.14. Information source  Medical record  Baby book  Other 3.15. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____ Date 3: ____/_____/_____ Date 4: ____/_____/_____
ENTRY 6, SECTION 3 3.16. Rotavirus  Yes  No  Unknown 3.17. Information source  Medical record  Baby book  Other 3.18. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____
ENTRY 7, SECTION 3 3.19. Meningococcal group C (MnCC)  Yes  No  Unknown 3.20. Information source  Medical record  Baby book  Other 3.21. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____ Date 3: ____/_____/_____ Date 4: ____/_____/_____
ENTRY 8, SECTION 3 3.22. Influenza (flu)  Yes  No  Unknown 3.23. Information source  Medical record  Baby book  Other 3.24. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____
ENTRY 9, SECTION 3 3.25. Yellow fever  Yes  No  Unknown 3.26. Information source  Medical record  Baby book  Other 3.27. Dates received Date 1: ____/_____/_____
ENTRY 10, SECTION 3 3.28. Measles, mumps, rubella (MMR)  Yes  No  Unknown 3.29. Information source  Medical record  Baby book  Other 3.30. Dates received Date 1: ____/_____/_____
ENTRY 11, SECTION 3 3.31. Hepatitis A (HAV)  Yes  No  Unknown 3.32. Information source  Medical record  Baby book  Other 3.33. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____
ENTRY 12, SECTION 3 3.34. Varicella  Yes  No  Unknown 3.35. Information source  Medical record  Baby book  Other 3.36. Dates received Date 1: ____/_____/_____ Date 2: ____/_____/_____
Section 4: Imaging and Diagnostics
Section 4-1: Hearing and Vision
4.1. Diagnostic hearing evaluation  Not performed  Performed  Unknown 4.2. If performed, date at time of evaluation Date: ____/_____/_____ 4.3. Information source  Medical record  Baby book  Other 4.4. Method of Evaluation  Otoacoustic emission testing  Automated auditory brainstem response  Auditory brainstem response  Tympanometry  Behavioral audiometry 4.5. Audiologic Results 4.5a. Type  Sensorineural  Conductive  Mixed  Unknown 4.5b. Severity  Slight  Mild  Moderate  Moderately severe  Severe  Profound  Unknown severity 4.5c. Laterality  Bilateral  Unilateral  Laterality unknown
4.6. Vision evaluation  Not Performed  Performed  Unknown 4.7. If performed, date at time of exam Date: ____/_____/_____ 4.8. Information source  Medical record  Baby book  Other 4.9. External exam  Normal  Abnormal  Unknown 4.10. Assessment of fixation and following  Normal  Abnormal  Unknown 4.11. Ocular motility  Normal  Abnormal  Unknown 4.12. Visual fields  Normal  Abnormal  Unknown 4.13. Pupil exam  Normal  Abnormal  Unknown 4.14. Refraction  Normal  Abnormal  Unknown 4.15. Fundus exam (indirect ophthalmoscopy of retina and optic nerve)  Normal  Abnormal  Unknown 4.16. Retcam photographs  Normal  Abnormal  Unknown 4.17. Findings Microphthalmia  Yes  No  Unknown Chorioretinitis  Yes  No  Unknown Macular pallor  Yes  No  Unknown Optic nerve abnormalities  Yes  No  Unknown Neurologic visual impairment  Yes  No  Unknown Delayed visual developmental milestones  Yes  No  Unknown Other retinal abnormalities  Yes  No  Unknown 4.18. Please describe findings below:
Section 4-2: Laboratory Testing
4.19. Zika testing on infant  Not performed on infant  Performed on infant  Unknown 4.20. If performed on infant, date at test Date: ____/_____/_____ 4.21. Information source  Medical record  Baby book  Other 4.22. Specimen type  Cord blood  Peripheral blood  Placenta  Fetal tissue  Cerebrospinal fluid (CSF)  Urine  Other, specify ____________________________ 4.23. Results 4.23a. PCR-RT  Positive  Negative  Inconclusive  Unknown 4.23b. IgM  Positive  Negative  Inconclusive  Unknown 4.23c. IgG  Positive  Negative  Inconclusive  Unknown 4.23d. PRNT  Positive  Negative  Inconclusive  Unknown 4.24. Please describe findings below:
4.25. Zika testing on mother  Not performed on mother  Performed on mother  Unknown 4.26. If performed on mother, date at test Date: ____/_____/_____ 4.27. Information source  Medical record  Baby book  Other 4.28. Specimen type  Maternal serum  Amniotic fluid  Urine  Other, specify ________________________ 4.29. Results: 4.29a. PCR-RT  Positive  Negative  Inconclusive  Unknown 4.29b. IgM  Positive  Negative  Inconclusive  Unknown 4.29c. IgG  Positive  Negative  Inconclusive  Unknown 4.29d. PRNT  Positive  Negative  Inconclusive  Unknown 4.30. Please describe findings below:
4.31. Prenatal infection testing on mother  Not performed on mother  Performed on mother  Unknown 4.32. If performed on mother, date of test Date: ____/_____/_____ Infant’s gestational age: ________ (weeks, days) 4.33. Information source  Medical record  Baby book  Other 4.34. Toxoplasmosis  Positive  Negative  Inconclusive  Unknown 4.35. Cytomegalovirus  Positive  Negative  Inconclusive  Unknown 4.36. Herpes Simplex =  Negative  Positive  Inconclusive  Unknown 4.37. Rubella  Positive  Negative  Inconclusive  Unknown 4.38. HIV  Positive  Negative  Inconclusive  Unknown 4.39. Syphilis  Positive  Negative  Inconclusive  Unknown 4.40. Dengue  Positive  Negative  Inconclusive  Unknown 4.41. Chikungunya  Positive  Negative  Inconclusive  Unknown 4.42. Other blood tests performed on mother (include dates, source and results):
4.43. Prenatal infection testing on infant  Not performed on infant  Performed on infant  Unknown 4.44. If performed on infant, date at test Date: ____/_____/_____ Age: ____________ 4.45. Information source  Medical record  Baby book  Other 4.46. Toxoplasmosis  Positive  Negative  Inconclusive  Unknown 4.47. Cytomegalovirus  Positive  Negative  Inconclusive  Unknown 4.48. Herpes Simplex Virus  Positive  Negative  Inconclusive  Unknown 4.49. Rubella  Positive  Negative  Inconclusive  Unknown 4.50. HIV  Positive  Negative  Inconclusive  Unknown 4.51. Syphilis  Positive  Negative  Inconclusive  Unknown 4.52. Dengue  Positive  Negative  Inconclusive  Unknown 4.53. Chikungunya  Positive  Negative  Inconclusive  Unknown 4.54. Other blood tests performed on infant (include dates, source and results):
Section 4-3: Neurologic Exams
ENTRY 1, SECTION 4-3 4.55. Neurologic exam  Not performed  Performed  Unknown 4.56. If performed, date at time of exam Date: ____/_____/_____ 4.57. Information source  Medical record  Baby book  Other 4.58. Findings: Normal  Yes  No  Unknown Hypertonia - Spasticity  Yes  No  Unknown Hypertonia - Dystonia  Yes  No  Unknown Hyperreflexia  Yes  No  Unknown Irritability  Yes  No  Unknown Tremors  Yes  No  Unknown Swallowing/feeding difficulties  Yes  No  Unknown Seizures  Yes  No  Unknown Posturing  Yes  No  Unknown Persistence of primitive reflexes  Yes  No  Unknown Hypotonia  Yes  No  Unknown Other neurologic abnormalities  Yes  No  Unknown 4.59. Please describe findings below:
ENTRY 2, SECTION 4-3 4.60. Neurologic exam  Not performed  Performed  Unknown 4.61. If performed, date at time of exam Date: ____/_____/_____ 4.62. Information source  Medical record  Baby book  Other 4.63. Findings: Normal  Yes  No  Unknown Hypertonia - Spasticity  Yes  No  Unknown Hypertonia - Dystonia  Yes  No  Unknown Hyperreflexia  Yes  No  Unknown Irritability  Yes  No  Unknown Tremors  Yes  No  Unknown Swallowing/feeding difficulties  Yes  No  Unknown Seizures  Yes  No  Unknown Posturing  Yes  No  Unknown Persistence of primitive reflexes  Yes  No  Unknown Hypotonia  Yes  No  Unknown Other neurologic abnormalities  Yes  No  Unknown 4.64. Please describe findings below:
Section 4-4: Imaging and Diagnostic Studies
ENTRY 1, SECTION 4-4 4.65. Imaging study  Cranial ultrasound  MRI  CT  Not performed 4.66. Date at time of study Date: ____/_____/_____ 4.67. Information source  Medical record  Baby book  Other 4.68. Findings: Encephalocele  Yes  No  Unknown Microcephaly/Micrencephaly  Yes  No  Unknown Intracranial calcification  Yes  No  Unknown Cerebral (brain) atrophy  Yes  No  Unknown Pachygyria  Yes  No  Unknown Lissencephaly  Yes  No  Unknown Abnormality of corpus callosum  Yes  No  Unknown Cerebellar abnormalities  Yes  No  Unknown Porencephaly  Yes  No  Unknown Hydranencephaly  Yes  No  Unknown Ventriculomegaly/Hydrocephaly  Yes  No  Unknown Other abnormalities  Yes  No  Unknown 4.69. Please describe findings below:
ENTRY 2, SECTION 4-4 4.70. Imaging study  Cranial ultrasound  MRI  CT  Not performed 4.71. Date at time of study Date: ____/_____/_____ 4.72. Information source  Medical record  Baby book  Other 4.73. Findings: Encephalocele  Yes  No  Unknown Microcephaly/Micrencephaly  Yes  No  Unknown Intracranial calcification  Yes  No  Unknown Cerebral (brain) atrophy  Yes  No  Unknown Pachygyria  Yes  No  Unknown Lissencephaly  Yes  No  Unknown Abnormality of corpus callosum  Yes  No  Unknown Cerebellar abnormalities  Yes  No  Unknown Porencephaly  Yes  No  Unknown Hydranencephaly  Yes  No  Unknown Ventriculomegaly/Hydrocephaly  Yes  No  Unknown Other abnormalities  Yes  No  Unknown 4.74. Please describe findings below:
ENTRY 3, SECTION 4-4 4.75. Imaging study  Cranial ultrasound  MRI  CT  Not performed 4.76. Date at time of study Date: ____/_____/_____ 4.77. Information source  Medical record  Baby book  Other 4.78. Findings: Encephalocele  Yes  No  Unknown Microcephaly/Micrencephaly  Yes  No  Unknown Intracranial calcification  Yes  No  Unknown Cerebral (brain) atrophy  Yes  No  Unknown Pachygyria  Yes  No  Unknown Lissencephaly  Yes  No  Unknown Abnormality of corpus callosum  Yes  No  Unknown Cerebellar abnormalities  Yes  No  Unknown Porencephaly  Yes  No  Unknown Hydranencephaly  Yes  No  Unknown Ventriculomegaly/Hydrocephaly  Yes  No  Unknown Other abnormalities  Yes  No  Unknown 4.79. Please describe findings below:
4.80. EEG  Not performed  Performed  Unknown 4.81. If performed, date at time of exam Date: ____/_____/_____ 4.82. Information source  Medical record  Baby book  Other 4.83. Findings: Epileptic waveform abnormalities - focal  Yes  No  Unknown Epileptic waveform abnormalities – generalized  Yes  No  Unknown Non-epileptic waveform abnormalities - focal  Yes  No  Unknown Non-epileptic waveform abnormalities – generalized  Yes  No  Unknown 4.84. Please describe findings below:
4.85. Other neurological tests/results/diagnoses (include dates and source of results):
Section 5: Early Intervention Referrals
ENTRY 1 5.1. Referred to early intervention/rehabilitation  Yes  No  Unknown 5.2. If referred, date at time of referral Date: ____/_____/_____ 5.3. Information source  Medical record  Baby book  Other 5.4. Services recommended? Physical therapy  Yes  No  Unknown Occupational therapy  Yes  No  Unknown Speech therapy  Yes  No  Unknown Special Education  Yes  No  Unknown Developmental stimulation  Yes  No  Unknown Family support  Yes  No  Unknown Other, specify __________________________ 5.5. Notes:
ENTRY 2 5.6. Referred to early intervention/rehabilitation  Yes  No  Unknown 5.7. If referred, date at time of referral Date: ____/_____/_____ 5.8. Information source  Medical record  Baby book  Other 5.9. Services recommended? Physical therapy  Yes  No  Unknown Occupational therapy  Yes  No  Unknown Speech therapy  Yes  No  Unknown Special Education  Yes  No  Unknown Developmental stimulation  Yes  No  Unknown Family support  Yes  No  Unknown Other, specify __________________________ 5.10. Notes:
Section 6: Medical Diagnoses
6.1. Diagnoses Gastroesophageal (GE) reflux  Yes  No  Unknown Seizures/epilepsy  Yes  No  Unknown Pneumonia  Yes  No  Unknown Other respiratory illness  Yes  No  Unknown Hydrocephalus requiring shunt  Yes  No  Unknown Feeding difficulties requiring nasogastric tube or gastrostomy tube  Yes  No  Unknown Developmental dysplasia of hips  Yes  No  Unknown List other diagnoses below: _____________________________ _____________________________ _____________________________ _____________________________		6.2. Date diagnosed	6.3. Information Source
			Medical record		Baby book	Other
		____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____ ____/_____/_____	          		          	          
Section 7: Medical Procedures (Including Surgeries)
How many procedures?  0  1  2  3  4  5  6  More than 6
ENTRY 1, SECTION 7 7.1. Type of procedure __________________________________________ 7.2. Date at time of procedure Date: ____/_____/_____ 7.3. Information source  Medical record  Baby book  Other 7.4.  Inpatient  Outpatient 7.5. Please describe below:
ENTRY 2, SECTION 7 7.6. Type of procedure __________________________________________ 7.7. Date at time of procedure Date: ____/_____/_____ 7.8. Information source  Medical record  Baby book  Other 7.9.  Inpatient  Outpatient 7.10. Please describe below:
ENTRY 3, SECTION 7 7.11. Type of procedure __________________________________________ 7.12. Date at time of procedure Date: ____/_____/_____ 7.13. Information source  Medical record  Baby book  Other 7.14.  Inpatient  Outpatient 7.15. Please describe below:
ENTRY 4, SECTION 7 7.16. Type of procedure __________________________________________ 7.17. Date at time of procedure Date: ____/_____/_____ 7.18. Information source  Medical record  Baby book  Other 7.19.  Inpatient  Outpatient 7.20. Please describe below:
ENTRY 5, SECTION 7 7.21. Type of procedure __________________________________________ 7.22. Date at time of procedure Date: ____/_____/_____ 7.23. Information source  Medical record  Baby book  Other 7.24.  Inpatient  Outpatient 7.25. Please describe below:
ENTRY 6, SECTION 7 7.26. Type of procedure __________________________________________ 7.27. Date at time of procedure Date: ____/_____/_____ 7.28. Information source  Medical record  Baby book  Other 7.29.  Inpatient  Outpatient 7.30. Please describe below:
Section 8: Hospitalizations
How many hospitalizations?  0  1  2 3  More than 3
ENTRY 1, SECTION 8 8.1. Reason for hospitalization __________________________________________ 8.2. Date of hospitalization Date: ____/_____/_____ 8.3. Information source  Medical record  Baby book  Other 8.4. Length of hospitalization _________________ (weeks, days) 8.5. Please describe additional pertinent details below:
ENTRY 2, SECTION 8 8.6. Reason for hospitalization __________________________________________ 8.7. Date of hospitalization Date: ____/_____/_____ 8.8. Information source  Medical record  Baby book  Other 8.9. Length of hospitalization _________________ (weeks, days) 8.10. Please describe additional pertinent details below:
ENTRY 3, SECTION 8 8.11. Reason for hospitalization __________________________________________ 8.12. Date of hospitalization Date: ____/_____/_____ 8.13. Information source  Medical record  Baby book  Other 8.14. Length of hospitalization _________________ (weeks, days) 8.15. Please describe additional pertinent details below:
Section 9: Medications
How many medications?  0  1  2  3  4  5  6  7  8  9  10  More than 10
ENTRY 1, SECTION 9 9.1. Name of medication ________________________________ 9.2. Date prescribed Date: ____/_____/_____ 9.3. Information source  Medical record  Baby book  Other 9.4. Dose ________________________ 9.5. Reason prescribed, if clearly noted: _________________________________________________ 9.6. Currently taking?  Yes  No  Unknown
ENTRY 2, SECTION 9 9.7. Name of medication ________________________________ 9.8. Date prescribed Date: ____/_____/_____ 9.9. Information source  Medical record  Baby book  Other 9.10. Dose ________________________ 9.11. Reason prescribed, if clearly noted: _________________________________________________ 9.12. Currently taking?  Yes  No  Unknown
ENTRY 3, SECTION 9 9.13. Name of medication ________________________________ 9.14. Date prescribed Date: ____/_____/_____ 9.15. Information source  Medical record  Baby book  Other 9.16. Dose ________________________ 9.17. Reason prescribed, if clearly noted: _________________________________________________ 9.18. Currently taking?  Yes  No  Unknown
ENTRY 4, SECTION 9 9.19. Name of medication ________________________________ 9.20. Date prescribed Date: ____/_____/_____ 9.21. Information source  Medical record  Baby book  Other 9.22. Dose ________________________ 9.23. Reason prescribed, if clearly noted: _________________________________________________ 9.24. Currently taking?  Yes  No  Unknown
ENTRY 5, SECTION 9 9.25. Name of medication ________________________________ 9.26. Date prescribed Date: ____/_____/_____ 9.27. Information source  Medical record  Baby book  Other 9.28. Dose ________________________ 9.29. Reason prescribed, if clearly noted: _________________________________________________ 9.30. Currently taking?  Yes  No  Unknown
ENTRY 6, SECTION 9 9.31. Name of medication ________________________________ 9.32. Date prescribed Date: ____/_____/_____ 9.33. Information source  Medical record  Baby book  Other, specify __________________________ 9.34. Dose ________________________ 9.35. Reason prescribed: _________________________________________________ 9.36. Currently taking?  Yes  No  Unknown
ENTRY 7, SECTION 9 9.37. Name of medication ________________________________ 9.39. Date prescribed Date: ____/_____/_____ 9.40. Information source  Medical record  Baby book  Other 9.40. Dose ________________________ 9.41. Reason prescribed: _________________________________________________ 9.42. Currently taking?  Yes  No  Unknown
ENTRY 8, SECTION 9 9.43. Name of medication ________________________________ 9.44. Date prescribed Date: ____/_____/_____ 9.45. Information source  Medical record  Baby book  Other 9.46. Dose ________________________ 9.47. Reason prescribed: _________________________________________________ 9.48. Currently taking?  Yes  No  Unknown
ENTRY 9, SECTION 9 9.49. Name of medication ________________________________ 9.50. Date prescribed Date: ____/_____/_____ 9.51. Information source  Medical record  Baby book  Other 9.52. Dose ________________________ 9.53. Reason prescribed: _________________________________________________ 9.54. Currently taking?  Yes  No  Unknown
ENTRY 10, SECTION 9 9.55. Name of medication ________________________________ 9.56. Date prescribed Date: ____/_____/_____ 9.57. Information source  Medical record  Baby book  Other 9.58. Dose ________________________ 9.59. Reason prescribed: _________________________________________________ 9.60. Currently taking?  Yes  No  Unknown
Section 10: Additional Notes
NOTES				SOURCE
END OF FORM