Chart Abstraction for the Investigation of GBS in relati

Form Approved

OMB No. 0920-XXXX

Exp. Date XX/XX/2016

Chart Abstraction Questionnaire for the Investigation of Guillain-Barré Syndrome in Relation to Arboviral Infections

Study ID Number PR- ____ ____ - ____ □ Case □ Control

The ID number begins with the 2 digit case number (for example PR01) followed by an “A” for the case patient, a “B” for the first control, a “C” for the second control, and a”D” for the third control. For example, the second control subject matched for case number 8 would be labeled “PR-08-C.”

The following pages are to be abstracted from the medical records / exam for cases and applicable controls:

Chart Abstractor: ____________________________ Abstraction Date: __ __ /__ __ /________

DD MM YYYY

1. a. For both, in the 2 months prior to __ __ /__ __ /____ (neuro onset date for case), did the individual seek care at a doctor/hospital at all with an acute illness (for cases, other than their neuro illness)? □ Yes □No □ Unknown

b. If so, when did they report first feeling sick? __ __ /__ __ /____

c. If so, what symptoms did they report having or what signs were noticed (check all that apply)?

□ Fevers □ Chills □ Nausea or Vomiting □ Diarrhea □ Muscle pains □ Joint pains □ Skin rash □ Abnormally red eyes

□ Headache □ Pain behind eyes □ Stiff neck □ Confusion

□ Abdominal pain □ Coughing □ Runny nose □ Sore throat □ Calf pain

d. If any blood was taken for this acute illness, please fill out the following for the INITIAL blood draw :

Date __ __ /__ __ /_____ WBC ____ HgB____ Plts _____ Na ____ K____

BUN ____ Cr ______ Glucose____ TBili____ AST ____ ALT____ AlkPhos ___

e. If so, were they hospitalized for this acute illness? □ Yes □ No □ Unknown

f. If so, did they receive any blood products / IVIG for this illness? □ Yes □ No □ Unknown

What product? _____________________ Date? __ __ /__ __ /________

g. If so, did they receive plasmapheresis / plasma exchange for this illness? □ Yes □ No □ Unknown

If yes, date? __ __ /__ __ /________

2. a. For both, was this patient tested for dengue at the time of acute illness? □ Yes □ No □ Unknown

b. If so, what was the date of the specimen collection? __ __ /__ __ /________

c. If so, which specimen(s) was/were collected: □ Serum □Blood □CSF

(If >1 specimen collected on individual, write in margin type of specimen, date collected, and result.)

d. If so, check the test(s) done and circle result (check all that apply)?

□ PCR Pos Neg Unknown

□ NS1 Pos Neg Unknown

□ IgM Pos Neg Unknown

□ IgG Pos Neg Unknown

3. a. For both, was this patient tested for chikungunya at the time of acute illness?

□ Yes □ No □ Unknown

b. If so, what was the date of the specimen collection? __ __ /__ __ /________

c. If so, which specimen was collected □ Serum □Blood □CSF

(If >1 specimen collected on individual, write in margin type of specimen, date collected, and result.)

d. If so, check the test(s) done and circle result (check all that apply)?

□ PCR Pos Neg Unknown

□ IgM Pos Neg Unknown

□ IgG Pos Neg Unknown

4. a. For both, was this patient tested for Zika virus at the time of acute illness?

□ Yes □ No □ Unknown

b. If so, what was the date of the specimen collection? __ __ /__ __ /________

c. If so, which specimen was collected: □ Serum □ Blood □ CSF □ Urine

(If >1 specimen collected on individual, write in margin type of specimen, date collected, and result.)

d. If so, check the test(s) done and circle result (check all that apply)?

□ PCR Pos Neg Unknown

□ IgM Pos Neg Unknown

□ IgG Pos Neg Unknown

5. a. For both, was this patient tested for leptospirosis at the time of acute illness? □ Yes □ No □ Unknown

b. If so, what was the date of the specimen collection? __ __ /__ __ /________

c. If so, which specimen was collected □ Serum □ Blood □ CSF

(If >1 specimen collected on individual, write in margin type of specimen, date collected, and result.)

d. If so, which test? ______________________________

e. If so, what was the result? ______________________________

6. For both, are there any already available leftover specimens related to the above acute illness?

a. Serum □ Yes □ No Collection Date __ __ /__ __ /________

b. Whole Blood □ Yes □ No Collection Date __ __ /__ __ /________

c. CSF □ Yes □ No Collection Date __ __ /__ __ /________

d. Urine □ Yes □ No Collection Date __ __ /__ __ /________

7. For cases, what was the date of neuro onset for the case? (neuro symptoms, not preceding acute febrile illness or diarrhea)

__ __ /__ __ /______

8. For cases, what neurologic symptoms occurred on the DAY OF ONSET (check all that apply)?

□ Leg weakness □ Arm weakness □ Face weakness □ Diplopia/Opthalmoplegia

□ Leg numbness/parasthesias □ Arm numbness/parasthesias □ Face numbness/parasthesias

□ SOB / respiratory distress □ Gait imbalance (not weakness) □ Hand clumsiness (not weakness)

9. For cases, what neurologic symptoms occurred AT ANY TIME during the neuro illness (check all that apply)?

□ Leg weakness □ Arm weakness □ Face weakness □ Diplopia/Ophthalmoplegia

□ Leg numbness/parasthesias □ Arm numbness/parasthesias □ Face numbness/parasthesias

□ SOB / respiratory distress □ Gait imbalance (not weakness) □ Hand clumsiness (not weakness)

10. For cases, how long from onset until maximum/worst neuro symptoms? ____________ minutes/hours/days/weeks

11. For cases, at their worst during this neuro illness, was the patient (check all that apply)?

□ Unable to walk without assistance (e.g. cane, walker) □ Unable to walk at all

□ Admitted to the hospital □ Admitted to the ICU/CCU □ Intubated

12. Hughes Disability Score at time of evaluation: (Date recorded ___/_____/ _________)

Hughes Disability Score: : F-score (0 to 6) Unknown

[0 = Complete recovery; no sequelae, 1 = Minor symptoms and capable of running, 2 = Able to walk 10 metres or more without assistance but unable to run, 3 = Able to walk 10 metres with help, 4 = Bedridden or chairbound (unable to walk 10 meters with help), 5 = Requiring assisted ventilation for at least part of the day, 6 = Dead]

13. If any blood was taken for this neurologic illness, please fill out the following for the INITIAL blood draw :

Date __ __ /__ __ /2015 WBC ____ HgB____ Plts _____ Na ____ K____

BUN ____ Cr ______ Glucose____ TBili____ AST ____ ALT____ AlkPhos ___

14. For cases, was a lumbar puncture (LP) done? □ Yes □ No □ Unknown

LP date ___/____/____ RBCS _______ WBCS ______ Protein (mg/dL)______ Glucose (mg/dL) _______

LP date ___/____/____ RBCS _______ WBCS ______ Protein (mg/dL)______ Glucose (mg/dL) _______

15. For cases, was there documented hyporeflexia/areflexia in the chart or by neurologists? □ Yes □ No □ Unknown

16. For cases, were any upper motor neuron signs found in the chart or by neurologists? □ Yes □ No □ Unknown

If yes, specify: __________________________________________________

17. For cases, are there any already available leftover specimens related to the above neuro illness?

a. Serum □ Yes □ No Collection Date __ __ /__ __ /________

b. Whole Blood □ Yes □ No Collection Date __ __ /__ __ /________

c. CSF □ Yes □ No Collection Date __ __ /__ __ /________

d. Urine □ Yes □ No Collection Date __ __ /__ __ /________

18. For cases, did they receive any blood products / IVIG for this neuro illness? □ Yes □ No □ Unknown

What product? _____________________ Date? __ __ /__ __ /________

19. For cases, were any of the following diseases tested for? If so, what was the result (including specimen and type of test)?

a. Campylobacter jejuni □ Yes □ No Result:___________________________

b. Mycoplasma pneumoniae □ Yes □ No Result:___________________________

c. Haemophilus influenza □ Yes □ No Result:___________________________

d. Salmonella species □ Yes □ No Result:___________________________

e. Cytomegalovirus (CMV) □ Yes □ No Result:___________________________

f. Epstein-Barr virus (EBV) □ Yes □ No Result:___________________________

g. Varicella-zoster virus (VZV) □ Yes □ No Result:___________________________

h. Human immunodeficiency virus (HIV) □ Yes □ No Result:___________________________

i. Enterovirus / Rhinovirus □ Yes □ No Result:___________________________

20. For cases, was neuro imaging done? If so, what was the result?

□ Yes □ No Result:_______________________________________________________________________

__________________________________________ Date __ __ /__ __ /________

21. For cases, were electro-diagnostics done (e.g. EMG)? If so, what were the results?

□ Yes □ No Result:_______________________________________________________________________

___________________________________________ Date __ __ /__ __ /________

22. For cases, what was the GBS Brighton level? 1 2 3 4 5

Levels of Diagnostic Certainty

Level 1	Level 2	Level 3	Level 4*	Level 5
Absence of an alternative diagnosis for weakness				NOT a case
Acute onset of bilateral and relatively symmetric flaccid weakness of the limbs			* Lacking documentation to fulfill minimal case criteria
Decreased or absent deep tendon reflexes in affected limbs
Monophasic illness pattern with weakness nadir between 12 hours and 28 days, followed by clinical plateau
Albuminocytologic dissociation (elevation of CSF protein level above laboratory normal value and CSF total white cell count < 50 cells/mm3)	CSF with a total white cell count < 50 cells/mm3 (with or without CSF protein elevation above laboratory normal value) or if CSF not collected or results not available, and electrodiagnostic studies consistent with GBS
Electrophysiologic findings consistent with GBS

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