| APPENDIX A |
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| Proposed Amendments to form CDC 54.1 (Malaria Case Surveillance Report) |
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| As a part of the montoring of the new treatment drug for use in the U.S., Artemether/lumefantrine, these questions have been added or updated to comply with the FDA protocol. |
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| ***Changes are in Bold font |
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| Current Form (Field Names) |
Current Value Set |
Proposed Form (Field Names) |
Proposed Value Set |
Justification |
| PART I |
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| NEW FIELD |
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Height |
____ ft. and _____in. |
Added to capture height data if available |
| NEW FIELD |
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Weight |
____lbs/kg (circle units) |
Added to capture weight data if available |
| Therapy for this attack (check all that apply) |
Chloroquine, Tetracycline, Doxycycline, Mefloquine, Exchange transfusion, Unknown, Primaquine, Quinine, Quinidine, Clindamyacin, Atovaquone/proguanil, Artesunate, Other (specify) |
Therapy for this attack (check all that apply) |
Chloroquine, Tetracycline, Doxycycline, Mefloquine, Exchange transfusion, Unknown, Primaquine, Quinine, Quinidine, Clindamyacin, Atovaquone/proguanil, Artesunate, Artemether/lumefantrine, Other (specify) |
Updated value set to capture the drug Artemether/lumefantrine available for treatment |
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| PART II |
NOTE: The expectation for PART II is that CDC staff will be completing this section, therefore the PRA change worksheet will not change (no additional Cost/Burden hours are added). States are allowed to complete section if desired, however are not obligated. |
| NEW FIELD |
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Please list all prescription and over the counter medicines the patient had taken during the 2 weeks before starting their treatment for malaria. |
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| NEW FIELD |
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Please list all prescription and over the counter medicines the patient had taken during the 4 weeks after starting their treatment for malaria. |
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| NEW FIELD |
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Was the medicine for malaria treatment taken as prescribed? |
No, doses missed/Yes, no doses missed/Unknown |
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| NEW FIELD |
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Did all signs or symptoms of malaria resolve without any additional malaria treatment within 7 days after treatment start? |
No/Yes/Unknown |
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| NEW FIELD |
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If yes, did the patient experience a recurrence of signs or symptoms of malaria during the 4 weeks after starting malaria treatment? |
No/Yes/Unknown |
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| NEW FIELD |
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Did the patient experience any adverse events within 4 weeks after receiving the malaria treatment? |
No/Yes/Unknown |
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| NEW FIELD |
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(If Yes): Event description |
Relationship to treatment suspected*/Time to onset since treatment start/Fatal?/Life-threatening?/Other seriousness?** |
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| * Suspected means that a causal relationship between the treatment and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. |
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| ** A serious adverse event is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant (i.e., jeopardizes the patient or may require medical or surgical intervention), or requires inpatient hospitalization or prolongation of existing hospitalization |