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Malaria Changes
ICR 201003-0920-010 · OMB 0920-0009 · Object 16615201.
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| APPENDIX A | ||||
| Proposed Amendments to form CDC 54.1 (Malaria Case Surveillance Report) | ||||
| 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. | ||||
| ***Changes are in Bold font | ||||
| Current Form (Field Names) | Current Value Set | Proposed Form (Field Names) | Proposed Value Set | Justification |
| PART I | ||||
| NEW FIELD | Height | ____ ft. and _____in. | Added to capture height data if available | |
| NEW FIELD | 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 |
| 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 | Please list all prescription and over the counter medicines the patient had taken during the 2 weeks before starting their treatment for malaria. | |||
| NEW FIELD | Please list all prescription and over the counter medicines the patient had taken during the 4 weeks after starting their treatment for malaria. | |||
| NEW FIELD | Was the medicine for malaria treatment taken as prescribed? | No, doses missed/Yes, no doses missed/Unknown | ||
| NEW FIELD | Did all signs or symptoms of malaria resolve without any additional malaria treatment within 7 days after treatment start? | No/Yes/Unknown | ||
| NEW FIELD | 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 | ||
| NEW FIELD | Did the patient experience any adverse events within 4 weeks after receiving the malaria treatment? | No/Yes/Unknown | ||
| NEW FIELD | (If Yes): Event description | Relationship to treatment suspected*/Time to onset since treatment start/Fatal?/Life-threatening?/Other seriousness?** | ||
| * 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. | ||||
| ** 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 | ||||
| File Type | application/vnd.ms-excel |
| File Title | Malaria Changes |
| Author | skm5 |
| Last Modified By | cww6 |
| File Modified | 2010-02-24 |
| File Created | 2008-07-17 |