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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",null,"Height","____ ft. and _____in.  ","Added to capture height data if available"]
["NEW FIELD",null,"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",null,"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",null,"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",null,"Was the medicine for malaria treatment taken as prescribed?"," No, doses missed/Yes, no doses missed/Unknown"]
["NEW FIELD",null,"Did all signs or symptoms of malaria resolve without any additional malaria treatment within 7 days after treatment start?  "," No/Yes/Unknown"]
["NEW FIELD",null,"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",null,"Did the patient experience any adverse events within 4 weeks after receiving the malaria treatment?"," No/Yes/Unknown"]
["NEW FIELD",null,"(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 "]

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