Closed nattarnoff closed 9 years ago
I agree with your revisions Greg. Do we know what "Serious Reactions" entails?
I don't. We may need to alter the query as well. Perhaps we pull back top 10 reactions.
I agree.
On Thu, Jun 25, 2015 at 1:31 PM, npage123 notifications@github.com wrote:
I agree with your revisions Greg. Do we know what "Serious Reactions" entails?
As I understand it, "Serious Reactions" are defined as:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious medically important event).
Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.
Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.
Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.
Jona
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Needs a merge back into this branch.
Charting is happening. Opening the PR to discuss how to communicate data - currently thinking:
1) Roll up data to monthly 2) rotate axis 3) Relabel Y axis "Serious Reactions"
Do we have additional data we want to show?
cc @jonadecker @npage123