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effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-e-surv-report-2-acute-pain.xlsx
September 20, 2022 - B
Any adverse event: 13.6% (11/81) vs. 18.6% (16/86) NR NR Fair
Abbreviations: CI = confidence interval … B
Any adverse event: 10.0% (6/60) vs. 18.6% (11/59), RR 0.54 (95% CI 0.21 to 1.36)
Nausea: 0.8% (1/60 … B
Any adverse event: 34% (26/76) vs. 9% (7/74), RR 3.62 (95% CI 1.67 to 7.82)
Dizziness: 7.9% (6/76) … B
Any adverse event: 11.6% (8/69) vs. 13.2% (9/68), p=0.57 NR Institutional grant Fair
Frants, 2021 … B
Any adverse event: 52.7% (15/46) vs. 8.8% (3/34), p=0.002
Any severe adverse event: 16.7% (6/36) vs
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effectivehealthcare.ahrq.gov/sites/default/files/exposure-definition-and-measurement_chapter-4.pptx
January 01, 2013 - In panel E, the exposure is a single event in time with an immediate effect that diminishes over time … exposed to the medication of interest if they had a single dose of the medication the day before the event … , as this would not have contributed to any risk reduction for the event. … reliably identify exposure to the procedure, but using only one may be insufficient to identify the event … there is a threshold effect and to explore a dose-response relationship between the exposure and the event
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effectivehealthcare.ahrq.gov/products/safety-vaccines/protocol
April 06, 2020 - The current CTCAE system (version 5) differentiates 837 adverse events within 26 adverse event domains … and grade 5 being death due to the event. … We will use the McHarm scale, a tool for structured critical appraisal of adverse event data reported … assessment (e.g., use of a scale or checklist) and whether adverse event data were collected actively … , i.e., to determine whether a specific adverse event is associated with a vaccine.
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effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/white-paper-lumbar-spondylolisthesis.pdf
March 01, 2021 - Of note, a directly asserted association
between adverse event and medical intervention may not be present … started on an oral hypoglycemic, one can infer that the
hypoglycemia is a medication-related adverse event … requiring a new hospitalization
• Myocardial infarction requiring a new hospitalization
• Any other event … OUTCOME
MEASURE DEFINITION
Post-treatment adverse events, defined as any treatment-related adverse event … intervention)
within 30 days of treatment
Use of opioids 30 days post-treatment is considered an adverse event
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/white-paper-lumbar-spondylolisthesis.pdf
March 01, 2021 - Of note, a directly asserted association
between adverse event and medical intervention may not be present … started on an oral hypoglycemic, one can infer that the
hypoglycemia is a medication-related adverse event … requiring a new hospitalization
• Myocardial infarction requiring a new hospitalization
• Any other event … OUTCOME
MEASURE DEFINITION
Post-treatment adverse events, defined as any treatment-related adverse event … intervention)
within 30 days of treatment
Use of opioids 30 days post-treatment is considered an adverse event
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/COVID-19-pharmaceutical-treatments.pdf
December 23, 2023 - Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) severity
category3
CTCAE event … instrument4: whether reporting was passive (i.e., outpatients contacted researchers if they
experienced an event … pre-determined list of events); whether the authors report the proportion of patients
experiencing each event … provide a statement of certainty on the association of each countermeasure with
each serious adverse event
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/antipsychotics-children_research-protocol.pdf
June 04, 2010 - Each event will be counted as if it represents a unique individual. … number of people
having an adverse event. … If a study mentions an adverse event in the discussion but does not
report data on that adverse event … We will not
assume an adverse event occurred unless a specific number of events are reported. … a dose-adverse
event analysis.
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/safety-vaccines-protocol.pdf
January 30, 2020 - and grade 5 being death due to the event. … The synthesis will report
how many studies have assessed an adverse event to answer KQ1a, KQ2a, and … We
will document how many times the event occurred in the study samples to address KQ1b,
KQ2b, and … KQ3b, i.e., to determine whether a specific adverse event is associated with a
vaccine. … Common Terminology Criteria for Adverse Events classification system (CTCAE) adverse event domains
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-263-postpartum-hypertensive-pregnancy-executive-summary.pdf
May 01, 2023 - Both successful
control of hypertension and effect on clinical event outcomes are important outcomes … )
No conclusions (rare event) for
patients without prior seizure
✓
No evidence of a difference … with prior
eclamptic seizure
Seizure
(preeclampsia with
severe features)
No conclusions (rare event … ) No conclusions (rare event)
Recurrent seizure
(eclampsia)
✓ ✓
Loading dose only MgSO4
regimens … yields shorter time to
start breastfeeding
No evidence
Infant morbidity No conclusions (rare event
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/risk-cardiovascular-disease-appendix-a.pdf
August 31, 2023 - arteriovenous or artery or arteries or arterial or vein or vein or veins or cerebrovascular) adj3
("adverse event … disturbance* or infection* or inflammation* or lesion* or
malformation* or symptom* or syndrome* or event
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/vaccine-safety_research-protocol.pdf
September 18, 2012 - of safety,9 including postlicensure
safety surveillance conducted by the FDA,10 the Vaccine Adverse Event … This report evaluated the scientific evidence for event-vaccine
relationships and covered many vaccines … Internet-based reporting to the vaccine adverse event
reporting system: a more timely and complete way … Tdap = Tetanus, diphtheria, and acellular pertussis
VAERS = Vaccine Adverse Event Reporting System … Adverse events of interest, included in electronic search terms
Adverse event Vaccine type
Acute
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/acute-pain-ems-protocol-amendment.pdf
January 28, 2019 - depression, hypotension, nausea,
vomiting, mental status changes, emergence delirium, any adverse event … (as in any subject that experienced an adverse event during the study
period)
• KQ2c:
o Needle … The original full publication will always be used as the primary data
source in the event discrepant … for
rare event outcome: a simulation study. … (as in any subject
that experienced an
adverse event during
the study period).
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effectivehealthcare.ahrq.gov/sites/default/files/methodsguide_chou_assessing_harms_when_comparing.pdf
November 01, 2008 - when a
significant proportion of published trials fail to report an important or critical adverse event … Serious adverse event Any adverse event with serious medical consequences, including death, hospital … Severe adverse event An adverse event whose intensity is considered severe (including “nonserious” adverse … Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
15. … and adverse event appearing at an appropriate
time interval after exposure)
Lack of alternative
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-harms_methods.pdf
November 01, 2008 - when a
significant proportion of published trials fail to report an important or critical adverse event … Serious adverse event Any adverse event with serious medical consequences, including death, hospital … Severe adverse event An adverse event whose intensity is considered severe (including “nonserious” adverse … Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
15. … and adverse event appearing at an appropriate
time interval after exposure)
Lack of alternative
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/plant-based-chronic-pain-appendix-f5.xlsx
January 12, 2021 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. … B
% (n/N)
Any adverse event: 88.4% (190/215) vs. 85.2% (184/216)
Serious adverse events: 13% (28/215)
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/plant-based-chronic-pain-review-q2-tables-f5.xlsx
March 15, 2021 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. … B
% (n/N)
Any adverse event: 88.4% (190/215) vs. 85.2% (184/216)
Serious adverse events: 13% (28/215)
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/radiation-therapy-brain-metases-protocol.pdf
October 10, 2019 - The broader
inclusion criteria for adverse event data take into account that rare adverse events are … Any specific adverse event most often assessed
4. Radiation necrosis
5. Fatigue
6. Seizure
7. … Disease-free survival (time to event, hazard ratio)
6. … What is a Serious Adverse Event? … https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/cannabis-annual-update2-table-e1.xlsx
March 13, 2023 - Adverse Event Intervention B, N of Any Adverse Event (Numerator) Intervention B, N Analyzed for Any … Event (Numberator Intervention C, N Analyzed for Any Adverse Event (Denominator) Intervention C, % … With Any Adverse Event Intervention D, N of Any Adverse Event (Numberator Intervention D, N Analyzed … A, % With Serious Adverse Event Intervention B, N of Serious Adverse Event (Numerator) Intervention … ) Intervention C, % With Serious Adverse Event Intervention D, N of Serious Adverse Event (Numerator)
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cannabis-2022-surv-rep-3-tables-F1-4.xlsx
January 01, 2022 - Adverse Event Intervention B, N of Any Adverse Event (Numerator) Intervention B, N Analyzed for Any … Event (Numerator) Intervention A, N Analyzed for Serious Adverse Event (Denominator) Intervention A, … % With Serious Adverse Event Intervention B, N of Serious Adverse Event (Numerator) Intervention B, … ) Intervention C, % With Serious Adverse Event Intervention D, N of Serious Adverse Event (Numerator) … to Adverse Event (Denominator) Intervention C, % With Withdrawals Due to Adverse Event Intervention D
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effectivehealthcare.ahrq.gov/products/trauma-child-interventions/research-protocol
March 26, 2012 - an anxiety disorder that can be diagnosed in children at least 1 month after exposure to a traumatic event … by having frequent memories of it (or in young children, reenacting the event through play), having … and frightening dreams, or developing repeated physical or emotional symptoms when reminded of the event … To establish the diagnosis, a clinician needs to establish that a traumatic event preceded onset of the … Although acute stress disorder (ASD) can be diagnosed in children immediately after the traumatic event