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effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/prioritization-selection-of-harms.pdf
February 01, 2018 - adverse
event,” or “any serious adverse event”; rather, the reports generally focused on specific adverse … MedWatch: The FDA Safety
Information and Adverse Event Reporting
Program. … What is a Serious
Adverse Event? 2016. … 4) Are there general (non-specific) harms (e.g., any adverse event, any serious adverse event,
withdrawal … Are there general (non-specific) harms (e.g., any adverse event, any serious adverse event,
withdrawal
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effectivehealthcare-admin.ahrq.gov/sites/default/files/product/pdf/dot-plots-methods.pdf
October 01, 2021 - plot for dichotomous outcomes, statins versus placebo or no statin
Abbreviations: AE = adverse event … Liver Enzyme
Abnormalities 11 200 22833 179 22103 1.10 0.90 1.35 0 High
Abbreviations: AE = adverse event … 2.37 2.99 0 High
Pruritus 30 710 7199 99 4255 3.51 2.47 5.16 0.5 High
Abbreviations: AE = adverse event … Advantages
of visualisations to evaluate and
communicate adverse event information in
randomised … Advantages
of visualisations to evaluate and
communicate adverse event information in
randomised controlled
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effectivehealthcare-admin.ahrq.gov/products/radiation-brain-metastases/protocol
June 01, 2021 - The broader inclusion criteria for adverse event data take into account that rare adverse events are … All analyses will consider the number of studies that assessed an adverse event and the observed events … Where studies report events for one arm, we will assume that no event occurred in the other study arm … The adverse event assessment will specifically include larger observational studies and not limit the … What is a Serious Adverse Event? Accessed on October 10, 2019.
IntHout J, Ioannidis JP, Borm GF.
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effectivehealthcare-admin.ahrq.gov/sites/default/files/delilberative-methods-design-abelson.pdf
January 11, 2017 - needs to be communicated clearly and often:
o recruitment stage
o beginning of first deliberation event
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/gestational-diabetes-screening-diagnosis_research-protocol.pdf
December 16, 2011 - with an adverse
event. … We will count each event as if it corresponded to a unique individual. … assumption may overestimate the number of patients that experience an adverse event. … If no event is reported in one treatment arm, a correction
factor of 0.5 will be added to each cell … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
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effectivehealthcare-admin.ahrq.gov/products/schizophrenia-adult/research-2017
February 01, 2018 - illness symptoms, negative symptoms, symptom response, and remission but greater incidence of adverse event … Older SGAs were similar to haloperidol on benefit outcomes but had fewer adverse event outcomes.
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effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cer-250-cannabis-2024-surv-rep-update-tables-e1-4.xlsx
January 01, 2024 - Adverse Event Intervention B, N of Any Adverse Event (Numerator) Intervention B, N Analyzed for Any … Event (Numerator) Intervention C, N Analyzed for Any Adverse Event (Denominator) Intervention C, % … With Any Adverse Event Intervention D, N of Any Adverse Event (Numerator) 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)
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effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/fatty-acids-cardiovascular-disease_executive.pdf
August 01, 2016 - Clinical Event Outcomes, RCTs
No RCTs reported clinical event outcomes for comparisons
of total n-3 … Clinical Event Outcomes, RCTs
Regarding clinical event outcomes, 19 trials in populations
at increased … Clinical Event Outcomes, RCTs
Regarding clinical event outcomes, one trial in an at
risk population … Clinical Event Outcomes, RCTs
No trial that reported clinical event outcomes evaluated
DHA alone. … Clinical Event Outcomes, RCTs
No trial that reported clinical event outcomes compared
marine oil FA
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effectivehealthcare-admin.ahrq.gov/sites/default/files/cf_deliberativemethodswebinar_desigingdeliberativeforum.pdf
May 18, 2012 - needs to be communicated
clearly and often:
– recruitment stage
– beginning of first deliberation event
-
effectivehealthcare-admin.ahrq.gov/products/high-cholestorol-medicines-update/research-protocol
December 01, 2019 - adherence as defined by the study investigator
SAEs as defined by the study investigator (e.g., an event … ; withdrawal due to an adverse event; cancer; serum aspartate transaminase and/or alanine aminotransferase … ; withdrawal due to an adverse event; cancer; serum AST and/or serum ALT elevated ≥3 times the ULN and … For sparse-data meta-analysis, we will employ the Peto odds ratio method when event rates are less than … When between-event rates are between 5 to 10 percent, substantial differences between the N of two arms
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effectivehealthcare-admin.ahrq.gov/products/depression-harms/research-protocol
May 01, 2019 - and between pharmacologic classes; thus the recommendation is to choose a medication based on adverse event … Outcomes:
We are interested in the following adverse effects for KQ1 and KQ2:
Any adverse event, … The original full publication will always be used as the primary data source in the event discrepant … Impact of including or excluding both-armed zero-event studies on using standard meta-analysis methods … for rare event outcome: a simulation study.
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effectivehealthcare-admin.ahrq.gov/products/vaccine-safety/research-protocol
December 01, 2020 - 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
-
effectivehealthcare-admin.ahrq.gov/products/thromboembolism-update/research-2017
January 01, 2021 - In THR, LMWH has lower VTE and adverse event risks than unfractionated heparin; LMWH and aspirin have … In THR, LMWH has lower VTE and adverse event risks than UFH, LMWH and aspirin have similar risks of VTE
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effectivehealthcare-admin.ahrq.gov/products/saturated-fat-replacement/protocol
November 01, 2024 - and low density lipoprotein cholesterol (LDL-c) concentration, and between LDL-c concentration and CV event … specificity and evidence-based guidance to optimize plasma lipoprotein profiles, with the goal of lowering CV event … prospectively We will aim for a minimum of about 10 observational studies for each specific intervention - CV event … acids and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223), we included: for cardiac event
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effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/plant-based-treatments-draft-report-2025-rct-table-app-e.xlsx
January 01, 2025 - Adverse Event Intervention B, N of Any Adverse Event (Numerator) Intervention B, N Analyzed for Any … Event (Numerator) Intervention C, N Analyzed for Any Adverse Event (Denominator) Intervention C, % … With Any Adverse Event Intervention D, N of Any Adverse Event (Numerator) 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)
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effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cannabis-2022-surv-rep-3-table-F5.xlsx
January 01, 2022 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. NR, RR for A vs. … B
Total patients reporting treatment related adverse event: 21.1% (71/337) vs. 35.0% (118/337), RR 0.60 … B
% (n/N)
Any adverse event: 88.4% (190/215) vs. 85.2% (184/216), RR 1.02 (95% CI 0.88 to 1.18)
Serious … SF-36 = short form 36 question survey; THC = tetrahydrocannabinol; TRAE = treatment related adverse event
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effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cannabis-2022-update-surv-rep-1-app-F-5.xlsx
January 01, 2022 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. NR, RR for A vs. … B
Total patients reporting treatment related adverse event: 21.1% (71/337) vs. 35.0% (118/337), RR 0.60 … B
% (n/N)
Any adverse event: 88.4% (190/215) vs. 85.2% (184/216), RR 1.02 (95% CI 0.88 to 1.18)
Serious … SF-36 = short form 36 question survey; THC = tetrahydrocannabinol; TRAE = treatment related adverse event
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cer-250-cannabis-evidence-summary-2022-update_0.pdf
January 01, 2022 - • Other key adverse event outcomes (psychosis, cannabis use disorder, cognitive
deficits) and outcomes … ) Insufficient (1)
Abbreviations: CBD = cannabidiol; CBDV = cannabidivarin; SAE = serious adverse event … ; SOE = strength of evidence; THC =
tetrahydrocannabinol; WAE = withdrawal due to adverse event. … Understanding how the
adverse event profiles of cannabis products compare with other available treatments … In order to better understand the
small to moderate improvements in pain, and the complete adverse event
-
effectivehealthcare-admin.ahrq.gov/news/grand-rounds-mhs
April 01, 2024 - Stewardship Interventions
Engaging Family Caregivers
Rapid Response Systems
Register now for the event
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cannabis-2023-surv-rep-4-table-E-5.xlsx
January 01, 2023 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) vs. NR, RR for A vs. … C
Any adverse event: 26.1% (91/348) vs. 14.9% (56/377); adjusted OR 1.00 (95% CI 0.64 to 1.58) NR No … B
Total patients reporting treatment related adverse event: 21.1% (71/337) vs. 35.0% (118/337), RR 0.60 … B
% (n/N)
Any adverse event: 88.4% (190/215) vs. 85.2% (184/216), RR 1.02 (95% CI 0.88 to 1.18)
Serious … SF-36 = short form 36 question survey; THC = tetrahydrocannabinol; TRAE = treatment related adverse event