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effectivehealthcare.ahrq.gov/products/radiation-brain-metastases/protocol
January 28, 2020 - 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.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
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/pbt-lsr-draft-ets-obs.xlsx
March 15, 2022 - C
% (n/N)
Any adverse event
3 months: 35% (19/49) vs. 47% (30/52) 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
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effectivehealthcare.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.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
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/plant-based-chronic-pain-review-q3-tables-f5.xlsx
June 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), RR 1.02 (95% CI 0.88 to 1.18)
Serious
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effectivehealthcare.ahrq.gov/sites/default/files/ch_10-user-guide-to-ocer_130129.pdf
January 01, 2011 - Time-to-event data with variable followup and
censoring of study outcomes are commonly
investigated … A number of
excellent textbooks describe the analysis of time-
to-event data.14-15
A high-level overview … )
linear regression,
GLMM, GEE
Repeated measures
ANOVA (MANOVA),
GLMM, GEE
GLMM, GEE
Time to event … Cox proportional
hazards regression
Variance-adjusted Cox
model or shared frailty
model
Time to event … As noted above, for time-to-event study outcomes,
time-dependent Cox regression models can be
used
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-e-surveillance-report-1-treatments-for-acute-pain.xlsx
December 22, 2021 - 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 … D
Any adverse event: 30.2% (62/205) vs. 46.2% (96/208) vs. 51.0% (105/206) vs. 23.2% (48/207)
Nausea:
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/cannabis-annual-update2-table-e5.xlsx
March 13, 2023 - 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.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.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
-
effectivehealthcare.ahrq.gov/products/adhd-heart-disease-adults/research
November 01, 2011 - Food and Drug Administration (FDA) Adverse Event Reporting System data have raised concern that attention-deficit
-
effectivehealthcare.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.ahrq.gov/sites/default/files/related_files/cannabis-2022-surv-rep-4-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. … 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
-
effectivehealthcare.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
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-250-cannabis-table-e5-2022-update_0.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
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/ehc-depression-research-protocol.pdf
February 07, 2018 - 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.
-
effectivehealthcare.ahrq.gov/products/depression-harms/research-protocol
February 07, 2018 - 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, as … 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.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_disposition-comments.pdf
October 07, 2011 - In
the studies that did report episodes of angioedema, this adverse
event was observed only in patients … Conceivably, information from adverse event databases
would support the clinical impression that the … They should also include studies that can
meaningfully examine cardiovascular/cerebrovascular event … Given the event rates and outcomes
presented in the table we felt that the odds
ratios were the more … Aside from the risk itself, the emergence of a new
adverse event from an outside meta-analysis raises
-
effectivehealthcare.ahrq.gov/products/high-cholestorol-medicines-update/research-protocol
May 17, 2013 - 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