-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-bone-fracture_research-protocol.pdf
May 14, 2010 - Some of these adverse effects - and the
dosing instructions implemented to avoid them - appear to reduce … • Outcomes:
- Any reported harms/adverse events (AEs) that can be directly associated with use … , 6)
2º Outcome: Adverse
effects of treatment
Factors that affect
Adherence/persistence
with … KQ4 assesses the evidence for adverse effects of treatment. … Common Terminology Criteria for Adverse Events (CTCAE).
Version 4.0.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/progestogens-preterm-birth_research-protocol.pdf
June 01, 2010 - future reproductive
outcomes)
Question 2
What is the nature and frequency of maternal and child adverse … e.g., infections and sepsis)
• Longer term outcomes
Question 3
How do the effectiveness, adverse … Question 4
How do the effectiveness, acceptability, adherence, adverse effects, and safety of progestogen … Question 5
How do the effectiveness, adverse effects, and safety of progestogen treatment differ based … Adverse events may occur at any point after the treatment is received, and are
affected by patient factors
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/lung-cancer-nonsurgical-therapies_research-protocol.pdf
February 22, 2012 - delivery of a cytotoxic dose of ionizing radiation to the tumor volume, while attempting to
minimize adverse … It involves numerous
treatment sessions, with dose fractionation, and can lead to adverse effects related … , hemoptysis, dermatitis, etc.), non–RT-associated adverse
events (e.g., pneumothorax, pleural effusion … Direct evidence of the
impact of the various therapies on health outcomes, including adverse effects … Direct evidence of the impact of the various therapies on health outcomes,
including adverse effects
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/celiac-disease_research-protocol.pdf
June 12, 2014 - which diagnostic methods were being examined for accuracy, and
what is meant by direct and indirect adverse … with IgA deficiency
f- Patients previously testing negative for CD
Question 4: What are the direct adverse … We provide below an analytic framework to illustrate the population, interventions,
outcomes, and adverse … event* OR adverse effect* OR harm* OR
enteropathy OR "quality of life" OR villous atrophy OR abdominal … effect* OR adverse event* OR harm* OR bleeding OR perforat* OR danger* OR
safe*[tiab] OR safety[tiab
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND-0491-140827.pdf
February 19, 2014 - imaging modalities and biopsies
Outcome(s): Morbidity, mortality, hospitalizations, occurrence of adverse … The associated costs and adverse
clinical outcomes are of particular concern due to the size of the
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/migraine-emergency_disposition-comments.pdf
November 27, 2012 - It fails to include certain key information as it did
not incorporate adverse event data from the FDA … It
was outside the scope of this review to search
the FDA’s adverse events database. … have the authors report on adverse
event data submitted to the FDA? … a network
meta-analysis for other adverse effects. … We grouped the adverse outcomes in
consultation with the technical expert panel
(Table 3).
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/head-neck-cancer_surveillance.pdf
August 01, 2012 - What is the comparative effectiveness of IMRT, 3DCRT, 2DRT, and proton beam therapy
regarding adverse … with fewer cases of
xerostomia at 6, 12, 24, and 36 months compared to 2DRT. 7 No signal
Other Adverse … Events: The incidence of other adverse events i.e. dermatitis 7 and dysphagia 6
favored IMRT treatment … The original CER reported
inconsistent results for other adverse events. … Similarly
inconsistent results
for adverse events
were found in the
original CER
1 signal (A1)
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/multiple-sclerosis_executive.pdf
April 01, 2015 - People with MS commonly switch between the available
DMTs, depending on tolerance, presence of adverse … Event
At Least
1 Serious
Adverse
Event
Treatment
Discontinuation
for Adverse
Event
Comparator … Dropouts
from observational studies are more likely to bias reporting
toward lack of adverse events … Adverse events and inefficacy or
progression of disability were two expected categories. … Current treatment
strategies for multiple sclerosis - efficacy versus neurological
adverse effects.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/osteoporosis-bone-fracture_disposition-comments.pdf
March 01, 2012 - We did not use a 0.5 correction factor for the adverse events
analysis. … We did not add a 0.5 correction factor for adverse events
analysis. … Finally, we do state explicitly that the study assessed fractures
as adverse events. … For this review, we relied solely on trial data for all but very rare
adverse events. … Peer Reviewer
4
General:
Adverse Events
The adverse events section is problematic.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/atrial-fibrillation-ablation_surveillance.pdf
May 16, 2013 - The overall rates of complications/major adverse events
were under 7%.9,10,15,18-20,25. … There were 84
studies that reported at least one adverse event
associated with RFA. … Most of the studies did not
report the time of occurrence of the adverse events. … Major adverse events associated with RFA are
relatively uncommon. … of the various
adverse events were not always comparable.
-
effectivehealthcare.ahrq.gov/sites/default/files/antipsychotics-children-update_executive.pdf
January 01, 2018 - Neuroleptic malignant
syndrome is a rare but serious adverse
effect. … In
KQ2, we assessed harms across conditions in terms of
adverse effects (AEs) categorized as major … Within each comparison,
we begin with findings for major adverse effects (AEs)
followed by general … Summary of findings for general adverse effects: Short-term durations of FGAs
versus SGAs
Outcome N … doses of SGAs (continued)
AE = adverse effect; BMI=body mass index; CI = confidence interval; CrI =
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/hepatitis-c_disposition-comments.pdf
November 27, 2012 - This is in contrast to Telaprevir’s
association with dermatological adverse events,
which are unique … Please revise to reflect an accurate
assessment of adverse event rates. … We have have made distinctions in our
report regarding the adverse events for each drug. … Please revise to
reflect an accurate assessment of adverse event
rates. … Anemia rates were calculated based
on clinician adverse event reports.
-
effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/hypertensive-disorders-pregnancy-protocol-amendment.pdf
April 20, 2022 - Reduction of health disparities* (increase in disparities included under Harms)
● Harms
o Severe adverse … ● Reduction of health disparities* (increase in disparities included under Harms)
● Maternal harms/adverse … loss of reflexes, reduced
urine output, need for calcium infusion)*
o Other clinically important adverse … events
• Adverse drug interactions
Literature Search Strategies to Identify Relevant Studies to … Association of Adverse Pregnancy Outcomes With
Hypertension 2 to 7 Years Postpartum.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-272-genitourinary-syndrome-disposition-comments.pdf
July 31, 2024 - Also, further
studies should also focus on WHY some
patients experienced adverse effects while
others … We
agree that assessing risk for adverse
effects is an area for future research
and note that many … the included
studies restricted participants to those
with few risk factors for complications
or adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/acs-pci-adjunctive-devices_surveillance.pdf
April 01, 2013 - Experts
Conclusion
from SCEPC
Conclusion #1
In the catheter aspiration trials, the risks of
major adverse … There was a paucity of trials available to
evaluate adverse events with any of the
embolic protection … conventional PCI
25 trials including
5,534 patients
Major adverse cardiac events were
significantly … Do Not Know
Conclusion #1
In the catheter aspiration trials, the risks of major adverse
cardiovascular … There was a paucity of trials available to evaluate
adverse events with any of the embolic protection
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/migraine-treatments-research-amended-protocol.pdf
January 09, 2020 - In addition to effectiveness, decisionmakers need information on potential adverse risks, and
special … Pain, function, pain relief satisfaction and quality of life,
harms/adverse events (including withdrawal … predicting risk of opioid
misuse, opioid use
disorder, or overdose
(KQ 1 h)
Mitigation strategies
Adverse … We will grade SOE for the two most critical health outcomes, pain,
function, quality of life, and adverse … treatment patterns of prophylactic and
acute migraine medications and incidence of opioid-related adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/deficit-hyperactivity-protocol.pdf
November 01, 2021 - Several instruments are available to monitor treatment response and adverse
effects over time, including … Monitoring also includes assessment of any adverse effects of treatment. … What are the adverse effects associated with being labeled correctly or
incorrectly as having ADHD? … In question 1d, we will assess whether the literature suggests
whether these adverse effects differ … Questions 2 and 3 will review
effectiveness as well as adverse outcomes.
III.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/pelvic-pain-surveillance-151130.pdf
July 10, 2015 - Perioperative
adverse events after minimally invasive abdominal sacrocolpopexy. … The
study comparing goserelin versus progestogen did not report on adverse effects. … Studies did not report on adverse effects. … Studies did not report on adverse effects. … effects (e.g. weight gain, bloatedness-the most common adverse effects).
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/ptsd-6-protocol.pdf
December 07, 2024 - events, serious adverse events
• Timing:
o No limitation on study duration or length of follow up … Serious Adverse Event Percent
3. Serious Adverse Event Detail
4. … Serious Adverse Events Numerator
5. Serious Adverse Events Denominator
6. … Withdrawal Due to Adverse Events Percent
7. Withdrawal Due to Adverse Events Detail
8. … Withdrawal Due to Adverse Events Numerator
9. Withdrawal Due to Adverse Events Denominator
10.
-
effectivehealthcare.ahrq.gov/sites/default/files/nursing-home-safety_disposition-comments.pdf
May 27, 2016 - We have revised the abstract to note the
trade-off between QoL and some types
of adverse events. … Peer reviewer #5 Background The list of adverse events is organized poorly. … The focus should be on adverse events. … I
wanted a list of adverse events they would discuss and why these
were chosen. … How this relates to harm and adverse
events is not articulated well.