-
effectivehealthcare-admin.ahrq.gov/sites/default/files/s66.pdf
October 01, 2007 - trials are of short duration3; and sample size constraints limit
their ability to identify infrequent adverse … to discontinuation of therapy.19 Overall, persistence reflects
clinical effectiveness, occurrence of adverse … New
Episodes
Median
Persistence
(d)* Events
Unadjusted
HR 95% CI
Adjusted
HR 95% CI P
Overall persistence … similar for these 2 medications46 and that
leflunomide is a useful alternative for those who experience
adverse
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/mrsa-screening_research.pdf
June 01, 2013 - incidence of HA-MRSA infection, morbidity (including
complications of MRSA infection), mortality, adverse … o From an emergency department (ED) perspective, we should expand our concept
of adverse events to … consider the broader impact on patient flow system-wide,
recognizing that some of the adverse outcomes … Does
not differentiate between cause
and effect or the sequence of
events. … Generally low since events
(exposures and outcomes) have
already occurred.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cell-free-dna-appendices.pdf
May 22, 2024 - KQ 5
• Radiation exposure from imaging,
harms from invasive procedures, other
adverse effects from … Harms Reported
Klein et al., 2021 4 CCGA
(3rd substudy)
Galleri (cfDNA) 0.4% (20/5,309) reported adverse … Events
Insufficient
Single arm
cohort study: 110
Higha Direct Unknown
(single study)
Unable … to
determinec
Not detected None No serious adverse events
reported. … b Radiation exposure is an indirect outcome for future adverse outcomes like secondary cancers.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cerebral-palsy-feeding_executive.pdf
March 01, 2013 - the Agency for Healthcare Research and
Quality (AHRQ) Effective Health Care program as
all possible adverse … consequences of an intervention,
including adverse events (Figure A).27
5
Key Questions
We have … resulting from these interventions can
include a change in growth status, improved swallowing,
or various adverse … feeding activities, physical and mental
health of the primary caregiver, pain or comfort, and
various adverse … postfundoplication) included bloating,
diarrhea (dumping syndrome), and intestinal obstruction;
these events
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/field-triage-glascow_research-protocol.pdf
February 25, 2016 - overtriage may be acceptable in order to prevent
undertriage, which may be more likely to result in adverse … Analytic Framework
The analytic framework illustrates the population, interventions, outcomes, and adverse
-
effectivehealthcare-admin.ahrq.gov/products/prevent-hai/protocol
August 01, 2024 - pathogen transmission (including MDRO; Sepsis; ICU stay related to HAI; Length of stay; Mortality; Adverse
-
effectivehealthcare-admin.ahrq.gov/products/advanced-care-decision-aids/research-protocol
December 01, 2019 - Were harms or adverse effects collected in the studies; what were they?
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/tech-brief-31-mobile-applications-self-mgmt.pdf
May 01, 2018 - activity; quality of life; functionality;
incidence of hypoglycemic and hyperglycemic episodes; harms and adverse … events; and all-cause
death. … Hypoglycemic events were
infrequent in both groups. … symptoms
No NR, p>.05 Self-Completion
Patient Outcome
Instrument
Depression No NR, p>.05 PHQ-9
Adverse … events
No None reported.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/autism-adolescents_surveillance.pdf
July 01, 2014 - Most
commonly reported adverse events
were nausea and fatigue. … reported adverse … events were nausea and
fatigue.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/hepatitis-c-screening_executive.pdf
November 01, 2012 - Key Question 3
What are the harms associated with screening for HCV
infection, including adverse effects … What are the harms associated with
screening for HCV infection, including
adverse effects such as anxiety … chronic HCV infection and
compensated cirrhosis with an Ishak fibrosis score of ≥3 reported
serious adverse … events in 1.1% of patients, including 0.6% serious
bleeds and 0.3% severe pain, with no deaths. … Benefits and adverse effects
of hepatitis C screening: early results of a screening program.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/survival-quality_research.pdf
April 01, 2013 - These unforeseen events clearly must be addressed in the protocol of studies and data
should be collected … Commonly, these
will be imaging studies at lesion sites difficult to quantify and/or evidence of adverse … events
related to disease. … Control %
(95% CI)
Any Grade
3/4 Adverse
Events in
Experimental
Group
N (%)
Any Grade
3 … /4 Adverse
Events in
Control
Group
N (%)
Cella,
201262
pazopanib vs.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/ems-blood-transfusion-protocol-amendment.pdf
February 04, 2025 - (hospital
only)
Adverse Events/Harms (including but not limited to the
following)
• Allergic reaction … intervals relative to a clinically important effect
estimate, sufficiency of sample size, and number of events
-
effectivehealthcare-admin.ahrq.gov/products/ems-blood-transfusion/protocol
February 01, 2025 - (hospital only) Adverse Events/Harms (including but not limited to the following) Allergic reaction Febrile … intervals relative to a clinically important effect estimate, sufficiency of sample size, and number of events
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/nonpharm-treatment-chronic-pain-protocol.pdf
December 11, 2018 - outcomes
from validated measures
Function/disability/pain interference
Pain
o Harms and adverse … outcomes from validated measures
for
• Function/disability/pain interferenced
• Paind
Harms and Adverse
-
effectivehealthcare-admin.ahrq.gov/products/noninvasive-nonpharm-pain-update/protocol
May 01, 2020 - outcomes from validated measures
Function/disability/pain interference
Pain
Harms and adverse … outcomes from validated measures for
Function/disability/pain interferenced
Pain d
Harms and Adverse
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/rapid-assessment-research-updates_research.pdf
September 15, 2008 - signals included major changes in the
6
characterization of effectiveness, new information about adverse … events, or some other warning about
the reliability of previous findings.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/opioid-use-disorder_research-protocol.pdf
February 24, 2016 - Adverse events/harms/safety issues reported
4.
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/tinnitus_research-protocol.pdf
February 22, 2012 - Quality of life
o Adverse effects
1. Worsening of tinnitus
2. Sedation
3. … Return to “normal” work
o Adverse effects
1. Worsening of tinnitus
2. Sedation
3. … Depression
Sleep disturbances
Self-reported loudness
Quality of life
Time until improvement
Adverse … In addition to
outcomes related to treatment effectiveness, all available data on harms or adverse
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/wysiwyg/white-paper-standardized-library.pdf
February 01, 2019 - Relationships between events raise a challenge because relationships are often not directly
asserted … • FHIR resources for additional relevant events: These might include procedures,
encounters, etc … • Temporal aspects for all events: These allow for inferred relationships. … Services
COMET Care Outcome Measures in Effectiveness Trials
CTCAE Common Terminology Criteria for Adverse … funding
objectives and outcome measures
generally broad: standard knee
and hip scores as well as adverse
-
effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/pressure-ulcer-prevention_research-protocol.pdf
January 10, 2012 - In addition to avoiding the pain and adverse health outcomes associated with pressure ulcers,
strategies