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effectivehealthcare.ahrq.gov/sites/default/files/pdf/rheumatoid-arthritis-medicine_research-protocol.pdf
December 06, 2010 - Many questions remain about the
risks of these agents across a spectrum of adverse events—from relatively … Morbidity, mortality, and other serious adverse events
ii. Tolerability
iii. Adherence
iv. … Other adverse effects
• Timing:
Minimum of 3 months of follow-up
• Settings:
Primary care … Also, adverse events may occur at any point after the treatment is received.
IV. Methods
A. … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
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 … 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 "clinical outcome*" OR complication* OR harm*
OR enteropathy OR "quality … effect* OR adverse event* OR harm* OR bleeding OR perforat* OR danger* OR
safe*[tiab] OR safety[tiab
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/medical-test-reviews-prognostic.ppt
June 01, 2012 - They predict beneficial/adverse responses to treatment. … A somewhat unique category of prognostic tests are ones used to predict beneficial or adverse responses … The other table is for those who did not experience the outcome event. … probability of the event, and the followup time. … Predictive tests, which are a category of prognostic tests, can be used to predict beneficial or adverse
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effectivehealthcare.ahrq.gov/sites/default/files/medical-test-reviews-prognostic.ppt
June 01, 2012 - They predict beneficial/adverse responses to treatment. … A somewhat unique category of prognostic tests are ones used to predict beneficial or adverse responses … The other table is for those who did not experience the outcome event. … probability of the event, and the followup time. … Predictive tests, which are a category of prognostic tests, can be used to predict beneficial or adverse
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/pneumonia-antibiotic-treatment_research-protocol.pdf
July 19, 2013 - Rates of antibiotic-related adverse events? … Rates of antibiotic-related adverse events? … Question 3
Does the evidence for morbidity, mortality, antibiotic-related adverse events, clinical … or
prospective cohort studies with an
eligible comparison group
• For KQ 1c, KQ 2c, and KQ 3:
adverse … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
effectivehealthcare.ahrq.gov/sites/default/files/assessing-the-risk-of-bias_draft-report.pdf
June 02, 2011 - Since many harms are not anticipated (the severity, the type of event -especially rare events,
the … event has occurred, accurately recall the details of the event, and then
―spontaneously‖ report this … There is also the issue of establishing an association between the event and the
intervention. … Is there a plausible biological mechanism linking the intervention to the adverse event? … Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
15.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/peripheral-artery-disease-treatment_executive.pdf
May 01, 2013 - What are the significant safety concerns associated
with each treatment strategy (e.g., adverse drug … What are the significant safety concerns associated
with each treatment strategy (e.g., adverse drug … Some RCTs
reported adverse events such as rash and wound leak. … Nonfatal MI
SOE=Insufficient
2 RCTs, 497 patients
Inconclusive evidence due to low event rates in … Nonfatal stroke
SOE=Insufficient
3 RCTs, 1932 patients
Inconclusive evidence due to low event rates
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effectivehealthcare.ahrq.gov/products/mhs4-computerized-cds/protocol
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/main-apps-surv-report-3-acute-pain.pdf
June 01, 2022 - NSAID
Opioid increased risk of:
Any adverse event: 11
trials, RR 1.72 (95% CI 1.29
to 2.28)
Nausea … Updated meta-analysis
Opioid increased risk of:
Any adverse event: 14 trials, RR
1.85 (95% CI 1.47 … , including any adverse event, nausea, dizziness, and somnolence. … Dental pain meta-analysis: Opioid versus NSAID for any adverse event
G-3
Figure G-3 … events (any
adverse
event,
drowsiness)
<1 day 1 (new) 154 Direct Imprecise Good Unable to
assess
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/head-neck-cancer-update_research-protocol.pdf
February 04, 2014 - any of these modalities is more
effective than the others: 1) in reducing normal tissue toxicity and adverse … Evidence was insufficient to draw relative
conclusions on survival or tumor control; adverse events … A quest to improve
upon survival rates and the adverse effect profile of conventional 2DRT has led to … event response criteria
– Follow-up frequency and duration
o Data analysis details, including: … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/measuring-blood-pressure_research-protocol.pdf
April 11, 2011 - relevant clinical outcomes (cardiovascular events, mortality, patient
satisfaction, quality of life, and adverse … o Adverse events related to treatment with antihypertensive agents (e.g.,
hypotensive episodes or orthostatic … Abbreviations: AE = adverse events; BP = blood pressure; CVD = cardiovascular disease; KQ =
key question … and clinical outcomes (mortality, cardiovascular events, patient
satisfaction, quality of life, and adverse … Summary of Protocol Amendments
In the event of protocol amendments, the date of each amendment will
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/adhd-future_research.pdf
May 01, 2012 - event
outcomes following treatment? … event outcomes following 12 months or more of
any combination of followup or treatment, including, … Few serious adverse events were noted. … event outcomes
following treatment? … event outcomes following 12 months or more of
any combination of follow-up or treatment, including,
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/medication-therapy-management_executive.pdf
November 01, 2014 - Too
often, however, medications are not used
appropriately.1-3 In the United States
in 2001, adverse … drug events led to an
estimated 4.3 million ambulatory visits.4
In addition to problems involving adverse … transition in care, targeting highly activated patients, targeting patients at time of high
risk for event … event
� Drug therapy problems that are resolved as defined by primary studies but typically including … Ambulatory care visits for
treating adverse drug effects in the United States, 1995-2001.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/allergy-seasonal_disposition-comments.pdf
July 17, 2013 - Text revised as follows: “Intranasal corticosteroids do not
appear to cause adverse events associated … Text revised to state: “Potential adverse events
resulting from systemic absorption, such as impaired … themselves admit that the “absence of placebo arms
particularly limited our assessment of harms, in which event … By binding other receptor
types, nonselective antihistamines can potentially cause
adverse effects. … ..In contrast, selective antihistamines may
have reduced incidence of adverse effects.”
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/stent-clopidogrel-practice_research.pdf
March 01, 2009 - Landmark analyses were performed among patients who were event-free
(no death, myocardial infarction … Among drug-eluting stent patients who
were event-free at twelve months, clopidogrel use continued to … cessation
of clopidogrel therapy.
8
This study identified 746 patients who were free of major
adverse … Similarly, patients who were
event-free at 12 months and completed the 12-month follow-up contact, … the four groups revealed disparities in event rates.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/prostate-cancer_executive.pdf
February 01, 2008 - All treatment options result in adverse
effects (primarily urinary, bowel, and sexual), although
the … Even if differences in therapeutic
effectiveness exist, differences in adverse effects,
convenience, … Adverse effects were reported, but definitions and
severity varied widely. … (AE defined as the
first occurrence of an event and higher incidences of hot flashes.)
11
Table … effects of Medium • Adverse event definitions and severity varied widely.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/registries-guide_executive.pdf
April 01, 2007 - Adverse Event Detection,
Processing, and Reporting
The U.S. … Food and Drug Administration defines an
adverse event (AE) as any untoward medical
occurrence in a patient … AEs are categorized according to the
seriousness and, for drugs, the expectedness of the
event. … event data falls into two
categories: those events that are intentionally
solicited (meaning data that … • For safety studies, personnel are appropriately trained to ask about complaints or adverse events
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-bias-individual-studies_methods.pdf
March 01, 2012 - Study investigators may assume that patients will know when an adverse event
has occurred, accurately … recall the details of the event, and then “spontaneously” report this at
the next outcome assessment … • Is there a plausible biological mechanism linking the intervention to the adverse event? … Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
15. … Adverse
effects. In: Higgins JPT, Green S, eds.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/celiac-disease_clinician.pdf
July 01, 2016 - evidence regarding the comparative accuracy (the balance of sensitivity and
specificity) and possible adverse … Endoscopy with multiple
duodenal biopsies has a very low risk of adverse events.
1. … Overview of Clinical Research Evidence
Table 3: Summary of Findings and Strength of Evidence for Adverse … Events Associated With Invasive Diagnostic Tests
Adverse
Events Test Type and No. of Studies (Na) Systematic … testing because of symptoms.
�� Evidence was also insufficient to determine the impact of
indirect adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/outcome-research-white-paper.pdf
June 01, 2022 - The intent of the adverse events measure was to capture all adverse events related to
depression treatment … While some adverse events were documented in patients’ medical records,
it was possible that patients … This project also assessed the feasibility of calculating the adverse events measure using
structured … A total of 36,844 adverse effects were extracted from 33,332
notes. … Events of
Interest
Adverse Events Depression treatment-related adverse events.