-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/musculoskeletal-disorders-imaging_research-protocol.pdf
August 05, 2010 - Evidence-based Practice Center Technical Brief Protocol
Project Title: Technical Brief - Use and Safety … What are the potential safety issues and harms of positional MRI technologies? … :
What published studies have reported on the diagnostic performance,
efficacy/effectiveness or safety … Additional data regarding the use and safety of positional MRI may be
added based on the results of … treatment decisions
d. impact on clinical and functional outcomes
vii Adverse events, harms and safety
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-214-afib-disposition-comments.pdf
October 30, 2019 - What is a “cumulative primary safety
rate”? … If this is really looking at safety, then it
seems very low (90% unsafe). … (safety on treatment population).
Reference: Patel MR, Mahaffey KW, Garg J, et al. … (safety on treatment population).
Reference: Patel MR, Mahaffey KW, Garg J, et al. … The safety population is used, which is the same
population used in other DOAC trials to assess
safety
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/angina-heart-attack-treatments_research-protocol.pdf
December 11, 2012 - What are the comparative effectiveness (dose and timing) and comparative safety of an
intravenous ( … What are the comparative effectiveness (dose and timing) and comparative safety of
coadministration … Do the effectiveness and
safety vary based on which initial anticoagulant is used or the combination … Do the
effectiveness and safety vary based on the dose of aspirin used?
b. … Do the effectiveness and safety vary by oral antiplatelet
therapy and PPI?
c.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-267-adhd-executive-summary.pdf
March 01, 2024 - • Despite the large body of research, comparative effectiveness and safety
information is limited … Despite the large body of research, comparative effectiveness and safety information
is limited. … Studies did not provide information on key comparative effectiveness
and safety outcomes, and SoE is
-
effectivehealthcare.ahrq.gov/sites/default/files/santa_eccs2012.pdf
February 01, 2013 - Slide 29: Identified Issues
From
Professional Societies
• Harmonization
• Safety
• Use of brand … names
• Cost estimates
From
Consumers
• Safety
• Plain
language
• Knowing
who the professional … societies are
• Measurement
• Cost
Slide 30: Safety
• Safety is the most powerful issue that … attracts consumers.
• What
does safety include?
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoarthritis-pain_research-protocol.pdf
August 05, 2010 - Evidence-based Practice Center Systematic Review Protocol
Project Title: Comparative Effectiveness and Safety … Systematic Review
This report will serve as an update to the 2006 report Comparative Effectiveness and
Safety … In addition,
efficacy and safety may vary for individual drugs within a class. … We will also
include studies that report safety in patients with rheumatoid arthritis or were taking … Comparative effectiveness
and safety of analgesics for osteoarthritis.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/patient-family-engagement-protocol.pdf
December 31, 2019 - Hospitalized patients' participation and its impact on quality of
care and patient safety. … Scoping review and approach to appraisal of interventions intended to
involve patients in patient safety … Speaking up about safety concerns: multi-setting
qualitative study of patients' views and experiences … Moving Forward with Patient- and Family-Centered Care: Partnerships for Quality and Safety. 2019. … Evaluation of Patient and Family Engagement Strategies to
Improve Medication Safety.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/crohns-disease_disposition-comments.pdf
February 25, 2014 - This is why most safety data come from post marketing observational studies. … studies invested the agents at various doses to
determine safety parameters. … that RCTs
typically are not designed to
assess all important safety
related outcomes. … All patients in global safety summary
were Crohn’s Disease patients. … Please consider inclusion of this safety data.
-
effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1412.pdf
December 01, 2014 - However, experts generally indicated a need for more
trials to determine the safety and efficacy of … One expert with a research perspective noted the limited amount of long-term safety and efficacy
data … However, some experts expressed concern regarding long-term safety and efficacy and the potential
for … The fourth trial (SCALE™ Sleep Apnea; n=340) was a safety and efficacy trial investigating
once-daily … A prospective,
randomized multicenter study to evaluate the
safety and efficacy of the ReShape Duo
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/stroke-atrial-fibrillation_disposition-comments.pdf
August 23, 2013 - (safety on treatment population). … (safety on treatment population). … HR
0.23;95% CI,0.09, 0.61, p=0.003 (safety on
treatment population). … (safety on
treatment population). … 75) and younger patients for both
efficacy and safety.
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/ace-inhibitor-arb-update_research-protocol.pdf
May 07, 2010 - control, cardiovascular risk reduction,
cardiovascular events, quality of life, and other outcomes) and safety … major cardiovascular events [myocardial infarction ,
stroke] and measures of quality of life)
o Safety … diabetes)
Adverse Events
•Weight gain
•Impaired renal function
•Angioedema
•Cough
•Hyperkalemia
Safety … demographics and
data needed for determining outcomes (intermediate outcomes, health outcomes, and safety … The safety outcomes will be framed to help identify angioedema and hyperkalemia,
which are both adverse
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/cancer-anemia_executive.pdf
May 01, 2006 - What are the comparative efficacy and safety of
epoetin (alfa or beta) and darbepoetin?
2. … How do alternative dosing strategies affect the
comparative efficacy and safety of epoetin and
darbepoetin … treatment or alternative criteria for discontinuing
therapy or duration of therapy affect the efficacy
and safety … Conclusions
Comparative efficacy and safety of
epoetin and darbepoetin
Three sets of trials were summarized … cancer
(n=351), showed poorer overall survival for patients
treated with epoetin; this prompted an FDA safety
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/juvenile-arthritis-dmards_surveillance.pdf
March 14, 2013 - Is the portion of the CER that is
probably or certainly out of date an issue of safety (a drug withdrawn … We did not identify
any studies that provide reliable information
on the comparative safety or rates … A phase II, multicenter, open-label study
evaluating dosing and preliminary safety
and efficacy of … Safety
profiles were similar
Key Question 5: What is the validity, reliability, responsiveness, and … We did not identify
any studies that provide reliable information
on the comparative safety or rates
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/juvenile-arthritis-dmards_surveillance.pdf
March 14, 2013 - Is the portion of the CER that is
probably or certainly out of date an issue of safety (a drug withdrawn … We did not identify
any studies that provide reliable information
on the comparative safety or rates … A phase II, multicenter, open-label study
evaluating dosing and preliminary safety
and efficacy of … Safety
profiles were similar
Key Question 5: What is the validity, reliability, responsiveness, and … We did not identify
any studies that provide reliable information
on the comparative safety or rates
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/juvenile-arthritis-dmards_disposition-comments.pdf
September 01, 2011 - All studies of safety were
addressed in KQ3. … Amgen considers this omission to be significant because of the body
of data, especially safety data, … Some examples of
imbalances in adverse event rates that favor the safety of placebo
over adalimumab … We
did not include safety data on adalimumab in
Table 7 because of the absence of a
comparator for … The fact that
there is little usable information about the effectiveness and safety of
many of the
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-f-surv-report-2-acute-pain.xlsx
October 08, 2025 - Yes No No No Yes No/No Yes Yes Yes Fair
Cooper, 2021 Yes Yes Yes Unclear Yes Yes Yes No/No Yes; for safety
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/app-f-surv-report-3-acute-pain.xlsx
October 08, 2025 - Yes No No No Yes No/No Yes Yes Yes Fair
Cooper, 2021 Yes Yes Yes Unclear Yes Yes Yes No/No Yes; for safety
-
effectivehealthcare.ahrq.gov/sites/default/files/naik.pdf
January 01, 2009 - explicit communication
• Communication is critical to
Decision Making
o Limits quality
and
safety … and social norms define most interactions
o Quality: achieving appropriate outcomes, ensuring safety … Redundancy can
aide outcomes
But poses safety risks—communication can mitigate
o Reducing waste
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/diagnostic-error-executive-summary.pdf
August 01, 2023 - facilitate the rapid
development and deployment of solutions to address this critically important patient
safety … Diagnostic error in the emergency
department: learning from national patient
safety incident report … Improving Diagnostic
Quality and Safety Final Report. 2017. … BMJ quality & safety. 2018 Jul;27(7):567-
70. doi: 10.1136/bmjqs-2018-007945.
-
effectivehealthcare.ahrq.gov/sites/default/files/related_files/stroke-atrial-fibrillation_executive.pdf
August 01, 2013 - Also, synthesis of the evidence on the safety and timing
of restarting patients on VKAs or antithrombin … • Two studies investigating the safety of dabigatran
versus warfarin in the periprocedural period … Strategies for Switching Between Warfarin
and Novel Oral Anticoagulants
There is currently no safety … Stroke Prevention After a Hemorrhagic
Event
There is currently no safety or effectiveness evidence … Thus, there is a need for studies assessing
the safety and effectiveness of different combinations