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effectivehealthcare.ahrq.gov/sites/default/files/related_files/lifecycle-assessment-disposition-comments.pdf
November 20, 2024 - KI Reviewer #2 Introduction [pg. 2, "that there is no impact or increased risk to
patient safety"]: … (environmental impact - or do you still mean
patient safety?) … Many of those factors, including patient
safety, can be quantified and compared to the
potential human … KI Reviewer #2 Findings [pg. 13, GQ1a, "frameworks included a human
health or patient safety component … Peer reviewer #1 Findings Page 19 line 31, LCA is not meant to consider
patient safety except in the
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/psoriasis-chronic_research-protocol.pdf
January 10, 2012 - To date, no comparative effectiveness review comparing the effectiveness and safety of
FDA-approved … with chronic plaque psoriasis, what is the comparative safety of systemic biologic
agents and systemic … followup),
patient baseline characteristics (including whether the patient is naïve to biologic therapy … We will also conduct
subgroup analyses based on the patient population evaluated, including patients … Efficacy and
safety results from the randomized controlled comparative study of adalimumab vs.
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effectivehealthcare.ahrq.gov/sites/default/files/substance-abuse-horizon-scan-high-impact-1406.pdf
January 01, 2020 - Experts wanted to see additional clinical trial data assessing
baclofen’s long-term safety and efficacy … Additionally, safety reporting from a bioavailability study in healthy volunteers
noted similar adverse … All adult volunteers, and 15 of 19 adolescent
volunteers were able to successfully remove the safety … The devices are not intended for laypersons and do not appear to have the audible
instructions, LED indicators … or increased risk of opioid
overdose.45 Overall, experts noted that because of Evzio’s extensive safety
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-tests-prognostic_methods.pdf
July 01, 2012 - How were previously established prognostic indicators or other prognostic assessments included in the … Were any previously established prognostic indicators or prediction models being used as comparators … Reviewers need to be aware of any previously established prognostic indicators
that should be included … • A large number of published reports focus on the associations between prognostic
indicators and … Efficacy and safety of quinidine therapy for
maintenance of sinus rhythm after
cardioversion.
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/mental-health-app-protocol-updated.pdf
January 01, 2018 - researchers, health care providers,
informaticians and technologists, app developers, as well as patient … We plan to have a separate call for patient/caregiver KI at the start of the
project, with questions … /clients and health care providers;
security and privacy features such as data usage and sharing of … Key substance
use and mental health indicators in the United States: Results from the 2019 National … how it works, how it is currently
used or might be used, and which features may be important from a patient
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/observational-research-scores_research.pdf
May 01, 2012 - about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and
services … , 10 diagnostic groups for hospital discharges, 10
diagnostic groups for outpatient visits, and 10 indicators … A common question in pharmacoepidemiologic studies of drug safety is whether the risk
conferred by a … Pharmacoepidemiology and Drug Safety
2008;17:546-555. … Pharmacoepidemiol Drug
Safety 2005;14(7):465-76.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/osteoarthritis-pain-disposition-120516.pdf
October 01, 2011 - Yes – pg. 404, Table 1. of the
Goldstein 2010 publication shows that the patient
demographics and baseline … Was the patient blinded? … Yes – pg. 404, Table 1. of the
Goldstein 2010 publication shows that the patient
demographics and baseline … Was the patient blinded? … The end
results of question four reinforced the need for
each patient to be treated based on their
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/ced%20-appendix-2.xlsx
May 29, 2025 - AHRQ revise the study design CED recommendation to provide patients more ethical and equitable coverage … KIs should have also represented life sciences industries, patients, and underrepresented populations … use of CED for on-label uses of drugs and biologics that have gone through FDA evaluation process for safety … use of CED for on-label uses of drugs and biologics that have gone through FDA evaluation process for safety … AHRQ revise the study design CED recommendation to provide patients more ethical and equitable coverage
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/mhs-iv-patient-safety-practices-year-2.pdf
May 01, 2025 - Director, General Patient Safety Program
Center for Quality Improvement and Patient
Safety
Agency … Patients for Patient Safety, U.S. … safety practices for responding to harms experienced by patients during
clinical care (N=8) ....... … safety outcomes
• Programs for responding to harms experienced by patients during clinical care … safety practices for responding to harms experienced by patients during
clinical care (N=8)
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/atypical-antipsychotics-off-label-update_disposition-comments.pdf
September 01, 2011 - and systematic, even
encyclopedic, compilation of information on treatment patterns, efficacy, and safety … Patient heterogenity is an
issue in most of our analyses. … Pharmacoepidemiology and drug safety (2011) DOI: 10.1002/pds.2082 The study
results
indicated 75% … The accessibility of patient information
is critically important. … Effects of extended release quetiapine fumarate (Quetiapine XR) on
patient-reported outcomes in patients
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/instrumental-variable-methods_research.pdf
April 01, 2010 - Instrumental variable methods in comparative safety
and effectiveness research. … Similarly, one could assess safety in these same patients by
exploring the association between formulary … In some cases, the concept of a “marginal patient” may be problematic as individual
patients may be … Distance must also not be related to patient characteristics. … first-stage regression, in particular the partial r-squared value and the first-stage F
statistic, both indicators
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/vte-prophyalaxis_research-protocol.pdf
March 01, 2011 - There is clinical uncertainty about the
optimal choice of VTE prophylaxis in this patient population … This CER will evaluate the comparative effectiveness and safety of
pharmacologic prophylaxis among patients … What is the comparative effectiveness and safety of IVC filters to prevent PE in hospitalized
patients … and individual patient risk factors. … Deep-vein thrombosis: advancing awareness to protect patient lives.
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/rheumatoid-arthritis-hospitalizations_research.pdf
October 01, 2008 - about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and
services … and we are evaluating the safety of tumor necrosis factor alpha
(TNF-α) antagonists in a cohort of … patients with rheumatoid arthritis (RA). … fraction of 65% without
further details and 1 had a report indicating normal ventricular function in a patient … with RA and could be used in assessments of medication safety.
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effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1406.pdf
June 01, 2014 - surgery, but choose to decline due to safety concerns. … for similar reasons, but mentioned long-term safety to be a concern. … health, many expressed concerns regarding long-term safety and efficacy. … data and postmarket safety evaluation—set
forth by FDA. … potential impact on patient health.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/recombinant-factor-viia_executive.pdf
May 01, 2010 - This report evaluates the level of evidence
currently available to support the
effectiveness and safety … The FDA drug approval process
mandates randomized clinical trials that demonstrate
efficacy and safety … Use of rFVIIa for selected
indications in patient with/undergoing cardiac
surgery
Key Question 4c. … • Are there patient subpopulations more likely to
benefit from rFVIIa use? … • Are there patient subpopulations where harms are
more likely?
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/stem-cell-children-future_research.pdf
February 01, 2012 - A disadvantage
of this over individual patient
randomization is that outcomes
for patients from a … A
disadvantage of this over
individual patient
randomization is that
outcomes for patients from a … post-ASCR
EFS 1 patient died of toxicity
at 3 months follow up. 5
patients were DOD at 5-
21 months … (70%),
partial remission in 1
patient (2%) and stable
disease in 13 patients
(28%). … with high-risk solid
tumors
Safety/Efficacy
study
30 patients (up
to 30 years of
age)
6/2006
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND-0576-150420.pdf
December 10, 2014 - Outcome(s): Restraint and seclusion rates; staff and patient injuries; cost and resource
utilization … inpatient psychiatric setting to manage aggressive
behavior of a person that may impact their own safety … or the safety of others, including staff. … The challenge is
to identify a standard of practice that ensures safety while maintaining patients’ … because of high interest from potential stakeholder
groups in this topic, particularly related to safety
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effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/multinational-registries-guide-3rd-ed-addendum-white-paper.pdf
February 01, 2018 - This, in turn, may affect the perceived effectiveness or
safety of the product if the registry does … Drug Safety. 2015 January
1;38(1):13-5.
4. Elger B, Biller-Andorno N, Mauron A, et al. … http://www.fda.gov/downloads/Drugs/Drug
Safety/ucm089809.pdf. Accessed January
10, 2017.
21. … Direct-to-patient research: piloting a new
approach to understanding drug safety
during pregnancy. … Balancing the Interests of Patient Data
Protection and Medication Safety
Monitoring in a Public-Private
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-202-thermoplasty-comments.pdf
December 14, 2017 - Effectiveness and Safety of Bronchial
Thermoplasty in Management of Asthma. … Safety and
feasibility of bronchial thermoplasty in asthma patients with
very severe fixed airflow … Safety and Feasibility of Bronchial
Thermoplasty in Asthma Patients with Very Severe Fixed
Airflow … PAS2 study patients treated with BT showed procedural safety
and clinical improvements during each of … , no information is available regarding BT’s
safety and efficacy in a broader population of patients
-
effectivehealthcare.ahrq.gov/sites/default/files/pdf/insulin-blood-sugar_research.pdf
August 01, 2015 - Patient Stakeholder
Baltimore, MD
Ruth Horowitz, M.D. … Study design:
Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention … Study design:
Endpoint Classification: Safety
Study
Intervention Model: Single Group
Assignment … Study design:
Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention … Study design:
Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention