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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/pdf/colon-cancer-gene-profiling_research-protocol.pdf
March 13, 2012 - The FDA
addresses the safety and effectiveness of diagnostic tests and the quality of the design
and … Historically, the FDA has subjected test kits to premarket
review of safety and effectiveness but not … Clinical utility should reflect patient outcomes such as
improved survival. … result from both preanalytic factors [e.g., sample
preparation] as well as analytic factors [such as reagents … Patient advocacy Web sites for colon cancer will be searched.
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/antipsychotics-children-future_research.pdf
February 01, 2012 - • Patient insight into illness? … Web-based prioritization exercises allowed each stakeholder to distribute a limited
number of star-shaped indicators … some safety outcomes tend to be more homogenous across studies (e.g., weight gain). … Patient registries with linkages of patient-reported outcomes to clinical datasets (such as
claims or … Challenge that patients tend
to be reluctant to accept
randomization.
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effectivehealthcare.ahrq.gov/sites/default/files/diabetes-horizon-scan-high-impact-1406.pdf
September 26, 2014 - for calibrating the
CGM (as applicable) and checking sensor performance as needed plus associated
reagents … Patients and
their diabetes care teams work to adjust patient insulin dosages using feedback from a … health
outcomes, citing safety concerns and limited efficacy data. … Summary of safety and effectiveness data
(SSED). MiniMed 530G system. P120010. … Efficacy and safety of insulin degludec in a
flexible dosing regimen vs insulin glargine in
patients
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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/peptic-ulcer-horizon-scan-high-impact-1506.pdf
June 01, 2015 - Treatments are aimed at symptomatic relief, but questions of safety and efficacy
remain. … However, other experts
thought the availability of a new IBS therapy with a seemingly good safety profile … Salix's TARGET 3 study examines the safety and
efficacy of repeat treatment with rifaximin 550 mg … -550
http://news.salix.com/press-release/salixs-target-3-study-examines-safety-and-efficacy-repeat-treatment-rifaximin … -550
http://news.salix.com/press-release/salixs-target-3-study-examines-safety-and-efficacy-repeat-treatment-rifaximin
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/hro-protocol.pdf
January 01, 2023 - stakeholders, clinical specialists, experts in patient
safety issues, and a patient/consumer perspective … groups
6
Study Parameter Inclusion criteria Exclusion criteria
• Patients receiving
care … /products/prioritization-patient-safety-practices
https://effectivehealthcare.ahrq.gov/products/prioritization-patient-safety-practices … The TEP included 15 experts in patient safety with representa... … To accomplish that task, we will review AHRQ’s Patient Safety Networ...
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effectivehealthcare.ahrq.gov/sites/default/files/pdf/crohns-disease_research-protocol.pdf
September 01, 2010 - Over time, 73% of patients will have a
relapsing and remitting course, while only 10% of patients will … Our proposal will address these aims, as well as the safety and patient-reported
outcomes representing … We aim to compare the effectiveness, safety and patient-reported outcomes
representing quality of life … The patient-reported outcomes will also help patients and caregivers to take into
consideration the … Objectives
We aim to compare the effectiveness, safety and patient-reported measures of individual
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/gerd-disposition-120104.pdf
April 01, 2011 - Summary of available data on patient
characteristics and response to prior medical
treatment have been … outcomes noted in question 1 include healing of erosive
esophagitis (EE), ambulatory pH, and other indicators … Commentator &
Affiliation
Section Comment Response
AstraZeneca esophagitis (EE), ambulatory pH, other indicators … comprising 11% of patients in the
trials.1 No overall differences were seen in the safety or effectiveness … The safety of
Thank you for your comments.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-193-naloxone-executive-summary.pdf
November 01, 2017 - arrest, function, quality of life,
other clinical sequelae of opioid overdose; health care
utilization indicators … National Highway Traffic Safety Administration. The national
EMS scope of practice model. … Joint meeting of the anesthetic and analgesic
drug products and the drug safety and risk management … Joint meeting
of anesthetic and analgesic drug products advisory
committee and drug safety and risk … Randomized controlled
trial comparing the effectiveness and safety of intranasal and
intramuscular
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/osteoarthritis-pain_executive.pdf
October 01, 2011 - We
also included studies that report safety in patients with
rheumatoid arthritis or who were taking … ), diclofenac (10/100
patient-years), and ibuprofen (11/100 patient-years). … disease
prevention, usually at lower
prophylactic doses
GI harms: A systematic review of individual patient … though diclofenac was associated with the highest rate
of hepatic laboratory abnormalities (78/1000 patient … -
years, vs. 16 to 28/1000 patient-years for the other
NSAIDs).
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/rfviia.pptx
May 01, 2010 - The talk will cover the current evidence on the effectiveness and safety of using recombinant activated … Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the … Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation … Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation … Safety is defined via thromboembolic events and mortality, but individual studies often lack the statistical
-
effectivehealthcare.ahrq.gov/sites/default/files/rfviia.pptx
May 01, 2010 - The talk will cover the current evidence on the effectiveness and safety of using recombinant activated … Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the … Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation … Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation … Safety is defined via thromboembolic events and mortality, but individual studies often lack the statistical
-
effectivehealthcare.ahrq.gov/products/depression-postpartum-screening/research-protocol
March 09, 2012 - Protocol Apr. 9, 2013 Systematic Review Feb. 1, 2017 Disposition of Comments Report Efficacy and Safety … There is high-quality evidence for effective treatment of patients who meet criteria for major depression … for Postpartum Depression
In evaluating strategies involving screening for postpartum depression, patients … inferences must be drawn from data on how well the screening test or strategy distinguishes between patients … identify women at risk for postpartum depression; the performance of a test designed to identify patients
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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 … It requires that the patient be placed in a tube lying flat, either prone or supine. … What are the potential safety issues and harms of positional MRI technologies? … i Types of patients/patient selection criteria: inclusion and exclusion criteria, characteristics
of … enrolled patients (demographics, disease spectrum).
-
effectivehealthcare.ahrq.gov/products/cancer-anemia-update/research-protocol
June 16, 2010 - The 2006 CER revealed safety concerns for the erythropoietic stimulants as a class. … In an individual patient data meta-analysis of 13,933 patients in 53 trials treated with epoetin alfa … Study and Independent Patient Level Meta-Analysis Selection:
Results from study- and patient-level meta-analysis … Erythropoietin or Darbepoetin for patients with cancer--meta-analysis based on individual patient data … Meta-analyses of safety data: a comparison of exact versus asymptotic methods.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/gerd_executive.pdf
September 01, 2011 - are made in
the report, its conclusions should have clinical
applicability because they laid out the safety … Objective outcomes addressed include
esophagitis healing, ambulatory pH, other indicators of
reflux, … placebo
in improving asthma symptoms, nocturnal asthma, or
use of asthma medications, or in objective indicators … Administrative databases can
provide additional data for addressing long-term
safety issues. … Objective outcomes addressed include
esophagitis healing, ambulatory pH, other indicators of reflux,
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effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1306.pdf
July 01, 2013 - safety evaluation. … , thus disrupting the current health care model for this patient population. … data
and postmarket safety evaluation—set forth by FDA. … data and postmarket safety evaluation—set forth by FDA. … would view lorcaserin if it demonstrates safety and efficacy in a
majority of patients.
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effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1312.pdf
December 01, 2013 - of administration would be unlikely to deter liraglutide use if it
demonstrates safety and efficacy … Duo positively if it demonstrates safety and efficacy in clinical trials. … , thus disrupting the current health care model for this patient population. … data and postmarket safety evaluation—set forth by FDA. … if it demonstrates both short- and long-term safety and efficacy in a
majority of patients.
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effectivehealthcare.ahrq.gov/sites/default/files/related_files/ischemic-stroke-treatment_executive.pdf
January 01, 2011 - report: author identification,
year of publication, study design characteristics, study
population, patient … different types of
neurothrombectomy devices, what are the
type(s) of devices, study designs and sizes,
patient … patient discharge. … We did not draw conclusions
regarding their effectiveness or safety. … the topic, including randomized
controlled trials to determine the optimal device(s) to
use, and the patient