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  1. 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.
  2. 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 reagentsPatient advocacy Web sites for colon cancer will be searched.
  3. 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.
  4. Diabetes Mellitus (pdf file)

    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 reagentsPatients 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
  5. 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.
  6. PEPTIC ULCER #11 (pdf file)

    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
  7. 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...
  8. 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
  9. 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.
  10. 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
  11. Layout 1 (pdf file)

    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).
  12. 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
  13. 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
  14. 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
  15. 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).
  16. 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.
  17. Layout 1 (pdf file)

    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,
  18. Obesity (pdf file)

    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.
  19. Obesity (pdf file)

    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.
  20. Layout 1 (pdf file)

    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, patientpatient 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

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