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  1. effectivehealthcare.ahrq.gov/sites/default/files/related_files/trauma-interventions-maltreatment-child_executive.pdf
    April 01, 2013 - and pharmacological) that address child well-being and/or promote positive child welfare outcomes (safetySafety (i.e., prevention of maltreatment recurrence) b. … 1,26 163 Insufficient PCIT Adaptation Package PCIT Adaptation Package Enhancedc Safety 1,31 … 75 Insufficient Usual care Safety 2,28, 31 153 Low, G1>G2; NRd PCIT Adaptation Package Enhancedc … Usual care Safety 1,31 88 Insufficient SafeCare Usual care Safety 1,29 2175 Moderate, G1>G2; HR=0.74
  2. effectivehealthcare.ahrq.gov/sites/default/files/related_files/main-apps-surv-report-3-acute-pain.pdf
    June 01, 2022 - Efficacy and safety of two fixed-dose combinations of tramadol hydrochloride and diclofenac sodium … Efficacy and safety of two fixed-dose combinations of tramadol hydrochloride and diclofenac sodium … Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain: … The efficacy and safety of gabapentinoids in total joint arthroplasty: systematic review and direct … Efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) for postoperative pain
  3. effectivehealthcare.ahrq.gov/sites/default/files/pdf/weight-gain-prevention_research-protocol.pdf
    January 01, 2020 - The safety issues to be addressed will also help individuals and clinicians to take into consideration … Objectives We aim to compare the effectiveness, safety and impact on quality of life of individual … Methods We will conduct a systematic review of the comparative effectiveness and safety of individual … Recommended duration of use Orlistat Alli, Xenical Oral 1-2 hours Lipase inhibitor BMI≥27 Safety … For the intermediate outcomes, safety and quality of life outcomes the timepoints of interest are:
  4. effectivehealthcare.ahrq.gov/sites/default/files/related_files/unpublished-drug-trials-white-paper.pdf
    December 01, 2024 - Integrating FDA reviews into systematic reviews might enhance the assessment of drug efficacy and safety … Efficacy and safety of paroxetine treatment for chronic PTSD: a fixed-dose, placebo- controlled study … Efficacy and safety of mifepristone in the treatment of male US veterans with posttraumatic stress
  5. S44 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/s44.pdf
    October 01, 2007 - administrative databases enable low-cost pragmatic randomized trials (PRTs) of drug effectiveness and safety … Low cost and simplicity of DD trials partly compensate for some limita- tions for evaluating drug safety … Presented at the DEcIDE Program Symposium Comparative Effectiveness and Safety: Emerging Methods, Agency … Therapeutics at University of British Columbia, concluded that neither the long-term effectiveness nor the safety … not know what an ethics review committee might have decided (before the withdrawal of rofecoxib for safety
  6. effectivehealthcare.ahrq.gov/sites/default/files/pulmonary-horizon-scan-high-impact-1512.pdf
    December 01, 2015 - The most common adverse reactions reported, including in the long-term safety study, include appetite … One phase III trial is ongoing, evaluating pirfenidone’s long-term safety and efficacy in patients … However, experts thought that patients are likely to accept lumacaftor/ivacaftor if long-term safety … Efficacy and safety of pirfenidone for idiopathic pulmonary fibrosis. … Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis.
  7. effectivehealthcare.ahrq.gov/sites/default/files/pdf/venous-ulcers-treatment-future_research.pdf
    January 01, 2014 - dressings”), local or systemic antimicrobials, and venous surgery.5 The comparative effectiveness and safety … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention … given Estimated primary completion date: Not given Purpose: Pilot Study to Evaluate the Safety … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention
  8. effectivehealthcare.ahrq.gov/sites/default/files/related_files/preterm-birth-terbutaline-pump_surveillance.pdf
    January 30, 2013 - questions to evaluates the level of evidence currently available to support the effectiveness and safety … The objectives of this review were to examine the efficacy, effectiveness, and safety of the SQ terbutaline … Cycle 1 (May 2012) No new eligible evidence was identifie d None None No new safety alert Both … evidence was identifie d safety alert conclusion was still valid, and they were not aware of any … Cycle 1 (May 2012) No new eligible evidence was identifie d None None No new safety alert Both
  9. effectivehealthcare.ahrq.gov/sites/default/files/pdf/preterm-birth-terbutaline-pump_surveillance.pdf
    January 30, 2013 - questions to evaluates the level of evidence currently available to support the effectiveness and safety … The objectives of this review were to examine the efficacy, effectiveness, and safety of the SQ terbutaline … Cycle 1 (May 2012) No new eligible evidence was identifie d None None No new safety alert Both … evidence was identifie d safety alert conclusion was still valid, and they were not aware of any … Cycle 1 (May 2012) No new eligible evidence was identifie d None None No new safety alert Both
  10. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/obesity_hi_impact.pdf
    April 17, 2012 - data and postmarket safety evaluation, set forth by the U.S. … In May 2010, FDA approved a revised label for orlistat, relaying new safety information to health care … FDA expressed concerns about the long-term cardiovascular safety profile in the overweight and obese … Experts also opined that further studies evaluating efficacy and safety are needed. … Safety and efficacy study of EndoBarrier in subjects with type II diabetes and obesity.
  11. effectivehealthcare.ahrq.gov/sites/default/files/pulmonary_hi_impact.pdf
    April 01, 2012 - In a clinical trial, the effectiveness and safety of BT versus a sham procedure in patients (n = 288) … Thermoplasty System for treatment-resistant asthma studies to investigate the system’s long-term safety … Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter … PMA P080032: FDA summary of safety and effectiveness data (SSED) for the Alair bronchial thermoplasty … Safety of bronchial thermoplasty out to 5 years in patients with severe refractory asthma: research
  12. effectivehealthcare.ahrq.gov/sites/default/files/related_files/head-neck-cancer_disposition-comments.pdf
    May 27, 2010 - Research Review Disposition of Comments Report Research Review Title: Comparative Effectiveness and Safety … Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer. … The field frequently relies upon institutional observational series to assess efficacy and safety of … All of these phase II multi-institutional trials have confirmed the feasibility and safety of IMRT across … Research Review Disposition of Comments Report Research Review Title: Comparative Effectiveness and Safety
  13. Diabetes Mellitus (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/diabetes-horizon-scan-high-impact-1406.pdf
    September 26, 2014 - Experts commenting on this intervention cited a limited amount of safety and efficacy data. … In September 2013, Ly and colleagues reported outcomes from a study assessing the safety and efficacy … The ASPIRE study reportedly met safety and efficacy endpoints and provided clinical validation for … Summary of safety and effectiveness data (SSED). MiniMed 530G system. P120010. … A study of the safety and efficacy of a new treatment for diabetic macular edema.
  14. effectivehealthcare.ahrq.gov/sites/default/files/pdf/cancer-anemia-update_research-protocol.pdf
    June 16, 2010 - The 2006 CER revealed safety concerns for the erythropoietic stimulants as a class. … Moreover, these safety concerns could not be narrowly attributed to use of ESAs to achieve high hemoglobin … In 2007, the FDA issued warnings and labeling changes consistent with the safety concerns raised in … a decade to treat various anemias; they have similar clinical efficacy.3,4 In a recent review of safety … Meta-analyses of safety data: a comparison of exact versus asymptotic methods.
  15. effectivehealthcare.ahrq.gov/sites/default/files/related_files/musculoskeletal-disorders-imaging_disposition-comments.pdf
    November 01, 2011 - Safety: The ramfiicaitons regarding potential need for alternative imaging methods (pg 16, lines 10- … 13) to rule out specific pathologies is to some extent a safety issue (e.g. ? … types of implications there may be for false + and false - Please see response above regarding safety … regarding the association between test diagnostic validity and potential implications for patient safety … vs. an adverse event related to the safety of the device or procedure?
  16. effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND-0376-140408.pdf
    November 06, 2013 - factors prompting the admission  Individual and family felt the stay was sufficient to address safety
  17. Untitled (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/pdf/infertility_research-protocol.pdf
    October 12, 2015 - KQ 1: What are the comparative safety and effectiveness of available treatment strategies for women … KQ 2: What are the comparative safety and effectiveness of available treatment strategies for women … KQ 3: What are the comparative safety and effectiveness of available treatment strategies for women … KQ 4: What are the comparative safety and effectiveness of available treatments for women with tubal … Safety of assisted reproductive technology in the United States, 2000-2011.
  18. effectivehealthcare.ahrq.gov/sites/default/files/pdf/allergy-seasonal_research-protocol.pdf
    March 08, 2012 - Potential safety concerns relate to the risk of systemic corticosteroid absorption and include adrenal … Efficacy and safety beyond 3 weeks in patients with SAR have not been established.32 5. … The safety of intranasal decongestants during pregnancy has not been studied. … For children, toddlers, and infants, treatment choices are increasingly limited due to safety concerns … For both mild and moderate/severe SAR, the comparative effectiveness and safety of SAR treatments used
  19. effectivehealthcare.ahrq.gov/sites/default/files/related_files/cerebral-palsy-feeding_executive.pdf
    March 01, 2013 - finding no effect, and smaller, less rigorous studies demonstrating improvements in efficiency and safety … No effect of these appliances was seen on safety. … two publications rated as fair quality on the PEDro scale, reported improved eating efficiency and safety … Positioning Increased feeding safety and efficiency 2b (limited) Low No RCTs, but positive results … Altering food consistency Increased feeding safety and efficiency 2b (limited) Low One experimental
  20. effectivehealthcare.ahrq.gov/sites/default/files/related_files/hypertension-pulmonary-arterial_executive.pdf
    April 01, 2013 - (PAH) and asymptomatic patients at high risk for PAH, what are the comparative effectiveness and safety … KQ 2: For patients with PAH, what are the comparative effectiveness and safety of (a) echocardiography … • There were no studies of the safety of biomarker and echocardiography testing, nor were there any … We found no studies describing the safety (or harms) of echocardiography or biomarker testing. … We did not identify any eligible studies published after 1990 that evaluated the safety or efficacy

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