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461. ECRI_Penn EPC FINAL Environ Cleaning Protocol 08_21_14 CC[1] (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/healthcare-infections_research-protocol.pdf
     January 01, 2014 - What criteria (clinical effectiveness, safety, adherence to FDA regulations, market value, others) … Centers for Disease Control and Prevention (CDC), Environmental Protection Agency (EPA), Occupational Safety … searched to identify clinical practice guidelines, white papers or position statements, regulatory or safety

462. Phenylketonuria Executive (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/phenylketonuria_executive.pdf
     February 01, 2012 - the treatment of PKU under the stipulation that studies regarding the drug’s efficacy and long-term safety … existing registry that is specific to use of Kuvan, the Phenylketonuria Demographic, Outcomes, and Safety … Long-term efficacy outcomes beyond 22 weeks and safety outcomes beyond 3 years are currently unavailable … Another commitment study that is reported as fulfilled is an open-label study to study the safety and … Safety of extended treatment with sapropterin dihydrochloride in patients with phenylketonuria: results

463. Evidence-based Practice Center Systematic Review Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/psoriasis-chronic_research-protocol.pdf
     January 10, 2012 - Published Online: January 10, 2012 this meta-analysis was the lack of comparative effectiveness and safety … To date, no comparative effectiveness review comparing the effectiveness and safety of FDA-approved … January 10, 2012 Question 2 In patients with chronic plaque psoriasis, what is the comparative safety … Synthesis KQs 1 and 2 explore the efficacy and safety of three classes of therapy for the treatment … Efficacy and safety results from the randomized controlled comparative study of adalimumab vs.

464. Disposition of Comments Report for CER 203 ADHD (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-203-adhd-disposition-comments.pdf
     January 01, 2018 - In my assessment, post-marketing surveillance studies of effectiveness and safety are badly missing … Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention- … Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attentiondeficit/ hyperactivity … A long-term o pen-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents … Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit

465. Evidence-based Practice Center Systematic Review Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/treatment-resistant-depression_disposition-comments.pdf
     September 01, 2011 - inclusion of this study further underscores the point that there is now substantial evidence of the safety … (2007) Efficacy and Safety of Transcranial Magnetic Stimulation in the Acute Treatment of Major Depression … of this data would dominate the sample database upon which to draw definitive conclusions about the safety … Mark George Key Question 4 The report does not cite the most recent worldwide safety and side effect … and collapses across all modalities of ECT which obscures the clinical reality that the efficacy and safety

466. Treatment Resistant Depression Surveillance FINAL (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/treatment-resistant-depression_surveillance.pdf
     April 01, 2016 - For adults with TRD, do nonpharmacologic interventions differ in their safety, adverse events, or adherence … 5 subject matter experts, and concluded that all conclusions related to comparative efficacy and safety … The assessment did not include additional safety concerns, and while several identified studies suggested … Key Question 4: For adults with TRD, do nonpharmacologic interventions differ in their safety, adverse … Current Literature Search (March 2016) Expert Opinion Surveillance Assessment In examining safety

467. Treatment of Osteoarthritis of the Knee: An Update (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoarthritis-knee-update_research-protocol.pdf
     June 15, 2016 - , exercise, braces and orthotics, and arthroscopic lavage, as well as the comparative efficacy and safety … to update if needed—a systematic review that was conducted in 20071that assessed the efficacy and safety … As a result of the divergent findings of several recent systematic reviews on the efficacy and safety … Because our EPC recently completed a SR on the effectiveness and safety of hyaluronic acid to treat … For assessments of safety, we will consider the consistency between the findings of trials to those

468. Management of Insomnia Disorder in Adults: Current State of the Evidence (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/insomnia_clinician.pdf
     August 01, 2017 - Therapy: Adverse Effects (See Table 3) �� Evidence regarding the long-term (more than 3 months) safety … Evidence regarding their longer-term efficacy and safety is limited or lacking. �� Outcome reporting

469. EPC Methods: An Exploration of Methods and Context for the Production of Rapid Reviews (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/rapid-review-production_white-paper.pdf
     February 01, 2015 - Lansdale, PA Guy Maddern, M.B.B.S., Ph.D., M.S., M.D., FRACS Surgical Director Australian Safety … The evidence of effectiveness and safety for sleeve gastrectomy suggested that it is less effective … The authors presented the clinical outcomes (safety and efficacy) discussed by each review, as well … Closer examination of the appropriateness of rapid products for issues of safety is needed. … Of specific interest is the validity of rapid products for assessing safety outcomes.

470. Recombinant-Factor-Viia Clinician (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/recombinant-factor-viia_clinician.pdf
     October 01, 2010 - rFVIIa) in the hospital setting has increased despite limited comparative data on its effectiveness and safety

471. #05 DEPRESSION (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/depression_hi_impact.pdf
     October 01, 2014 - For example, TMS is contraindicated in patients with implanted DBS devices, and the safety of ECT in … off, how to provide feedback to clinicians about the stimulation parameters, and how to recognize safety … Government has approved clinical trials assessing the safety and efficacy of MDMA for the treatment … In published results in one safety trial investigating MDMA-assisted psychotherapy in women with PTSD … The safety and efficacy of {+/-}3,4- methylenedioxymethamphetamine-assisted psychotherapy in subjects

472. Disposition of Comments for CER 160 Binge Eating Disorder (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/binge-eating-disposition-160504.pdf
     December 09, 2015 - Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating … the published data on which the drug was approved is inadequate to reach conclusions on long-term safety … However, these data should be presented, even if only to say that more data on longer terms safety … Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating … American College of Neuropsychopharmacology (ACNP 2012) • Lisdexamfetamine Dimesylate Safety and

473. Disposition of Comments Report for Antiplatelet and Anticoagulant Treatments for Unstable Angina/Non-ST Elevation Myocardial Infarction (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/angina-heart-attack-treatments_disposition-comments.pdf
     January 01, 2014 - Peer Reviewer 2 Methods The authors should consistently report separately efficacy and safety. … suggests higher support for this agent, whereas there really is no efficacy advantage but only a safety … We describe the subgroup findings for efficacy and safety endpoints when reported in the publications … This section should be renamed “impact of clopidogrel loading on efficacy and safety of bivalirudin … As such the focus should be comparisons of efficacy and safety in the subgroups with early and deferred

474. Disposition of Comments Report for Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/cad-women-diagnosis_disposition-comments.pdf
     June 12, 2012 - The safety during stress echo was shown with both genders (Males/females in contrast cohort = 57.4% … Safety of contrast agent use during stress echocardiography: a 4-year experience from a single-center … Specifically, the authors wrote that radiation safety concerns are different between women and men. … We have added more details about the radiation risk to the Safety Concerns and Risks section. … Another key objective identified was the safety of each modality.

475. 08 Functional Limitations Potential High Impact 2012-12-10 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/08_functional_limitations_potential_high_impact_2012-12-10.pdf
     January 01, 2012 - Several experts thought safety concerns could be a barrier to clinician acceptance, because device … Overall, this device’s perceived complex nature, the existence of alternatives, and limited safety … FDA did not cite any clinical safety or efficacy issues or request any additional clinical studies … Several experts thought safety concerns could be a barrier to clinician acceptance, because device … Experts expressed concerns over limited efficacy and safety studies available for this device.

476. Lysosomal-Storage-Diseases-Therapies Research-Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/lysosomal-storage-diseases-therapies_research-protocol.pdf
     November 15, 2012 - What are the potential safety issues and harms with ERT? 2. … What published and unpublished studies have reported on the use and safety of this intervention? … Adverse events/harms/safety issues reported 4.

477. medication-assisted-treatment-protocol-160224 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/opioid-use-disorder_research-protocol.pdf
     February 24, 2016 - Adverse events/harms/safety issues reported 4.   … review, and summarize the available literature to address Guiding Question 3 on the efficacy and safety … Draft  Inclusion  and  Exclusion  Criteria  for  Guiding  Question  3  on  the  Efficacy  and   Safety

478. Diagnosis of Celiac Disease: Current State of the Evidence (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/celiac-disease_clinician.pdf
     July 01, 2016 - endoscopy (VCE) for various suspected small-intestine pathologies, as no systematic reviews contained safety … systematic review represents a review of upper GI endoscopy in general, as no systematic reviews contained safety

479. Horizon-Scan Research-Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/horizon-scan_research-protocol.pdf
     December 01, 2011 - Potential Patient and Clinical Staff Safety Issues 17. … Patient Safety Issues (if applicable) 15. Required Resources 16. … data from conferences or published articles reporting different results or confirming efficacy and safety … Safety data that could change perspectives c. … Has a patient safety alert been issued that could signal a safety/efficacy change in perspectives?

480. Crosscutting-Horizon-Scan-High-Impact-1406 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/crosscutting-horizon-scan-high-impact-1406.pdf
     June 01, 2014 - Although propofol may be preferred for these reasons, its use is complicated by safety concerns. … of the controversy among clinical specialties (gastroenterology versus anesthesiology) about its safety … potential benefits of wider access to propofol-mediated sedation were significant enough to offset safety … The intent is to improve seniors’ safety, clinical outcomes, and quality of care and to reduce admissions … the Sedasys can be used.7 The FDA approval requires that EES conduct two postmarketing studies on safety