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221. Surveillance & Identification of Triggers for Updating Systematic Reviews for the EHC Program (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/head-neck-cancer_surveillance.pdf
     August 01, 2012 - for Updating Systematic Reviews for the EHC Program CER # 20: Comparative effectiveness and safety … KQ4 up to date • Expert opinion: conclusions for KQ1-4 still valid • There are no new significant safety … up to date • Expert opinion: conclusions for KQ1-4 are still valid • There are no new significant safety … FDA surveillance alerts (Cycle 2): No relevant safety alerts. 10 1st Assessment Conclusion: … Comparative effectiveness and safety of radiotherapy treatments for head and neck cancer.

222. Atrial-Fibrillation Executive (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/atrial-fibrillation_executive.pdf
     June 01, 2013 - Scope and Key Questions This CER was funded by AHRQ and is designed to evaluate the comparative safety … Specifically: • KQ 1: What are the comparative safety and effectiveness of pharmacological agents … • KQ 2: What are the comparative safety and effectiveness of a strict rate-control strategy versus … Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups … • Data are also insufficient as to whether the safety and effectiveness of these therapies differ

223. Systematic Review on Opioid Treatments for Chronic Pain: Surveillance Report 2 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/opioid-chronic-pain-surveillance-report-2.pdf
     April 01, 2022 - Safety Events Associated with Tramadol Use Among Older Adults with Osteoarthritis. … Safety Events Associated with Tramadol Use Among Older Adults with Osteoarthritis. … Predicting opioid therapy safety in pancreatic cancer patients. … Safety and efficacy of the unique opioid buprenorphine for the treatment of chronic pain. … Efficacy and safety of morphine hydrochloride in cancer patients with chronic pain.

224. Whole-Body Vibration Therapy for Osteoporosis (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-vibration-therapy_technical-brief.pdf
     January 01, 2020 - However, safety concerns emerged from key informant discussions, including unknown long-term harms … Some platforms have safety features, such as a handrail for balance. … Vibration exposure, therapeutic and occupational, presents safety concerns. … A number of safety issues for consumers, including safety features available on the devices and the … Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials.

225. Obesity (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1312.pdf
     December 01, 2013 - data and postmarket safety evaluation—set forth by FDA.23,24 Until mid-2012, orlistat, a pancreatic … data and postmarket safety evaluation—set forth by FDA.23,24 Until mid-2012, orlistat, a pancreatic … If liraglutide demonstrates safety and long-term efficacy, it could fulfill a large unmet 14 … data and postmarket safety evaluation—set forth by FDA. … A prospective, randomized multicenter study to evaluate the safety and efficacy of the ReShape Duo

226. AHRQ's Evidence-based Practice Center Division Annual Report 2022: Solving the Puzzle for Evidence-Based Decision Making (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-year-in-review-2022.pdf
     January 01, 2022 - Department of Transporation National Highway Traffic Safety Administration (NHTSA). … The modifying effect of the serum-to-dialysate potassium gradient on the cardiovascular safety of SSRIs … Patient Safety Practices To Address Harms Resulting From Patient-Clinician Real-Time Clinical Encounters … Patient Safety Practices To Address Harms Resulting From Patient-Clinician Real-Time Clinical Encounters … Agency for Healthcare Research and Quality (AHRQ) – Center for Quality Improvement and Patient Safety

227. AHRQ Evidence-Based Practice Center (EPC) Program Research Gaps Summary: Pain Management (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/gaps-pain-management.pdf
     January 01, 2023 - Explanatory and pragmatic trials with long-term followup to evaluate differential effectiveness and safety … Study Design • Longitudinal explanatory and pragmatic trials to evaluate effectiveness and safety … Design • Trials with sufficient sample size designed to evaluate differential effectiveness and safety … • Studies with sufficient size to evaluate differential effectiveness and safety of treatments in … products/acute-pain-ems/research Purpose This report, nominated by the National Highway Traffic Safety

228. Layout 1 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_executive.pdf
     June 01, 2011 - adult patients with essential hypertension, how do ACEIs, ARBs, and direct renin inhibitors differ in safety … For RCTs, this translates to a difference in renin inhibitors differ in safety, Insufficient rates of … For RCTs, this translated to an absolute difference in renin inhibitors differ in safety, ARB); withdrawals … major cardiovascular events [myocardial infarction (MI), stroke] and measures of quality of life). • Safety … (For practical reasons, we separate safety/adverse events and tolerability/persistence [including switch

229. PREGNANCY, INCLUDING PRETERM BIRTH #12 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pregnancy-horizon-scan-high-impact-1506.pdf
     November 01, 2016 - GnRH receptor agonists, some of which are available in generic formulations, if it shows improved safety … A clinical study to evaluate the safety and efficacy of elagolix in subjects with moderate to severe … Study to evaluate the long-term safety and efficacy of elagolix in subjects with moderate to severe … A global phase 3 study to evaluate the safety and efficacy of elagolix in subjects with moderate … Global study to evaluate the long-term safety and efficacy of elagolix in subjects with moderate

230. Evidence-based Practice Center Systematic Review Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/type-2-diabetes-medications-update_research-protocol.pdf
     April 06, 2010 - Evidence-based Practice Center Systematic Review Protocol Project Title: Comparative Effectiveness and Safety … Key Question 3: In adults age 18 or older with type 2 diabetes mellitus, what is the comparative safety …  Macular edema or decreased vision  Gastrointestinal (GI) side effects Key Question 4: Do safety … Outcomes include intermediate outcomes, long-term outcomes, safety, adverse events, mortality, and quality … Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults With Type 2 Diabetes.

231. PREGNANCY, INCLUDING PRETERM BIRTH #12 (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pregnancy-horizon-scan-high-impact-1512.pdf
     November 01, 2016 - GnRH receptor agonists, some of which are available in generic formulations, if it shows improved safety … Study to evaluate the long-term safety and efficacy of elagolix in subjects with moderate to severe … A global phase 3 study to evaluate the safety and efficacy of elagolix in subjects with moderate … Global study to evaluate the long-term safety and efficacy of elagolix in subjects with moderate … A clinical study to evaluate the safety and efficacy of elagolix in subjects with moderate to severe

232. RESPONSE TO REQUEST FOR WORK ASSIGNMENT (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/copd-anticholinergic-medicines_research.pdf
     December 01, 2009 - patients, and policymakers seeking unbiased information about the outcomes, clinical effectiveness, safety … Methodologic challenges to studying patient safety and comparative effectiveness. … Pooled clinical trial analysis of tiotropium safety. Chest 2006 Dec;130(6):1695-703. 20. … The multiple propensity score for analysis of dose- response relationships in drug safety studies. … Methodologic challenges to studying patient safety and comparative effectiveness.

233. Obesity (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/obesity-horizon-scan-high-impact-1306.pdf
     July 01, 2013 - safety evaluation. … data and postmarket safety evaluation—set forth by FDA. … If liraglutide demonstrates safety and long-term efficacy, it could fulfill a large unmet need. … data and postmarket safety evaluation—set forth by FDA. … A prospective, randomized multicenter study to evaluate the safety and efficacy of the ReShape Duo

234. Antipsychotics-Adults Executive (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/antipsychotics-adults_executive.pdf
     August 01, 2012 - Tables with a summary of findings for efficacy and safety are presented below. … Summary of the strength of evidence for medication-associated adverse events and safety (KQ3) Adverse … In general, the findings for AEs were consistent between reviews, showing poorer safety profiles with … focused on the comparative effectiveness of FGAs versus SGAs, but not on their effectiveness and safety … Finally, data on long-term safety are lacking and urgently needed. 14 References 1.

235. Evidence-based Practice Center Systematic Review Protocol (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/progestogens-preterm-birth_research-protocol.pdf
     June 01, 2010 - be supported, including its mechanism of action, clinical indications, optimal forms, dosing, and safety … of gestation, because unresolved issues such as optimal route of drug delivery and long-term drug safety … sepsis) • Longer term outcomes Question 3 How do the effectiveness, adverse effects, and safety … Question 4 How do the effectiveness, acceptability, adherence, adverse effects, and safety of progestogen … Question 5 How do the effectiveness, adverse effects, and safety of progestogen treatment differ based

236. Disposition of Comments for Migraine in Adults: Preventive Pharmacologic Treatments (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/migraine-prevention_disposition-comments.pdf
     April 18, 2013 - Reviewer 3 ES: Treatment safety is defined by the rates of adverse effects that lead to treatment … not true, it also includes all AE reports We revised this sentence as follows: “Treatment safety is … Pediatric safety trials should examine adverse effects at 12 months or more. … safety but no efficacy report. to what purpose? … effects) rather than “general safety” or “reasonable tolerability” of the drugs.

237. Cover Page (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/it-architecture-for-post-marketing-surveillance-arizona-cert.pdf
     September 01, 2007 - Keywords: Adverse event reporting, community pharmacy safety network, post-marketing surveillance … The DERMS system is based on a community pharmacy based safety network and involves the participation … reviewers and researchers on a quarterly basis for analyzing drug interactions and monitoring drug safety … part of the CPSN, the DERMS system can be adapted to serve as a general pharmacy based patient safety … In the case of confirmed adverse effects, a report can be sent to the FDA’s office of drug safety.

238. Case Study Comparing Bayesian and Frequentist Approaches for Multiple Treatment Comparisons (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/indirect-comparisons_research.pdf
     March 01, 2013 - While frequentist and Bayesian analyses produced broadly comparable odds ratios of safety and efficacy … As such, treatment decisions should be made based on comparative safety of the drugs. … Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study. … Efficacy and safety of tolterodine in patients with detrusor instability: a dose-ranging study. … Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome.

239. Methods Research Report: Testing a Machine Learning Tool for Facilitating Living Systematic Reviews of Chronic Pain Treatments (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-report-testing-machine-learning-tool-chronic-pain.pdf
     November 01, 2020 - A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. … Evaluation of efficacy and safety of gabapentin, duloxetine, and pregabalin in patients with painful … Comparative safety and tolerability of duloxetine vs. … Effectiveness and safety of Tapentadol Prolonged Release (PR) versus a combination of Tapentadol PR … A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety

240. Health-Careassociated-Infections Executive (pdf file)
     effectivehealthcare.ahrq.gov/sites/default/files/related_files/health-careassociated-infections_executive.pdf
     November 01, 2012 - practices:8 • Theory behind patient safety practice • Existing patient safety infrastructure • External … patient safety culture and teamwork at the unit level. … Assessing the Evidence for Context-Sensitive Effectiveness and Safety of Patient Safety Practices: … Advancing the science of patient safety. Ann Intern Med. 2011 May 17;154(10):693-6. … What are the most effective strategies for improving quality and safety of health care?