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  1. Layout 1 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/juvenile-arthritis-dmards_executive.pdf
    September 01, 2011 - may increasingly lead to long-term disease remission, there are many unanswered questions about the safety … How do the efficacy, effectiveness, safety, and adverse effects of treatment with DMARDs differ among … How do the efficacy, effectiveness, Insufficient Only one study—an RCT of methotrexate versus safety, … We did not identify any studies that provide reliable information on the comparative safety or rates
  2. effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-infertility_research.pdf
    June 01, 2017 - The objectives of this SR are to evaluate the comparative safety and effectiveness of treatment strategies … The KQs are listed below: KQ 1: What are the comparative safety and effectiveness of available treatment … KQ 2: 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
  3. effectivehealthcare.ahrq.gov/sites/default/files/related_files/acs-pci-adjunctive-devices_disposition-comments.pdf
    March 01, 2012 - I think it is also important to note that safety is UNCLEAR given sparse data and lack of power. … Insufficient evidence compared between devices, and safety remains unclear. … Safety, because of potential type II error, is mostly unclear. … Due to type II error, the safety of these devices is unclear.
  4. effectivehealthcare.ahrq.gov/sites/default/files/arthritis_hi_impact.pdf
    January 01, 2014 - IL-1 may be a problematic target with respect to safety in the gout patient population, however, and … and tolerability due to safety concerns over infections reported in trials thus far. … These safety concerns may present barriers to approval or barriers to diffusion if approved. … These safety concerns may present significant barriers to approval and diffusion if approved. … SLE: belimumab safety, efficacy sustained over 6 years. [internet].
  5. effectivehealthcare.ahrq.gov/sites/default/files/pdf/migraine-emergency_research-protocol.pdf
    July 18, 2011 - Question 5 Does the effectiveness and safety of the parenteral pharmacological interventions vary … Question 6 Does the effectiveness and safety of adding parenteral or oral CSs to acute parenteral … Safety: RCTs, NRCTs, and prospective cohort studies. … Dodick D, Lipton RB, Martin V, et al, for the Triptan Cardiovascular Safety Expert Panel. … Consensus statement: cardiovascular safety profile of triptans (5-HT agonists) in the acute treatment
  6. effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND_0352_09-22-2010.pdf
    January 01, 2010 - depression treatment will be a good companion to an in-process AHRQ EHC Program review titled Efficacy and Safety
  7. #14 SUBSTANCE ABUSE (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/substance-abuse-horizon-scan-high-impact-1506.pdf
    June 01, 2015 - available at a discount, close to Federal Supply Schedule pricing, for colleges, universities, public safety … have unintended consequences, such as promoting continued opioid abuse by increasing the perceived safety … Each device has a sealed product indicator window; a removable needle safety guard; and the auto-injector … auto-injectors, the Evzio carton contains a “trainer” device, which has an identical size, shape, and safety … solution to a reference product; a user-experience study with adult and juvenile volunteers; and a safety
  8. effectivehealthcare.ahrq.gov/sites/default/files/pdf/preterm-birth-terbutaline-pump_research-protocol.pdf
    October 18, 2010 - such as delay in delivery) are therefore common and meta-analyses are used to assess efficacy and safety … Further, they indicated that the lack of information on the safety of the treatment as well as the cost … Given the lack of efficacy, effectiveness, and safety data, as well as substantial cost, it is clear … Finally, published RCTs do not provide the necessary insight into questions regarding the safety of … Further, observational studies have been identified that explore issues of terbutaline safety.
  9. Menopause Executive (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/menopause_executive.pdf
    March 01, 2015 - Although no salient long term benefits were identified, neither were safety signals apparent. … Safety data are also needed for the broad array of herbs and botanicals used to treat menopausal symptoms … and efficacy, but the manufacturers are not required to submit the safety or efficacy data to FDA. … Although the gap is most concerning regarding safety, efficacy issues are important as well. … some nonhormone therapies, with reasonable certainty (i.e., moderate or greater SOE), significant safety
  10. effectivehealthcare.ahrq.gov/sites/default/files/related_files/management-adhd-adults-protocol.pdf
    June 10, 2024 - adherence.96, 106-108 Purpose of the Review This systematic review will assess the comparative safety … How do comparative safety and effectiveness vary by patient characteristics, such as age, sex/gender … Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. … Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD. … Efficacy, safety and variability in pharmacotherapy for adults with attention deficit hyperactivity
  11. effectivehealthcare.ahrq.gov/sites/default/files/related_files/management-adhd-adults-protocol-amendment.pdf
    January 08, 2025 - adherence.96, 106-108 Purpose of the Review This systematic review will assess the comparative safety … How do comparative safety and effectiveness vary by patient characteristics, such as age, sex, race, … Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. … Safety and tolerability of once versus twice daily atomoxetine in adults with ADHD. … Efficacy, safety and variability in pharmacotherapy for adults with attention deficit hyperactivity
  12. effectivehealthcare.ahrq.gov/sites/default/files/related_files/asthma-immunotherapy-2010_disposition-comments.pdf
    January 01, 2010 - Further, small studies [Phase I (safety); Phase II (dose- ranging; mechanistic)] may show effects which … subcutaneous immunotherapy, there are few studies of SLIT in moderate or severe asthmatics, and the safety … off label use of licensed products for SLIT by physicians who are falsely comforted by the current safety … The mandate of this AHRQ report is to provide evidence for the effect and safety of allergen immunotherapy … controlled European clinical trials that demonstrated clinical efficacy and a sufficient degree of safety
  13. effectivehealthcare.ahrq.gov/sites/default/files/ch_5-user-guide-to-ocer_130129.pdf
    January 01, 2012 - A comparison between aripiprazole, an antipsychotic agent with a relatively favorable metabolic safety … data sources can be linked to enhance the validity of observational comparative effectiveness and safety … same indication does not necessarily remove confounding by severity.21 For clinical effectiveness or safety … comparators, as explained in the previous section, are generally more appropriate, particularly for safety … appropriate when comparing two treatments with expected differences in the timing of beneficial or safety
  14. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ptsd-adult-treatment_disposition-comments.pdf
    April 03, 2013 - …" a) Seeking Safety (SS) was designed for both genders. … The relevant paragraph was (and still is) in the Seeking Safety results section titled Prevention … We agree that this study has some limitations that limit what we can conclude about seeking safety … Further studies would be needed to determine whether seeking safety is efficacious for improving … We also changed it to “seeking safety” rather than “safety seeking” to be consistent with wording
  15. effectivehealthcare.ahrq.gov/sites/default/files/related_files/recombinant-factor-viia_disposition-comments.pdf
    June 01, 2010 - It is unfair to label all companies as profit-driven over safety- driven. … Further, this trial was designed primarily as a safety and proof-of- concept trial. … Unfortunately, the two large, randomized controlled trials on the efficacy and safety of rFVIIa in … Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. … Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage.
  16. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/10_obesity_potential_high_impact_june_2012.pdf
    January 01, 2012 - significantly increased the regulatory bar for gaining approval—specifically regarding preapproval safety … data and postmarket safety evaluation—set forth by the U.S. … Kushner and colleagues announced results from a phase III clinical trial (SEQUEL) evaluating the safety … 2011, Allison and colleagues announced results from a 56-week clinical trial (EQUIP) evaluating the safetySafety and efficacy study of EndoBarrier in subjects with type II diabetes and obesity.
  17. effectivehealthcare.ahrq.gov/sites/default/files/ch_6-user-guide-to-ocer_130129.pdf
    October 30, 2012 - The varying definitions of MACE included one related to safety only [composite of death, MI, and stent … thrombosis (ST)], and two relating to both safety and effectiveness [composite of death, MI, ST, … The safety-only definition of MACE yielded a hazard ratio of 1.75 (p<0.05), indicating that patients … However, for the composite of safety and effectiveness endpoints, the risk of 1-year MACE was greatly … For example, once a safety signal has been identified and publicized, physicians have been alerted
  18. effectivehealthcare.ahrq.gov/sites/default/files/related_files/urinary-incontinence-treatment_surveillance.pdf
    October 29, 2012 - • There are no safety concerns Summary Decision: This CER’s priority for updating is Low … magnitude/direction of changes in estimates, potential changes in practice or therapy preference, safetySafety surveillance alerts: None Conclusion: Up to date Key Questions # 2 Signals from studies … Safety surveillance alerts: None Conclusion: 5/11 conclusions are possibly out of date 17 … Efficacy  and  safety  of  oxybutynin   chloride  topical  gel  for  women  with
  19. effectivehealthcare.ahrq.gov/sites/default/files/pdf/TND_0265_02-29-2008.pdf
    January 01, 2008 - How do the effectiveness and safety of pharmacologic and nonpharmacologic pain management interventions
  20. effectivehealthcare.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-year-in-review-2021.pdf
    January 01, 2021 - National Highway Traffic Safety Administration funding opportunity on airway management (2021) Prehospital … Safety of Vaccines Used for Routine Immunization in the United States: An Update DOI: 10.23970/AHRQEPCCER244 … Safety of vaccines used for routine immunization in the United States: An updated systematic review … National Highway Traffic Safety Administration (NHTSA) 5. … Agency for Healthcare Research and Quality (AHRQ) - Center for Quality Improvement and Patient Safety

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