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1161. 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?

1162. Layout 1 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/related_files/gerd_executive.pdf
      September 01, 2011 - publication of approximately 3,000 new studies; the introduction of novel drugs; the recognition of new drug safety … are made in the report, its conclusions should have clinical applicability because they laid out the safety … potential necessity for lifelong medical therapy raises the possibility of unidentified long- term safety … Therefore, systematic monitoring of long-term safety data on PPIs should be emphasized, as well as better … Administrative databases can provide additional data for addressing long-term safety issues.

1163. Patient-Centered-Medical-Home Executive (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/related_files/patient-centered-medical-home_executive.pdf
      July 01, 2012 - variety of health care needs of patients and to improve patient and staff experiences, outcomes, safety … care that uses alternative methods of communication, and a systems-based approach to quality and safety … comprehensive PCMH interventions hold promise as a pathway to improved primary health care quality, safety … A systems-based approach to improving quality and safety 3. … increased provider burden (e.g., enhanced access through 24/7 coverage and email) and potential patient safety

1164. PEPTIC ULCER #11 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/peptic-ulcer-horizon-scan-high-impact-1312.pdf
      December 01, 2013 - and efficacy and the lack of long-term data on safety and efficacy. … Additional scrutiny of teduglutide’s safety and its impact on cost of care is likely going forward … However, other experts noted that clinicians may hesitate to perform this procedure until more safety … Summary of safety and effectiveness data (SSED). LINX reflux management system. P100049. … The LINX reflux management system: confirmed safety and efficacy now at 4 years.

1165. Functional-Limitations-Horizon-Scan-High-Impact-1306 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/functional-limitations-horizon-scan-high-impact-1306.pdf
      June 01, 2013 - 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 … Safety concerns could be a barrier to clinician acceptance, several experts thought, because device … The device’s perceived complex nature, the existence of comparators, and limited safety and efficacy … Safety and performance evaluation of ReWalk reciprocating gait orthosis (RGO).

1166. Horizon Scanning Protocol and Operations Manual January 2013 Revision (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/ahrq-healthcare-horizon-scan-protocol-operations-manual_130826.pdf
      August 01, 2013 - Potential Patient and Clinical Staff Safety Issues 14. … Patient Safety Issues (if applicable) 11. Required Resources 12. … data from conferences or published articles reporting different results or confirming efficacy and safety … Safety data that could change perspectives 4. … A patient safety alert been issued that could signal a safety/efficacy change in perspectives?

1167. Autism-Update Clinician (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/pdf/autism-update_clinician.pdf
      September 01, 2014 - According to the United States Food and Drug Administration, there are serious safety issues associated

1168. Disposition of Comments for Evidence Report #208 Part 5 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/related_files/public-reporting-quality-improvement_disposition-comments.pdf
      July 26, 2012 - directions of public reporting -- for example, in support of value-based purchasing, administration-wide safety … The report also highlights that public reporting should make a distinction between quality and safety … precision of the evidence for public reporting outcomes, with special focus on separating quality and safety … repository that can contain information on public reporting, while separating data on quality and safety … take tremendous time from care- givers on the front line and may actually detract from quality and safety

1169. Urinary-Incontinence-Treatment Executive (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/related_files/urinary-incontinence-treatment_executive.pdf
      April 01, 2012 - Several retrospective observational studies analyzed the long-term comparative effectiveness and safety … safety was rarely available in RCTs, despite high discontinuation rates suggesting that there were … drugs’ adverse effects in clinical practice could provide information about long-term comparative safety … • Evidence is insufficient for the long-term safety of pharmacological treatments. … Safety profile of tolterodine as used in general practice in England: results of prescription-event

1170. Crosscutting-Horizon-Scan-High-Impact-1412 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/crosscutting-horizon-scan-high-impact-1412.pdf
      December 01, 2014 - Although propofol may be preferred for these reasons, safety concerns complicate its use. … benefits of wider access to ES-4 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 primary endpoint was a composite safety measure (area under the curve of oxygen desaturation [AUCDesat … the Sedasys can be used.7 The FDA approval requires that EES conduct two postmarketing studies on safety

1171. Gout Executive-2016 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/related_files/gout_executive-2016.pdf
      January 01, 2016 - The safety of tests used to diagnose gout also needs to be considered. … Potential safety concerns include acute physical discomfort from joint aspiration and long-term effects … Therefore, we have undertaken a systematic review of studies examining the accuracy and safety of tests … The focus of this report is on evaluating the validity and safety of existing diagnostic methods for … Summary of findings on comparative accuracy and safety of gout diagnostic methods Outcomes Level

1172. S29 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/s29.pdf
      October 01, 2007 - They pointed out that if existing evidence suggested that 2 or more drugs had comparable efficacy and safety … whether less expensive is as effective) Would not be a significant factor; medication effectiveness and safety … Would not have similar evidence-base for both drugs; 1 yr not sufficient to evaluate safety or side effect … Choose study drugs (treatment arms) for which there is no evidence of differential effectiveness or safety

1173. Arthritis-Knee-Physical-Therapy Research-Protocol (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/pdf/arthritis-knee-physical-therapy_research-protocol.pdf
      April 01, 2010 - integration or reintegration Injury prevention or reduction with use of devices and equipment Safety … o Long-term outcomes (>3 months) • Settings Outpatient and home-based care settings • Safety … We will monitor the FDA Web site for warnings and safety information for all eligible devices. … Evidence-based Practice Center Systematic Review Protocol Outpatient and home-based care settings • Safety

1174. Arthritis and Nontraumatic Joint Disease (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/arthritis-horizon-scan-high-impact-1506.pdf
      June 01, 2015 - Novartis Pharmaceuticals. 16 week efficacy and 2 year long term safety and efficacy of secukinumab … Novartis Pharmaceuticals. 16 week efficacy and 5 year long term efficacy, safety and tolerability … anti-interleukin-17a monoclonal antibody, improves active psoriatic arthritis: 24-week efficacy and safety … antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety … 17a-monoclonal-antibody-improves-active-psoriatic-arthritis-and-inhibits-radiographic-progression-efficacy-and-safety-data-from-a-phase

1175. Urinary-Incontinence-Treatment Research-Protocol (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/pdf/urinary-incontinence-treatment_research-protocol.pdf
      September 30, 2010 - Minnesota Pulsegen device Certificate of Approval for Use of GS Symbol No. 95 44 083; LGA, Equipment Safety … Twin (Vitacon AS, Trondheim, Norway) Vaginal cones Mabella cones (Vitacon AS, Trond-heim, Norway) Safety … We will monitor the FDA website for warnings and safety information for all eligible drugs and devices … will analyze the harmful effects of drugs from all sources including efficacy, effectiveness, and safety … Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis

1176. Arthritis and Nontraumatic Joint Disease (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/01_arthritis_potential_high_impact_2012-12-10.pdf
      January 01, 2012 - pricing than injectable biologic therapies, but some experts expressed strong concerns regarding its safety … stated MSC therapy is investigational because of insufficient evidence or insufficient long-term safety … Both groups had similar safety profiles. 29 In a study of patients with knee OA (Outerbridge grades … such as a hospital blood bank or blood processing laboratory) according to standard blood processing safety … These safety concerns could present significant barriers to diffusion.

1177. Insulin Delivery and Glucose Monitoring Methods: Future Research Needs (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/pdf/insulin-blood-sugar_research.pdf
      August 01, 2015 - Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention … Study design: Endpoint Classification: Safety Study Intervention Model: Single Group Assignment … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention … Study design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention

1178. DEMENTIA INCLUDING ALZHEIMER'S #04 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/dementia_horizon-scan-high_impact-1306-revised.pdf
      July 09, 2013 - some thought that knowing that a patient has AD could aid planning for patients in terms of patient safety … florbetapir scan does not establish a diagnosis of AD or other cognitive disorder, and florbetapir’s safety … the other hand, some experts thought that having the diagnosis would enable planning for patient safety … They thought that the drug’s well-known safety profile and long history of use (in diabetes) would … Safety and effectiveness study of intranasal insulin glulisine on cognitive and memory in mild-mod

1179. #05 DEPRESSION (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/depression-horizon-scan-high-impact-1412.pdf
      December 01, 2014 - Adoption could be limited by ketamine’s cost, inconsistent clinical trial data, and safety risks, multiple … But one expert with a research 5 background, citing ketamine’s safety risk and lack of long-term … and clinician adoption, predicted that acceptance would be limited; these experts cited ketamine’s safety … In contrast, scopolamine’s known safety profile and possible oral and patch delivery options, bolstered … A study to evaluate the safety and efficacy of intranasal esketamine in treatment-resistant depression

1180. DEMENTIA INCLUDING ALZHEIMER'S #04 (pdf file)
      effectivehealthcare.ahrq.gov/sites/default/files/dementia_hi_impact.pdf
      January 01, 2012 - the other hand, some thought that knowing that a patient has AD could aid planning in terms of safety … On the other hand, some experts thought that having the diagnosis would enable planing for safety … A diagnosis could, however aid patients and families in planning for the care and safety of the patient