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  1. effectivehealthcare.ahrq.gov/sites/default/files/related_files/abnormal-uterine-bleeding_disposition-comments.pdf
    March 21, 2013 - AUB-E wasn’t acknowledged and patients were not systematically evaluated for AUB-C. … For KQ1B, risk of bias associated with blinding of patients, personnel and outcome assessment was … For KQ1A, risk of bias associated with blinding of patients and personnel and incomplete outcome data … section identifies 4 studies that may provide additional information on relative effectiveness and safety … commended for a careful and detailed analysis of a large number of studies assessing effectiveness and safety
  2. effectivehealthcare.ahrq.gov/sites/default/files/08_functional_limitations_potential_high_impact_2012-12-10.pdf
    January 01, 2012 - Use of the system would represent a way to purportedly enhance patient mobility and allow patients … of dimethyl fumarate because of the efficacy and safety profile reported in patients with RRMS. … Experts remained divided on per-patient costs with OBI-1 therapy, but thought clinicians and patients … Regarding potential acceptance by patients and clinicians, one clinical expert commented, “The safety … One research expert opined that elderly patients may have more reservations than a younger patient
  3. effectivehealthcare.ahrq.gov/sites/default/files/pdf/bariatric-surgery_research.pdf
    June 01, 2010 - about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and … We tabulated the number of unique therapeutic classes of drug that the patient had ―on hand‖ at the … If this supply would result in the patient having sufficient drug ―on hand‖ to overlap with a seven … day window surrounding the time point of interest, the patient was considered to have been on this … utilization variables (hospitalizations, outpatient visits, medical and pharmacy payments) and other indicators
  4. Hi Les, (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/pdf/rtc-design-principles_research.pdf
    January 01, 2009 - the new test produces other benefits, such as improved safety or reduced costs. … more efficient RCT designs may be possible.1,2 In other situations, comparative evidence about the safety … itself, such as safety and acceptability, without changing patient management. … As shown in Figure 1, differences in test safety and test accuracy always deserve consideration. … Alternatively, if the new test is intended to provide other attributes such as improved safety, the
  5. effectivehealthcare.ahrq.gov/sites/default/files/related_files/cad-women-diagnosis_executive.pdf
    June 01, 2012 - In secondary analyses, we explored a broader patient population by including those studies that had … Insufficient 13 studies (9 good quality, 4 fair) reported data pertinent to safety concerns or risks … Study results on these issues were reported for the total patient population and did not separate the … Third, most studies lacked long-term followup of the patient population, which affected our ability … Reporting of risk, harms, and/or safety outcomes.
  6. effectivehealthcare.ahrq.gov/sites/default/files/ahrq-healthcare-horizon-scan-protocol-operations-manual-151001.pdf
    September 01, 2015 - Anticipated Cost Per Patient (if known) 11. … Potential Patient and Clinical Staff Safety Issues 14. … Patient Safety Issues (if applicable) 11. Required Resources 12. … as • Additional, stronger, confirmatory data that could change perspectives on potential impact • Safetysafety alert been issued that could signal a safety/efficacy change in perspectives 2.
  7. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ahrq-healthcare-horizon-scan-protocol-operations-manual-151001.pdf
    September 01, 2015 - Anticipated Cost Per Patient (if known) 11. … Potential Patient and Clinical Staff Safety Issues 14. … Patient Safety Issues (if applicable) 11. Required Resources 12. … as • Additional, stronger, confirmatory data that could change perspectives on potential impact • Safetysafety alert been issued that could signal a safety/efficacy change in perspectives 2.
  8. effectivehealthcare.ahrq.gov/sites/default/files/pdf/health-systems-research.pdf
    October 01, 2017 - The experience and reputation are the most important indicators a KI uses for whether a source will … They were interested in the most reasonable actions, not necessarily a list of options, to use in patient … How to use evidence that is frequently not applicable to the typical patient or patient subset seen … KIs were concerned about the extent to which the evidence in the literature is applicable to the patient … to get these patients and so how can we sort of assess these patients in a way that really helps us
  9. effectivehealthcare.ahrq.gov/sites/default/files/related_files/coronary-artery-stenting_disposition-comments.pdf
    February 26, 2013 - ) with Figures 3 and 4 which for patient level data are shown for 6 RCT’s and 6 non-randomized studies … This is consistent with patients included in the various FFR trials – all patients were assessed by … Improved patient-centered outcomes from FFR have been demonstrated in a wide variety of patient subsets … of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization), safety … Enrollment in FAME II was recently halted early by the DSMB (data safety and monitoring board) due
  10. effectivehealthcare.ahrq.gov/sites/default/files/pdf/transparency-tympanostomy_research.pdf
    June 01, 2017 - The information in this report is intended to help health care decisionmakers—patients and clinicians … information, i.e., in the context of available resources and circumstances presented by individual patients … NCT01404611 gives results for 330 patients for time to cessation of otorrhea and adverse events up to … NCT01908803 gives results for 68 patients for proportion of subjects with sustained clinical cure at … Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion
  11. effectivehealthcare.ahrq.gov/sites/default/files/related_files/arthritis-psoriatric_surveillance.pdf
    March 01, 2013 - patients with PsA, do drug therapies differ in their ability to improve patient-reported symptoms, functional … The most commonly reported SIE in PsA patients was urinary tract infection (0.4 per 100 patient years … Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis … No safety issues noted. … The most commonly reported SIE in PsA patients was urinary tract infection (0.4 per 100 patient
  12. effectivehealthcare.ahrq.gov/sites/default/files/pulmonary-horizon-scan-high-impact-1512.pdf
    December 01, 2015 - According to the Cystic Fibrosis Foundation’s 2014 patient registry, almost 47% of CF patients in the … 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 safetySafety and efficacy of treatment with lumacaftor in combination with ivacaftor in patients with CF … Safety and tolerability of nintedanib in patients with Ipf: interim analysis from an open-label extension
  13. effectivehealthcare.ahrq.gov/sites/default/files/functional-limitations-horizon-scan-high-impact-1306.pdf
    June 01, 2013 - Using the system would represent a way to purportedly enhance patient mobility and allow patients to … fumarate because of the efficacy and safety profile reported in patients with RRMS, the experts thought … Regarding acceptance by both patients and clinicians, one clinical expert commented, “The safety profile … Experts generally agreed that potential patient adoption would be high because of patients’ desire to … One research expert opined that elderly patients may have more reservations than a younger patient
  14. effectivehealthcare.ahrq.gov/products/hypothyroidism-hyperthyroidism-screening-treatment/research-protocol
    March 10, 2010 - over 35 years of age every 5 years (more frequently if the patient is at increased risk), but has not … sh] toxicity [sh] contraindications [sh] complications [sh] 1 OR 2 OR 3 OR 4 OR 5 (safe OR safety … adverse [tiab] (effect$ OR reaction$ OR event$ OR outcome$) [tiab] 8 AND 9 10 OR 7 OR 6 P Patient … issues of testing Patient Satisfaction[Mesh] Perception"[Mesh] Family[Mesh] Stress, Physiological … Committee on Patient S, Quality I, Committee on Professional L.
  15. 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 safetySafety data that could change perspectives c. … Has a patient safety alert been issued that could signal a safety/efficacy change in perspectives?
  16. effectivehealthcare.ahrq.gov/sites/default/files/pdf/adhd-future_research.pdf
    May 01, 2012 - attention on the strength and limits of evidence from research studies about the effectiveness and safety … For KQ 2, long-term effectiveness and safety studies of several psychostimulants in children over the … Web-based prioritization exercises allowed each stakeholder to distribute a limited number of star-shaped indicators … or patient derived information … Many patients and providers are likely to switch treatments if patients experience harmful side effects
  17. effectivehealthcare.ahrq.gov/sites/default/files/01_-arthritis_potential_high_impact_june_2012.pdf
    January 01, 2012 - These safety concerns may present barriers to approval or barriers to diffusion if approved. … determinations stated MSC therapy is investigational because of insufficient evidence or long-term safety … Both groups had similar safety profiles. 29 In a study of patients with knee OA (Outerbridge grades … as a hospital blood bank or blood processing laboratory) according to standard blood processing safety … These safety concerns may present significant barriers to approval and diffusion if approved.
  18. effectivehealthcare.ahrq.gov/products/osteoarthritis-knee-update/research-protocol
    June 16, 2016 - update if needed--a systematic review that was conducted in 2007 1 that 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 OA … for scientific information packets that contain any unpublished information on the efficacy and/or safety … For assessments of safety, we will consider the consistency between the findings of trials to those of
  19. Layout 1 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/renal-artery-stenosis_executive.pdf
    October 01, 2006 - This report summarizes the evidence evaluating the effect and safety of angioplasty with stent placements … What are the patient characteristics, including etiology, predominant clinical presentation, and severity … A variety of indicators of the severity of ARAS and of health problems, such as poorer kidney function … The reviewed studies did not report any indicators that may predict improved outcomes. … The other trial included patients with lower grade stenosis (>50 percent) but did not exclude patients
  20. effectivehealthcare.ahrq.gov/sites/default/files/antipsychotics-children-update-disposition-170621.pdf
    March 16, 2017 - develop, for example if tardive dyskinesia takes years to develop then one is less certain about the safety … Was this a covariates model with subgroup indicators as covariates? … , and Thioridazine, 15 patients. … Ref 123 had one patient discontinue however it does not appear that this was considered a major AE … The objectives of this study were to collect safety data in long term treatment of pediatric subjects

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