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  1. #14 SUBSTANCE ABUSE (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/substance-abuse-horizon-scan-high-impact-1412.pdf
    December 01, 2014 - Experts wanted to see additional clinical trial data assessing baclofen’s long-term safety and efficacy … solution to a reference product; a user experience study with adult and juvenile volunteers; and a safety … All adult volunteers, and 15 of 19 adolescent volunteers, successfully used Evzio, removing the safety … to patients’ families that it be available for emergency use at home. … , and patients’ families, the experts concluded.
  2. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/psoriasis-chronic_disposition-comments.pdf
    November 27, 2012 - For this reason, it is also important to capture long-term safety to obtain a global aspect of how … these therapies impact patient care, both benefits and harms. … For KQ 1, what does this patient population look like? … Efficacy and safety of infliximab vs. … One patient was reported to have hypertension in patients who switched from methotrexate to infliximab
  3. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/crohns-disease_disposition-comments.pdf
    February 25, 2014 - centered outcomes, and observational studies along with RCT for safety. … All patients in global safety summary were Crohn’s Disease patients. … Please consider inclusion of this safety data. … According to our analytic framework, patient-reported outcomes are relevant. … questions in terms of final patient important outcomes.
  4. effectivehealthcare-admin.ahrq.gov/sites/default/files/wysiwyg/pdf/mhs-IV-epc-grand-rounds-slides.pptx
    January 01, 2023 - safety and quality researchers; policymakers who work on patient safety and quality issues. 10 MHS … safety issues, and patient/consumer perspective. … safety subject matter experts within Penn Medicine and JHU’s Armstrong Institute for Patient Safety … , AHRQ’s Patient Safety Network (PSNet) website, the Joint Commission’s National Patient Safety Goals … , the National Quality Forum’s Patient Safety Report, and Becker’s Hospital Review 10 Top Patient Safety
  5. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/registries-guide-2nd-edition_disposition-comments.pdf
    March 03, 2010 - who get entered into registry vs. (2) universe of patients with condition of interest to provide an … General The use of registries for product safety assessment should augment all of the other safetysafety assessments. … and patient complexity. … used to examine safety for medical devices.
  6. effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/weight-gain-prevention_research-protocol.pdf
    January 01, 2020 - help provide an evidence base for future practice guidelines to influence individual decision making, patient … The safety issues to be addressed will also help individuals and clinicians to take into consideration … Objectives We aim to compare the effectiveness, safety and impact on quality of life of individual … Health Indicators Warehouse. Healthy Weight in Adults. … http://www.healthindicators.gov/Indicators/Healthyweightinadults_1207/Profile/Data . 3.
  7. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/stem-cell-children_surveillance.pdf
    October 29, 2012 - , 4, 5 and 6 up to date • Expert opinion: conclusions still valid • There are no new significant safety … using searches through August, 2011 and addressed six key questions to evaluate effectiveness and safety … Administration (FDA), Health Canada, and Medicines and Healthcare Products Regulatory Agency (MHRA) safety … Taken into consideration the totality of evidence (i.e., updating signals, expert opinion, and safety … Experts: Still valid Safety surveillance alerts: No Conclusion: Up to date 7 Table 1.
  8. effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/antipsychotics-children_research-protocol.pdf
    June 04, 2010 - • The following outcomes were added: patient or parent/caregiver preferences, work-related functional … outcomes, patient insight into illness. … followup), patient baseline characteristics (diagnosis and age at diagnosis, age, sex, race, weight … in each group, and the number of patients affected. … Adults Pediatric use: safety & effectiveness not established in patients <18 yr 1. agranulocytosis
  9. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/osteoarthritis-pain-2006_appendixes.pdf
    January 01, 2006 - Peds: safety and efficacy not established in pediatric patients sulindac Elimination half-life: … Patient masked? … Patient masked? … Trials of etoricoxib and lumiracoxib (Safety only) Author Year Patient masked? … Patient global response pooled data indicated that patients taking 25mg rofecoxib v celecoxib had good-excellent
  10. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-anemia-update_disposition-comments.pdf
    April 25, 2013 - or specific patient populations since there is evidence that certain groups of patients may not necessarily … However, that group was part of the patient population defined for the review. … more in this manuscript because it is relevant to clinical practice and it is the reason for ongoing safety … measures in accordance with the AHRQ Methods Guide, these data are clinically important to consider for safety … Since the 2008 ODAC meeting, there have been no new safety signals that would warrant the conclusion
  11. Diabetes Mellitus (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/diabetes-horizon-scan-high-impact-1306.pdf
    January 01, 2016 - for calibrating the CGM (as applicable) and checking sensor performance as needed plus associated reagents … But the experts called for longer safety and efficacy studies to determine whether this system would … Genentech has a patient assistance program to help defray costs for qualified patients.135 Several … Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to … Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus
  12. Layout 1 (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-anemia_executive.pdf
    May 01, 2006 - What are the comparative efficacy and safety of epoetin (alfa or beta) and darbepoetin? 2. … Are any patient characteristics at baseline or early hematologic changes useful to select patients or … empirically evaluated to determine whether the degree of change is perceptible and meaningful to the patient … treated with epoetin; this prompted an FDA safety review in May 2004 and revised product labeling to … Neither higher than recommended target Hb nor any other single patient- or treatment- related factor
  13. effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/diabetes-update-2015_research-protocol.pdf
    January 01, 2015 - patients who cannot initiate or who cannot tolerate metformin remains unclear. … outcomes will be especially useful to clinicians, patients, investigators, guideline developers, and … Patients and patient advocates also will find the information valuable when making decisions about treatment … • We will exclude studies of patients with type 1 diabetes, impaired glucose tolerance, metabolic … using a co-morbidity scale or index; by including other medical conditions or medications used by the patient
  14. Layout 1 (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cancer-radiation_executive.pdf
    November 01, 2009 - Each of four reviewers extracted study, patient, and treatment characteristics; clinical outcomes; and … CS=cancer-specific survival; GI=gastrointestinal; OvS=overall survival. 3 Most studies reported patient … This Technical Brief did not intend to assess outcomes or evaluate the validity of claims on the safety … focused systematic reviews will not be able to provide a definitive answer on the effectiveness and safety … studies (preferably randomized) are likely necessary to provide meaningful answers on the relative safety
  15. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cannabis-2023-surv-rep-4.pdf
    January 01, 2023 - Cannabis for chronic pain: cardiovascular safety in a nationwide Danish study. … Pharmacokinetics and pharmacodynamics of cannabis- based medicine in a patient population included in … Medicinal cannabis for Australian patients with chronic refractory pain including arthritis.
  16. effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/health-careassociated-infections_executive.pdf
    November 01, 2012 - safety practices:8 • Theory behind patient safety practice • Existing patient safety infrastructure … patient safety culture and teamwork at the unit level. … Safety Practice 9 3 4 0 16 Existing Patient Safety Infrastructure 8 6 2 4 20 External Factors 9 7 … 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.
  17. Untitled (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/field-triage-glascow_research-protocol.pdf
    February 25, 2016 - severity score ≥16, head AIS score >2 or >3, presence of intracranial hemorrhage, and utilization indicators … •   KQ1: Predictive utility for mortality, morbidity, injury severity score ≥16,25 or utilization indicators … score  of  Glasgow   Coma  Scale Intermediate   outcomes Over-­  or  under-­ triage   Utilization  indicators … National Highway Traffic Safety Administration. Washington, DC. … patients.
  18. S16 (pdf file)

    effectivehealthcare-admin.ahrq.gov/sites/default/files/s16.pdf
    October 01, 2007 - evidence is centered on the protocol-driven ran- domized trials, which the FDA requires to establish safety … information from industry-funded trials may remain unpublished, limiting the ability to examine potential safety … carefully studied in trials (especially rare or slow emerging harms); explore sources of heterogeneity in safety … may depend on severity of strokes, patient preferences. … patients; audits could examine the rates at which women and patients over age 80 are undergoing surgery
  19. effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/colon-cancer-gene-profiling_technical-brief.pdf
    December 01, 2012 - Patient-oriented and patient-advocacy Web sites for colon cancer were searched. … These GEP assays are all prognostic indicators. Table 1. … The FDA addresses the safety and effectiveness of diagnostic tests and the quality of the design and … Historically, the FDA has subjected test kits to premarket review of safety and effectiveness, but not … result from both preanalytic factors (e.g., sample preparation) as well as analytic factors (such as reagents
  20. #05 DEPRESSION (pdf file)

    effectivehealthcare-admin.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 … be limited; these experts cited ketamine’s safety risks and lack of robust clinical trial data as … 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

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