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  1. effectivehealthcare.ahrq.gov/sites/default/files/related_files/depression-pregnancy-postpartum_executive.pdf
    July 01, 2014 - are often concerned about the safety of pharmacological treatment during pregnancy and the postpartum … effective in pregnancy, but the developing fetus and changes in maternal physiology raise questions about safety … For safety of the fetus, the FDA Pregnancy Category of antidepressant medications taken during pregnancy … Patient comorbidities (e.g., anxiety diagnoses)? c. … Efficacy and Safety of Screening for Postpartum Depression. Comparative Effectiveness Review 106.
  2. effectivehealthcare.ahrq.gov/sites/default/files/related_files/juvenile-arthritis-dmards_surveillance.pdf
    March 14, 2013 - However, the responsiveness of several of these measures, including functional status and parent/patient … Efficacy and safety of repeat courses of rituximab treatment in patients with severe refractory juvenile … Safety and efficacy of tocilizumab, an anti- IL-6-receptor monoclonal antibody, in patients with polyarticular-course … placebo including 60 infections (2 serious) vs 15, combined phases included 39 serious AEs (0.25/patient … However, the responsiveness of several of these measures, including functional status and parent/patient
  3. effectivehealthcare.ahrq.gov/sites/default/files/pdf/juvenile-arthritis-dmards_surveillance.pdf
    March 14, 2013 - However, the responsiveness of several of these measures, including functional status and parent/patient … Efficacy and safety of repeat courses of rituximab treatment in patients with severe refractory juvenile … Safety and efficacy of tocilizumab, an anti- IL-6-receptor monoclonal antibody, in patients with polyarticular-course … placebo including 60 infections (2 serious) vs 15, combined phases included 39 serious AEs (0.25/patient … However, the responsiveness of several of these measures, including functional status and parent/patient
  4. effectivehealthcare.ahrq.gov/sites/default/files/12_pregnancy_potential_high_impact_2012-12-11.pdf
    January 01, 2012 - milk from a source other than her own, only milk from a source that has been screened to ensure its safety … intervention. 15-21 All experts saw a significant unmet need for more innovative ways to supply VLBW patients … All experts agreed that donor human milk has the potential to significantly improve patient health … Overall, experts agreed that although more safety and efficacy studies must be performed to determine … Food and Drug Administration Center for Food Safety and Applied Nutrition; 2010 Dec 6. 6 p.
  5. effectivehealthcare.ahrq.gov/sites/default/files/related_files/chronic-kidney-disease-anemia-2011_disposition-comments.pdf
    January 01, 2011 - uptake of the former two tests will result in any significant improvement in intermediate outcomes, safetySafety has not been shown in the studies comparing these biomarkers. … biomarkers in diagnosing iron deficiency, I do not believe that necessarily predicts response to iron, safety … We agree with safety concerns, and problems of our draft conclusion. … Since most CKD patients (and nearly all ESRD) patients don’t respond to oral iron focus would be mostly
  6. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ehc-research-gaps-telehealth.pdf
    April 01, 2023 - • Some patients perceive telehealth as a barrier to improved health outcomes owing to the absence … • P-P telehealth to support direct patient care may provide benefits for in patient care, for neonates … Interventions • Studies to determine the optimal structure and safety for routine and alternative … , and are cost-effective for the health system, patients, and their caregivers. … depression, fear of partner, coercive control, self-efficacy, post-traumatic stress disorder, and safety
  7. effectivehealthcare.ahrq.gov/sites/default/files/pdf/breast-cancer-imaging_research-protocol.pdf
    December 17, 2013 - • What are the advantages (e.g., sensitivity and specificity) and disadvantages (e.g., safety issues … patients with metastatic breast cancer. … Input from Key Informants will also be sought to determine safety issues that may be associated with … ; (b) health insurance policies; (c) patient preferences. … Patient Advocates [n=3] 1.
  8. effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-222-evidence-summary-health-equity.pdf
    January 01, 2020 - Effectiveness of Patient- Provider Approaches KQ4. … of Evidence; Applicability Colorectal cancer screening Low income 1 RCT (240) No effect among safety … Studies enrolled low- income, Alaska Native and American Indian, and Latina patients. … Comparison groups included patients receiving usual care or alternative services without patient navigation … Breast cancer screening rates were higher with patient navigation; lay health workers; patient education
  9. effectivehealthcare.ahrq.gov/sites/default/files/cer-244-safety-of-vaccines.pdf
    May 25, 2021 - The level of certainty is not there to support strength of association based on SoE for the patient … Neonatal Nurses (AWHONN) Discussion We would suggest addressing including the process of how patient … and for those whose patients are demonstrating vaccine hesitancy. … The handout should provide relevant links for clinician use and for patient use— maybe two handouts … and a forecast for immunizations due for use by a vaccination provider in determining appropriate client
  10. effectivehealthcare.ahrq.gov/sites/default/files/pdf/cad-women-diagnosis-future_research_1.pdf
    February 01, 2013 - Recommended study design: an observational study of patients with varying patient risk profiles. … Safety concerns Insufficient 13 studies (9 good quality, 4 fair) reported data pertinent to safetyPatient Advocate We identified a patient advocate to represent the research priorities and issues from … Recommended study design: an observational study of patients with varying patient risk profiles. 7 … Artery Disease, NCT01368770, RCT of 500 patients.
  11. effectivehealthcare.ahrq.gov/sites/default/files/pdf/cancer-radiation_technical-brief.pdf
    November 01, 2009 - Type of cancer and patient eligibility criteria 3.b. … For many patients in whom a whole region has to be irradiated (e.g., the whole pelvis in some patients … For example, in patients with glial tumors it ranged from 5 to 39 months, whereas in patients with … Types of cancer and patient eligibility criteria 3.b. … Adverse events, harms, and safety issues reported
  12. effectivehealthcare.ahrq.gov/sites/default/files/related_files/binge-eating-disposition-160504.pdf
    December 09, 2015 - Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating … the published data on which the drug was approved is inadequate to reach conclusions on long-term safety … However, these data should be presented, even if only to say that more data on longer terms safety … Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating … American College of Neuropsychopharmacology (ACNP 2012) • Lisdexamfetamine Dimesylate Safety and
  13. effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoarthritis-knee-update_research-protocol.pdf
    June 15, 2016 - , exercise, braces and orthotics, and arthroscopic lavage, as well as the comparative efficacy and safety … to update if needed—a systematic review that was conducted in 20071that 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 … For assessments of safety, we will consider the consistency between the findings of trials to those
  14. 8 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/pdf/methods-guidance-harms_methods.pdf
    November 01, 2008 - Observational studies based on patient registries. … Celecoxib Long-term Arthritis Safety Study [see comment]. … http://www3.niaid.nih.gov/research/resource s/DAIDSClinRsrch/Safety/. … Rather, adverse events are identified based on patient reports made on their own initiative. … Safety Substantive evidence of an absence of harm.
  15. 8 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/methodsguide_chou_assessing_harms_when_comparing.pdf
    November 01, 2008 - Observational studies based on patient registries. … Celecoxib Long-term Arthritis Safety Study [see comment]. … http://www3.niaid.nih.gov/research/resource s/DAIDSClinRsrch/Safety/. … Rather, adverse events are identified based on patient reports made on their own initiative. … Safety Substantive evidence of an absence of harm.
  16. effectivehealthcare.ahrq.gov/sites/default/files/infectious-disease-horizon-scan-high-impact-1512.pdf
    January 28, 2016 - : Preliminary data are available for the ongoing phase III “Ebola ça suffit” trial evaluating the safetyPatients (n=7,651) who had direct or indirect contact with a patient who had confirmed EVD (an epidemiologically … one with a health systems and one with a research background wanted more data to demonstrate the safety … all-oral HCV drugs to remain high because of their high efficacy, safety, and short treatment duration … FDA drug safety communication: FDA warns of serious liver injury risk with hepatitis C treatments
  17. effectivehealthcare.ahrq.gov/sites/default/files/related_files/cad-women-diagnosis_disposition-comments.pdf
    June 12, 2012 - The safety during stress echo was shown with both genders (Males/females in contrast cohort = 57.4% … cohort study of 26,774 patients. … cohort study of 26,774 patients. … Another key objective identified was the safety of each modality. … the actual patient population of interest.
  18. effectivehealthcare.ahrq.gov/sites/default/files/prostatic-hyperplasia-medications_disposition-comments.pdf
    May 26, 2016 - This leads to a large variable practice which introduces expense, unnecessary patient risk and prolonged … that it synthesizes new medications and aids clinicians seeks evidence-based review on appropriate patient … These might be meaningful to patients and providers, too. … of study limitations and imprecision in measurement, it remains unclear if an appreciable number of patient … with OAB--and explicitly note (applicability) that there are little data on the effectiveness and safety
  19. Layout 1 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/atypical-antipsychotics-off-label-update_executive.pdf
    September 01, 2011 - Comparative Effectiveness of Off-label Use of Atypical Antipsychotics reviewed the scientific evidence on the safety … potentially fatal blood disorder of bone marrow suppression, and it requires frequent blood tests for safety … Most trials used flexible dosing, resulting in patients taking a wide range of doses. … future research, standardized measures of disease severity might allow for greater knowledge of the patient … Trials assessing the newer agents’ efficacy and safety are necessary if they are to be used off-label
  20. Diabetes Mellitus (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/07_diabetes_potential_high_impact_june_2012.pdf
    January 01, 2012 - moderately high potential for impact on the health care system, provided additional efficacy and safety … announced the formal submission of a reply to the complete letter response issued by FDA over potential safety … concerns. 12 Along with updates to safety information about ongoing or completed studies, included … Experts expressed a desire for further data evaluating safety and efficacy of these modifications to … Efficacy and safety of exenatide once weekly versus liraglutide in subjects with type 2 diabetes

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