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  1. effectivehealthcare.ahrq.gov/sites/default/files/related_files/Evidence%20Summary_0_0.pdf
    April 01, 2020 - with moderate or severe disorders and for patients with mild disorders who do not improve. … accounts for underlying patient characteristics. … A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with … Suicidality in pediatric patients treated with antidepressant drugs. … Treatment for Adolescents with Depression Study (TADS): safety results.
  2. effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/research-gap-primary-care-summary-table.pdf
    March 01, 2022 - https://effectivehealthcare.ahrq.gov/products/safety-vaccines/research 7 Automated-Entry Patient-Generated … for patients, implementation of an opioid safety initiative, provision of patient information and … adaptations of the ACCESS model) may improve system-level markers, including guideline-based quality indicators … Direct patient care strategies are those that directly inform the patients’ own treatment decisions … Evidence Gaps Study Populations • With the exception of critically ill patients, studies of patient
  3. CERs Report cover (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/future05-breastcancer-10-5-2010final.pdf
    September 01, 2010 - attention on the strength and limits of evidence from research studies about the effectiveness and safetyPatient - understanding why more patients do not use SERMs b. … C2: What factors influence patient and clinician decision making? … A Phase I, open label, oral, single-dose, escalating, randomized, parallel study to evaluate safety … Tamoxifen-associated vasculitis in a breast cancer patient.
  4. effectivehealthcare.ahrq.gov/sites/default/files/related_files/rotator-cuff-tear-surveillance-140925.pdf
    February 01, 2014 - No Signal 3.3 Safety surveillance alerts [Cycle 3] There were no safety surveillance alerts relevant … and University of California, Los Angeles (UCLA) scores Clinical outcomes of pain intensity and patient … Papadopoulos 2011 Functional outcome 57 patients (62 Arthroscopic Factors predictive of: Patient age, … Nho SJ, et 2009 Prospective analysis 193 patients who All-arthroscopic repair Patient demographic and … Overall, 72 of the 137 studies examined the impact of prognostic factors on patient outcomes.
  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/related_files/tonsillectomy-disposition-170415.pdf
    January 17, 2017 - objective of systematically reviewing the evidence from research studies about the effectiveness and safety … The key findings are important for clinicians, patients and stakeholders. … Adequate allocation concealment prevents foreknowledge of the group to which a patient would be assigned … Peer reviewer #4 Results KQ4: Were there differences in the risk tonsillectomy by age of the patient … Adequate allocation concealment prevents foreknowledge of the group to which a patient would be assigned
  7. effectivehealthcare.ahrq.gov/sites/default/files/related_files/prostate-cancer-surveillance_disposition-comments.pdf
    December 01, 2011 - also allowed Gleason 7 patients. … Behavioral indicators. … disease-specific outcomes of these studies, acknowledging that it will give only a general sense of the safety … We have clarified that no study used formal assessment of any behavioral indicators. … researchers in the field of AS should be lauded for their efforts to advance this field and enhance the safety
  8. effectivehealthcare.ahrq.gov/sites/default/files/ch_4-user-guide-to-ocer_130129.pdf
    January 01, 2010 - Each intervention (e.g., medication, surgery, patient education program) requires a unique and thoughtful … characteristics of exposure, observational comparative effectiveness studies often have to rely on proxy indicators … This example may be best illustrated by a comparative safety evaluation of the impact of oral corticosteroids … Is it necessary to know whether a given medication was taken by the patient on a particular day or … The characteristics of the exposure and the patient population are likely to influence the validity
  9. effectivehealthcare.ahrq.gov/sites/default/files/related_files/alcohol-misuse-drug-therapy_disposition-comments.pdf
    May 13, 2014 - For example, for disulfiram, we know this is a magic bullet to stop drinking if the patient takes the … For instance, if a patient is taking disulfiram and drinks, the person will know if he/she is taking … Hepatic safety of injectable extended- release naltrexone in patients with chronic hepatitis C and HIV … #1; Alkermes, Inc., Bernard Silverman, maker of Vivitrol Results Review Key Question 3 and Safety … Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV
  10. S166 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/s166.pdf
    October 01, 2007 - The efficacy and safety of benzodiazepines and nonbenzodiazepines, relative to placebo, were compared … Office of Medical Applications of Research (OMAR) to perform a systematic review of the efficacy and safety … authors to make decisions about the main comparisons to be meta-analyzed with respect to the efficacy and safety … To examine the relative efficacy and safety of active treatments, we performed indirect comparisons (
  11. effectivehealthcare.ahrq.gov/sites/default/files/pdf/urinary-incontinence-treatment_research-protocol.pdf
    September 30, 2010 - UI because of sampling and self- selection of the survey participants.1 Clinic-based studies include patients … methods help to prescribe appropriate treatments for different types of incontinence to best benefit patients … We will monitor the FDA website for warnings and safety information for all eligible drugs and devices … Patient outcomes (clinical events). … Attributable risk will be calculated as the outcome events rate in patients exposed to different clinical
  12. effectivehealthcare.ahrq.gov/sites/default/files/related_files/wireless-motility-capsule_executive.pdf
    May 01, 2013 - Testing can explain why a patient fails basic therapy and can help identify or exclude patients as … scintigraphy† Harms Low 2 Harms associated with WMC are minimal and no major safety issues were reported … scintigraphy Patient-centered outcomes Insufficient 0 No studies reported on patient-centered outcomes … such as patient satisfaction or change in symptom scores. … Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
  13. effectivehealthcare.ahrq.gov/sites/default/files/pdf/renal-update_research-protocol.pdf
    January 15, 2015 - In the United States, 12 to 14 percent of new patients entering dialysis programs have been found to … cases.10 Especially given the inconclusive evidence to date, it is important to best understand which patient … What are the patient characteristics, including etiology, predominant clinical presentation, and severity … Analytic framework for evaluating the effectiveness and  safety of treatments for renal artery stenosis … publications or interview or lectures or legal cases or legislation or letter or news or newspaper article or patient
  14. effectivehealthcare.ahrq.gov/sites/default/files/study-objectives-and-questions-chapter-1.pptx
    January 01, 2013 - Synthesize the literature and characterize the known effects of the exposures and interventions on patient … synthesize the literature and characterize the known effects of the exposures and interventions on patient … investigators should summarize in the protocol what is known about the efficacy, effectiveness, and safety … Based on a conceptual model, define study questions using PICOTS: Population: What is the patient population … How do patients and other stakeholders define a meaningful difference between interventions?
  15. effectivehealthcare.ahrq.gov/sites/default/files/pdf/binge-eating_clinician.pdf
    May 01, 2016 - sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events, and the safety … These patients should be monitored for emergence and worsening of suicidal thoughts and behaviors. … treatment outcomes among important subgroups defined by age, sex, race, ethnicity, or other relevant patient … the importance of talking with their health care professionals if any adverse effects develop �� Patient … To order free print copies of the patient resource, call the AHRQ Publications Clearinghouse at 800-
  16. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ptsd-protocol.pdf
    July 10, 2018 - or their loved ones are considering, and augment and inform the use of existing tools to assist in patient … • Settings—No restriction by location of either the provider or patient (e.g., military base, Veterans … Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more. … Number of trauma types and traumatic events experienced per patient* c. … Exclusion of patients with suicidality* Outcomes a.
  17. effectivehealthcare.ahrq.gov/sites/default/files/pdf/ptsd-protocol.pdf
    July 10, 2018 - or their loved ones are considering, and augment and inform the use of existing tools to assist in patient … • Settings—No restriction by location of either the provider or patient (e.g., military base, Veterans … Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more. … Number of trauma types and traumatic events experienced per patient* c. … Exclusion of patients with suicidality* Outcomes a.
  18. 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
  19. effectivehealthcare.ahrq.gov/sites/default/files/crosscutting-horizon-scan-high-impact-1312.pdf
    December 01, 2013 - designed to cater to the special needs of the senior population (people aged 65 and older) to improve safetysafety.20,21 During the transition, medications may be altered and self-care responsibilities increased … The authors also reported “strong indicators of clinical effectiveness and a 98 percent ‘would recommend … effectiveness and safety. … In general, experts called for more substantial data proving the safety and effectiveness of this care
  20. effectivehealthcare.ahrq.gov/sites/default/files/related_files/chronic-pain-opioid-treatment_executive.pdf
    September 19, 2014 - *Including opioid management plans, patient education, urine drug screening, use of prescription drug … http://www.cdc.gov/homeandrecreational safety/overdose/ facts.html. Accessed July 17, 2014. 22. … Long-term safety and tolerability of tapentadol extended release for the management of chronic low … Methadone safety: a clinical practice guideline from the American Pain Society and College on Problems … The efficacy and safety of fentanyl buccal tablet compared with immediate-release oxycodone for the

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