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  1. effectivehealthcare.ahrq.gov/products/phenylketonuria/research-protocol
    February 08, 2011 - dopamine, in the brain. 16,17 Despite potential benefits, there is uncertainty about the efficacy and safety … of the long-term use of LNAAs and about the target patient population, including the appropriateness … , the safety and efficacy of using sapropterin dihydrochloride in children under the age of 8, including … long-term effects of pharmacological treatment or the desired Phe concentration ranges for various patient … Primary outcomes in a patient: Decreasing Phe levels in the blood Improved nutritional status Quality
  2. #05 DEPRESSION (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/depression-horizon-scan-high-impact-1312.pdf
    October 01, 2014 - DBS to the subcallosal cingulate white matter supported the long-term safety and antidepressant efficacy … The safety of ECT in patients with an implanted DBS system has not been established. … ketamine would have a minimal impact on health outcomes in the absence of data on long-term effects, safety … Efficacy and safety of mifepristone for the treatment of psychotic depression. … Neuropsychological safety of nucleus accumbens deep brain stimulation for major depression: effects
  3. effectivehealthcare.ahrq.gov/products/antipsychotics-children/research-protocol
    June 04, 2010 - , patient insight into illness. … insight into illness Patient or parent/care provider reported outcomes, including levels of physical … insight into illness Patient or parent/care provider reported outcomes, including levels of physical … followup), patient baseline characteristics (diagnosis and age at diagnosis, age, sex, race, weight, … Adults Pediatric use: safety & effectiveness not established in patients <18 yr 1. agranulocytosis
  4. Untitled (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/pdf/antipsychotics-children-update_research-protocol.pdf
    December 04, 2015 - Within each KQ, we will assess outcomes for subgroups of patients or studies based on patient and clinical … (patientsafety, effectiveness, and policy challenges. … Efficacy and safety of second-generation antipsychotics in children and adolescents with psychotic and … Drug Safety. 2011 Aug 1;34(8):651-68. PMID: 21751826. 17.
  5. effectivehealthcare.ahrq.gov/products/atypical-antipsychotics-off-label-update/research-protocol
    May 19, 2010 - Comparative Effectiveness of Off-label Use of Atypical Antipsychotics reviewed the scientific evidence on the safety … risk of death and antipsychotics drugs, and comparison of the development of adverse effects between patients … Studies that did not report any outcomes of efficacy, effectiveness, safety/adverse events, or utilization … We will define loss to follow-up as the number of patients excluded from efficacy analyses, expressed … as a proportion of the number of patients randomized.
  6. effectivehealthcare.ahrq.gov/health-topics/health-occupations
    January 17, 2012 - Presentation) Presentation April 19, 2012 Using Deliberative Methods to Engage Patients … White Paper September 30, 2009 Instrumental Variable Methods in Comparative Safety … Effectiveness Systematic Reviews Methods Guide – Chapter October 5, 2009 How Patients … Meta-Analysis for Binary Outcomes Research Report March 20, 2013 Eliciting Patients … February 23, 2012 Clinical Effectiveness of Coronary Stents in the Elderly: Results From 262,700 Patients
  7. effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-203-adhd-disposition-comments.pdf
    January 01, 2018 - In my assessment, post-marketing surveillance studies of effectiveness and safety are badly missing … These outcomes were seen as being both patient-centered and most critical for decisionmaking across … Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention- … A long-term o pen-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents … Atomoxetine improves patient and family coping in attention deficit/hyperactivity disorder: a randomized
  8. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update-surveillance-160328.pdf
    March 28, 2016 - $Comparative$efficacy$and$safety$of$aliskiren$and$ irbesartan$in$patients$with$hypertension$and$metabolic … $Antihypertensive$efficacy$and$ safety$of$olmesartan$medoxomil$and$ramipril$in$elderly$patients$with … $ rather$than$hypertensive$ patients),$it$highlights$the$safety$ concerns$associated$with$ combining … $Antihypertensive$efficacy$and$safety$of$olmesartan$medoxomil$and$ ramipril$in$elderly$patients$with … $Comparative$efficacy$and$safety$of$aliskiren$and$irbesartan$in$patients$with$ hypertension$and$metabolic
  9. effectivehealthcare.ahrq.gov/sites/default/files/related_files/ace-inhibitor-arb-update_disposition-comments.pdf
    October 07, 2011 - daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient … For Results Key Question 2, safety information, please note that ACE inhibitors pose unique, albeit … congestive heart failure, or nephropathy); however all have examined an overlapping set of efficacy and safety … of “class effects”, specifically related to ACEIs and ARBs, discussing that mechanism of action, safety … We underscore the importance of updating any corollary materials (e.g., patient guides) in order to
  10. effectivehealthcare.ahrq.gov/sites/default/files/pdf/coronary-stents-outcomes_research.pdf
    January 01, 2010 - about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and services … Effectiveness and Safety of Drug- Eluting Stents in Ontario. … Balancing Efficacy and Safety of Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary … Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents. … Unadjusted baseline characteristics of patients in study population Patient Characteristics Study
  11. effectivehealthcare.ahrq.gov/sites/default/files/related_files/healthcare-system-draft-technical-brief.pdf
    February 01, 2023 - Patient-level interventions refer to those targeted at patients, such as patient education. … an Urban Safety-Net Setting. … Community–Clinical Linkages: The Effects of the Healthy Here Wellness Referral Center on Chronic Disease Indicators … Impact of a Primary Care CKD Registry in a US Public Safety-Net Health Care Delivery System: A Pragmatic … Evaluating Patient Navigation to Improve First Appointment No-show Rates in Uninsured Patients with
  12. effectivehealthcare.ahrq.gov/sites/default/files/related_files/juvenile-arthritis-dmards_disposition-comments.pdf
    September 01, 2011 - As a clinician, I want to know how best to treat an individual patient with a defined subtype of JIA … One patient experiences a hematoma occurring on day 108 which was deemed unrelated to the study drug … Acute infusional adverse events were reported in one (2%) patient in the abatacept group and two (3% … All studies of safety were addressed in KQ3. … Of the 14 patients enrolled in the infliximab arm, 5 patients failed to complete 12 months – 4 because
  13. Layout 1 (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/related_files/type-2-diabetes-insulin_executive.pdf
    September 01, 2008 - However, the addition of insulin to treatment Comparative Effectiveness, Safety, and Indications of … A number of patient-related factors have been identified that may help physicians to select patients … Insulin lispro 75/25 was associated with a higher rate of overall hypoglycemia measured as episode/patient … Key Question 4: Effect of premixed insulin analogues based on patient characteristics Comparison of … injection patterns and glucose testing depending on the type of medication regimen prescribed, evaluating patient
  14. effectivehealthcare.ahrq.gov/products/rural-telehealth/protocol
    January 15, 2021 - or patient populations.  … Population(s): Rural individual patients, patient families/care partners, and patient populations … including but not limited to time to diagnosis or time to treatment KQ2: Indicators and measures … KQ2: Indicators and measures of uptake of telehealth (e.g., rates of use, timing to implementation) … The Rural Health Safety Net Under Pressure: Rural Hospital Vulnerability . 2020.
  15. effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-lesions-evaluation_research-protocol.pdf
    August 23, 2010 - What are the potential safety issues and harms associated with the use of non-invasive diagnostic techniques … Guiding question 3: What published and unpublished studies have reported on the use and safety of these … Provide a synthesis of the following information: i Indication/patient inclusion criteria ii Type … of techniques/modalities iii Study design and size iv Role of the test in patient management v … Strategies for early melanoma detection: Approaches to the patient with nevi.
  16. Obesity (pdf file)

    effectivehealthcare.ahrq.gov/sites/default/files/10_obesity_potential_high_impact_june_2012.pdf
    January 01, 2012 - significantly increased the regulatory bar for gaining approval—specifically regarding preapproval safety … data and postmarket safety evaluation—set forth by the U.S. … Kushner and colleagues announced results from a phase III clinical trial (SEQUEL) evaluating the safety … However, potential increase in per- patient costs might serve as barriers to acceptance by some patientsSafety and efficacy study of EndoBarrier in subjects with type II diabetes and obesity.
  17. effectivehealthcare.ahrq.gov/sites/default/files/study-design-considerations-chapter-2.pptx
    January 01, 2013 - Cohort design has the potential to increase efficiency Well suited for rare adverse events in vaccine safety … The design was originally proposed for rare adverse events in vaccine safety studies for which it seems … Regardless of the design chosen, selection of appropriate data source(s), the patient population, inclusion … Regardless of the design chosen, selection of appropriate data source(s), the patient population, inclusion … Regardless of the design chosen, selection of appropriate data source(s), the patient population, inclusion
  18. effectivehealthcare.ahrq.gov/products/antipsychotics-children-update/research-protocol
    December 07, 2015 - Within each KQ, we will assess outcomes for subgroups of patients or studies based on patient and clinical … Broadened use of atypical antipsychotics: safety, effectiveness, and policy challenges. … Efficacy and safety of second-generation antipsychotics in children and adolescents with psychotic and … Drug Safety. 2011 Aug 1;34(8):651-68. PMID: 21751826. Correll CU, Penzner JB, Parikh UH, et al. … Limited evidence in children <12 years Use and safety have not been evaluated in other childhood
  19. effectivehealthcare.ahrq.gov/sites/default/files/related_files/musculoskeletal-disorders-imaging_disposition-comments.pdf
    November 01, 2011 - Safety: The ramfiicaitons regarding potential need for alternative imaging methods (pg 16, lines 10- … 13) to rule out specific pathologies is to some extent a safety issue (e.g. ? … safety/outcomes. … vs. an adverse event related to the safety of the device or procedure? … frequency of positive MRI exams on clinically asymptomatic patients.
  20. effectivehealthcare.ahrq.gov/sites/default/files/related_files/urinary-incontinence-treatment_surveillance.pdf
    October 29, 2012 - • There are no safety concerns Summary Decision: This CER’s priority for updating is Low … UUI in 40% patients on 150 U; p=0.022 • >75% improvement versus baseline in UUI in 40% patients on 100 … UUI in 40% patients on 150 U; p=0.022 >75% improvement versus baseline in UUI in 40% patients on … The  efficacy  and  safety  of  solifenacin   in  patients  with  overactive  bladder … in 40% patients on 150 U; p=0.022 >75% improvement versus baseline in UUI in 40% patients on 100

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