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Background: Nonopioid Analgesics for Osteoarthritis

Presentation: Analgesics for Osteoarthritis—An Update
Keywords: analgesics | osteoarthritis | background
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Background: Treatment

Presentation: Angiotensin-Converting Enzyme Inhibitors (ACEIs), Angiotensin II Receptor Antagonists (ARBs), or Direct Renin Inhibitors (DRI) for Adults With Hypertension
Keywords: treatment | hypertension | diet | exercise | weight | antihypertensive medication
Intervention and Applicability: Examples. Studies of behavioral modification to promote healthy diet employ a larger number and longer duration of visits than those available to most community patients. The use of pill counts in antiretroviral trials does not always translate into effectiveness in real-world practice. Combining iron and zinc attenuates the ability of iron to raise hemoglobin levels. Trials of carotid endarterectomy select surgeons with extensive experience and low complication rates and are not representative of average vascular surgeons.
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Intervention and Applicability: Examples

Presentation: Assessing Applicability
Keywords: intervention | applicability
This slide includes a table with two columns and four rows. Column 1, row 1: potential advantages. Column 2, row 1: potential disadvantages.Column 1, row 2: Higher dose delivered to tumor. Column 2, row 2: Higher total body dose. Column 1, row 3: Sparing of normal, surrounding tissue from radiation damage. Column 2, row 3: Increased risk of marginal miss and dose perturbation. Column 1, row 4: Decreased toxicity. Column 2, row 4: time and expense. A definition of abreviations is included on the slide: IMRT = intensity-modulated radiation therapy; 2DRT = two-dimensional radiation therapy; 3DCRT = three-dimensional conformal radiation therapy. A footnote includes the following references: (1) Ballivy O, Santamaria RG, Borbalas AL, et al. Clinical application of intensity-modulated radiotherapy for head and neck cancer. Clin Transl Oncol 2008;10:407-14; (2) Burri MK, Bevan A, Roach M III. Advances in radiation therapy: conventional to 3D, to IMRT, to 4D, and beyond. CA Cancer J Clin 2005;55:117-34; (3) Mendenhall WM, Amdur RJ, Palta JR. Intensity-modulated radiotherapy in the standard management of head and neck cancer: promises and pitfalls. J Clin Oncol 2006;24:2618-23; (4) Samson DJ, Ratko TA, Rothenberg BM, et al. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer, Comparative Effectiveness Review No. 20 (Prepared by the Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC014-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=447.
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Potential Advantages and Disadvantages of IMRT When Compared With 2DRT and 3DCRT

Presentation: Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer
Keywords: 2DRT | 3DCRT | adverse events | head and neck cancer | IMRT | outcomes | safety | treatment | radiotherapy
The Coagulation Cascade: rFVIIa Mechanism of Action Recombinant activated factor VII is a form of human factor VII produced by recombinant technology. The molecule is 406 amino acids in length and has a molecular weight of 50 kDa. As a protein-based therapy, it must be given intravenously to facilitate coagulation at sites of bleeding and has a half-life of 2.5 hours. This intravenously delivered product works as a potent procoagulant by effectively bypassing parts of the clotting process normally required for clotting. rFVIIa helps to promote clotting in two ways: At physiologic levels and in association with tissue factor (e.g., on damaged tissue), it activates factors IX and X to initiate the clotting leading to formation of a thrombin plug, which allows for clot stability. This normal physiological mechanism suggests that rFVIIa activity is targeted to areas of tissue damage. In pharmacological doses, it also binds to activated platelets and drives the process of thrombin clot formation forward via factor X activation, even in the absence of tissue factor. This mechanism is relatively specific to areas of tissue damage. These mechanisms effectively bypass portions of the clotting process that are normally required for clotting to occur. Thus, clotting can occur despite factor deficiencies (in factors VII, VIII, IX, and XI) or when the number or function of platelets is reduced. It can facilitate control of bleeding in situations where standard human blood product transfusions have failed. While mainly used for hemophilia and related conditions, off-label use of rFVIIa has increased in the hospital setting. Practice patterns have outstripped available evidence as rFVIIa off-label use has transitioned from extraordinarily infrequent use to more common application.
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The Coagulation Cascade: rFVIIa Mechanism of Action

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: coagulation cascade | mechanism of action | recombinant factor VIIa
Characteristics of Comparative Studies on Off-Label rFVIIa Use With the exception of use in ICH, study sample sizes were small (median of 24 treated patients). The doses used in the studies that are the focus of this effectiveness review varied from 5 to 956 mcg/kg of patient weight, and only for intracranial hemorrhage was there a sufficient range of doses to assess the impact of rFVIIa dosing on outcomes. Most studies used indirect endpoints as their primary outcomes, particularly red blood cell (RBC) transfusion requirements. Direct outcomes, such as mortality, functional status, or thromboembolic events, were frequently reported, but most studies were individually underpowered to evaluate them. Most clinical research on rFVIIa has been directed and sponsored by Novo Nordisk, the product’s manufacturer. The strength of evidence available from existing studies was thereby compromised by small study size, use of indirect outcomes, and heterogeneity in dosage and indication. The applicability was diminished by less acutely ill patients and a mismatch between existing research and real-world patterns of indication and types of use.
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Characteristics of Comparative Studies on Off-Label rFVIIa Use

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Keywords: comparative effectiveness | recombinant factor VIIa | off-label | strength of evidence
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Background: Treatment of GERD (2 of 2)

Presentation: Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update
Keywords: endoscopic | H2RA | histamine type 2 receptor antagonist | lifestyle modification | PPI | proton pump inhibitor | surgery | treatment
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Clinical Questions Addressed by the CER (2 of 3)

Presentation: Comparative Effectiveness of Management Strategies for Adults With Gastroesophageal Reflux Disease: An Update
Keywords: key question | comparative effectiveness | systematic review
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Key Question 1: – Clinical Bottom Line: Harms Associated With Medical Interventions

Presentation: Comparative Effectiveness of Therapies for Children With Autism Spectrum Disorders
Keywords: outcomes | strength of evidence | treatment | therapy | interventions | medical | harms
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Adverse Events Experienced by Patients Taking Risperidone and Aripiprazole

Presentation: Comparative Effectiveness of Therapies for Children With Autism Spectrum Disorders
Keywords: outcomes | strength of evidence | treatment | therapy | interventions | medical | harms
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Rationale for Update

Presentation: Comparing Medications for Adults With Type 2 Diabetes
Keywords: comparative effectiveness review | systematic review | type 2 diabetes | noninsulin injectables | DPP-4 inhibitors | medications for type 2 diabetes
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Conceptual Model

Presentation: Comparing Medications for Adults With Type 2 Diabetes
Keywords: conceptual model | initial medical treatment | outcomes | type 2 diabetes
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