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"complications"

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Overview: Results for Nonstandard Interventions to Treat CDI or Reduce the Risk of Recurrence

Comparative Effectiveness of Oral Agents: NSAIDs versus Other Agents

Comparative Adverse Effects of Oral Agents: GI Effects (1 of 2)

Comparative Adverse Effects of Oral Agents: GI effects (2 of 2)

Factors Affecting Outcomes: Demographic Subgroups

Effects of Adding an H-2 Antagonist, Misoprostol, or a PPI on GI Adverse Effects Associated With NSAIDs (1 of 3)

Effects of Adding an H-2 Antagonist, Misoprostol, or a PPI on GI Adverse Effects Associated With NSAIDs (3 of 3)

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.

Intervention and Applicability: Examples

Setting and Applicability: Examples. Studies evaluating the benefits of breast self-examinations conducted in China and Russia, countries that do not employ routine mammography screening as in the United States. Studies of open surgical abdominal aortic aneurysm repair showing an inverse relationship between hospital volume and short-term mortality.

Setting and Applicability: Examples

Summary of Outcomes for Most Common Off-Label, In-Hospital Uses of rFVIIa
Overall study quality is fair to poor and the strength of evidence is low, with the exception of meta-analyses of intracranial hemorrhage that had moderate strength of evidence for all outcomes and of a meta-analysis of adult cardiac surgery studies that had moderate strength of evidence for the thromboembolic event outcome. Clinical efficacy is often defined via indirect/surrogate outcomes, such as transfusion requirements, change in hematoma volume, or ICU length of stay. Safety is defined via thromboembolic events and mortality, but individual studies often lack the statistical power to assess these outcomes. Evidence of rFVIIa benefit is suggested for several indications, but largely via the surrogate outcomes used in the included studies and with an uncertain relationship to improved patient survival or functional status. In addition, for some uses, rFVIIa produces an increased risk of thromboembolism. Current evidence of low strength suggests the potential for benefits to exceed harms for bleeding from body trauma. There are no indications where potential risks are likely to greatly exceed the benefits. Intracranial hemorrhage: There are four RCTs and one observational study involving 968 rFVIIa-treated patients. Treatment with rFVIIa reduced expansion of intracranial hematoma volume relative to usual care, but increased the risk of arterial thromboembolic events and did not reduce the rates of mortality or poor functional outcome. Current evidence of moderate strength suggests that neither benefits nor harms substantially exceed each other. Adult cardiac surgery: There are two RCTs and four included comparative observational studies with 251 patients receiving prophylactic or therapeutic rFVIIa. These studies showed that rFVIIa likely increased the risk of thrombembolic events, but failed to show an effect of rFVIIa on other outcomes, including mortality. rFVIIa use for this indication is increasing in the U.S. Body trauma: There are two RCTs and two comparative observational studies examining rFVIIa treatment in 257 patients experiencing massive blood loss from trauma. These suggested a possible reduced rate of ARDS, most likely to be present in cases of blunt trauma, but these findings are complicated by the exclusion of patients with early mortality from both of the RCTs and one of the cohort studies. There is no evidence of effect on mortality or of increased thromboembolic events with treatment. Current evidence of low strength suggests the potential for benefit and little evidence of increased harm.
Additional Off-Label Uses of rFVIIa Requiring Future Research
Medical conditions include: cancer-related conditions, gastrointestinal bleeding not related to liver disease, hematopoietic stem cell transplantation, liver disease (other than transplantation), neonatal conditions (beyond cardiac surgery), obstetrical conditions, primary clotting disorders (other than hemophilia), pulmonary conditions (e.g., pulmonary hemorrhage, pulmonary transplantation), and secondary clotting disorders (e.g., complications of warfarin anticoagulation).
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