Response to 'Concerns Regarding the Use of Oral Anticoagulants (Rivaroxaban and Apixaban) for Venous Thromboembolism Prophylaxis in Plastic Surgery Patients'
| Autor: | Eric Ruff, Rolando Morales, Henry Mentz, Paul Fortes, Kristi L. Hustak, Christopher Patronella, Germán Newall |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Rivaroxaban business.industry education Alternative medicine General Medicine 030230 surgery Institutional review board humanities Surgery 03 medical and health sciences 0302 clinical medicine Private practice 030220 oncology & carcinogenesis Family medicine Agency (sociology) medicine Apixaban business health care economics and organizations Declaration of Helsinki medicine.drug Accreditation |
| Zdroj: | Aesthetic Surgery Journal. 36:NP265-NP268 |
| ISSN: | 1527-330X 1090-820X |
| Popis: | We appreciate the opportunity to reply to Dr Swanson's letter to the editor1 regarding our article2 on the use of factor Xa inhibitors in body contouring procedures. Chemoprophylaxis remains a hot topic in plastic surgery, in part due to the paucity of data regarding the safety and efficacy of newer medications such as factor Xa inhibitors. We believe that small investigational studies are crucial in the initial analysis of this novel class of anticoagulants, and, as such, we would like to address Dr Swanson's specific concerns regarding the article. Dr Swanson quickly identified an oversight in describing the lack of Institutional Review Board (IRB) approval.1 We agree that IRB approval is ideal, however our study was a retrospective chart review involving the collection and study of existing data, which is considered exempt from IRB approval.3 Furthermore, though the guidelines of the World Medical Association Declaration of Helsinki are intended for international authors, our study is consistent with the recently published multicenter study by Hunstad et al, who used these standards in assuring appropriate ethical research practices for evaluating an oral Factor Xa inhibitor.4 We applaud Dr Swanson and all other private practices that pursue formal IRB approval through accredited agencies. However, it should be noted that at least one of Dr Swanson's studies has received IRB approval through his own private office-based surgical center, which presents a strong conflict of interest.5 In our exploration of private third-party IRB accredited agencies, we discovered that there were a wide spectrum of “accreditations.” It was difficult to identify which agency would be best suited for our studies. There were also significant financial and administrative requirements depending on the agency. The Accreditation of Human Research Protection Programs for Surgeons in Private Practice, for example, requires $12,500 in application … |
| Databáze: | OpenAIRE |
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