The Institutional Review Board: A Discussion of the Importance of Ethical, Evidence-Based Research in Plastic Surgery

Vingan, Nicole R; Kenkel, Jeffrey M.

doi:10.1093/asj/sjab363

Cited by 3 publications

(15 citation statements)

References 12 publications

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“…Review and approval by an IRB is required for all projects that involve research with human subjects 14,15 . Medical journal guidelines insist on it 15 . In addition, the approval must precede the start of the research 15 .…”

Section: Discussionmentioning

confidence: 99%

The Keller Funnel, Capsular Contracture, and Conflict of Interest

Swanson

2023

Ann Plast Surg

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Background The Keller funnel (Allergan; AbbVie Inc, North Chicago, IL) is commonly used to insert breast implants as part of a “no touch” protocol. Many plastic surgeons believe that this device reduces the risk of capsular contracture. This review was undertaken to evaluate the evidence regarding any reduction in capsular contracture rate, other possible benefits, safety and to investigate financial conflict of interest. Methods A PubMed electronic literature search was conducted to identify studies comparing capsular contracture rates with and without the Keller funnel. The Open Payments database was accessed for information regarding corporate payments to plastic surgeons. Results Two retrospective historical case-control studies, published in 2016 and 2018, were identified. Both studies had important confounders, including implant type and placement, which are known to affect capsular contracture rates. Major financial conflicts of interest were present. Most authors did not disclose these conflicts, which totaled more than $1 million and were usually categorized as gifts from Allergan, which purchased the Keller funnel in 2017. Discussion Financial conflict of interest, along with publication bias, creates a bias toward publication of positive findings. No reliable evidence supports a “no touch” technique, which is a misnomer because manual handling of implants is unavoidable, even when using a funnel. Recent microbiological studies do not support a specific bacterial etiology for capsular contracture. No evidence supports contamination by the surgeon touching the implant. Among other proposed benefits, such as reduced operating time, less contamination, a shorter incision, and less implant trauma, only a slightly shorter incision (1 cm) is supported by the evidence. The cost is $150 per funnel. Conclusions No reliable evidence supports the use of a Keller funnel to reduce the risk of capsular contracture. Both supportive studies contain confounding variables, limited follow-up time, and no plausible scientific basis for efficacy. Institutional review board approval of studies on human subjects is not optional. Financial conflicts of interest are extraordinary in their magnitude and potential for creating undue influence. Greater transparency and honest disclosures are needed.

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Section: Discussionmentioning

confidence: 99%

The Keller Funnel, Capsular Contracture, and Conflict of Interest

Swanson

2023

Ann Plast Surg

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“…Institutional review boards are available for surgeons in private practice. 26 , 27 I have used one for years—Advarra (Columbia, MD), which is accredited by the Association for the Accreditation of Human Research Protection Programs. 27 Clinical trials need to be registered.…”

Section: Institutional Review Board Approvalmentioning

confidence: 99%

“…27 Clinical trials need to be registered. 10 , 26 For a prospective study, IRB approval is needed before the study starts. 26 For a retrospective study, it is usually possible to obtain a waiver.…”

Section: Institutional Review Board Approvalmentioning

confidence: 99%

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Peer Review

Swanson

2023

Ann Plast Surg

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Little information is available regarding how to review a plastic surgery manuscript. This vital responsibility ensures that publications meet an acceptable scientific standard. Thoughtful and thorough reviews are essential to protect patients and surgeons from unscientific practices and products. This discussion provides information for the reviewer, gained from the author's experience, including examples of a thorough review, likely to be useful to the editor, and a cursory one that is unhelpful. The first consideration is relevance. Prerequisites for publication include institutional review board approval, disclosure of financial conflicts, and discussion of the regulatory status of devices. Particular attention is needed to check for conflicts of interest, which are endemic in plastic surgery today. In view of the common practice of using computer-generated imaging, reviewers need to be especially vigilant for inauthentic “photoshopped” photographs. Examples of published images that have been digitally altered are provided. If data are available, it may be possible to check the statistical tests. Reviewers need to be aware of the practice of p-hacking. A quick literature search can identify relevant but unreferenced publications. The manuscript needs to be properly organized into sections. Minor points may be made regarding style. The study design and methodology need to be evaluated to be sure that the conclusions are well supported by data. Randomized studies are rarely feasible. Fortunately, well-done prospective observational studies in consecutive patients can be just as useful. Realistic complication rates are expected. Meta-analyses in plastic surgery are often subject to confounding variables. Comments should be available to the authors; confidential comments hidden from authors are discouraged. Like honesty, transparency is the best policy. Manuscripts should be evaluated solely for merit, not the identity of the author or institution. Timeliness of submission of the review is appreciated by authors. Evidence-based medicine is concerned solely with the facts. The 2 basic criteria are a solid scientific basis and reliable evidence of efficacy. Reviewers need to keep an open mind. Studies that challenge the status quo are often the most valuable ones and are needed for the advancement of the specialty.

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“…research of existing data or specimens, demonstrations projects, and taste research [20]. It is not clear that this study fits one of these exemptions.…”

mentioning

confidence: 93%

The Case Against Betadine Irrigation of Breast Implant Pockets

Swanson

2022

Aesth Plast Surg

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The Institutional Review Board: A Discussion of the Importance of Ethical, Evidence-Based Research in Plastic Surgery

Cited by 3 publications

References 12 publications

The Keller Funnel, Capsular Contracture, and Conflict of Interest

The Keller Funnel, Capsular Contracture, and Conflict of Interest

Peer Review

The Case Against Betadine Irrigation of Breast Implant Pockets

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