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Low Evidence Levels Have Far-Reaching Consequences for Funct… : Plastic and Reconstructive Surgery


In the era of evidence-based medicine, clinicians are strongly encouraged to provide the highest level of evidence about the effectiveness of medical procedures. Absence of level I or II evidence can have far-reaching consequences. In The Netherlands, for example, health insurance carriers are collectively starting to decline expense coverages for functional rhinoplasty, given the fact that there are no randomized controlled trials or meta-analyses that support the effectiveness of nasal valve surgery. Subsequently, an increasing percentage of Dutch patients with moderate to severe nasal obstruction are withheld from care that is globally deemed effective. An important question arises: Is it realistic to expect high evidence levels from the field of rhinoplasty?

Historically, rhinoplasty surgeons have acknowledged the importance of critically appraising and describing surgical results, which is illustrated by numerous outcome publications. That most of these articles denote level IV and V evidence does not imply a reluctance to perform randomized controlled trials, but merely illustrates the presence of major challenges, such as sample size recruitment, randomization, blinding, ethical approval, and funding.1,2 Even if these challenges were overcome, there are additional reasons why it is unlikely that top level evidence will become available soon.

An important disturbing factor in rhinoplasty outcome evaluations is heterogeneity. Rhinoplasty is not a demarcated surgical procedure but a collective term for a large variety of surgical maneuvers, frequently combined to correct a wide anatomical variation of structural deformities. Even when cosmetic rhinoplasty is distinguished from functional rhinoplasty, a certain overlap is present. In other words, rhinoplasty is no exact science and is characterized by a tremendous heterogeneity on surgical and anatomical levels. Powered evidence about the effectiveness of a specific rhinoplasty technique requires homogeneity on both levels, which is rarely present.

A second disturbing factor is the lack of validated objective instruments that are responsive to change in nasal obstruction following functional rhinoplasty. Presently, there is no global consensus on the value of such instruments, and literature reports poor correlations with patient sensation of nasal airflow.3,4 Fortunately, validated patient-reported outcome measures are gaining international acceptance as suitable rhinoplasty outcome instruments, but their subjective nature is sometimes criticized.

All things considered, is it fair for insurance companies to discard lower evidence publications and to set major consequences to an absence of level I and II evidence? The answer to that question is not that simple. It does clarify the need for an evidence-based response, which might be found in large outcome data registries. Big data analyses from prospectively acquired outcome registries could produce powered prediction models that reliably indicate what effect may be expected from functional rhinoplasty, given specific anatomical, surgical, and patient-specific characteristics (potential level IIc evidence). Such registries are available in the field of facial plastic surgery but usually lack the most important parameter of effectiveness: patient-reported satisfaction.5 The time has come for rhinoplasty surgeons to collaborate, and collectively invest resources to fuel big data outcome registries.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.

REFERENCES

1. Loiselle F, Mahabir RC, Harrop AR. Levels of evidence in plastic surgery research over 20 years. Plast Reconstr Surg. 2008;121:207e–211e.

2. Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128:305–310.

3. André RF, Vuyk HD, Ahmed A, Graamans K, Nolst Trenité GJ. Correlation between subjective and objective evaluation of the nasal airway: A systematic review of the highest level of evidence. Clin Otolaryngol. 2009;34:518–525.

4. Pawar SS, Garcia GJ, Kimbell JS, Rhee JS. Objective measures in aesthetic and functional nasal surgery: Perspectives on nasal form and function. Facial Plast Surg. 2010;26:320–327.

5. Smith AM, Chaiet SR. Big data in facial plastic and reconstructive surgery: From large databases to registries. Curr Opin Otolaryngol Head Neck Surg. 2017;25:273–279.

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