Manual Plastic & Hand Surgery in Clinical Practice: Classifications and Definitions

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Responses were compared using descriptive statistics. Nine hundred eighty-two hand surgeons 76 percent orthopedic and 24 percent plastic responded, representing a 39 percent response rate. Most plastic surgery hand practices were academic-based 41 percent , whereas orthopedic practices were private 67 percent. Orthopedic and plastic surgery hand surgeons differ significantly in their clinical practice patterns.

Plastic & Hand Surgery in Clinical Practice: Classifications and Definitions

Differences in clinical exposure during training are reflected in practice and persist over time. Referral patterns and practice situations are also contributors to ultimate practice patterns. National Center for Biotechnology Information , U. Didn't get the message?

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Such measures are likely to improve study quality. Disclosure: The author has no financial interest to declare in relation to the content of this article. The Article Processing Charge was paid for by the author. Supplemental digital content is available for this article.

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Clickable URL citations appear in the text. The work cannot be changed in any way or used commercially. The Level of Evidence pyramid was introduced to Plastic and Reconstructive Surgery in July as a means of grading articles and encouraging a higher level of evidence in plastic surgery publications. The lack of science in plastic surgery is well recognized.

Evidence-based medicine is not intended to be static but rather a dynamic, lifelong process 12 , 13 that recognizes the need to evolve. Such a study has not been reported in the plastic surgery literature. A 2-year period of publications in Plastic and Reconstructive Surgery , July through June , was retrospectively evaluated. All articles with a Level of Evidence rating published in the Cosmetic Section were included. This classification modifies the traditional Level of Evidence ranking 1 and grade of recommendation Table 2.

Table 4 provides the study design and methodology characteristics for the first 10 articles. Table 5 summarizes the findings.

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  5. Three articles were assigned a level 1. A level 2 study is a prospective comparison of treatment cohorts, a level 3 study is a retrospective case-control study, and a level 4 study is a case series. The numbers of studies designated to each group are not normally distributed Fig.

    The present grade classification used by Plastic and Reconstructive Surgery 4 provides recommendations based on current knowledge irrespective of the study. A low-quality study that concludes, for example, that smoking increases the complication rate may receive a low grade of recommendation, despite support in the literature. Because methodology is considered in the CLEAR numerical rating 1—5 , the grade tends to be closely linked. Only 3 studies were designated level 1. In their level 1 study, Costa-Ferreira et al 24 did not control for an important confounding variable—electrodissection.

    Paradoxically, all 3 level 1 studies arrive at unreliable conclusions that encourage the reader to needlessly 1 purchase a 6-figure instrument, 22 2 compromise the esthetic result of an abdominoplasty, 24 and 3 deny surgery to one third of prospective cosmetic rhinoplasty patients. Randomized trials balance both known and unknown confounders and avoid selection bias 3 , 18 , 28 —at least theoretically. However, surgery is a much different discipline.

    Unlike a pill, a procedure is not identical from patient to patient, 11 , 18 placebos and blinding are usually not possible, and randomization is not well accepted by patients, 11 , 16 , 28 surgeons, 16 , 28 , 33 or referral sources. Other shortcomings include a lack of external validity generalizability , 3 , 18 , 28 , 35 the fact that surgeons are rarely equally proficient in and enthusiastic about 2 different techniques 32 and cost. Two rigorous reviews published in the same issue of The New England Journal of Medicine in reveal that randomized trials and observational studies usually produce similar results.

    They attribute the greater homogeneity of observational studies to their broader representation of the general population. Randomized trials are inflexible and disallow modifications that might better suit individual patients. Inadequate concealment of randomization and treatment assignments can cause serious bias that may exceed the magnitude of the treatment effect.

    Reviews of randomized trials in plastic surgery uniformly report low quality.

    Hand Surgery

    Ethical considerations prohibit randomization of patients into 2 groups, one of which constitutes a known inferior treatment. Predictably, such studies tend to find no difference in treatment effects. This discussion leads to a catch If investigators compare one operation with another, they already believe one treatment is superior or they would not be conducting the study. If the difference is so slight that there is no consistent evidence one way or the other, the study is probably pointless. Fortunately, most clinical questions in plastic surgery do not concern whether a procedure is superior to nothing.

    Most randomized controlled trials in plastic surgery evaluate nonsurgical interventions.

    Plastic & Hand Surgery in Clinical Practice

    Studies using historical controls are predisposed to find that the newer therapy is superior to its predecessor. If the treatment effect is dramatic eg, breast self-consciousness after augmentation , a control group is unnecessary eg, a control group of women not electing to have a breast augmentation. A prospective study with a dramatic effect, but no control group, can qualify as a CLEAR level 2 study if other requirements are met Table 1.

    The literature consistently supports the superiority of a prospective study. A prospective study is always preferred over a retrospective study if it is feasible. The difference is the vantage point—literally looking forward vs looking backward. The outcome of a prospective study is unknown when it is undertaken, making the investigator less prejudiced. By definition, in a prospective study, the study is conceived before the data are collected. Selection bias and confounders are reduced by specifying eligibility criteria, encouraging follow-up appointments, standardizing and calibrating photographs and measurements, and administering contemporaneous surveys rather than years later.

    An example would be a study to determine whether patient gender affects seroma rates after body contouring surgery. A prospective study would take care to record patient weights on the same scales, preoperative weight loss, intraoperative use of electrodissection, and tissue resection weights. Some of these important details might be missing in a retrospective study. Prospective studies usually disclose more realistic complication rates than retrospective studies.

    Classifications and Definitions

    Unavoidable confounders eg, a difference in mean body mass indices may be managed using an analysis of covariance or other statistical adjustment. Patient satisfaction and improved quality of life, 80 , 81 assessed using patient-derived outcome measures, are the hallmarks of successful plastic surgery. Morbidity and mortality measures are less relevant to plastic surgery than other surgical disciplines.

    Over 2 decades ago, Goldwyn 83 cautioned that selectively reporting better results does nothing to advance the specialty. Nevertheless, a requirement for consecutive patients is conspicuously absent from the existing Level of Evidence rating likely because of its nonsurgical origins.

    Glossary - Plastic and Reconstructive Surgery | Stanford Health Care

    Both series receive the same catchall level 4 designation. Insisting on consecutive patients 1 sends a message to investigators to report all results and 2 prevents studies of selected patients that include higher level design characteristics from receiving undeserved higher rankings. Like a framework built on a weak foundation, no other study attribute can compensate for an unrepresentative patient sample.

    When discussing consecutive patients, it is important to be precise. Many studies would improve from a CLEAR 5 to a CLEAR 4 ranking, or higher, simply by including consecutive patients eg, clinical studies or consecutive patients subject to reasonable inclusion criteria that usually include sufficient time for resolution of swelling eg, measurement and outcome studies. A nonconsecutive case series is just a plural form of a case report and is therefore no more deserving of a higher rank.

    It is not difficult to report consecutive patients. Although level 1 studies will continue to be rare, it is realistic to expect a more balanced distribution of articles between levels 2 and 5. Sample size calculation is an important part of any prospective study, whether randomized or not, 28 , 56 , 86 but is infrequently performed 3.