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LIBERTI: A SMART study in plastic surgery.

ABSTRACT: BACKGROUND/AIMS:Laser treatment of burns scars is considered by some providers to be standard of care. However, there is little evidence-based research as to the true benefit. A number of factors hinder evaluation of the benefit of laser treatment. These include significant heterogeneity in patient response and possible delayed effects from the laser treatment. Moreover, laser treatments are often provided sequentially using different types of equipment and settings, so there are effectively a large number of overall treatment options that need to be compared. We propose a trial capable of coping with these issues and that also attempts to take advantage of the heterogeneous response in order to estimate optimal treatment plans personalized to each individual patient. It will be the first large-scale randomized trial to compare the effectiveness of laser treatments for burns scars and, to our knowledge, the very first example of the utility of a Sequential Multiple Assignment Randomized Trial in plastic surgery. METHODS:We propose using a Sequential Multiple Assignment Randomized Trial design to investigate the effect of various permutations of laser treatment on hypertrophic burn scars. We will compare and test hypotheses regarding laser treatment effects at a general population level. Simultaneously, we hope to use the data generated to discover possible beneficial personalized treatment plans, tailored to individual patient characteristics. RESULTS:We show that the proposed trial has good power to detect laser treatment effect at the overall population level, despite comparing a large number of treatment combinations. The trial will simultaneously provide high-quality data appropriate for estimating precision-medicine treatment rules. We detail population-level comparisons of interest and corresponding sample size calculations. We provide simulations to suggest the power of the trial to detect laser effect and also the possible benefits of personalization of laser treatment to individual characteristics. CONCLUSION:We propose, to our knowledge, the first use of a Sequential Multiple Assignment Randomized Trial in surgery. The trial is rigorously designed so that it is reasonably straightforward to implement and powered to answer general overall questions of interest. The trial is also designed to provide data that are suitable for the estimation of beneficial precision-medicine treatment rules that depend both on individual patient characteristics and on-going real-time patient response to treatment.

SUBMITTER: Hibbard JC

PROVIDER: S-EPMC5990436 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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LIBERTI: A SMART study in plastic surgery.

Hibbard Jonathan C JC Friedstat Jonathan S JS Thomas Sonia M SM Edkins Renee E RE Hultman C Scott CS Kosorok Michael R MR

Clinical trials (London, England) 20180325 3

<h4>Background/aims</h4>Laser treatment of burns scars is considered by some providers to be standard of care. However, there is little evidence-based research as to the true benefit. A number of factors hinder evaluation of the benefit of laser treatment. These include significant heterogeneity in patient response and possible delayed effects from the laser treatment. Moreover, laser treatments are often provided sequentially using different types of equipment and settings, so there are effecti ...[more]

PMID: 29577741

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Project description:ObjectivesThe wide variety of operations that a plastic surgeon can deal with creates confusion regarding its proper scope. This confusion was observed in primary physicians as well as medical students. Increasing the perception of medical students toward plastic surgery can aid in career decision-making and early referral patterns. The aim of this study is to gauge a holistic overview of how medical students and interns perceive the plastic and aesthetic surgical specialty in King Faisal University and to suggest a recommended plan.MethodsAn online questionnaire was distributed equally to male and female medical students and interns in a local medical institute. The questionnaire constituted three sections; the first included the biographical data. The second is concerned with the different case scenarios and specialties to be chosen. The third is concerned with the previous clinical exposures. The data were analyzed by SPSS version 21. Between comparison, chi-square tests, Mann-Whitney U-test, and Kruskal-Wallis tests were applied. Normality tests were conducted using the Shapiro-Wilk's test.ResultsTwo hundred ninety-two students and interns have participated and completed the questionnaire. There were 189 males and 103 females. Plastic surgery was most commonly chosen in the following case scenarios; burn of the hand (74%), broken nose (64.7%), and cosmetic nose reshaping (80.8%). However, plastic surgery was infrequently chosen (selected by <30% of students) in many areas of hands and peripheral neuropathies (severed finger extensor tendon (26.4%), fractured scaphoid (12.7%), carpal tunnel syndrome (14.4%), brachial plexus injury (16.1%)). The most common source of information was the social media, and the least one is meeting with doctors and professors.ConclusionMedical students and interns lack a full view of plastic and reconstructive surgery, especially in hand and peripheral neuropathies. Improving the education of medical students and interns is recommended and needed.

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LIBERTI: A SMART study in plastic surgery.

Publications

LIBERTI: A SMART study in plastic surgery.

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