Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interfaces Versus Standard Management in the Treatment of Limb Amputation: A Systematic Review and Meta-Analysis.

Introduction: Painful neuromas are a common postoperative complication of limb amputation often treated with secondary reinnervation. Surgical reinnervation include Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Nerve Interface (RPNI), and can be primary and secondary. The aim of this review is to assess the effects of primary TMR/RPNI at the time of limb amputation on the incidence and intensity of post-operative neuroma and pain. Methods: This review was registered a priori on PROSPERO (CRD42021264360). A search of the following databases was performed in June 2021: Medline, EMBASE, and CENTRAL. Unpublished trials were searched using clinicaltrials.gov. All randomized and non-randomized studies assessing amputation with a reinnervation strategy (TMR, RPNI) were included. Outcomes evaluated included the incidences of painful neuroma, phantom limb pain (PLP), residual limb pain (RLP), as well as severity of pain, and Pain intensity, behavior, and interference (PROMIS). Results: Eleven studies were included in this systematic review, and five observational studies for quantitative synthesis. Observational study evidence suggests that TMR/RPNI results in a statistically significant reduction in incidence, pain scores and PROMIS scores of PLP and RLP. Decreased incidence of neuromas favored primary TMR/RPNI, but this did not achieve statistical significance (p = 0.07). Included studies had moderate to critical risk of bias. Conclusion: The observational data suggests that primary TMR/RPNI reduces incidence, pain scores and PROMIS scores of PLP and RLP. Going forward, randomized trials are warranted to evaluate this research question, particularly to improve the certainty of evidence.

Introduction: Les névromes douloureux sont une complication postopératoire courante de l'amputation d'un membre qui est souvent traitée par réinnervation secondaire. La réinnervation chirurgicale inclut la réinnervation musculaire ciblée (TMR) et l'interface nerveuse périphérique régénérative (RPNI) qui peuvent être primaires ou secondaires. Le but de cette revue était d'évaluer les effets de la TMR/RPNI primaires au moment de l'amputation du membre sur l'incidence et l'intensité du névrome et de la douleur postopératoire. Méthodes: Cette revue a été enregistrée a priori sur PROSPERO (CRD42021264360). Une recherche a été réalisée en juin 2021 dans les bases de données suivantes : MEDLINE, EMBASE et CENTRAL. Les essais non publiés ont été recherchés à l'aide du site clinicaltrials.gov. Toutes les études randomisées et non randomisées évaluant l'amputation avec stratégie de réinnervation (TMR, RPNI) ont été incluses. L'évaluation des résultats a inclus l'incidence des névromes douloureux, des douleurs du membre fantôme (PLP), de douleur résiduelle du membre (RLP) ainsi que la sévérité de la douleur, l'intensité de la douleur, le comportement et l'interférence (PROMIS). Résultats: Onze études ont été incluses dans cette revue systématique et cinq études observationnelles pour la synthèse quantitative. Les données probantes d'étude observationnelle suggèrent que la TMR/RPNI entraîne une réduction statistiquement significative de l'incidence, des scores de douleur et des scores PROMIS des PLP et RLP. La baisse de l'incidence des névromes favorisait les TMR/RPNI primaires, mais sans atteindre la signification statistique (P = 0,07). Les études incluses comportaient des risques de biais modérés à critiques. Conclusion: Les données observationnelles suggèrent que les TMR/RPNI réduisent l'incidence, les scores de douleur et les scores PROMIS de PLP et RLP. La réalisation d'essais randomisés est justifiée pour aller de l'avant et évaluer cette question de recherche, en particulier pour améliorer la certitude des données probantes.

Closed Incision Negative Pressure Therapy Versus Traditional Dressings for Low Transverse Abdominal Incisions Healing by Primary Closure: A Systematic Review and Meta-Analysis.

Background: Closed incision negative pressure therapy (ciNPT) devices may reduce wound healing complications when applied to closed surgical incisions. The aim of this review was to assess the effects of ciNPT versus standard dressings in patients undergoing primary closure of high tension, lower transverse abdominal incisions. Methods: This review was registered a priori on PROSPERO (CRD42021252048). A search of the following databases was performed in February 2021: Medline, EMBASE, and CENTRAL. Unpublished trials were searched using clinicaltrials.gov. All randomized and nonrandomized studies comparing ciNPT to standard dressings were included. Two independent reviewers performed screening and data extraction. Outcomes evaluated the incidence of wound dehiscence, surgical site infection, total abdominal complications, time to drain removal, and seroma formation. Main Results: Ten studies were included in quantitative and narrative synthesis. Observational study evidence suggests ciNPT likely reduces the incidence of wound dehiscence (odds ratio [OR] 0.57 [0.44-0.96], P = .03) and total abdominal complications (OR 0.34 [0.21-0.54], P < .01). Decreased incidence of seroma formation favored ciNPT (OR 0.65 [0.24-1.76], P = .40); however, this did not achieve significance. Randomized and non-randomized study evidence was very uncertain about the effect of ciNPT on the remaining outcomes. Conclusions: The current best randomized study evidence is very uncertain about the effect of ciNPT on these outcomes. Observational study evidence suggests ciNPT likely results in a statistically significant reduction in abdominal wound dehiscence and total abdominal complications. Additional randomized trials are warranted to limit the impact of bias on the overall certainty of the evidence.

Historique : Les dispositifs de traitement par pression négative sur des plaies d'incision fermées (TPNPIf) pourraient réduire les complications liées à la cicatrisation des plaies lorsqu'ils sont appliqués à des incisions chirurgicales fermées. La présente analyse visait à évaluer les effets du TPNPIf par rapport aux pansements habituels après la suture primitive d'incisions abdominales transversales basses. Méthodologie : La présente analyse a été enregistrée à l'avance dans PROSPERO (CRD42021252048). Les chercheurs ont fouillé les bases de données Medline, EMBASE et CENTRAL en février 2021. Ils ont extrait les études non publiées à l'aide de clinicaltrials.gov. Ils ont inclus toutes les études randomisées et non randomisées comparant les TPNPIf aux pansements habituels. Deux réviseurs indépendants ont procédé à la sélection et à l'extraction des données. Comme mesures de résultats, les chercheurs ont évalué l'incidence de déhiscence des plaies, d'infection au foyer de l'opération, de complications abdominales totales, de période jusqu'au retrait du drain et de formation de sérome. Principaux Résultats : Dix études ont été incluses dans la synthèse quantitative et narrative. Selon les données tirées d'études observationnelles, le TPNPIf réduit probablement l'incidence de déhiscence des plaies [RC 0,57 (0,44, 0,96), P = ,03] et les complications abdominales totales [RC 0,34 (0,21, 0,54), P < ,01]. La diminution de l'incidence de formation de sérome favorisait le TPNPIf [RC 0,65 (0,24 à 1,76), P = ,40], mais n'était pas statistiquement significative. La certitude établie par les données des études randomisées et non randomisées était très faible quant à l'effet du TPNPIf sur les autres résultats. Conclusions : Selon les meilleures données sur les études randomisées actuelles, l'effet du TPNPIf sur les résultats est très incertain. Selon les données sur les études observationnelles, le TPNPIf entraîne probablement une réduction statistiquement significative de la déhiscence des plaies abdominales et des complications abdominales totales. D'autres études aléatoires devront être réalisées pour réduire les répercussions des biais sur la certitude globale des données probantes.

"Spin" in Plastic Surgery Randomized Controlled Trials with Statistically Nonsignificant Primary Outcomes: A Systematic Review.

BACKGROUND: "Spin" refers to a manipulation of language that implies benefit for an intervention when none may exist. Randomized controlled trials (RCTs) in other fields have been demonstrated to employ spin, which can mislead clinicians to use ineffective or unsafe interventions. This study's objective was to determine the strategies, severity, and extent of spin in plastic surgery RCTs with nonsignificant primary outcomes. METHODS: A literature search of the top 15 plastic surgery journals using MEDLINE was performed (2000 through 2020). Parallel 1:1 RCTs with a clearly identified primary outcome showing statistically nonsignificant results ( P > 0.05) were included. Screening, data extraction, and spin analysis were performed by two independent reviewers. The spin analysis was then independently assessed in duplicate by two plastic surgery residents with graduate-level training in clinical epidemiology. RESULTS: From 3497 studies identified, 92 RCTs were included in this study. Spin strategies were identified in 78 RCTs (85%), including 64 abstracts (70%) and 77 main texts (84%). Severity of spin was rated moderate or high in 43 abstract conclusions (47%) and 42 main text conclusions (46%). The most identified spin strategy in the abstract was claiming equivalence for statistically nonsignificant results (26%); in the main text, focusing on another objective (24%). CONCLUSIONS: This study suggests that 85% of statistically nonsignificant RCTs in plastic surgery employ spin. Readers of plastic surgery research should be aware of strategies, whether intentional or unintentional, used to manipulate language in reports of statistically nonsignificant RCTs when applying research findings to clinical practice.

Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

OBJECTIVE: CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. DESIGN: Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. SETTING: Seven cleft centres in Canada, the USA, and UK were involved. PATIENTS/PARTICIPANTS: Patients were aged eight to 29 years with CL/P. INTERVENTIONS: Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). MAIN OUTCOME MEASURE(S): The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. RESULTS: Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. CONCLUSIONS: Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

Evaluation of "Spin" in the Abstracts of Systematic Reviews and Meta-analyses of Therapeutic Interventions Published in High-Impact Plastic Surgery Journals: A Systematic Review.

BACKGROUND: "Spin" is a form of reporting bias where there is an misappropriated presentation of study results, often overstating efficacy or understating harms. Abstracts of systematic reviews in other clinical domains have been demonstrated to employ spin, which may lead to clinical recommendations that are not justified by the literature. OBJECTIVES: The objective of this study was to determine the prevalence of spin strategies in abstracts of plastic surgery systematic reviews. METHODS: A literature search was conducted using MEDLINE, Embase, and CENTRAL, to identify all systematic reviews published in the top five plastic surgery journals from 2015-2021. Screening, data extraction, and spin analysis were performed by two independent reviewers. Data checking of the spin analysis was performed by a plastic surgery resident with graduate level training in clinical epidemiology. RESULTS: From an initial search of 826 systematic reviews, 60 systematic reviews and meta-analyses were included in this study. Various types of spin were identified in 73% of systematic review abstracts (n=44). "Conclusion claims the beneficial effect of the experimental treatment despite high risk of bias in primary studies," was the most prevalent type of spin and was identified in 63% of systematic reviews (n=38). There were no significant associations between the presence of spin and study characteristics. CONCLUSIONS: The present study found that 73% of abstracts in plastic surgery systematic reviews contain spin. Although systemic reviews represent the highest level of evidence, readers should be aware of types of "spin" when interpreting results and incorporating recommendations into patient care.

Systematic review of reporting quality of economic evaluations in plastic surgery based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

BACKGROUND: Economic evaluations in healthcare are designed to inform decisions by the estimation of cost and effect trade-off of two or more interventions. This review identified and appraised the quality of reporting of economic evaluations in plastic surgery based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. METHODS: Electronic databases were searched: MEDLINE, EMBASE, The Cochrane Library, Ovid Health Star, and Business Source Complete from January 1, 2012 to November 30, 2019. Data extracted included: the type of economic evaluation (i.e., cost-utility analysis (CUA), cost-effectiveness analysis (CEA), cost-benefit analysis (CBA), cost-minimization analysis (CMA)), domain of plastic surgery, journal, year, and country of publication. The CHEERS checklist (with 24 items) was used to appraise the quality of reporting. RESULTS: Ninety-two economic evaluations were identified; CUA (10%), CEA (31%), CBA (4%), and CMA (50%). Breast surgery was the top domain (48%). Most were conducted in the USA (61%) and published in Plastic and Reconstructive Surgery journal (28%). One-third were published in the last two years. The average CHEERS checklist compliance score was 15 (63%). The average CHEERS checklist compliance score per type of evaluation was 19 (77%) for CUA, 17 (70%) for CEA, 13 (52%) for CBA, and 14 (57%) for CMA. The least reported CHEERS checklist items included: time horizon (15%), discount rate (18%), and assessment of heterogeneity (15%). Thirty-two percent of studies were inappropriately titled (i.e., methodologically incorrect). CONCLUSION: Quality of reporting of economic evaluations is suboptimal. The CHEERS checklist should be consulted when performing and reporting economic evaluations in plastic surgery.

Reporting Outcomes and Outcome Measures in Thumb Carpometacarpal Joint Osteoarthritis: A Systematic Review.

PURPOSE: In the thumb carpometacarpal (CMC) joint osteoarthritis (OA) literature, there is substantial heterogeneity in outcome and outcome measure reporting. This could be rectified by a standardized core outcome set (COS). This study aimed to identify a comprehensive list of outcomes and outcome measures for thumb CMC joint OA, which represents the first step in developing a COS. METHODS: A computerized search of MEDLINE, EMBASE, Cochrane, and CINAHL was performed to identify randomized controlled trials, as well as observational studies involving at least 50 participants aged greater than 18 years undergoing surgery for thumb CMC joint OA. Reported outcomes and outcome measures were extracted from these trials and summarized. RESULTS: This search yielded 3,498 unique articles, 97 of which were used for analysis. A total of 33 unique outcomes and 25 unique outcome measures were identified. The most frequently used outcomes were complications (78), postoperative pain (73), radiologic outcomes (64), and grip strength (63). Within each reported outcome, there was substantial variation in how the outcome was measured. Of the 25 unique outcome measures, 10 were validated. Of the remaining 15, 12 were created ad hoc by the author. The Disabilities of the Arm, Shoulder, and Hand questionnaire was the most commonly reported outcome measure (34%). CONCLUSIONS: There is a lack of consensus on critical outcomes after surgery for thumb CMC joint OA. A standardized COS created by stakeholder consensus would improve the consistency and therefore the quality of future research. CLINICAL RELEVANCE: This systematic review of outcomes represents the first step in developing a core outcome set for thumb CMC joint OA.

Reporting Outcomes and Outcome Measures in Digital Replantation: A Systematic Review.

Introduction There is a lack of consensus on what the critical outcomes in replantation are and how best to measure them. This review aims to identify all reported outcomes and respective outcome measures used in digital replantation. Materials and Methods Randomized controlled trials, cohort studies, and single-arm observational studies of adults undergoing replantation with at least one well-described outcome or outcome measure were identified. Primary outcomes were classified into six domains, and outcome measures were classified into eight domains. The clinimetric properties were identified and reported. A total of 56 observational studies met the inclusion criteria. Results In total, 29 continuous and 29 categorical outcomes were identified, and 87 scales and instruments were identified. The most frequently used outcomes were survival of replanted digit, sensation, and time in hospital. Outcomes and measures were most variable in domains of viability, quality of life, and motor function. Only eight measures used across these domains were validated and proven reliable. Conclusion Lack of consensus creates an obstacle to reporting, understanding, and comparing the effectiveness of various replantation strategies.

Secondary Implant Augmentation in the Subpectoral Plane following Abdominal-based Perforator Flaps for Breast Reconstruction.

BACKGROUND: Abdominal-based perforator flaps are the gold standard for autologous breast reconstruction. However, among patients with a small-to-medium amount of redundant abdominal tissue, this may result in an inadequate breast mound. Secondary implant augmentation has been reported as one method to augment volume, address breast mound asymmetry, and enhance overall aesthetic outcome. We aim to analyze postoperative complications associated with the secondary implant augmentation following a primary breast reconstruction with abdominal perforator flaps. METHODS: This retrospective study included patients who underwent secondary implant augmentation following abdominal-based perforator flap breast reconstruction. Patient characteristics, immediate versus delayed reconstruction, type of flap used, indication for secondary augmentation as well as perioperative and postoperative complication including flap or implant loss were reviewed and analyzed. RESULTS: Twenty-four patients met inclusion criteria. Forty flaps were performed (16 bilateral and 8 unilateral). A total of 36 implants were placed in subpectoral plane in a secondary revision procedure. The mean time between secondary augmentation and index procedure was 22 months. Average implant volume was 270 g. No intraoperative complication or flap loss was recorded. Postoperative surgical site infection occurred in a total of 4 patients (17%) with 3 patients requiring explantation of a total of 4 implants. CONCLUSIONS: Secondary augmentation of abdominal-based perforator flap using a permanent implant is an effective method to address volume and asymmetry and to enhance aesthetic outcome. In our study, however, we observed a higher than expected rate of postoperative infection.

Reporting Outcomes and Outcome Measures in Cubital Tunnel Syndrome: A Systematic Review.

PURPOSE: Comparison between studies assessing outcomes after surgical treatment of cubital tunnel syndrome (CuTS) has proven to be difficult owing to variations in outcome reporting. This study aimed to identify outcomes and outcome measures used to evaluate postoperative results for CuTS. METHODS: We performed computerized database searches of MEDLINE and EMBASE. Studies with 20 or more patients aged 18 and older who were undergoing medial epicondylectomy, endoscopic decompression, open simple decompression, or decompression with subcutaneous, submuscular, or intramuscular transposition for ulnar neuropathy at the elbow were included. Outcomes and outcome measures were extracted and tabulated. RESULTS: Of the 101 studies included, 45 unique outcomes and 31 postoperative outcome measures were identified. These included 7 condition-specific, clinician-reported instruments; 4 condition-specific, clinician-reported instruments; 8 patient-reported, generic instruments; 11 clinician-generated instruments; and one utility measure. Outcome measures were divided into 6 unique domains. Overall, 60% of studies used condition-specific outcome measures. The frequency of any condition-specific outcome measure ranged from 1% to 37% of included studies. CONCLUSIONS: There is marked heterogeneity in outcomes and outcome measures used to assess CuTS. A standardized core outcome set is needed to compare results of various techniques of cubital tunnel decompression. CLINICAL RELEVANCE: This study builds on the existing literature to support the notion that there is marked heterogeneity in outcomes and outcome measures used to assess CuTS. The authors believe that a future standardized set of core outcomes is needed to limit heterogeneity among studies assessing postoperative outcomes in CuTS to compare these interventions more easily and pool results in the form of systematic reviews and meta-analyses.

A systematic review identifying outcomes and outcome measures in Dupuytren's disease research.

This systematic review summarizes the outcome reporting standards in Dupuytren's disease treatment research. A search of Ovid Medline, Ovid Embase, and CINAHL was conducted. Randomized controlled trials, cohort studies, and case series published between 1997 and 2017, investigating treatment of Dupuytren's disease with fasciectomy, fasciotomy, or collagenase, were eligible for inclusion. Range of motion was the most commonly reported outcome, appearing in 77% of included studies. Outcomes, such as range of motion, recurrence, and clinical success, were frequently defined, however many different definitions were used. We identified 37 unique measurement methods for range of motion, 28 for recurrence, and 25 for clinical success. Most outcomes were assessed at multiple time points, and only a few studies reported results according to established clinical significance thresholds. Development of a core outcome set will help standardize outcome reporting, and ensure future research in this field is relevant, interpretable, and amenable to systematic review and/or meta-analysis.

Patient-Reported Measurement of Breast Asymmetry Using Archimedes' Principle in Breast Reduction Mammaplasty: A Retrospective Study.

Introduction Breast hypertrophy is a common condition that is often treated with breast reduction surgery. A large percentage of breast hypertrophy patients have notable asymmetry between breasts. Methods The purpose of this study was to investigate a method of measuring breast asymmetry, one that allows patients to determine the asymmetry of their own breasts at home with ease, and to assess its accuracy and role in a surgical practice. A retrospective chart review was conducted, wherein self-measurements of breast asymmetry using a variation of Bouman's technique were compared with the recorded intra-operative resected tissue mass. Results In total, 47 patients with asymmetry were included in the study. The difference between patient-reported measurements and resected breast tissue mass varied from 0 grams to 240 grams. Of the 47 patients, 38% were able to measure their breast difference within a remarkable 10 grams as compared to the resected breast tissue, of which four patients were accurate to less than one gram. The majority (70%) of patients accurately measured their asymmetry within 50 grams, which was determined to be a clinically significant amount based on a survey of plastic surgeons performed for the study. Conclusion The breast measurement technique presented in this study appears to be effective and accurate for most patients with suspected asymmetry undergoing reduction mammaplasty that stands to reduce pre-operative planning time. Patient-reported breast measurement may emerge as a valuable tool in clinical and research pursuits; however, further research on this topic is indicated at this time.

Perspectives and Consensus among International Orthopaedic Surgeons during Initial and Mid-lockdown Phases of Coronavirus Disease.

With a lot of uncertainty, unclear, and frequently changing management protocols, COVID-19 has significantly impacted the orthopaedic surgical practice during this pandemic crisis. Surgeons around the world needed closed introspection, contemplation, and prospective consensual recommendations for safe surgical practice and prevention of viral contamination. One hundred orthopaedic surgeons from 50 countries were sent a Google online form with a questionnaire explicating protocols for admission, surgeries, discharge, follow-up, relevant information affecting their surgical practices, difficulties faced, and many more important issues that happened during and after the lockdown. Ten surgeons critically construed and interpreted the data to form rationale guidelines and recommendations. Of the total, hand and microsurgery surgeons (52%), trauma surgeons (32%), joint replacement surgeons (20%), and arthroscopy surgeons (14%) actively participated in the survey. Surgeons from national public health care/government college hospitals (44%) and private/semiprivate practitioners (54%) were involved in the study. Countries had lockdown started as early as January 3, 2020 with the implementation of partial or complete lifting of lockdown in few countries while writing this article. Surgeons (58%) did not stop their surgical practice or clinics but preferred only emergency cases during the lockdown. Most of the surgeons (49%) had three-fourths reduction in their total patients turn-up and the remaining cases were managed by conservative (54%) methods. There was a 50 to 75% reduction in the number of surgeries. Surgeons did perform emergency procedures without COVID-19 tests but preferred reverse transcription polymerase chain reaction (RT-PCR; 77%) and computed tomography (CT) scan chest (12%) tests for all elective surgical cases. Open fracture and emergency procedures (60%) and distal radius (55%) fractures were the most commonly performed surgeries. Surgeons preferred full personal protection equipment kits (69%) with a respirator (N95/FFP3), but in the case of unavailability, they used surgical masks and normal gowns. Regional/local anesthesia (70%) remained their choice for surgery to prevent the aerosolized risk of contaminations. Essential surgical follow-up with limited persons and visits was encouraged by 70% of the surgeons, whereas teleconsultation and telerehabilitation by 30% of the surgeons. Despite the protective equipment, one-third of the surgeons were afraid of getting infected and 56% feared of infecting their near and dear ones. Orthopaedic surgeons in private practice did face 50 to 75% financial loss and have to furlough 25% staff and 50% paramedical persons. Orthopaedics meetings were cancelled, and virtual meetings have become the preferred mode of sharing the knowledge and experiences avoiding human contacts. Staying at home, reading, and writing manuscripts became more interesting and an interesting lifestyle change is seen among the surgeons. Unanimously and without any doubt all accepted the fact that COVID-19 pandemic has reached an unprecedented level where personal hygiene, hand washing, social distancing, and safe surgical practices are the viable antidotes, and they have all slowly integrated these practices into their lives. Strict adherence to local authority recommendations and guidelines, uniform and standardized norms for admission, inpatient, and discharge, mandatory RT-PCR tests before surgery and in selective cases with CT scan chest, optimizing and regularizing the surgeries, avoiding and delaying nonemergency surgeries and follow-up protocols, use of teleconsultations cautiously, and working in close association with the World Health Organization and national health care systems will provide a conducive and safe working environment for orthopaedic surgeons and their fraternity and also will prevent the resurgence of COVID-19.

Reporting Outcomes and Outcome Measures in Open Rhinoplasty: A Systematic Review.

BACKGROUND: Comparative studies have shown little statistical difference in outcomes following rhinoplasty, demonstrating near equivalent results across all surgical techniques. Cross-study comparisons of these trials are difficult because variation in outcome reporting prevents statistical pooling and analysis. OBJECTIVES: The authors sought to identify all outcomes and outcome measures used to evaluate postoperative results in rhinoplasty. METHODS: An extensive computerized database search of MEDLINE and EMBASE was performed; all trials involving n ≥ 20 patients, aged 18 years and older undergoing a primary, open rhinoplasty procedure, were included for review. RESULTS: Of the 3235 citations initially screened, 72 studies met the stated inclusion criteria. A total of 53 unique outcomes and 55 postoperative outcome measures were identified. Outcomes were divided into 6 unique domains: objective signs, subjective symptom severity, physical function related to activities of daily living, patient satisfaction, surgeon satisfaction, and quality of life. The identified outcome measures consisted of 5 nasal-specific, author-reported instruments; 5 nasal specific, patient-reported instruments; 5 patient-reported, generic instruments; and 40 author-generated instruments. Of the outcome measures identified, the Rhinoplasty Outcomes Evaluation, Sino-Nasal Outcome Test-22, and FACE-Q were the only instruments to demonstrate adequate validity, reliability, and responsiveness to change in patients who underwent a rhinoplasty procedure. CONCLUSIONS: There is heterogeneity in the outcomes and outcome measures employed to assess postsurgical outcomes following rhinoplasty. A standardized core outcome set is urgently needed to make it possible for future investigators to compare results of various techniques in rhinoplasty surgery.

The Reporting Quality of Randomized Controlled Trial Abstracts in Plastic Surgery.

BACKGROUND: When evaluating randomized controlled trials (RCTs), clinicians will often refer to the abstract for an initial assessment of the results and to determine whether a full-text review is warranted. OBJECTIVES: This project aims to assess the reporting quality of RCT abstracts published within the top 5 plastic surgery journals utilizing the Consolidated Standards of Reporting Trials (CONSORT) for abstracts checklist. METHODS: A computerized database search of OVID MEDLINE was performed. All primary RCTs published within the top 5 plastic surgery journals (by 2016 International Scientific Indexing impact factor) from 2011 to 2018 were included. Two reviewers, blinded to journal and author, independently and in duplicate, scored abstracts employing the 16-item CONSORT for abstracts checklist. RESULTS: This review identified 126 RCTs that satisfied the inclusion criteria. Included studies were distributed across 5 journals: Plastic and Reconstructive Surgery (n = 83), JAMA Facial Plastic Surgery (n = 8), Aesthetic Surgery Journal (n = 33), Journal of Reconstructive Microsurgery (n = 2), and the Journal of Hand Surgery-European Volume (n = 0). Mean overall item adherence across all abstracts was 7 (SD ± 2). The most poorly reported items were "trial registration," "method of randomization," and "source of trial funding" and appeared in 4%, 2.4%, and 0% of abstracts, respectively. CONCLUSIONS: There is limited adherence to the CONSORT for abstracts checklist among RCT abstracts published within the top 5 plastic surgery journals. Given the reliance of clinicians on abstract reporting, omitting essential trial details can lead to an inaccurate interpretation of trial results and improper application in clinical practice. Active endorsement of the CONSORT for abstracts checklist is required to improve the quality of RCT abstract reporting.

Outcomes and Outcome Measures in Breast Reduction Mammaplasty: A Systematic Review.

BACKGROUND: Reduction mammaplasty remains critical to the treatment of breast hypertrophy. No technique has been shown to be superior; however, comparison between studies is difficult due to variation in outcome reporting. OBJECTIVES: The authors sought to identify a comprehensive list of outcomes and outcome measures in reduction mammaplasty. METHODS: A comprehensive computerized search was performed. Included studies were randomized or nonrandomized controlled trials involving at least 100 cases of female breast hypertrophy and patients of all ages who underwent 1 or more defined reduction mammaplasty technique. Outcomes and outcome measures were extracted and tabulated. RESULTS: A total 106 articles were eligible for inclusion; 57 unique outcomes and 16 outcome measures were identified. Frequency of patient-reported and author-reported outcomes were 44% and 88%, respectively. Postoperative complications were the most frequently reported outcome (82.2%). Quality-of-life outcomes were accounted for in 37.7% of studies. Outcome measures were either condition-specific or generic; frequencies were as low as 1% and as high as 5.6%. Five scales were formally assessed in the breast reduction populations. Clinical measures were defined in 15.1% of studies. CONCLUSIONS: There is marked heterogeneity in reporting of outcomes and outcome measures in the literature. A standardized outcome set is needed to compare outcomes of various reduction mammaplasty techniques.

The Fragility of Statistically Significant Randomized Controlled Trials in Plastic Surgery.

BACKGROUND: The fragility index has been proposed as a metric to evaluate the robustness of statistically significant findings in randomized controlled trials. It measures the number of events that a trial result relies on to maintain statistical significance. This study examines the robustness of statistically significant results from randomized controlled trials in the plastic surgery literature. METHODS: A systematic literature search of the 15 highest impact plastic surgery journals was conducted to identify randomized controlled trials published between 2000 and 2017 that reported a statistically significant dichotomous outcome (p < 0.05). The fragility index of each study was calculated using Fisher's exact test. Multiple linear regression was used to determine trial characteristics associated with the fragility index. RESULTS: The 90 eligible randomized controlled trials had a median sample size of 73.5 patients (25th to 75th percentile, 50 to 115) and a median of 20 events (25th to 75th percentile, 11 to 33.5) for the chosen outcome. The median fragility index was 1 (25th to 75th percentile, 0 to 4), indicating that statistical significance would be lost in half of the randomized controlled trials if a single patient had a change in event status. The fragility index was 0 in 24 of 90 (27 percent) randomized controlled trials, meaning the outcome immediately lost statistical significance on recalculation of the p value using Fisher's exact test. CONCLUSIONS: The results of randomized controlled trials in plastic surgery demonstrate substantial fragility, as statistically significant results were found to hinge on a small number of events. The fragility index offers an intuitive and simple metric to complement the p value and determine the confidence in the results of randomized controlled trials.