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 Unpublished trials were searched using clinicaltrials.gov.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 Observational Studies in Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Systematic Review.

The deep inferior epigastric artery perforator (DIEP) flap is widely used in autologous breast reconstruction. However, the technique relies heavily on nonrandomized observational research, which has been found to have high risk of bias. "Spin" can be used to inappropriately present study findings to exaggerate benefits or minimize harms. The primary objective was to assess the prevalence of spin in nonrandomized observational studies on DIEP reconstruction. The secondary objectives were to determine the prevalence of each spin category and strategy. Methods: MEDLINE and Embase databases were searched from January 1, 2015, to November 15, 2022. Spin was assessed in abstracts and full-texts of included studies according to criteria proposed by Lazarus et al. Results: There were 77 studies included for review. The overall prevalence of spin was 87.0%. Studies used a median of two spin strategies (interquartile range: 1-3). The most common strategies identified were causal language or claims (n = 41/77, 53.2%), inadequate extrapolation to larger population, intervention, or outcome (n = 27/77, 35.1%), inadequate implication for clinical practice (n = 25/77, 32.5%), use of linguistic spin (n = 22/77, 28.6%), and no consideration of the limitations (n = 21/77, 27.3%). There were no significant associations between selected study characteristics and the presence of spin. Conclusions: The prevalence of spin is high in nonrandomized observational studies on DIEP reconstruction. Causal language or claims are the most common strategy. Investigators, reviewers, and readers should familiarize themselves with spin strategies to avoid misinterpretation of research in DIEP reconstruction.

Best Practices for FACE-Q Aesthetics Research: A Systematic Review of Study Methodology.

BACKGROUND: The FACE-Q Aesthetics module is a validated patient-reported outcome measure (PROM) that evaluates perspectives on facial aesthetic treatments. Improper administration and poor study methodology can compromise the validity and interpretation of this PROM. OBJECTIVES: This systematic review sought to evaluate the administration and scoring of the FACE-Q Aesthetics scales within the literature. METHODS: A search of Ovid Medline, Embase, Cochrane, and Web of Science was performed on December 20, 2022, with the assistance of a health-research librarian (CRD42022383676). Studies that examined facial aesthetic interventions using the FACE-Q Aesthetics module as a primary or secondary outcome measure were included for analysis. RESULTS: There were 114 studies included. The Face Overall (n = 52, 45.6%), Psychological (n = 45, 39.4%), and Social (n = 43, 37.7%) scales were most frequently reported. Errors in FACE-Q administration were identified in 30 (26.3%) studies. The most common error was the presentation of raw ordinal scores rather than the converted Q score (n = 23). Most studies reported a time horizon for their primary analysis (n = 76, 66.7%); however, only 4 studies provided a rationale for this selection. Sample size calculations for the primary outcome were rarely performed (n = 9, 7.9%). CONCLUSIONS: There continues to be limitations in PROM administration and the quality of articles that report FACE-Q Aesthetic scale data. The authors suggest that future investigators using the FACE-Q refer to the User's Guide regarding administration and scoring of this scale, report a rationale for the study time horizon, and provide an a priori sample size calculation for the primary outcome of interest.

Impact of Completing FACE-Q Craniofacial Module Scales on Children and Young Adults with Facial Differences: An International Study.

BACKGROUND: The FACE-Q Craniofacial Module measures outcomes that matter to patients with diverse craniofacial conditions. However, it is not known whether completing a patient-reported outcome measure (PROM) has a negative impact on patients, particularly children. This study aims to investigate the impact of completing the FACE-Q Craniofacial Module and identify factors associated with a negative impact. METHODS: Participants were between 8 and 29 years of age, had a facial difference, and completed at least one module of the FACE-Q Craniofacial Module as part of the international field-test study between December of 2016 and 2019. Participants were asked three questions: "Did you like or dislike answering this questionnaire?" "Did answering these questions change how you feel about how you look?" and "Did answering this questionnaire make you feel unhappy or happy?" Univariate and multivariable logistic regression analyses were used to evaluate variables associated with a negative response. RESULTS: The sample included 927 participants. Most patients responded neutrally to all impact questions: 42.7% neither disliked nor liked the questionnaire; 76.6% felt the same about how they looked; and 72.7% felt neither unhappy nor happy after completion. Negative responses represented a small proportion of patients across all three impact questions (<13.2%). Increased craniofacial severity, more scales completed, and lower scores on all FACE-Q scales were associated with negative responses for all three impact questions ( P <0.01). CONCLUSIONS: This study provides evidence that the FACE-Q Craniofacial Module is acceptable for most participants. Clinicians and study investigators should follow up with patients after completing this PROM to address areas of concern in scale scores. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Interpreting the BREAST-Q for Breast-Conserving Therapy: Minimal Important Differences and Clinical Reference Values.

BACKGROUND: The BREAST-Q is an important tool for evaluating patient satisfaction and quality of life in breast-conserving therapy (BCT) patients, but its clinical utility is limited by the lack of guidance on score interpretation. This study determines reference values and the minimal important difference (MID) for the BREAST-Q BCT module. METHODS: A retrospective review of BCT patients at Memorial Sloan Kettering Cancer Center from January 2011 to December 2021 was performed. Descriptive statistics were used to summarize median BREAST-Q scores. Distribution-based analyses estimated MIDs based on 0.2 standard deviation of baseline BREAST-Q scores and 0.2 standardized response mean of the difference between baseline and 1-year postoperative BREAST-Q scores. MIDs for different clinical groupings based on body mass index, radiation, and reexcision also were estimated. RESULTS: Overall, 8060 patients were included for determining reference values, and 5673 patients were included for estimating MIDs. Median BREAST-Q scores trended upwards and stabilized by 2 years after surgery for all domains except Physical Well-Being of the Chest, which decreased and stabilized by 2 years. A score interpretation tool, the Real-Time Engagement and Communication Tool, was created based on 25th percentile, median, and 75th percentile scores trajectories. All MID estimates ranged from 3 to 5 points; 4 points was determined to be appropriate for use in clinical practice and research. CONCLUSIONS: Reference values and MIDs are crucial to BREAST-Q score interpretation, which can lead to improved clinical evaluation and decision making and improved research methodology. Future research should validate this study's findings in different patient cohorts.

Comparing Breast Sensation between Alloplastic and Autologous Breast Reconstruction Patients Using the BREAST-Q Sensation Module.

BACKGROUND: Sensory recovery of the breast is a compelling frontier in comprehensive postmastectomy breast reconstruction. This study uses the BREAST-Q Sensation Module to evaluate the differences in women who underwent an alloplastic versus autologous breast reconstruction. METHODS: Women with a history of breast cancer and postmastectomy breast reconstruction were recruited through the Love Research Army, United States. Participants completed the BREAST-Q Sensation Module, which consists of three scales: Breast Symptoms, Breast Sensation, and Quality of Life Impact. Descriptive statistics and multiple linear regression analyses were used to compare outcomes between women undergoing alloplastic or autologous breast reconstruction. RESULTS: Of 1204 respondents, 933 were included for analysis: 620 (66.5 percent) underwent alloplastic reconstruction and 313 (33.5 percent) underwent autologous reconstruction. The average age and body mass index were 59.2 ± 10.1 years and 26 ± 5 kg/m 2 , respectively. Autologous reconstruction patients scored an average of 6.1 points (95 percent CI, 3.9 to 8.4; p < 0.001) and 5.3 points (95 percent CI, 2.5 to 8.1; p = 0.001) higher on the Breast Symptoms and Quality of Life Impact scales, respectively. No difference (0.0 points, 95 percent CI, -2.9 to 3.0; p = 0.75) was observed for the Breast Sensation scale. Increased time since reconstruction had a positive impact on Breast Symptoms scale scores. Radiotherapy negatively affected scores on both Breast Symptoms and Quality of Life Impact scales. CONCLUSIONS: Autologous breast reconstruction may be associated with fewer abnormal breast sensations and better sensation-related quality of life in comparison to alloplastic reconstruction. This information can be incorporated during preoperative patient counseling when discussing reconstructive options.

Best Practices for BREAST-Q Research: A Systematic Review of Study Methodology.

BACKGROUND: Data heterogeneity and methodologic errors hinder the ability to draw clinically meaningful conclusions from studies using the BREAST-Q Reconstruction Module patient-reported outcome measure. In this systematic review, the authors evaluate the quality of BREAST-Q Reconstruction Module administration in relation to the BREAST-Q version 2.0 user's guide and the reporting of key methodology characteristics. The authors also describe a framework for improving the quality of BREAST-Q data analysis and reporting. METHODS: The authors conducted a systematic search of PubMed, Embase, Cochrane CENTRAL, and Ovid HAPI databases to identify articles on the BREAST-Q Reconstruction Module to assess postmastectomy breast reconstruction outcomes. The authors registered the protocol before study implementation on Open Science Framework ( https://osf.io/c5236 ) and adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data on mode of BREAST-Q administration, time horizon justification, and sample size calculation were collected. RESULTS: The authors included 185 studies in the analysis. Errors in BREAST-Q administration were identified in 36 studies (19.5 percent). Appropriate administration of the BREAST-Q could not be determined in 63 studies (34.1 percent) because of insufficient reporting. Time horizon for the primary outcome was reported in 71 studies (38.4 percent), with only 17 (9.2 percent) reporting a sample size calculation. CONCLUSIONS: The authors identified important yet actionable shortcomings in the BREAST-Q literature. Researchers are encouraged to review the BREAST-Q user's guide in the study design phase to mitigate errors in patient-reported outcome measure administration and reporting for future trials using the BREAST-Q Reconstruction Module. Adhering to these guidelines will allow for greater clinical utility and generalizability of BREAST-Q research.

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.

Improving the Science in Plastic Surgery.

SUMMARY: In 1906, George Bernard Shaw criticized the medical profession for its lack of science and compassion. Since then, advances in both medical and surgical subspecialties have improved quality of patient care. Unfortunately, the reporting of these advances is variable and is frequently biased. Such limitations lead to false claims, wasted research dollars, and inability to synthesize and apply evidence to practice. It was hoped that the introduction of evidence-based medicine would improve the quality of health care and decrease health dollar waste. For this to occur, however, credible "best evidence"-one of the components of evidence-based medicine-is required. This article provides a framework for credible research evidence in plastic surgery, as follows: (1) stating the clinical research question, (2) selecting the proper study design, (3) measuring critical (important) outcomes, (4) using the correct scale(s) to measure the outcomes, (5) including economic evaluations with clinical (effectiveness) studies, and (6) reporting a study's results using the Enhancing the Quality and Transparency of Health Research, or EQUATOR, guidelines. Surgeon investigators are encouraged to continue improving the science in plastic surgery by applying the framework outlined in this article. Improving surgical clinical research should decrease resource waste and provide patients with improved evidence-based care.

Canadian Expert Opinion on Breast Reconstruction Access: Strategies to Optimize Care during COVID-19.

BACKGROUND: Breast reconstructive services are medically necessary, time-sensitive procedures with meaningful health-related quality of life benefits for breast cancer survivors. The COVID-19 global pandemic has resulted in unprecedented restrictions in surgical access, including access to breast reconstructive services. A national approach is needed to guide the strategic use of resources during times of fluctuating restrictions on surgical access due to COVID-19 demands on hospital capacity. METHODS: A national team of experts were convened for critical review of healthcare needs and development of recommendations and strategies for patients seeking breast reconstruction during the pandemic. Following critical review of literature, expert discussion by teleconference meetings, and evidenced-based consensus, best practice recommendations were developed to guide national provision of breast reconstructive services. RESULTS: Recommendations include strategic use of multidisciplinary teams for patient selection and triage with centralized coordinated use of alternate treatment plans during times of resource restrictions. With shared decision-making, patient-centered shifting and consolidation of resources facilitate efficient allocation. Targeted application of perioperative management strategies and surgical treatment plans maximize the provision of breast reconstructive services. CONCLUSIONS: A unified national approach to strategically reorganize healthcare delivery is feasible to uphold standards of patient-centered care for patients interested in breast reconstruction.

Managing postoperative pain in adult outpatients: a systematic review and meta-analysis comparing codeine with NSAIDs.

BACKGROUND: Analgesics that contain codeine are commonly prescribed for postoperative pain, but it is unclear how they compare with nonopioid alternatives. We sought to compare the effectiveness of codeine and nonsteroidal anti-inflammatory drugs (NSAIDs) for adults who underwent outpatient surgery. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials comparing codeine and NSAIDs for postoperative pain in outpatient surgery. We searched MEDLINE and Embase from inception to October 2019 for eligible studies. Our primary outcome was the patient pain score, converted to a standard 10-point intensity scale. Our secondary outcomes were patient-reported global assessments and adverse effects. We used random-effects models and grading of recommendations assessment, development and evaluation (GRADE) to assess the quality of evidence. RESULTS: Forty studies, including 102 trial arms and 5116 patients, met inclusion criteria. The studies had low risk of bias and low-to-moderate heterogeneity. Compared with codeine, NSAIDs were associated with better pain scores at 6 hours (weighted mean difference [WMD] 0.93 points, 95% confidence interval [CI] 0.71 to 1.15) and at 12 hours (WMD 0.79, 95% CI 0.38 to 1.19). Stronger NSAID superiority at 6 hours was observed among trials where acetaminophen was coadministered at equivalent doses between groups (WMD 1.18, 95% CI 0.87 to 1.48). NSAIDs were associated with better global assessments at 6 hours (WMD -0.88, 95% CI -1.04 to -0.72) and at 24 hours (WMD -0.67, 95% CI -0.95 to -0.40), and were associated with fewer adverse effects, including bleeding events. INTERPRETATION: We found that adult outpatients report better pain scores, better global assessments and fewer adverse effects when their postoperative pain is treated with NSAIDs than with codeine. Clinicians across all specialties can use this information to improve both pain management and opioid stewardship.

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.

Giving Meaning to Differences in BREAST-Q Scores: Minimal Important Difference for Breast Reconstruction Patients.

BACKGROUND: The reconstruction module of the BREAST-Q patient-reported outcome measure is frequently used by investigators and in clinical practice. A minimal important difference establishes the smallest change in outcome measure score that patients perceive to be important. To enhance interpretability of the BREAST-Q reconstruction module, the authors determined minimal important difference estimates using distribution-based methods. METHODS: An analysis of prospectively collected data from 3052 Mastectomy Reconstruction Outcomes Consortium patients was performed. The authors used distribution-based methods to investigate the minimal important difference for the entire patient sample and three clinically relevant groups. The authors used both 0.2 SD units (effect size) and the standardized response mean value of 0.2 as distribution-based criteria. Clinical experience was used to guide and assess appropriateness of results. RESULTS: A total of 3052 patients had BREAST-Q data available for analysis. The average age and body mass index were 49.5 and 26.8, respectively. The minimal important difference estimates for each domain were 4 (Satisfaction with Breasts), 4 (Psychosocial Well-being), 3 (Physical Well-being), and 4 (Sexual Well-being). The minimal important difference estimates for each domain were similar when compared within the three clinically relevant groups. CONCLUSIONS: The authors propose that a minimal important difference score of 4 points on the transformed 0 to 100 scale is clinically useful when assessing an individual patient's outcome using the reconstruction module of the BREAST-Q. When designing research studies, investigators should use the minimal important difference estimate for their domain of interest when calculating sample size. The authors acknowledge that distribution-based minimal important differences are estimates and may vary based on patient population and context.

Elective Revisions after Breast Reconstruction: Results from the Mastectomy Reconstruction Outcomes Consortium.

BACKGROUND: Rates of breast reconstruction following mastectomy continue to increase. The objective of this study was to determine the frequency of elective revision surgery and the number of procedures required to achieve a stable breast reconstruction 2 years after mastectomy. METHODS: Women undergoing first-time breast reconstruction after mastectomy were enrolled and followed for 2 years, with completion of reconstruction occurring in 1996. Patients were classified based on the absence or presence of complications. Comparisons within cohorts were performed to determine factors associated with revisions and total procedures. Mixed-effects regression modeling identified factors associated with elective revisions and total operations. RESULTS: Overall, 1534 patients (76.9 percent) had no complications, among whom 40.2 percent underwent elective revisions. The average number of elective revisions differed by modality (p < 0.001), with abdominally based free autologous reconstruction patients undergoing the greatest number of elective revisions (mean, 0.7). The mean total number of procedures also differed (p < 0.001), with tissue expander/implant reconstruction patients undergoing the greatest total number of procedures (mean, 2.4). Complications occurred in 462 patients (23.1 percent), with 67.1 percent of these patients undergoing elective revisions, which was significantly higher than among patients without complications (p < 0.001). The mean number of procedures again differed by modality (p < 0.001) and followed similar trends, but with an increased mean number of revisions and procedures overall. Mixed-effects regression modeling demonstrated that patients experiencing complications had increased odds of undergoing elective revision procedures (OR, 3.2; p < 0.001). CONCLUSIONS: Breast reconstruction patients without complications undergo over two procedures on average to achieve satisfactory reconstruction, with 40 percent electing revisions. If a complication occurs, the number of procedures increases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.