Improving the Impact of BODY-Q Scores Through Minimal Important Differences in Body Contouring Surgery: An International Prospective Cohort Study.

BACKGROUND: The BODY-Q is a widely used patient-reported outcome measure for comprehensive assessment of treatment outcomes specific to patients undergoing body contouring surgery (BCS). However, for BODY-Q to be meaningfully interpreted and used in clinical practice, minimal important difference (MID) scores are needed. A MID is defined as the smallest change in outcome measure score that patients perceive important. OBJECTIVES: The aim of this study was to determine BODY-Q MID estimates for patients undergoing BCS to enhance the interpretability of the BODY-Q. METHODS: Data from an international, prospective cohort from Denmark, Finland, Germany, Italy, the Netherlands, and Poland were included. Two distribution-based methods were used to estimate MID: 0.2 standard deviations of mean baseline scores and the mean standardized response change of BODY-Q scores from baseline to 3 years postoperatively. RESULTS: A total of 12,554 assessments from 3,237 participants (mean age; 42.5±9.3 years; body mass index; 28.9±4.9 kg/m2) were included. Baseline MID scores ranged from 1 to 5 in the health-related quality of life (HRQL) scales and 3 to 6 in the appearance scales. The estimated MID scores from baseline to 3 years follow-up ranged from 4 to 5 in HRQL and from 4 to 8 in the appearance scales. CONCLUSIONS: The BODY-Q MID estimates from before BCS to 3 years postoperatively ranged from 4 to 8 and are recommended for use to interpret patients' BODY-Q scores, evaluate treatment effects of different BCS procedures, and for calculating sample size for future studies.

Establishing test-retest reliability and the smallest detectable change of FACE-Q Aesthetic Module scales.

BACKGROUND: The test-retest (TRT) reliability of FACE-Q Aesthetic scales is yet to be assessed. The aim of this study was to establish the TRT reliability of 17 FACE-Q Aesthetic scales and determine the smallest detectable change (SDC) that can be identified using these scales. METHODS: Data were collected from an online international sample platform (Prolific). Participants ≥20 years old, who had been to a dermatologist or plastic surgeon for a facial aesthetic treatment within the past 12 months were asked to provide demographic and clinical information and complete an online REDcap survey consisting of 17 FACE-Q Aesthetic scales. Participants were asked if they would be willing to complete the survey again in 7 days. Only the participants who reported no important change in the scale construct and completed the retest within 14 days were included. RESULTS: A total of 342 unique participants completed the TRT survey. The mean age of the sample was 36.6 (±11.5) years, and 82.4% were female. With outlier data removed, all FACE-Q scales demonstrated an intraclass correlation coefficient >0.70 indicating "good" TRT reliability. The standard error of measurement for the included scales ranged from 3.37 to 11.87, corresponding to a range of SDCgroup from 0.95 to 3.23 and SDCind from 9.34 to 32.91. CONCLUSION: All included FACE-Q scales demonstrated sufficient TRT reliability and stability overall after the outlier data were removed. Moreover, the authors calculated the values for the SDC for these scales.

Minimal important difference in weight loss following bariatric surgery: Enhancing BODY-Q interpretability.

BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery.

Patient factors associated with cancer worry post-breast reconstruction: A cross-sectional study.

PURPOSE: The BREAST-Q Breast Cancer module is a patient-reported outcome measure for women with breast cancer diagnosis. Our research team developed and validated a novel BREAST-Q scale for this module that measures quality of life outcomes specific to cancer worry. The aim of this study was to investigate patient related breast reconstruction factors that are associated with worse scores on the new BREAST-Q Cancer Worry Scale. METHODS: Women with a history of breast cancer treated with mastectomy and reconstruction, aged ≥18 years, and English-speaking were recruited through the Love Research Army between October and November 2019. Participants completed demographic and clinical questions alongside the BREAST-Q Cancer Worry Scale. Univariable and multivariable regression analyses were used to identify participant characteristics associated with cancer worry scores. RESULTS: Among the 554 potential respondents, 538 (97.1%) completed the Cancer Worry Scale. The average patient age was 58.4 (+9.8) years. Cancer Worry scores were normally distributed with a mean of 46.4 (+17.2). Cancer Worry scores were significantly associated (p < 0.01) with younger age, history of radiation therapy, complications associated with breast surgery since diagnosis, use of textured breast implants, and shorter duration since surgery. CONCLUSIONS: This exploratory analysis provides evidence of patient characteristics that may be associated with cancer worry following postmastectomy breast reconstruction.

Further psychometric evaluation of the WOUND-Q: A responsiveness study.

The WOUND-Q is a modular patient-reported outcome measure (PROM) with 13 scales measuring constructs across 4 domains (i.e., wound characteristics, health related quality of life, experience of care and wound treatment). The psychometrics of the WOUND-Q were previously assessed and the 13 scales evidenced good validity and reliability. However, the responsiveness (i.e., ability to detect clinical change) of the WOUND-Q has yet to be assessed. The objective of this study was to evaluate responsiveness for 9 WOUND-Q scales that assess outcomes, in a sample of people 18 years of age or older with chronic wounds that were present for at least 3 months. This study conducted a 4 month follow-up of 421 participants who completed the WOUND-Q as part of a previous psychometric study. Participants completed an online survey answering questions about their current wound state (e.g., number, type, size, smell, drainage), anchor questions about change, as well as the WOUND-Q scales that they had completed in their initial assessment. Pre-defined hypotheses were tested with a 75% acceptance threshold indicating sufficient evidence of responsiveness. Minimally important differences (MIDs) were also calculated using both anchor-based and distribution-based methods. Of 390 invited participants, 320 provided responses, ranging in age from 19 to 84 years. Acceptance of hypotheses ranged from 60% to 100%, with only the Symptom scale not meeting the 75% threshold. The findings of this study provide evidence that the WOUND-Q can validly measure clinical change in patients with chronic wounds.

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 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.

A comparison of skin grafts versus local flaps for facial skin cancer from the patient perspective: protocol for a feasibility study.

BRIEF ABSTRACT: This is a protocol to assess feasibility of conducting a prospective cohort study comparing local flaps versus skin grafts for surgical excision of skin cancer from the face. INTRODUCTION: Skin cancer is the most common malignancy worldwide and the face is one of the most common locations of occurrence. Surgical excision is the most popular treatment for small lesions of the face. Defects can be reconstructed using local flaps or skin grafts. There is a paucity of literature evaluating outcomes after skin cancer surgery from the patient's perspective using valid measurement tools. The purpose of this study is to assess the feasibility of conducting a prospective observational cohort study. The primary outcomes include recruitment rates, eligibility rate, compliance of intervention and rate of completion of the primary outcome (FACE-Q scales) at 3 months. Secondary outcomes include examining patient characteristic and FACE-Q score differences between local flaps to skin grafts and adverse events. METHODS AND ANALYSIS: This study is a prospective cohort study consisting of an anticipated 30 patients aged ≥18 years. The study population will consist of a consecutive sample of non-melanoma facial skin cancer patients undergoing a skin graft or local flap. Patients will be followed and evaluated with the FACE-Q questionnaire at 2 weeks, 3 months, 6 months and 1 year post-operation. The following criteria will determine success: patients who meet eligibility criteria >70%; recruitment rate >70%; compliance with intervention >90%; rate of completion of full-scale prospective study primary outcome (FACE-Q at 3 months) >80%; retention rate at 6-month follow-up visit >70%. DISCUSSION: The findings of this study will be used to guide the sample size calculation for a future, large-scale prospective study.Trial registration: ClinicalTrials.gov (NCT04842279).

The Effects of Tranexamic Acid in Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: Tranexamic acid (TXA) is used in trauma and surgical settings. Its role in reducing postoperative blood loss in breast surgery remains unclear. The primary objective of this study was to determine the effect of TXA on postoperative blood loss in breast surgery. METHODS: Searches of the PubMed, Ovid MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases were performed from inception to April 3, 2020. Inclusion criteria were any retrospective reviews, prospective cohort studies, and randomized controlled trials that administered TXA (topical or intravenously) in the context of breast surgery. Quality of studies were evaluated using the risk of bias in randomized trials tool and the risk of bias in nonrandomized studies of interventions tool. Data were pooled, and a meta-analysis was performed. RESULTS: In total, seven studies were included, representing 1226 patients (TXA, 632 patients; control, 622 patients). TXA was administered as follows: topically (20 mL of 25 mg/mL TXA intraoperatively; n =258 patients), intravenously (1 to 3 g perioperatively; n = 743 patients), or both (1 to 3 g daily up to 5 days postoperatively; n = 253 patients). TXA administration reduced hematoma formation in breast surgery (risk ratio, 0.48; 95% CI, 0.32 to 0.73), with no effect on drain output (mean difference, -84.12 mL; 95% CI, -206.53 to 38.29 mL), seroma formation (risk ratio, 0.92; 95% CI, 0.60 to 1.40), or infection rates (risk ratio, 1.01; 95% CI, 0.46 to 2.21). No adverse effects were reported. CONCLUSION: The use of TXA in breast surgery is a safe and effective modality with low-level evidence that it reduces hematoma rates without affecting seroma rates, postoperative drain output, or infection rates.

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.

The Impact of Psychiatric Diagnoses on Patient-reported Satisfaction and Quality of Life in Postmastectomy Breast Reconstruction.

OBJECTIVE: The purpose of this study was to determine the prevalence of psychiatric diagnoses among a sample of breast reconstruction patients and measure the association between these diagnoses and reconstruction-related, patient-reported outcomes. BACKGROUND: The impact of psychiatric disorders in conjunction with breast cancer diagnosis, treatment, and reconstruction have the potential to cause significant patient distress but remains not well understood. METHODS: A retrospective review of postmastectomy breast reconstruction patients from 2007 to 2018 at Memorial Sloan Kettering Cancer Center was conducted. Patient demographics, comorbidities, cancer characteristics, psychiatric diagnoses, and BREAST-Q Reconstruction Module scores (measuring satisfaction with breast, well-being of the chest, psychosocial, and sexual well-being) at postoperative years 1 to 3 were examined. Mixed-effects models and cross-sectional linear regressions were conducted to measure the effect of psychiatric diagnostic class type and number on scores. RESULTS: Of 7414 total patients, 50.1% had at least 1 psychiatric diagnosis. Patients with any psychiatric diagnoses before reconstruction had significantly lower BREAST-Q scores for all domains at all time points. Anxiety (50%) and depression (27.6%) disorders were the most prevalent and had the greatest impact on BREAST-Q scores. Patients with a greater number of psychiatric diagnostic classes had significantly worse patient-reported outcomes compared with patients with no psychiatric diagnosis. Psychosocial (ß: -7.29; 95% confidence interval: -8.67, -5.91), and sexual well-being (ß: -7.99; 95% confidence interval: -9.57, -6.40) were most sensitive to the impact of psychiatric diagnoses. CONCLUSIONS: Mental health status is associated with psychosocial and sexual well-being after breast reconstruction surgery as measured with the BREAST-Q. Future research will need to determine what interventions (eg, screening, early referral) can help improve outcomes for breast cancer patients with psychiatric disorders undergoing breast reconstruction.

"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.

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.