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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.
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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.
Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Quality of Life , Reference Values , Patient Reported Outcome Measures , Mastectomy, Segmental/methods , Mammaplasty/methods , Patient Satisfaction , Breast Neoplasms/surgeryABSTRACT
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.
Subject(s)
Quality of Life , Humans , Esthetics , PsychometricsABSTRACT
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.
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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.
Subject(s)
Analgesics, Opioid/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Codeine/administration & dosage , Pain, Postoperative/drug therapy , Ambulatory Surgical Procedures/adverse effects , Analgesics, Opioid/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Codeine/adverse effects , Humans , Randomized Controlled Trials as TopicABSTRACT
Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.
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Patient Reported Outcome Measures , Patient Satisfaction , Plastic Surgery Procedures , Quality of Life , Humans , Reproducibility of ResultsABSTRACT
OBJECTIVE: In the anastomotic coupling device literature, no comparative study has reported operative times, included consecutive patients, or used a matched comparison group. Our objective was to analyze patency and operative time in free flaps with venous anastomoses performed with ACD versus hand-sewn. METHODS: For consecutive free flaps, re-explorations and complications were reviewed in duplicate. Operative times for ACD versus hand-sewn were compared for: (1) matched unilateral DIEPs, and (2) re-explorations. RESULTS: Overall, 147 ACD and 144 hand-sewn flaps were included. Venous thrombosis was significantly lower with ACD (1/147[1%] vs.9/144[6%], P < 0.01). There was no difference in re-exploration for venous insufficiency, or overall re-exploration. Re-exploration time was significantly shorter with ACD (69mins vs.205mins, P = 0.009). CONCLUSIONS: ACD significantly decreases venous thrombosis compared to hand-sewn veins, and significantly shortens re-exploration time. Outcomes allow an estimate of cost utility for the ACD in decreasing venous thromboses and shortening re-exploration time. © 2015 Wiley Periodicals, Inc. Microsurgery 36:372-377, 2016.
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BACKGROUND: A number of randomized controlled trials (RCTs) have investigated the role of perioperative corticosteroids in rhinoplasty. Each of these trials however has an insufficient sample sizes to reach definitive conclusions and detect harms. Three recent reviews have analyzed edema and ecchymosis outcomes following rhinoplasty; each arrived at a different conclusion and recommendation. OBJECTIVE: To estimate the effectiveness of systemic perioperative corticosteroid treatment compared to placebo for clinical outcomes in rhinoplasty using a methodologically rigorous meta-analysis. METHODS: Electronic databases were searched without language restriction. Included trials were randomized controlled trials of systemic perioperative corticosteroid treatment vs placebo in rhinoplasty evaluating at least one of: edema, ecchymosis, bleeding, cosmetic outcome, and patient satisfaction. The Cochrane risk of bias tool was applied to included trials, and the quality of evidence for each outcome was assessed using the GRADE approach. RESULTS: Analyses included 336 patients from eight trials. Perioperative corticosteroids reduced the worst edema (SMD: -1.03, 95%CI -1.30 to -0.76, P < .001) and ecchymosis (SMD: -0.78, 95%CI -1.09 to 0.47, P < .001) after rhinoplasty. At one day postoperative, a single dose of perioperative corticosteroid reduced edema (SMD -1.15, 95%CI -1.42 to -0.87, P < .001) and ecchymosis (SMD -0.79, 95%CI -1.05 to -0.52, P < .001). No clinical benefit in edema or ecchymosis was found seven days postoperatively, nor did intraoperative bleeding increase. CONCLUSIONS: There is high quality evidence to support perioperative systemic corticosteroid treatment in rhinoplasty to reduce short-term edema and ecchymosis without increased intraoperative bleeding. These findings are not present at seven days. For future trials, we suggest evaluation of patient satisfaction, and correlation with long-term cosmetic outcome. LEVEL OF EVIDENCE 2: Therapeutic.
Subject(s)
Adrenal Cortex Hormones/administration & dosage , Ecchymosis/prevention & control , Edema/prevention & control , Perioperative Care/methods , Rhinoplasty/adverse effects , Adrenal Cortex Hormones/adverse effects , Chi-Square Distribution , Drug Administration Schedule , Ecchymosis/diagnosis , Ecchymosis/etiology , Edema/diagnosis , Edema/etiology , Humans , Perioperative Care/adverse effects , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
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.
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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.
Subject(s)
Esthetics , Face , Humans , Female , Male , Reproducibility of Results , Adult , Surveys and Questionnaires , Middle Aged , Patient Satisfaction/statistics & numerical data , Young AdultABSTRACT
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.
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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.
Subject(s)
Emotions , Patient Satisfaction , Humans , Child , Young Adult , Surveys and Questionnaires , Quality of Life , Patient Reported Outcome MeasuresABSTRACT
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.
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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.
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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.
Subject(s)
Plastic Surgery Procedures , Surgeons , Surgery, Plastic , Cost-Benefit Analysis , Evidence-Based Medicine , HumansABSTRACT
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.
Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Mastectomy/adverse effects , Breast Neoplasms/surgery , Breast Neoplasms/radiotherapy , Quality of Life , Patient Satisfaction , Mammaplasty/psychology , SensationABSTRACT
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.
Subject(s)
Breast Neoplasms , Mammaplasty , Female , Humans , Mammaplasty/methods , Mastectomy , Patient Reported Outcome Measures , Research DesignABSTRACT
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.