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.

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.

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.

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.

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).

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.

Pelvic Reconstruction following Abdominoperineal Resection and Pelvic Exenteration: Management Practices among Plastic and Colorectal Surgeons.

BACKGROUND: Pelvic reconstruction with a muscle flap significantly improves postoperative outcomes following abdominoperineal resection (APR). Despite it being the gold standard, significant surgeon-selection bias remains with respect to the necessity of pelvic obliteration, flap choice, and ostomy placement. The objective of the study was to characterize management practices among colorectal surgeons (CSs) and plastic surgeons (PSs). METHODS: Specialty-specific surveys were distributed electronically to CSs and PSs via surgical societies. Surveys were designed to illustrate geographic and specialty-specific differences in management. RESULTS: Of 106 (54 CSs and 52 PSs) respondents (58% Canada, 21% Europe, 14% the United States, and 6% Asia/Africa), significant interdisciplinary differences in practices were observed. Most respondents indicated that multidisciplinary meetings were not performed (74% of CSs and 78% of PSs). For a nonradiated pelvic dead space with small perineal defect, 91% of CSs and 56% of PSs indicated that flap reconstruction was not required. For a radiated pelvic dead space with small perineal defect, only 54% of CSs and 6% of PSs indicated that there was no need for flap reconstruction. With respect to ostomy placement, 87% of CSs and 21% of PSs indicated that stoma placement through the rectus was superior. When two ostomies were required, most CSs preferred exteriorizing ostomies through bilateral recti and requesting thigh-based reconstruction. PSs favored the vertical rectus abdominis muscle (VRAM; 52%) over the gracilis (23%) and inferior gluteal artery perforator (IGAP; 23%) flaps. Among PSs, North Americans favor abdominally based flaps (VRAM 60%), while Europeans favor gluteal-based flaps (IGAP 78%). CONCLUSION: A lack of standardization continues to exist with respect to the reconstruction of pelvic defects following APR and pelvic exenteration. Geographic and interdisciplinary biases with respect to ostomy placement, flap choice, and role for pelvic obliteration continues to influence reconstructive practices. These cases should continue to be approached on a case by case basis, driven by pathology, presence of radiation, comorbidities, and the size of the pelvic and perineal defect.

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.

Development and Psychometric Validation of the BREAST-Q Animation Deformity Scale for Women Undergoing an Implant-Based Breast Reconstruction After Mastectomy.

BACKGROUND: To assess the impact of animation deformity on health-related quality of life, a content-specific, valid, and reliable patient-reported outcome measure is needed. This report describes the development and validation of the BREAST-Q Animation Deformity scale. METHODS: Women with breast cancer who had an implant-based reconstruction provided data. In phase 1 (January 2017 and December 2018), qualitive and cognitive patient interviews and expert input were used to develop and refine scale content. In phase 2 (March to June 2019), a field test study with members of the Love Research Army (LRA) was conducted. Rasch Measurement Theory (RMT) analysis was used to examine psychometric properties. RESULTS: In phase 1 of the study, qualitative (n = 11) and cognitive (n = 4) interview data and expert input (n = 9) led to the development of a 12-item scale measuring animation deformity. In phase 2, 651 LRA members provided data and 349 participated in a test-retest study. In the RMT analysis, the data fit the Rasch model (X2(96) = 104.06; p = 0.27). The scale's reliability was high, with person separation index and Cronbach alpha values with/without extremes of ≥ 0.84 and ≥ 0.92 respectively, and an intraclass correlation coefficient of 0.92 (95% confidence interval, 0.90-0.94). Mean scores on the Animation Deformity scale varied as predicted across subgroups of participants who reported differing amounts of change in breast appearance when their arms were lifted overhead or when they lifted something heavy, and for increasing happiness with the overall outcome of their breast reconstruction. CONCLUSION: The 12-item Animation Deformity scale forms a new scale in the BREAST-Q Reconstruction Module that can be used in comparative effectiveness research or to inform clinical care.

Development and Psychometric Validation of the BREAST-Q Sensation Module for Women Undergoing Post-Mastectomy Breast Reconstruction.

BACKGROUND: Reconstructive techniques for restoring sensation to the breast after mastectomy continue to evolve. The BREAST-Q is a patient-reported outcome measure that can be used to evaluate outcomes of breast cancer treatments; however, it previously lacked scales to measure breast sensation. This paper outlines the development and validation of the BREAST-Q Sensation Module. METHODS: Phase 1 (January 2017 through December 2018) involved qualitative and cognitive interviews with women who had undergone breast reconstruction, as well as expert input, to develop and refine the scales. In phase 2 (March through June 2019), Love Research Army (LRA) members completed the scales, and Rasch Measurement Theory (RMT) analysis was performed to examine the reliability and validity of the scales. RESULTS: In this study, 36 qualitative and 7 cognitive interviews were conducted, and input from 18 experts was obtained. Three scales were developed to measure breast Symptoms (e.g., throbbing, burning, tingling), Sensation (e.g., feeling with light touch, through clothing, sexually), and Quality of Life impact of sensation loss. In phase 2, 1204 LRA members completed the scales. Data for each scale fit the RMT model. Reliability was high, with Person Separation Index, Cronbach alpha, and intraclass correlation coefficient values of 0.81 or higher (with and without extremes) for all three scales. Mean scores were higher (better) on the Symptoms and Quality of Life impact scales for the participants with unilateral (vs. bilateral) and autologous (vs. alloplastic) reconstruction, and for the participants who were farther out from their reconstruction. CONCLUSION: The BREAST-Q Sensation Module can be used alone or in conjunction with other BREAST-Q scales to inform clinical care and to evaluate outcomes of new surgical approaches to restoration of breast sensation.

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.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

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.

Pregnancy and parental leave among plastic surgery residents in Canada: a nationwide survey of attitudes and experiences.

SUMMARY: Small surgical residency programs like plastic surgery can be challenging environments to accommodate parental leave. This study aimed to report the experiences, attitudes and perceived support of Canadian plastic surgery residents, recent graduates and staff surgeons with respect to pregnancy and parenting during training. Residents and staff surgeons were invited via email to participate in an online survey. The results presented here explore experiences of pregnancy and parental leave of current plastic surgery residents and staff surgeons. Residents' and staff surgeons' perceptions of program director support, policies, negative comments and the impact of parental leave on the workload of others were also explored. Although the findings suggest that there may be improvements in the support of program directors, there continues to be a negative attitude in surgical culture toward pregnancy during residency. The perceived confusion of respondents with respect to programspecific policies emphasizes the need for open conversations and standardization of parental leave.

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

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

Reduced venous thrombosis and re-exploration time with anastomotic coupling device: A cohort study.

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.

Perioperative Corticosteroids Reduce Short-Term Edema and Ecchymosis in Rhinoplasty: A Meta-Analysis.

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.

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.

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.