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.

Outcomes in Subfascial versus Subglandular Planes in Breast Augmentation: A Systematic Review and Meta-Analysis.

Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared to the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial compared to subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on Medline, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies were included that assessed the use of the subfascial plane for breast augmentation. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and seven comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared to subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases risk of capsular contracture, hematoma, and rippling compared to the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings.

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).

Tension Reduction With Force Modulating Tissue Bridges Reduces Wounds in Breast Surgery.

BACKGROUND: Tension on healing wounds increases the risk of dehiscence and poor or pathologic scar formation. Force modulating tissue bridges (FMTBs) represent a new class of wound closure and support devices designed to offload tension on healing wounds to improve wound healing and scar outcomes. OBJECTIVES: The study was undertaken to assess the efficacy of FMTBs to reduce the risk of wound healing complications in elective breast surgery. METHODS: One hundred twenty-two consecutive patients undergoing bilateral aesthetic breast surgery underwent intraoperative placement of FMTBs on the vertical limb closure site. A matched case-control cohort of 121 consecutive patients was established for comparison. Wounds were considered significant if larger than 3 mm in diameter. The primary outcome of breast wounds >3 mm was reported with a relative risk, and all outcomes were framed with number needed to treat. RESULTS: The control and intervention cohorts had similar demographics, comorbidities, type of operation, and incision pattern utilized. Within the FMTB group, 96.7% (n = 118) patients completed treatment per protocol. Significant wounds occurred in 1.7% (n = 2) of patients in the tissue bridge vs 15.2% (n = 19) in controls on a per patient/per protocol basis (89% reduction, P < .001). Statistically significant improvements were maintained on sensitivity analyses with intention to treat, even when minor wounds were included. There were no complications noted related to FMTBs. CONCLUSIONS: FMTBs are safe and highly effective at reducing the risk of wound formation in elective breast surgery. Results are consistent with sensitivity analyses based on clinical and methodological factors. Further research will assess long-term scar outcomes.

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.

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.

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

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

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

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

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.

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

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

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

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

Users' guide to the surgical literature: how to assess a qualitative study.

SUMMARY: Qualitative research contributes to the medical literature through the observation, description and interpretation of theories about social interactions and individual experiences as they occur in their natural setting. This type of research has the potential to enhance the understanding of surgeons' and patients' preferences, attitudes and beliefs, as well as assess how these may change with time. To date, there is no widely accepted standard for the methodological assessment of qualitative research. Despite ongoing debate, this article seeks to familiarize surgeons with the basic techniques for the critical appraisal of qualitative studies in the surgical literature.

Attitudes Toward and Management of Fibromyalgia: A National Survey of Canadian Rheumatologists and Critical Appraisal of Guidelines.

BACKGROUND: Canadian rheumatologists' attitudes toward and management of fibromyalgia remain uncertain. OBJECTIVE: The aim of this study was to explore management strategies and attitudes of Canadian rheumatologists toward fibromyalgia and concordance with guideline recommendations. METHODS: We administered a 17-item cross-sectional survey to Canadian rheumatologists and explored the concordance between respondents' management practices with the 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia. RESULTS: Among 331 Canadian rheumatologists who were approached, 140 returned the survey for a 42% response rate. The majority felt that fibromyalgia was a useful clinical diagnosis (110/138 [80%]) but was divided as to whether fibromyalgia was objectively defined (75/138 [54%]) or a psychosocial condition (42/138 [30%]) or could result in an inability to work (37/138 [27%]). Contrary to guideline recommendations, most (82/134 [61%]) endorsed that tender points were useful for diagnosis. Half endorsed potentially refusing consultations with fibromyalgia patients, and only 42% (59/139) agreed that there were effective therapies for this syndrome. Consistent with the guideline, most respondents managed fibromyalgia with education, exercise therapy, antidepressants, and nonnarcotic analgesics (≥89% for all); however, fewer than half agreed that any of these modalities were effective (endorsement ranged from 9% to 47%). Assessment of the 2012 guideline revealed a number of important limitations. CONCLUSIONS: Canadian rheumatologists largely do not provide primary care for fibromyalgia. Most adhere to guideline recommendations for management of fibromyalgia, but few endorse these interventions as effective. Further research, including updating of the 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia, is required to inform this disconnect.

Users' guide to the surgical literature: how to assess an article using surrogate end points.

SUMMARY: Phase 3 randomized controlled trials are the widely accepted gold standard through which treatment decisions are made, as they assess the efficacy of a novel treatment against the control on the relevant patient population. The effectiveness of the novel treatment should be derived by measuring patient-important outcomes; however, to accurately assess these outcomes, clinical trials often require extensive patient follow-up and large sample sizes that can incur substantial expense. For this reason, investigators substitute surrogate end points to reduce the sample size and duration of a trial, ultimately reducing cost. The purpose of this article is to help surgeons appraise the surgical literature that use surrogate end points for patient-important outcomes.

Trigger Finger Release Using Wide-Awake Local Anesthesia No Tourniquet Versus Local Anesthesia With a Tourniquet: A Systematic Review and Meta-analysis.

Trigger finger release (TFR) is a common hand surgery, historically performed using a tourniquet. Recently, wide-awake local anesthesia no tourniquet (WALANT) has gained popularity due to ostensible advantages such as improved patient pain, satisfaction, lower rate of complications, and decreased cost. This systematic review compares outcomes of WALANT for TFR with local anesthesia with a tourniquet (LAWT). MEDLINE, Embase, CINAHL, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched. All English-language peer-reviewed randomized and observational studies assessing TFR in adults were included. Quality of evidence was assessed with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. Eleven studies (4 randomized controlled trials, 7 observational) including 1233 patients were identified. In the WALANT group, pain on injection was statistically nonsignificantly lower (mean difference [MD]: -1.69 points, 95% confidence interval [CI] = -4.14 to 0.76, P = .18) and postoperative pain was statistically lower in 2 studies. Patient and physician satisfaction were higher and analgesic use was lower in WALANT. There were no significant differences between groups for functional outcomes or rates of adverse events. Preoperative time was longer (MD: 26.43 minutes, 95% CI = 15.36 to 37.51, P < .01), operative time similar (MD: -0.59 minutes, 95% CI = -2.37 to 1.20, P = .52), postoperative time shorter (MD: -27.72 minutes, 95% CI = -36.95 to -18.48, P < .01), and cost lower (MD: -52.2%, 95% CI = -79.9% to -24.5%) in WALANT versus LAWT. The GRADE certainty of evidence of these results ranges from very low to low. This systematic review does not confirm superiority of WALANT over LAWT for TFR due to moderate to high risk of bias of included studies; further robust trials must be conducted.

Estimating the Minimal Clinically Important Difference on the Visual Analogue Scale for Carpometacarpal Thumb Joint Osteoarthritis.

BACKGROUND: The minimal clinically important difference (MCID) is the smallest perceived treatment effect that patients deem clinically significant. There is currently no agreement on an appropriate MCID for the pain visual analogue scale (VAS) in the context of thumb osteoarthritis (OA). METHODS: We approximated MCIDs using a distribution-based approach that pooled standard deviations (SDs) associated with baseline mean values of the pain VAS (0-100 mm). We extracted the data from randomized controlled trials (RCTs) included in a systematic review of adults with long-term OA of the thumb. We excluded RCTs that did not report baseline SD values. The MCIDs were derived at 0.4 and 0.5 SDs of the pooled SD and compared with previously published MCIDs for the pain VAS in OA. RESULTS: A total of 403 patients were pooled from 7 RCTs for the analysis. The mean baseline VAS pain score was 5.6 cm. We derived an MCID of 0.72 cm at 0.4 SDs and 0.91 cm at 0.5 SDs using baseline SDs. We found that MCIDs derived from a distribution-based approach approximated published MCIDs for the VAS for pain for OA in the knee and hip. CONCLUSION: The authors propose that a change of 0.7 to 0.9 cm on the VAS is clinically meaningful in the context of long-term OA of the thumb.