Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

OBJECTIVE: CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. DESIGN: Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. SETTING: Seven cleft centres in Canada, the USA, and UK were involved. PATIENTS/PARTICIPANTS: Patients were aged eight to 29 years with CL/P. INTERVENTIONS: Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). MAIN OUTCOME MEASURE(S): The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. RESULTS: Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. CONCLUSIONS: Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

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.

Are We Measuring What Really Counts?

Most published clinical research is faulty because of many reasons, one being faulty design. A remedy to this problem is the correct utilization of the PICOT (population, intervention, comparative intervention, outcome and time horizon) format in the design of a clinical research question. One element of the PICOT format, "outcome," has not been assessed adequately in aesthetic surgery. In this review, we found that in the last decade of all randomized controlled trials and comparative studies published in Aesthetic Surgery Journal, only about half specified a primary outcome. Regrettably, only 40% reported both a primary outcome and justification for choosing this outcome. This poses a credibility issue with the conclusions of the majority of published studies. There is an urgent need to develop critical outcome sets for aesthetic procedures to be utilized by future investigators. With such a critical outcome set, we will be able to pool the results of multiple studies on the same subject and reach conclusive results.

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.

Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain.

BACKGROUND: Cleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual's appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain. METHODS: The CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed. RESULTS: The field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions. CONCLUSION: Translation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved.

Dupuytren's contracture and handwork: A case-control study.

OBJECTIVE: The objective of this study was to examine the association between Dupuytren's contracture (DC), repetitive handwork (RHW), heavy handwork (HHW), and/or vibration exposure. METHODS: Frequency and intensity of the three types of handwork were collected and compared between DC patients and controls. Hours of work were weighted by average "frequency," for RHW, and average "intensity," for HHW and use of vibrating tool. Logistic regression was used to evaluate risk of developing DC associated with the above-mentioned factors. RESULTS: Data from 129 cases (74 clinical, 106 controls) was analyzed. Family history, male gender and age (decades) were associated with increased risk of DC. Results indicate that the risk becomes substantial after about 30 years of steady RHW. Independent effects of intensity-weighted HHW and vibrating exposure were not established. CONCLUSIONS: Frequency-weighted RHW increases DC risk. Additionally, a strong association between DC, male gender and heredity was found.

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.

Users' guide to the surgical literature: how to assess a noninferiority trial.

SUMMARY: A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.

Estimation of health-related-quality of life depends on which utility measure is selected for patients with carpal tunnel syndrome.

STUDY DESIGN: Cross-sectional. INTRODUCTION: Carpal tunnel syndrome (CTS) refers to the compression neuropathy of the median nerve at the wrist. PURPOSE OF THE STUDY: To establish the interinstrument reliability, convergent construct validity, and the levels of agreement of health utility indexes 2 and 3 (HUI-2 and HUI-3), EuroQol 5-dimensions (EQ-5D), EuroQol-visual analog scale (EQ-VAS) and to determine the difference of these utility measures based on age and gender in patients with carpal tunnel syndrome. METHODS: Seventy-four patients with a confirmed diagnosis of carpal tunnel syndrome completed the 3 questionnaires and EQ-VAS a month before surgery. Demographic characteristics were reported. Intraclass correlation coefficients were used to assess relative interinstrument reliability. Pearson correlation coefficients (r) were used to establish convergent construct validity. Bland-Altman plots and t tests were used to describe the levels of agreement between the 4 utility measures. A 2-way analysis of variance was performed to determine the effect of age and gender on the utility measures; HUI-2, HUI-3, and EQ-5D. RESULTS: The intraclass correlation coefficients were 0.85 for HUI-3 vs HUI-2 and 0.80 for HUI-2 vs EQ-VAS. Pearson correlation coefficients ranged from 0.60 to 0.89; HUI-3 vs HUI-2: 0.89, and HUI-3 vs EQ-5D: 0.60. One-sample t test demonstrated significant differences between HUI-3 vs HUI-2, HUI-3 vs EQ-5D, and HUI-3 vs EQ-VAS measures, with mean differences of -0.12, -0.15, and -0.14, respectively. A 2-way analysis of variance test controlling for age and gender indicated neither as predictors of outcome scores. CONCLUSIONS: The HUI-3 vs HUI-2 and HUI-2 vs EQ-VAS demonstrated excellent interinstrument relative reliability measures. The HUI-3 vs HUI-2 displayed very strong convergent construct validity measures, and strong validity measures were established between the remaining utility measures. In addition, the pair-wise utility comparisons demonstrated minimal bias between HUI-2 vs EQ-5D, HUI-2 vs EQ-VAS, and EQ-VAS vs EQ-5D measures. DISCUSSION: N/A. LEVEL OF EVIDENCE: N/A.

Users' guide to the surgical literature: how to assess an article about harm in surgery.

CLINICALSCENARIO: You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not.

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.

A systematic review of utilities in hand surgery literature.

PURPOSE: To systematically review the literature to determine if utilities (a quantitative way to express patient preferences for health outcomes) have been measured in hand surgery studies. METHODS: A literature search was conducted using Cochrane, EMBASE, HealthSTAR, MEDLINE, and CINAHL electronic databases (1966-2013). This search was supplemented by cited and manual reference searches and expert consultation to retrieve all relevant studies. Studies were selected by 2 independent reviewers if they pertained to hand or wrist surgery, were published in English, and measured utilities as an outcome. Descriptive data were extracted, including the hand surgery procedure investigated, study design, value of utilities, and methodology of utilities measurement. RESULTS: Eleven studies were included after reviewing 989 studies. Most hand conditions were associated with utilities less than 0.8. Utilities in the reviewed studies were measured using different methods and from different subjects. Three studies paradoxically mapped greater utilities for poorer heath states. CONCLUSIONS: Hand conditions cause impairment, as evidenced by their utilities. Measurement of utilities remains uncommon in hand surgery literature. Future studies should not only measure utilities but also do so with consistent and appropriate methodology to ensure that mapped values are valid and comparable. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/decision analysis III.

Users' guide to the surgical literature: how to perform a high-quality literature search.

The article "Users" guide to the surgical literature: how to perform a "literature search" was published in 2003, but the continuing technological developments in databases and search filters have rendered that guide out of date. The present guide fills an existing gap in this area; it provides the reader with strategies for developing a searchable clinical question, creating an efficient search strategy,accessing appropriate databases, and skillfully retrieving the best evidence to address the research question.

Methodological guide to adopting new aesthetic surgical innovations.

Aesthetic surgery is known for its prolific introduction of new techniques, devices, and products. The implementation of any aesthetic innovation, however, may inadvertently expose patients to potential complications and adverse events. How do we decide whether a new technique or technology is superior-in both safety and effectiveness-compared with prevailing interventions? In this paper, we present some basic steps anchored in evidence-based surgery that aesthetic surgeons need to pursue in the adoption of a new technique, technology, or product. These steps include: (1) gaining familiarity with and understanding the levels of evidence; (2) performing an effective literature search; (3) formulating a critical appraisal of an article; (4) making the decision to adopt or reject; (5) recognizing the need for continued assessment; (6) acknowledging the need for education and credentialing; and (7) translation of the gathered knowledge. We hope that this paper will foster critical thinking and reduce the reliance on "photographic evidence" in aesthetic surgery literature.