Development of a core outcome set for basal cell carcinoma.

BACKGROUND: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. OBJECTIVE: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. METHODS: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. RESULTS: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. LIMITATIONS: English-speaking patients and professionals rated outcomes extracted from English language studies. CONCLUSION: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

Influence of Pitching Release Location on Ulnar Collateral Ligament Reconstruction Risk Among Major League Baseball Pitchers.

BACKGROUND: Medial ulnar collateral ligament (UCL) reconstruction is a common procedure performed among Major League Baseball (MLB) pitchers. The etiology of UCL injury is complex and is not entirely understood. HYPOTHESIS: To better understand risk factors for requiring UCL reconstruction, we hypothesized that pitchers who eventually undergo the procedure will exhibit different throwing mechanics as measured by pitch-tracking data points, such as velocity and release location. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: Pitch-tracking and demographic data were gathered for 140 MLB pitchers who had undergone UCL reconstruction between the 2010 and 2017 seasons. Pitch type, release location, and velocity were compared between the surgical cohort and a matched-control cohort. RESULTS: When compared with controls, the mean pitch release location for pitchers who required UCL reconstruction was 12.2 cm more lateral in the year immediately preceding surgery (P = .001). Furthermore, within the surgical cohort, the horizontal release location was 3.4 cm more lateral immediately preceding surgery compared with 2 years earlier (P = .036). Binary logistic regression indicated an odds ratio of 0.51, suggesting a roughly 5% increased odds of UCL reconstruction for every 10 cm of increased lateral release location (P = .048). Both the surgical and the control cohorts threw similar rates of fastballs and had similar mean pitch velocity and fastball velocity. Control pitchers displayed a significant decrease over time in mean pitch velocity (P = .005) and mean fastball velocity, while pitchers in the UCL reconstruction cohort did not (P = .012). CONCLUSION: Pitch tracking indicates that the mean release point is more lateral in pitchers preceding UCL reconstruction as compared with controls, suggesting that a more lateral pitch release location is an independent risk factor for UCL injury and reconstruction.

Patients believe that cosmetic procedures affect their quality of life: An interview study of patient-reported motivations.

BACKGROUND: Although treatments to address cosmetic concerns are common, patients' self-reported motives for considering such procedures have not been systematically explored. OBJECTIVE: To develop a framework of categories to describe patients' self-reported motivations for undergoing minimally invasive cosmetic procedures. METHODS: Face-to-face, semistructured patient interviews were conducted with adult participants who had undergone or were considering minimally invasive cosmetic dermatologic procedures. A qualitative constant comparative approach was used to analyze interview transcripts, yielding themes and subthemes. RESULTS: A total of 30 interviews were completed. Most patient-reported motivations for cosmetic procedures could be subsumed under 8 general categories (themes): (1) mental and emotional health, (2) cosmetic appearance, (3) physical health, (4) work and/or school success, (5) social well-being, (6) cost and/or convenience, (7) procedural perceptions, and (8) timing of treatment. Many individual motivations in these categories were unrelated to desire for physical beauty. In particular, participants wanted to avoid being self-conscious, enhance confidence, reduce the time and expense required to conceal physical imperfections, and be perceived as capable at work. LIMITATIONS: Only English-speaking patients in the United States were interviewed. CONCLUSION: Patient-reported motivations for cosmetic procedures mostly pertained to physical and psychosocial well-being. Indeed, a desire for improved cosmetic appearance was only 1 of the 8 themes revealed through the patient interviews.

Self-reported Patient Motivations for Seeking Cosmetic Procedures.

Importance: Despite the growing popularity of cosmetic procedures, the sociocultural and quality-of-life factors that motivate patients to undergo such procedures are not well understood. Objective: To estimate the relative importance of factors that motivate patients to seek minimally invasive cosmetic procedures. Design, Setting, and Participants: This prospective, multicenter observational study was performed at 2 academic and 11 private dermatology practice sites that represented all US geographic regions. Adult patients presenting for cosmetic consultation or treatment from December 4, 2016, through August 9, 2017, were eligible for participation. Exposures: Participants completed a survey instrument based on a recently developed subjective framework of motivations and a demographic questionnaire. Main Outcomes and Measures: Primary outcomes were the self-reported most common motivations in each quality-of-life category. Secondary outcomes were other frequently reported motivations and those associated with specific procedures. Results: Of 529 eligible patients, 511 agreed to participate, were enrolled, and completed the survey. Typical respondents were female (440 [86.1%]), 45 years or older (286 [56.0%]), white (386 [75.5%]), and college educated (469 [91.8%]) and had previously received at least 2 cosmetic procedures (270 [52.8%]). Apart from motivations pertaining to aesthetic appearance, including the desire for beautiful skin and a youthful, attractive appearance, motives related to physical health, such as preventing worsening of condition or symptoms (253 of 475 [53.3%]), and psychosocial well-being, such as the desire to feel happier and more confident or improve total quality of life (314 of 467 [67.2%]), treat oneself or celebrate (284 of 463 [61.3%]), and look good professionally (261 of 476 [54.8%]) were commonly reported. Motivations related to cost and convenience were rated as less important (68 of 483 [14.1%]). Most motivations were internally generated, designed to please the patients and not others, with patients making the decision to undergo cosmetic procedures themselves and spouses seldom being influential. Patients younger than 45 years were more likely to undertake procedures to prevent aging (54 of 212 [25.5%] vs 42 of 286 [14.7%] among patients ≥45 years; P < .001). Patients seeking certain procedures, such as body contouring (19 of 22 [86.4%]), acne scar treatment (36 of 42 [85.7%]), and tattoo removal (8 of 11 [72.7%]), were more likely to report psychological and emotional motivations. Conclusions and Relevance: This initial prospective, multicenter study comprehensively assessed why patients seek minimally invasive cosmetic procedures. Common reasons included emotional, psychological, and practical motivations in addition to the desire to enhance physical appearance. Differences relative to patient age and procedures sought may need further exploration.

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. METHODS/DESIGN: Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants - physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN). DISCUSSION: This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.

Changes in pitching mechanics after ulnar collateral ligament reconstruction in major league baseball pitchers.

BACKGROUND: Medial ulnar collateral ligament (UCL) reconstruction is a common procedure performed on Major League Baseball pitchers. Variations in pitching mechanics before and after UCL reconstructive surgery are not well understood. METHODS: Publicly available pitch tracking data (PITCHf/x) were compared for all Major League Baseball pitchers who underwent UCL reconstruction between 2008 and 2013. Specific parameters analyzed were fastball percentage, release location, velocity, and movement of each pitch type. These data were compared before and after UCL reconstructive surgery and compared with a randomly selected control cohort. RESULTS: There were no statistically significant changes in pitch selection or pitch accuracy after UCL reconstruction, nor was there a decrease in pitch velocity. The average pitch release location for 4-seam and 2-seam fastballs, curveballs, and changeups is more medial after UCL reconstruction (P < .01). Four-seam fastballs and sliders showed decreased horizontal breaking movement after surgery (P < .05), whereas curveballs showed increased downward breaking movement after surgery (P < .05). CONCLUSIONS: Pitch selection, pitch velocity, and pitch accuracy do not significantly change after UCL reconstruction, nor do players who require UCL reconstruction have significantly different pitch selection, velocity, or accuracy than a randomly selected control cohort. Pitch release location is more medial after UCL reconstruction for all pitch types except sliders. Breaking movement of fastballs, sliders, and curveballs changes after UCL reconstruction.