Establishing Consensus for Mohs Micrographic Surgical Techniques in the Treatment of Melanoma in Situ for Future Clinical Trials: A Modified Delphi Study.

BACKGROUND: Mohs micrographic surgery (MMS) is a promising treatment modality for melanoma in situ (MIS). However, variations in surgical technique limit the generalizability of existing data and may impede future study of MMS in clinical trials. METHODS: A modified Delphi method was selected to establish consensus on optimal MMS techniques for treating MIS in future clinical trials. The Delphi method was selected due to the limited current data, the wide range of techniques used in the field, and the intention to establish a standardized technique for future clinical trials. A literature review and interviews with experienced MMS surgeons were performed to identify dimensions of the MMS technique for MIS that (1) likely impacted costs or outcomes of the procedure, and (2) showed significant variability between surgeons. A total of 8 dimensions of technical variation were selected. The Delphi process consisted of 2 rounds of voting and commentary, during which 44 expert Mohs surgeons across the United States rated their agreement with specific recommendations using a Likert scale. RESULTS: Five of eight recommendations achieved consensus in Round 1. All 3 of the remaining recommendations achieved consensus in Round 2. Techniques achieving consensus in Round 1 included the use of a starting peripheral margin of ≤5 mm, application of immunohistochemistry, frozen tissue processing, and resecting to the depth of subcutaneous fat. Consensus on the use of Wood's lamp, dermatoscope, and negative tissue controls was established in Round 2. CONCLUSIONS: This study generated 8 consensus recommendations intended to offer guidance for Mohs surgeons treating MIS. The adoption of these recommendations will promote standardization to facilitate comparisons of aggregate data in multicenter clinical trials.

Skin Color Match in Head and Neck Reconstructive Surgery.

OBJECTIVES/HYPOTHESIS: To quantify the degree of color match achieved during microvascular facial reconstruction, and to describe a novel technique for improving reconstructive skin color match. We hypothesize that split-thickness skin grafts (STSG) placed atop de-epithelialized free tissue produces better facial skin color match than free tissue with intact epithelium. STUDY DESIGN: Cross sectional photographic study of reconstructed facial skin color match. METHODS: Sixty-eight adults, who underwent head and neck reconstructive surgery, were divided into six categories based on cutaneous reconstructive technique: cervicofacial flap, radial forearm free flap (RFFF), fibula free flap, anterolateral thigh free flap (ALT), STSG over adiopofascial flap (STAFF), and STSG over myogenous flap (STMF). Averaged color samplings of the reconstructed defect and adjacent normal skin were taken from digital photographs. The color difference was calculated using the delta-E calculation. Blinded expert observers also rated the degree of color match. Nonparametric cohort contrast and correlation statistical analyses were performed. RESULTS: The mean delta-E's and 10-point Likert ratings for the ALT, fibula, RFFF, STAFF, STMF, and cervicofacial flaps were 11.6, 10.0, 7.7, 6.3, 8.8, and 4.7, and 5.1, 6.4, 2.4, 3.2, 2.7, and 1.1, respectively. Likert scale inter-rater correlation was strong, with coefficient = 0.80. CONCLUSIONS: On average, STSG over de-epithelialized myogenous and adipofascial free tissue transfers produced a better color match than the skin paddles of donor sites, with the exception of the radial forearm donor site. Delta-E values obtained from photos correlated well with expert ratings of color match. This reliable technique for quantifying color match may be used in future studies. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1753-1759, 2022.

Office-Based Surgical Intervention for Hidradenitis Suppurativa (HS): A Focused Review for Dermatologists.

Easily accessible office-based procedures that require minimal resources may facilitate timely surgical management of hidradenitis suppurativa (HS). This review focuses on excision and unroofing as two surgical HS treatments that can be tailored to the outpatient setting. Fifty-five articles were included in our review, representing 3914 patients. The majority were retrospective studies (58%, n = 32), and the studies reported data both across patients and by number of treated lesions. Recurrence rates for unroofing (14.5%) were found to be half that of excision (30%) across patients (p = 0.015) and slightly lower across lesions [20% recurrence vs 26% for excision (p = 0.023)]. Complication rates at the lesion level were also significantly associated with procedure, with rates after excision more than double those after roofing (26% vs. 12%, p < 0.001). The complication rate after combined medical and surgical therapy did not differ between procedures. Studies also suggest that continuing medical therapy in the perioperative period may be associated with improved recurrence rates, although delayed wound healing with biologic therapy has been reported. The existing data are limited by low-quality uncontrolled studies with small sample sizes, variable reporting of outcomes, and lack of uniform definitions for recurrence and remission. Further systematic prospective studies are needed to better compare complication and recurrence rates across these procedures in HS, especially in the context of concomitant medical therapy.

An expert panel consensus on opioid-prescribing guidelines for dermatologic procedures.

BACKGROUND: Opioid overprescribing is a major contributor to the opioid crisis. The lack of procedure-specific guidelines contributes to the vast differences in prescribing practices. OBJECTIVE: To create opioid-prescribing consensus guidelines for common dermatologic procedures. METHODS: We used a 4-step modified Delphi method to conduct a systematic discussion among a panel of dermatologists in the fields of general dermatology, dermatologic surgery, and cosmetics/phlebology to develop opioid prescribing guidelines for some of the most common dermatologic procedural scenarios. Guidelines were developed for opioid-naive patients undergoing routine procedures. Opioid tablets were defined as oxycodone 5-mg oral equivalents. RESULTS: Postoperative pain after most uncomplicated procedures (76%) can be adequately managed with acetaminophen and/or ibuprofen. Group consensus identified no specific dermatologic scenario that routinely requires more than 15 oxycodone 5-mg oral equivalents to manage postoperative pain. Group consensus found that 23% of the procedural scenarios routinely require 1 to 10 opioid tablets, and only 1 routinely requires 1 to 15 opioid tablets. LIMITATIONS: These recommendations are based on expert consensus in lieu of quality evidence-based outcomes research. These recommendations must be individualized to accommodate patients' comorbidities. CONCLUSIONS: Procedure-specific opioid prescribing guidelines may serve as a foundation to produce effective and responsible postoperative pain management strategies after dermatologic interventions.

Cutaneous fibrolipomatous hamartoma: Report of 2 cases with retrocalcaneal location.

Precalcaneal congenital fibrolipomatous hamartoma is an underreported benign entity that has been described in the literature under different names. We present two cases of unilateral fibrolipomatous hamartoma (FLH) appearing in a unique location: on the posterior aspect of the foot overlying the heel. We propose the term "FLH of the skin" as a more inclusive and less confusing term for this condition, thus allowing distinction with FLH arising from neural tissue. High-frequency ultrasonography appears to be a useful diagnostic tool that may avoid unnecessary biopsies for this condition.

p16, Cyclin D1, and HIF-1α Predict Outcomes of Patients with Oropharyngeal Squamous Cell Carcinoma Treated with Definitive Intensity-Modulated Radiation Therapy.

We evaluated a panel of 8 immunohistochemical biomarkers as predictors of clinical response to definitive intensity-modulated radiotherapy in patients with oropharyngeal squamous cell carcinoma (OPSCC). 106 patients with OPSCC were treated to a total dose of 66-70 Gy and retrospectively analyzed for locoregional control (LRC), disease-free survival (DFS), and overall survival (OS). All tumors had p16 immunohistochemical staining, and 101 tumors also had epidermal growth factor receptor (EGFR) staining. 53% of the patients had sufficient archived pathologic specimens for incorporation into a tissue microarray for immunohistochemical analysis for cyclophilin B, cyclin D1, p21, hypoxia-inducible factor-1α (HIF-1α), carbonic anhydrase, and major vault protein. Median followup was 27.2 months. 66% of the tumors were p16 positive, and 34% were p16 negative. On univariate analysis, the following correlations were statistically significant: p16 positive staining with higher LRC (P = 0.005) and longer DFS (P < 0.001); cyclin D1 positive staining with lower LRC (P = 0.033) and shorter DFS (P = 0.002); HIF-1α positive staining with shorter DFS (P = 0.039). On multivariate analysis, p16 was the only significant independent predictor of DFS (P = 0.023). After immunohistochemical examination of a panel of 8 biomarkers, our study could only verify p16 as an independent prognostic factor in OPSCC.

p16 not a prognostic marker for hypopharyngeal squamous cell carcinoma.

OBJECTIVE: To investigate the prognostic significance of p16 in patients with hypopharyngeal squamous cell carcinoma (HPSCC) and to evaluate the relationship between p16 and human papillomavirus (HPV). Unlike in oropharyngeal SCC (OPSCC), the prognostic significance of p16 in HPSCC and its association with HPV is unclear. DESIGN: Retrospective medical chart review. SETTING: University tertiary referral center. PATIENTS: A total of 27 patients with HPSCC treated with definitive radiation therapy between 2002 and 2011 whose tissue was available for immunohistochemical analysis. INTERVENTIONS: Twenty-two patients were treated with chemoradiation, and 5 with radiation alone. All tumor biopsy specimens were analyzed for p16 and, when sufficient tissue was available, for HPV DNA. MAIN OUTCOME MEASURES: Overall survival (OS), locoregional control (LRC), disease-free survival (DFS), and laryngoesophageal dysfunction-free survival (LEDFS) were analyzed according to p16 status. RESULTS: Findings for p16 were positive in 9 tumors and negative in 18 tumors. Median follow-up was 29.3 months. There was no significant difference in OS, LRC, DFS, or LEDFS for patients with p16-positive vs p16-negative tumors. Only 1 of the 19 tumors tested for HPV was found to be HPV positive. When used as a test for HPV, p16 had a positive predictive value of 17%. CONCLUSIONS: In contrast to OPSCC, p16 expression in patients with HPSCC had a low positive predictive value for HPV and did not predict improved OS, LRC, DFS, or LEDFS. Thus, for HPSCC, p16 is not a prognostic biomarker. Caution must be taken when extrapolating the prognostic significance of p16 in patients with OPSCC to patients with head and neck SCC of other subsites.

Validation of the insomnia severity index as a web-based measure.

Although the Insomnia Severity Index (ISI) is already administered online, this frequently used instrument has not been validated for Web delivery. This study compares online and paper-and-pencil ISI versions completed by participants in a randomized controlled trial testing an Internet-delivered intervention for insomnia. Forty-three adults with insomnia completed both ISI versions during pre- (Assessment 1) and post-intervention (Assessment 2). Correlations between total scores of both versions were significant (rs ≥ .98, ps < .001). For both ISI versions, internal consistency was acceptable (Assessment 1, α = .61; Assessment 2, α ≥ .88). Among participants not receiving the parent study intervention, correlations between 1 format at Assessment 1 and the alternative format at Assessment 2 were generally significant (rs = .26-.82). Together, findings suggest the ISI can be delivered online.

Heavy drinking on college campuses: no reason to change minimum legal drinking age of 21.

The recent Amethyst Initiative argues that a minimum legal drinking age (MLDA) of 21 has created a culture of heavy alcohol use on college campuses by making drinking clandestine and extreme. This group and others argue that lowering the MLDA will reduce the problem of "binge drinking" on college campuses. However, such a policy change would remove one of the most researched and supported policies in the nation's alcohol control arsenal. There is little evidence that other interventions or policies are capable of working on the same broad level as MLDA 21, and there could also be a deleterious ripple effect in related legislation because MLDA 21 works in conjunction with other drinking laws. In addition, historic and international experiences with a lowered MLDA indicate there are serious social and public health consequences. Instead of removing efficacious interventions, we must remain committed to implementing and enforcing evidence-based practices and legislation.

Efficacy of an Internet-based behavioral intervention for adults with insomnia.

CONTEXT: Insomnia is a major health problem with significant psychological, health, and economic consequences. However, availability of one of the most effective insomnia treatments, cognitive behavioral therapy, is significantly limited. The Internet may be a key conduit for delivering this intervention. OBJECTIVE: To evaluate the efficacy of a structured behavioral Internet intervention for adults with insomnia. DESIGN, SETTING, AND PARTICIPANTS: Forty-five adults were randomly assigned to an Internet intervention (n = 22) or wait-list control group (n = 23). Forty-four eligible participants (mean [SD] age, 44.86 [11.03] years; 34 women) who had a history of sleep difficulties longer than 10 years on average (mean [SD], 10.59 [8.89] years) were included in the analyses. INTERVENTION: The Internet intervention is based on well-established face-to-face cognitive behavioral therapy incorporating the primary components of sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. MAIN OUTCOME MEASURES: The Insomnia Severity Index and daily sleep diary data were used to determine changes in insomnia severity and the main sleep variables, including wake after sleep onset and sleep efficiency. RESULTS: Intention-to-treat analyses showed that scores on the Insomnia Severity Index significantly improved from 15.73 (95% confidence interval [CI], 14.07 to 17.39) to 6.59 (95% CI, 4.73 to 8.45) for the Internet group but did not change for the control group (16.27 [95% CI, 14.61 to 17.94] to 15.50 [95% CI, 13.64 to 17.36]) (F(1,42) = 29.64; P < .001). The Internet group maintained their gains at the 6-month follow-up. Internet participants also achieved significant decreases in wake after sleep onset (55% [95% CI, 34% to 76%]) and increases in sleep efficiency (16% [95% CI, 9% to 22%]) compared with the nonsignificant control group changes of wake after sleep onset (8% [95% CI, -17% to 33%) and sleep efficiency (3%; 95% CI, -4% to 9%). CONCLUSIONS: Participants who received the Internet intervention for insomnia significantly improved their sleep, whereas the control group did not have a significant change. The Internet appears to have considerable potential in delivering a structured behavioral program for insomnia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00328250.

Real world use of an Internet intervention for pediatric encopresis.

BACKGROUND: The Internet is a significant source of medical information and is now being shown to be an important conduit for delivering various health-related interventions. OBJECTIVE: This paper aimed to examine the utility and impact of an Internet intervention for childhood encopresis as part of standard medical care in a "real world" setting. METHODS: Patients diagnosed with encopresis were given a Web-based information prescription to use an Internet intervention for pediatric encopresis. A total of 22 families utilized the intervention between July 2004 and June 2006. A chart review and phone interview were undertaken to collect user characteristics; defecation-related information, including frequency of soiling, bowel movements (BMs) in the toilet, and amount of pain associated with defecation; and information on computer/Internet usage. Three questionnaires were used to examine the utility of, impact of, and adherence to the Internet intervention. Program utilization was obtained from a data tracking system that monitored usage in real time. RESULTS: Overall, parents rated the Internet intervention as enjoyable, understandable, and easy to use. They indicated that the Internet intervention positively affected their children, decreasing overall accidents and increasing child comfort on the toilet at home. Of the 20 children who initially reported fecal accidents, 19 (95%) experienced at least a 50% improvement, with a reduction of accident frequency from one fecal accident per day to one accident per week. Although it is not clear whether this improvement is directly related to the use of the Internet intervention, patient feedback suggests that the program was an important element, further establishing Internet interventions as a viable and desirable addition to standard medical care for pediatric encopresis. CONCLUSIONS: To our knowledge, this is the first time a pediatric Internet intervention has been examined as part of a "real world" setting. This is an important step toward establishing Internet interventions as an adjunctive component to treatment of pediatric patients in a clinical setting, particularly given the positive user feedback, possible cost savings, and significant potential for large-scale dissemination.

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia.

Insomnia is a major health problem, with significant psychological, health, and economic consequences. Studies have demonstrated that cognitive-behavioural therapy can effectively treat insomnia; however, treatment availability is limited by many factors, including a lack of trained clinicians. One potential way to overcome these barriers is to use the Internet to deliver treatment. Toward this aim, we developed a self-guided, interactive, tailored Internet intervention for adults with insomnia (SHUTi: Sleep Healthy Using The Internet). The current paper provides a detailed description of SHUTi and examines users' perceptions of the intervention's usefulness and effectiveness. The study was part of a larger randomised controlled trial (RCT) to test the efficacy of SHUTi, but findings in this paper are based only on the 21 participants who completed the post-assessment after using SHUTi. The overwhelming majority rated SHUTi as convenient, understandable, and useful. Nearly all (95%) indicated that the program had at least somewhat improved their sleep, sleep efficiency, and overall quality of life. Ninety percent perceived the intervention as effective and predicted it would be effective in producing a long-term cure. Although these results were based on a small sample, they provide encouraging evidence of the potential for Internet interventions to be accepted by patients.