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.

Restrictive dermopathy: Three new patients with ZMPSTE24 mutations and a review of the literature.

Restrictive dermopathy (RD) is a rare and lethal laminopathy caused by mutations in LMNA or ZMPSTE24. This series reports 3 patients with RD and reviews the literature of the 113 previously reported cases, including highlights of the unique constellation of clinical findings in RD, as well as histologic, radiographic, and genetic features. Early recognition of these characteristic features is vital to establish a prompt diagnosis and provide adequate family counseling for this terminal condition.

Factitial panniculitis as a manifestation of self-imposed factitious disorder.

Factitious disorder imposed on self is characterized by self-induction. Dermatitis artefacta, the cutaneous subtype of factitious disorder imposed on self, can have a variety of atypical presentations. A 36-year-old woman with an extensive past medical history presented with painful nodules on her abdomen, thighs, and arms. Histologic evaluation identified panniculitis with foreign body material seen under polarization. Chart review from previous hospital visits established a history of factitious disorder imposed on self and upon subsequent search of the hospital room, syringes with an unknown substance were found. Factitial panniculitis should be considered in cases with atypical lesions or locations that do not conform to the presentation of organic causes of panniculitis. Management should include a multidisciplinary approach that prioritizes patient safety and establishes a therapeutic patient-provider relationship.

Utility of a High-Resolution Superficial Diagnostic Ultrasound System for Assessing Skin Thickness: A Cross-Sectional Study.

BACKGROUND: Compared with other imaging modalities, ultrasound is relatively deeply penetrating and can be used to evaluate deep dermal and subcutaneous structures. OBJECTIVE: Image skin thickness of the face and neck using high-frequency diagnostic ultrasound devices. MATERIALS AND METHODS: Skin overlying 20 different predesignated face and neck anatomic sites in 32 individuals was imaged using 2 commercially available high-frequency diagnostic ultrasound devices, a dedicated imaging device and a diagnostic device bundled with a therapeutic device. At each site, the subcutaneous and combined epidermal and dermal layer thicknesses were assessed by blinded expert raters. RESULTS: Similar skin thickness measurements were obtained. Notably, subcutaneous fat depth was measured to be 0.2 cm at the forehead; 0.5 cm at the mental eminence; and 0.6 cm at the submental, supraglenoid, and temporal regions. The combined epidermal and dermal thickness was approximately 0.1 cm at the zygomatic process, suborbital area, inferior malar region, gonion, supraglenoid area, and nasolabial-buccal, and nasolabial fold regions. CONCLUSION: This is the first study using high-resolution superficial diagnostic ultrasound to map skin thickness of the face and neck at standard anatomic locations. Ultrasound is an inexpensive, noninvasive, and convenient means to monitor dermatologic conditions and guide their treatment.

Patient Preferences for Pain Control After Mohs Micrographic Surgery: A Single-Center Discrete Choice Experiment.

Importance: Patient preferences for pain medications after Mohs micrographic surgery are important to understand and have not been fully studied. Objective: To evaluate patient preferences for pain management with only over-the-counter medications (OTCs) or OTCs plus opioids after Mohs micrographic surgery given varying levels of theoretical pain and opioid addiction risk. Design, Setting, and Participants: This prospective discrete choice experiment was conducted in a single academic medical center from August 2021 to April 2022 among patients undergoing Mohs surgery and their accompanying support persons (≥18 years). A prospective survey was administered to all participants using the Conjointly platform. Data were analyzed from May 2022 to February 2023. Main outcome and measure: The primary outcome was the pain level at which half of the respondents chose OTCs plus opioids equally to only OTCs for pain management. This pain threshold was determined for varying opioid addiction risk profiles (low, 0%; low-moderate, 2%; moderate-high, 6%; high, 12%) and measured via a discrete choice experiment and linear interpolation of associated parameters (pain levels and risk of addiction). Results: Of the 295 respondents (mean [SD] age, 64.6 [13.1] years; 174 [59%] were female; race and ethnicity were not considered) who completed the discrete choice experiment, 101 (34%) stated that they would never consider opioids for pain management regardless of the pain level experienced, and 147 (50%) expressed concern regarding possible opioid addiction. Across all scenarios, 224 respondents (76%) preferred only OTCs vs OTCs plus opioids after Mohs surgery for pain control. When the theoretical risk of addiction was low (0%), half of the respondents expressed a preference for OTCs plus opioids given pain levels of 6.5 on a 10-point scale (90% CI, 5.7-7.5). At higher opioid addiction risk profiles (2%, 6%, 12%), an equal preference for OTCs plus opioids and only OTCs was not achieved. In these scenarios, patients favored only OTCs despite experiencing high levels of pain. Conclusion and relevance: The findings of this prospective discrete choice experiment indicate that the perceived risk of opioid addiction affects the patient's choice of pain medications after Mohs surgery. It is important to engage patients undergoing Mohs surgery in shared decision-making discussions to determine the optimal pain control plan for each individual. These findings may encourage future research on the risks associated with long-term opioid use after Mohs surgery.

Voting behavior during FDA Medical Device Advisory Committee panel meetings.

OBJECTIVES: During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of this study is to assess the relationship, if any, between individual votes and Panel recommendations and: (1) the composition of Panels, specifically the expertise and demographic features of individual members; or (2) Panel members' propensity to speak during Panel deliberations. METHODS: This was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbatim transcripts available publicly from the FDA. Number of words spoken, directionality of votes on device approval, profession, and demographics were collected. RESULTS: 658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.0184) and other non-physician voting members less (-213 words; P = 0.0306), than physicians. Speaking more was associated with abstaining (P = 0.0179), and with voting against the majority (P = 0.0153). Non-physician, non-biostatistician members (P = 0.0109), and those having attended more meetings as a voting member (P = 0.0249) were more likely to vote against approval. In bivariable analysis, unanimous Panels had a greater proportion of biostatisticians (mean 0.1580; 95% CI 0.1237-0.1923) than non-unanimous Panels (0.1107; 95% CI 0.0912-0.1301; p = 0.0201). CONCLUSIONS: Panelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads to greater voting consensus. Having a diversity of opinions on Panels, including in sufficient numbers those members likely to dissent from majority views, may help ensure that a diversity of opinions are aired before decision-making.

Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial.

Importance: Patients undergoing skin surgery under local anesthesia can experience anxiety. Adjuvant intraoperative anxiety reduction methods may help. Objectives: To assess whether hand-holding or holding a stress ball reduces patient anxiety during excisional surgery of head or neck skin cancer with the patient under local anesthesia and to measure pain and patient satisfaction. Design, Setting, and Participants: In this nonblinded, single-center randomized clinical trial, performed from January 24 through April 26, 2017, at a dermatology outpatient service in an urban, academic medical center, a consecutive sample of 135 adults who required excisional removal of nonmelanoma skin cancer of the head or neck was randomized and studied. Interventions: Participants were randomized 1:1:1 to 3 groups: hand-holding, stress ball, or control (treatment as usual). Participants in the hand-holding group had a female researcher hold one of their hands during administration of anesthesia and extirpation, and those in the stress ball group held a round compressible ball and squeezed it as desired during the same period. Main Outcomes and Measures: The primary outcome was anxiety, measured by a visual analog scale (VAS), 6-item State Trait Anxiety Inventory (STAI), and physiologic measures (blood pressure and heart rate). Secondary outcomes were pain during the procedure and overall participant satisfaction. In addition, participants were asked how many hours they spent researching the procedure before surgery. Results: A total of 135 participants, 45 per study arm, were enrolled (mean [SD] age, 65.5 [13.9] years; 84 [62.2%] male; 134 [99.3%] white). There were no withdrawals or dropouts. Anxiety decreased over time in all groups, but no significant differences were found in the 3 anxiety measures across the 3 groups (VAS anxiety score before: control group, 3.11; hand-holding group, 3.04; stress ball group, 3.09 [P > .99]; VAS anxiety score during: control group, 1.89; hand-holding group, 2.31; stress ball group, 2.47 [P = .55]; STAI score: control group, 8.91; hand-holding group, 8.93; stress ball group, 8.76 [P = .96]). The 3 groups also did not significantly differ in postprocedure pain scores (control group, 0.78; hand-holding group, 0.64; stress ball group, 0.67; P = .85). Almost all participants (134 [99.2%]) were very satisfied. Participants who had done research had higher preoperative VAS anxiety scores (researched, 3.84; did not research, 2.62; P = .04). Conclusions and Relevance: Hand-holding and squeezing a stress ball do not appear to provide incremental anxiety reduction in patients during excisional skin cancer surgery. It is possible that some subgroups may respond better or that patients may respond better when able to select and tailor their preferred anxiety reduction method. Trial Registration: ClinicalTrials.gov identifier: NCT02816996.

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

BACKGROUND: Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. METHODS/DESIGN: Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. DISCUSSION: Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

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.

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

BACKGROUND: Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. METHODS/DESIGN: A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. DISCUSSION: The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

Observation for assessment of clinician performance: a narrative review.

BACKGROUND: Video recorded and in-person observations are methods of quality assessment and monitoring that have been employed in high risk industries. In the medical field, observations have been used to evaluate the quality and safety of various clinical processes. This review summarises studies utilising video recorded or in-person observations for assessing clinician performance in medicine and surgery. METHODS: A search of MEDLINE (PubMed) was conducted using a combination of medical subject headings (MeSH) terms. Articles were included if they described the use of in-person or video recorded observations to assess clinician practices in three categories: (1) teamwork and communication between clinicians; (2) errors and weaknesses in practice; and (3) compliance and adherence to interventions or guidelines. RESULTS: The initial search criteria returned 3215 studies, 223 of which were identified for full text review. A total of 69 studies were included in the final set of literature. Observations were most commonly used in data dense and high risk environments, such as the emergency department or operating room. The most common use was for assessing teamwork and communication factors. CONCLUSIONS: Observations are useful for the improvement of healthcare delivery through the identification of clinician lapses and weaknesses that affect quality and safety. Limitations of observations include the Hawthorne effect and the necessity of trained observers to capture and analyse the notes or videos. The comprehensive, subtle and sensitive information observations provided can supplement traditional quality assessment methods and inform targeted interventions to improve patient safety and the quality of care.