Implementation and evaluation of a Tele-OSCE in oral and maxillofacial surgery - a pilot report.

Background: The ongoing changes in learning and education towards digitalisation have been rapidly accelerated by the COVID-19 pandemic. Especially in dental education where contact to the oral cavity is an integral part of training the chosen digital examination methods and training formats must undergo high requirements to full fill the goal of a real alternative to face-to-face exams. Therefore, this study compared student performance in a newly developed Tele-OSCE with a prior OSCE examinations in presence within an oral- and maxillofacial surgery curriculum. Methods: Study participants were fourth-year (in a five year curriculum) dental students and board certified maxillofacial surgeons (examiners) that took part in a newly developed Tele-OSCE that comprised three five-minute stations (structured facial examination, management mandibular fracture and squamous cell carcinoma) using the zoom® software. Student performance was measured using validated OSCE-Checklists and compared to a previous OSCE examination from the winter term 2019 with the same OSCE stations that was conducted in presence. Significant differences were tested using the Mann-Whitney U test. Furthermore, the new Tele-OSCE was evaluated by students and examiners using previously developed questionnaires. Results: Sixty-six dental students (study group: n=34, summer term 2021, control group: n=32 winter term 2019) and nine examiners participated in the study. Compared to previous non-pandemic OSCEs, there were no significant (p=0.53) differences in overall student performance. Evaluation of the Tele-OSCE showed that the demonstration and rating of practical skills was limited due to missing standard patients or phantoms, however, students did not fear to be misjudged. The demonstration and rating of anamnestic and consultation competencies was seen as unproblematic by students and examiners. Discussion: This pilot-study showed the feasibility of a Tele-OSCE as a formative examination in dental education. However, both students and examiners felt that the demonstration and assessment of practical skills was limited due the new examination format. Nevertheless, Tele-OSCEs might offer an alternative to enable students to complete their dental training.

c-Kit inhibitors for unresectable or metastatic mucosal, acral or chronically sun-damaged melanoma: a systematic review and one-arm meta-analysis.

BACKGROUND: Activating genomic alterations of the receptor tyrosine kinase KIT are found preferentially in certain melanoma subtypes such as acral and mucosal melanoma or melanoma arising in chronically sun-damaged skin. However, the therapeutic value of c-Kit inhibitors for these subtypes currently remains unclear. OBJECTIVES: The objective of this study was to summarise the efficacy and safety of c-Kit inhibitors for unresectable or metastatic mucosal, acral or chronically sun-damaged melanoma. METHODS: We performed a systematic literature research in MEDLINE, Embase and CENTRAL and hand searched pertinent trial registers and conference abstracts for eligible trials until 23rd June 2020. Results were pooled using a random-effects model to calculate pooled proportions of objective response rates (ORRs) and severe adverse events (sAEs) from unselected KIT mutant or amplified cohorts. RESULTS: Nineteen single-arm studies with an overall sample size of 601 patients were included. The studies investigated imatinib (n = 8), nilotinib (n = 7), dasatinib (n = 3) and sunitinib (n = 1). The pooled ORR for all inhibitors was 15% (95% confidence interval [CI]: 12-18%). Subgroup analysis revealed the highest ORR (20%; 95% CI: 14-26%) for nilotinib. The ORR for mucosal melanoma was 14% (95% CI: 6-24%) and 22% for acral lentiginous melanoma (95% CI: 14-30%). At least one sAE was reported in 42% of patients (95% CI: 34-50%). CONCLUSIONS: c-Kit inhibitors represent a valuable treatment option for patients with KIT-mutant melanoma, in particular for mutations of exons 11 and 13. Furthermore, high-quality trials are urgently needed to investigate putative combinations of specific targeted therapies with immunotherapy.

Long-term efficacy of interventions for actinic keratosis: protocol for a systematic review and network meta-analysis.

BACKGROUND: Actinic keratoses (AK) are common precancerous lesions of the skin due to cumulative sun exposure. A variety of interventions are available for the treatment; however, the majority of randomised controlled trials (RCTs) and meta-analyses focus on short-term efficacy outcomes. This network meta-analysis aims to investigate the long-term (> 12 months) efficacy of interventions for AK. METHODS: To identify relevant studies, we will perform a systematic literature research in MEDLINE, Embase, and CENTRAL and hand-search pertinent trial registers. Two authors will independently screen titles and abstracts for eligibility. We will include RCTs with an inter-individual (parallel arm) design. The study population includes patients with a clinical or histopathologic diagnosis of AK. Eligibility will be restricted to the following interventions: surgical approaches, cryosurgery, ablative laser treatment, topical drug treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, or photodynamic therapy. As outcomes, we will consider the following endpoints: (1) the participant complete clearance rate, (2) the participant partial clearance rate, (3) the lesion-specific clearance, (4) the mean lesion reduction per patient, and (5) the number of withdrawals due to adverse events after at least 12 months after the end of treatment. Monotherapy or placebo will serve as a comparison. Estimates of effects from individual studies will be pooled using a random-effects model. Heterogeneity will be evaluated based on I2 and chi-square test. The risk of bias will be estimated with the Cochrane Risk of Bias Tool by two review authors independently. The quality of evidence of the outcomes will be assessed with the GRADE approach. A network meta-analysis will be performed to combine direct and indirect evidence from the included RCTs. DISCUSSION: The potential of interventions to achieve a sustained clearance of AK has not been assessed to date. To investigate the long-term efficacy of interventions is important as the natural disease course is highly variable and relapses occur frequently even after initial lesion clearance. This review will help to set a framework for clinical decision making in patients with AK. SYSTEMATIC REVIEW REGISTRATION: CRD42018095903 (PROSPERO).

Laser-assisted photodynamic therapy for actinic keratosis: A systematic review and meta-analysis.

BACKGROUND: Photodynamic therapy (PDT) is an effective intervention for actinic keratosis and field cancerization. Ablative fractional lasers may facilitate the delivery of photosensitizers and thereby improve the effects of PDT. OBJECTIVE: To summarize the current evidence on the efficacy and safety of laser-assisted PDT. METHODS: We performed a systematic literature research in Medline, Embase, and the Cochrane Central Register of Controlled Trials and hand-searched pertinent trial registers for eligible randomized controlled trials. Results from individual studies were pooled by using a random-effects model. The risk of bias was estimated with the Cochrane Risk of Bias Tool, and the quality of evidence of the outcomes was assessed with the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS: Of 817 records initially identified, 7 randomized controlled trials were included in the qualitative analysis and 4 were included in the meta-analysis. Laser-assisted PDT showed significantly higher clearance rates than did PDT monotherapy (risk ratio, 1.33; 95% confidence interval, 1.24-1.42; I2 = 25%; P < .01). There was no difference in pain intensity between laser-assisted PDT and other interventions (mean difference, 0.31; 95% confidence interval, -0.12 to 0.74; I2 = 0%; P = .16). The included studies showed a high risk of bias. LIMITATIONS: The clinical heterogeneity of included studies. CONCLUSION: Laser-assisted PDT is more efficient but not more painful than PDT or laser treatment only.