Validation of the Quality Analysis of Medical Artificial Intelligence (QAMAI) tool: a new tool to assess the quality of health information provided by AI platforms.

BACKGROUND: The widespread diffusion of Artificial Intelligence (AI) platforms is revolutionizing how health-related information is disseminated, thereby highlighting the need for tools to evaluate the quality of such information. This study aimed to propose and validate the Quality Assessment of Medical Artificial Intelligence (QAMAI), a tool specifically designed to assess the quality of health information provided by AI platforms. METHODS: The QAMAI tool has been developed by a panel of experts following guidelines for the development of new questionnaires. A total of 30 responses from ChatGPT4, addressing patient queries, theoretical questions, and clinical head and neck surgery scenarios were assessed by 27 reviewers from 25 academic centers worldwide. Construct validity, internal consistency, inter-rater and test-retest reliability were assessed to validate the tool. RESULTS: The validation was conducted on the basis of 792 assessments for the 30 responses given by ChatGPT4. The results of the exploratory factor analysis revealed a unidimensional structure of the QAMAI with a single factor comprising all the items that explained 51.1% of the variance with factor loadings ranging from 0.449 to 0.856. Overall internal consistency was high (Cronbach's alpha = 0.837). The Interclass Correlation Coefficient was 0.983 (95% CI 0.973-0.991; F (29,542) = 68.3; p < 0.001), indicating excellent reliability. Test-retest reliability analysis revealed a moderate-to-strong correlation with a Pearson's coefficient of 0.876 (95% CI 0.859-0.891; p < 0.001). CONCLUSIONS: The QAMAI tool demonstrated significant reliability and validity in assessing the quality of health information provided by AI platforms. Such a tool might become particularly important/useful for physicians as patients increasingly seek medical information on AI platforms.

Cemiplimab in Ultra-Octogenarian Patients with Cutaneous Squamous Cell Carcinoma: The Real-Life Experience of a Tertiary Referral Center.

BACKGROUND: The incidence of cutaneous squamous cell carcinoma (cSCC) is rapidly increasing, paralleling the aging of the population. cSCC predominantly affects chronically sun-exposed areas, such as the head and neck region. At our tertiary center, a multidisciplinary approach to non-melanoma skin cancer is provided for locally advanced cSCC. METHODS: We retrospectively revised all patients with locally advanced/metastatic cSCC treated with anti-PD1 antibody (Cemiplimab) at our Institution from January 2020 to March 2023 (minimum follow-up of 4 months on treatment). RESULTS: Overall, we consecutively treated 20 ultra-octogenarian patients, of whom 15 were males and 5 were females (median age: 86.9 years). Despite age, a median number of concomitant drugs, and comorbidities, efficacy, and safety were superimposable with the available literature. No patients reported treatment-related adverse events of grade 3 or higher. Grade 2 adverse events were reported in 25% of patients. Overall, the response rate was 65%, with 50% partial responses and 20% long-lasting stable disease. The median duration of response was 14 months. The G8 elderly score was assessed in all patients, and the median score was 12 (range 9-14). CONCLUSIONS: Among ultra-octogenarian patients, a clinical benefit from Cemiplimab was obtained in most, including tumor shrinkage and pain relief. Cemiplimab confirmed its effectiveness in elderly patients in a real-life setting, with no new safety concerns.

Accuracy of ChatGPT-Generated Information on Head and Neck and Oromaxillofacial Surgery: A Multicenter Collaborative Analysis.

OBJECTIVE: To investigate the accuracy of Chat-Based Generative Pre-trained Transformer (ChatGPT) in answering questions and solving clinical scenarios of head and neck surgery. STUDY DESIGN: Observational and valuative study. SETTING: Eighteen surgeons from 14 Italian head and neck surgery units. METHODS: A total of 144 clinical questions encompassing different subspecialities of head and neck surgery and 15 comprehensive clinical scenarios were developed. Questions and scenarios were inputted into ChatGPT4, and the resulting answers were evaluated by the researchers using accuracy (range 1-6), completeness (range 1-3), and references' quality Likert scales. RESULTS: The overall median score of open-ended questions was 6 (interquartile range[IQR]: 5-6) for accuracy and 3 (IQR: 2-3) for completeness. Overall, the reviewers rated the answer as entirely or nearly entirely correct in 87.2% of cases and as comprehensive and covering all aspects of the question in 73% of cases. The artificial intelligence (AI) model achieved a correct response in 84.7% of the closed-ended questions (11 wrong answers). As for the clinical scenarios, ChatGPT provided a fully or nearly fully correct diagnosis in 81.7% of cases. The proposed diagnostic or therapeutic procedure was judged to be complete in 56.7% of cases. The overall quality of the bibliographic references was poor, and sources were nonexistent in 46.4% of the cases. CONCLUSION: The results generally demonstrate a good level of accuracy in the AI's answers. The AI's ability to resolve complex clinical scenarios is promising, but it still falls short of being considered a reliable support for the decision-making process of specialists in head-neck surgery.

Sonidegib in Locally Advanced Basal Cell Carcinoma: A Monocentric Retrospective Experience and a Review of Published Real-Life Data.

Basal cell carcinoma (BCC) represents the most common skin cancer and locally advanced BCC (laBCC) refers to an aggressive, large, infiltrative BCC that cannot be treated by surgery or radiotherapy. Sonidegib is a Hedghehog inhibitor (HHi) indicated for laBCC. This is a monocentric retrospective real-life study of laBCCs receiving Sonidegib treatment. Although Sonidegib is widely used, since its approval by Food and Drug Administration in 2015, only a limited number of real-life experiences have been reported. Eleven patients, including four patients diagnosed with Basal Cell Naevus syndrome, received treatment with Sonidegib for laBCCs. Seven (63.6%) patients experienced adverse events (AEs) but only three had to discontinue treatment and were therefore excluded from the following results. Four patients (50%) achieved complete clinical remission (CR); in all cases the remission was confirmed by biopsy. Partial response (PR) was found in three patients out of eight (37.5%). One patient out of eight (12.5%) showed a steady disease (SD). None of the patients showed signs of progression during treatment with HHi. Sonidegib showed the same efficacy in treating laBCCs as already seen in trials. All four patients suffering from Basal Cell Naevus syndrome achieved disease control by being treated with Sonidegib. Consequently, we strongly advise the joint management of laBCCs through a multidisciplinary team whenever feasible.

Basal Cell Carcinoma and Hedgehog Pathway Inhibitors: Focus on Immune Response.

Basal cell carcinoma (BCC) is the most common form of skin cancer, affecting more often elderly patients, but sometimes even younger ones, particularly if immunocompromised or genetically predisposed. Specifically, the Gorlin-Goltz syndrome, an autosomal dominant genodermatosis, also known as nevoid basal cell carcinoma syndrome, characterizes for multiple early onset BCCs. It is caused by a germline mutation in PTCH1, a tumor suppressor gene whose product is the key component of Hedgehog (Hh) signaling pathway, which also appears somatically mutated in more than 85% of sporadic BCCs. Hh pathway inhibitors vismodegib and sonidegib are currently indicated for BCC, in adults with advanced or recurred tumor following surgery or radiation therapy. The principal mechanism of action of these drugs is the inhibition of Smoothened (SMO), a transmembrane protein involved in Hh signal transduction, that plays a role in both cellular differentiation and cancer development. Some studies have reported effects of Hh pathway inhibitors at different levels of the immune response, from cytotoxic T cells to a modified local cytokines pattern. Given the specific relation between immune system and BCC development in some conditions, we will review BCC with focus on immune system changes mediated by Hh signaling pathway and induced by the inhibitors vismodegib and sonidegib in the treatment of BCC. Thus, we will give an overview of their effects on the local immune response, as well as a brief note on the supposed function of Hh pathway inhibition on the systemic one.

An approach to evaluate the quality of radiological reports in Head and Neck cancer loco-regional staging: experience of two Academic Hospitals.

OBJECTIVES: To evaluate the quality of the reports of loco-regional staging computed tomography (CT) or magnetic resonance imaging (MRI) in head and neck (H&N) cancer. METHODS: Consecutive reports of staging CT and MRI of all H&N cancer cases from 2018 to 2020 were collected. We created lists of quality indicators for tumor (T) for each district and for node (N). We marked these as 0 or 1 in the report calculating a report score (RS) and a maximum sum (MS) of each list. Two radiologists and two otolaryngologists in consensus classified reports as low quality (LQ) if the RS fell in the percentage range 0-59% of MS and as high quality (HQ) if it fell in the range 60-100%, annotating technique and district. We evaluated the distribution of reports in these categories. RESULTS: Two hundred thirty-seven reports (97 CT and 140 MRI) of 95 oral cavity, 52 laryngeal, 47 oropharyngeal, 19 hypo-pharyngeal, 14 parotid, and 10 nasopharyngeal cancers were included. Sixty-six percent of all the reports were LQ for T, 66% out of all the MRI reports, and 65% out of all CT reports were LQ. Eight-five percent of reports were HQ for N, 85% out of all the MRI reports, and 82% out of all CT reports were HQ. Reports of oral cavity, oro-nasopharynx, and parotid were LQ, respectively, in 76%, 73%, 100% and 92 out of cases. CONCLUSION: Reports of staging CT/MRI in H&N cancer were LQ for T description and HQ for N description.

Comparing prognostic utility between the 8th edition of TNM staging system and the lymph node ratio for oral squamous cell carcinoma.

BACKGROUND: Lymph node metastasis in oral squamous cell carcinoma (OSCC) is associated with poor prognosis. The 8th edition of TNM has implemented new nodal staging criteria. We assess the prognostic utility of the lymph node ratio (LNR) and compare it to that of pN in the TNM 8th edition. METHODS: One hundred and forty-two patients with OSCC were retrospectively studied. Nodal staging was performed using the TMN 8th edition and the prognostic value of the LNR in terms of overall survival (OS) and disease-free survival (DFS) was evaluated. RESULTS: Fifty-seven patients were eligible for inclusion. The LNR was independently prognostic of OS (p = 0.02). Instead N classification was not significantly predictive of OS (p = 0.10). High LNRs resulted in decreases in OS of approximately 40% within 6 months after surgery. CONCLUSIONS: The LNR identifies patients with poor outcomes better than N classification. The lack of reliable LNR cutoffs compromises its utility in clinical practice.

Accuracy of Fibula Reconstruction Using Patient-Specific Cad/Cam Plates: A Multicenter Study on 47 Patients.

OBJECTIVES: This prospective study evaluated the accuracy of mandibular reconstruction using free fibular flaps (by comparing virtual plans to the three-dimensional postoperative results), and the extent of bone-to-bone contact after computer-assisted surgery. METHODS: We included 65 patients who underwent partial-continuity mandibular resections from February 2013 to January 2017, and evaluated virtual planning, surgical techniques, and accuracy. RESULTS: Forty-seven patients were analysed. A total of 112 fibular segments received 54 implants. We measured 227 distances between landmarks to assess the accuracy of reconstruction. Postoperative reconstruction accuracy ranged from 0.5 to 3 mm. CONCLUSION: Virtual surgical planning very accurately translated simulation into reality, particularly in patients requiring large, complex mandibular reconstructions using multiple fibular segments. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2169-E2175, 2021.

The Effect of Orthognathic Surgery on Soft-Tissue Facial Asymmetry: A Longitudinal Three-Dimensional Analysis.

In modern orthognathic surgery, the functional results cannot disregard a good aesthetic outcome. In this study, a stereophotogrammetric longitudinal analysis of the symmetry of facial thirds was performed in 18 patients affected by Class III skeletal malocclusion, with clinical asymmetry, treated with a bimaxillary osteotomy. Their 3-dimensional facial images were acquired in the preoperative phase and 6, 12, and 24 months after surgery, and compared to those obtained in a control group of 23 subjects with Class I skeletal occlusion, without clinical asymmetry and no history of traumas or alterations at the maxillo-facial area. Images of the hemi-faces of the subjects were divided into thirds (upper, middle, lower), mirrored and superimposed to their contralateral ones; soft-tissue facial symmetry was obtained as the root mean square distance between the hemi-faces in the three thirds.In patients, no significant differences in facial symmetry (root mean square distance) were found among the study time points (analysis of variance, P > 0.05); the lower facial third was more asymmetric than the upper one (Tukey honestly significant difference P < 0.05). Patients were significantly more asymmetric than the control subjects (Student t, P < 0.05). In conclusion, patients with Class III malocclusion exhibited a higher level of facial asymmetry than control subjects; their asymmetry did not change significantly in the different phases of the surgical and orthodontic treatment and throughout a 24-month follow-up. In skeletal Class III patients, bimaxillary osteotomy did not modify the level of asymmetry in any facial third.

Role of Axial Split Osteotomy of Free Fibula Flap in Mandibular Reconstruction and Dental Rehabilitation.

The fibula free flap (FFF) is regarded as the gold standard in mandibular reconstruction. Dental rehabilitation is important to improve the health-related quality of life of patients undergoing mandibular reconstruction. FFF provides adequate cortical bone osseous tissue for use in dental implantation. The application of "axial split osteotomy" via a double-barrel fibula graft may enable discrepancies between the native mandible and FFF to be avoided, thereby improving the likelihood of early and successful dental rehabilitation.

Computer-Aided Design and Computer-Aided Manufacturing Versus Conventional Free Fibula Flap Reconstruction in Benign Mandibular Lesions: An Italian Cost Analysis.

PURPOSE: The cost of computer-aided design and computer-aided manufacturing (CAD-CAM) technology has created obstacles for its widespread use despite its several advantages. This study compared the cost of CAD-CAM technology with that of the conventional freehand technique in fibula reshaping for mandibular reconstruction. MATERIALS AND METHODS: A retrospective comparative study was conducted at the Maxillofacial and Dental Unit of the Fondazione Ca' Granda IRCCS Ospedale Maggiore Policlinico (Milan, Italy). The study compared 15 patients in the CAD-CAM group with 10 patients in the conventional freehand group. Only benign pathologic lesions that required at least 3 fibular segments for reconstruction were included. The consumption of resources was estimated using micro-costing analysis (activity-based costing approach). RESULTS: The CAD-CAM group included 15 patients (7 men and 8 women) with a mean age of 42.2 ± 1.5 years, and the conventional freehand group included 10 patients (4 men and 6 women) with a mean age of 40.8 ± 0.9 years. Although CAD-CAM was a statistically expensive procedure in the perioperative phase (P < .0001), no significant difference was shown in total health care costs between the 2 groups (P = .98). CONCLUSION: CAD-CAM technology had a comparable expense to the conventional freehand technique, specifically for defects requiring at least 3 fibular segments.

Phenytoin and gingival mucosa: A molecular investigation.

Several distinct classes of drugs, such as anticonvulsants, immunosuppressants, and calcium channel blockers, caused gingival overgrowth. One of the main drugs associated with the gingival overgrowth is the anti-epileptic such as phenytoin, which affects gingival tissues by altering extracellular matrix metabolism. In our study, we evaluate the effect of phenytoin, a drug whose active substance is phenytoin, on gingival fibroblasts of healthy volunteers. Gene expression of 29 genes was investigated in gingival fibroblasts' cell culture treated with phenytoin compared with untreated cells. Among the studied genes, only 13 genes (CXCL5, CXCL10, CCR1, CCR3, CCR5, CCR6, IL-1A, IL-1B, IL-5, IL-7, IL-6R, BMP-2, and TNFSF-10) were statistically significant. All but one gene resulted downregulated after 24 h of treatment with phenytoin. BPM2 was the only, although weakly, up-expressed gene. Probably, we have not highlighted overexpression of the other inflammatory molecules because the study was performed on healthy people. Many studies show that phenytoin induces the overexpression of these cytokines but, probably, in our study, the drug does not have the same effect because we used gingival fibroblasts of healthy people.

Drug-induced gingival hyperplasia: An in vitro study using amlodipine and human gingival fibroblasts.

Gingival overgrowth is a serious side effect that accompanies the use of amlodipine. Several conflicting theories have been proposed to explain the fibroblast's function in gingival overgrowth. To determine whether amlodipine alters the inflammatory responses, we investigated its effects on gingival fibroblast gene expression as compared with untreated cells. Fragments of gingival tissue of healthy volunteers (11 years old boy, 68 years old woman, and 20 years old men) were collected during operation. Gene expression of 29 genes was investigated in gingival fibroblast cell culture treated with amlodipine, compared with untreated cells. Among the studied genes, only 15 (CCL1, CCL2D, CCL5, CCL8, CXCL5, CXCL10, CCR1, CCR10, IL1A, IL1B, IL5, IL7, IL8, SPP1, and TNFSF10) were significantly deregulated. In particular, the most evident overexpressed genes in treated cells were CCR10 and IL1A. These results seem to indicate a possible role of amlodipine in the inflammatory response of treated human gingival fibroblasts.

Copy number variation analysis of twin pairs discordant for cleft lip with or without cleft palate.

Non-syndromic cleft lip with or without cleft palate (nsCL/P) is a frequent orofacial malformation. The comparison of concordance rate observed in monozygotic and dizygotic twins supports high level of heritability and a strong genetic component. However, phenotype concordance for orofacial cleft in monozygotic twins is about 50%. The aim of the present investigation was to detect postzygotic events that may account for discordance in monozygotic twins. High-density SNP microarrays hybridization was used to genotype two pairs of monozygotic twins discordant for nsCL/P. Discordant SNP genotypes and copy number variants were analyzed to identify genetic differences responsible of phenotype discrepancy. A number of differences were observed, none involving known nsCL/P candidate genes or genomic regions. Considering the limitation of the study, related to the small sample size and to the large-scale investigation method, the results suggest that the detection of discordant events in other monozygotic twin pairs would be remarkable and warrant further investigations.

Use of CAD-CAM technology to improve orthognathic surgery outcomes in patients with severe obstructive sleep apnoea syndrome.

INTRODUCTION: Although multilevel surgery is the mainstay treatment for severe obstructive sleep apnoea syndrome (OSAS), bi-maxillary surgery (maxillomandibular advancement [MMA]) is the most efficacious single procedure for the expansion of the whole pharyngeal airway. MMA is an alternative to the gold standard of continuous positive airway pressure and is equivalent to tracheotomy. PATIENTS AND METHOD: Computer-aided design/computer-aided manufacturing (CAD-CAM) technology was used to virtually assess the degree of mandibular and/or maxillary advancement and rotation required to obtain adequate posterior airway space (PAS) in eight patients (seven males, one female). The mean age of the patients was 45.5 years (range, 27-51 years), and the average body mass index was 28.9 kg/m2 (range, 21.9-31.8 kg/m2). RESULTS: The study group showed significant mandibular advancement, widening of the PAS, and reduction of the apnoea hypopnea index (p < 0.0001, p < 0.0001, and p < 0.0002, respectively). Moreover, patient satisfaction scores regarding postoperative facial profile changes showed excellent compliance. CONCLUSION: This study demonstrated that bi-maxillary surgery is an efficient single surgical procedure in patients with multilevel OSAS. CAD-CAM technology aided surgeons in performing this operation precisely and enabled patients to expect specific facial profiles.

Donor-Site Morbidity After Osteocutaneous Free Fibula Transfer: Longitudinal Analysis of Gait Performance.

PURPOSE: The purpose was to evaluate donor-site clinical morbidity and changes in kinematic gait parameters after the harvest of a vascularized free fibula flap for facial reconstruction. MATERIALS AND METHODS: We enrolled 14 patients (aged 50 ± 15 years) in a longitudinal study. Every patient underwent a double evaluation in which a presurgical assessment and 6-month postsurgical assessment were performed. Subjective donor-site evaluation was carried out through unstructured clinical questioning about pain, paresthesia, walking ability, and restrictions in activity. Further subjective evaluations were assessed through the Western Ontario and McMaster Universities Osteoarthritis Index and the Point Evaluation System for Lower Extremity Fibulectomy. A clinical evaluation of the donor site assessed muscular deficits, sensibility disturbance, and wound healing. Temporal and spatial kinematic parameters were measured through gait analysis during overground walking at a comfortable speed. RESULTS: Postsurgical clinical examinations detected 1 patient affected by a neurologic disorder and 3 patients with donor-site pain, whereas 10 patients (71%) declared no residual alterations in the operated leg. On average, the Western Ontario and McMaster Universities Osteoarthritis Index score was 367 of 2,400, and the Point Evaluation System for Lower Extremity Fibulectomy score was 19 of 24. Presurgical versus postsurgical gait analysis comparison showed no significant differences in gait parameters except for a 6% reduction in the double-support phase. Stance values were higher for the operated limb in both evaluations (+1.3% before surgery, +1.8% after surgery). No alterations were detected in the range of motion of the lower-limb joints. CONCLUSIONS: Considering the slight modification of the gait pattern, which is not usually perceived by patients, vascularized free fibula flap harvest was generally associated with successful functional and subjective outcomes of the donor site.

Fibula free flap pedicle ossification: Experience of two centres and a review of the literature.

PURPOSE: The osteogenic potential of vascularized periosteum has been described in a few cases in the literature, and many different factors have been pointed out as plausible. Our aim was to review the literature in order to give a complete overview of this topic and to report on our clinical experience. PATIENTS & METHODS: Our experience includes three patients who underwent maxillectomy and FFF reconstruction. A progressive reduction in mouth opening was noticed in the months after surgery, and CT scans showed calcified tissue around the pedicle. Surgical revisions were performed. No recurrences were noticed. A full systematic literature review was conducted, including studies published on or before September 2016. RESULTS: Clinically, free flap pedicle ossification is presented as trismus, hard swelling, and severe pain during movements, although the diagnosis is scarce and often fortuitous. From January 2010 to January 2016 we performed 68 FFF reconstructions, and the incidence of FFF pedicle ossification in our experience was 4.4%. CONCLUSION: Ossification of FFF pedicle is uncommon, but when it occurs, it has dramatic clinical consequences. Follow-up CT scan can be useful in diagnosis. In our experience, surgery should be performed only when the patient is symptomatic.

Three-Dimensional Stereophotogrammetric Evaluation of the Efficacy of Autologous Fat Grafting in the Treatment of Parry-Romberg Syndrome.

Autologous fat grafting is a surgical procedure used to correct volumetric defects, atrophies, and sclerosis. Three-dimensional (3D) facial photography may enable researchers to quantify the success of surgical procedures through volumetric and surface assessments. Using 3D photography, the authors assessed the results of autologous fat grafting performed in a 15-year-old patient affected by Parry-Romberg syndrome, a rare condition resulting in progressive hemifacial atrophy of skin, subcutaneous tissues and, ultimately, bone. Stereophotogrammetric acquisitions were performed before and 4 months after the surgical intervention. The obtained results were objectively assessed in terms of facial symmetry through calculation of root mean square deviation point-to-point distance between the treated and healthy side, and volume modifications between pre- and postsurgical 3D facial scans. Four months after surgery, 73% of injected adipose tissue was resorbed, whereas facial symmetry increased up to 63%. The proposed method is not invasive and provides quantitative information about the surgical and esthetic outcomes. Clinicians could better plan surgery, and the patients could be more motivated and compliant to the treatment.