Aesthetic Surgical Pathway in Permanent Facial Filler Removal.

Although permanent fillers have been introduced in order to get long-lasting results, many studies have shown numerous severe and disfiguring complications. Nonsurgical procedures may mitigate those adverse events but the only way to remove the filler previously injected is represented by surgical excision. We present a pathway of facial surgical accesses to be performed achieving two goals: permanent filler removal and restore facial aesthetic balance. The proposed surgical accesses are already standardized in aesthetic surgical practice in order to avoid direct excision and unpleasant facial scar. A total of 231 patients underwent surgery for permanent filler removal and aesthetic restoration of the involved facial area, represented by forehead, glabella, nose, cheeks, eyelids, chin, jawline, and lips. Magnetic resonance evaluation was performed with the exception of lip patients who were evaluated with ultrasound. Postoperative follow-up was 12 months to 6 years. Subjective and objective methods were used for outcome evaluation according to the FACE-Q questionnaire. Functional and aesthetic correction was scored using the patient-graded Global Aesthetic Improvement Scale (GAIS), overall patient satisfaction was assessed by a five-point scale questionnaire. Functional and aesthetic restoration was globally recognized as improved according to the GAIS. Patients reported high levels of satisfaction assessed by a five-point scale questionnaire. A very good satisfaction level was registered in both subjective and objective judgment scores. To the best of our knowledge, we present the largest case series regarding surgical removal of permanent facial fillers. A proper preoperative evaluation, filler removal followed by restorative facial aesthetic surgery technique is paramount to approach challenging cases.

Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records.

The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto's disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto's disease.

Investigation on the Biological Safety and Activity of a Gluconolactone-Based Lotion for Dermocosmetic Application.

(1) Background: Cosmeceuticals are formulas enriched with active ingredients that exert efficacy on different skin molecular targets. (2) Methods: Cell viability and the absence of potential irritant risk were evaluated on keratinocytes (HaCaT), fibroblasts (NHDF), adipocytes (3T3-L1), sebocytes (PCi-SEB_CAU) and reconstructed human epidermis (RHE), respectively. Several treatments were performed to evaluate the ability of the lotion to stimulate the production of collagen and elastin, stimulate the differentiation of keratinocytes and reduce the number of senescent cells following UVB stimulation. In addition, the modulation of genes involved in the production, storage and accumulation of sebum were investigated. (3) Results: The results obtained demonstrated the biosafety of the formula in all cell lines tested. The 24-h treatment with non-cytotoxic concentrations determined an increase in the expression of the collagen (COL1A1), elastin (ELN) and involucrin (IVL) genes, while a reduction of peroxisome proliferator-activated receptor-gamma (PPARγ) gene expression and a reduction of SA-ßgal-positive cells were found. Moreover, the treatment did not interfere with normal steroid 5-alpha reductase (5RDA3) gene expression levels. (4) Conclusions: Data collected demonstrated the biosafety of the lotion, the non-comedogenic property and a multi targets anti-aging effect. In particular, data collected on the booster lotion make it a valid way to counteract the pore dilatation aging related.

Antimicrobial Efficacy Assessment and Rheological Investigation of Two Different Hand Sanitizers Compared with the Standard Reference WHO Formulation 1.

(1) Background: recently, the use of alcohol-based hand sanitizers (ABHSs) has become very frequent, and an evaluation of the stability and effectiveness of their formulations is a critical topic which should be carefully considered. (2) Methods: starting from the characterization of the hand sanitizers object of the study, our interest was focused on their rheological behavior in order to confirm their intrinsic features, but also the stability of each formulation in different conditions of shear and temperature; the second aspect concerns the antimicrobial assessment through a panel of in vitro and in vivo experimental trials. (3) Results: rheological investigation confirmed good stability for the two hand sanitizers in gel formula with respect to the reference in liquid formula; the antimicrobial activity evaluation showed good efficacy of each formulation both in vitro and in vivo. (4) Conclusions: altogether, our overview presents a valid quality control assessment to ensure the stability and efficacy of an alcohol-based hand sanitizer.

HA PEGylated Filler in Association with an Infrared Energy Device for the Treatment of Facial Skin Aging: 150 Day Follow-Up Data Report.

BACKGROUND: The face is the area most exposed to the normal course of skin aging, both intrinsically and extrinsically. The aim of the study was to evaluate the cellular and clinical response of a therapeutic protocol aimed at countering facial skin aging. MATERIALS AND METHODS: Twenty female patients with facial skin laxity and photodamage underwent combined therapy including mesotherapy using non-cross-linked hyaluronic acid with calcium hydroxyapatite and an infrared energy-based device treatment with subsequent implementation of PEG-cross-linked hyaluronic acid soft tissue fillers. To evaluate the benefits, patients underwent histological, immunological, and biomechanical evaluations before the treatment and at 21 and 150 days after the treatment. RESULTS: The histological results at 21 days and 150 days after the procedure showed an increase in the number of fibroblasts and angiogenesis. As for the immunological aspect, it was shown that the treatment has an immunomodulating action, avoiding the activation of CD4 and CD8 cells. Biomechanical data showed that, at 150 days after treatment, the average changes in skin elasticity increased by 72% and the skin hydration increased by 49%. CONCLUSIONS: A combination of an infrared energy-based device treatment with both non-cross-linked hyaluronic acid and novel PEG-cross-linked hyaluronic acid leads to numerous positive cutaneous changes after histological, immunological, and biomechanical evaluations.

Nonsurgical Reshaping of the Lower Jaw With Hyaluronic Acid Fillers: A Retrospective Case Series.

Introduction: Nonsurgical aesthetic treatments of the lower face are increasing in demand. In particular, they aim to restore facial youth following the changes due to progressive resorption of facial skeleton and atrophy of facial fat compartments which give the perception of a descent face. Objectives: The aim of this research is to describe the nonsurgical reshaping of the aged lower jaw by means of hyaluronic acid fillers. Methods: A retrospective analysis of data from adult female patients undergoing treatment with hyaluronic acid injections in the lower third of the face was performed. Injection techniques, relevant anatomy of the anatomical area and rheological properties of the fillers to be used are highlighted. Results: Thirty-six consecutive patients were enrolled (100% female; mean age: 45.7 years). A minimum of 4 up to 7 vials of hyaluronic acid filler was injected to achieve the desired results. The visual analogue scale was used to assess patient satisfaction. Thirty-two patients (88.8%) rated their appearance post-treatment with a satisfaction score ranging between 85% and 100%. A total absence of ecchymosis and/or swelling in the early postoperative days has been highlighted. There were no cases of infection, paresthesia, hematoma or necrosis. Conclusions: For those patients not willing to undergo surgery, the jawline remodelling with hyaluronic acid fillers seems to be a viable option for ameliorating the definition of the lower third of the face. Nonetheless, it is mandatory to perform multilayer injections using fillers with different rheological properties.

Regorafenib beyond the Second Line in Relapsed Glioblastoma: A Case Report and Literature Review.

Glioblastoma multiforme (GBM) is one of the most frequent and aggressive primary tumors in the central nervous system, representing more than 60% of all brain tumors in adults. Primary GBM remains incurable with a poor prognosis both for limited therapeutic alternatives and for a high risk of progression or recurrence. In fact, at recurrence, the few treatment options available, and often characterized by limited effectiveness, have always been an Achilles' heel. The recent approval of second line of regorafenib, a multikinase inhibitor, has given hope after several years of darkness for new therapies in the treatment of GBM. Indeed, in the REGOMA trial, a phase 2 study, regorafenib was the first drug to show a statistically significant improvement in median overall survival compared with lomustine group, usually used in the second-line treatment after temozolomide failure. We report a case of a 43-year-old patient affected by GBM in treatment with regorafenib in third line of therapy with good disease control and long PFS.

An Italian Online Survey Regarding the Use of Hyaluronidase in Previously Hyaluronic Acid-Injected Noses Looking for Surgical Rhinoplasty.

Background: Nonsurgical nasal reshaping (nSNR) with hyaluronic acid (HA) filler is a well-established procedure performed to ameliorate nasal appearance and is considered a valid alternative to surgical rhinoplasty in selected patients. Objectives: The aim of our study is to evaluate the decision-making process and management of patients undergoing rhinoplasty, with previous HA filler injection, and evaluate if consensus could be achieved to recommend guidelines. Methods: Between April and May 2021, an online survey was sent to 402 Italian surgeons of different specialties. The survey collected information regarding the types of treatment of patients who have previously undergone nSNR, who should undergo surgical rhinoplasty. For those surgeons using hyaluronidase, an additional information was collected. Results: In a range of time of 2 months (April and May 2021), a total of 72 surgeons replied and completed the survey: out of the 402 questionnaires sent, the response rate was approximately 18%. The majority of respondents (61.5%) replied to inject hyaluronidase (HYAL) in patients who had to undergo a rhinoplasty but reported previous nSNR. Of the surgeons who use HYAL, 70% performed rhinoplasty after a waiting time of 3 to 4 weeks. Conclusions: Either direct surgical approach or hyaluronidase injection first seems to be a viable options. The use of HYAL before surgery is the choice with the broadest consensus in our survey. However, a larger case-control study with long follow-ups is necessary to understand if in patient seeking surgical rhinoplasty who already received nSNR, the injection of hyaluronidase before surgery is mandatory, recommended, or not.

Rheological Investigation as Tool to Assess Physicochemical Stability of a Hyaluronic Acid Dermal Filler Cross-Linked with Polyethylene Glycol Diglycidyl Ether and Containing Calcium Hydroxyapatite, Glycine and L-Proline.

(1) Background: Dermal fillers are commonly used in aesthetic practice and their rheological characterization is of much interest today, as well as the stability study of the finished formula against external stimuli of a different nature (biological and physicochemical). Rheological tools have been exploited to characterize the physiochemical behaviour of a hyaluronic acid (HA) based dermal filler subjected to different thermal conditions over time. The collected results provide an index of its rheological stability. (2) Methods: After a preliminary Amplitude sweep test, the Frequency sweep test was performed in order to study the stability of a HA dermal filler cross-linked with Polyethylene Glycol Diglycidyl Ether (PEGDE) and containing Calcium Hydroxyapatite (CaHA), Glycine and L-Proline subjected to different conditions. Also, a shear rate ramp test was performed in order to investigate the filler's flow behavior. (3) Results and Conclusions: G' (elastic modulus), G'' (viscous modulus) and consequentially tan δ (tangent of the phase angle) show a similar trend at different thermal conditions, underlining that the product is not affected by the storage conditions. The viscosity of the dermal filler decreases with an increasing shear rate, so a non-Newtonian shear thinning pseudoplastic behavior was demonstrated in all tested conditions.

Sorafenib in Metastatic Papillary Thyroid Carcinoma with BRAF K601E Mutation on Liquid Biopsy: A Case Report and Literature Review.

Differentiated thyroid cancer (DTC) includes papillary and follicular carcinomas and is the most common type of thyroid cancer. The incidence of this cancer has increased in the last few years, and even if its prognosis is generally good for a subset of patients that does not respond to radioactive iodine (RAI) therapy, the prognosis is much worse: the median overall survival (OS) from discovery of metastasis is 3-5 years and the 10-year survival rate is only 10%. Several mutations, including RAS or RET, as well as BRAF signaling, are associated with thyroid cancer. Liquid biopsy may be useful in selected patient to identify genomic alterations and thus allowing for a precision medicine approach with target therapy. Sorafenib, an oral multi-kinase inhibitor, can be used in the treatment of DTC. Case presentation: A 77 years old. man with diagnosis of metastatic DTC and evidence of presence of mutation of BRAF K601E on liquid biopsy was treated with sorafenib, showing a good response to the treatment and an improvement in the quality of life (QoL). Currently, this patient is still on treatment with sorafenib, gaining control of a multi-metastatic disease, generally characterized by a very poor prognosis. In conclusion, sorafenib has an active role in the treatment of DTC. It also has been considered the standard of care for patients with advanced unresectable hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC). In our case we observe the efficacy of using sorafenib in Papillary thyroid carcinoma (PTC) such as confirming both stable disease (SD) in the CT scan as clinical benefit with an increase in QoL. Therefore, use of sorafenib remains an important treatment option, even in case of BRAF mutation, despite a rapidly evolving treatment landscape. It also seems important to perform liquid biopsies, especially in patients in whom it is not possible to repeat a new tissue biopsy. Ongoing clinical trials continue to evaluate sorafenib in different settings, and in combination with other therapies in DTC and HCC.

Kabat Rehabilitation in Facial Nerve Palsy after Parotid Gland Tumor Surgery: A Case-Control Study.

Temporary facial nerve palsy after parotid tumor surgery ranges from 14 to 65%, depending on surgery, tumor type, and subsite. The study aimed to evaluate the role of Kabat physical rehabilitation in the outcomes of patients affected by severe facial nerve palsy following parotid gland surgery. The results and clinical data of two groups, Kabat and non-Kabat (control), were statistically compared. Descriptive statistics, the multiple linear regression model, difference in difference approach, and the generalized linear model were used. F-Test, Chi-square test, McFadden R-squared, and adjusted R-squared were used to assess the significance. The results showed that the House-Brackmann (HB) stage of patients who had physiotherapy performed were lower than the control group. The decrease of HB staging in the Kabat group at 3 months was -0.71 on average, thus the probability of having a high HB stage decreased by about 13% using Kabat therapy. The results are statistically significant, and indicated that when the Kabat rehabilitation protocol is performed, mainly in the cases of a high-grade HB score, the patients showed a better and faster improvement in postoperative facial nerve palsy.

Condylar Fractures: Multistep Surgical Planning by Mini-Invasive Approach, Patient Series.

PURPOSE: Surgical treatment for condylar fractures is a challenging procedure most debated in scientific literature without a broad consensus on the selection of surgical techniques to be used and relative indications.The goal of this work is to propose a multistep surgical planning for condylar fractures based on an effective mini-invasive approach and safe procedure aimed to avoid as much as possible skin incision in the aesthetic areas of the face and neck, to decrease the risk of facial nerve injury. METHODS: Ten patients with dislocated condylar neck fractures and sub-condylar fractures were included in this study.All the patients were studied with radiological images, computed tomography scans with three-dimensional reconstructions preoperatively and immediate postoperatively.Patients were evaluated pre- and post-operatively for dental occlusion, bone fragment alignment after reduction and after fixation, facial nerve functionality, skin scarring, temporomandibular joint functionality, temporomandibular joint symptomatology, and patient satisfaction. RESULTS: Results were satisfactory for different parameters evaluated. No significant complications resulted in follow-up, particularly for facial nerve injury. By using this multistep procedure with each stage functional to the following one, the authors achieved satisfactory results following treatment of dislocated condylar fractures.

Biophysical and Biological Tools to Better Characterize the Stability, Safety and Efficacy of a Cosmeceutical for Acne-Prone Skin.

(1) Background: Acne is a widespread skin disease, especially among adolescents. Following the COVID-19 pandemic and the use of masks, the problem has been affecting a greater number of people, and the attention of the skin care beauty routine cosmetics has been focused on the "Maskne", caused by the sebum excretion rate (SER) that stimulates microbial proliferation. (2) Methods: the present study was focused on the rheological characterization and quality assurance of the preservative system of an anti-acne serum. The biological effectiveness (cytotoxicity-skin and eye irritation-antimicrobial, biofilm eradication and anti-inflammatory activity) was evaluated in a monolayer cell line of keratinocytes (HaCaT) and on 3D models (reconstructed human epidermis, RHE and human reconstructed corneal epithelium, HCE). The Cutibacterium acnes, as the most relevant acne-inducing bacterium, is chosen as a pro-inflammatory stimulus and to evaluate the antimicrobial activity of the serum. (3) Results and Conclusions: Rheology allows to simulate serum behavior at rest, extrusion and application, so the serum could be defined as having a solid-like behavior and being pseudoplastic. The preservative system is in compliance with the criteria of the reference standard. Biological effectiveness evaluation shows non-cytotoxic and irritant behavior with a good antimicrobial and anti-inflammatory activity of the formulation, supporting the effectiveness of the serum for acne-prone skin treatment.

Assessment of sleep disturbance in oral lichen planus and validation of PSQI: A case-control multicenter study from the SIPMO (Italian Society of Oral Pathology and Medicine).

BACKGROUND: The wellbeing of oral lichen planus patients (OLPs) may be strongly influenced by a poor quality of sleep (QoS) and psychological impairment. The aims were to analyze the prevalence of sleep disturbance, anxiety, and depression in OLPs and to validate the Pittsburgh Sleep Quality Index (PSQI) in OLPs. METHODS: Three hundred keratotic OLPs (K-OLPs), 300 with predominant non-keratotic OLP (nK-OLPs), and 300 controls were recruited in 15 Italian universities. The PSQI, Epworth Sleepiness Scale (ESS), Hamilton Rating Scales for Depression and Anxiety (HAM-D and HAM-A), Numeric Rating Scale (NRS), and Total Pain Rating Index (T-PRI) were administered. RESULTS: Oral lichen planus patients had statistically higher scores than the controls in the majority of the PSQI sub-items (p-values < 0.001**). Moreover, OLPs had higher scores in the HAM-D, HAM-A, NRS, and T-PRI (p-values < 0.001**). No differences in the PSQI sub-items' scores were found between the K-OLPs and nK-OLPs, although nK-OLPs suffered from higher levels of anxiety, depression, and pain (p-values: HAM-A, 0.007**, HAM-D, 0.009**, NRS, <0.001**, T-PRI, <0.001**). The female gender, anxiety, depression (p-value: 0.007**, 0.001**, 0.020*) and the intensity of pain, anxiety, and depression (p-value: 0.006**, <0.001**, 0.014*) were independent predictors of poor sleep (PSQI > 5) in K-OLPs and nK-OLPs, respectively. The PSQI's validation demonstrated good internal consistency and reliability of both the total and subscale of the PSQI. CONCLUSIONS: The OLPs reported an overall impaired QoS, which seemed to be an independent parameter according to the regression analysis. Hence, clinicians should assess QoS in OLPs and treat sleep disturbances in order to improve OLPs management.

Botulinum toxin type A injections for masticatory muscles hypertrophy: A systematic review.

The aim of this study is to compare the efficacy of single-point injection of botulinum toxin A versus multi-point operative protocols found in the literature in reducing hypertrophy in patients with masticatory muscle hypertrophy. A systematic review was performed in accordance with the Park et al., 2018 guidelines, selecting articles from PubMed, Google Scholar, Web of Science and Ovid databases up to July 8, 2020.28 studies met the eligibility criteria. 748 patients were treated for masseter hypertrophy (MH) and 4 patients for temporal muscle hypertrophy. As for MH: in 45.2% of cases 3 injection sites (IS) were used, in 18.8% 1 IS, in 16.2% 2 IS, in 13% 5 IS, in 4.1% 6 IS, 2.7% 4 IS. At three months, the mean reduction in masseter muscle thickness is 26-31% when 1 IS was used, 28% in 2 IS, 12-27% in 3 IS and 22-30% in 6 IS. Heterogeneity of results, high bias level and selective reports led to a difficult efficacy comparison of the injection techniques described. Data suggest that the lowest number of IS possible should be used until stronger evidences are presented. Homogeneity in pre- and post-operative protocols is needed to establish a reliable setting for the condition under study.

Surgical Lip Remodeling Following Permanent Filler Injection: A Scoping Review.

ABSTRACT: Over the years, several techniques have been introduced to obtain permanent lip enhancement, such as the use of silicone lip implants or the off-label use of permanent fillers. Although some reports indicate that permanent lip filler is safe, many others describe early- and late-onset complications. The main issue with permanent lip fillers is the lack of a standard technique to correct undesirable results. The aim of this scoping review was to list and evaluate the surgical pathways described in literature to correct lip deformity resulted from the injection of permanent fillers. The methods and the inclusion criteria of this work were specified in advance and documented in a protocol, according to the PRISMA 2009 checklist. The research was carried out on electronic databases PubMed, Cochrane Library, and Scopus databases identifying articles from March 1991 to December 2020 and conducted up to December 23rd, 2020. Articles language was limited to English. The selection process identified 3 retrospective studies eligible for inclusion. 73 patients and a total of 111 lips (72 upper and 39 lower) were considered. Two early complications were identified, 1 suture dehiscence and 1 total lip mucosa necrosis. Surgical lip remodeling following permanent filler injection seems to be an effective approach although the surgical pathway needs to be customized per each patient. Complication rate seems to be coherent to lip surgery performed with reconstructive purposes. To confirm these data case-control studies with much wider cohorts are needed to reach statistical significance.

A Practical Approach for the In Vitro Safety and Efficacy Assessment of an Anti-Ageing Cosmetic Cream Enriched with Functional Compounds.

(1) Background: Cosmeceuticals are topical products applied to human skin to prevent skin ageing and maintain a healthy skin appearance. Their effectiveness is closely linked to the compounds present in a final formulation. In this article, we propose a panel of in vitro tests to support the efficacy assessment of an anti-ageing cream enriched with functional compounds. (2) Methods: biocompatibility and the irritant effect were evaluated on reconstructed human epidermis (RHE) and corneal epithelium (HCE) 3D models. After a preliminary MTT assay, normal human dermal fibroblasts (NHDF) and keratinocytes (HaCaT) were used to evaluate the extracellular matrix (ECM) protein synthesis, and interleukin-6 (IL-6) and metalloproteinase-1 (MMP-1) production. (3) Results: data collected showed good biocompatibility and demonstrated the absence of the irritant effect in both 3D models. Therefore, we demonstrated a statistical increase in collagen and elastin productions in NHDF cells. In HaCaT cells, we highlighted an anti-inflammatory effect through a reduction in IL-6 levels in inflammatory stimulated conditions. Moreover, the reduction of MMP-1 production after UV-B radiation was demonstrated, showing significant photo-protection. (4) Conclusion: a multiple in vitro assays approach is proposed for the valid and practical assessment of the anti-ageing protection, anti-inflammatory and biocompatible claims that can be assigned to a cosmetic product containing functional compounds.

In Vitro Hair Growth Promoting Effect of a Noncrosslinked Hyaluronic Acid in Human Dermal Papilla Cells.

Dermal papilla cells (DPCs) are a source of nutrients and growth factors, which support the proliferation and growth of keratinocytes as well as promoting the induction of new hair follicles and maintenance of hair growth. The protection from reactive oxygen species (ROS) and the promotion of angiogenesis are considered two of the basal mechanisms to preserve the growth of the hair follicle. In this study, a noncrosslinked hyaluronic acid (HA) filler (HYDRO DELUXE BIO, Matex Lab S.p.A.) containing several amino acids was tested with in vitro assays on human follicle dermal papilla cells (HFDPCs). The experiments were carried out to investigate the possible protection against oxidative stress and the ability to increase the vascular endothelial growth factor (VEGF) release. The results demonstrated the restoration of cell viability against UVB-induced cytotoxicity and an increase in the VEGF secretion. These data demonstrate the capability of the product to modulate human dermal papilla cells, suggesting a future use in mesotherapy, a minimally invasive local intradermal therapy (LIT), after further clinical investigations.

Health-Related Quality of Life in Oral Cancer Patients: Scoping Review and Critical Appraisal of Investigated Determinants.

BACKGROUND: health-related quality of life (HRQOL) represents a secondary endpoint of medical interventions in oncological patients. Our aim was to highlight potential sources of bias that could be encountered when evaluating HRQOL in oral cancer patients. METHODS: this review followed PRISMA-ScR recommendations. PARTICIPANTS: patients treated for oral cancer. CONCEPT: HRQOL assessed by EORTC QLQ-C30 and QLQ-H&N35/QLQ-H&N43. A critical appraisal of included studies was performed to evaluate the accuracy of data stratification with respect to HRQOL determinants. RESULTS: overall, 30 studies met the inclusion criteria, totaling 1833 patients. In total, 8 sociodemographic (SDG) and 15 disease/treatment-specific (DT) HRQOL determinants (independent variables) were identified. The mean number of the independent variables was 6.1 (SD, 4.3)-5.0 (SD, 4.0) DT-related and 1.1 (SD, 1.8) SDG-related variables per article. None of the included papers considered all the identified determinants simultaneously. CONCLUSIONS: a substantial lack of evidence regarding HRQOL determinants was demonstrated. This strongly weakens the reliability of the reported findings due to the challenging presence of baseline confounding, selection, and omitted variable biases. The proposed approach recommends the use of further evaluation tools that gather more variables in a single score together with a selection of more homogeneous, reproducible, and comparable cohorts based on the identified baseline confounding.