Tool For Assessment Of Patients Research Articles

VM-PATHI Correlates With Cognitive Function Improvement After Successful Treatment in Patients With Vestibular Migraine.

To assess changes in cognitive function in vestibular migraine patients undergoing treatment. Prospective cohort. Single-institution tertiary-care center. Thirty-four patients with vestibular migraine were included in the study. Average age at diagnosis was 47.9 years. A majority of patients (91.2%) were female. Vestibular therapies included pharmacologic treatment (67.6%), mindfulness-based stress reduction (58.8%), vestibular physical therapy (20.6%), and lifestyle changes only (2.9%). Pretreatment and posttreatment questionnaires were collected including the Cognitive Failures Questionnaire (CFQ), Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI), and Dizziness Handicap Inventory. Median time between pretreatment and posttreatment questionnaire was 4.4 months (range, 2.8-15.6. mo). CFQ scores decreased in subjects who responded to treatment, as defined by those with a positive change in VM-PATHI score (average decrease, 6.5; p = 0.03). CFQ scores did not improve in subjects who had no improvement in their vestibular condition, as defined by no change or an increase in VM-PATHI score (average increase, 2.0; p = 0.53). Univariate linear regression showed that VM-PATHI score change was highly predictive of CFQ change (p < 0.01, r2 = 0.36). Multivariate regression demonstrated that the VM-PATHI (p = 0.03) and not the Dizziness Handicap Inventory (p = 0.10) predicted changes in CFQ score. Self-reported cognitive dysfunction improves with successful treatment of vestibular migraine.

Efficiency of whole-body positron emission tomography/computed tomography using 18F-Fluorodeoxyglucose in detecting the cause of elevated cancer antigen 125 serum level in treated ovarian cancer patients

BackgroundOvarian cancer is one of the leading causes of death in females worldwide. Early diagnosis and accurate staging are mandatory for proper management. Anatomic imaging and serum cancer antigen 125 (CA 125) measurement have been widely used for follow up of treated ovarian cancer patients to detect residual or recurrent neoplasia. The aim of this study was to assess the value of whole-body positron emission tomography/computed tomography using 18F-Fluorodeoxyglucose (18F-FDG PET/CT) in follow up of ovarian cancer patients presented with elevated CA 125 serum level.ResultsThe current study was performed over a period of 2 years between March 2019 and March 2022. Seventy-six patients were included with history of treated ovarian cancer (underwent either surgical resection and/or received radio/chemotherapy) but were subsequently presented rising tumor marker CA-125 serum level (more than 35 U/ml). All patients underwent a 18F-FDG PET/CT scanning on whole body. The FDG-PET results were correlated with histological findings, radiological or tumor marker/clinical follow-up. The patients with inconsistent findings were followed up with U/S, post contrast pelviabdominal CT, MRI or PET/CT 3–6 months later. The 18FDG PET/CT scan was positive in 62 patients, and it was negative in 14 patients. Specificity, sensitivity, negative predictive value, as well as positive predictive value and diagnostic accuracy of integrated PET/CT, were found to be 92.3%, 96.3%, 96.1%, 85.7% and 98.4%, respectively.Conclusions18F-FDG PET/CT is a valuable imaging tool for assessment of ovarian cancer patients presented with elevated CA-125 tumor marker serum level.

Translating and adapting the Alcohol Use Disorders Identification Test (AUDIT) for use in the Russian Federation: A multicentre pilot study to inform validation procedures

Aims: The Alcohol Use Disorders Identification Test (AUDIT) is one of the most widely used screening instruments worldwide. Although it was translated into many languages, not many country-specific adaptations exist, and a formal validation procedure of the Russian version has been carried out only recently. The present contribution documents the different steps taken to formally translate and adapt a Russian-specific version of the AUDIT (RUS-AUDIT). Methods: The AUDIT was translated into Russian following an established protocol, revised and adapted to the country context using an expert panel, and field-tested in an iterative approach, in line with WHO rules on instrument translation and adaptation A total of three pilot phases were carried out on 134 patients from primary healthcare (PHC) and 33 patients from specialised alcohol treatment facilities (narcology), guided by a specially established advisory board. Changes in each version were informed by the findings of the previous pilot phase and a thorough panel discussion. Results: Based on the findings of three different pilot phases, the RUS-AUDIT was developed as a paper-and-pencil interview for PHC professionals. Since various issues with representation and counting of standard drinks for the second test item arose, a special show card was developed to support the assessment. Preliminary AUDIT-C scores indicated that more than one-third of the screened women (34.2%) and about half of the screened men (50.9%) from PHC facilities have exceeded risk thresholds. Conclusions: The RUS-AUDIT was constructed as a feasible assessment tool for interviewers and patients. The large number of PHC patients who exceed the risk threshold has corroborated the need for formal validation and Russia-specific cut-off scores, considering the specific drinking patterns.

Neuropsychological Assessment in Patients with Traumatic Brain Injury: A Comprehensive Review with Clinical Recommendations.

Traumatic brain injury is damage to the brain occurring after birth, often resulting in the deterioration of cognitive, behavioural, and emotional functions. Neuropsychological evaluation can assist clinicians to better assess the patient's clinical condition, reach differential diagnoses, and develop interventional strategies. However, considering the multiple rating scales available, it is not easy to establish which tool is most suitable for the different brain injury conditions. The aim of this review is to investigate and describe the most used neurocognitive assessment tools in patients with traumatic brain injury to provide clinicians with clear indications on their use in clinical practice. Indeed, during the acute phase, after the head trauma, alertness and wakefulness of the patients affected by a disorder of consciousness can be assessed using different scales, such as the Coma Recovery Scale-Revised. In both postacute and chronic phases after traumatic brain injury, general cognitive assessment tools (such as the Mini Mental State Examination) or more specific cognitive tests (e.g., Wisconsin Card Sorting Test and Trail Making Test) could be administered according to the patient's functional status. In this way, clinicians may be aware of the patient's neuropsychological and cognitive level, so they can guarantee a personalized and tailored rehabilitation approach in this frail patient population.

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Dietary factors and hypertension risk in West Africa: a systematic review and meta-analysis of observational studies.

Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa. Although diet is implicated as a contributor to this trend, nutritional guidelines in West Africa are not tailored to address this concern. This study aimed to address this limitation by investigating dietary factors common to West Africa and evaluating their association with hypertension. PubMed, Scopus, Web of Science, and Medline were searched to identify studies that investigated diet and hypertension in West African adults. All meta-analyses used a generic inverse-variance random effects model, with subgroup analyses by age, BMI, and study location, and were performed in R. Three thousand, two hundred ninety-eight studies were identified, of which 31 ( n = 48 809 participants) satisfied inclusion criteria - all cross-sectional. Meta-analyses of the association between dietary factors and hypertension included dietary fat [odds ratio (OR) = 1.76; 95% confidence interval (95% CI) 1.44-2.14; P < 0.0001], red meat (OR = 1.51; 95% CI: 1.04-2.18; P = 0.03), junk-food (OR = 1.41; 95% CI: 1.19-1.67; P < 0.0001), dietary salt (OR = 1.25; 95% CI: 1.12-1.40; P < 0.0001), alcohol (OR = 1.17; 95% CI: 1.03-1.32; P = 0.013), and 'fruits and vegetables' (OR = 0.80; 95% CI: 0.24-1.17; P < 0.0001). Subgroup analyses suggested that 'fruit and vegetable' consumption is less protective in the elderly. High consumption of dietary salt, red meat, dietary fat, junk food, and alcohol are associated with increased odds of hypertension, whereas high fruit and vegetable appear protective. This region-specific evidence will support the development of nutritional assessment tools for clinicians, patients, and researchers aiming to reduce hypertension in West Africa.

Joint awareness following periacetabular osteotomy in patients with hip dysplasia.

The aims of this study were to validate the Forgotten Joint Score-12 (FJS-12) in the postoperative evaluation of periacetabular osteotomy (PAO), identify factors associated with joint awareness after PAO, and determine the FJS-12 threshold for patient-acceptable symptom state (PASS). Data from 686 patients (882 hips) with hip dysplasia who underwent transposition osteotomy of the acetabulum, a type of PAO, between 1998 and 2019 were reviewed. After screening the study included 442 patients (582 hips; response rate, 78%). Patients who completed a study questionnaire consisting of the visual analogue scale (VAS) for pain and satisfaction, FJS-12, and Hip disability and Osteoarthritis Outcome Score (HOOS) were included. The ceiling effects, internal consistency, convergent validity, and PASS thresholds of FJS-12 were investigated. The median follow-up was 12 years (interquartile range 7 to 16). The ceiling effect of FJS-12 was 7.2%, the lowest of all the measures examined. FJS-12 correlated with all HOOS subscales (ρ = 0.72 to 0.77, p < 0.001) and pain and satisfaction-VAS (ρ = -0.63 and 0.56, p < 0.001), suggesting good convergent validity. Cronbach's α was 0.95 for the FJS-12, which indicated excellent internal consistency. The median FJS-12 score for preoperative Tönnis grade 0 hips (60 points) was higher than that for grade 1 (51 points) or 2 (46 points). When PASS was defined as pain-VAS < 21 and satisfaction-VAS ≥ 77, the FJS-12 threshold that maximized the sensitivity and specificity for detecting PASS was 50 points (area under the curve (AUC) = 0.85). Our results suggest that FJS-12 is a valid and reliable assessment tool for patients undergoing PAO, and the threshold of 50 points may be useful to determine patient satisfaction following PAO in clinical settings. Further investigation of the factors influencing postoperative joint awareness may enable improved prediction of treatment efficacy and informed decision-making regarding the indication of PAO.

Minimum Clinically Important Difference for Nonsurgical Interventions for Spinal Diseases: Choosing the Appropriate Values for an Integrative Medical Approach

The minimal clinically important difference (MCID) plays a crucial role in the design and interpretation of clinical trials, as it helps in distinguishing between statistically significant and clinically meaningful outcomes. This scoping review aims to collate and appraise the current research concerning the validation of MCIDs for surgical and nonsurgical measures for spine disorders. Two databases of MEDLINE (PubMed and EMBASE) were searched. There were 1,590 studies retrieved and 79 were selected as eligible for review. Measurement tools such as the Oswestry Disability Index, Neck Disability Index, Numeric Rating Scale, and Visual Analogue Scale were assessed by regions and interventions. A total of 24 studies identified MCIDs on nonsurgical interventions, and 55 studies identified MCIDs on surgical interventions. The range of MCIDs varied greatly depending on study population, specific interventions, calculation methods, and outcomes. This scoping review emphasizes the complexity and variability in determining MCIDs for musculoskeletal or neurodegenerative spinal diseases, influenced by several factors including the intervention type, measurement tool, patient characteristics, and disease severity. Given the wide range of reported MCIDs, it is crucial to consider the specific context when interpreting these values in clinical and research settings. To select an appropriate MCID value for comparison in a clinical trial, careful consideration of the patient group, intervention, assessment tools, and primary outcomes is necessary to ensure that the chosen MCID aligns with the research question at hand.

Comprehensively analysis of immunophenotyping signature in triple-negative breast cancer patients based on machine learning.

Immunotherapy is a promising strategy for triple-negative breast cancer (TNBC) patients, however, the overall survival (OS) of 5-years is still not satisfactory. Hence, developing more valuable prognostic signature is urgently needed for clinical practice. This study established and verified an effective risk model based on machine learning methods through a series of publicly available datasets. Furthermore, the correlation between risk signature and chemotherapy drug sensitivity were also performed. The findings showed that comprehensive immune typing is highly effective and accurate in assessing prognosis of TNBC patients. Analysis showed that IL18R1, BTN3A1, CD160, CD226, IL12B, GNLY and PDCD1LG2 are key genes that may affect immune typing of TNBC patients. The risk signature plays a robust ability in prognosis prediction compared with other clinicopathological features in TNBC patients. In addition, the effect of our constructed risk model on immunotherapy response was superior to TIDE results. Finally, high-risk groups were more sensitive to MR-1220, GSK2110183 and temsirolimus, indicating that risk characteristics could predict drug sensitivity in TNBC patients to a certain extent. This study proposes an immunophenotype-based risk assessment model that provides a more accurate prognostic assessment tool for patients with TNBC and also predicts new potential compounds by performing machine learning algorithms.

Review of self-efficacy assessment scales for geriatric patients with urinary incontinence.

Urinary incontinence is a common condition in the elderly, which can be improved with rehabilitation. However, compliance with the rehabilitation regimen is influenced by the level of self-efficacy. Self-efficacy of elderly patients in dealing with urinary incontinence can be clinically assessed and understood by using a suitable scale, to implement specific improvement measures. At present, the tools used for assessing the self-efficacy of elderly patients with urinary incontinence include the General Self-Efficacy Scale (GSES), the Pelvic Floor Muscle Self-efficacy Scale, the Geriatric Self-efficacy Index for Urinary Incontinence, and the Yoga Self-Efficacy Scale. Most of these tools are suitable for female patients with urinary incontinence, but lack relevance to the disease characteristics of geriatric patients. In this study, we reviewed the self-efficacy assessment tools for geriatric patients with urinary incontinence, to provide a reference for related research. It is important to accurately assess the self-efficacy of patients with geriatric UI to effectively enhance their level of self-efficacy, so that patients with geriatric UI can avail early help and quickly reintegrate with family and society.

Reliability and validity of the Forgotten Joint Score-12 for total ankle replacement and ankle arthrodesis.

This study evaluated the reliability and validity of the Forgotten Joint Score-12 (FJS-12)-a measure of patients' ability to forget their joints in daily life-in patients who underwent total ankle replacement (TAR) or ankle arthrodesis (AA). Patients who underwent TAR or AA were recruited from seven hospitals. The patients completed the Japanese version of FJS-12 twice, at an interval of two weeks, at a minimum of one year postoperatively. Additionally, they answered the Self-Administered Foot Evaluation Questionnaire and EuroQoL 5-Dimension 5-Level as comparators. The construct validity, internal consistency, test-retest reliability, measurement error, and floor and ceiling effects were evaluated. A total of 115 patients (median age, 72 years), comprising 50 and 65 patients in the TAR and AA groups respectively, were evaluated. The mean FJS-12 scores were 65 and 58 for the TAR and AA groups, respectively, with no significant difference between groups (P = 0.20). Correlations between the FJS-12 and Self-Administered Foot Evaluation Questionnaire subscale scores were good to moderate. The correlation coefficient ranged from 0.39 to 0.71 and 0.55 to 0.79 in the TAR and AA groups, respectively. The correlation between the FJS-12 and EuroQoL 5-Dimension 5-Level scores was poor in both groups. The internal consistency was adequate, with Cronbach's α greater than 0.9 in both groups. The intraclass correlation coefficients of test-retest reliability was 0.77 and 0.98 in the TAR and AA groups, respectively. The 95% minimal detectable change values were 18.0 and 7.2 points in the TAR and AA groups, respectively. No floor or ceiling effect was observed in either group. The Japanese version of FJS-12 is a valid and reliable questionnaire for measuring joint awareness in patients with TAR or AA. The FJS-12 can be a useful tool for the postoperative assessment of patients with end-stage ankle arthritis.

The acromegaly treatment satisfaction questionnaire (Acro-TSQ): turkish adaptation, validity, and reliability study.

The patient-reported outcome becomes important to evaluate the situation perceived by the patients and to develop new strategies. This study aims to adapt the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ), which was specially developed for patients with acromegaly, into Turkish by conducting a validity and reliability study. After the translation and back-translation process, Acro-TSQ was filled in by face-to-face interviews with 136 patients diagnosed with acromegaly and currently receiving somatostatin analogue injection therapy. Internal consistency, content validity, construct validity, and reliability of the scale were determined. Acro-TSQ had a six-factor structure and explained 77.2% of the total variance in the variable. The Cronbach alpha value calculated for internal reliability showed high internal consistency (Cronbach's alpha = 0.870). Factor loads of all items were found to be between 0.567 and 0.958. As a result of EFA analysis, one item fell into a different factor in the Turkish version of the Acro-TSQ, different from its original form. CFA analysis shows that acceptable fit values are obtained for fit indices. The Acro-TSQ, a patient-reported outcome tool, shows good internal consistency, and good reliability, suggesting it is an appropriate assessment tool for patients with acromegaly in the Turkish population.

Implementation of a novel nursing assessment tool in geriatric trauma patients with proximal femur fractures.

Geriatric trauma patients represent a special challenge in postoperative care and are prone to specific complications. The goal of this study was to analyse the predictive potential of a novel nursing assessment tool, the outcome-oriented nursing assessment for acute care (ePA-AC), in geriatric trauma patients with proximal femur fractures (PFF). A retrospective cohort study of geriatric trauma patients aged ≥ 70 years with PFF was conducted at a level 1 trauma centre. The ePA-AC is a routinely used tool that evaluates pneumonia; confusion, delirium and dementia (CDD); decubitus (Braden Score); the risk of falls; the Fried Frailty index (FFI); and nutrition. Assessment of the novel tool included analysis of its ability to predict complications including delirium, pneumonia and decubitus. The novel ePA-AC tool was investigated in 71 geriatric trauma patients. In total, 49 patients (67.7%) developed at least one complication. The most common complication was delirium (n = 22, 44.9%). The group with complications (Group C) had a significantly higher FFI compared with the group without complications (Group NC) (1.7 ± 0.5 vs 1.2 ± 0.4, p = 0.002). Group C had a significantly higher risk score for malnutrition compared with Group NC (6.3 ± 3.4 vs 3.9 ± 2.8, p = 0.004). A higher FFI score increased the risk of developing complications (odds ratio [OR] 9.8, 95% confidence interval [CI] 2.0 to 47.7, p = 0.005). A higher CDD score increased the risk of developing delirium (OR 9.3, 95% CI 2.9 to 29.4, p < 0.001). The FFI, CDD, and nutritional assessment tools are associated with the development of complications in geriatric trauma patients with PFF. These tools can support the identification of geriatric patients at risk and might guide individualised treatment strategies and preventive measures.

Development of cervical cancer patient reported clinical outcome assessment scale (CC-PRO137): A dedicated tool for multidimensional evaluation of treatment outcomes.

5537 Background: Worldwide, cervical cancer ranks fourth among female malignant tumors in terms of both incidence and mortality. In addition, there is an increasing trend of cervical cancer incidence among younger women. Since the uterus is located at the center of vascular-neural traffic of the pelvic floor, cervical cancer surgery may damage the function of multiple systems such as urinary, digestive, neurological, endocrine, and pelvic floor muscles, and further lead to short- and long-term effects in the psychological domain including sexual status, anxiety, and depression. Therefore, we developed the current scale, Cervical Cancer Patient Reported Clinical Outcome Assessment Scale (CC-PRO137), aimed to construct a functional patient self-report system scale to conveniently and accurately quantify the quality of life of cervical cancer patients from multiple dimensions. Methods: Items included in the scale were proposed by gynecologic oncologist, and were evaluated and modified by experts in various specialties. This scale (CC-PRO137) includes 3 domains and 13 modules, including physiological systems, psychological related symptoms, social life status. A total of 304 participants were tested within 6 and 12 months postoperatively. Subgroup analyses were carried out for different time period, stages, surgical methods and adjuvant treatment plans. Results: The reliability analysis showed that the Cronbach's α in each module of the physiological domain was between 0.602-0.929, the composite reliability was between 0.226-0.946, and the test-retest reliability was between 0.660-0.829; the Cronbach’s α of the psychological domain were between 0.700-0.940, the composite reliability was between 0.584-0.950, and the test-retest reliability was between 0.697-0.807; the Cronbach’s α of the social domain was between 0.836-0.861, the composite reliability was between 0.777-0.886, the test-retest reliability was between 0.732-0.792, and the reliability of each module was optimal. The content validity adopted the expert judgment. Convergent validity (CV) analysis showed that the average variance extraction of each module in the physiological domain was between 0.382-0.706, in the psychological domain was between 0.433-0.801, and in the social domain was 0.440-0.616. The convergent validity of each module was acceptable. Conclusions: Our results showed the effectiveness of CC-PRO137 as a comprehensive assessment tool for cervical cancer patients' quality of life, suggesting that the scale can accurately measure subtle changes postoperatively. CC-PRO137 can be a useful tool to quantitatively assess cervical cancer patients.

Clinical utility of geriatric assessment tools in older patients with gastrointestinal cancer.

Geriatric 8 (G8) and instrumental activities of daily living (IADL) are recommended to predict overall survival (OS) or risk of serious adverse events (SAEs) in older cancer patients. However, the clinical utility is relatively unknown in older patients suffering malnutrition with gastrointestinal (GI) cancer, including gastric cancer (GC) and pancreatic cancer (PC). We retrospectively included patients aged ≥65 years with GC, PC, and colorectal cancer (CRC) who received a G8 questionnaire at first visit from April 2018 to March 2020. The associations between G8/IADL and safety or OS were assessed in patients with advanced/unresectable tumors. Of 207 patients (median age: 75 years), the median G8 score was 10.5 and normal G8 score rate was 6.8%. Both the median G8 score and normal G8 (>14) score rate numerically increased in the order of GC < PC < CRC. There was no clear association between the G8 standard cutoff value of 14 and SAEs or OS. However, OS was significantly longer in patients with G8 >11 than in those with G8 ≤11 (19.3 vs. 10.5 months, p = 0.0017). Furthermore, OS was significantly better in patients with normal IADL than in those with abnormal IADL (17.6 vs. 11.4 months, p = 0.049). The G8 cutoff value of 14 would not be clinically useful in patients with GI cancer for predicting OS or SAEs; however, the cutoff value of 11 and IADL may be useful to predict OS for older patients with GI cancers including GC and PC.

Psychometric Properties of Assessment Tools for Depression, Anxiety, Distress, and Psychological Problems in Breast Cancer Patients: A Systematic Review.

Various and accurate psychiatric assessments in patients with breast cancer who frequently suffer from psychological problems due to long-term survivors are warranted. This systematic review aimed to investigate the current evidence on psychometric properties of psychiatric assessment for evaluating psychological problems in breast cancer patients. This systematic review progressed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Four electronic databases such as Web of Science, PubMed, Embase, and Cumulative Index to Nursing and Allied Health Literature were searched. This study protocol was registered on Open Science Framework. Of the 2,040 articles, 21 papers were finally included. Among them, only five studies showed the performance of psychiatric assessment tools. Among 13 assessment tools used in the selected articles, the Hospital Anxiety and Depression Scale (HADS), Distress Thermometer (DT), or Mini-Mental Adjustment to Cancer Scale was frequently used for the evaluation of psychological problems. The DT and Psychosocial Distress Questionnaire-Breast Cancer showed acceptable performances for the prediction of depression and anxiety assessed by the HADS. This systematic review found psychiatric assessment tools with acceptable reliability and validity for breast cancer patients. However, comparative studies on reliability and validity of various scales are required to provide useful information for the selection of appropriate assessment tools based on the clinical settings and treatment stages of breast cancer. Joint research among the fields of psychiatry and breast surgery is needed for research to establish the convergent, concurrent, and predictive validity of psychiatric assessment tools in breast cancer patients.

Elevated sHLA-G plasma levels post chemotherapy combined with ILT-2 rs10416697C allele status of the sHLA-G-related receptor predict poorest disease outcome in early triple-negative breast cancer patients.

Triple negative breast cancer (TNBC) shows an aggressive growing and spreading behavior and has limited treatment options, often leading to inferior disease outcome. Therefore, surrogate markers are urgently needed to identify patients at high risk of recurrence and more importantly, to identify additional therapeutic targets enabling further treatment options. Based on the key role of the non-classical human leukocyte antigen G (HLA-G) and its related receptor immunoglobulin-like transcript receptor-2 (ILT-2) in immune evasion mechanisms of tumors, members of this ligand-receptor axis appear to be promising tool for both, defining risk groups and potential therapeutic targets. To follow this, sHLA-G levels before and after chemotherapy (CT), HLA-G 3' UTR haplotypes, and allele variations rs10416697 at the distal gene promoter region of ILT-2 were defined in healthy female controls and early TNBC patients. The results obtained were associated with clinical status, presence of circulating tumor cell (CTC) subtypes, and disease outcome of patients in terms of progression-free or overall survival. sHLA-G plasma levels were increased in TNBC patients post-CT compared to levels of patients pre-CT or controls. High post-CT sHLA-G levels were associated with the development of distant metastases, the presence of ERCC1 or PIK3CA-CTC subtypes post-CT, and poorer disease outcome in uni- or multivariate analysis. HLA-G 3' UTR genotypes did not influence disease outcome but ILT-2 rs10416697C allele was associated with AURKA-positive CTC and with adverse disease outcome by uni- and multivariate analysis. The prognostic value of the combined risk factors (high sHLA-G levels post-CT and ILT-2 rs10416697C allele carrier status) was an even better independent indicator for disease outcome in TNBC than the lymph nodal status pre-CT. This combination allowed the identification of patients with high risk of early progression/death with positive nodal status pre-CT or with non-pathological complete therapy response. The results of this study highlight for the first time that the combination of high levels of sHLA-G post-CT with ILT-2 rs10416697C allele receptor status is a promising tool for the risk assessment of TNBC patients and support the concept to use HLA-G/ILT-2 ligand-receptor axis as therapeutic targets.

(351) Cross Cultural Adaptation and Psychometric Validation of The Arizona Sexual Experiences Scale (ASEX) into Bangla

Abstract Introduction Sexual Dysfunction affecting all age groups. We need standard tool for proper assessment and management of patient with Sexual Dysfunctions. However, there is severe scarcity of validated tool in Bangla to assess Sexual Dysfunctions in our cultural context. The Arizona Sexual Experience Scale is widely used validated tool to screen and assess severity of Sexual Dysfunctions for clinical management and research. Objective To develop a culturally adapted and validated Bangla version of The Arizona Sexual Experience Scale (ASEX) to assess Sexual Dysfunctions. Methods This was a cross sectional validation study conducted from June, 2019 to Mar, 2021. After receiving the approval from original author of The Arizona Sexual Experience Scale (ASEX), it was forward and backward translated followed by the expert committee review the initial Bangla version of the scale was developed. Afterward this scale was applied on 56 patients with Sexual Dysfunctions and evaluated validity (Content validity, Face validity and Construct validity) and reliability (Internal consistency). Data analysis performed by Statistical Package for Social Science (SPSS) version- 24. Results The Bangla Arizona Sexual Experience Scale (ASEX) showed very good psychometric property with a Cronbach’s alpha value of 0.756. The Factor analysis based one the Eigen value revealed the Bangla version has one component. Conclusions The study commented the Bangla version of the ASEX (ASEX- Bangla) can be used for assessment of Sexual Dysfunctions in Bangladesh and it will help in further management of the sexual dysfunction in the country and will also help in future research in this area. Disclosure No

Development, multi-institutional external validation, and algorithmic audit of an artificial intelligence-based Side-specific Extra-Prostatic Extension Risk Assessment tool (SEPERA) for patients undergoing radical prostatectomy: a retrospective cohort study

Accurate prediction of side-specific extraprostatic extension (ssEPE) is essential for performing nerve-sparing surgery to mitigate treatment-related side-effects such as impotence and incontinence in patients with localised prostate cancer. Artificial intelligence (AI) might provide robust and personalised ssEPE predictions to better inform nerve-sparing strategy during radical prostatectomy. We aimed to develop, externally validate, and perform an algorithmic audit of an AI-based Side-specific Extra-Prostatic Extension Risk Assessment tool (SEPERA). Each prostatic lobe was treated as an individual case such that each patient contributed two cases to the overall cohort. SEPERA was trained on 1022 cases from a community hospital network (Trillium Health Partners; Mississauga, ON, Canada) between 2010 and 2020. Subsequently, SEPERA was externally validated on 3914 cases across three academic centres: Princess Margaret Cancer Centre (Toronto, ON, Canada) from 2008 to 2020; L'Institut Mutualiste Montsouris (Paris, France) from 2010 to 2020; and Jules Bordet Institute (Brussels, Belgium) from 2015 to 2020. Model performance was characterised by area under the receiver operating characteristic curve (AUROC), area under the precision recall curve (AUPRC), calibration, and net benefit. SEPERA was compared against contemporary nomograms (ie, Sayyid nomogram, Soeterik nomogram [non-MRI and MRI]), as well as a separate logistic regression model using the same variables included in SEPERA. An algorithmic audit was performed to assess model bias and identify common patient characteristics among predictive errors. Overall, 2468 patients comprising 4936 cases (ie, prostatic lobes) were included in this study. SEPERA was well calibrated and had the best performance across all validation cohorts (pooled AUROC of 0·77 [95% CI 0·75-0·78] and pooled AUPRC of 0·61 [0·58-0·63]). In patients with pathological ssEPE despite benign ipsilateral biopsies, SEPERA correctly predicted ssEPE in 72 (68%) of 106 cases compared with the other models (47 [44%] in the logistic regression model, none in the Sayyid model, 13 [12%] in the Soeterik non-MRI model, and five [5%] in the Soeterik MRI model). SEPERA had higher net benefit than the other models to predict ssEPE, enabling more patients to safely undergo nerve-sparing. In the algorithmic audit, no evidence of model bias was observed, with no significant difference in AUROC when stratified by race, biopsy year, age, biopsy type (systematic only vs systematic and MRI-targeted biopsy), biopsy location (academic vs community), and D'Amico risk group. According to the audit, the most common errors were false positives, particularly for older patients with high-risk disease. No aggressive tumours (ie, grade >2 or high-risk disease) were found among false negatives. We demonstrated the accuracy, safety, and generalisability of using SEPERA to personalise nerve-sparing approaches during radical prostatectomy. None.

DYMUS-Hr self-assessment questionnaire (Croatian version) for dysphagia in multiple sclerosis-validity, reliability, and cross-cultural adaptation.

The prevalence of dysphagia in the early phases of multiple sclerosis is 30-40%, with an estimated of 30% of cases going undiagnosed cases. Such complications can lead to malnutrition, dehydration, and aspiration pneumonia and have a great impact on the quality of life and psychosocial status of a person with MS. The aim of this study was the validation of dysphagia in multiple sclerosis self-assessment questionnaire (DYMUS) in the Croatian language. The cross-cultural adaptation process included a back-forward translation technique of the English language version of DYMUS to the Croatian language, with pilot testing on 30 participants. The validity and reliability of the Croatian version of DYMUS (DYMUS-Hr) was applied to 106 MS patients, with comparison to the Eating Assessment Tool (EAT10), the Water Swallowing Test (WST), and a dichotomous self-assessment question. In the assessment of test-retest reliability, 99 MS patients were included. Internal consistency of DYMUS-Hr was very good (Cronbach's alpha-0.837); Cronbach's alpha was 0.819 for the "dysphagia for solids", and 0.562 for "dysphagia for liquids" subscale. A significant correlation (p < 0.001) was found between DYMUS-Hr and EAT10 (Spearman's rho-0.787), and WST (Spearman's rho-0.483). Construct validity was assessed with the self-assessment question and interpreted with the Mann-Whitney U test. Test-retest reliability showed moderate to substantial Cohen's Kappa reliability for each item. DYMUS-Hr is a valid and reliable screening assessment tool for patients with MS. There is a general lack of awareness about dysphagia symptoms among patients with MS; consequently, this disorder receives inadequate attention and often goes untreated.