Reliability and agreement of subjective and objective non-invasive break-up time measurements in contact lens wearers.

PURPOSE: To assess the reliability and agreement of non-invasive break-up time (NIBUT) in symptomatic and asymptomatic contact lens (CL) wearers using automatic objective and conventional subjective techniques. METHODS: In this prospective cross-sectional study, soft CL wearers, classified into symptomatic and asymptomatic based on the Contact Lens Dry Eye Questionnaire-8, underwent NIBUT assessment with the CL in situ. The CA-800 Corneal Analyzer and the EasyTear® VIEW+ Tearscope were used for objective and subjective evaluation, respectively. The within-subject repeatability and intraclass correlation coefficient (ICC) were calculated. The agreement between the devices was compared using the Bland-Altman method. RESULTS: A total of 141 CL wearers (51 male and 90 female) with a mean age of 33.6 (SD = 12.2) years were included. The repeatability and ICC values obtained with the CA-800 device when measuring NIBUT were 5.4 s and 58.6% across the whole sample, 4.2 s and 48.8% for the asymptomatic group and 7.1 s and 68.4% for the symptomatic group. When using the subjective method (EasyTear®), the respective repeatability and ICC values were 7.3 s and 32.7% for the whole sample, 6.5 s and 30.4% for the asymptomatic group and 8.6 s and 35.9% for the symptomatic group. The CA-800 device provided significantly (p < 0.001) shorter NIBUT values compared with EasyTear® for the whole sample (3.3 [2.9] vs. 8.1 [3.4] s), the asymptomatic (3.3 [3.0] vs. 7.7 [3.6] s) and the symptomatic (3.8 [2.9] vs. 8.6 [3.0] s) groups. CONCLUSION: Objective (CA-800) NIBUT assessment provides more reliable measurements than the conventional subjective technique using the EasyTear® device. However, CL practitioners should also be aware that the objective method indicates shorter NIBUT values. Symptomatic CL wearers may also need a higher number of NIBUT measurements to obtain reliable estimations.

Visual Performance and Higher Order Aberrations Obtained With Omafilcon A Dual-Focus and Single-Vision Contact Lens Designs.

OBJECTIVE: The purpose of this study was to assess the visual performance and monochromatic higher-order aberrations (HOAs) obtained while wearing a MiSight dual-focus (DF) contact lenses (CL) in comparison with a single-vision contact lens (SVCL). METHODS: A randomized, double-masked, cross-over study was performed. Participants were fitted with a DFCL and a SVCL composed of the same material (omafilcon A) and parameters. Logarithm of the Minimum Angle of Resolution high-contrast (100%) and low-contrast (10%) visual acuity (VA) and contrast sensitivity (CS) for 3, 6, 12, and 18 cycles per degree were measured. Higher-order aberrations were also evaluated using a Hartmann-Shack aberrometer with the CLs on. RESULTS: Twenty-four subjects (21 females and 3 males) with a mean age of 21.9±1.9 years (range: 18-27) were included. Low-contrast VA was significantly lower with the DFCL regarding the SVCL design (0.39±0.23 vs 0.25±0.18, P=0.002). However, there were no differences in high-contrast VA between both CLs (-0.03±0.10 vs -0.09±0.14, P=0.187). Contrast sensitivity was lower with the DFCL under all spatial frequencies (P≤0.048). Second-, third-, fourth-, and fifth-order aberrations were significantly (P<0.001) higher for the DFCL. There were also significant differences between DFCL and SVCL in defocus (0.87±0.28 vs 0.16±0.35, P<0.001), oblique trefoil (-0.16±0.27 vs -0.01±0.08, P=0.005), vertical coma (0.13±0.17 vs 0.00±0.08, P=0.002), and spherical aberration (0.09±0.11 vs -0.02±0.05, P=0.002). CONCLUSION: Visual performance for detecting low-contrast targets is reduced when wearing MiSight DFCL compared with a SVCL with the same material. The main reason might be the induction of second-order and HOAs by the DFCL design.

Quality of Tissue Samples Obtained by Endoscopic Ultrasound-Guided Liver Biopsy: A Randomized, Controlled Clinical Trial.

INTRODUCTION: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at comparing the adequacy of samples obtained by EUS-LB with percutaneous LB. METHODS: A single-center, randomized, controlled clinical trial was designed. Patients undergoing LB were randomly assigned to EUS-LB or percutaneous LB groups. EUS-LB was performed with a 19-gauge Franseen core needle through a transduodenal and transgastric route. Percutaneous LB was performed with a 16-gauge Tru-Cut needle. The main outcome was the percentage of adequate samples obtained. Secondary outcomes were the percentage of accurate histologic diagnosis, number of complete portal tracts (CPT), total and longest specimen length (TSL and LSL), sample fragmentation, adverse events, and patients' satisfaction. An adequate specimen was defined as TSL ≥20 mm and including ≥11 CPT. RESULTS: Ninety patients were randomized (44 to EUS-LB and 46 to percutaneous LB) and included in the analysis. The percentage of adequate tissue samples was 32.6% and 70.4% for percutaneous LB and EUS-LB, respectively ( P < 0.001). A final histologic diagnosis was provided in all cases but one. TSL was longer after EUS-LB (23.5 vs 17.5 mm, P = 0.01), whereas the number of CPT was similar in both groups. Sample fragmentation occurred more often after EUS-LB ( P < 0.001). No differences in adverse events were found. Satisfaction reported with both procedures was high. DISCUSSION: EUS-LB is safe and accurate and may be considered an alternative to percutaneous LB for the evaluation of parenchymal liver diseases.

Fendrix vs Engerix-B for Primo-Vaccination Against Hepatitis B Infection in Patients With Inflammatory Bowel Disease: A Randomized Clinical Trial.

INTRODUCTION: To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD). METHODS: Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose. RESULTS: A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti-tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up. DISCUSSION: We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti-tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.

Morphological and functional changes of chronic pancreatitis in patients with dyspepsia: A prospective, observational, cross-sectional study.

OBJECTIVE: Whether chronic pancreatitis (CP) may present with dyspepsia is controversial. We aimed at evaluating the frequency and risk factors of changes of CP in patients presenting with epigastric pain syndrome (EPS)-like symptoms. DESIGN: A prospective, observational, cross-sectional study was carried out in patients with EPS-like symptoms. Patients underwent endoscopic ultrasound (EUS) evaluation of the pancreas, and changes of CP were defined as the presence of five or more EUS criteria of the disease. In patients with 3 or 4 EUS criteria, magnetic resonance dynamic evaluation of the pancreas (MRI/sMRCP) and endoscopic pancreatic function test (ePFT) were carried out to confirm or exclude the presence of changes of CP. A multivariate logistic regression analysis was performed to evaluate factors associated with CP findings, and results are shown as odds ratio (OR) and 95% confidence interval (CI). RESULTS: 213 patients were included. Changes of CP were confirmed by EUS (≥5 criteria) in 18 patients (8.4%). Thirty-four patients had 3-4 EUS criteria, and changes of CP were confirmed in 27 of them by MRI/sMRCP and ePFT (12.7%). Morphological and functional findings of CP were then present in 45 patients (21.1%). Male gender (OR 2.97; 95%CI 1.39-6.37) and alcohol and tobacco consumption (OR 6.56; 95%CI 1.97-21.85) were associated with the presence of changes of CP. CONCLUSION: Morphological and functional changes of CP are frequent in patients with EPS-like symptoms. Whether these pancreatic changes explain EPS-like symptoms requires further investigation.

Increased Risk of Mortality Associated With Pancreatic Exocrine Insufficiency in Patients With Chronic Pancreatitis.

BACKGROUND: Pancreatic exocrine insufficiency (PEI) is a common serious complication in chronic pancreatitis (CP); however, little is known about its effect on mortality in these patients. In this study, we assessed the mortality risk of PEI in patients with CP. STUDY: A prospective, longitudinal cohort study conducted in patients with CP under long-term follow-up. CP and PEI were diagnosed using pancreatic imaging and the C-labeled mixed triglyceride breath test, respectively. Multivariate analysis was performed to evaluate the impact of PEI and other clinical features on mortality risk. RESULTS: Patients (N=430) were analyzed (79.1% male; mean age, 47.8 y) during a mean follow-up of 8.6±4.6 years. PEI prevalence was 29.3% and mortality was 10.9%. Most frequent causes of death were cancer (40.4%), infection (21.3%), and acute cardiovascular event (14.9%). Multivariate analyses showed associations between increased mortality and presence of PEI [hazard ratio (HR), 2.59; 95% confidence interval (CI), 1.42-4.71; P<0.003], liver cirrhosis (HR, 3.87; 95% CI, 1.95-7.69; P<0.001), age at diagnosis (HR, 1.05; 95% CI, 1.03-1.09; P<0.001), toxic etiology of CP (HR, 3.11; 95% CI, 1.11-8.70; P<0.05) and respiratory comorbidity (HR, 2.19; 95% CI, 1.12-4.31; P<0.03). Nutritional markers were significantly lower in patients with PEI versus those without PEI (P<0.001) and in those who died versus survivors (P<0.001). CONCLUSIONS: PEI was a significant independent risk factor for mortality in patients with CP. These results support further research into the optimal treatment of PEI to reduce mortality in this population.

Hysteroscopic Removal of Retained Products of Conception Implanted Over a Focal Area of Adenomyosis: A Case Report.

STUDY OBJECTIVE: To describe a technique for hysteroscopic removal of retained products of conception (RPOC) implanted over an area of adenomyosis. DESIGN: A case report (Canadian Task Force classification III). SETTING: RPOC is an unfortunate complication that may occur after the resolution of a normal pregnancy; it is more common after early pregnancy termination or spontaneous miscarriage [1]. Immediate consequences of RPOC include persistent vaginal bleeding, abdominal pain, pelvic infection, fever, and dilated cervix. Moreover, known long-term complications include the formation of intrauterine adhesions (IUAs) with the potential creation of Asherman syndrome resulting in adverse reproductive outcomes caused by subfertility, chronic pelvic pain, menstrual disturbances, and severe pregnancy complications such as abnormal placentation including the placenta accreta spectrum [2,3]. A recently published American Association of Gynecologic Laparoscopists practice report on IUAs suggests that the surgical approach used to treat intrauterine pathology could have an impact with greater risk for IUA formation when blind versus procedures under direct visualization are performed [4]. INTERVENTIONS: A 35-year-old patient who presented with persistent bleeding for over 5 weeks. The patient has a long history of dysmenorrhea and heavy menstrual bleeding. Magnetic resonance imaging revealed the presence of adenomyosis. She had an unfortunate spontaneous abortion at 8 weeks of gestation. On physical examination, she was found to have a dilated uterine cervix with persistent vaginal bleeding; there were no signs of infection. Pelvic ultrasound revealed an intrauterine hyperechogenic vascularized area of 2 × 2, 8 × 2 cm implanted over a focal area of adenomyosis, which is consistent with the presence of RPOC. With the aim of minimizing possible acute complications such as bleeding, infection, and uterine perforation, a hysteroscopic approach was taken to avoid performing a blind dilation and curettage. A secondary benefit of a hysteroscopic approach is a lower incidence of long-term complications such as IUAs and the consequent Asherman syndrome. We describe a hysteroscopic technique in which the use of electrosurgery is limited to minimize thermal damage of the endometrium, highlighting important tips and tricks of the procedure. CONCLUSION: Hysteroscopic removal of RPOC is a feasible and safe management option of this complication of pregnancy. We strongly suggest avoiding performing blind procedures such as dilation and curettage and favor the adoption of this modality that allows the removal of retained products of conception under direct visualization.

Assessing mouse alternatives to access to computer: a case study of a user with cerebral palsy.

The purpose of this study is to describe the process of assessment of three assistive devices to meet the needs of a woman with cerebral palsy (CP) in order to provide her with computer access and use. The user has quadriplegic CP, with anarthria, using a syllabic keyboard. Devices were evaluated through a three-step approach: (a) use of a questionnaire to preselect potential assistive technologies, (b) use of an eTAO tool to determine the effectiveness of each devised, and (c) a conducting semi-structured interview to obtain qualitative data. Touch screen, joystick, and trackball were the preselected devices. The best device that met the user's needs and priorities was joystick. The finding was corroborated by both the eTAO tool and the semi-structured interview. Computers are a basic form of social participation. It is important to consider the special needs and priorities of users and to try different devices when undertaking a device-selection process. Environmental and personal factors have to be considered, as well. This leads to a need to evaluate new tools in order to provide the appropriate support. The eTAO could be a suitable instrument for this purpose. Additional research is also needed to understand how to better match devices with different user populations and how to comprehensively evaluate emerging technologies relative to users with disabilities.

Clinical characterisation of contact lens discomfort progression.

PURPOSE: This study aimed to assess the subjective and objective differences among the steps of the contact lens discomfort (CLD) progression classification established by the Tear Film & Ocular Surface Society (TFOS) using questionnaires and clinical signs, and to propose a simplified classification. METHODS: Contact lens (CL) wearers were evaluated in a single visit. The Contact Lens Dry Eye Questionnaire (CLDEQ)-8, the Contact Lens Discomfort Index, and Visual Analog Scales for discomfort and dryness were administered. The non-invasive break-up time, the tear film lipid layer thickness, conjunctival hyperaemia and papillae, lid-parallel conjunctival folds, the fluorescein tear film break-up time, corneal and conjunctival staining, lid wiper epitheliopathy, and the Schirmer test were assessed. Sign and symptom scores were compared among TFOS CLD progression steps using analysis of variance or the Kruskal-Wallis H test. Steps 1 and 2 (reduced comfort), and steps 3 and 4 (reduced wearing time) of the TFOS classification were combined to obtain a simplified classification, and the same comparison was performed. A p-value ≤ 0.05 was considered statistically significant. RESULTS: One hundred-fifty CL wearers (97 women and 53 men) aged 34.4 ± 12.6 years were included. In the TFOS classification, there were significant differences between step 0 (no CLD) and the rest of the severity steps for the scores obtained in all questionnaires (p ≤ 0.015). All steps were differentiated (p ≤ 0.032) based on the simplified classification for all questionnaires, except steps 1 and 2 for the CLDEQ-8 and dryness VAS (p = 0.089 and p = 0.051, respectively). There were no differences (all p ≥ 0.06) between the sign scores among the steps of either classification. CONCLUSION: CLD management is encouraged from its first appearance. Simplifying the phases of CLD severity may allow a more accurate classification and a better awareness of the problem by clinicians and CL wearers by using more straightforward simple messages.

Gene expression changes in conjunctival cells associated with contact lens wear and discomfort.

PURPOSE: This study aimed to analyze the differences in the expression of pain-related genes in conjunctival epithelial cells among symptomatic contact lens (CL) wearers (SCLWs), asymptomatic CL wearers (ACLWs), and non-CL wearers (non-CLWs). METHODS: For this study, 60 participants (20 non-CLWs, 40 CLWs) were enrolled. The CLW group comprised 20 ACLWs and 20 SCLWs according to the Contact Lens Dry Eye Questionnaire short form©. Conjunctival cells were collected using impression cytology, and RNA was isolated and used to determine the expression levels of 85 human genes involved in neuropathic and inflammatory pain. The effects of CL wear and discomfort were evaluated using mixed-effects ANOVA with partially nested fixed-effects model. Gene set enrichment analysis was performed to assign biological meaning to sets of differentially expressed genes. RESULTS: Six genes (CD200, EDN1, GRIN1, PTGS1, P2RX7, and TNF) were significantly upregulated in CLWs compared to non-CLWs. Eleven genes (ADORA1, BDKRB1, CACNA1B, DBH, GRIN1, GRM1, HTR1A, PDYN, PTGS1, P2RX3, and TNF) were downregulated in SCLWs compared to ACLWs. These genes were mainly related to pain, synaptic transmission and signaling, ion transport, calcium transport and concentration, and cell-cell signaling. CONCLUSIONS: CL wear modified the expression of pain- and inflammation-related genes in conjunctival epithelial cells. These changes may be in part, along with other mechanisms, responsible for CL discomfort in SCLWs.

Tear Cytokines as Predictive Biomarkers of Success in Contact Lens Discomfort Management.

PURPOSE: To analyze changes in tear levels of inflammatory mediators in symptomatic contact lens (CL) wearers after refitting with daily disposable CLs and to identify potential biomarkers of success in CL discomfort (CLD) management. METHODS: Symptomatic CL wearers (CLDEQ-8 ≥ 12) were refitted (V1) with daily disposable CLs (Delefilcon A). After one month (V2), participants were classified into the post-fitting non-symptomatic (CLDEQ <12) and symptomatic (CLDEQ ≥12) groups. At each visit, the participants were clinically evaluated, tears were collected, and 20 inflammatory mediators and substance P (SP) were measured using multiplex immunobead analysis and ELISA, respectively. The detection rates and concentrations were compared between visits and groups, and logistic regression models were performed. RESULTS: Forty-three subjects (32 women/11 men; mean age: 23.2 ± 4.9 years) were enrolled. The IL-1ß and IL-9 detection rates were higher at V2 (p ≤ 0.044). The detection rates of IL-1ß, IL-9, MIP-1α/CCL3, and MMP-9 at V1 (p ≤ 0.045) and IL-17A at V2 (p ≤ 0.014) were higher in the post-fitting symptomatic group. The tear IL-9 concentration was increased at V2 (p = 0.018). The tear concentrations of fractalkine/CX3CL1, IL-2, IL-6, IL-10, MCP-3/CCL7, MIP-1ß, NGF, RANTES/CCL5, and TNF-α were higher in the post-fitting symptomatic group (p ≤ 0.044). Additionally, levels of fractalkine/CX3CL1, IL-2, IL-6, IL-10, RANTES/CCL5, and TNF-α at V1 were significantly associated with the post-fitting grouping (p ≤ 0.044). CONCLUSIONS: Low tear concentrations of specific inflammatory mediators may be used as a predictive biomarker of success for refitting symptomatic CL wearers with daily disposable CLs. However, complementary treatments might be required for symptomatic CL wearers with higher levels of these inflammatory molecules.

Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.

INTRODUCTION: To evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments. METHODS: A single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23 °C, 50% relative humidity) and an adverse controlled environment (ACE) (23 °C, 10% relative humidity, 0.43 m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis. RESULTS: Nineteen women and one man (mean age, 58.9 ± 12.3 years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1 month of treatment; improvements were maintained after 3 months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1 month (from 5.4 to 5.8) and 3 months (from 5.0 to 5.9) after treatment. CONCLUSION: Topical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04492878.

Intestinal absorption and pancreatic function are preserved in anorexia nervosa patients in both a severely malnourished state and after recovery.

INTRODUCTION: Anorexia nervosa (AN) is characterised by a refusal to normal body weight accompanied by a marked restriction of food intake, frequently leading to severe malnutrition. In severe malnutrition and wasting syndromes, mucosal atrophy, altered gastrointestinal motility and pancreatic atrophy, which alter digestive function and can exacerbate malnutrition, have been described. The objective of this work was to determine intestinal absorption and pancreatic function in severely malnourished AN patients before and after recovery. METHODS: Ten severely malnourished AN women were studied at hospital admittance (body mass index = 11.44-16.16 kg/m(2)) and after weight recovery with artificial nutrition (body mass index ≥ 20 kg/m(2)). A (13)C-labelled triglycerides digestion test, faecal elastase test and d-xylose absorption test were performed. RESULTS: In nine patients, (13)C-labelled triglycerides digestion tests and the faecal elastase and d-xylose tests were normal both before and after weight recovery. In one patient, the results were abnormal, and they led to the detection of a previously undiagnosed celiac disease in addition to her AN. CONCLUSION: In this series, there was neither intestinal absorption nor pancreatic function disturbances in severely malnourished AN patients either before or after weight recovery. The usefulness of these tests in the differentiation of functional versus structural changes needs further studies.

Associations between Menopausal Hormone Therapy and Colorectal, Lung, or Melanoma Cancer Recurrence and Mortality: A Narrative Review.

Objective: to develop eligibility criteria for use in non-gynecological cancer patients. Methods: We searched all the articles published in peer-reviewed journals up to March 2021. We utilized the PICOS standards and the following selection criteria: menopausal women with a history of non-gynecological and non-breast cancer who underwent hormone replacement therapy (HRT) using various preparations (oestrogens alone or in combination with a progestogen, tibolone, or tissue selective oestrogen complex) and different routes of administration (including oral, transdermal, vaginal, or intra-nasal). We focused on randomized controlled trials as well as relevant extension studies or follow-up reports, specifically examining recurrence and mortality outcomes. Results: Women colorectal cancer survivors who use MHT have a lower risk of death from any cause than those survivors who do not use MHT. Women who are skin melanoma survivors using MHT have a longer survival rate than non-MHT survivors. There is no evidence that women lung cancer survivors who use MHT have a different survival rate than those who do not use MHT. Conclusions: MHT is safe for women who have a history of colorectal, lung, or skin melanoma cancers.

Diurnal variation on tear stability and correlation with tear cytokine concentration.

PURPOSE: To investigate the effect of time of day on tear evaporation rate (TER) and tear break-up time, and its possible relationship with the concentration of inflammatory tear molecules (cytokines) in healthy subjects. METHODS: Participants with healthy ocular surfaces attended 3 visits, including the screening visit (V0), the 2nd visit (V1) and the 3rd visit (V2). There were 7-day intervals between visits. Participants with Dry Eye Disease (DED) were excluded by using appropriate clinical tests during V0. Clinical evaluation (TER and Non-Invasive Tear Break-Up Time (NITBUT)) and tear collection were performed during V1 and V2, between 9 and 10AM and 3-4PM. The relative humidity and temperature of the examination room were also measured. The tear fluid concentrations of 15 cytokines were measured by multiplex bead analysis. RESULTS: Seven men and 10 women (mean age ± S.D; 25.1 ± 6.63 years old) participated in the study. There were no differences in neither the TER and NITBUT outcomes, nor humidity and temperature among times or visits. Eleven out of the 15 cytokines measured were detectable in tear fluids in > 50% of the participants. In the tear levels, no significant (p > 0.05) inter- and/or intra-day differences were detected for EGF, fractalkine, IL-1RA, IL-1ß and IP-10. However, significant inter-day differences were found in the tear levels of IL-10 (p = 0.027), IFN-γ (p = 0.035) and TNF-α(p = 0.04) and intra-day differences in the tear levels of IL-8/CXCL8 (p = 0.034) and MCP-1 (p = 0.002). A significant correlation between TER and IL1-ß, IL-2, and Fractalkine (p = 0.03, p = 0.03 and p = 0.046, respectively) was found at V1. CONCLUSIONS: NITBUT and TER values had no significant variability over the course of a day (AM versus PM), or on different days in healthy participants when humidity and temperature were constant. However, some tear molecule levels did show inter- and intra-day variability, having an inconsistent and moderate correlation with TER diurnal variation.

Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group.

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.

Value of skin tests for managing allergic hypersensitivity reactions to platinum compounds.

Background Platinum-based therapy continues to be one of the pillars of the treatment of different types of cancer. However, many times the responsible clinician renounces its use after the appearance of a hypersensitivity reaction. Objective To assess the value of skin tests (ST) in clinical practice to address the treatment of patients with suspicion of immediate hypersensitivity reactions (HSRs) to platinum compounds. Method Single-center retrospective study of 3 years. Adult patients treated with any platinum compound who experienced HSR symptoms and for whom an oncologist requested ST, were included. ST with cisplatin, carboplatin and oxaliplatin were performed. Results Twenty-two patients were included. ST were positive in 12 patients (54.5%), of which 4 (33%) presented cross-reactivity to another platinum compound. Fifteen patients continued platinum-based chemotherapy: 9 patients with positive ST (4 continued by desensitization and 5 with another platinum compound) and 6 patients with negative ST, of which 1 repeated an HSR. A NPV of 0.91 was calculated. Conclusion ST helped physicians identify patients most susceptible to platinum derivative allergies and resume platinum-based therapy in many patients for whom no suitable therapeutic alternative was clinically acceptable.