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.

Development and Psychometric Validation of a Screening Questionnaire to Detect Excessive Menstrual Blood Loss That Interferes in Quality of Life: The SAMANTA Questionnaire.

Background: Heavy menstrual bleeding (HMB) affects up to 35% of women at some point in their lives, and has an important impact on their quality of life (QoL). Current techniques to assess and quantify menstrual blood loss are inconvenient and the correlation between actual and perceived blood loss is poor. This study aimed to develop and validate a screening questionnaire in Spanish to identify HMB in women of reproductive age. Methods: The study consisted of two phases: the conceptual development of a set of items to discriminate between women with and without HMB and the assessment of the sensitivity and specificity of these items. Correlation of the screening tool with women's perception of the intensity of bleeding and the interference in their daily life activities was also assessed. Results: An initial set of 46 items were identified, from which 21 items were selected following the cognitive interviews. For the psychometric validation phase, 389 patients were enrolled, of whom 364 were assessable: 211 cases with Pictorial Blood loss Assessment Chart-confirmed excessive menstrual loss (EML) and 153 controls. Six items met entry criteria in the model and together yielded a sensitivity of 86.7% and specificity of 89.5% to identify cases and controls. These items were weighted according to their contribution to the final model to yield a tool that can be scored from 0 to 10 being 3 the cutoff point to diagnose EML that interferes in QoL. Conclusions: The 6-item SAMANTA questionnaire represents a valid screening tool to easily identify women with EML that interfere with QoL.

Calidad de vida relacionada con la salud en pacientes con cáncer escamocelular bucal, en la ciudad de Medellín (Colombia) / Health-related quality of life of patients with oral squamous cell carcinoma in Medellin (Colombia)

RESUMEN Objetivo: Determinar la CVRS de pacientes sobrevivientes al cáncer escamocelular bucal (CEB) tratados en la ciudad de Medellín en el periodo 2000-2011 y sus factores relacionados. Métodos: Estudio transversal anidado a una cohorte dinámica de análisis de supervivencia, en pacientes con CEB tratados en nueve centros oncológicos de la ciudad. Participaron 95 sobrevivientes. Según información de la historia clínica y encuesta estructurada, se recolectaron variables sociodemográficas y clínicas y el instrumento QLQ-C30 para CVRS. Se realizó análisis descriptivo, análisis bivariado entre las funciones del instrumento de CVRS según variables del estudio y análisis multivariado por regresión logística para observar las variables que más influyen en la CVRS en estos pacientes (odds ratio [OR], intervalos de confianza al 95% [IC 95%]). Resultados: Las escalas de calidad de vida y salud general y las escalas funcionales presentaron puntajes por encima del 75%, indicando mejor situación en estos aspectos. Cuando se analizan la escala de síntomas y de enfermedad y tratamiento, los puntajes no superan el 25%. Se presentaron diferencias estadísticamente significativas entre algunas funciones y dimensiones de la escala. Al analizar la CVRS en el modelo de regresión logística, las personas con problemas financieros (OR 22.93; IC 95% 5.11-102.84) reportaron más afectación en su CVRS. Conclusiones: La CVRS y sus diferentes dimensiones se ven afectadas en estos pacientes por factores sociodemográficos y clínicos.

ABSTRACT Objective: To determine the health-related quality of life (HRQoL) and associated factors of oral squamous cell carcinoma (OSCC) survivor patients. Methods: We conducted a cross-sectional study nested in a survival analysis dynamic cohort of OSCC patients cared for in nine cancer centers in the city of Medellin during the period 2000-2011. 95 survivors participated in this research. Sociodemographic and clinical variables were collected by clinical record and a survey. In addition, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was used for the assessment of HRQoL. We did a descriptive analysis of the study variables and a bivariate analysis between the dimensions of the QLQ-C30 instrument and the different study variables. Finally, we performed a multivariate analysis to observe the most influent variables in the HRQoL in these patients (odds ratios [OR], and 95% confidence intervals [95% CI]). Results: The scales of quality of life, global health, and functional scales presented scores above 75%, which indicates a better situation in these aspects. The scores of the scales of symptoms and symptoms of disease and treatment did not exceed 25%. Statistically significant differences occurred between some functions and dimensions of the scale. In the analysis of HRQoL by logistic regression model, patients with financial difficulties (OR 22.93, 95% CI 5.11-102.84) had a greater negative impact on their HRQoL. Conclusions: In these patients, HRQoL in its different dimensions is affected by some sociodemographic and clinical variables.

Mutations in the mitochondrial complex I assembly factor NDUFAF6 cause isolated bilateral striatal necrosis and progressive dystonia in childhood.

AIM: To perform a deep phenotype characterisation in a pedigree of 3 siblings with Leigh syndrome and compound heterozygous NDUFAF6 mutations. METHOD: A multi-gene panel of childhood-onset basal ganglia neurodegeneration inherited conditions was analysed followed by functional studies in fibroblasts. RESULTS: Three siblings developed gait dystonia in infancy followed by rapid progression to generalised dystonia and psychomotor regression. Brain magnetic resonance showed symmetric and bilateral cytotoxic lesions in the putamen and proliferation of the lenticular-striate arteries, latter spreading to the caudate and progressing to cavitation and volume loss. We identified a frameshift novel change (c.554_558delTTCTT; p.Tyr187AsnfsTer65) and a pathogenic missense change (c.371T>C; p.Ile124Thr) in the NDUFAF6 gene, which segregated with an autosomal recessive inheritance within the family. Patient mutations were associated with the absence of the NDUFAF6 protein and reduced activity and assembly of mature complex I in fibroblasts. By functional complementation assay, the mutant phenotype was rescued by the canonical version of the NDUFAF6. A literature review of 14 NDUFAF6 patients showed a consistent phenotype of an early childhood insidious onset neurological regression with prominent dystonia associated with basal ganglia degeneration and long survival. INTERPRETATION: NDUFAF6-related Leigh syndrome is a relevant cause of childhood onset dystonia and isolated bilateral striatal necrosis. By genetic complementation, we could demonstrate the pathogenicity of novel genetic variants in NDUFAF6.

Características Sociodemográficas y Clínicas de los Pacientes Tratados por Primera Vez por Cáncer Escamocelular Oral. Medellín, Colombia / Sociodemographic and Clinic Characteristics of the Patients Threatened at First Time for Squamous Cell Oral Cancer. Medellín, Colombia

RESUMEN: Este estudio pretendió describir las características sociodemográficas y clínicas de los pacientes tratados por primera vez por cáncer escamocelular oral (CEB) en Medellín (Colombia). Para ello se realizó un estudio descriptivo anidado en una cohorte dinámica retrospectiva de casos de CEB, procedente de 9 centros oncológicos especializados de la ciudad entre 2000 y 2011, según la información de las historias clínicas y clasificadas según la CIE-10. Se recolectaron variables sociodemográficas y clínicas como: tratamiento recibido, localización del tumor, estadio del tumor, atención recibida (profesional), reporte de consumo de alcohol o cigarrillo, complicaciones asociadas al tratamiento de CEB. Se describieron las variables del estudio y pruebas Chi cuadrado para observar diferencias entre algunas características clínicas y el sexo. Se encontraron 778 casos de CEB en el periodo estudiado, con una edad promedio de diagnóstico de 63,5 (±13,6) años. Más de la mitad tenían estratos socioeconómicos y niveles educativos bajos. Un 56 % de las mujeres y un 63 % de los hombres fueron diagnosticados en un estadio IV del tumor. Los tratamientos más realizados fueron de tipo combinado o cirugía. Un 35% presentaron problemas cardiovasculares, aunque no se reportaron diferencias estadísticamente significativas entre la presencia de determinadas comorbilidades y el sexo. Se reportó el consumo de alcohol en un 19 % y de cigarrillo en un 51 % con mayor consumo en hombres en ambos casos y diferencias estadísticamente significativas (p<0,0001) con respecto a las mujeres. En cuanto a complicaciones asociadas al tratamiento para CEB, se reportaron con mayor frecuencia disfagia (47 %) y mucositis (24 %). Más de la mitad de los tumores de presentaron en la lengua. Se requieren estrategias que permitan sistemas de vigilancia epidemiológica para el CEB, así como mejorar los programas de prevención y tratamiento precoz para esta enfermedad en consonancia con las políticas y los planes nacionales y globales.

ABSTRACT: This study aimed to describe the sociodemographic and clinical characteristics of patients treated for first-time oral squamous cell carcinoma (OSCC), in Medellín (Colombia). For this purpose, a descriptive study was carried out within a retrospective dynamic cohort of OSCC cases from 9 specialized oncology centers in the city between 2000 and 2011, according to the information of the clinical records and classified according to the ICD-10. Sociodemographic characteristics were recorded and clinical variables were collected such as: Treatment received, tumor location, tumor stage, care received (professional), report of alcohol or cigarette consumption, complications associated with OSCC treatment. The study variables were described, and Chi square test was calculated in order to observe differences between some clinical characteristics and sex. In the study period 778 cases of OSCC were found, with an average age of diagnosis of 63.5 (± 13.6) years. More than half had low socioeconomic and educational levels. Fifty six percent of women and 63 % of men were diagnosed in stage IV of the tumor. Treatments performed most, were either combined or for surgery. Thirty five percent of the cases had cardiovascular problems, although no statistically significant differences were reported between the presence of certain comorbidities and sex. Alcohol consumption was reported in 19 % and smoking in 51 %, with higher consumption in men in both cases and statistically significant differences (p <0.0001) with respect to women. Regarding complications associated with treatment for OSCC, dysphagia (47 %) and mucositis (24 %) were reported more frequently. More than half of the tumors were presented in the tongue. Strategies are required that allow epidemiological surveillance systems for the OSCC, as well as to improve prevention and early treatment programs for this disease in line with national and global policies and plans.

Extended regimens of combined hormonal contraception to reduce symptoms related to withdrawal bleeding and the hormone-free interval: a systematic review of randomised and observational studies.

OBJECTIVE: To assess whether continuous and extended regimens (CRs/ERs) of combined hormonal contraceptives (CHCs) improve symptoms related to withdrawal bleeding or the hormone-free interval and to compare the efficacy, safety, and cost of CRs/ERs to those of conventional 28-day regimens. STUDY DESIGN: A literature search of the PubMed database was conducted for randomised clinical trials (RCTs) and observational studies published in any language between 2006 and 2013. RESULTS: Sixteen RCTs and 14 observational studies evaluated issues related to our objectives. CRs/ERs, whose efficacy and safety were comparable to those described for conventional regimens, were preferred due to their improvement of symptoms related to withdrawal bleeding or the hormone-free interval and the lower costs resulting from the reduced incidence of these symptoms. CONCLUSION: The contraceptive efficacy and safety of CR/ER use of CHCs is at least equal to that of 28-days conventional regimens, and this use may have some cost savings. CRs/ERs are recommended for women willing to take a CHC for treatment of symptoms related to withdrawal bleeding or the hormone-free interval.

Methadone patient-controlled analgesia for postoperative pain: a randomized, controlled, double-blind study.

PURPOSE: Postoperative pain is an important health-care issue. Patient-controlled analgesia (PCA) is considered the gold standard for systemic postoperative pain treatment. Methadone PCA is used for patients with chronic pain and those in the palliative care setting. However, its efficacy as a first-line drug for acute postoperative pain is unknown. This study evaluated the use of postoperative methadone PCA after total hip arthroplasty (THA) compared with morphine PCA. METHODS: This was a randomized, double-blind, controlled, parallel-group study. Patients were randomized into two groups: group methadone--methadone PCA, and group morphine--morphine PCA, for postoperative analgesia. Drugs were delivered through PCA pumps throughout the first 24 h after surgery (T1:6, T2:12, T3:18, T4:24 h). RESULTS: Opioid consumption in 24 h was significantly lower for group methadone than for group morphine. Group methadone patients experienced significantly less pain than group morphine at rest. Pain after movement was significantly lower in group methadone at T1 and T3 and marginally lower at T2 and T4. Adverse events more frequently reported were sleepiness, nausea, and vomiting, but no statistical difference between groups was found. CONCLUSION: This study demonstrated that methadone PCA prompted less opioid consumption and lower pain scores at rest and at motion in comparison with morphine PCA as postoperative analgesia after THA.

Tuberculosis among homeless population from Medellín, Colombia: associated mental disorders and socio-demographic characteristics.

Homeless people are highly susceptible to tuberculosis. It has been suggested that this population have high rates of mental disorders associated with tuberculosis. We assessed tuberculosis incidence, its transmission patterns and association with socio-demographic factors and mental disorders in Colombian homeless people. Prospective study which socio-demographic characteristics and mental disorders were assessed through interviews. Sputa from patients with respiratory symptoms were processed and clinical isolates analyzed by IS6110-RFLP. Multivariate analysis performed by logistic regression model. From 426 homeless studied, tuberculosis incidence found was 7.9 %. 44 % of isolates were clustering. It was found high risk of having tuberculosis associated with income from drugs trade (OR: 3.40 [95 % CI: 1.28-9.05]), dysthymia (OR: 2.54 [95 % CI: 1.10-5.86]) and receiving food from other homeless (OR: 2.47 [95 % CI: 1.16-5.25]). Tuberculosis incidence and degree of transmission are high in homeless studied. Implementing programs to better control tuberculosis among homeless population must consider socio-demographic factors and mental disorders associated with the disease.

Continuation rate of combined hormonal contraception: a prospective multicenter study.

BACKGROUND: Data from clinical trials regarding continuation of use and contraceptive efficacy do not always apply to the general public. Therefore, a study among typical users was conducted to assess the continuation rate at the end of 12 cycles of combined hormonal contraceptive methods, reasons for discontinuation, and the Pearl index. METHODS: Prospective, observational, and multicenter study of 3443 women aged 18 to 49 years starting one of the three combined hormonal contraception methods available in Spain (the vaginal ring, the contraceptive pill, and the transdermal skin patch). RESULTS: The study population (intention-to-treat analysis) included 3443 women, of whom 45.4% were included in the vaginal ring group, 42.6% the pill group, and 12.1% the skin patch group. The continuation rate at 12 cycles was 45.9% for the pill, 42.3% for the vaginal ring, and 26.0% for the skin patch. The Pearl index was 0.61 (95% confidence interval [CI] 0-1.2) for the pill, 0.61 (95% CI 0-1.1) for the vaginal ring, and 2.34 (95% CI 0.3-9) for the skin patch (p<0.001). CONCLUSION: At 12 cycles, the vaginal ring and the pill showed similar continuation rates and effectiveness, which were significantly higher than the skin patch.

Self-described impact of noncompliance among users of a combined hormonal contraceptive method.

BACKGROUND: A number of factors related to the user and the method affect contraceptive compliance. STUDY DESIGN: This cross-sectional multicenter study was designed to assess self-described impact of noncompliant behavior among 26,250 typical users of a combined hormonal contraceptive method who consulted their physicians for control visits. A self-administered questionnaire was completed. RESULTS: Sixty-five percent of women used the pill, 23% the vaginal ring and 12% the transdermal patch. Noncompliant behavior (missing/delays in taking/application, insertion or removal of the pill/skin patch/vaginal ring) was recorded in 71% of pill users, 32% of patch users and 21.6% of vaginal ring users (p<.0001). Emergency contraception was requested by 14% of pill users, 11% of patch users and 6.3% of ring users. About 40% of women in all groups called or visited a physician. Seventy percent of women continued to have active sex life, and 60% used an additional contraceptive method. Noncompliant behavior negatively affected work activities and/or couple relationships in 10-20% of cases. More than 50% of women reported they were worried and about 20% were scared due to inconsistent use of the contraceptive method. After filling out the questionnaire, 64.7% of pill users continued to prefer the pill, 61.7% of patch users preferred the patch and 96.6% of women using the vaginal ring preferred the ring. CONCLUSIONS: Noncompliant behavior had noticeable effects on emotional well-being, prompted request for physicians' advice, and use of emergency contraception. Despite recognition of problems associated with inconsistent use, women tended to prefer the currently used contraceptive method.

Factors affecting women's selection of a combined hormonal contraceptive method: the TEAM-06 Spanish cross-sectional study.

BACKGROUND: Contraceptive efficacy and side effects are primary concerns of women when choosing a contraceptive method. STUDY DESIGN: This cross-sectional multicenter study was designed to assess the reasons for selecting the contraceptive pill, the skin patch or the vaginal ring in 9700 women, aged 18-49 years, who consulted their doctors for starting or re-initiating combined hormonal contraception. A self-administered questionnaire regarding the reasons for the selection made and for the refusal of the remaining two methods was completed. RESULTS: The vaginal ring showed the highest acceptance (46%) compared with the pill (39%) and the skin patch (15%), particularly in women aged 35-39 years. The ring and the skin patch were mainly preferred because of the lower probability of inadvertent omission (62% of cases), convenience, and monthly or weekly frequency of use. The pill was preferred because of its proven efficacy (60% of cases) and ease of use. The acceptance of the skin patch increased with age and the pill was mostly accepted only by women in the youngest age groups. CONCLUSIONS: Convenience, frequency of use and lower probability of inadvertent omission were the primary determinants of contraceptive choice rather than the women's profile.