Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials.

OBJECTIVE: Develop and obtain content validity of a new tool for Evaluating and Classifying the Severity of Adverse Events for Psychotherapeutic Clinical Trials (EVAD). METHOD: Study of the development process of EVAD in four stages: (1) identify the domain and concept definition through a literature review, (2) instrument design, (3) expert judgment of the EVAD items through Gwent's concordance coefficient, and (4) applicability. RESULTS: In the absence of a consistent conceptual framework of adverse events in psychotherapeutic clinical trials, we have developed a framework and defined it. We have designed EVAD items and their complementary tool for rating adverse events. Content validation by expert judges resulted in CVR = 1.0 for each item and CVI = 0.79 in sufficiency, 0.76 in clarity, 0.91 in coherence and 0.95 in relevance for all items (p < 0.001). Final version of EVAD were applied to three participants for 7 weeks. Overall EVAD seems to be clear and meaningful for participants. CONCLUSIONS: EVAD is a semistructured interview based on a consistent conceptual framework, and proven content validity following the most important guidelines described in the literature. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03878186.

Necrotic lesion in an immunosuppressed patient / Lesión necrótica en un paciente inmunosuprimido

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Erectile Dysfunction Among HIV Patients Undergoing Highly Active Antiretroviral Therapy: Dyslipidemia as a Main Risk Factor.

OBJECTIVE: To assess the prevalence and risk factors of erectile dysfunction (ED) in HIV patients from the HIV clinic of a tertiary referral center in Mexico City. DESIGN: Prevalence was obtained from cross-sectional studies, and the International Index of Erectile Function (IIEF), a standardized method, was used to assess ED. METHODS: A cross-sectional study was performed in the HIV clinic. Participants completed the IIEF to allow ED assessment. Information on demographics, clinical and HIV-related variables was retrieved from their medical records. RESULTS: One hundred and nine patients were included, with a mean age of 39.9 ± 8.8 years. ED was present in 65.1% of the individuals. Patients had been diagnosed with HIV for a mean of 92.7 ± 70.3 months and had undergone a mean 56.4 ± 45.5 months of HAART. The only variable associated with ED in the univariate analysis was dyslipidemia, and this association was also found in the multivariate analysis (P = 0.01). CONCLUSIONS: ED is highly prevalent in HIV patients. Dyslipidemia should be considered as a risk factor for ED in HIV patients. Romero-Velez G, Lisker-Cervantes A, Villeda-Sandoval CI, Sotomayor de Zavaleta M, Olvera-Posada D, Sierra-Madero JG, Arreguin-Camacho LO, and Castillejos-Molina RA. Erectile dysfunction among HIV patients undergoing highly active antiretroviral therapy: Dyslipidemia as a main risk factor. Sex Med 2014;2:24-30.

Transfusion-associated HIV infection in Mexico related to paid blood donors; HIV epidemic.

The objective of the study was to describe the clinical, epidemiological profile and conditional incubation period in a group of transfusion-associated HIV-infected (TAHI) patients seen in five national tertiary care centres in Mexico from 1983 to April 1998. Date of transfusions, AIDS diagnoses, opportunistic infections and malignancies were collected. The incubation period was estimated through a non-parametric conditional analysis. One hundred and fifty-seven TAHI cases were analysed. The frequency of TAHI by year of transfusion was: 0.6% in 1980 and 1981, 4.5% in 1984, 22.4% in 1985, 54.5% in 1986, 10.3% in 1987, 0.6% in 1988, 1.9% in 1989 and 1990, 1.3% in 1993 and 0.6% in 1994 and 1996. The median incubation period was 4.3 years. A well-defined epidemic period of HIV-infection among blood-recipients was identified that coincided with the HIV-epidemic among paid donors. TAHI patients in Mexico developed AIDS in a shorter time than that described for other populations.