Validation of the RAND 36-Item Health Survey questionnaire in Brazil / Validação do questionário RAND 36-Item Health Survey no Brasil

ABSTRACT Background: Health-related quality of life is frequently used as an outcome measure that improves the quality of care. The SF-36 and RAND-36 were derived from the Medical Outcomes Study. Objective The present study aimed to validate the RAND-36 in Brazil, in healthy individuals and patients with liver disease. Methods: Confirmatory factor analysis (CFA) was conducted by using JASP Software. The parameters of the items were estimated using the Robust Diagonally Weighted Least Squares (RDWLS) approach. Comparative fit index (CFI), Goodness-of-fit index (GFI), Tucker-Lewis Index (TLI) and the root mean square error of approximation (RMSEA) were evaluated. Internal consistency was measured using the Composite reliability index. Convergent validity between RAND-36 domains and Work Ability Index (WAI) was conducted. Results: This validation study included 763 individuals, 400 (52.4%) with chronic liver disease. The most prevalent liver diseases were hepatitis C (13.9%), alcoholic liver disease (11.8%), and steatosis (12.1%). The measurement model tested using the CFA obtained the following adjustment indicators: X2 (df): 599.65 (498); CFI: 0.998; GFI: 0.998; TLI: 0.998; RMSEA: 0.016 (90%CI: 0.011-.021). Convergent validity of RAND-36 and total WAI ranged from medium to large correlation. Conclusion: The RAND-36 is effective in measuring the perception of health-related quality of life in individuals with and without chronic liver disease. The results of our study support the developer's claims for the reliability of the RAND-36 version 1 as a measure of health-related quality of life. The evidence for the construct validity of the RAND-36 was substantial.

RESUMO Contexto: A qualidade de vida relacionada à saúde é frequentemente usada como uma medida de resultado que melhora a qualidade da atenção à saúde. O SF-36 e o RAND-36 foram derivados do Medical Outcomes Study. Objetivo O presente estudo teve como objetivo validar o RAND-36 no Brasil, em indivíduos saudáveis e pacientes com doença hepática. Métodos: A análise fatorial confirmatória (AFC) foi realizada usando o software JASP. Os parâmetros do elemento foram estimados usando o método Robust Diagonally Weighted Least Squares (RDWLS). O índice de ajuste comparativo (CFI), o índice de adequação (GFI), o índice de Tucker-Lewis (TLI) e o erro quadrático médio de aproximação (RMSEA) foram avaliados. A consistência interna foi medida pelo índice de confiabilidade composta. A validade convergente foi realizada entre os domínios do RAND-36 e o Índice de Capacidade para o Trabalho (ICT). Resultados : Este estudo de validação incluiu 763 indivíduos, 400 (52,4%) com doença hepática crônica. As doenças hepáticas mais prevalentes foram hepatite C (13,9%), doença alcoólica do fígado (11,8%) e esteatose (12,1%). O modelo de medida testado com a AFC obteve os seguintes indicadores de ajuste: X2 (gl): 599,65 (498); CFI: 0,998; GFI: 0,998; TLI: 0,998; RMSEA: 0,016 (90%CI: 0,011-0,021). A validade convergente do RAND-36 e do ICT total variou de média a grande correlação. Conclusão: O RAND-36 é eficaz para medir a percepção da qualidade de vida relacionada à saúde em indivíduos com e sem doença hepática crônica. Os resultados do nosso estudo apoiam as afirmações dos desenvolvedores sobre a confiabilidade do RAND-36 versão 1 como uma medida de qualidade de vida relacionada à saúde. A evidência para a validade do construto do RAND-36 foi substancial.

Prevalence and risk factors for erectile dysfunction in HIV-infected patients in Salvador, Brazil

ABSTRACT Background: Effective antiretroviral therapy (ART) has increased life expectancy for HIV patients to levels close to that observed for general population. Comorbidities are also increasing, due to ageing of such population. Erectile dysfunction (ED) has been a frequent finding in men living with HIV. Objectives: The goals of the present study were to define the prevalence of ED and associated factors in HIV-infected men, in a referral center of Salvador city, Brazil. Methods: HIV-infected men ≥18 years of age, receiving care at the AIDS Clinics of Complexo Hospitalar Professor Edgard Santos (C-HUPES), Universidade Federal da Bahia were consecutively included in the study until the estimated sample size (N = 134) was reached. Patients filled a structured questionnaire on clinical-epidemiological characteristics, as well as the International Index on Erectile Function to assess ED. Results: Most (55%) were black and single (79%), mean age 44.8 years. ED was detected in 29 (21.6%) patients; 86% of ED cases were classified as severe. The only factors associated with ED were low income (p = 0.02) and unemployment (p = 0.01). No association was found between ED and frequency of comorbidities, age, or ART used by patients. Conclusion: In a referral center in Salvador city, socio-economic problems were the main factors associated with ED. Psychological impact of poor social conditions should be routinely assessed in patients with ED to implement preventive measures for ED.

Changes health-related quality of life in HIV-infected patients following initiation of antiretroviral therapy: a longitudinal study

Abstract Background: Several tools have been developed to evaluate HIV health-related quality of life (HRQoL) during and after antiretroviral therapy (ART). Few longitudinal studies evaluated the effect of ART on the quality of life of HIV patients. Objective: To evaluate changes in HRQoL in HIV-infected individuals one year after initiating ART. Methods: A prospective study was conducted from May 2016 to July 2018. Data on clinical and sociodemographic characteristics of 91 HIV-infected patients were collected prior to initiation of ART and one year thereafter. Demographic and clinical data were collected and the questionnaires 36-item Short Form Health Survey (SF-36) and HIV/AIDS-targeted quality of life (HAT-QoL) were administered in both periods. Asymptomatic individuals, aged ≥18 years, were included in the study. Patients who discontinued treatment were excluded. The association between predictors of physical and mental HRQoL was analyzed by multiple linear regression analysis. Results: Patients were predominantly male (78.0%), mean age 35.3 ± 10.7 years, with no stable relationship (80.2%), and no comorbidities (73.6%). Most of the SF-36 domains improved after one year, particularly Physical Function (p = 0.0001), General Health (p = 0.0001), Social Functioning (p = 0.0001), Mental Health (p = 0.001), and Mental Component Summary (p = 0.004). HAT-QoL domains improved in the Overall Function (p = 0.0001), Life Satisfaction (p = 0.0001), Provider Trust (p = 0.001), and Sexual Function (p = 0.0001) domains. Sex (p = 0.032), age (p = 0.001), income (p = 0.007), and stable relationship (p = 0.004) were good predictors of the Physical Component Summary. Sex (p = 0.002) and stable relationship (p = 0.038) were good predictors of the Mental Component Summary. SF-36 and HAT-QoL scales presented strong correlations, except for Medication Concerns (0.15-0.37), HIV Mastery (0.18-0.38), Disclosure Worries (−0.15 to 0.07), and Provider Trust (−0.07 to 0.15). Conclusions: ART improved HRQoL after one year of use. The HAT-QoL and SF-36 correlated well and are good tools to evaluate HRQoL in HIV-infected patients on ART.

HLA-B*14 allele predicts HIV-1 mother-to-child-transmission, in Salvador, Brazil

ABSTRACT Background: Class I human leukocyte antigens, especially the molecules encoded at the B locus (HLA-B), are associated with AIDS progression risk. Different groups of HLA-B alleles have been associated to a protective effect or increasing susceptibility to HIV infection and are expressed from the earliest stages of gestation. Objective: The aim of this study was to evaluate which variants of HLA-B are associated with the risk of HIV vertical transmission in infected pregnant women and in their offspring, in a referral center in Salvador Bahia. Methods: We performed HLA-B genotyping in 52 HIV-infected mothers and their children exposed to HIV-1 during pregnancy (N = 65) in Salvador, Brazil. We compared the HLA-B alleles frequency in mothers, uninfected and infected children, according to the use of antiretroviral prophylaxis. Results: Absence of antiretroviral antenatal and postnatal prophylaxis was significantly associated with vertical transmission of HIV-1 (p = <0.01, and p = <0.01 respectively). Frequency of HLA-B*14 (29.2%, p = 0.002), HLA-B*18 (16.7%, p = 0.04) or HLA-B*14:1 (20.8%, p = 0.01) alleles subgroups were significantly higher in HIV-1 infected children and persisted (HLA-B*14, p = 0.04) even after adjusting for use of antiretroviral prophylaxis. No significant difference in expression of HLA-B alleles was observed among mothers who transmitted the virus compared to those who did not. Conclusions: Expression of HLA-B*14 allele in children exposed to HIV-1 is predictive of vertical transmission and reinforces the important role of genetics in mother-to-child transmission.

Dinapenia e qualidade de vida em indivíduos infectados pelo HIV / Dynapenia and quality of life in HIV-infected individuals

O surgimento da terapia antirretroviral (TARV) eficaz, transformou o perfil evolutivo da infecção pelo vírus da imunodeficiência humana adquirida (HIV) em uma doença crônica, com o aumento da expectativa de vida e complicações relacionadas ao uso desta, como a fraqueza muscular. Objetivo: Descrever a ocorrência de dinapenia e sua relação com qualidade de vida em indivíduos infectados com HIV. Métodos: Estudo observacional, de corte transversal, onde a força de preensão palmar foi avaliada através da dinamometria. Foram incluídos indivíduos infectados pelo HIV com idade ≥18 anos e capacidade para aferição da força muscular. O diagnóstico de dinapenia foi determinado pelos critérios definidos pela literatura para avaliação da força de preensão palmar e o índice de massa corporal (IMC). Para avaliação da qualidade de vida utilizou-se o questionário de qualidade de vida Short-Form Health Survey (SF-36). Outras variáveis mensuradas foram tempo de uso de TARV e o Índice de Comorbidades de Charlson (ICC), além de idade, sexo e peso. Resultados: A presença de dinapenia foi de 11,6% na amostra estudada. Houve associação de dinapenia com as variáveis idade (p=0,0001), presença de cormobidades (p=0,0001), menor força de preensão palmar (p=0,0001) e menor IMC (p=0,033). A qualidade de vida mostrou-se comprometida tanto nos domínios de aspectos físicos quanto nos de aspectos mentais. Conclusão: Existe dinapenia em uma parte dos indivíduos com HIV e houve associação desta com pior qualidade de vida, sugerindo a necessidade de rastreio e tratamento deste problema nessa população, muitas vezes subnotificado

The appearance of effective antiretroviral therapy (ART) has transformed the evolutionary profile of acquired human immunodeficiency virus (HIV) into a chronic disease, with increased life expectancy but complications related to its use, such as muscle weakness. Objective: Describe the occurrence of dynapenia and its relationship with quality of life in HIV infected individuals. Methods: This is a cross-sectional observational study, in which handgrip strength was evaluated with handgrip dynamometry. HIV-infected individuals aged ≥18 years and ability to have muscle strength measured were included. The diagnosis of dynapenia was determined by the literature for handgrip strength evaluation and body mass index (BMI). Short-Form Health Survey (SF-36) was used to evaluate the quality of life, and other variables such as time to use ART and the Charlson Comorbidity Index (CCI), as well as age, gender and weight were recorded. Results: The presence of dynapenia was 11.6% in the sample studied. There was an association of dynapenia with the variables age (p = 0.0001), presence of cormobities (p = 0.0001), lower handgrip strength (p = 0.0001) and lower BMI (p = 0.033). The quality of life has been compromised in both the physical and mental domains. Conclusion: There is dynapenia in part of the individuals with HIV and its association with poorer quality of life was found, what suggests the necessity of screening and treatment of this often underreported health problem in this population

Quality of life, anxiety and depression in patients with HIV/AIDS who present poor adherence to antiretroviral therapy: a cross-sectional study in Salvador, Brazil

Abstract The introduction of highly active antiretroviral therapy marked a major gain in efficacy of HIV/AIDS treatment and a reduction in morbidity and mortality of the infected patients. However, high levels of adherence are required to obtain virologic suppression. In Brazil, the policy of free and universal access to antiretroviral therapy has been in place since 1996, although there are reports of poor adherence. Objective To define the clinical, demographic and psychological characteristics, and quality of life of patients with HIV/AIDS who present poor adherence to highly active antiretroviral therapy. Methods This was a cross-sectional study. To be included in the study patients had to be 18 through 65 years old, diagnosed with HIV/AIDS, having the two previous viral loads above 500 copies, a surrogate for poor adherence to antiretrovirals. The following instruments were applied to all eligible patients: the sociodemographic questionnaire "Adherence Follow-up Questionnaire", the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), and the 36-Item Short Form Survey. Results 47 patients were evaluated, 70.2% were female, mean age of 41.9 years (±10.5), 46.8% were single, 51.1% self-reported adherence ≥95%, 46.8% mentioned depression as the main reason for not taking the medication, 59.5% presented symptoms of moderate to severe depression, and 44.7% presented symptoms of moderate to severe anxiety. Finally, regarding health-related quality of life these patients obtained low scores in all dimensions, physical component summary of 43.96 (±9.64) and mental component summary of 33.19 (±13.35). Conclusion The psychological component is considered to be fundamental in the management of HIV/AIDS patients. Psychoeducation should be conducted at the initial evaluation to reduce negative beliefs regarding antiretroviral therapy Assessment of anxiety and depression symptoms should be done throughout therapy as both psycological conditions are associated with patient adherence, success of treatment, and ultimately with patients' quality of life.

Anogenital infection by Chlamydia trachomatis and Neisseria gonorrhoeae in HIV-infected men and women in Salvador, Brazil

ABSTRACT Background: Infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae are the most common bacterial sexually transmitted infections throughout the world. These sexually transmitted infections are a growing problem in people living with HIV/AIDS. However, the presence of these agents in extra genital sites, remains poorly studied in our country. The objective of this study was to estimate the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae anal and genital infection in people living with HIV/AIDS followed in a reference center in Salvador, Brazil. Methods: Cross-sectional study, from June 2013 to June 2015. Proven HIV-infected people attending this reference center were invited. Clinical and epidemiological data were obtained through interview with standardized form. Chlamydia trachomatis and Neisseria gonorrhoeae screening was performed using qPCR (COBAS 4800® Roche). Results: The frequency of positive cases of Chlamydia trachomatis and Neisseria gonorrhoeae was 12.3% in total, 9.2% cases amongst women and 17.1% amongst men. We found 14.0% of positive cases in anus and 3.1% in genital region in men, while 5.6% and 3.6%, in women, respectively. Among men, anal infection was associated with age <29 years (p = 0.033), report of anal intercourse (p = 0.029), pain during anal intercourse (p = 0.028). On the other hand, no association between genital infection and other variables were detected in bivariate analysis. Among women, we detected an association between Chlamydia trachomatis genital infection and age <29 years (p < 0.001), younger age at first sexual intercourse (p = 0.048), pregnancy (p < 0.001), viral load >50 copies/mL (p = 0.020), and no antiretroviral use (p = 0.008). Anal infection in women was associated with age <29 years old (p < 0.001) and pregnancy (p = 0.023), and was not associated with report of anal intercourse (p = 0.485). Conclusion: Missed opportunities for diagnosis in extra genital sites could impact on HIV transmission. The extra genital sites need to be considered to break the HIV and bacterial sexually transmitted infections chain-of-transmission.

Adherence to antiretroviral therapy of Brazilian HIV-infected children and their caregivers

Abstract Background Successful treatment of HIV-positive children requires a high level of adherence (at least 95%) to highly active antiretroviral therapy. Adherence is influenced by factors related to the child and caregivers. Objectives To evaluate children and caregivers characteristics associated to children's adherence. Methods Cross-sectional study, from September 2013 to June 2015, comprising a sample of caregivers of perinatally HIV-infected children, in the age group of 1–12 years, under antiretroviral therapy for at least 6 months and on follow-up in two AIDS reference centers in Salvador, Bahia. Caregiver self-reports were the sole source of 4 days adherence and sociodemographic information. Study participants who reported an intake >95% of prescribed medication were considered adherents. A variable, (“Composed Adherence”), was created to better evaluate adherence. Results We included 77 children and their caregivers. 88.3% of the caregivers were female, the median age was 38.0 years (IQR 33.5–47.5), 48.1% were white or mixed, 72.7% lived in Salvador and 53.2% had no fixed income. The 4 days child's adherence was associated only to caregivers that received less than a minimum salary (p < 0.05), 70.1% of the caregivers had less than four years of formal education, 81.8% were children's relative and 53.2% of the caregivers were HIV positive. The caregiver's pharmacy refill, long-term adherence and 4 days adherence, were significantly associated with composed adherence (p < 0.05). Child's long-term adherence was strongly associated to the 4 days child's adherence referred by caregiver (p < 0.001). Conclusions Our results suggest the need of improvement in HIV-infected children adherence, through reinforcement of the caregivers own adherence.

Brazilian experience in EU-CORE: daptomycin registry and treatment of serious Gram-positive infections

OBJECTIVES: To collect data about non-controlled prescribing use of daptomycin and its impact among Brazilian patients with serious Gram positive bacterial infection, as well as the efficacy and safety outcomes. MATERIALS AND METHODS: This is a multi-center, retrospective, non-interventional registry (August 01, 2009 to June 30, 2011) to collect data on 120 patients (44 patients in the first year and 76 patients in the second year) who had received at least one dose of commercial daptomycin in Brazil for the treatment of serious Gram-positive bacterial infection. RESULTS: Right-sided endocarditis (15.8%), complicated skin and soft tissue infections (cSSTI)wound (15.0%) and bacteremia-catheter-related (14.2%) were the most frequent primary infections; lung (21.7%) was the most common site for infection. Daptomycin was used empirically in 76 (63.3%) patients, and methicillin-resistant Staphylococcus aureus (MRSA) was the most common suspected pathogen (86.1%). 82.5% of the cultures were obtained prior to or shortly after initiation of daptomycin therapy. Staphylococcus spp. - coagulase negative, MRSA, and methicillin-susceptible S. aureus were the most frequently identified pathogens (23.8%, 23.8% and 12.5%, respectively). The most common daptomycin dose administered for bacteremia and cSSTI was 6 mg/kg (30.6%) and 4 mg/kg (51.7%), respectively. The median duration of inpatient daptomycin therapy was 14 days. Most patients (57.1%) did not receive daptomycin while in intensive care unit. Carbapenem (22.5%) was the most commonly used antibiotic concomitantly. The patients showed clinical improvement after two days (median) following the start of daptomycin therapy. The clinical success rate was 80.8% and the overall rate of treatment failure was 10.8%. The main reasons for daptomycin discontinuation were successful end of therapy (75.8%), switched therapy (11.7%), and treatment failure (4.2%). Daptomycin demonstrated a favorable safety and tolerability profile regardless of treatment duration. CONCLUSIONS: Daptomycin had a relevant role in the treatment of Gram-positive infections in the clinical practice setting in Brazil.

Syphilis and HIV-1 among parturient women in Salvador, Brazil: low prevalence of syphilis and high rate of loss to follow-up in HIV-infected women

BACKGROUND: The occurrence of syphilis and HIV-1 infections during pregnancy are major risks to the fetus due to mother-to-child transmission (MTCT). OBJECTIVES: To determine peripartum seroprevalence and risk factors of syphilis and HIV-1 infection among pregnant women in Salvador, Brazil, and the rate of HIV-1 MTCT. METHODS:Cross-sectional study of pregnant women who were admitted for delivery in a reference maternity hospital between May 2008 and March 2009 was conducted. Women were screened for HIV-1 infection and syphilis, and interviewed regarding demographic, behavioral and obstetric data. Newborns to HIV-infected mothers were tested by b-DNA and DNA-PCR to detect HIV-1. RESULTS: A total 3300/8516 women were evaluated. Mean age was 25.8 ± 7.3 years. HIV-1 and syphilis seroprevalence rates were 0.84% (28/3300) and 0.51% (17/3300), respectively. HIV-1 infection was associated with: low education (p = 0.04), having a partner with known HIV infection (p < 0.0001) or with previous sexually transmitted infection (p < 0.0001), blood transfusion (p = 0.003), or accidental exposure to blood (p = 0.003). Syphilis was associated with being Caucasian (p = 0.02), having no steady partner (p = 0.02), being a housewife (p = 0.01), having an intravenous drug user (IVDU) sexual partner (p = 0.04) or a sexual partner with previous STI (p < 0.001). Higher education (p = 0.04) was protective against HIV-infection. Attending a prenatal care program was protective against syphilis (p = 0.008) and HIV-1 (p = 0.02). No case of HIV-1 MTCT was detected, but 25% of children born to HIV-infected mothers were lost to follow up. CONCLUSIONS: In Salvador, peripartum prevalence of syphilis and HIV-1 infection among pregnant women were low, and associated with classic risk factors for both infections. The great proportion of very late diagnosis of HIV infection, and the high rate of loss of follow-up among positive mothers and their infants are of high concern.

Risk factors for infection by extended-spectrum beta-lactamase producing Klebsiella pneumoniae in a tertiary hospital in Salvador, Brazil

Nosocomial infection caused by extended-spectrum beta-lactamase producing Klebsiella pneumoniae (ESBL-Kp) have been frequently reported worldwide. We have no information on such problems in Bahia, Brazil. OBJECTIVES: Evaluate the risk factors for nosocomial infections caused by ESBL-Kp, in a tertiary hospital, in Bahia, Brazil. MATERIAL AND METHODS: We evaluated all reported cases of nosocomial infections caused by ESBL-Kp in a private, tertiary hospital, in Salvador, Brazil, from 2000 through 2004. We compared patients with a diagnosis of ESBL-Kp (cases) and patients infected by non-ESBL producing K. pneumoniae (controls). Mean age, underlying disease, and frequency of invasive procedures were compared between the two groups. History of previous use of antibiotics was also analyzed. RESULTS: Based on multivariate analysis, previous use of antibiotics, diagnosis of malignant diseases, and diabetes mellitus were independent risk factors for acquisition of ESBL-Kp infection. No correlation was found for age, use of corticosteroids, diagnosis of chronic renal failure or AIDS, and infection by ESBL-Kp. CONCLUSION: Our findings suggest that the use of antibiotics or underlying disease that increases the chance of antibiotic are the main risk factors for ESBL-Kp infections. Programs focusing on rational use of antibiotics are mandatory for prevention and control of such infections.

Clinical and epidemiological features of patients with chronic hepatitis C co-infected with HIV

Co-infection with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) is increasingly common and affects the clinical course of chronic hepatitis C. Highly active antiretroviral therapy has improved the life expectancy of HIV infected patients, but, by extending survival, it permits the development of HCV cirrhosis. This study tried to evaluate clinical and epidemiological features of patients with chronic hepatitis C co-infected with HIV. We evaluated 134 HCV-infected patients: i) group A - 65 co-infected HCV/HIV patients, ii) group B - 69 mono-infected HCV patients. The impact of HIV infection on HCV liver disease was analyzed using Child's score, ultrasound findings and liver histology. Patients were subjected to HCV genotyping and anti-HBs dosage. Patients mean age was 42.4 years (±9.1) and 97 (72.4 percent) were males. Injected drug use and homo/bisexual practice were more frequently encountered in the co-infected group: 68.3 percent and 78.0 percent, respectively. Antibodies against hepatitis B virus (anti-HBs) were found in only 38.1 percent of the patients (66.7 percent group A x 33.3 percent group B). Ten out of 14 individuals (71.4 percent) who had liver disease (Child B or C) and 25 out of 34 (73.5 percent) who showed ultrasound evidence of chronic liver disease were in the co-infection group. HCV genotype-2/3 was more frequently encountered in co-infected patients (36.9 percent group A vs. 21.8 percent group B). Conclusions: a) HIV infection seems to adversely affect the clinical course of chronic hepatitis C, b) injected drug use, bi/homosexual practice and genotype-2/3 were more frequently encountered in co-infected patients, c) immunization against HBV should be encouraged in these patients.