10 research outputs found

    The ethics of testing a test: randomized trials of the health impact of diagnostic tests for infectious diseases.

    No full text
    In the last decade, many new rapid diagnostic tests for infectious diseases have been developed. In general, these new tests are developed with the intent to optimize feasibility and population health, not accuracy alone. However, unlike drugs or vaccines, diagnostic tests are evaluated and licensed on the basis of accuracy, not health impact (eg, reduced morbidity or mortality). Thus, these tests are sometimes recommended or scaled up for purposes of improving population health without randomized evidence that they do so. We highlight the importance of randomized trials to evaluate the health impact of novel diagnostics and note that such trials raise distinctive ethical challenges of equipoise, equity, and informed consent. We discuss the distinction between equipoise for patient-important outcomes versus diagnostic accuracy, the equity implications of evaluating health impact of diagnostics under routine conditions, and the importance of offering reasonable choices for informed consent in diagnostic trials

    Gender-related barriers and delays in accessing tuberculosis diagnostic and treatment services: a systematic review of qualitative studies. Tuberc Res Treat.

    No full text
    Background. Tuberculosis (TB) remains a significant global public health problem with known gender-related (male versus female) disparities. We reviewed the qualitative evidence (written/spoken narrative) for gender-related differences limiting TB service access from symptom onset to treatment initiation. Methods. Following a systematic process, we searched 12 electronic databases, included qualitative studies that assessed gender differences in accessing TB diagnostic and treatment services, abstracted data, and assessed study validity. Using a modified "inductive coding" system, we synthesized emergent themes within defined barriers and delays limiting access at the individual and provider/system levels and examined gender-related differences. Results. Among 13,448 studies, 28 studies were included. All were conducted in developing countries and assessed individual-level barriers; 11 (39%) assessed provider/system-level barriers, 18 (64%) surveyed persons with suspected or diagnosed TB, and 7 (25%) exclusively surveyed randomly sampled community members or health care workers. Each barrier affected both genders but had gendervariable nature and impact reflecting sociodemographic themes. Women experienced financial and physical dependence, lower general literacy, and household stigma, whereas men faced work-related financial and physical barriers and community-based stigma. Conclusions. In developing countries, barriers limiting access to TB care have context-specific gender-related differences that can inform integrated interventions to optimize TB services

    ResistĂȘncia aos medicamentos anti-tuberculose de cepas de Mycobacterium tuberculosis isoladas de pacientes atendidos em hospital geral de referĂȘncia para tratamento de AIDS no Rio de Janeiro

    No full text
    INTRODUÇÃO: A tuberculose tem trazido importantes desafios ao setor de saĂșde. O Brasil tem alta prevalĂȘncia da doença e o Estado do Rio de Janeiro possui as maiores taxas de incidĂȘncia do paĂ­s. O municĂ­pio do Rio de Janeiro Ă© responsĂĄvel pela maior notificação do estado e cerca de 30% dos casos diagnosticados tĂȘm origem em hospitais. OBJETIVO: Estimar a prevalĂȘncia de resistĂȘncia inicial e adquirida e identificar fatores associados Ă  ocorrĂȘncia de resistĂȘncia em hospital geral referĂȘncia para tratamento de AIDS no Rio de Janeiro. MÉTODO: Foram analisadas cepas de Mycobacterium tuberculosis de 165 pacientes, entre agosto de 1.996 e fevereiro de 1.998. RESULTADOS: Vinte por cento (33/165) apresentaram resistĂȘncia a pelo menos um medicamento: 13% (22/165) Ă  isoniazida, 1,8% (3/165) Ă  rifampicina e 3,6% (6/165) a ambas. Entre pacientes infectados pelo HIV (52/165), 28,85% (15/52) apresentaram resistĂȘncia a pelo menos um fĂĄrmaco. ResistĂȘncia adquirida ocorreu em 12,5% dos pacientes que referiram tratamento anterior (3/24), com associação significativa com imagem radiolĂłgica nĂŁo cavitĂĄria (p = 0,05). ResistĂȘncia inicial ocorreu em 18,4% dos pacientes virgens de tratamento (26/141), com associação significativa com ser profissional de saĂșde (p = 0,004), desemprego (p = 0,03) e diarrĂ©ia (p = 0,01) na anĂĄlise bivariada. Na anĂĄlise multivariada, ser profissional de saĂșde manteve-se fortemente associado com a ocorrĂȘncia de resistĂȘncia inicial (p = 0,002). CONCLUSÃO: Taxas de resistĂȘncia elevadas foram encontradas nesta sĂ©rie. Estes achados corroboram a necessidade de que atenção maior seja dada Ă  tuberculose em ambiente hospitalar, em especial no que diz respeito Ă  preocupante associação entre resistĂȘncia nas cepas isoladas e profissionais de saĂșde

    Undiagnosed tuberculosis among HIV clinic attendees: association with antiretroviral therapy and implications for intensified case finding, isoniazid preventive therapy, and infection control.

    No full text
    OBJECTIVES: Initiation of antiretroviral therapy (ART) and the 3I's are strategies to prevent HIV-associated tuberculosis (TB). We describe factors associated with undiagnosed TB among HIV-infected patients attending an HIV clinic in South Africa and discuss implications for the 3 Is. DESIGN: Convenience sample of HIV clinic attendees. METHODS: HIV-infected participants were assessed for TB using a symptom screen, sputum-smear microscopy, sputum and blood mycobacterial culture, fine needle aspiration of enlarged lymph nodes, and chest radiography. RESULTS: Four hundred twenty-two participants were enrolled. The median age and CD4+ T-cell count were 37 years [interquartile range (IQR): 31-44 years] and 215 cells per microliter (IQR: 107-347 cells/ÎŒL). Forty-seven percent had been on ART for a median duration of 8 months (IQR: 3.3-22.8 months). Three hundred sixty-one participants (85.6%) reported TB symptoms. Twenty-seven participants (6.4%) met criteria for bacteriologically confirmed TB and 50 (11.6%) for any form of TB. Bacteriologically confirmed TB was associated with CD4+ T-cell counts ≀100 cells per microliter (odds ratio: 5.05, 95% confidence interval: 1.69 to 15.12) when compared with CD4+ T-cell counts >200 cells per microliter and hemoglobin {hemoglobin < 10 g/dL [odds ratio 3.12 (95% confidence interval: 1.26 to 7.72)]}. CONCLUSIONS: Undiagnosed TB among HIV-infected ambulatory patients was associated with low CD4+ T-cell counts regardless of ART status. TB screening algorithms which include CD4+ T-cell count and hemoglobin testing may be an effective way to identify HIV-infected clinic attendees at highest risk of undiagnosed TB. Isoniazid preventive therapy and TB infection control are essential for reducing occurrence of HIV-associated TB even after ART initiation

    Diagnostic accuracy of a urine lipoarabinomannan enzyme-linked immunosorbent assay for screening ambulatory HIV-infected persons for tuberculosis.

    No full text
    OBJECTIVE: To assess the diagnostic accuracy of the urine lipoarabinomannan (LAM) test among ambulatory HIV-infected persons. DESIGN: Cross-sectional. METHODS: HIV-infected persons consecutively presenting to the HIV Clinic at Tembisa Main Clinic in Ekhuruleni, South Africa, were screened for symptoms of tuberculosis (TB) and asked to provide sputum and blood samples for smears for acid-fast bacilli and mycobacterial culture and a urine specimen for a LAM enzyme-linked immunosorbent assay. Fine needle aspirates were obtained from participants with enlarged lymph nodes and sent for histopathology. Nonpregnant participants underwent chest x-ray. RESULTS: : Four hundred twenty-two HIV-infected participants were enrolled with median age 37 years (interquartile range: 31-44 years), median CD4+ T-cell count 215 cells per microliter (interquartile range: 107-347 cells/ÎŒL), and 212 (50%) receiving antiretroviral therapy. Thirty (7%) had active TB: 18 with only pulmonary TB, 5 with only extrapulmonary TB, and 7 with both pulmonary TB and extrapulmonary TB. Twenty-seven percent [95% confidence interval (CI): 12% to 48%] of TB cases were sputum acid-fast bacilli positive. The sensitivity and specificity of the urine LAM compared with the gold standard of positive bacteriology or histopathology were 32% (95% CI: 16% to 52%) and 98% (95% CI: 96% to 99%), respectively. Urine LAM had higher sensitivity in TB cases with higher bacillary burdens, though these differences were not statistically significant. CONCLUSIONS: The sensitivity of urine LAM testing is inadequate to replace mycobacterial culture. In contrast to prior research on the urine LAM, this study was conducted among less sick, ambulatory HIV-infected patients presenting for routine care
    corecore