Venous thromboembolic disease in adults admitted to hospital in a setting with a high burden of HIV and TB.

BACKGROUND: HIV and tuberculosis (TB) independently cause an increased risk for venous thromboembolic disease (VTE): deep vein thrombosis (DVT) and/or pulmonary embolism (PE). Data from high HIV and TB burden settings describing VTE are scarce. The Wells' DVT and PE scores are widely used but their utility in these settings has not been reported on extensively. OBJECTIVES: To evaluate new onset VTE, compare clinical characteristics by HIV status, and the presence or absence of TB disease in our setting. We also calculate the Wells' score for all patients. METHODS: A prospective cohort of adult in-patients with radiologically confirmed VTE were recruited into the study between September 2015 and May 2016. Demographics, presence of TB, HIV status, duration of treatment, CD4 count, viral load, VTE risk factors, and parameters to calculate the Wells' score were collected. RESULTS: We recruited 100 patients. Most of the patients were HIV-infected (n=59), 39 had TB disease and 32 were HIV/TB co-infected. Most of the patients had DVT only (n=83); 11 had PE, and 6 had both DVT and PE. More than a third of patients on antiretroviral treatment (ART) (43%; n=18/42) were on treatment for <6 months. Half of the patients (51%; n=20/39) were on TB treatment for <1 month. The median (interquartile range (IQR)) DVT and PE Wells' score in all sub-groups was 3.0 (1.0 - 4.0) and 3.0 (2.5 - 4.5), respectively. CONCLUSION: HIV/TB co-infection appears to confer a risk for VTE, especially early after initiation of ART and/or TB treatment, and therefore requires careful monitoring for VTE and early initiation of thrombo-prophylaxis.

Predictors of delay in the diagnosis and treatment of suspected tuberculosis in HIV co-infected patients in South Africa.

SETTING: In South Africa, the majority of tuberculosis (TB) patients are co-infected with the human immunodeficiency virus (HIV), and delays in diagnosis and treatment likely exacerbate morbidity and mortality. OBJECTIVE: To determine predictors of delays in the diagnosis and treatment of hospitalised suspected pulmonary TB patients co-infected with HIV. DESIGN: Post-analysis of data collected in a three-centre prospective cohort of in-patients clinically diagnosed with active TB in three hospitals in South Africa between 2006 and 2009 during the first 24 h of admission. Delay was assessed by asking time of first symptoms and any prior health-seeking behaviour for this episode of illness. RESULTS: Data from a total of 891 participants with a median age of 36 years and a CD4 count of 67 cells/mm(3) were analysed. Median patient, system and total delays were respectively 28, 1 and 28 days. Unemployment, treatment at Tshepong Hospital, alcohol consumption, crowding index, seeking prior treatment, cotrimoxazole treatment and WHO Stage 4 disease predicted prolonged total delay. CONCLUSION: Patient delay in seeking care for TB in this high HIV prevalence setting is substantial. Factors identified with delay could be used to develop interventions to improve care seeking and earlier diagnosis of TB.

Using VCT statistics from Kenya in understanding the association between gender and HIV.

This paper demonstrates the importance of utilising official statistics from the voluntary counselling and testing centres (VCT) to determine the association between gender and HIV infection rates in Kenya.The study design adopted was a record based survey of data collected from VCT sites in Kenya between the second quarter of 2001 and the second quarter of 2004. Of those who were tested, significantly more females tested positive (P<0.0001) and had twice as high a chance of being infected by HIV (Odds ratio 2.27 with CI 2.23 to 2.31) than males.We conclude that VCT statistics may lead to better planning of services and gender sensitive interventions if utilised well.

Intention-to-treat analysis in the chronic suppurative otitis media trials.

OBJECTIVE: To determine the extent of application of the intention to treat principle in the chronic suppurative otitis media (CSOM) randomised controlled trials. DESIGN: Data were extracted from 28 CSOM randomised controlled trials. MAIN OUTCOME MEASURES: Conceptual and methodological approaches of dealing with protocol deviations with respect to withdrawal, missing response and non-compliance. RESULTS: Of the 28 CSOM trials included in this study, only one (4%) trial mentioned intention-to-treat (ITT) analysis. However, 10(36%) other trials which did not mention ITT, had no protocol deviations and thus carried out an ITT analysis by default. It is highly likely that a biased treatment effect existed in the trial that mentioned ITT since the authors undertook a complete case analysis disregarding the 22% protocol deviators. There were no attempts in any of the trials to impute for missing responses and carrying out a sensitivity analysis. For trials with a big percentage of protocol deviations, the validity of their results are brought to question. CONCLUSIONS: In practice, not all those entered into a randomised-controlled trial will complete the trial. Thus intention-to-treat analysis is an important aspect of randomised controlled trials of health care interventions which tries to bridge this gap. It is important for authors to explicitly state the protocol deviations, the methods used to handle them and the potential effect with reference to bias and study outcome.