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Evaluation of the performance of clinical predictors in estimating the probability of pulmonary tuberculosis among smear-negative cases in Northern Ethiopia: a cross-sectional study.

ABSTRACT: OBJECTIVES:To evaluate the performance of the predictors in estimating the probability of pulmonary tuberculosis (PTB) when all versus only significant variables are combined into a decision model (1) among all clinical suspects and (2) among smear-negative cases based on the results of culture tests. DESIGN:A cross-sectional study. SETTING:Two public referral hospitals in Tigray, Ethiopia. PARTICIPANTS:A total of 426 consecutive adult patients admitted to the hospitals with clinical suspicion of PTB were screened by sputum smear microscopy and chest radiograph (chest X-ray (CXR)) in accordance with the Ethiopian guidelines of the National Tuberculosis and Leprosy Program. Discontinuation of antituberculosis therapy in the past 3 months, unproductive cough, HIV positivity and unwillingness to give written informed consent were the basis of exclusion from the study. PRIMARY AND SECONDARY OUTCOME MEASURES:A total of 354 patients were included in the final analysis, while 72 patients were excluded because culture tests were not done. RESULTS:The strongest predictive variables of culture-positive PTB among patients with clinical suspicion were a positive smear test (OR 172; 95% CI 23.23 to 1273.54) and having CXR lesions compatible with PTB (OR 10.401; 95% CI 5.862 to 18.454). The regression model had a good predictive performance for identifying culture-positive PTB among patients with clinical suspicion (area under the curve (AUC) 0.84), but it was rather poor in patients with a negative smear result (AUC 0.64). Combining all the predictors in the model compared with only the independent significant variables did not really improve its performance to identify culture-positive (AUC 0.84-0.87) and culture-negative (AUC 0.64-0.69) PTB. CONCLUSIONS:Our finding suggests that predictive models based on clinical variables will not be useful to discriminate patients with culture-negative PTB from patients with culture-positive PTB among patients with smear-negative cases.

SUBMITTER: George M

PROVIDER: S-EPMC7640509 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Evaluation of the performance of clinical predictors in estimating the probability of pulmonary tuberculosis among smear-negative cases in Northern Ethiopia: a cross-sectional study.

George Mala M Dinant Geert-Jan GJ Kentiba Efrem E Teshome Teklu T Teshome Abinet A Tsegaye Behailu B Spigt Mark M

BMJ open 20201103 11

<h4>Objectives</h4>To evaluate the performance of the predictors in estimating the probability of pulmonary tuberculosis (PTB) when all versus only significant variables are combined into a decision model (1) among all clinical suspects and (2) among smear-negative cases based on the results of culture tests.<h4>Design</h4>A cross-sectional study.<h4>Setting</h4>Two public referral hospitals in Tigray, Ethiopia.<h4>Participants</h4>A total of 426 consecutive adult patients admitted to the hospit ...[more]

PMID: 33148731

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Project description:BackgroundSputum smear conversion is a key indicator of treatment response and reduced infectivity among bacteriologically confirmed pulmonary tuberculosis (PTB) patients. This study aimed at estimating sputum smear conversion and identifying factors hindering sputum smear conversion among bacteriologically confirmed PTB cases in East Gojjam Zone, Northwest Ethiopia.MethodsA total of 282 bacteriologically confirmed PTB patients were followed for 22 weeks through weekly sputum smear examination. Due to the absence of sputum culture and rapid diagnostic services, sputum smear conversion evaluation was conducted microscopically using acid-fast-bacilli staining technique of sediments from a 5% sodium hypochlorite concentration technique. Data on socio-demographic, clinical profile and personal behavior variables were collected using a pretested interviewer-administered questionnaire. Various descriptive statistics including mean, median with interquartile range (IQR), and proportions were computed to describe study objectives. Factors of sputum smear conversion were identified by multivariable logistic regression analysis and statistical significance was determined at a p value < 0.05.ResultsOver half, 166 (59%) of bacteriologically confirmed PTB patients were males and 147 (52%) were rural dwellers. The mean age of respondents was 35 ± 5 SD years. About 88 (31.2%) of bacteriologically confirmed PTB patients had comorbidities, 102 (36.2%) faced stigma, and 54 (19%) history of cigarette smoking. The median sputum smear conversions during the intensive phase and 5th months of treatment follow up were 35 dyas (IQR: 21-56 days) and 53 days (IQR: 28-82 days), respectuvely. The majority, 85% (95% CI 76-93%) and 95% (95% CI 85-99%) of bacteriologically confirmed PTB patients underwent sputum smear conversion at the end of 2nd and 5th months of treatment, respectively. Poor knowledge on TB, being HIV positive, higher smear grading, having diabetes mellitus, undernutrition, cigarette smoking, facing societal stigma, and TB service delays were positively associated with the length of sputum smear conversion (p value < 0.05).ConclusionBased on this study, the median sputum smear conversion time was higher compared to TB program expectations and findings from former studies. The study also identified important factors associated with sputum smear conversion time. Improving health literacy of the community by revising the existing community awareness strategies is essential to enhance treatment adherence and lower infectiousness after treatment initiation.

Project description:BackgroundThe 2007 WHO algorithm for diagnosis of smear-negative pulmonary tuberculosis (PTB) including Mycobacterium tuberculosis (MTB) culture was evaluated in a HIV prevalent area of Kenya.MethodsPTB smear-negative adult suspects were included in a prospective diagnostic study (2009-2011). In addition, program data (2008-2009) were retrospectively analysed. At the first consultation, clinical examination, chest X-ray, and sputum culture (Thin-Layer-Agar and Lowenstein-Jensen) were performed. Patients not started on TB treatment were clinically re-assessed after antibiotic course. The algorithm performance was calculated using culture as reference standard.Results380 patients were included prospectively and 406 analyzed retrospectively. Culture was positive for MTB in 17.5% (61/348) and 21.8% (72/330) of cases. Sensitivity of the clinical-radiological algorithm was 55.0% and 31.9% in the prospective study and the program data analysis, respectively. Specificity, positive and negative predictive values were 72.9%, 29.7% and 88.6% in the prospective study and 79.8%, 30.7% and 80.8% in the program data analysis. Performing culture increased the number of confirmed TB patients started on treatment by 43.3% in the prospective study and by 44.4% in the program data analysis. Median time to treatment of confirmed TB patients was 6 days in the prospective study and 27 days in the retrospective study. Inter-reader agreement for X-ray interpretation between the study clinician and a radiologist was low (Kappa coefficient?=?0.11, 95%CI: 0.09-0.12). In a multivariate logistic analysis, past TB history, number of symptoms and signs at the clinical exam were independently associated with risk of overtreatment.ConclusionThe clinical-radiological algorithm is suboptimal to diagnose smear-negative PTB. Culture increases significantly the proportion of confirmed TB cases started on treatment. Better access to rapid MTB culture and development of new diagnostic tests is necessary.

Dataset Information

Evaluation of the performance of clinical predictors in estimating the probability of pulmonary tuberculosis among smear-negative cases in Northern Ethiopia: a cross-sectional study.

Publications

Evaluation of the performance of clinical predictors in estimating the probability of pulmonary tuberculosis among smear-negative cases in Northern Ethiopia: a cross-sectional study.

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