Can Follow-Up Examination of Tuberculosis Patients Be Simplified? A Study in Chhattisgarh, India

Kundu, Debashish; Kumar, Ajay; Satyanarayana, Srinath; Dewan, Puneet; Nair, Sreenivas Achuthan; Khaparde, Kshitij; Nayak, Priyakanta; Bergh, Rafaël Van den; Manzi, Marcel; Enarson, Donald A.; Deshpande, Madhav Rao; Chandraker, Sachin

doi:10.1371/journal.pone.0051038

Cited by 6 publications

(5 citation statements)

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“…This is similar to reports from other studies from India. [4][5][6]8,13 Missing these would mean not extending the intensive phase of treatment or a delay in switching to the retreatment regimen for a very small number of patients. Both these measures are no longer recommended by the WHO.…”

Section: Discussionmentioning

confidence: 99%

“…3 Previous operational research studies conducted in India and other countries in Africa have found that the proportion of patients with the first sample smear-negative and the second smear-positive (NP) was low, ranging from 0.3% to 4.1%, irrespective of the month of follow-up examination and category of TB patient. [4][5][6][7] There is also evidence to suggest that most of these results, where only one of the two smears are positive, are culture-negative, meaning that there were no viable tubercle bacilli. 8 Based on this evidence, India's Revised National Tuberculosis Control Programme made a national policy decision in 2016 to examine only one sputum specimen during follow-up examinations.…”

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confidence: 99%

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How many sputum samples should be examined during follow-up of tuberculosis patients in Myanmar: two or one?

Win

Kumar

Kyaw

et al. 2018

public health action

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

How many sputum samples should be examined during follow-up of tuberculosis patients in Myanmar: two or one?

Win

Kumar

Kyaw

et al. 2018

public health action

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“…Hence, we will also benefit from the savings in cost and time incurred for the laboratory, which can be used for further improving quality of smear microscopy. In a study done in various microscopy centres of the state of Chattisgarh, India in 2012, decreasing the number of sputum examinations during follow-up can reduce the overall laboratory workload by 15% [31]. Therefore, we strongly recommend discontinuation of examining third sample if the first two were confirmed especially in areas where sputum culture could not be done.…”

Section: Discussionmentioning

confidence: 99%

Value of Repeated Direct Smear Sputum Examination in the Diagnosis of Pulmonary Tuberculosis

Hassan¹,

Omar²,

Khalil³

et al. 2014

OJRD

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Introduction: The examination of three sputum samples per suspect has been severely criticized from a public health viewpoint and several recent trials have documented the relative inefficiency of the third smear and the necessity for confirmation of a positive smear has also been contested. Aim: This study, undertaken in Qena, Egypt, aimed to determine the usefulness of examining the second and third direct smear microscopy (DSM) specimen in the diagnosis of pulmonary TB. Patients and methods: A retrospective study using record review at TB outpatient clinic; Qena Chest Hospital, Egypt, was done from 2010-2013. Direct smear results were collected as one of the following combinations PNN, PPP, PPN, PNP, NNP, NPP, and NPN, NNN, where N is a negative and P a positive smear. The proportion of positive, first, second and third specimen were calculated. Cases were considered positive having at least one positive smear confirmed by another positive one in the absence of sputum culture. Results: Out of 9420 recorded suspects, 719 of them were positive, so smear positivity was 7.6%. The majority of them were diagnosed from the first sample (96.4%). For only 3.6% (26 of 719), the second smear was positive and a third specimen was required (NPP) to make a definitive diagnosis of TB. No recorded isolated positive or negative smears in the third sample (NNP or PPN). Conclusions: These data indicated that, in our locality with limited financial resources, the incremental yield of a second sputum direct smear examination was low, and the third one was negligible indicating that examination of two sputum samples is enough among pulmonary TB patients. A third sample is required only as confirmatory if the second sample was positive. Smear microscopy can be substantially simplified with favourable resource implications.

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“…Previous studies have demonstrated the low incremental yield of the second specimen and the potential to reduce laboratory workload and costs for the programme by examining only one specimen. 3 Given the benefits for the patient of eliminating the additional visit required for the second examination, we strongly recommend the following change in global policy: a switch from two specimens to one specimen during follow-up and confirmation of a positive smear by a second positive smear before declaring a patient a bacteriological failure. This is in line with the recommendation of The Union.…”

Section: Public Health Action 2 Vs 1 Specimens During Follow-up 306mentioning

confidence: 99%

“…1,2 Previous operational research from India and other countries has shown that the incremental yield of a second smear was very low, irrespective of the month of f ollow-up and category of TB patient, and have questioned the value of a second smear. [3][4][5] Previous studies have also shown that the specificity of smear microscopy to detect living tubercle bacilli during treatment follow-up is low: more than two thirds of all follow-up smear-positives were culture-negative. [6][7][8][9] In addition, whenever only one of the two smears was positive, they were mainly graded as scanty or '1+ positive', possibly indicating fewer and mostly non-viable bacilli.…”

mentioning

confidence: 99%

Number of sputum specimens during treatment follow-up of tuberculosis patients: two or one?

Kumar

Kumar²,

Claassens

et al. 2013

public health action

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STUDY POPULATION, DESIGN AND METHODSWe reviewed the records of new culture-confirmed smear-positive TB patients enrolled into four clinical trials conducted between January 2000 and July 2012 at the National Institute for Research in Tuberculosis (NIRT) in Chennai, India. The patients received the Category I 6-month rifampicin-containing intermittent regimen (2(EHRZ) 3 /4(HR) 3 *) and underwent monthly follow-up sputum examinations on three sputum specimens (two overnight specimens and one spot sample) at every visit. Sputum smear examination was performed using fluorescence microscopy and culture on Löwenstein-Jensen medium (modified Petroff's method). Smears were prepared directly from unprocessed sputum, stained with auramine rhodamine, read under fluorescence microscopy and graded as follows: <6 bacilli/high power field (HPF; 1+), 6-100 bacilli/HPF (2+), and >100 bacilli/HPF or large clumps (3+). 10 We collected information on the results of sputum smear (with grading) and culture during treatment follow-up at months 1-6, including age, sex and human immunodeficiency virus (HIV) status.Data were double-entered and analysed using EpiData version 3.1 (EpiData Association, Odense, Denmark).As they were of better quality, we used the two overnight specimens for the primary analysis of the pattern of serial smear results. We also analysed other combinations of importance for the programme: a spot specimen with the first overnight specimen and then separately with the second overnight specimen. The subject was considered culture-negative only if all specimens tested were culture-negative (defined as lack of growth of tubercle bacilli after 3 months). The proportion of smear-positive, culture-negative samples was calculated for every month of follow-up. For the purposes of examining the relationship between smear grading and culture, the unit of analysis was the specimen rather than the patient. Results: Among 520 patients (176 infected with the human immunodeficiency virus), the proportions of culturenegative patients with NN, discordant (PN or NP) and PP patterns were approximately 98%, 80% and 40%, respectively. The smear-positive culture-negative phenomenon was more frequent in follow-up smear results graded 1+, followed by 2+ and 3+. Conclusion: There is justification for discontinuing the examination of second specimens during treatment followup among TB patients. However, a positive result on the first smear needs to be confirmed by a second positive result before making clinical management decisions. The World Health Organization may need to reconsider its recommendation on this issue. International Union Against Tuberculosis and Lung Disease The World Health Organization (WHO) recommends that two sputum examinations be performed during treatment follow-up of tuberculosis (TB) patients and that a positive result in any one of the samples be considered smear-positive. 1,2 Previous operational research from India and other countries has shown that the incremental yield of a second smear was very low, irrespec...

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Can Follow-Up Examination of Tuberculosis Patients Be Simplified? A Study in Chhattisgarh, India

Cited by 6 publications

References 1 publication

How many sputum samples should be examined during follow-up of tuberculosis patients in Myanmar: two or one?

How many sputum samples should be examined during follow-up of tuberculosis patients in Myanmar: two or one?

Value of Repeated Direct Smear Sputum Examination in the Diagnosis of Pulmonary Tuberculosis

Number of sputum specimens during treatment follow-up of tuberculosis patients: two or one?

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