Letters National clinical audit results database

Clinical audit: more of a dream than a reality in India

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2514 (Published 03 April 2014) Cite this as: BMJ 2014;348:g2514

Clinical audit of India’s TB program (DOTS)

Anti-tuberculosis drugs were always given in daily doses. Twenty high burden countries continue that practice. India switched to thrice-weekly dosing in 1998, enrolling 15 million TB patients since, self-claiming 85% success.

Three Systematic Reviews have examined the ‘Daily v/s Thrice-weekly’ controversy. Cochrane[1] found ‘insufficient evidence to compare…’ the two. Review in Thorax[2] ‘…justifies…Daily… (particularly in initial phase) …’ Azhar[3] stated ‘Relapse rate is high (almost 10%) in India….higher than…international studies’, blaming India’s thrice-weekly regimen.

Paradox: India alone can resolve this controversy. Details of 15 million patients (given thrice-weekly doses) stand captured within hand-written registers, whose custodian (Govt. of India) and technical adviser (WHO) did not digitize (till 2012), release, or publish this 15-year data; systematic clinical audit was never conducted. A credible, transparent data-bank would have been a goldmine for research. Author’s 4-year clinical audit cum retrospective record review of thrice-weekly era in an Indian district (Faridabad) reveals that too many registered patients come back sick, meriting re-registration/re-treatment!

Serious issues need urgent investigation: DOTS (Directly observed treatment short-course) is a confusing term. Several national TB programs, even poles apart, are popularly called DOTS. Nepal’s DOTS is daily-regimen, Indian DOTS is thrice-weekly. In retreatment cases, both offer Streptomycin for an initial two months; that comes to 60 injections (one vial daily) in Nepal; 24 injections (three per week) in India, which appears inadequate, especially in Failure cases!

In Re-treatment patients, no cataloging of source of previous treatment - whether govt.’s DOTS, or private doctors who skeptically continue feeding daily-dose to 50% Indian patients; escalating confusion.
Cured patients are not followed - to quantify relapse.

Cavitary* tuberculosis is best treated with …daily IP…[4]. (*Indian program is sputum-smear based; chest X-ray not mandatory; who has cavities is unknown. Follow up of even sputum-negative PTB (diagnosed by X-rays) is by sputum-tests alone)!

Betraying lack of conviction in thrice-weekly system, India has recently reverted back to Daily-regimen for drug-resistant cases.

In 2698 sub-district TB Units, a supervisor alone is authorized to compile RNTCP reports. Floods or earthquake hit targets; fudging, safeguarding data – a survival skill, thwarting transparency!

Supervision (while patient swallows seven tablets!) is unfeasible. Sporadic drug-shortages (of Streptomycin, pediatric kits) go unreported; contract workers are scared, say nothing. No law for whistle-blowers. Entire govt. system may turn hostile, denying data or creating new fake registers!

Indian studies (over thrice-weekly) are meager, unexciting for international journals (and vice-versa), published locally; hence ineffective.

1. Mwandumba HC, Squire SB, Fully intermittent dosing with drugs for treating tuberculosis in adults. Cochrane Database of Systematic Reviews 2001, Issue 4, Art. No. CD000970
2. Kwok Chui Chang1, Chi Chiu Leung1, Jacques Grosset2, Wing Wai Yew, Review; Treatment of tuberculosis and optimal dosing schedules Thorax doi: 10.1136/thx.2010.148585
3. GS Azhar – DOTS for TB relapse in India: A Systematic Review. Lung India. 2012.29(2).
4. Kwok C. Chang, Chi C. Leung, Wing W, Yew, Shiu L. Chan, and Cheuk M. Tam, Dosing Schedules of 6-Month Regimens and Relapse for Pulmonary Tuberculosis, American Journal of Respiratory and Critical Care Medicine, Vol. 174, No. 10 (2006), pp. 1153-1158.

Key words: Tuberculosis, TB, DOTS, RNTCP, Relapse, Re-treatment, Re-registration, Intermittent regimen, Routine program conditions, Clinical audit.

Competing interests: No competing interests

10 September 2014
Medical Officer TB Control, District TB Center, RNTCP, BK Govt. Civil Hospital, Faridabad, Haryana, India
House No. 593, Sector 16, Faridabad, Haryana, India.