Are tuberculosis patients in a tertiary care hospital in Hyderabad, India being managed according to national guidelines?

Abstract

A tertiary health care facility (Government General and Chest hospital) in Hyderabad, India.
To assess a) the extent of compliance of specialists to standardized national (RNTCP) tuberculosis management guidelines and b) if patients on discharge from hospital were being appropriately linked up with peripheral health facilities for continuation of anti-Tuberculosis (TB) treatment.
A descriptive study using routine programme data and involving all TB patients admitted to inpatient care from 1(st) January to 30(th) June, 2010.
There were a total of 3120 patients admitted of whom, 1218 (39%) required anti-TB treatment. Of these 1104 (98%) were treated with one of the RNTCP recommended regimens, while 28 (2%) were treated with non-RNTCP regimens. The latter included individually tailored MDR-TB treatment regimens for 19 patients and adhoc regimens for nine patients. A total of 957 (86%) patients were eventually discharged from the hospital of whom 921 (96%) had a referral form filled for continuing treatment at a peripheral health facility. Formal feedback from peripheral health facilities on continuation of TB treatment was received for 682 (74%) patients. In a tertiary health facility with specialists the great majority of TB patients are managed in line with national guidelines. However a number of short-comings were revealed and measures to rectify these are discussed.

Full text

Page 1

Are Tuberculosis Patients in a Tertiary Care Hospital in
Hyderabad, India Being Managed According to National
Guidelines?
Kiran Kumar Kondapaka1*, Surapaneni Venkateswara Prasad1, Srinath Satyanarayana2, Subhakar
Kandi1, Rony Zachariah3, Anthony David Harries4,5, Sharath Burugina Nagaraja6, Shailaja Tetali7,
Raghupathy Anchala7, Nanda Kishore Kannuri7, Krishna Murthy8, Dhanamurthy Koppu1, Latha
Vangari9, Sreenivas Rao10
1Department of Pulmonary Medicine, Osmania Medical College, Hyderabad, India, 2International Union Against Tuberculosis and Lung Disease (The Union), South East
Asia Regional Office, New Delhi, India, 3Medecins sans Frontieres, Medical Department (Operational Research), Brussels Operational Center, Brussels, Luxembourg,
4International Union Against Tuberculosis and Lung Disease (The Union), Paris, France, 5Department of Infectious and Tropical Diseases, London School of Hygiene and
Tropical Medicine, London, United Kingdom, 6Office of the WHO Representative in India, New Delhi, India, 7Public Health Foundation of India (Indian Institute of Public
Health-Hyderabad), Hyderabad, India, 8Department of Pulmonary Medicine, Gandhi Medical College, Hyderabad, India, 9Department of Pediatrics, Osmania Medical
College, Hyderabad, India, 10State Tuberculosis Office, Andhra Pradesh, India
Abstract
Setting: A tertiary health care facility (Government General and Chest hospital) in Hyderabad, India.
Objectives: To assess a) the extent of compliance of specialists to standardized national (RNTCP) tuberculosis management
guidelines and b) if patients on discharge from hospital were being appropriately linked up with peripheral health facilities
for continuation of anti-Tuberculosis (TB) treatment.
Methods: A descriptive study using routine programme data and involving all TB patients admitted to inpatient care from
1stJanuary to 30thJune, 2010.
Results and Conclusions: There were a total of 3120 patients admitted of whom, 1218 (39%) required anti-TB treatment. Of
these 1104 (98%) were treated with one of the RNTCP recommended regimens, while 28 (2%) were treated with non-RNTCP
regimens. The latter included individually tailored MDR-TB treatment regimens for 19 patients and adhoc regimens for nine
patients. A total of 957 (86%) patients were eventually discharged from the hospital of whom 921 (96%) had a referral form
filled for continuing treatment at a peripheral health facility. Formal feedback from peripheral health facilities on
continuation of TB treatment was received for 682 (74%) patients. In a tertiary health facility with specialists the great
majority of TB patients are managed in line with national guidelines. However a number of short-comings were revealed
and measures to rectify these are discussed.
Citation: Kondapaka KK, Prasad SV, Satyanarayana S, Kandi S, Zachariah R, et al. (2012) Are Tuberculosis Patients in a Tertiary Care Hospital in Hyderabad, India
Being Managed According to National Guidelines? PLoS ONE 7(1): e30281. doi:10.1371/journal.pone.0030281
Editor: Madhukar Pai, McGill University, Canada
Received May 1, 2011; Accepted December 13, 2011; Published January 17, 2012
Copyright: ? 2012 Kondapaka et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This research was supported through an operational research course which was funded through a memorandum of understanding between the
Centre for Operational Research at The International Union Against Tuberculosis and Lung Disease (The Union) and the Public Health Foundation of India (PHFI).
The course was facilitated by faculty from the PHFI, The Union and The Operational Research Unit, Medecins sans Frontieres, Brussels Operational Centre,
Luxembourg. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
* E-mail: kiran033@yahoo.com
Introduction
India is one of the high tuberculosis (TB) burden countries in
the world accounting for nearly 20% of the global incidence of 9.4
million TB cases [1]. The Government of India has been
implementing a Revised National Tuberculosis Control Pro-
gramme (RNTCP) since 1997 in order to control the national TB
burden [2]. All health facilities including tertiary care centers are
required to follow standardized RNTCP guidelines for the
management of TB. In 2009, 92,071 (10%) smear positive cases
notified under RNTCP were diagnosed in tertiary care hospitals
including medical college hospitals [3].
The Government General and Chest Hospital (GG&CH) in
Hyderabad, India is one of the main tertiary care centres in the
state of Andhra Pradesh, where patients with TB requiring
inpatient care are admitted. This specialized hospital receives
patients from all over the state and beyond, and is well resourced
with specialized chest physicians and sophisticated diagnostic
facilities and has access to various types of anti-TB drugs. There is
a concern that specialized clinicians in such hospitals might not be
strictly following standardized RNTCP management guidelines as
they might be inclined to tailor TB management including drug
regimens to the specific needs of individual patients.
PLoS ONE | www.plosone.org1 January 2012 | Volume 7 | Issue 1 | e30281

Page 2

There is no published literature on whether such specialized
centers comply with stipulated national TB management guide-
lines. In addition, no information exists on whether these patients
successfully link up with peripheral health facilities for continua-
tion of their anti-TB treatment after discharge from hospital
inpatient care.
In this study we thus assessed a) the extent of compliance of the
GGCH to RNTCP management guidelines and b) if patients on
discharge were being appropriately linked up with peripheral
health facilities for continuation of anti-TB treatment.
Methods
Design
This was a descriptive study involving a retrospective record
review.
Study setting and population
GG&CH is a 670 bed hospital, linked to two medical colleges
providing out-patient and in-patient care for TB and chest
diseases. All patients presenting to the out patient department of
the hospital are examined and those diagnosed with all TB and
meriting in-patient admission receive anti-TB treatment on the
wards. The decision to admit the TB patients for inpatient care
rests with the specialist physicians depending on their assessment
of the clinical seriousness of the patients and there are no uniform
standard clinical or other criteria for admission. Once their
condition becomes stable enough to allow discharge, they continue
anti-TB treatment in a peripheral health facility.
The RNTCP follows WHO recommended guidelines for the
management of TB patients [2,4]. All TB patients requiring anti-
TB treatment are categorized and treated with thrice weekly
intermittent anti- TB treatment in a supervised manner. (Table 1)
During the hospital stay, all patients are registered and a
treatment card is provided. Directly observed treatment (DOTS) is
provided by the ward staff.
On discharge from the hospital ward, patients are formally
referred (by filling a referral for treatment form) to a DOTS TB
unit (TU) closest to the patient’s residence for continuation of anti-
TB treatment. The Medical officer of the respective unit sends a
formal feedback (usually by post) to the hospital acknowledging
reception of the patient at the peripheral facility by filling a
feedback form which will reach the tertiary care facility by post or
in person from the respective district TB officer. All referrals and
feedbacks are documented on a ‘referral for treatment’ register
maintained at GG&CH and updated on a daily basis.
The study population included all patients admitted to the
inpatient ward with a diagnosis of TB during the period 1st
January to 30thJune 2010.
Assessing compliance to RNTCP management guidelines
Data collected from case records and treatment cards of those
admitted to the GG&CH wards with a diagnosis of TB were
assessed to measure compliance to one of the recommended
RNTCP treatment regimens. If a patient was placed on an anti-
TB regimen as recommended by RNTCP guidelines, this was
defined as being compliant. If this was altered in any way, the
status was designated as being non compliant with RNTCP
guidelines. A successful linkage to continuing anti-TB care for a
given patient was defined as physical availability of a feedback
form, acknowledging reception of the referred patient at the
peripheral health facility.
Data collection and analysis
Data from the patient case records, the referral register and
feedback forms were used to gather information related to this
study. These data were entered into a pre-structured format on
Microsoft Excel. The data were analyzed using Epi-Info (version
6.0 CDC, Atlanta, USA).
Ethics Approval
The study was approved by the Ethics Advisory Group of the
International Union against Tuberculosis and Lung Diseases, the
Institutional Ethics Committee of the Public Health Foundation
of India and by the institutional ethical committee of Govern-
ment General and Chest Hospital. The activity was determined
to be a retrospective programme evaluation of the implementa-
tion of national guidelines, hence individual patient consent was
deemed unnecessary. Electronic databases created for this
analysis were stripped of personal health identifiers and
maintained securely.
Table 1. Treatment categories and regimens for TB patients in India.
Treatment categoryType of patients
Treatment regimens***
Intensive PhaseContinuation phase
Category 1New sputum smear-positive PTB New sputum smear-negative
PTB, seriously ill* New EPTB, seriously ill*
2(H3R3Z3E3)4(H3R3)
Category 2Sputum smear-positive relapse Sputum smear-positive treatment
failure Sputum smear-positive treatment after default
2(H3R3Z3E3S3)+1(H3R3Z3E3)5(H3R3E3)
Category 3New sputum smear-negative, not seriously ill** New EPTB, not
seriously ill**
2(H3R3Z3)4(H3R3)
Category 4All patients with diagnosed Multidrug resistant TB6 (9) Km levo Eto Cs Z E18 Ofx Eto Cs E
PTB=Pulmonary tuberculosis: EPTB=Extra pulmonary tuberculosis.
*In children, seriously ill sputum smear-negative PTB includes all forms of sputum smear-negative PTB other than primary complex. Seriously ill EPTB includes TB
meningitis (TBM), disseminated TB, TB pericarditis, TB peritonitis and intestinal TB, bilateral extensive pleurisy, spinal TB with or without neurological complications,
genitourinary TB, and bone and joint TB.
**Not seriously ill sputum smear-negative PTB includes primary complex. Not seriously ill EPTB includes lymph node TB and unilateral pleural effusion.
***Prefix indicates month and subscript indicates thrice weekly.
H=Isoniazid, R=Rifampicin, Z=Pyrazinamide, E=Ethambutol, S=Streptomycin, Km=Kanamycin, Levo=Levofloxacin, Eto=Ethionamide, Cs=Cycloserine,
doi:10.1371/journal.pone.0030281.t001
Adherence to National TB Guidelines
PLoS ONE | www.plosone.org2 January 2012 | Volume 7 | Issue 1 | e30281

Page 3

Results
Characteristics of the study population
A total of 3120 individuals were admitted to GG&CH, of whom
1876 (60%) did not have active TB and 26 (1%) died before any
diagnosis could be made. A total of 1218 patients were admitted to
inpatient care with active TB and were thus included in the
analysis (Figure 1). These patients included 905 (74%) males,
1133 with pulmonary TB and 85 extra pulmonary TB cases.
Compliance to existing RNTCP guidelines
Of 1218 patients with active TB, 86(7%) died or left hospital
before initiating anti-TB treatment. A total of 1104(98%) were
placed on a regimen that was included in RNTCP guidelines, 28
(2%) were placed on a non stipulated regimen. (Figure 1). Of
these 28 patients, 19 were placed on tailored MDR-TB treatment
regimens based on drug sensitivity testing. The remaining nine
patients were found to be on ad-hoc regimens started prior to
admission at GG&CH but these regimens remained unchanged.
Table 2 shows the type of TB in relation to treatment regimens
used. Despite being on an existing RNTCP regimen, 17 patients
were placed on a non recommended RNTCP drug regimen
category for reasons that were not specified in the patient records
(Table 2).
Successful linkage after discharge for continuing anti-TB
treatment
Out of the 1104 patients on a RNTCP regimen, 921(96%) were
eventually referred for continuation of treatment at peripheral
centres from where a formal feedback was received for 682 (74%)
patients (Figure 2).
Discussion
This study shows that 98% of patients with active TB admitted
to a tertiary facility in India are placed on an anti-TB drug
regimen that is included in the RNTCP guidelines. Formal
feedback on referral was received from peripheral faculties for
seven out of ten discharged patents. This is the only published
study in the literature assessing the degree of compliance of a
tertiary facility with national guidelines and the findings are
encouraging. Importantly, the study shows that the great majority
of clinicians in such specialized facilities do indeed comply with the
recommended national guidelines for TB management despite the
Figure 1. Type of tuberculosis treatment for tuberculosis patients admitted to the Government General and Chest Hospital,
Hyderabad, India.
doi:10.1371/journal.pone.0030281.g001
Adherence to National TB Guidelines
PLoS ONE | www.plosone.org3 January 2012 | Volume 7 | Issue 1 | e30281

Page 4

Table 2. Type of Tuberculosis and treatment regimens of TB patients admitted to Government General and Chest Hospital,
Hyderabad, India (2010).
Treatment regimens
Type of tuberculosis
RNTCP regimens*Non-RNTCP regimens
Total Cat-1Cat-2Cat-3Cat-4 Unknown regimensMDR-TB regimens**Ad-hoc regimens
New Tuberculosis cases 696 63414 280 1109
Retreatment cases38512 37300000
MDR-TB51000 320190
Total 1132646 3872832 11 199
*RNTCP- Revised National Tuberculosis Control Programme.
**Regimen formulated based on the drug susceptibility of the individual patient to first and second line anti- TB treatment.
Cat-1=Category 1, Cat-2=category 2, Cat-3=Category 3, Cat-4=Category 4.
doi:10.1371/journal.pone.0030281.t002
Figure 2. Referral for treatment and feedback status of patients initiated on RNTCP treatment Regimen at Government General and
Chest Hospital, Hyderabad, India.
doi:10.1371/journal.pone.0030281.g002
Adherence to National TB Guidelines
PLoS ONE | www.plosone.org4January 2012 | Volume 7 | Issue 1 | e30281

Page 5

concern that the contrary might be the case. However this study
reveals a number of programmatic issues that merit consideration.
First, 19 patients were found to be on an ‘‘individually tailored’’
MDR-TB treatment. These patents belonged to districts that did
not have access to a TB facility offering MDR-TB treatment (a so
called DOTS-Plus facility). These patients had drug sensitivity
testing performed and their drug regimens were then tailored
according to the drug sensitivity patterns. Furthermore, the state
Government covers the cost of treatment for these patients. Thus,
the divergence from stipulated RNTCP guidelines is justified but
this reflects the relative lack of access to DOTS-Plus sites in some
districts in Andhra Pradesh. This situation needs to be improved.
The lack of access to effective and standardized MDR-TB
regimens tends to increase the dependence on tailored drug
regimens [5,6].
Second, nine patients who were started on an ad-hoc non
RNTCP regimen before arriving at the GG&CH were simply
continued and discharged on their non-recommended regimens. It
would have been expected that these regimens be corrected by the
tertiary facility.
Third, 17 patients were offered a drug regimen that was not
recommended for their TB type. The reasons for this are unclear
but this merits further investigation as it indicates non-compliance
with national guidelines.
Finally, feedback on referrals was not received in three out of
ten individuals referred to peripheral faculties for continuation of
anti-TB treatment. These patients were lost to follow-up,
indicating deficiencies in referral for treatment and feedback and
such patients due to ineffective mechanisms may become
defaulters or MDR patients. This highlights the need for better
links and discussions with peripheral facilities as well as active
tracing of feedback. Use of mobile telephones can be considered as
a way to improve this linkage [7].
The strengths of this study are that a large number of TB
patients were included in the study; information was gathered on
an individual basis and cross-checked using patients records and
cards and thus we believe that the data are robust and reliable.
Since we used routine programme data, the findings are likely to
reflect the operational reality on the ground. We also followed
STROBE guidelines on reporting of observational studies [8].
This study faces the usual limitations of observational studies.
In conclusion, in a tertiary health facility in Hyderabad, India
the great majority of TB patients are managed in line with
national guidelines. A number of important short-comings were
revealed and these need to be addressed.
Acknowledgments
Our sincere thanks to Dr. P. Navaneeth Sagar Reddy, Superintendent and
Head of the Department of Pulmonary Medicine, Government General
and Chest Hospital, Hyderabad, for the valuable support. We also
acknowledge the support of the State TB Cell of Andhra Pradesh, In-
Charge Medical Officer, and other RNTCP staff of the GG&CH.
Dr. Kiran Kumar Kondapaka is a post graduate student in MD
pulmonary medicine in Osmania Medical College, Government General
and Chest Hospital, Hyderabad, India.
Author Contributions
Conceived and designed the experiments: KK SVP SS SK RZ ADH SBN
ST RA NK KM DK SR. Performed the experiments: KK SVP SS SK RZ
ADH SBN ST RA NK KM DK SR. Analyzed the data: KK SVP SS RZ
ADH SBN ST RA NK. Contributed reagents/materials/analysis tools:
KK SVP SS SK RZ ADH SBN ST RA NK KM DK SR LV. Wrote the
paper: KK SVP SS SK RZ ADH SBN ST RA NK KM DK SR LV.
References
1. World Health Organisation, Geneva (2010) WHO Report on Global
Tuberculosis Control: Epidemiology, Strategy, Financing World Health
Organisation, Geneva; 2010.
2. Central Tuberculosis Division (2005) Technical and Operational Guidelines for
Tuberculosis Control, Revised National Tuberculosis Control Programme.
Directorate General of Health Services, Ministry of Health and Family Welfare,
Government of India. 2005.
3. Central Tuberculosis Division (2010) Tuberculosis India 2010. Annual Report of
the Revised National Tuberculosis Control Programme. Directorate General of
Health Services, Ministry of Health and Family Welfare, Government of India.
4. World Health Organisation, Geneva (2003) Treatment of Tuberculosis.
Guidelines for National Programmes. 3rd Edition.
5. World Health Organisation, Geneva (2009) Key bottlenecks in M/XDR-TB
control and patient care. Available: http://www.who.int/tb/challenges/mdr/
bottlenecks/en/index.html. Accessed 2011 April 5.
6. World Health Organisation Geneva (2010) Multidrug and extensively drug-
resistant TB (M/XDR-TB). Global Report on Surveillance and Response
(WHO/HTM/TB/2010.3).
7. Harlow T (1999) TB net tracking network provides continuity of care for mobile
TB patients. Am J Public Health Oct;89(10): 1581–2.
8. von EE, Altman DG, Egger M, Pocock SJ, Gotzsche PC, et al. (2007) The
Strengthening the Reporting of Observational Studies in Epidemiology
(STROBE) statement: guidelines for reporting observational studies. Lancet
Oct 20;370(9596): 1453–7.
Adherence to National TB Guidelines
PLoS ONE | www.plosone.org5January 2012 | Volume 7 | Issue 1 | e30281