Operational research within a Global Fund supported tuberculosis project in India: why, how and its contribution towards change in policy and practice

Figures & data

Figure 1. Flow diagram showing the structure of the OR courses undertaken by the Global Fund project in India.

Table 1. Number of participants, protocols developed, protocols implemented, and peer-reviewed publications by course cohort – Global Fund Project – India, April 2010 – September 2016.

	Training Cohort 1	Training Cohort 2	Training Cohort 3	Total N (%^a)
Number of applications received	68	42	39	149
Number of protocols-teams selected for the training programme	16	14	14	44
Month of first module	Sep, 2010	Mar, 2012	Sep, 2014
Number of teams in the first module	15	14	14	44 (100%)
Month of second module	Mar, 2011	Mar, 2012	Sep, 2014
Number of teams in the second module	14	14	14	42 (95%)
Month of third module	Aug, 2011	Jun, 2013	Jul, 2015
Number of teams in the third module	12	11	11	34 (77%)
Number manuscripts submitted to peer-review*	12	9	9	30 (68%)
Number (%) manuscripts accepted for publication**	12 (75%)	9 (64%)	7 (50%)***	28 (64%)

^a= denominator is the number of teams selected for the training programme; each team comprised of 2–3 participants in the first two training cohorts and one participant in the third training cohort.

* Includes submission to scientific journals or CDC clearance

** As of 17 September 2017

*** 2 still under review

Table 2. OR questions that were undertaken in the first OR course (2010–2011) and the status of their publication in international peer-reviewed scientific journals.

Original OR question/topic	Completed & published
1. What proportion of TB patients would have been additionally diagnosed to have Diabetes Mellitus, if all TB patients are actively screened for DM?	Yes [36]
2. What is the HIV Sero-prevalence among TB suspects (aged 18 years or more) examined for diagnostic smear microscopy at Designated Microscopy Centres (DMCs) of Mandya district, South India?	Yes [30]
3. What is the HIV Sero-prevalence among TB suspects (aged 18 years or more) examined for diagnostic smear microscopy at Designated Microscopy Centres in Vizianagaram district, South India?	Yes [31]
4. Does watching a video of a narrative of cured TB patients (photo-voice) increase adherence to TB medications among new TB patients?	Yes [58]
5. Among pulmonary TB suspects examined for smear microscopy in a DMC, is there an increase in yield of sputum positive cases when the sputum is concentrated by ‘overnight bleach sedimentation’ technique as compared to direct microscopy?	Yes [65]
6. What is the additional yield of TB suspects and sputum smear positive TB cases by intensified case finding among household contacts of TB cases?	Yes [48]
7. Among all smear positive patients registered in 3Q10 what are the factors for delay in initiation of RNTCP treatment after diagnosis in 1 district (Bardhaman) of West Bengal and 1 district (Nalgonda) of Andhra Pradesh?	Yes [51]
8. What is the usefulness of the result of mid CP follow-up sputum smear examinations in declaring outcomes and guiding further management of smear positive TB patients under RNTCP?	Yes [32]
9. Do private practitioners who are exposed to RNTCP involvement efforts report better diagnostic and treatment practices for TB than practitioners who are not exposed with regards to International Standards of TB Care (ISTC)?	Yes [42]
10. Are there any differences in TB management practices by private practitioners in Vishakhapatnam as compared to ISTC	Yes [41]
11. Among TB patients registered under RNTCP what are the patient and provider related factors associated with non-testing for HIV?	Yes [53]
12. What proportion of the diagnosed TB patients in Medical Colleges of West Bengal and Meghalaya, are availing RNTCP treatment services?	Yes [52]
13. What is the duration between onset of symptoms and diagnosis in a cohort of smear positive TB patients diagnosed in the district of Patna by Revised National Tuberculosis Control Programme (RNTCP) and what factors are associated with delay in diagnosis?	No (data not collected)
14. What are KAP among providers of alternate systems of medicine regarding diagnosis, treatment and management of patients with cough as well as chest symptomatic?	No (data not collected)
15. What are the risk factors for death and default among New Smear Positive TB cases in Karnataka?	No (data collected but not analysed and written up)
16. What is the impact of single sputum sample examination during follow ups on management of pulmonary TB patients in RNTCP?	No (data analysed and but manuscript not written up)

Table 3. OR questions/topics that were undertaken in the second OR course (2011–2012) the status of their publication in international peer-reviewed scientific journals.

Original OR question/topic	Completed & published
17. Prospective study on inclusion of the family member as a DOT provider for paediatric patients in state of Gujarat	Yes [29]
18. Intensified Case Finding from the Community Level in 10 identified low case detection districts, Odisha, April–September 2012 – a Descriptive Study	Yes [46]
19.Contribution of Mobile Medical Unit for identifying TB suspects and cases in Mohali District, Punjab	Yes [56]
20. Intensified TB case finding at Nutritional Rehabilitation Centres of Bihar, India	Yes [50]
21. Factors for default (loss to follow-up) in drug-resistant TB (DR-TB) treatment: qualitative evaluation of patient and provider reported determinants for DR-TB treatment interruptions in Nagpur, Maharashtra	Yes [47]
22. Isoniazid preventive treatment (IPT) in two districts of Tamil Nadu, India: does practice follow policy?	Yes [49]
23. Introduction of a system of TB case notification among the private practitioners in Pune City: Is it operationally feasible?	Yes [54]
24. Treatment outcomes of MDR-TB patients in Kerala, India	Yes [55]
25. A comparative study on same day sputum smear microscopy with the conventional method in the diagnosis of sputum positive pulmonary TB	Yes [66]
26. Does a real-time web-based patient monitoring system reduce patient drop-outs in the diagnostic and treatment pathway for drug-resistant TB (DR-TB) in Hyderabad district, South India?	No (Published as abstract)*
27. Assessment of the sediment re-decontamination technique in recovering TB bacilli from cultures contaminated on Lowenstein-Jensen medium.	No (paper written but not submitted)
28. Status of MDR-TB suspects after 12–15 months under RNTCP: Programmatic and patient related factors for failure to test MDR-TB	No (Data not collected)
29. Universal access to TB care: Do all TB patients diagnosed in medical colleges come to Revised National TB Control programme?	No (Data not collected)
30. Why do DR-TB patients default in Andhra Pradesh, India?	No (Data not collected)

*Jaju J, Achanta S, Purad CC, Ajay MV Kumar, Ghosh S, Dewan PK, Moonan PK, A Sreenivas. e-SMARTS - Electronic Surveillance and Management of drug Resistant Tuberculosis: An innovative approach towards better patient management in India. Int Tuberc Lung Dis 2013;17(12) Supplement 2:S490.

Table 4. OR questions/topics that were undertaken in the third OR course (2014–2015) and the status of their publication in international peer-reviewed scientific journals.

Original OR question/topic	Completed & published
31. Compliance with infection control practices in sputum microscopy centres: a study from Kerala, India	Yes [57]
32. Incidence of Drug Induced hypothyroidism during Intensive Phase of treatment for multi drug resistance TB among patients registered under PMDT in Karnataka, India	Yes [33]
33. Will sensitizing qualified private practitioners and Ayurveda medical officers improve symptomatic referral and TB case detection in Bilaspur District, Himachal Pradesh, India?	Yes [66]
34. TB notification: perspectives and challenges from private health care providers, Delhi – A qualitative study	Yes [67]
35. Has the Policy of implementing decentralized TB diagnostic and HIV testing facilities at PHIs other than DMCs and Integrated Counselling and Testing  Centres (ICTCs) – led to increase in TB-HIV case notification in Rajasthan State, India?	Yes [68]
36. Pilot study to explore the feasibility of smoking cessation intervention in smokers with pulmonary TB in RNTCP	Completed, Under peer-review
37. Effect of monitoring DR-TB patients through selected follow-up cultures vis-à-vis the standard schedule among patients treated at Maharashtra, India.	Yes [69]
38. Relationship between nutritional support and TB treatment outcomes among persons living below the poverty-line in West Bengal, India	Yes [70]
39. Knowledge, Attitude and Practices of TB Airborne Infection Control among Antiretroviral Treatment (ART) Centre Health Care Workers	Completed, Under peer-review
40. To assess awareness of pulmonary TB, diagnosis and treatment, as per Standards for TB care in India and perceived constraints in practice of these standards among private practitioners in Cochin city, Kerala, India	Completed (manuscript not written)
41. Is Line Probe Assay (LPA) a valuable tool for testing Extra Pulmonary samples in Programmatic Management of DR-TB: Experience in Kerala State, India	No (Data not collected)
42. Does integration of active follow up of smear negative chest symptomatics not diagnosed as TB, into the routine system through Accredited Social Health Activists (ASHA) increase case detection of pulmonary TB?	No (Data not collected)
43. Will daily Short Message Service (SMS) Reminders Reduce Initial loss to follow up of Smear Positive TB Patients Following Diagnosis? A blinded randomized control trial in one district of South India	No (Data not collected)
44. Association between specific gene mutations conferring Isoniazid mono resistance in pulmonary patients continued on first line of anti-TB drugs and their treatment outcomes in Jharkhand	No (Data not collected)

Figure 2. Flow diagram showing the number of OR studies published under the Global Fund project (n = 42) and their pathways for impact on policy/practice. Notes: Five studies had direct impact on changes in policy and practice; Four studies had impact on policies and practices through other studies; Three studies led to decisions for scaling up TB control interventions in the country; 30 studies had limited impact on national level policies.

Balakrishnan S, Vijayan S, Nair S, et al. High diabetes prevalence among tuberculosis cases in Kerala, India. Gordon S V., editor. PLoS One. 2012;7:e46502.

 PubMed Web of Science ®Google Scholar

Naik B, Am V K, Lal K, et al. HIV prevalence among persons suspected of tuberculosis: policy implications for India. J Acquir Immune Defic Syndr. 2012;59:e72–e76.

 Web of Science ®Google Scholar

Achanta S, Am V K, Nagaraja SB, et al. Feasibility and effectiveness of provider initiated HIV testing and counseling of TB suspects in Vizianagaram district, South India. Pai M, editor. PLoS One. 2012;7:e41378.

 Web of Science ®Google Scholar

Shelke SC, Adhav PS, Moonan PK, et al. Photovoice: a novel approach to improving antituberculosis treatment adherence in pune, India. Tuberc Res Treat. 2014;2014:302601.

 Google Scholar

Vishnu PH, Bhat P, Bansal A, et al. Is bleach-sedimented smear microscopy an alternative to direct microscopy under programme conditions in India? Public Heal Action. 2013;I:23–25.

 Google Scholar

Khaparde K, Jethani P, Dewan PK, et al. Evaluation of TB case finding through systematic contact investigation, Chhattisgarh, India. Tuberc Res Treat. 2015;2015:670167.

 Google Scholar

Paul D, Busireddy A, Nagaraja SB, et al. Factors associated with delays in treatment initiation after tuberculosis diagnosis in two districts of India. Pai M, editor. PLoS One. 2012;7:e39040.

 Web of Science ®Google Scholar

Gandhi MP, Am V K, Toshniwal MN, et al. Sputum smear microscopy at two months into continuation-phase: should it be done in all patients with sputum smear-positive tuberculosis? Pai M, editor. PLoS One. 2012;7:e39296.

 Web of Science ®Google Scholar

Bharaswadkar S, Kanchar A, Thakur N, et al. Tuberculosis management practices of private practitioners in Pune municipal corporation, India. Dowdy DW, editor. PLoS One. 2014;9:e97993.

 Web of Science ®Google Scholar

Achanta S, Jaju J, Am V K, et al. Tuberculosis management practices by private practitioners in Andhra Pradesh, India. Pai M, Editor. PLoS One. 2013;8:e71119.

 Web of Science ®Google Scholar

Bishnu B, Bhaduri S, Am V K, et al. What are the reasons for poor uptake of HIV testing among patients with TB in an Eastern India District? Kranzer K, editor. PLoS One. 2013;8:e55229.

 Web of Science ®Google Scholar

Quazi TA, Sarkar S, Borgohain G, et al. Are all patients diagnosed with tuberculosis in Indian medical colleges referred to the RNTCP? [Short communication]. Int J Tuberc Lung Dis. 2012;16:1083–1085.

 Web of Science ®Google Scholar

Dave PV, Shah AN, Nimavat PB, et al. Direct observation of treatment provided by a family member as compared to non-family member among children with new tuberculosis: a pragmatic, non-inferiority, cluster-randomized trial in Gujarat, India. Diemert DJ, editor. PLoS One. 2016;11:e0148488.

 Web of Science ®Google Scholar

Parija D, Patra TK, Am V K, et al. Impact of awareness drives and community-based active tuberculosis case finding in Odisha, India. Int J Tuberc Lung Dis. 2014;18:1105–1107.

 Web of Science ®Google Scholar

Binepal G, Agarwal P, Kaur N, et al. Screening difficult-to-reach populations for tuberculosis using a mobile medical unit, Punjab India. Public Heal Action. 2015;5:241–245.

 Web of Science ®Google Scholar

Pathak RR, Mishra BK, Moonan PK, et al. Can intensified tuberculosis case finding efforts at nutrition rehabilitation centers lead to pediatric case detection in Bihar, India? J Tuberc Res. 2016;4:46–54.

 Google Scholar

Deshmukh RD, Dhande DJ, Sachdeva KS, et al. Patient and provider reported reasons for lost to follow up in MDRTB treatment: A qualitative study from a drug resistant TB centre in India. Subbian S, editor. PLoS One. 2015;10:e0135802.

 Web of Science ®Google Scholar

Shivaramakrishna HR, Frederick A, Shazia A, et al. Isoniazid preventive treatment in children in two districts of South India: does practice follow policy? Int J Tuberc Lung Dis. 2014;18:919–924.

 Web of Science ®Google Scholar

Yeole RD, Khillare K, Chadha VK, et al. Tuberculosis case notification by private practitioners in Pune, India: how well are we doing? Public Heal Action. 2015;5:173–179.

 Web of Science ®Google Scholar

Duraisamy K, Mrithyunjayan S, Ghosh S, et al. Does Alcohol consumption during multidrug-resistant tuberculosis treatment affect outcome? A population-based study in Kerala, India. Ann Am Thorac Soc. 2014;11:712–718.

 Google Scholar

Bhardwaj RR, Oeltmann JE, Ravichandra C, et al. Engaging private providers and Ayurvedic practitioners in Bilaspur, India: did it increase TB case detection? Public Heal Action. 2016;6:154–156.

 Web of Science ®Google Scholar

Aslesh OP, Ubaid NP, Nagaraja SB, et al. Compliance with infection control practices in sputum microscopy centres: a study from Kerala, India. Public Heal Action. 2015;5:255–260.

 Web of Science ®Google Scholar

Munivenkatappa S, Anil S, Naik B, et al. Drug-induced hypothyroidism during anti-tuberculosis treatment of multidrug-resistant tuberculosis: notes from the field. J Tuberc Res. 2016;4:105–110.

 Google Scholar

Satpati M, Nagaraja SB, Shewade HD, et al. TB notification from private health sector in Delhi, India: challenges encountered by programme personnel and private health care providers. Tuberc Res Treat. 2017;2017:6346892.

 Google Scholar

Sinha SK, Saxena A, Mishra V, et al. Integration and decentralisation of TB-HIV services increases HIV testing of TB cases in Rajasthan, India. Public Heal Action. 2017;7:71–73.

 Web of Science ®Google Scholar

Suryawanshi SL, Shewade HD, Nagaraja SB, et al. Unfavourable outcomes among patients with MDR-TB on the standard 24-month regimen in Maharashtra, India. Public Heal Action. 2017;7:116–122.

 PubMed Web of Science ®Google Scholar

Samuel B, Volkmann T, Cornelius S, et al. Relationship between nutritional support and tuberculosis treatment outcomes in West Bengal, India. J Tuberc Res. 2016;4:213–219.

 PubMedGoogle Scholar