OPerational guidelines for tuberculosis

1. Operational Research- how to go
about
Dr Suryawanshi Sanjay
WHO National Consultant , CTD

2. •Operational research aims to improve the quality,
effectiveness, efficiency and accessibility(coverage) of the
control efforts.
•Operational studies should generally be:
• of low cost and limited staff time, because they should not deviate
excessive resources from service delivery and disease reduction,
• of short duration, because the results should be available rapidly to
decide on program changes, if necessary,
• based on simple standard protocols, to be repeated in different
environments, and
• giving priority to test solutions to identified problems and to develop
new implementation methods to improve the programme.
Introduction

3. Criteria for CTD selection of OR topics for issuing
‘Calls for Proposals
• Necessity: Is the activity dealing with a priority topic for NTEP?
• Applicability: Will the information generated yield a clear path to the implementation of
programme interventions or improvements?
• Impact: What impact can the interventions have on access and use of TB services,
case detection and treatment outcomes?
• Alternatives to obtain information: Is this research activity likely to be accomplished by
other means, such as review of existing research, direct commission, through national
institutes, or by external parties?
• Timeliness: Is the activity likely to be complete within a reasonable time frame to lead to
interventions?

4. Operational Research:
• Operational research should be directed on a priority basis, toward the broader objectives:
• To increase case detection of Microbiologically Confirmed cases –
• To improve DOT services to make them more patient-friendly and ensure that treatment is directly
observed
• Medical colleges have the resources and expertise to undertake appropriate research
studies with the ultimate objective of having consensus guidelines for the diagnosis and
management of childhood TB and extra-pulmonary forms of TB.
• In addition, the medical colleges are at an advantage to undertake studies on:-
• Multi-Drug Resistance
• Profile and treatment outcomes of admitted patients
• HIV/TB co-infection diagnosis and management
• Research proposals from individual medical colleges should be screened by STF and sent to Central TB Division.
All medical colleges should form a core group for at least 4 members with representatives from the
Department of Medicine, Chest Medicine, Microbiology & community medicine.
• OR Needs 2012-1017.doc ; Format for designing operational research proposal.pdf;

5. Instructions for Thesis and Operational Research..1
• NTEP promotes thesis and Operational Research in the State which would help in improving the program
performance and also facilitate policy at the State and National level. Separate Medical College budget is
provided for Thesis and Operational Research in the PIP of Concerned district and State.
All Medical Colleges interested in a Thesis in NTEP by PG Students OR any Operational Research project need
to submit the electronic copy of the proposals to the state OR Committee with the copy to District TB, STO
State OR Chairman (__________) and State TB office at stomh@rntcp.org and copy to
mpconsultants@rntcp.org.
a. Proposals are to be submitted in the prescribed NTEP Operational Research (OR) proposal format.
b. Proposals are to be submitted with ethical committee approval as per requirement
c. Institutional approval: Before submission, all studies should have agreement from the host (public or
private) institution where they will take place, and the endorsement should accompany the proposal.
Projects that require changes to normal NTEP procedures in public health facilities (such as changes in
diagnostic, treatment or registration/reporting procedures) should be discussed with the DTO or STO
to ensure that the OR study will not adversely affect case management and will be acceptable by the
programme.

6. • Approval of funds for OR proposals upto 2 lakhs is available at State Operational
Research Committe while upto 5 lakhs with Zonal Operational Research
Committee and >5 lakhs shall be sent to National Operational Research
Committee
• Process of Approval: Principal Investigator is invited for Operational Reserach
Committee meeting to present the proposal. Recommendations of OR Committee
members needs to be incorporated by the Principal Investigator(PI) for either
submission or resubmission.
• Release of Funds:
• Concerned DTO/CTOs are instructed by State TB Office to release the funds
for Thesis /Operational research approved by the committee in timely
manner from the Account head of ‘Medical College’
Instructions for Thesis and Operational Research..2

7. • On approval of a proposal, the Principal Investigator will sign a Memorandum of
Undertaking (MoU) with the TB programme manager on behalf of the society for
the release of funds. The MoU will include the objects for which they will utilize
the funds and the timeline for the study. It will also include a commitment from
them to return the funds if the study cannot be taken up due to any reason, and
other relevant clauses.
• Funds will be released in the name of the institution and not the individuals, so
that the College/ Department can continue the study to its completion/return the
funds in the event that the Principal Investigator or a Co-investigator is moved
from the college during the course of the study.
• Funds for OR proposals will be released in three installments – 50 % at the
beginning of the study, 30% at mid point of the study when a particular milestone
has been achieved and remaining 20% after the final report is made available .
Instructions for Thesis and Operational Research..1

8. • Funds for OR proposals will be released in three installments – 50 % at the beginning
of the study, 30% at mid point of the study when a particular milestone has been
achieved and remaining 20% after the final report is made available .
• Thesis grants will be released at 80% in the beginning and remaining 20% after the
final report is made available.
• Operational Research Committee has been established under the chairmanship of
Dr.Radha Munje, Prof. and HoD, Dept. of Respiratory Medicine, IGGMCH Nagpur as
OR Committee chairman in State. OR Committee meets regularly for necessary
approvals of the Thesis and Operational Research from the Medical Colleges in State.
Instructions for Thesis and Operational Research..1

9. • Progress on the research studies (including the final report), funded
by the State OR Committee should be submitted by PI every 6 months
as it has to be informed further to Zonal and National OR Committee.
• Submission of Completed Thesis/Operational Research: Competed
Thesis/Operational Research to be submitted to State OR
Committee
• State OR Committee encourages publication of the findings of OR in peer
reviewed journals. Any Publications to be intimated to the State OR
Committee.
Instructions for Thesis and Operational Research..1

10. Procedures and Time benchmarks for OR Proposals submitted directly to STF/ZTF

11. Scoring Sheet

12. Scoring Sheet

13. Postgraduate Thesis support
• PG students undertaking research on a topic listed on the NTEP Operational Research
Agenda are eligible for a Rs 20,000 grant.
• To apply, PG students should:
• Seek ethical approval of proposals involving human subjects,
• Seek institutional endorsement and, for proposals involving changes in normal RNTCP
• operational or technical procedures, guidance from the DTO/STO, and
• o Submit 4 hard-copies and an electronic copy of the thesis (and approval/endorsement if
• pertinent) to the Nodal Officer of the Core Committee of the Medical College.
• The Nodal Officer is to forward the proposals to the Chairman STF by 28 February or 31
September.
• The proposals are to be assessed by the State OR committees (during the March-June
meetings, or the October-December meetings). The decision to approve should be taken
by the State OR Committee only.
• Approved proposals are to be funded by 30 June / 31 December at the latest.