Improving and Harmonizing Operational Research in Tuberculosis Anthony D Harries The Union, Paris, France

1. Agree on what we are talking about

“What” is operational research Research into strategies, interventions, tools or knowledge which can improve health care delivery

Guiding principles in setting operational research agendas Define program / health system objectives Identify constraints to meeting objectives Ask research questions around constraints

Research questions Three themes: Lack of knowledge? Lack of a tool or intervention? Inefficient use of a tool or intervention?

Theme – “inefficient use of a tool” sputum smears for diagnosing PTB Objective of NTP = high quality sputum smear diagnosis using three sputum smears per patient Constraint = three smears per patient are demanding for the laboratory technicians Research question = are two smears as efficient as three smears for diagnosing smear-positive pulmonary TB Answer the question in a number of different ways

Research methodology Descriptive or cross-sectional studies Case-control studies Cohort studies (prospective, retrospective) Research is carried out within the routine system

What is not operational research: Basic science research Randomised controlled clinical trials [RCT] – where research is conducted in a strictly controlled environment, with inclusion and exclusion criteria – efficacy is the end point

The need for RCT and Operational Research RCT Provides information on efficacy of intervention in special groups of patients Operational Research Provides information on the effectiveness of the intervention in the heterogeneous world of routine patient care

Routine TB quarterly data monitoring system on cases and outcomes Data used for operational research

2. Recognise the challenges and barriers to operational research

The needs of Operational research: Protocol development Searching for funds Collecting and analysing data Writing the papers Dealing with peer review revisions TIME There is no dedicated time available The first problem

The second problem I don’t have the SKILLS to do research What data do I collect? How do I collect data? How do I make sense of the data? How do I analyse the data? I cannot write I cannot get started I have too many good ideas I spend all my time re-writing There is no logic to my thoughts The editorial demands are too much

Programme managers do NOT recognise the relevance of operational research The third problem

The fourth problem Individuals return to RLS with MPH or PhD Why are they not involved in operational research? Appointed to senior-level management posts No infrastructure for research “I have no mentor” No opportunities No support for research back home

3. Find real solutions

1. Involve Programmes Involve programme staff right at the start Ensure that research questions are relevant to programme implementation and connected to health service delivery Set up a good coordination mechanisms to provide clear strategy about setting of research priorities

International Expertise WHO The Union LSTM / LSHTM / KNCV NTP Malawi Institutions Medical School NGOs National AIDS Programme Research Ideas Malawi TB Programme Management Group Implementation of research by the various groups

NTP programme investment Appoint research officer, who can work alongside NTP manager Support in-service training Work with partners in developing research training workshops, writing skills workshop Annual review meetings to present research Emphasize publications in national and international journals

2. Build the capacity Training symposia Training courses In-service training Masters degrees Doctorates BUT…………….

Japan International TB Course: participants developed ORP 11 (39%) started ORP on return to home 1 wrote a paper 0 published a paper Ohkado A et al, IJTLD 2009 – in press

Union / MSF paradigm for operational research training course Purpose: To develop the practical skills for conducting and publishing operational research Approach: Careful selection of participants Need to achieve milestones to remain in the course Target-oriented – success of the course judged on whether participants complete research and submit a scientific paper

Three modules Module 1: research questions, protocol development, ethics ( 5 days) – August 2009 Module 2: Data management and data analysis (5 days) – October 2009 Module 3: Paper writing, includes data presentation, interpretation and policy implications (5 days) – March 2010

Operational Research Fellows Careful selection of fellows Employed full-time / part-time through Union Mentors identified Attached to programmes or linked institutions 12-month contracts Deliverables= 2 papers submitted each year Linkage to PhD programme (under development)

4. Invest in Research

NTP Programme level Clear objectives and activities around operational research Clear targets – number of projects implemented, projects completed, papers written, papers published, program policy and practice changed Well defined budget line including research allowances, internet connectivity, conference attendances

International Support for Research GFATM – 10% of country proposal can go for M&E and operational research The Union – two mechanisms for support (Treat-TB and Centre for Operational Research) The Wellcome Trust African Institutions Initiative (seven consortia of 18 African countries partnered with 6 Northern hemisphere countries) European & Developing Countries Clinical Trials Partnership

5. Develop Partnerships and Harmonize the efforts

Ministry of Health NTP WHO NGOs The Union MSF Schools of Tropical Medicine LSTM, LSHTM ITM TB Associations KNCV HIV Associations IAS Governmental Bodies Local country (MRC) CDC, USA Medical Colleges International Universities Johns Hopkins

Harmonisation Should we develop an international TB operational research agenda? Should we keep a database of what research is taking place, where and by whom? Who should take the international lead?

“Learn by Doing” Partner with colleagues and friends, and realise that we may not always have it initially correct