Improving and Harmonizing Operational Research

in Tuberculosis

Anthony D HarriesThe Union, Paris, France

1. Agree on what we are talking about

“What” is operational research

Research into

strategies, interventions, tools or knowledgewhich

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 onefficacy of interventionin special groups ofpatients

Operational Research

Provides information onthe effectiveness of theintervention in theheterogeneous world ofroutine 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:2001 - 2007

• 28 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