Improving and Harmonizing Operational Research in Tuberculosis

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Improving and Harmonizing Operational Researchin
Tuberculosis

• Anthony D Harries
• The Union, Paris, France

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1. Agree on what we are talking about
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What is operational research

• Research
• into
• strategies, interventions, tools or knowledge
• which
• can improve health care delivery

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Guiding principles in setting operational
research agendas

• Define program / health system objectives
• Identify constraints to meeting objectives
• Ask research questions around constraints

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Research questions

• Three themes
• Lack of knowledge?
• Lack of a tool or intervention?
• Inefficient use of a tool or intervention?

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Theme inefficient use of a toolsputum 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

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Research methodology

• Descriptive or cross-sectional studies
• Case-control studies
• Cohort studies (prospective, retrospective)

Research is carried out within the routine system
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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

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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

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Routine TB quarterly data monitoring system on
cases and outcomes
Data used for operational research
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2. Recognise the challenges and barriers to
operational research
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The first problem
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
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The second problem
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
I dont have the SKILLS to do research
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Programme managers do NOT recognise the relevance
of operational research
The third problem
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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
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3. Find real solutions
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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

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

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2. Build the capacity

• Training symposia
• Training courses
• In-service training
• Masters degrees
• Doctorates
• BUT.

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Japan International TB Course2001 - 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
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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

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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

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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)

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4. Invest in Research
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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

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International Support for Research

• GFATM 10 of country proposal can go for ME
  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

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

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