AN EXAMPLE OF OPERATIONAL RESEARCH AND CAPACITY BUILDING

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AN EXAMPLE OF OPERATIONAL RESEARCHANDCAPACITY
BUILDING

• The Union, Paris, France
• MSF, Brussels, Belgium

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National TB Programme, Malawi

• Model DOTS Programme
• Management by District TB officers
• Excellent Monitoring and Evaluation, using
  Registers and quarterly cohort reporting
• 27,000 cases of TB registered per annum
• HIV-prevalence in TB patients 70

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The Problem

• Between 1987 to 1999
• Patients with Relapse smear-positive PTB in
  Malawi declined from 6 to 3
• No reported cases of recurrent smear-negative TB
• BUT
• HIV-prevalence in TB patients increased 30 to
  70
• Research literature from Africa strongly showed
  that recurrent TB increases as HIV-prevalence
  increases

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Maybe the Malawi NTP was missing recurrent
tuberculosis under routine programme settings
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The research question

• Are patients with relapse smear-positive
  Pulmonary TB and recurrent smear-negative TB
  being incorrectly registered as having new TB
  under routine programme conditions?

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Methodology (1)

• Setting all 43 hospitals in Malawi that
  register TB patients were visited from Jan-Mar
  1999
• Patient sample all patients registered as new
  TB and were receiving treatment in hospital were
  asked about previous TB
• Data collection into structured questionnaire
  demographic and clinical details plus data on
  previous TB (when, type, outcome)

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Methodology (2)

• Data validation wherever possible previous
  episode of TB verified from previous TB identity
  cards (10 validated)
• Analysis and statistics used Epi Info simple
  comparisons using chi-squared tests
• Ethics approval Malawi National Health Science
  Research Committee

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Results
Trans Roy Soc Trop Med Hyg 2000 94 247-249
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Analysis

• Compared to patients with smear-positive PTB,
  a previous episode of TB was significantly more
  common in -
• patients with smear-negative PTB
• (OR 3.5, 95 CI 2.1 - 5.7, p lt 0.001)
• patients with EPTB
• (OR 2.0, 95 CI 1.1 - 3.7, p lt 0.05)

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Interpretation of Study

• Patients with relapse TB and recurrent TB were
  incorrectly registered under routine programme
  settings as new patients
• This mistake was more common in patients with
  smear-negative PTB and EPTB
• The reasons for these mistakes were not identified

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What next?

• Results and implications of incorrect recording
  discussed with NTP staff at the annual NTP
  seminar
• Central Unit prepared interim guidelines about
  diagnosis and management of recurrent TB
• Guidelines were incorporated into revised
  National TB Manual

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A similar study was repeated one year later from
Jan-Jun 2000

• Same aim to determine whether patients
  registered with new smear-negative PTB or new
  EPTB were correctly diagnosed
• Same methodology as the study in 1999 except the
  focus was on smear-negative PTB and EPTB

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Operational Research Jan-Jun 2000

• Type of TB Registered New Previous
  TB
• sm-ve PTB 214 10 (5)
• EPTB 213 2 (1)
• a big improvement on the previous
  year

Trans Roy Soc Trop Med Hyg 2001 95 503-504
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How did this operational research impact on the
Malawi National TB Control Programme?
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Malawi TB case notifications
Recurrent TB relapse, failure, treatment after
default, recurrent sm-ve TB
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PREVENTING RECURRENT TBTHE NEXT QUESTION

• Give all patients RH throughout instead of EH in
  continuation phase
• Give secondary isoniazid preventive therapy to
  HIV-positive patients to prevent re-infection
• Put all HIV-positive TB patients on ART

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The Union/ MSF Model for sustainable operational
research

• Building the capacity

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Background

• The Union and MSF have years of experience and
  are strongly advocate for operational research
• DOTS Recording and Reporting information system
  in NTP allows data to be used to audit
  performance and to monitor results of
  interventions
• GFATM allows 5 -10 of each grant for ME /
  operational research. Funding now available.

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Operational Research Training
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Previous training models

• Class of 15 20 people
• One week course on methods and data handling
• Participants return to countries little product
  from the field
• WHY?? no financial support, no paper writing
  skills, no mentorship, no time

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Union / MSF proposal for a new type of course

• Purpose To develop the practical skills for
  conducting and publishing operational research
• Approach
• Target-oriented
• Participants go through the whole research
  process and complete the course with a defined
  product
• Participants expected to train and lead others to
  maximise impact

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Three modules

• Module 1 research questions and protocol
  development ( 5 days) August
• Module 2 Data management and data analysis (5
  days) October
• Module 3 Paper writing, includes data
  presentation, interpretation and policy
  implications (5 days) - February

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Target Audience

• Operational research fellows (mandatory)
• Successful applicants (doctor, nurse, paramedical
  officer, data analyst)
• No more than 12 participants in total per course.
  All three modules to be completed and these are
  funded through the Union

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To be a successful applicant

• Defined criteria-
• Engaged in programme work and will return to this
  work
• Supervisors endorsement that they have time and
  opportunity to carry out the research
• Competent in English and computer literate
• Have done MPH or equivalent or come strongly
  recommended
• There is a stated and acceptable mentor at
  country level
• Funding for research can be acquired through
  other sources
• Application-
• Submit curriculum vitae plus two references
• Complete application form with1/2 page written on
  programme problem and research question

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Module 1 Protocol development 5 days

• Define the research question
• Protocol development authorship, aims and
  objectives, study population and sampling
  definition of variables and outcomes ethical
  issues draft questionnaire or data collection
  instrument logistics and budgets
• Outcome draft protocol and ethics application
  form written by each participant

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Tasks between Module 1 and Module 2

• Each participant must have refined the protocol
  with the mentor and should submit it within two
  weeks to
• Union Ethics Advisory Group (EAG)
• National Ethics Committee

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Module 2Data management and analysis 5 days

• Purpose efficient quality assured data
• Content data entry and analysis, using Epi-Data
• Outcome draft instrument for electronic data
  entry

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Tasks between Module 2 and Module 3
Each participant must have completed their
study, entered their data and validated their
data set Each participant will also be
encouraged to attend with a draft paper already
written these to be sent to the Union before
the course
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Module 3Paper writing 5 days

• Learn principles of writing scientific papers
• Learn how to do on-line submission
• Learn how to deal with peer review,
  point-by-point responses and revision of paper
• Learn how research may influence policy/practice
• Outcome draft paper

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Tasks after Module 3

• Finalise draft paper with mentors support
• Submit paper to international peer-reviewed
  journal within two weeks of completing module 3

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Operational Research Fellowships
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1. Specific responsibilities

• Attend all three Operational research training
  modules
• Work under mentorship of local Union staff
• Assume responsibility for research protocol
  development (including ethics submission), data
  collection and analysis

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1. Specific responsibilities (cont)

• Paper written within 3 months of completion of
  research project
• Present research findings at national and
  international conferences
• Submit at least two papers per year to
  peer-reviewed journals

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2. Skills and competencies

• Local health care personnel (doctors,
  paramedicals, nurses, data analysts) working in
  programmes, MOH or larger health care
  institutions

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3. Selection process

• Strong recommendations from respected colleagues
• Strong support from directors of programmes or
  health institutions
• Good curriculum vitae plus two excellent
  references

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4. Support

• Performance-based financial support
• One year contracts, renewable, can move from
  junior to senior fellowships
• Performance- based failure to submit 2 papers in
  which the fellow is first author in 12-months
  no renewal of contract

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4. Support (cont)

• Support to attend the mandatory training course
  of three modules on OR
• Support to attend national and international
  conferences where they will present their
  research
• Support to submit their papers for consideration
  of a PhD

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5. Union Commitment

• Support for up to 6 Operational Research Fellows
  for 2 years initially
• Envisage long-term support

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Conclusion on Training

• This is target-orientated training
• Product papers that can influence policy and
  practice
• Long term vision capacity building and
  development of leadership in operational research

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Centre for Operational Research The Union and
MSF Belgium

• Anthony Harries
• Hans Rieder
• Don Enarson
• Mary Edginton
• Karen Bissell
• Selma Berger
• Nathalie Guillerm
• Cécile Sevel
• Tony Reid, MSF Belgium
• Rony Zachariah, MSF Belgium

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Response from Participants

• Is there an interest for operational research
  training in countries, in regions, for particular
  professions?
• Does this Union/MSF approach fit with your needs?
  
• Are you able to allocate or find the funding for
  these courses?
• Centre for Operational Research
  cor_at_theunion.org www.theunion.org