general overview of operations and implementation research
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General overview of operations and implementation research. Emily A. Bobrow, PhD, MPH Senior Research Officer IAS Rome 20 July 2011. Overview. Definitions Research Monitoring and Evaluation (M&E) and Quality I mprovement (QI) vs. Research - PowerPoint PPT PresentationTRANSCRIPT
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General overview of operations and implementation research
Emily A. Bobrow, PhD, MPHSenior Research Officer
IAS Rome20 July 2011
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Overview
• Definitions– Research
– Monitoring and Evaluation (M&E) and Quality Improvement (QI) vs. Research
– Operations Research (OR) & Implementation Research (IR)
• Examples of OR/IR studies
• Criteria for prioritizing OR/IR questions
• OR/IR common study designs
• Research ethics
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Technical definition of research
A systematic process of discovering new knowledge, involving application of the scientific method to make generalizable statements based upon specific inquiries
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Making a Distinction: Research vs. M&E/QI
Research M&E/QI
Purpose Test or generate a hypothesis Assess a program/process
Starting Point Prospectively designed, formal written hypothesis
An established set of standards
Risks/Burdens May put subjects at risk No risk, with the exception of confidentiality concerns
End point Answer a research question Improve the program/process
Analysis Determine validity of hypothesis
Compare the program/process to established guidelines
Intended result Conclusions may be generalized beyond a specific program/process, contribute to overall scientific literature
Conclusions apply only to specific program/process, and shared with those related to program/process
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Research and service provision feed each other!
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Using M&E Data for Research Purposes
• M&E data is used to generate research questions
• Routine data to conduct a research study
• For application for research funding
• For advocacy to Ministry of Health and implementing partners
• Using research findings to inform M&E strategy
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OR/IR definitions and audience
• Definitions– Operations research: • Focus on operational issues of specific health
programs
– Implementation research:• Focus on strategies for specific products or
services
Remme JHF, Adam T, Becerra-Posada F, D’Arcangues C, Devlin M, et al. (2010) Defining Research to Improve Health Systems. PLoS Med 7(11): e1001000. doi:10.1371/journal.pmed.1001000
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Definitions of OR/IRPrimary CharacteristicsFocus of the research
Users of the Research Outputs
Utility of the Research Outputs
Research DomainOperational/Operations
Operational issues of specific healthprograms
Health care providers and programmanagers
Local
Implementation Implementation strategies for specificproducts or services
Program managers, R&D managers
Local/broad
Health System Issues affecting some or all of thebuilding blocks of a health system
Health system managers, policy makers
Broad
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Examples of OR and IR questions
OR question: • Which locations should be targeted for delivering HIV
prevention services in Kabale district, Uganda? • Remember the definition of OR:
– Focus on the operational issues of specific health programs
IR question• How do we effectively implement option A to HIV-
exposed infants through ANC clinics in Western Kenya?• Remember the definition of IR:
– Focus on strategies for specific products or services
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Terminology
• Operations Research = Operational Research = Programmatic Research = Implementation Research = Implementation Science = Translational Research
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How is OR/IR different from other types of research?
• All types of health research try to improve health
• All types of research can use similar methodologies– Quantitative, qualitative, observational studies,
experimental studies
• Difference = focus and goal– Focus within the routine health system– Goal is to improve programs and to inform policy
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Intervention: TBA Log in MalawiDrawings used for illiterate TBAs
Has started pushing at her home
The mother’s condition is good
The mother has taken NVP
The mother is on ARVs
The mother has died
The baby’s condition is good
The baby has taken NVP
The baby has died
Has been referred to hospital
Delivery during the day
Delivery at night
DATE
NAME OF CLIENT PMTCT#
NAME OF TBA_______________
MONTH
Hosseinipour MC et al. Improving uptake of PMTCT services in Lilongwe, Malawi. EGPAF OR Think Tank, Oct 2009
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The Early Infant Diagnosis (EID) Cascade in Tanzania, Q4 2009
Infants tested results back pos PCR pos. results parents
referred enrolled treated started ART0
200
400
600
800
1000
1200
#
W. Schimana, G. Kasori, J. Songoro, G. Mbita, A. Mwangomale, C. Kimario, J. Van’t Pad Bosch. Systematic analysis of the early infant diagnosis (EID) cascade and implementation of specific interventions: Lessons from a program to increase identification and treatment of infants with HIV in Tanzania. IAS Rome 2011.
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Information - Intervention
• WHY?• Long turnaround time due to:
- Inconsistent sample transportation- Inconsistent result collection and distribution- Under staffing of the lab
- Lab support- Outsourcing of transport- Linking EID to loss to follow-up
(LTFU)
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Change due to introduction of courier service
Q4 09 Q1 10 Q2 10 Q3 100
200
400
600
800
1000
1200
1400
1600
DBS takenresult back
Courier service introduced
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The EID Cascade Q4 2009
pos PCR pos. results parents
referred enrolled treated started ART0
10
20
30
40
50
60
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Turnaround time reduced through courier service and lab support
Staff sensitization and introduction of LTFU tracking system
Q4 09 Q1 10 Q2 10 Q3 10 Q4 100
20
40
60
80
100
120
140
pos. DBSParents informed
#
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The EID Cascade Q4 2009
pos PCR pos. results parents
referred enrolled started ART0
10
20
30
40
50
60
%
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Q4 09 Q1 10 Q2 10 Q3 100
10
20
30
40
50
60
70
80
90
infants enrolledinfantes initiated on ART%
Clinical mentoring
Confidence building of
mentors
Initiation of HIV-infected infants on ART
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Existing national PMTCT program based on sdNVP
Draft scale up plans developed(Jan ’08)
Formation of national working group(Dec ’07)
Collaborative operational research on changing ARV prophylaxis regimen in PMTCT (June ’06-Dec ’07)
Resource mobilisation(Feb – May ’08)
Adaptation of national tools(July ’08)
WHO guidelines, August 2006
Regional exchange visit (May 2008)
Directive from MOHCW leadershipScale up (July ‘08)
National, Provincial and District sensitisation and planning on prelim results (May – onwards ’08)
Results from operational
research
Keatinge J et al. Using operational research to influence policy and programme developments: lessons learnt from Zimbabwe. EGPAF OR Think Tank, Oct 2009
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Criteria for prioritizing OR/IR questions
• Relevance• Avoidance of duplication• Timeliness (urgency of need for data)• Political acceptability• Feasibility• Applicability of possible results or
recommendations• Ethically acceptable
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InterventionGroup
Result
Result
Comparison Group
compare
Study Population
Common OR/IR designQuasi-experimental
NO Random Assignment
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Another common OR/IR designPre-post test design
Time
Pre-test Post-test
Study Population
Intervention
Compare
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Important to remember . . . • There is no best study design
• Match the design to your research question • Then consider . . .
– Feasibility• Time• Money• Other resources
• Make sure you have a multi-disciplinary team assembled at the start of your planning
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Also important . . . Research Ethics
Definition of Human Subjects Research • “Human subject” are individuals whose physiologic or
behavioral characteristics and responses are the object of study in research. Under the federal regulations, human subjects are defines as: living individuals(s) about whom an investigator conducting research obtains:– Data through intervention or interaction with the individual, or– Identifiable private information
Federal Policy, 45 CFR 46.102
• Human subjects research requires approval from an Institutional Review Board (IRB) or Research Ethics Committee (REC/RC)
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Thank you!