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General overview of operations and implementation research

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1 General overview of operations and implementation research
Emily A. Bobrow, PhD, MPH Senior Research Officer IAS Rome 20 July 2011

2 Overview Definitions Examples of OR/IR studies
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

3 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

4 Making a Distinction: Research vs. 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

5 Research and service provision feed each other!

6 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

7 OR/IR definitions and audience
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): e doi: /journal.pmed

8 Definitions of OR/IR Primary Characteristics Focus of the research
Users of the Research Outputs Utility of the Research Outputs Research Domain Operational/ Operations Operational issues of specific health programs Health care providers and program managers Local Implementation Implementation strategies for specific products or services Program managers, R&D managers Local/broad Health System Issues affecting some or all of the building blocks of a health system Health system managers, policy makers Broad

9 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

10 Terminology Operations Research = Operational Research = Programmatic Research = Implementation Research = Implementation Science = Translational Research

11 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

12 Intervention: TBA Log in Malawi Drawings 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 12

13 The Early Infant Diagnosis (EID) Cascade in Tanzania, Q4 2009
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.

14 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)

15 Change due to introduction of courier service
Courier service introduced

16 The EID Cascade Q4 2009

17 Turnaround time reduced through courier service and lab support
Staff sensitization and introduction of LTFU tracking system

18 The EID Cascade Q4 2009

19 Initiation of HIV-infected infants on ART

20 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 leadership Scale 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 20

21 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

22 Common OR/IR design Quasi-experimental compare Study Population
Intervention Group Result compare Study Population Comparison Group Result Quasi-experimental design – we often use this type of study in public health and when we do operations research NO Random Assignment 22

23 Another common OR/IR design Pre-post test design
Intervention Study Population Compare Pre-test Post-test Time

24 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

25 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 Human subjects research requires approval from an Institutional Review Board (IRB) or Research Ethics Committee (REC/RC)

26 Thank you!


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