General overview of operations and implementation research

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

2. 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

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

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 • 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

8. Definitions of OR/IR

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 MalawiDrawings used for illiterate TBAs NAME OF TBA _______________ MONTH Hosseinipour MC et al. Improving uptake of PMTCT services in Lilongwe, Malawi. EGPAF OR Think Tank, Oct 2009

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 WHO guidelines, August 2006 Collaborative operational research on changing ARV prophylaxis regimen in PMTCT(June ’06-Dec ’07) Formation of national working group (Dec ’07) Results from operational research Draft scale up plans developed (Jan ’08) Resource mobilisation (Feb – May ’08) Regional exchange visit (May 2008) National, Provincial and District sensitisation and planning on prelim results (May – onwards ’08) Adaptation of national tools (July ’08) Directive from MOHCW leadership Scale up (July ‘08) Keatinge J et al. Using operational research to influence policy and programme developments: lessons learnt from Zimbabwe. EGPAF OR Think Tank, Oct 2009

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 Intervention Group Result compare Study Population Result Comparison Group NO Random Assignment

23. Another common OR/IR designPre-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 46.102 • Human subjects research requires approval from an Institutional Review Board (IRB) or Research Ethics Committee (REC/RC)

26. Thank you!