Module-1

Specific Learning Objectives:

• To describe the breadth of health-related research, the spectrum of health systems research (HSR) and the sub-domains of operational research (OR) and implementation research (IR);

• To differentiate HSR and specifically IR from biomedical/traditional clinical research;

• To describe the interrelationship between HSR and epidemiology, and surveillance;

• To distinguish potential differences between quality improvement and IR;

• To define the specific features of IR including the rationale and goals, study design and context within which research takes place.

Learning Methodology:

Interactive lecture with discussion encouraged between participants; quizzes using the different case scenarios to define and differentiate the different types of HSR.

MODULE 1

Introduction to

Implementation Research

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
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MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
MODULE 1

Introduction to

Implementation Research

Ethics in Implementation research

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
• To describe the breadth and spectrum
of health systems research, and the sub-domains of operational research and implementation research

• To differentiate health systems research and specifically implementation research from biomedical/ traditional clinical research

• To describe the interrelationship between health systems research, epidemiology and surveillance

• To distinguish potential differences between quality improvement and implementation research

• To define implementation research including the rationale and goals, study design and context within which research takes place

Slide 2

Introduction to Implementation Research

Learning Objectives

Introduction to Implementation Research

Slide 2

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 3

Introduction to Implementation Research

Session Outline

1. What is health systems research?

2. How does implementation research differ from biomedical/clinical research?

3. How does implementation research differ from epidemiology and surveillance?

4. Distinction between implementation research, quality improvement and public health

5. Focus on implementation research:

• Rationale and goals

• Study design

• Context

6. Considerations in planning and conduct of implementation research

Introduction to Implementation Research

Slide 3

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 4

Introduction to Implementation Research

Health Related Research

Introduction to Implementation Research

Slide 4

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 5

Introduction to Implementation Research

The Components of A Health System

Using the example of the WHO building blocks

Introduction to Implementation Research

Slide 5

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 6

Introduction to Implementation Research

Basic Science Research: e.g. Malaria

• Identification of malaria parasite

• Understanding pathophysiology of disease

• Development of targeted medical therapy

White et al., Lancet 2014, Su & Miller (2015)

The discovery of artemisinin and the
Nobel Prize in Physiology or Medicine

Introduction to Implementation Research

Slide 6

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 7

Introduction to Implementation Research

Clinical Research: e.g. Malaria

• Phase 1, 2, 3 clinical trials to determine efficacy and safety of drugs to treat malaria

• Randomized controlled trials (RCTs) to determine effectiveness of drug and to compare new therapies with old therapies meta-analysis

White et al. (2014)

Introduction to Implementation Research

Slide 7

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 8

Introduction to Implementation Research

Much Research in Past Years Has Been Biomedical…

Who.int

Introduction to Implementation Research

Slide 8

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 9

Introduction to Implementation Research

Example of Epidemiology and Surveillance: e.g. Malaria

Who.int

Introduction to Implementation Research

Slide 9

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 10

Introduction to Implementation Research

Epidemiology and Surveillance…

Who.int

Introduction to Implementation Research

Slide 10

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 11

Introduction to Implementation Research

Health-Related Research

Who.int

Introduction to Implementation Research

Slide 11

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 12

Introduction to Implementation Research

Domains of Health System Research

Remme et al., 2010

Introduction to Implementation Research

Slide 12

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 13

Introduction to Implementation Research

Health Systems Research

WHO (2014a)

the brains of the health system

also the eyes and ears…

Introduction to Implementation Research

Slide 13

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 14

Introduction to Implementation Research

Health Systems Research

How does abolition of user fees change access
to primary health care?

Does using pictures instead of words on tablet packaging improve correct usage of home-based malaria management (HMM) in a border region of the Democratic Republic of the Congo where refugee communities speak many languages?

Does deployment of trained lay community health workers using rapid malaria testing reduce delay in initiation of appropriate malaria management?

Introduction to Implementation Research

Slide 14

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 15

Introduction to Implementation Research

Definitions and Aims

Health systems research

• Addresses health system and policy questions

• Not disease-specific

• Systems functioning

• Impacts performance of the whole health system

• Broad scope of questions including health financing, governance, policy, planning, management, human resources, service delivery, and quality of care

Remme et al. (2010)

Introduction to Implementation Research

Slide 15

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 16

Introduction to Implementation Research

Definitions and Aims

Implementation Research

• Develop systematic strategies to take a proven intervention and apply it in the real world

• Goal is to improve access to and use of effective interventions in populations in need

• Focus on diseases where a control tool exists and would significantly reduce burden of disease

• Demand-driven

Remme et al. (2010); WHO (nd)

Introduction to Implementation Research

Slide 16

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 17

Introduction to Implementation Research

Definitions and Aims

Operational Research

• Find solutions to local operational problems within specific health programmes

• ‘Trouble shooting’ local bottlenecks

• Focuses on service delivery components of the health system

• Addresses problems under control of programme managers

Remme et al. (2010); WHO (nd)

Introduction to Implementation Research

Slide 17

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 18

Introduction to Implementation Research

Examples of Why Implementation Research is Necessary…

Operational Research

• How do we increase consistent use by appropriate individuals?

We know antiretrovirals (ARVs) prolong life in HIV

• How can we improve the proportion of HIV-positive people treated effectively?

We know Mass Drug Administration (MDA) reduces incidence of lymphatic filariasis (LF)

• How do we engage the community to participate and achieve optimal community protection?

Remme et al. (2010)

Introduction to Implementation Research

Slide 18

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 19

Introduction to Implementation Research

The Problem: Translating Evidence Into Policy And Practice
− Why So Variable? Why So Slow?

Brooks et al. (2012)

Introduction to Implementation Research

Slide 19

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 20

Introduction to Implementation Research

WHO (2014a)

Factors which affect implementation

• E.g. geographical location, poverty, understanding of disease

Processes of implementation

• E.g. distribute insecticide treated nets at ante-natal clinics, co-management of HIV and TB

Outcomes of implementation

• E.g. impact on deaths from malaria, improved cure rates of TB in HIV-positive patients

What Does Implementation Research Study?

Introduction to Implementation Research

Slide 20

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 21

Introduction to Implementation Research

Remme et al. (2010)

• Health managers and teams

• Policy-makers

• Practitioners

• Communities

• Individuals

Often not research ‘experts’ therefore they need clear, evidence-based outputs

Target Audience of Implementation Research

Introduction to Implementation Research

Slide 21

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 22

Introduction to Implementation Research

Macklin (2014)

E.g. Hand washing to reduce puerperal infection:

Introduction of education on hand washing to all clinics and tracking pre- and post-intervention outcomes

• Tracking of rates of puerperal sepsis

E.g. Disinfecting water to reduce diarrhoeal illness:

Addition of disinfectant to water in all high-risk areas

• Track rates of diarrhoeal illness

Implementation Research VS. Quality Improvement or Public Health Practice?

Introduction to Implementation Research

Slide 22

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 23

Introduction to Implementation Research

WHO (2014a)

Framework

• Acceptability

• Appropriateness

• Feasibility

• Effectiveness

• Cost

• Coverage

• Sustainability

Focus on ‘Strategies’ in Implementation Research

Introduction to Implementation Research

Slide 23

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 24

Introduction to Implementation Research

WHO (2014a)

• Optimize health-care delivery

• Improve uptake of research findings

• Ideally an effective process can be generalized to other settings

• Multi-stakeholder engagement to jointly address problems

• Inform policy development for sustainable solutions

Goals for Implementation Research

Introduction to Implementation Research

Slide 24

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 25

Introduction to Implementation Research

WHO/TDR (2014)

The Health System is Complex and Must be Considered in Implementation Research

Introduction to Implementation Research

Slide 25

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 26

Introduction to Implementation Research

Hyder et al. (2014)

• Health education

• Provision of incentives or subsidies

• Introduction of monitoring tools

• Guideline implementation

• Implementation of multi-faceted packages

• Implementation of new treatment methods

• Change in delivery systems

Typical Implementation Research Interventions – Examples?

Introduction to Implementation Research

Slide 26

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 27

Introduction to Implementation Research

Gopichandran et al. (2016)

Phases of Implementation Research and Major Ethical Considerations

Introduction to Implementation Research

Slide 27

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 28

Introduction to Implementation Research

Hyder et al. (2014)

Implementation Research

Implementation research takes what we know
and turns it into what we do

• Integral to policy development and execution

• Requires active and ongoing engagement with all stakeholders throughout the process to optimize chances of success

Introduction to Implementation Research

Slide 28

Notes

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies
Slide 29

Introduction to Implementation Research

References and Reading Materials

• Brooks A, Smith TA, de Savigny D, Lengeler C. BMC Public Health. 2012;12:683.

• Gopichandran V, Luyckx VA, Biller-Andorno N, Fairchild A, Singh J, Nhan T et al. Developing the ethics of implementation research in health. Impl. Sci. 2016;11:161.

• Hyder AA, Rattani A, Krubiner C, Bachani AM, Tran NT. Ethical review of health systems research in low- and middle-income countries: a conceptual exploration. Am J Bioethics. 2014;14:28–37.

• Macklin R. Ethical challenges in implementation research. Publ Health Ethics. 2014;7:86–93.

• Remme JHF, Taghreed A, Becerra-Posada F, D’Arcanques C, Devlin M, Gardner C et al. Defining research to improve health system. PLoS Med. 2010;7:e1001000.

• Su X-Z; Miller LH. Discovery of artemisinin and the Nobel Prize in Physiology or Medicine. Sci China Life Sci. 2015;58;1175–9.

• White NJ, Pukrittayakamee S, Tran Tinh Hien, Abul Faiz M, Mokuolu OA. Malaria. Lancet. 2014;383:723–35.

• WHO. Framework for Operations and Implementation Research in Health and Disease Control programs. Geneva: World Health Organization; 2008.

• WHO. Implementation research in health. A practical guide. Geneva: World Health Organization; 2014a.

• WHO/TDR. Implementation research toolkit. Geneva: World Health Organization; 2014.

MODULE 1

Introduction to

Implementation Research

MODULE 2

Ethical Considerations in

Implementation Research

MODULE 3

Ethical Issues in Planning

Implementation Research

MODULE 4

Ethical Issues in the

Conduct of Implementation

Research

MODULE 5

Ethical Issues in the

Post–Research Phase of

Implementation Research

MODULE 6

In-Depth Ethical Analysis of

Implementation Research

Using Case Studies

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