Implementation science aims to study methods to promote the uptake of evidence-based practices into routine healthcare. It focuses on evaluating the process of implementation and its impact on the targeted evidence-based practice. Implementation studies commonly employ mixed quantitative and qualitative methods to evaluate the process, formative outcomes, and summative impact of implementation strategies. Key outcomes include measures of adoption rates, fidelity, costs and sustainability of implementing evidence-based practices into real-world healthcare settings.

1. Implementation Science
Dr. Akanksha Dani
JR2
Community Medicine

2. Evidence Based Practices (EBP)
Evidence based practice is the conscientious use of current best evidence in making
decisions about patient care
It is defined in terms of three legged tool
1.The best available research evidence bearing on whether and why a treatment works
2.Clinical expertise (clinical judgement and experience) to rapidly identify each patient’s
unique health state and diagnosis, their individual risks and benefits of potential
interventions
3. Patient preferences and values

3. Systematic reviews & meta-
analysis of RCTs
RCTs
Cohort Studies
Case-control studies
Cross-sectional surveys
Case reports
Uncontrolled data (expert
opinions, perspective…)
No control
group
People with/without condition
(prospective)
People with/without condition
(retrospective)
EVIDENCE HIRARCHY

4. Efficacy and Effectiveness Trials

5. Background
- It has been widely reported that EBPs take on an average 17 years to be
incorporated into routine general practice
- Research to practice gap-
Whether Published findings of the researchers are translated into
PUBLIC HEALTH IMPACT has not been a concern of traditional healthcare
researcher

6. Know – do gap
Bridging the know-do
gap is one of the most
important challenge for
public health in this
century. It also poses
the great opportunity
for strengthening
health system
know Do

8. Implementation Science
Definition:
The scientific study of methods to promote the systematic uptake
of research findings and other evidence based practices into
routine practice and hence improve the quality and effectiveness
of health services

9. What Implementation Research will do??
1.Quantify gap between routine and potential care with proven or
promising interventions
2.Barrier analysis to understand hinders for change to occur
3.Describe what they do to implement a change
4.Enable successful adaptation and implementation of interventions
5.Assess implementation and outcomes
6.Understand sustainability of changes

12. Discovery Development Delivery
Improved
Health
Outcomes
What is
pathophysiology
?
What is
diagnosis &
intervention How do we best
deliver the
intervention
Does the
intervention &
delivery model
work?
Role of delivery system in closing the know do gaps

14. Implementation research requires - TRANS-DESCIPLINARY RESEARCH
That may include-
• Health Service Researcher
• Economists
• Sociologists
• Anthropologists
• Organizational Scientists
• Operational partners in administration
• Front line clinicians
• Patient

15. Quality Improvement Implementation Science Dissemination
Begin with specific problem in a
specific healthcare system
Typically begins with an EBPs that are
underutilized
Spread of information about the
intervention
Recognized at the level of the provider
& led to the design & trial of strategies
to improve a specific problem of a
specific healthcare system
Identifies and addresses resultant
quality gaps at provider clinic or
Healthcare system level
Implementation science takes as a
part of its mission an explicit goal of
developing generalizable knowledge
that can be widely applied beyond the
individual system under study

17. Examples in
Implementation science
Presenter : Dr. Rashmi Kulkarni (JR3)
Guide : Dr. Shrikala Acharya
(Additional Professor )
Dept of Community Medicine
Seth GSMC and KEMH

18. IR
CHARACTERISTICS
APPLICATION
Systematic The systematic study of how a specific set
of activities integrate an evidence-based
public health intervention within specific
settings and how health outcomes vary
across communities
Multidisciplinary • Analysis of biological, social, economic,
political, system, and
environmental factors that impact
implementation
• Interdisciplinary collaborations between
behavioral and social scientists, clinicians,
epidemiologists, statisticians, engineers,
business analysts, policy makers, and
stakeholders

19. IR CHARACTERISTICS APPLICATION IN USE
Contextual • relevant to local specificities and need
• Generates generalizable knowledge that
can be applied across contexts
• Culture, community
Complex • Dynamic and adaptive
• Multi-scale: occurs at multiple levels of
health care systems and
• community practices
• Analyzes multi-component programs
and policies

20. IR is NOT
• Routine, applied operations research
• Basic biomedical research (e.g., discovery of a new gene pathway or
etiology research)
• Initial or replication of intervention efficacy trials in a top-down
controlled setting
• Routine program progress reporting
• M & E – part of IR. Not synonymous.

21. e.g. zinc deficiency and diarrhea
• What is the association of zinc
deficiency with severity of
diarrhoea?
Epidemiological
research
• What is the effect of Zinc as an
adjunct in treatment of diarrhoea?
Clinical Efficacy
research
• What is the effect of programme
of promoting zinc as a adjunct in
treatment of diarrhoea?
Programme
effectiveness
research
• How can the barriers to scaling up zinc
promotion programme overcome so
that it reaches all children with
diarrhea?
Implementation
Research

22. • Operational research (OR) - focuses on a specific, local,
clearly defined setting and context.
• Implementation research (IR) starts with a specific
setting and applies findings to broader contexts
through scale-up and other implementation processes.
• Health systems research (HSR) focuses on a broader
context, covering many settings under the umbrella of
an entire system.

24. Voluntary Medical Male Circumcision Scale-up
in Eastern and Southern Africa
• With evidence that male circumcision (MC) reduces the risk of HIV
transmission in specific settings, countries in Eastern and Southern
Africa are working to scale up MC service delivery and coverage.
Delivering this evidence-based male circumcision intervention
includes opportunities for operations research, implementation
research, and health systems research.

25. Operational Research
• Which locations should be targeted for
delivering MC services in Eastern Africa?
Implementation research
• How can access to MC services among
populations who are currently not reached by
MC services be improved?
Health System Research
• What has been the impact of the rapid scale-up
of MC programs on fragile health

26. IR Constraints to scale up
• Funding
• stakeholder access to information at different levels
• lack of political support
• frequent changes in staff or policies at any level
• lack of skilled facilitators,
• influence and relationship of different contextual levels (individual,
organization, community, policy)

27. Interventions with skilled birth attendants to address
the MDG of improving maternal, newborn, and child
health
Level of
Constraint
Type of Constraint Potential intervention
Community/househ
old
Perceptions of SBAs, decision
making
Community-level
promotion of
services and behavioral
modifications to increase
demand for
services
Health services
delivery
• Shortage and distribution of
appropriately qualified staff (of
appropriate gender)
• Adequate drugs and medical
supplies
• Lack of equipment and
Infrastructure
Task-shifting and
redistribution of
Personnel and resources

28. Level of
Constraint
Type of
Constraint
Potential
intervention
Health sector policy
and
strategic management
Employment systems,
supply
procurement
processes
Task-shifting and
redistribution of
personnel
Public policies cutting
across sectors
Poor availability of
communication
Poor transport
infrastructure
Quality assurance and
monitoring
Transportation
vouchers
Environmental and
contextual
characteristics
Corruption, weak
government
Geographic barriers
Transparency
Transportation
vouchers

29. Approaches to identify constraints
• Systematic analysis
• Discussion with concerned stakeholders
• Routine monitoring of health sector activities
• Annual health sector review meetings

30. RE-AIM FRAMEWORK
RE-AIM Design Questions
Reach Who is intended to benefit, and who actually
participates or is exposed to the intervention?
Effectiveness What is the most important benefits you are trying
to achieve and what is the likelihood of negative
outcomes?
Adoption Where is the program or policy applied, and WHO
applied it?
Implementation How consistently is the program or policy delivered;
How will it be adapted; How much will it cost; and
How/Why will the results come about?
Maintenance When will the initiative become operational; how
long will it be sustained (setting level); and how long
are the results sustained (individual level)?

31. Planned parenthood and smoking cessation
example
• Patient randomized study (n = 1154) in low income Planned
Parenthood clinics.
• Eligible and target population = women smokers coming into clinic for
contraception, wellness, or non-pregnancy follow-up.
• Intervention - 9-minute tailored video, clinician advice to quit, brief
behavioral counseling, follow-up phone calls.
• Control - Advice to Quit and Stop Smoking brochure.
Glasgow R et al. A brief smoking cessation intervention. AJPH, 2000, 90: 786-789

32. REAIM Framework
• Reach:
• 99% of planned parenthood clinics had identified smoking
status,
• 76% of smokers approached participated,
• no differences on demographics for participants vs.
decliners
• Effectiveness: at 6-week follow-up,
• 10.2% quit – Intervention group
• 6.9% quit – Control group (p<.05)
• Adoption:
• Approached 4 clinics in lowest SES neighborhoods in area

33. • Implementation:
• >85% on all components
• except phone calls (43%)
• Maintenance: (after 6 months F/U)
• Individual level: Higher but not significant (30-day
biochemically validated abstinence: 6.4% vs 3.8%)
• Conclusion :
This brief, clinic based intervention appears to be
effective in reaching and enhancing cessation among
female smokers, a traditionally underserved population.

34. Discussion with concerned stakeholders
1. Specify and describe :
• A discussion of TB control with stakeholders
• Constraint - increasing defaulter rate of TB patients.
• Possible causes - poor health services management, social stigma,
negative attitudes of health workers towards TB patients.

35. 2. Quantify and Elaborate :
• How widespread the problem is?
• In which regions it occurs more persistently?
• Potential areas of low compliance, who is most affected ?
• consequences of the problem. (increasing morbidity, deaths, waste of
resources, development of multi-drug resistance, etc.)

36. 3. Identify Contributing factors :
• Poorly trained staff - inadequate TB health education materials,
limited patient understanding of treatment, or failure to provide
systematic advice and counseling to patients.
• These factors may inhibit patient understanding of treatment
requirements,causing the high defaulter rate.

37. Q: Please select the best example of an
implementation research question.
A. What is the effect of zinc as an adjunct for treatment of diarrhea?
B. What is the effect of distributing insecticide-treated nets to prevent
malaria in vulnerable populations?
C. How can tuberculosis treatment be delivered effectively in rural
areas?
D. Does a health education program increase access to antiretroviral
therapy?

38. Answer
C. How can tuberculosis treatment
be delivered effectively in rural areas?

39. Thank You

40. IMPLEMENTATION SCIENCE
Dr. Ashwini B. Sapkal
Junior Resident 2
Department of Community Medicine
Seth GSMC & KEM Hospital
Parel, Mumbai

41. Principles and methods of implementation science
Implementation studies differ from clinical studies
The first step in understanding implementation studies is to distinguish
implementation processes from the EBPs they seek to implement
An implementation intervention is “a single method or technique to facilitate
An implementation strategy is “an integrated set, bundle, or package of discreet
implementation interventions ideally selected to address specific identified barriers
to implementation success” .

42. Implementation interventions may include, for example, efforts to change
behaviour at the patient, provider, system, or even policy level.
Common examples include strategies at the provider level such as
education/training, audit-feedback, and performance incentives.

43. Strategies targeting the provider, team, or clinic levels may
include QI techniques or other systems redesign efforts, team-
based performance incentives, Learning collaboratives, or
community-engagement.
Facilitation, guided efforts by internal or external
organizational staff to support multiple levels of system
change through provider or team-based coaching, is
increasingly recognized as critical to the success of many
implementation effects .

44. In contrast to clinical research, in which typically focuses on the health effects of an EBP,
implementation studies typically focus on rates and quality of use of EBPs rather than
their effects.
Such EBPs may be as “simple” as
increasing use of a single medication such as beta-blockers in individuals who have
experienced a myocardial infarction
OR
the use of metabolic side effect monitoring for individuals taking antipsychotic
medications
OR
as “complex” as instituting psychotherapies like cognitive behavioral therapy or even
multi-component care paradigms such as the collaborative chronic care model.

45. Implementation strategy and the EBP are two different concept
For instance, in studying the effects of a program to increase
effective cognitive-behavioral therapy use for bipolar disorder, the
impact of cognitive-behavioral therapy on health status would be
an EBP outcome (and more typically a focus for a clinical study)
while measuring the proportion of clinicians providing cognitive
behavioural therapy, or proportion of patients who attend a
minimum level of cognitive-behavioural therapy sessions would
be a more typical implementation study outcome.

46. Thus the crux of implementation studies is their focus
on evaluating the process of implementation and its
impact on the EBP of interest.

47. Definations:
Evaluation research :
It refers to the kind of applied social research that attempts to evaluate the
effectiveness of social programs
Impact
:Measures how well program deliver an intervention and the outcomes
- Example: Is ART treatment program (as a preventive strategy) reducing HIV
incidence?

48. Impact Evaluation:

49. • These studies can involve one or more of three broad types of
evaluation
1] Process evaluation
2] Formative evaluation
3] Summative evaluation

50. 1] Process Evaluation:
• It describes the characteristics of use of an EBP.
• Data are collected before, during, and/or after the implementation and
analysed by the research team without feedback to the implementation
team and without intent to change the ongoing process.
• Process evaluation can be undertaken in a purely observational study
(e.g., In preparation for developing an implementation strategy) or during
the course of a spontaneous or planned system or policy change.

51. 2] Formative Evaluation :
• It utilizes the same methods as process evaluation
• In this data are fed back to the implementation team and/or staff in
the target system during the study in order to adapt and improve the
process of implementation during the course of the protocol.
• Formative evaluation is conceptually similar to fidelity monitoring that
goes on as part of any traditional clinical trial, but differs in that it is
specified a priority in a study hypothesis or research question

52. • A quantitative version of formative evaluation in clinical trials is the use of
sequential multiple assignment randomized trials (SMART) or adaptive
intervention designs, which are used to either augment or switch
treatments at critical decision points where there is evidence of initial
non-response .
• The use of formative evaluation has implications for controlled trial
validity, which may differ between clinical and implementation trials.

53. 3] Summative Evaluation :
• It is a compilation, at study end, of the impact of the implementation
strategy.
• Summative evaluation measures typically assess impacts on process of care
(e.g., Increased use or quality of targeted EBP).
• Another common component of summative evaluation is to characterize the
economic impact of an implementation strategy and its effects.

54. • Implementation studies most commonly do not employ formal cost
effectiveness analyses but conduct focal “business impact analyses” .
• Such analyses focus on estimating the financial consequences of
adoption of a clinical practice within a specific healthcare setting or
system
• Typically this includes costs to the system associated with both the
implementation strategy and the utilization of the EBP.

55. Types of Evaluation Data :
Data for the process, formative, and/or summative evaluation can come from various
sources and can include either or both of quantitative and qualitative data.
Data can be collected across various levels of observation including patients, providers,
systems and broader environmental factors such as community, policy, or economic
indices.

56. Common quantitative measures include structured surveys and tools that
assess
For ex: organizational context, provider attitudes and behaviours, or
patient receptivity to change.
Administrative data are often utilized, either in focal target populations or
at the broader system level to characterize
For ex : baseline and change in rates of utilization of particular practices.

57. Measures of fidelity to the EBP are often central components
of the evaluation plan, and these can be quantitative,
qualitative, or both.
Common qualitative data collection methods include semi-
structured interviews with patients, providers or other
stakeholders, focus groups ,direct observation of clinical
processes and document review.

58. Qualitative data collection and analysis can either be structured as a
hypothesis-free exploration or related approaches or can utilize
directed content analysis to address pre specified issues such as
hypothesis-testing or measurement of intervention fidelity.
Most implementation evaluation processes include mixed qualitative
and quantitative measures and require careful attention in the study
design to the various ways to combine such data.

59. Implementation outcomes:
Implementation
Outcome
Definition
Acceptability Perception amongst stakeholders new intervention is agreeable
Adoption Intension to apply or application of new intervention
Appropriateness Perceived relevance of intervention to a setting, audience or
problem
Feasibility Extent to which an intervention can be applied
Fidelity Extent to which an intervention gets applied as originally designed
/ intended
Implementation costs Costs of the delivery strategy including the costs of the
intervention itself
Coverage Extent to which eligible patients / population actually receive
intervention
Sustainability Extent to which a new intervention becomes routinely available / is
maintained post introduction

61. RE-AIM FRAMEWORK- IMI CAMPAIGN
RE-AIM Design Questions
Reach Background Data : Situational analysis based on data from
- National survey
-HMIS
-WHO Concurrent monitoring and Evaluation
Selection Criteria : Estimated no. of children who missed DPT3 / P3 >13000
OR
DPT3 / P3 Coverage < 70%
173 Districts( Rural)
17 Urban Areas
Effectiveness
[Risk reduction ]
For Mission Indradhanush – 6.7 % increase in immunization coverage
Adoption 3 round in 2017 and 2 rounds in 2018
Intersectoral Coordination- Other Ministries, other programs, mobilizers and
partners

62. Implementation
(Level of enforcement)
Precampaign Activity : Situational Analysis
-Training and Orientation
-Preperation of microplan after headcount survey
-Assessment of District readiness by -National Monitors
,common review of mission
-Initiation of first round and subsequent round
Maintenance( Sustainability) Daily Reporting -
ANM Planning unit District Unit state unit
National unit
30 Cluster sampling -
Coverage Evaluation - Twice in a year ( in 5 rounds)

63. Controlled
Implementation Trials
Dr. Barsha Pathak
JR-3
Dept. Of Community Medicine

64. Concept
• The controlled implementation trial helps to
identify barriers and facilitators of evidence based
practices (EBP) under naturalistic conditions.
• How is it DIFFERENT????
• In other studies seek to enhance EBP ADOPTION by
employing specific implementation strategies.

65. TYPES
1. PARALLEL GROUP
2.INTERRUPTED TIME-SERIES
3. STEP-WEDGE
4.SMART [randomisation]

66. design concept
• Parallel Design
Randomised and prospective.
• Stepped Wedged
Receive implementation support
• SMART Design
Multivariate nested analysis.
• Time-series Design
Outcome of interest is measured at multiple time
points prior and after implementation effort.

67. Implementation science
versus
Traditional health services
& Clinical trial

68. 1. They focus on the impact of the implementation
strategy on the use of an Evidence based practice (EBP)
rather than health impact of the EBP itself.
2. They take a fundamentally different aspect to validate.

69. • STUDY
Efficacy design OR Effective design
 WHAT THEY FOCUS ON ???
Eg.
• Addressed the health system issues and constraints.
• Integrated health service provision in non-specialised
settings by-
New human resources, improving capacity,
strengthening information centre, health financing,
overall leadership and governance.

70. WHAT DOES A IMPLEMENTATION SCIENCE DESIGN DO
???

71. • Implementation science will explain us how evidence-
based interventions work in real world/usual practice
settings.
• I.S pays particular attention to the audience that will be
using the evidence-based research.
• The context in which implementation of an
evidence-based study is occurring and the factors that
influence its implementation.

72. EXAMPLE
Implementation Science for
closing the treatment gap for
mental disorders

73. BACKGROUND
• At least 10% of the world’s population is affected by
one of a wide range of mental disorders.
• However, knowledge about mental health disease
has improved and also cost-effectiveness of
interventions has improved.

74. • THE TREATMENT GAP HAS
REMAINED SIGNIFICANTLY
LARGE!!!
( specially in low and middle
income countries.)

75. • To bridge the treatment gap for mental disorders, WHO envisages
that the treatment for priority mental disorders will be provided by
primary care doctors.
• Hence, large scale training to train the general practitioners were
taken up. But recent evaluation process underlines the limited
effectiveness of training interventions.
• BUT WHY ????

76. Practical Difficulties
• Evidence based Interventions working in only 50%
replication site.
• Unpredictable behaviour of the system around.
• Lack of capacity to integrate.
Hence - “ CONTEXT IS EVERYTHING” (by I.S)

77. • This project is trying to address the “knowledge-
action gap”.
• Evidence to support the implementation and
scale-up of mental health care in primary care
and maternal health care.
• A comprehensive mental health care plan has
been developed.
• The role of PRIME team was restricted to
capacity building of staff on WHO mhGAP
training material and evaluation of the outcome.
PRIME-PROJECT

78. • On evaluation they found that there was a poor
translation of evidence-based WHO mhGAP
guideline interventions into routine practices.
• The barriers found were -
1. Providers were not particularly supportive.
2. Non-availability of psycho-tropic drugs and lack
of reporting of mental health indicators in
routine health management information system.
3. Poor accountability of district administration.
4. Low priority accorded to mental disorder.

79. • Ultimately, the PRIME team proceeded with
implementation phase.
• CHANGE-PACKAGE was designed.
i.e.
1.Mental health service delivery through existing public health
system in LMICs can be strengthened only with strong
facilitation by an external resource team.
2.An additional human resource in the form of a case
manager is essential to establish true collaborative models of
care.

80. Measurement of Implementation Sciences.
• ACCEPTABILITY.
• ADOPTION
• APPROPRIATENESS
• FEASIBILITY
• IMPLEMENTATION COSTS
• COVERAGE AND SUSTAINABILITY.

81. Efficacy Design
Principles
Effectiveness Design
Principles
Implementation
Design Principles.
Hypothesis
Interventions are
implemented
Interventions are
implemented may be
followed but not
sustained
Interventions are adopted
and sustained.
Population & Settings Any specialised setting.
Non-specialised practice
sites.
Unit of observation may
be patients, providers or
primary health care
centre, typical setting is
non-specialized practice
sites.
Outcome measures
Health outcomes are
many
Short and specific
Emphasize on Adoption
measures
Inventions clinicians
PhDs,MSWs are hired &
trained by PI
Counsellors for mental
health
Endogenous counsellors.
Context
At all costs, Trial should
be successful
Work within “typical”
conditions
Maintain typical
conditions.
Validity emphasis Internal>>external External>>internal
Plan to optimise protocol
in real time using
formative evaluation
while systematically
documenting adaptations