Introduction to Outcome Research Objectives: 1. Define the terms related to outcome research 2. Discuss basis of outcome research with relation to Donabedian‟s theory. 3. Describe methods/approaches/types of outcome research. 4. Understand methodologies of outcome research. Outcome Research: Outcomes research is a broad umbrella term without a consistent definition. It tends to describe research that is concerned with the effectiveness of public-health interventions and health services; that is, the outcomes of these services. Aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome. Measures include parameters such as improved health, lowered morbidity or mortality, and improvement of abnormal states (such as elevated blood pressure). Theoretical Basis of Outcomes Research: The theorist Avedis Donabedian (1966) proposed a theory of quality health care and the process of evaluating it. The three dimensions of the model are health, subjects of care, and providers of care. The concept of health has Three aspects; Physical-physiological function, Psychological function, and Social function. The concept subjects of care has two primary aspects: patient and person. A patient is defined as someone who has already gained access to some care, and a person as someone who may or may not have gained access to care. Each of these concepts is further categorized by the concepts individual and aggregate. Within patient, the aggregate is a caseload; within person, the aggregate is a target population or a community. The concept providers of care shows levels of aggregation and organization of providers. The first level is the individual practitioner. At this level, consideration is given to the individual provider rather than others who might be involved in the subject’s care, whether individual or aggregate. As the levels progress, providers of care include several practitioners, who might be of the same profession or different professions and “who may be providing care concurrently, as individuals, or jointly, as a team”. At higher levels of aggregation, the provider of care is institutions, programs, or the healthcare system as a whole. The essence of Donabedian’s framework is the physical-physiological function of the individual patient being cared for by the individual practitioner. Examining quality at this level is relatively simple. When more than one practitioner is involved, both individual and joint contributions to quality must be evaluated. Concepts such as coordination and teamwork must be conceptually and operationally defined. When a person is the subject of care, an important attribute is access. When an aggregate is the subject of care, an important attribute is resource allocation. Access and resource allocation are interrelated, because they each define who gets care, the kind of care received, and how much care is received.

2. Introduction to Outcome Research
Shakir Rahman
BScN, MScN, MSc Applied Psychology, PhD Nursing (Candidate)
University of Minnesota USA
Principal & Assistant Professor
Ayub International College of Nursing & AHS Peshawar
Visiting Faculty
Swabi College of Nursing & Health Sciences Swabi
Nowshera College of Nursing & Health Sciences Nowshera
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3. Objectives
At the completion of this unit learners will be able to:
1. Define the terms related to outcome research
2. Discuss basis of outcome research with relation to Donabedian‟s
theory.
3. Describe methods/approaches/types of outcome research.
4. Understand methodologies of outcome research.
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4. Outcome Research
• Outcomes research is a broad umbrella term without a consistent
definition.
• It tends to describe research that is concerned with the
effectiveness of public-health interventions and health services;
that is, the outcomes of these services.
• Aimed at assessing the quality and effectiveness of health care as
measured by the attainment of a specified end result or outcome.
• Measures include parameters such as improved health, lowered
morbidity or mortality, and improvement of abnormal states
(such as elevated blood pressure). 4
7/19/2023

5. Theoretical Basis of Outcomes
Research
• The theorist Avedis Donabedian (1966) proposed a theory of
quality health care and the process of evaluating it.
• The three dimensions of the model are health, subjects of care,
and providers of care.
• The concept of health has Three aspects; Physical-physiological
function, Psychological function, and Social function.
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6. 7/19/2023 6

7. Cont.…
• The concept subjects of care has two primary aspects: patient
and person.
• A patient is defined as someone who has already gained access
to some care, and a person as someone who may or may not
have gained access to care.
• Each of these concepts is further categorized by the concepts
individual and aggregate.
• Within patient, the aggregate is a caseload; within person, the
aggregate is a target population or a community.
7/19/2023 7

8. Cont.…
• The concept providers of care shows levels of aggregation and organization
of providers.
• The first level is the individual practitioner. At this level, consideration is
given to the individual provider rather than others who might be involved in
the subject’s care, whether individual or aggregate.
• As the levels progress, providers of care include several practitioners, who
might be of the same profession or different professions and “who may be
providing care concurrently, as individuals, or jointly, as a team”.
• At higher levels of aggregation, the provider of care is institutions,
programs, or the healthcare system as a whole
7/19/2023 8

9. Cont.…
• The essence of Donabedian’s framework is the physical-physiological function of
the individual patient being cared for by the individual practitioner. Examining
quality at this level is relatively simple.
• When more than one practitioner is involved, both individual and joint contributions
to quality must be evaluated.
• Concepts such as coordination and teamwork must be conceptually and
operationally defined. When a person is the subject of care, an important attribute is
access.
• When an aggregate is the subject of care, an important attribute is resource
allocation. Access and resource allocation are interrelated, because they each define
who gets care, the kind of care received, and how much care is received.
7/19/2023 9

10. Types of Outcome Research
• Outcomes research can be economic (pharmacoeconomics),
clinical (comparative clinical effectiveness research) or
humanistic (health-related quality of life).
• Pharmacoeconomics:
• Identifies measures and compares the costs and consequences of
the use of alternative pharmaceutical products and services and
their impact within health care systems or society.
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11. Cont.…
• The costs associated with economic evaluation methods are
derived from many different sources and include both direct and
indirect costs, some of which are difficult to measure. These
might include medical, pharmacy, patient productivity, and level
of activity costs.
• Comparative Clinical Effectiveness Research:
• Evaluating and comparing health outcomes and clinical
effectiveness, risks and benefits of two or more medical
treatments, services or items
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12. Cont.…
• Health-related Quality of Life (HRQoL):
• Typically used to measure the effects of chronic illness,
treatments and disabilities, is a multi-dimensional concept that
focuses on the impact health status has on quality of life.
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13. Methodologies of outcome research
• Identify the Research Question
• Identify how subjects get enrolled in the study
• Identify the treatments being compared
• Identify the outcomes being assessed
• Identify the study design
• Evaluate the possibility for bias and confounding
– Blinding
– Random Allocation
– Differential dropout
– Appropriate Statistical Analysis
• Evaluate for Statistical Power
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14. Step 01: Identify the Research Question
• Is patient satisfaction, quality of life, return to work,
improved function and or pain with those getting one type
of treatment as compared to another?
• Is pain reduced and mobility maintained? Is treatment
cost-effective?
• Do the benefits of a particular treatment outweigh the
risks?
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15. Step 02: Identify how subjects get enrolled in
the study
• The procedures by which a study enrolls potential study
subjects helps to understand to what degree the findings
in the study population can be generalized to other
clinical populations.
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16. Step 03: Identify treatments being compared
• To identify the treatments or interventions the study seeks to
compare.
• The choice of comparisons is the central feature that confers
clinical and scientific value to a study.
• The study questions reflect the interests, values and motivations
of the clinical and research community to provide optimal care
for patients. From a methodological standpoint, however, the
treatments compared should be
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17. Cont.…
1. Distinguishable
2. Medically justifiable
3. Compatible with the needs of the patient
4. Have reasonable doubt regarding relative efficacy
5. Mode of administration that is compatible with the
methodological requirements of the study
6. Mode of administration that is similar to real-world clinical
practice
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18. Step 04: Identify the outcomes being assessed
• Patient-oriented outcomes
• Clinician-oriented outcomes
• Cost/health care utilization
• Societal outcomes
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19. Step 05: Identify the study design being used
• Cross - sectional
• Case Control
• Cohort
• Randomized Controlled Trials
• Quasi Experimental
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20. Step 06: evaluate the methods used to control for
bias and confounding
• Confounding is a factor that is associated with both with
treatment and outcome.
• Confounding can mask the observed statistical association
between treatment and outcome, either inflating the estimate or
diminishing it.
• Bias is the systematic misrepresentation of rates or associations
observed in a study
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21. Cont.….
• Bias can be introduced in the way subjects are recruited, data are
collected, or by using an incorrect statistical analysis procedure
for the study design used.
• The common methodological tools used to control for bias and
confounding include: blinding, control of cross-over,
randomization, control of differential follow-up, and correct
statistical analysis.
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