Patient-Reported
Outcomes (PROs) is “ a unique health status indicator that reveals the
current and past scenarios of a ones health condition by the patient them self,
without any other interpretation (clinician or care giver). “Patient-Reported
Outcome” (PRO) is considered a broad phenomenon, encompassing various factors
of perceiving and quantifying a person’s health status, which includes health
conditions (physical and mental), health related quality of life (HRQOL), social
well being, clinical trials, functional status linked with the treatment taken
by the patient etc.
Literature
has identified several crucial factors for development of a PRO instrument
namely
- Study parameters should hold strong literature
support
- Should possess a conceptual structure
- Should be drafted based on a end-point
model
- Study must possess ideal number of study
items
- The model should conceal identity of the
patients
- Reproducible at any given point of time
- The questionnaire should be simplified and
understandable to the patients
The universal
availability of the content is expected to bring upon striking changes in the
policies by the regulatory
authorities, drug developers, researchers, technologists and be used for advanced
clinical trials over the time.
The commonly known
types of PRO instruments are
- Generic
- Disease
specific
- Population
specific
- Dimension
specific
- Individualized
- Summary items
- Utility
measures
Generic PRO
instrument:
Generic PRO instruments
are used to measure broad health aspects, illness outcomes and are applicable
for a wide spectrum of patient groups and population across the countries. The
key benefits of generic PRO instrument is that they are ideally suitable to
evaluate large number of health disorders and can be used for comparative
studies among different patient groups, treatment methods to determine the
competency of the models.
Disease specific:
This instrument aims
to estimate the patient's view of a specific disease or disorder Specific
instruments are made developed targeting specific health ailments. For example:
Rheumatoid Arthritis Quality of Life questionnaire (RAQoL) developed to evaluate
the patient purview of health care and quality of life with Rheumatoid Arthritis,
Population specific:
Population-specific
instrument are developed targeting a specific demographic group (children or
elderly people) and geographic groups. The term “Population specific” can be
classified based on disease condition, treatment methods, population and
geography.
Dimension specific:
Dimension-specific
instrument evaluates a particular aspect of a person’s health. The classic
examples are physical function, psychological wellness, personal strengths,
global health perspectives, specific role based perceptions (house hold works,
job, finance), personal put up (appearance,
spiritual viewpoint, gratification).
\ Individualized
PRO instrument:
Individualized
instruments enable patients to frame their own choice of items and can evaluate
the significance of individual items such as the health issue, other concerns
or factors that are not predetermined by the evaluator.
Summary Items:
Summary item is a
versatile PRO instrument where respondents are asked to consolidate the varied
aspect of health condition via a single item or a very small number of items.
It is less time consuming and is used to get inputs from large sample groups of
a general population leading to ample correlative evidences. However, summary item restricts
the specific inferences that can be made on a specific health disorder, which
is due to its conciseness.
Utility measures:
Utility measures, involves
choice or values pertaining to an individual health condition and represents it
as a single index/score. This PRO instrument evaluates the overall strength of
health status in a society and is used for cost-utility analysis.
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