How To Develop And Evaluate A Pro Instrument? - Pubrica

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Full Information : https://bit.ly/2VPA4uX

What is PRO?

PRO or Patient-reported outcome is a relatively novel method to evaluate the outcome of any treatment by clinician or researcher (in clinical trial) purely based on the inputs got from the patient alone.

Ask the doctor, why ask the patient?

Objective data regarding outcome can be given by the treating physician (cure/survival/disability limitation), by investigations (return of deranged biochemistry to normal) and by the caregiver (return to functional normality). These are Observer-reported outcomes (OROs) and medicine has long relied on these for evidence-based management.

Any illness followed by its treatment weighs physically, mentally, emotionally, economically on the patient. Patients perceive the outcome of the treatment in comparison to their expectations based on prior knowledge. Patient response and compliance to treatment are intricately linked to the ultimate treatment outcome.

What information do I want from the patient? – The PRO instrument:

The outcome of interest that we want to study is the PRO Concept, ...
... while the PRO instrument is the means to collect the data related to the PRO concept, in the form of questionnaire and the information and documentation that supports its use.

In other words, PRO instrument is a questionnaire that compiles data related to the PRO concept of interest which can be summarized as a score.
Content validity is the extent to which an instrument measures the concept of interest that is desired from both the developer’s and user’s perspective.

Stepsinvolved are: -
1. Defining the concept – concept should be clearly defined based on review and literature gap analysisof existing PRO instruments as well as taking inputs from scientific research services, domain specialists, developers and most importantly the patients or the users and should focus on the core characteristics.
2. Conceptual Framework – Breakdown the concept to sub-concepts and finally to items or the questions that will be included in the questionnaire. Each item should be crisp and clear with focus on only one aspect. It should not unnecessarily cause strain to the patient in recalling.
3. End-point Model– Endpoint is the final measured outcome of the treatment that will be compared, and an endpoint model summarises all the endpoint based on OROs and PROs.
4. Review of Preliminary Instrument –
Literacy review is done to understand the proportion of people who may or may not have the literacy level to take the questionnaire.
Translation review is done to ensure conceptual equivalence when translated to another language.

Cognitive interview is the process where the user is made to take the questionnaire by thinking aloud to understand the approach of the user to the questions and that it follows the intention of the item. This is done until saturation is reached on the information received for reviewing the instrument.
5. Reliability Testing – Measure to estimate reproducibility and consistent true estimation of outcomes under consideration. It is further described below.
6. Validation –
It is an ongoing never-ending process of improving the instrument by repeated feedback mechanism.

Evaluating PRO instrument:

As clinical validation data accumulates, a PRO instrument undergoes review and revision to make them robust. It includes the evaluating for the following: -
1. Validity– is the extent to which the scores and their interpretations, supported by theoretical evidence, correlate with the proposed use of the instrument.
2. Reliability-
a. Reproducibility or test-retest reliability-It is assessed under same conditions in same user in a close span of time to assess any variations in recording results that can be attributed to the instrument. It is calculated by intra-class correlation coefficient (ICC).
b. Internal consistency- The items should deliver same scores in similar situations consistently. It is determined by Cronbach’s alpha or coefficient of reliability.
c. Floor and ceiling effect– i.e. the instrument’s ability to measure extremes of construct helps choose the proper instrument for the study.
d. Inter-interviewer reliability-there should not be significant difference in scores when interviewed by two different interviewers.
e. Variability – Instrument should have ability to detect changes when outcomes are different, else it is no good.

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