PRO instrument and its types – Pubrica

1. PROINSTRUMENT AND ITSTYPES An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline PopulationSpecific Dimension Specific Individualized PRO Instrument SummaryItems UtilityMeasures Introduction PRO Instrument Types of PROInstruments Generic PRO Instrument Disease Specific

3. Introduction 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 otherinterpretation. “Patient-Reported Outcome” (PRO) is considered a broad phenomenon, encompassing various factors of perceiving and quantifying a person’s health status, which includes health related quality of life (HRQOL), social well being and clinicaltrials. This self- appraisal system is high essential to identify the best practices of a health care that is qualified to be a good outcome leading to a patient centered health care system.

4. PROInstrument A PRO instrument is a rating scale that critically evaluates the health outcomes, satisfaction scores etc in a patientsviewpoint. PRO instruments are considered as a primordial quality indicator for health care service, which gives valuable insights to the policy makers, demand market and clinicalresearchers. Literature has identified several crucial factors for development of a PRO instrumentnamely 1. Study parameters should hold strongliteraturesupport Contd..

5. Should possess a conceptualstructure Should be drafted based on a end-pointmodel Study must possess ideal number of studyitems The model should conceal identity of thepatients Reproducible at any given point oftime The questionnaire should be simplified and understandable to thepatients The universal availability of the content is expected to bring upon striking changes in the policies by the regulatoryauthorities, drug developers, researchers, technologists and be used for advanced clinical trialsover thetime.

6. Types of PROInstruments Individualized Summary items Utilitymeasures Generic Disease specific Populationspecific Dimensionspecific

7. Generic PROInstrument 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 thecountries. 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 themodels. This instrument is less sensitive as compared to other models. Classic examples may include SF-36, which studies the physical and mental component of health in an 8-dimensional scoring matrix, Psychological General Well-BeingIndex.

8. DiseaseSpecific This instrument aims to estimate the patient's view of a specific disease ordisorder Specific instruments are made developed targeting specific healthailments. 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, activity limitations, emotional function, and environmentalvulnerability.

9. PopulationSpecific Population-specific instrument are developed targeting a specific demographic group and geographicgroups. The term “Population specific” can be classified based on disease condition, treatment methods, population andgeography. The population specific PRO is a sensitive tool is developed in precise manner to obtain information’s in a narrowedwindow. Example: The Child Health and Illness Profile/CHIP developed for adolescents; Cambridge PulmonaryHypertension Outcome Review(CAMPHOR)

10. DimensionSpecific Dimension-specific instrument evaluates a particular aspect of a person’shealth. The classic examples are physical function, psychological wellness, personal strengths, global health perspectives, specific role basedperceptions. This instrument is resourceful in providing specific information as compared to the generic or population specific PRO instruments and they are highlycompetent. It provides wide range of reliable data for a betterinterpretation.

11. Individualized PROInstrument Individualized instruments enable patients to frame their own choice of items and can evaluate the significance of individualitems. It basically responds to the concerns of the individual patient and not based onany healthstandard. Therefore individualized instruments are known to have higher contentvalidity. Classic example of this PRO instrument is: The Patient Generated Index where the respondents are asked to list the five most important areas of their lives; Schedule for the Evaluation of IndividualQualityof Life(SEIQoL)

12. SummaryItems Summary item is a versatile PRO instrument where respondents are asked to consolidate the varied aspect of health condition via a singleitem. It is less time consuming and is used to get inputs from large sample groups of a general population leading to ample correlativeevidences. Summary item restricts the specific inferences that can be made on a specific health disorder, which is due to itsconciseness. Example: Questions in General Household Survey; the General Household Survey for England and Wales on chronic illness anddisability.

13. UtilityMeasures Utility measures, involves choice or values pertaining to an individual health condition and represents it as a singleindex/score. This PRO instrument evaluates the overall strength of health status in a society and is used for cost-utilityanalysis. It is used to compare treatment methods of different health problems andits economicevaluation. Example: TheEuroQolEQ-5D contains five items namely mobility, pain/discomfort and anxiety/depression; Utility measure for major, unipolardepression.

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