PRO Instruments
The PRO instruments must be well designed, structured and meets certain standard requirements if it is to provide useful information. All the PRO instruments must be meaningful and provide useful data. The interviewer simply assesses in noting the views of the patient and he himself does not use his technical or professional knowledge to identify the problem. The PRO cannot be used for professional assistance to the patient. The PRO must be well targeted for specific types of people and relevant and based on theoretical data. PRO instruments should be reliable, valid and truly responsive with well-formed structure of scales that score the patient’s reports very well. The PRO instruments must be tested thoroughly using the appropriate methods and reported with its summary of scales the instrument is aimed to look at.
The most commonly used PRO instruments help to assess on the following constructs:
Symptoms are the effects before a disease or infection is caused. They are also termed as impairments.
1. Functioning: This is done to test how the treatment functions well in the patient’s point of view. It determines the disability of the drug or the patient.
2. Health related Quality of life: This includes the previous two instruments, the impairments and the disability and allows patients to report its outcome on the healthy life.
3. Quality of life: This is a step far beyond the health related quality of life. The quality of life allows users to fulfill their needs, physical and emotional without any restriction and report the outcome.
The instruments that are used to identify the impairments or the symptoms of a disease within a patient are more commonly used in all clinics. This makes the physician to identify the problem more clearly. Instruments that involve assessment of personal care, use of locomotives and routine life activities are the disability instruments. The health related quality of life (HQRL) is generally multi-dimensional instrument with combing the aspects of the impairments and the disability questionnaires and allowing person to report its outcome on the personal life status. The Quality of life is done by asking the patient’s ability to fulfill their needs and requirements both physical and emotional without any emotional restrictions. The needs-based model is often used for QoL.
Sometimes the approval of drug by the FDA or the regulatory authorities is based on the PRO instruments. Evidences show that six cancer drugs were approved just because of the PRO instruments. Out of which one was accepted truly because of the relief in pain, suppression of symptoms that the patients reported. The instrument used to identify it was called as pain intensity scale. The other five drugs were seen attacking the cancer itself. By instruments assessment, even the drug functioning within the patient is well identified and this would help FDA to decide on approving the drug. In some cases, where the person is potentially not satisfied with the drug and find that the drug causes more pain than the normal treatment, he can report it in the PRO questionnaire, which will be used in deciding further about the drug in the market.
