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Condition-specific HRQL instrument
A measure of Health-Related Quality of Life that is designed to be applicable to a single disease or health condition, and that summarizes individual's health in the various areas most important to that clinical condition.
Cultural Adaptation
The passage of an instrument from a source language to a target language with cross-cultural equivalence in appropriate, acceptable and natural language. It comprises two phases: (1) the linguistic validation of the source instrument into a target language, and (2) the psychometric validation of the target language version obtained through phase (1).
Generic Quality of Life instrument
A measure of Health-Related Quality of Life (HRQL) that is designed to be broadly applicable across diseases and health conditions, populations, and healthcare interventions and that summarizes individual's health across the various aspects of HRQoL.
HRQoL
Health Related Quality of Life. It represents the patient's evaluation of the impact of a health condition and its treatment on daily life.
Instrument syn . = measure, assessment
The tool through which subjects (patients, caregivers, etc.) report their perceptions of their health outcomes/health-related quality of life, the object of the cultural adaptation process. Instruments can be questionnaires, rating scales, checklists, inventory, indices, profiles, etc. They can be self-administered or interviewer-administered.
Item banking
Files or databases including all questions and responses (items) constituting an instrument or questionnaire, or several instruments or questionnaires related to a same condition, population or pathology.
Literature review
Non-quantitative summary of existing published literature made by experts who select and weigh findings available from the literature.
Outcomes Research
The collection and analysis of data on the use of health care products, procedures, services and programs, and the evaluation of the clinical, economic, quality of life, and patient satisfaction outcomes of that care to determine the value of those products, procedures, services and programs.
Pharmacoeconomics
The field of study that evaluates the behavior of individuals, firms and markets relevant to the use of pharmaceutical products, services and programs, and which frequently focuses on the costs and consequences of that use.
PRO
Patient Reported Outcomes. It is defined in Willke et al.* as follows: The term "Patient-Reported Outcomes" (PROs) has evolved to include any endpoint derived from patient reports, whether collected in the clinic, in a diary, or by other means, including single-item outcome measures, event logs, symptom reports, formal instruments to measure health-related quality of life (HRQoL), health status, adherence, and satisfaction with treatment. This term coincides with the explicit interest from drug development researchers and regulatory authorities in the appropriate utilization and reporting of treatment impact measures.
*Willke R.J., Burke L.B., Erickson P. Measuring treatment impact: a review of patient- reported outcomes and other efficacy endpoints in approved product labels. Controlled Clinical Trials, 2004; 25: 535-552
Psychometric evaluation
Assessment of reliability, validity, responsiveness, interpretation and burden of survey instruments and questionnaires.
Reference values
The range or frequency distribution of a measurement in a population. Usually, a gold standard provides a value (or number) for comparison; in HRQL, this gold standard does not exist, therefore the reference value is used as a basis for comparison when describing a condition, population or pathology.
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GLOSSARY
