The PAC-QOL is a brief but comprehensive assessment of the burden of constipation on patients' everyday functioning and well-being. Multinational studies demonstrate that the PAC-QOL is internally consistent, reproducible, valid, and responsive to improvements over time.
SUMMARY
BackgroundHealth-related quality of life (HRQoL) has been rarely evaluated as a primary endpoint in the assessment of the effect of probiotics on the irritable bowel syndrome (IBS).
The added value for assessing the health-related quality of life (HRQOL) in chronic conditions is now well documented for evaluation of treatment eflectiveness in clinical trials and as a criterion for licensing new medications and in policy decisions. However; European standards still need to be developed for the measurement and reporting of HRQOL in clinical trials. This is one of the objectives of the European Regulatory Issues on Quality of Life Assessment (ERIQA) Working Group. This document reviews the major issues arising from the selection of an HRQOL instrument; the integration of HRQOL assessment into the research protocol (methodological design, practicalities of HRQOL administration and collection, prevention and handling of missing data); the statistical analysis plan: and the presentation and interpretation of the results. Finally, to gain wider acceptance, whether HRQOL is considered as a primary or secondary endpoint, the scientific principles of clinical trial design should apply to HRQOL.
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