World Association for Chinese Quality of Life (WACQOL) 世界華人生活質素學會 An International Organization Dedicated
to the Education and Research of Quality of Life in the Chinese Population
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The CONSORT PRO is an extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement for reporting randomized controlled trials that involved patient-reported outcomes as the primary outcome or an essential secondary outcome.
This guidance document was developed by the European Research Group on Health Outcomes (ERGHO). It summarizes the key considerations when choosing an instrument for assessing health outcome in practice. It also compiles a list of health outcome instruments in ambulatory care.
The development of the guidance document from the US Food & Drug Administration (FDA) responded to the increasing importance and need of using quality of life as health outcome indicators. The FDA concerns if there is substantial evidence supporting a patient-reported outcome (PRO) is measuring what it intends to measure, which empasses reliability, valdity and responsiveness. The document has received considerable attention in both the industry and academia. It has also been discussed in a BMJ editorial.