Health Qual Life Out
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Health Qual Life Out · Sep 2006
EditorialHow a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure.
The evaluation and use of patient reported outcome (PRO) measures requires detailed understanding of the meaning of the outcome of interest. The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials. One section of the guidance document specifically deals with advice about the use of the minimal important difference (MID) that we redefined as the smallest difference in score in the outcome of interest that informed patients or informed proxies perceive as important. ⋯ Investigators are encouraged to use reliable and valid methods to achieve meaningfulness of their results, preferably those that rely on patients to estimate what constitutes a minimal important, small, moderate, or large difference. However, acquiring the meaningfulness of PRO measures transcends beyond a concept of the MID and we advocate that dichotomizing the scores of patient-reported outcome measures facilitate interpretability of clinical trial results for those who need to understand trial results after a labelling claim has been granted. Irrespective of the strategy investigators use to estimate these values, from the individual patient perspective it is much more relevant if investigators report both the estimated thresholds and the proportion of patients achieving that benefit.
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Health Qual Life Out · Jan 2003
EditorialClinical and outcome research in oncology. The need for integration.
Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. ⋯ In the USA specific interdisciplinary projects have been launched by the NCI. In Europe there is a lack of such initiatives. The correct placement of OR in the anti-cancer drug development process will guarantee the highest possible standard of validity and reliability of OR at European level and better integration of both translational and outcome research in the mainstream of clinical research into anti-cancer drugs, thus speeding up the introduction of the results of patient-oriented translational clinical research into clinical practice.