Estimating clinically significant differences in quality of life outcomes

Saint Louis University, St Louis, MO 63103, USA.
Quality of Life Research (Impact Factor: 2.86). 04/2005; 14(2):285-95. DOI: 10.1007/s11136-004-0705-2
Source: PubMed

ABSTRACT This report extracts important considerations for determining and applying clinically significant differences in quality of life (QOL) measures from six published articles written by 30 international experts, in the field of QOL assessment and evaluation. The original six articles were presented at the Symposium on Clinical Significance of Quality of Life Measures in Cancer Patients at the Mayo Clinic in April 2002 and subsequently were published in Mayo Clinic Proceedings.
Specific examples and formulas are given for anchor-based methods, as well as distribution-based methods that correspond to known or relevant anchors to determine important differences in QOL measures. Important prerequisites for clinical significance associated with instrument selection, responsiveness, and the reporting of QOL trial results are provided. We also discuss estimating the number needed to treat (NNT) relative to clinically significant thresholds. Finally, we provide a rationale for applying group-derived standards to individual assessments.
While no single method for determining clinical significance is unilaterally endorsed, the investigation and full reporting of multiple methods for establishing clinically significant change levels for a QOL measure, and greater direct involvement of clinicians in clinical significance studies are strongly encouraged.

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    • "There are a number of widely accepted assessments of the clinical significance of change in an intervention, using both anchor-based (i.e., clinical) and distribution-based (i.e., statistical) assessments [26] [28]. Anchor-based approaches are methods that relate change to an external event, rating, or condition, while distribution-based methods link clinical significance to a statistical parameter of group or individual data [28]. Examination of the yoga and cancer intervention literature reveals minimal reporting of anchor-based metrics. "
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    • "However, participants had higher scores at the follow-up in five HRQoL domains, showing that their MH and BP had improved from baseline. The improvements from baseline in VT, SF, RE and MH are by effect sizes judged to be clinically significant differences (Wyrwich et al. 2005). These improvements reflect that participants feel happier, more peaceful and calmer (MH) and that they have more energy (VT) after 2 months. "
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