Estimating clinically significant differences in quality of life outcomes
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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ABSTRACT: To validate the Dentine Hypersensitivity Experience Questionnaire in terms of responsiveness to change and to determine the minimally important difference (MID). The study was a secondary analysisof data from three randomised controlled trials with 311 participants. Three aspects of responsiveness were examined: change within individuals, differences between people who improved, stayed the same or worsened using an external referent, and change due to treatment. Responsiveness to treatments of differing efficacywas assessed in trials with negative and active controls. The measureshowed excellent internal reliability, test-retest reliability and criterion validity. The measure was highly responsive to change within individuals (Cohen's effect sizes: 0.28, 0.56, 0.86) showing decreases in the total score (i.e. improvement in OHrQoL) across all trials. The effect sizes in participants whose self-reported QoL'improved' were large (0.73 - 1.31).DHEQ detected a treatment effect in one of two negative control trials (effect size: 0.47). DHEQ scores were similar in the test and control groups in the active control trial. The minimally important differencerange wasbetween 22 and 39 points. The measure is longitudinally reliable, valid and responsive and can discriminate between treatments of different efficacy. This article is protected by copyright. All rights reserved.Journal Of Clinical Periodontology 10/2013; 41(1). DOI:10.1111/jcpe.12181
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ABSTRACT: Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004-2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.Evidence-based Complementary and Alternative Medicine 10/2012; 2012(1741-427X):642576. DOI:10.1155/2012/642576
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ABSTRACT: This paper is a report of a study of health-related quality of life and post-traumatic stress disorder symptoms in patients attending an Accident and Emergency department because of psychosocial crises. Psychosocial crises are commonplace globally, but there is little knowledge about patients attending Accident and Emergency departments because of psychosocial crises. Data were collected at an Accident and Emergency department in Norway from September 2008 to June 2009. A total of 99 adults participated in the baseline study and 41 of these participated at 2 months follow-up. The Short Form-36 Health Survey and the Post Traumatic Symptom Scale were used to obtain data. Participants reported significantly lower scores in all health-related quality of life domains at baseline compared with the general Norwegian population. The mental health score was two standard deviations below the norm. Health-related quality of life scores were improved and post-traumatic stress disorder symptoms were reduced after 2 months. High levels of post-traumatic stress disorder symptoms were reported by 78% of the participants at baseline and 59% at follow-up. Participants with high levels of post-traumatic stress disorder symptoms at follow-up also reported low health-related quality of life scores. This study suggests a need for an acute psychosocial intervention and an opportunity to receive follow-up support at Accident and Emergency departments.Journal of Advanced Nursing 07/2011; 68(2):402-13. DOI:10.1111/j.1365-2648.2011.05752.x