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A statistically significant improvement in nasal obstruction ratings following septoplasty is not necessarily clinically important. This study aimed to establish useful measures of septoplasty success, namely the minimal clinically important difference and the desirable clinically important difference.
Methods
Patients rated nasal obstruction on a 0–100 visual analogue scale pre-operatively and at 5.5 months post-operatively. Global outcome rating (completely, much, or somewhat improved, unchanged or worse) served as the anchor post-operatively. Minimal clinically important difference is the visual analogue scale value between ‘somewhat improved’ and ‘unchanged’, and the desirable clinically important difference is that between ‘much’ and ‘somewhat improved’.
Results
Statistically significant improvement in visual analogue scale scores was not clinically important. The minimal clinically important difference (daytime value of 9.5) represented 15.1 per cent improvement and the desirable clinically important difference (daytime value of 28.5) represented 45.2 per cent, without gender or age differences.
Conclusion
Clinical success can be defined using a minimal clinically important difference of 15 per cent improvement over a patient's baseline value. Other studies’ ratings of ‘satisfactory’ outcome coincided with a desirable clinically important difference of 45 per cent over baseline. These values are suggested as relevant indicators of septoplasty success.
The Patient Health Questionnaire (PHQ-9), the Beck Depression Inventory (BDI-II) and the Generalised Anxiety Disorder Assessment (GAD-7) are widely used in the evaluation of interventions for depression and anxiety. The smallest reduction in depressive symptoms that matter to patients is known as the Minimum Clinically Important Difference (MCID). Little empirical study of the MCID for these scales exists.
Methods
A prospective cohort of 400 patients in UK primary care were interviewed on four occasions, 2 weeks apart. At each time point, participants completed all three questionnaires and a ‘global rating of change’ scale (GRS). MCID estimation relied on estimated changes in symptoms according to reported improvement on the GRS scale, stratified by baseline severity on the Clinical Interview Schedule (CIS-R).
Results
For moderate baseline severity, those who reported improvement on the GRS had a reduction of 21% (95% confidence interval (CI) −26.7 to −14.9) on the PHQ-9; 23% (95% CI −27.8 to −18.0) on the BDI-II and 26.8% (95% CI −33.5 to −20.1) on the GAD-7. The corresponding threshold scores below which participants were more likely to report improvement were −1.7, −3.5 and −1.5 points on the PHQ-9, BDI-II and GAD-7, respectively. Patients with milder symptoms require much larger reductions as percentage of their baseline to endorse improvement.
Conclusions
An MCID representing 20% reduction of scores in these scales, is a useful guide for patients with moderately severe symptoms. If treatment had the same effect on patients irrespective of baseline severity, those with low symptoms are unlikely to notice a benefit.
The Beck Depression Inventory, 2nd edition (BDI-II) is widely used in research on depression. However, the minimal clinically important difference (MCID) is unknown. MCID can be estimated in several ways. Here we take a patient-centred approach, anchoring the change on the BDI-II to the patient's global report of improvement.
Method
We used data collected (n = 1039) from three randomized controlled trials for the management of depression. Improvement on a ‘global rating of change’ question was compared with changes in BDI-II scores using general linear modelling to explore baseline dependency, assessing whether MCID is best measured in absolute terms (i.e. difference) or as percent reduction in scores from baseline (i.e. ratio), and receiver operator characteristics (ROC) to estimate MCID according to the optimal threshold above which individuals report feeling ‘better’.
Results
Improvement in BDI-II scores associated with reporting feeling ‘better’ depended on initial depression severity, and statistical modelling indicated that MCID is best measured on a ratio scale as a percentage reduction of score. We estimated a MCID of a 17.5% reduction in scores from baseline from ROC analyses. The corresponding estimate for individuals with longer duration depression who had not responded to antidepressants was higher at 32%.
Conclusions
MCID on the BDI-II is dependent on baseline severity, is best measured on a ratio scale, and the MCID for treatment-resistant depression is larger than that for more typical depression. This has important implications for clinical trials and practice.
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