Home About us Contact
|
Home About us Contact | ||
|
|
||
Minimal Important Difference (minimal + important_difference)
Selected AbstractsWhat changes in health-related quality of life matter to multiple myeloma patients?EUROPEAN JOURNAL OF HAEMATOLOGY, Issue 4 2010A prospective study Abstract Objective: To determine the clinical significance of changes in quality-of-life scores in patients with multiple myeloma (MM), we have estimated the minimal important difference (MID) for the health-related quality-of-life instrument, the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. The MID is the smallest change in a quality-of-life score considered important to patients. Methods: Between 2006 and 2008, 239 patients with MM completed the EORTC QLQ-C30 at inclusion (T1) and after 3 months (T2). At T2, a structured quality-of-life interview was also performed. MIDs were calculated by using mean score changes (T2,T1) for patients who in the interview stated they had improved, deteriorated or were unchanged. MIDs were also estimated by the receiver-operating characteristic (ROC) curve method as well as by calculation effect sizes using standard deviations of baseline scores. Results: MIDs varied slightly depending on the method used. Patients stating in the interview that they had ,improved' or ,deteriorated' had a corresponding change in EORTC QLQ-C30 score ranging from 6 to15 (improvement) and from 9 to17 (deterioration) (scale range 0,100). The ROC analysis indicated that changes in score from 7 to17 represent clinically important changes to patients. The effect size method suggested 5,6 to be a small and 11,15 to be a medium change. Conclusion: Calculation of MIDs as mean score changes or by ROC analysis suggested that a change in the EORTC QLQ-C30 score in the range of approximately 6,17 is considered important by patients with MM. These MIDs are closer to a medium effect size than to a small effect size. Our findings imply that mean score changes smaller than 6 are unlikely to be important to the patients, even if these changes are statistically significant. [source] Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA2LEN taskforce position paperALLERGY, Issue 3 2010I. Baiardini To cite this article: Baiardini I, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, van Wijk RG, La Grutta S, Lombardi C, Maurer M, Pinto AM, Ridolo E, Senna GE, Terreehorst I, Todo Bom A, Bousquet J, Zuberbier T, Braido F. Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA2LEN taskforce position paper. Allergy 2010; 65: 290,295. Abstract The aim of this Global Allergy and Asthma European Network (GA2LEN) consensus report is to provide recommendations for patient-reported outcomes (PROs) evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological economic and social impact. During the last 40 years, PROs have gained large consideration and use in the scientific community, to gain a better understanding of patients' subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient-related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors' indications without modification and performing a cross-cultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre,post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides health-related quality of life, and clinical data. [source] Desloratadine relieves nasal congestion and improves quality-of-life in persistent allergic rhinitisALLERGY, Issue 11 2009K. Holmberg Background:, Symptoms of allergic rhinitis (AR), particularly nasal congestion, can impair quality-of-life (QoL). However, only a modest correlation exists between these symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores, suggesting that both be evaluated for a complete assessment of health. Methods:, Subjects with a ,2-year history of moderate-to-severe AR to dust mite or cat dander were randomized to desloratadine 5 mg/day (n = 293) or placebo/day (n = 291) for 28 days. Primary endpoint was change from baseline in a.m./p.m. nasal congestion score. Secondary outcomes included change from baseline in total nasal symptom score, individual symptom scores and RQLQ scores (completed on days 1, 7, and 28). Results:, The Allergic Rhinitis and its Impact on Asthma criteria for persistent allergic rhinitis (PER) were fulfilled by 99% of subjects in the placebo arm. Between-treatment difference in a.m./p.m. nasal congestion score, observed from day 8 onward, significantly favored desloratadine (P = 0.0003). Desloratadine significantly improved a.m./p.m. nasal congestion and RQLQ scores after 1 week and at treatment end (P < 0.05). Improvements in 5 of 7 RQLQ domain scores exceeded the minimal important difference. On days 7 and 28, desloratadine was also significantly superior to placebo in mean change from baseline in a.m./p.m. total nasal symptom score and rhinorrhea score (both P , 0.01). Symptomatic benefit was primarily driven by improvement in nasal congestion and rhinorrhea. Conclusions:, Desloratadine 5 mg/day significantly improved symptoms associated with PER, including nasal congestion, and provided significant improvement in QoL after 1 week of treatment. [source] Assessing the responsiveness of measures of oral health-related quality of lifeCOMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 1 2004David Locker Abstract ,,, Objectives: This paper illustrates ways of assessing the responsiveness of measures of oral health-related quality of life (OHRQoL) by examining the sensitivity of the oral health impact profile (OHIP)-14 to change when used to evaluate a dental care program for the elderly. Methods: One hundred and sixteen elderly patients attending four municipally funded dental clinics completed a copy of the OHIP-14 prior to treatment and 1 month after the completion of treatment. The post-treatment questionnaire also included a global transition judgement that assessed subjects' perceptions of change in their oral health following treatment at the clinics. Change scores were calculated by subtracting post-treatment OHIP-14 scores from pre-treatment scores. The longitudinal construct validity of these change scores were assessed by means of their association with the global transition judgements. Measures of responsiveness included effect sizes for the change scores, the minimal important difference, and Guyatt's responsiveness index. An receiver operating characteristic (ROC) curve was constructed to determine the accuracy of the change scores in predicting whether patients had improved or not as a result of the treatment. Results: Based on the global transition judgements, 60.2% of subjects reported improved oral health, 33.6% reported no change, and only 6.2% reported that it was a little worse. These changes are reflected in mean pre- and post-treatment OHIP-14 scores that declined from 15.8 to 11.5 (P < 0.001). Mean change scores showed a consistent gradient in the expected direction across categories of the global transition judgement, but differences between the groups were not significant. However, paired t -tests showed no significant differences in the pre- and post-treatment scores of stable subjects, but showed significant declines for subjects who reported improvement. Analysis of data from stable subjects indicated that OHIP-14 had excellent test,retest reliability with an intraclass correlation coefficient (ICC) of 0.84. Effect size based on change scores for all subjects and subgroups of subjects were small to moderate. The ROC analysis indicated that OHIP-14 change scores were not good ,diagnostic tests' of improvement. The minimal important difference for the OHIP-14 was of 5-scale points, but detecting this difference would require relatively large sample sizes. Conclusions: OHIP-14 appeared to be responsive to change. However, the magnitude of change that it detected in the context described here was modest, probably because it was designed primarily as a discriminative measure. The psychometric properties of the global transition judgements that often provide the ,gold standard' for responsiveness studies need to be established. [source] | ||||||||||