Meaningful change in cancer-specific quality-of-life scores: Differences between improvement and worsening
ABSTRACT There has been increased recent attention to the clinical meaningfulness of group change scores on health-related quality of life (HRQL) questionnaires. It has been assumed that improvements and declines of comparable magnitude have the same meaning or value.
We assessed 308 cancer patients with the Functional Assessment of Cancer Therapy (FACT) and a Global Rating of Change. Patients were classified into five levels of change in HRQL and its dimensions based upon their responses to retrospective ratings of change after 2 months: sizably worse, minimally worse, no change, minimally better, and sizably better. Raw score and standardized score changes on the FACT-G subscales and total score were then compared across different categories of patient-rated change.
The relationship between actual FACT change scores and retrospective ratings of change was modest but usually statistically significant (r: 0.07 to 0.35). Change scores associated with each retrospective rating category were evaluated to determine estimates of meaningful difference. Patients who reported global worsening of HRQL dimensions had considerably larger change scores than those reporting comparable global improvements. Although related to a ceiling effect, this remained true even after removing cases that began near the ceiling of the questionnaire.
Relatively small gains in HRQL have significant value. Comparable declines may be less meaningful, perhaps due to patients' tendency to minimize personal negative evaluations about one's condition. This has important implications for the interpretation of the meaningfulness of change scores in HRQL questionnaires. Factors such as adaptation to disease, response shift, dispositional optimism and the need for signs of clinical improvement may be contributing to the results and should be investigated in future studies.
- SourceAvailable from: Wilco C H Jacobs
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- "To explore the adequateness of the GPR as anchor, we calculated the correlation coefficients (Spearman's rho) of the general GPR with the change score of RMDQ-23 and of the leg painespecific GPR with the change score of VAS leg pain. For an adequate anchor, the correlation with change scores should show coefficients larger than 0.5  . Two subgroup analyses were performed. "
ABSTRACT: Multi-item questionnaires are frequently used to measure outcomes in randomized controlled trials (RCTs) in patients with sciatica. Knowing the minimaly important change (MIC) values for these instruments will facilitate interpretation of change scores. MIC values have been shown to be dependent on baseline values. The question is whether they also depend on the type of intervention. To estimate the MIC of the Roland Morris Disability Questionnaire (modified 23 item version) (RMDQ) and of intensity of leg pain measured by a Visual Analogue Scale (VAS) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values. This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica. Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain. We used the receiver operator characteristic (ROC) method to assess the MIC. Global Perceived Recovery (rated 8 weeks after baseline) was used as anchor. Subgroups were created based on type of treatment and baseline severity. The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5. The values were 8.1 and 6.9 for surgery and conservative treatment, respectively. For high and low baseline values, the MICs were 9.0 and 4.9, respectively, irrespective of treatment received. The MIC values of the VAS leg pain were 34.4 for the total group. For surgery and conservative treatment, the MIC values were 38.5 and 30.4, respectively, whereas for groups with high and low baseline values, MIC values of 53.5 and 17.2 were found. The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values, although the type of intervention appeared to influence the MIC value only slightly. Copyright © 2014 Elsevier Inc. All rights reserved.Journal of Clinical Epidemiology 11/2014; 68(5). DOI:10.1016/j.jclinepi.2014.07.008 · 5.48 Impact Factor
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- "Varios estudios han encontrado coincidencias entre la estimación del CCS o de la DMI con dichos criterios (Norman, Sloan y Wyrwich, 2003; Rejas et al., 2008; Wyrwich, 2004; Wyrwich et al., 1999). Esta equivalencia entre las valoraciones de los métodos internos y externos (recordemos que, en el presente estudio, los métodos internos han presentado tasas excesivamente altas de falsos positivos) podría estar evidenciando la presencia de sesgos en los métodos externos: los pacientes suelen presentar sesgos mnémicos que favorecen las percepciones positivas sobre los efectos de un tratamiento (ver, por ejemplo, Cella et al., 2002). Nuestros resultados indican que, para decidir que se ha producido un cambio estadísticamente fiable, la mejor estrategia consiste en aplicar el criterio 1.96(DIT) o, lo que resulta equivalente cuando las desviaciones típicas del pre y del post son similares y la correlación test-retest es aproximadamente .8, "
ABSTRACT: In applied research and in clinical practice we often need to assess the change experienced by patients as a result of the treatment they have received. This paper assesses the performance of several statistical methods designed to estimate such change. This study focuses on one aspect that still has not received attention: the rate of false positives. We have simulated a situation of no-change (pre-post design with no change between pre and post) in which the behavior of nine different statistics have been evaluated. Three different sample sizes (25, 50 and 100) were used and 1000 samples of each size were simulated. To evaluate the behavior of the chosen statistics we have calculated the percentage of times that each statistic has detected change. Since no-change is the simulated situation, any occurrence of change should be considered a false positive. Results are quite striking: none of the nine statistics evaluated offers an acceptable behavior. Good performance is achieved only when the standard deviation of pre-post differences and the traditional criteria are used and not when those proposed by the literature related to the clinical significance are used.Anales de Psicología 05/2013; 29(2):301-310. DOI:10.6018/analesps.29.2.139031 · 0.55 Impact Factor
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- "Therefore , our results for improvement are not as clear as those for deterioration . However , despite this limitation , the study does provide some preliminary evidence that the MIC deterioration and the MIC improvement are not necessarily equal ( Cella et al . , 2002b ) ."
ABSTRACT: To select the most useful evaluative outcome measures for early multiple sclerosis, we included 156 recently diagnosed patients in a 3-year follow-up study, and assessed them on 23 outcome measures in the domains of disease-specific outcomes, physical functioning, mental health, social functioning and general health. A global rating scale (GRS) and the Expanded Disability Status Scale (EDSS) were used as external criteria to determine the minimally important change (MIC) for each outcome measure. Subsequently, we determined whether the outcome measures could detect their MIC reliably. From these, per domain the outcome measure that was found to be most sensitive to changes (responsive) was identified. At group level, 11 outcomes of the domains of physical functioning, mental health, social functioning and general health could reliably detect the MIC. Of these 11, the most responsive measures per domain were the Medical Outcome Study 36 Short Form sub-scale physical functioning (SF36pf), the Disability and Impact Profile (DIP) sub-scale psychological, the Rehabilitation Activities Profile sub-scale occupation (RAPocc) and the SF36 sub-scale health, respectively. Overall, the most responsive measures were the SF36pf and the RAPocc. In individual patients, none of the measures could reliably detect the MIC. In sum, in the early stages of multiple sclerosis the most useful evaluative outcome measures for research are the SF36pf (physical functioning) and the RAPocc (social functioning).Brain 11/2006; 129(Pt 10):2648-59. DOI:10.1093/brain/awl223 · 10.23 Impact Factor