Meaningful change in cancer-specific quality of life scores: Differences between improving and worsening

Evanston Northwestern Healthcare and Northwestern University, Evanston, Illinois 60201, USA.
Quality of Life Research (Impact Factor: 2.49). 06/2002; 11(3):207-21. DOI: 10.1016/S0149-2918(02)85118-9
Source: PubMed


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.

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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 [15] [16]. Two subgroup analyses were performed. "
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    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 · 3.42 Impact Factor
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    • "The participants’ self-assessed QoL will be measured using the FACT-G questionnaire, a validated tool that has been widely used in this setting [47]. It contains 27 questions with a 5-point scale, which assesses four domains of patient QoL: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. "
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    ABSTRACT: Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made.Methods/design: In a double-blinded randomised-controlled trial, chemotherapy-naive patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naive patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms.Trial registration: Identifier: ACTRN12613000120774.
    BMC Complementary and Alternative Medicine 04/2014; 14(1):134. DOI:10.1186/1472-6882-14-134 · 2.02 Impact Factor
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    • "These approaches have also been used to investigate participants’ judgments of the clinical importance of change in other outcome measures [14,36]. These questions are commonly used as an external anchor by which to assess the responsiveness of measure to patient rated meaningful health change (See the FACT (Functional Assessment of Cancer Therapy questionnaire and Health Related Quality of life in a study of oncology patients [15])). Global ratings of change have also been used to elucidate clinically important changes in scores in quality of life of instruments in chronic heart and lung disease [37,38], in asthma [38] and cancer treatment [39]. "
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    ABSTRACT: Patient reports or ratings are essential for measuring the quality of patient care. Measures designed for this purpose tend to focus on the processes and structures of care rather than the outcomes of it. The latter is arguably the most valid indicator of the quality of care patients receive. Typically this information is gathered by probing patient satisfaction with treatment as part of an investigation of satisfaction with hospital care. More recently patient ratings of the outcome of treatment have been obtained to measure treatment efficacy in clinical trials. However, a more direct approach is to ask patients to assess the benefit of treatment on their current health status. We performed a structured literature review on patient reported satisfaction with outcomes of treatment and direct patient assessments of the same. The purpose of this was to identify suitable candidate questions for a short instrument to tap patient evaluations of in-patient hospital interventions. Articles were included if they dealt with patient satisfaction or patient assessment of outcomes of treatment. Articles were excluded if they dealt more generally with patient satisfaction with care. We identified 169 papers, 79 were included in the review. The findings of this review suggest that there are a number of benefits of directly asking patients to assess the outcome of hospital treatment. Importantly this approach reflects outcomes relevant to the patient and is also more likely to reflect patient report in routine clinical practice. There is also evidence that such approaches have face validity and construct validity. The problems associated with this approach (i.e. response bias), are those common to patient reported outcome surveys, but employing appropriate strategies can minimize them. Furthermore, employing a simple set of questions that asks patients to assess outcomes of treatment they receive can be time and resource efficient in comparison to administering lengthy measures. This approach could be tested for potential generic use as an evaluative measure for patients in hospital settings.
    Health and Quality of Life Outcomes 01/2014; 12(1):5. DOI:10.1186/1477-7525-12-5 · 2.12 Impact Factor
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