Mapping the EORTC QLQ C-30 onto the EQ-5D Instrument: The Potential to Estimate QALYs without Generic Preference Data

Objectives:  The aim of this article is to map the European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 onto the EQ-5D measure to enable the estimation of health state values based on the EORTC QLQ C-30 data. The EORTC QLQ C-30 is of interest because it is the most commonly used instrument to measure the quality of life of cancer patients.
Methods:  Regression analysis is used to establish the relationship between the two instruments. The performance of the model is assessed in terms of how well the responses to the EORTC QLQ C-30 predict the EQ-5D responses for a separate data set.
Results:  The results showed that the model explaining EQ-5D values predicted well. All of the actual values were within the 95% confidence intervals of the predicted values. More importantly, predicted difference in quality-adjusted life-years (QALYs) between the arms of the trial was almost identical to the actual difference.
Conclusion:  There is potential to estimate EQ-5D values using responses to the disease-specific EORTC QLQ C-30 measure of quality of life. Such potential implies that in studies that do not include disease-specific measures, it might still be possible to estimate QALYs.     

Health-related quality of life among breast,prostate, and colorectal cancer patients with end-stage disease

Purpose

To explore end-stage breast, prostate, and colorectal cancer patients’ health-related quality of life (HRQoL); to compare results obtained by different HRQoL instruments; and to explore factors related to impaired HRQoL.

Methods

A cross-sectional observational study utilized two generic HRQoL instruments, the 15D and the EQ-5D, and a cancer-specific instrument, the EORTC QLQ-C30. Patients were recruited from the Helsinki University Hospital’s Department of Oncology and from a local hospice.

Results

Of the 114 palliative care patients included in the analysis, 27 had breast cancer, 30 had prostate cancer, and 57 had colorectal cancer. Of these, 28 % died within 3 months after their response, while 32 % died within three to 6 months, and 39 % died more than 6 months after. Utility values varied widely by instrument: the 15D gave the highest utility values and VAS the lowest (15D: 0.74, EQ-5D: 0.59 and VAS: 55). Patients close to death had lower HRQoL scores independently from the instrument used. The EQ-5D showed a pronounced ceiling effect, with 13 % of patients reporting full health, whereas the corresponding figures for the 15D and VAS were 1 and 0 %, respectively. Fatigue was the most common symptom and also predicted impaired HRQoL most significantly.

Conclusions

All instruments were applicable for the evaluation of HRQoL among end-stage cancer patients. Fatigue seemed to be the most significant deteriorating factor, whereas clinical and demographic factors had less of an effect on HRQoL.     

Quality of life of people with venous leg ulcers: A comparison of the discriminative and responsive characteristics of two generic and a disease specific instruments

Background: Venous leg ulcers are an important source of morbidity in society. Measuring the impact of leg ulcers on quality of life is important within clinical and economic evaluations. In this study we report a validation study of the leg ulcer disease specific Hyland questionnaire and compare its discriminative and responsive characteristics to general health quality of life measures: the SF-12 and EQ-5D. Methods: HRQoL of venous leg ulcer patients from 9 UK regions was measured using SF-12, EQ-5D and Hyland, at baseline and every three months for 1 year. Psychometric analysis was used to confirm the validity of the Hyland questionnaire. Quarterly scores for all instruments were calculated. Effect size and standardised mean difference were used to investigate the responsiveness to ulcer healing and discriminative abilities of the instruments. Results: Three hundred and eighty seven individuals were recruited into the VenUS I study. Baseline health related quality of life data from the study participants suggested a two factor solution for the Hyland. This questionnaire was associated with small and moderate ability to discriminate individuals according to age, mobility, initial ulcer size and ulcer duration. SF-12 and EQ-5D had good evaluative properties; both instruments were responsive to changes in HRQoL after ulcer healing. High levels of bodily pain were reported in the SF-12 questionnaire, whilst only minor ulcer related discomfort was reported in the Hyland. Discussion: SF-12 and EQ-5D are suitable for exploring dimensions of health related quality of life in people with chronic venous leg ulceration. The responsiveness to healing of the Hyland questionnaire is unclear. We would recommend the use of generic instruments for the measurement of HRQoL in patients with venous leg ulcers.     

Assessment of health-related quality of life in individuals with depressive symptoms: validity and responsiveness of the EQ-5D-3L and the SF-6D

Background

The EQ-5D and the SF-6D are examples of commonly used generic preference-based instruments for assessing health-related quality of life (HRQoL). However, their suitability for mental disorders has been repeatedly questioned.

Objective

To assess the responsiveness and convergent validity of the EQ-5D-3L and SF-6D in patients with depressive symptoms.

Methods

The data analyzed were from cardiac patients with depressive symptoms and were collected as part of the SPIRR-CAD (Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease) trial. The EQ-5D-3L and SF-6D were compared with the HADS (Hospital Anxiety and Depression Scale) and PHQ-9 (Patient Health Questionnaire) as disease-specific instruments. Convergent validity was assessed using Spearman’s rank correlation. Effect sizes were calculated and ROC analysis was performed to determine responsiveness.

Results

Data from 566 patients were analysed. The SF-6D correlated considerably better with the disease-specific instruments (|r_s|= 0.63–0.68) than the EQ-5D-3L (|r_s|= 0.51–0.56). The internal responsiveness of the SF-6D was in the upper range of a small effect (ES: − 0.44 and − 0.47), while no effect could be determined for the EQ-5D-3L. Neither the SF-6D nor the EQ-5D-3L showed acceptable external responsiveness for classifying patients’ depressive symptoms as improved or not improved. The ability to detect patients whose condition has deteriorated was only acceptable for the EQ-5D-3L.

Conclusion

Overall, both the convergent validity and responsiveness of the SF-6D are better than those of the EQ-5D-3L in patients with depressive symptoms. The SF-6D appears, therefore, more recommendable for use in studies to evaluate interventions for this population.

     

Validity, reliability and responsiveness of the EQ-5D in German stroke patients undergoing rehabilitation

Purpose

To analyse the psychometric properties of the EQ-5D in German stroke survivors undergoing neurological rehabilitation.

Methods

The EQ-5D, the Hospital Anxiety and Depression Scale (HADS) and the Stroke Impact Scale (SIS) were completed before (210 subjects) and after (183 subjects) a patient education programme in seven rehabilitation clinics in Bavaria, Germany. A postal follow-up was conducted after 6?months. Acceptance, validity, reliability and responsiveness of the EQ-5D were tested. The SIS subscales were used as external anchors to classify the patients into change groups between the measurements.

Results

The proportion of missing answers ranged from 4.7 to 8.6%. Between 16 and 19% reported no problems in any EQ-5D dimension. At baseline, correlations between EQ-5D index and the SIS subscales ranged from 0.15 (communication) to 0.60 (mobility). Correlations with the EQ VAS were slightly smaller. All scores were reliable in test?Cretest with intraclass correlations ranging from 0.67 to 0.81. EQ-5D index and EQ VAS were consistently responsive only to improvements in health, showing small- to medium effect sizes (0.27?C0.42).

Conclusions

The EQ-5D has shown reasonable validity, reliability and, more limited, responsiveness in stroke patients with mild to moderate limitations of functional status, allowing it to be used in clinical trials in rehabilitation.     

Comparison of Generic,Condition-Specific,and Mapped Health State Utility Values for Multiple Myeloma Cancer

ObjectiveResource allocation informed by cost-utility analysis requires that the benefits be comparable across patient groups and interventions. One option is to recommend the use of one generic utility measure, but this raises the issue of comparability when the preferred measure is inappropriate or unavailable. Many cancer trials do not include generic measures such as the EuroQol five-dimensional (EQ-5D) questionnaire and instead include condition-specific measures and use these to generate utility estimates. We analyze the comparability of generic, condition-specific, and mapped utility values for a multiple myeloma cancer patient data set.MethodsGeneric EQ-5D, condition-specific EORTC-8D, and EQ-5D utility values mapped from the EORTC QLQ-C30 were compared by using psychometric and statistical analysis to determine discrimination across severity groups, responsiveness, and agreement.ResultsGeneric, condition-specific, and mapped utility estimates were responsive over time and show discriminative validity. The EQ-5D had higher responsiveness and detected a greater change across severity groups and treatment periods than did the EORTC-8D but has a higher proportion of responses at full health (12.8%). Differences in the EQ-5D and the EORTC-8D were due at least in part to differences in the classification system. Mapped EQ-5D estimates had a smaller SD and do not reflect the severe range of health states reported by using the EQ-5D.ConclusionsOur findings suggest that condition-specific EORTC-8D or mapped EQ-5D utility estimates are broadly comparable to directly obtained EQ-5D utilities for a multiple myeloma patient data set. However, EORTC-8D estimates captured changes in quality of life for patients in mild health states that were not captured by the EQ-5D, but estimated lower utility gains than did the use of the EQ-5D directly.     

Relationship between Health-Related Quality of Life, Pain, and Functional Disability in Neuropathic Pain Patients with Failed Back Surgery Syndrome

Objectives:  Patients with failed back surgery syndrome (FBSS) and chronic neuropathic pain experience levels of health-related quality of life (HRQoL) that are considerably lower than those reported in other areas of chronic pain. The aim of this article was to quantify the extent to which reductions in (leg and back) pain and disability over time translate into improvements in generic HRQoL as measured by the EuroQoL-5D and SF-36 instruments.
Methods:  Using data from the multinational Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome trial, we explore the relationship between generic HRQoL—assessed using two instruments often used in clinical trials (i.e., the SF-36 and EuroQol-5D)—and disease-specific outcome measures (i.e., Oswestry disability index [ODI], leg and back pain visual analog scale [VAS]) in neuropathic patients with FBSS.
Results:  In our sample of 100 FBSS patients, generic HRQoL was moderately associated with ODI (correlation coefficient: −0.462 to −0.638) and mildly associated with leg pain VAS (correlation coefficient: −0.165 to −0.436). The multilevel regression analysis results indicate that functional ability (as measured by the ODI) is significantly associated with HRQoL, regardless of the generic HRQoL instrument used. On the other hand, changes over time in leg pain were significantly associated with changes in the EuroQoL-5D and physical component summary scores, but not with the mental component summary score.
Conclusions:  Reduction in leg pain and functional disability is statistically significantly associated with improvements in generic HRQoL. This is the first study to investigate the longitudinal relationship between generic and disease-specific HRQoL of neuropathic pain patients with FBSS, using multinational data.     

Responsiveness of generic health-related quality of life measures in stroke

Objective: To compare five preference-based generic measures of health-related quality of life (HRQOL) in terms of change scores, correlations among change scores, responsiveness, and quality adjusted life-years (QALYs) gained. Design: Observational longitudinal cohort study where clinical measures and self-assessed HRQOL measures were administered to stroke patients at baseline and at 6 months. Patients were categorized as ‘stable’, ‘some improvement’ and ‘large improvement’ using the Barthel Index, Modified Rankin Scale (MRS), and Center for Epidemiologic Studies Depression Scale (CES-D). For each group, paired t -tests and variants of effect size were used to compare the responsiveness of preference-based HRQOL summary scores, including the EQ-5D VAS and index-based score, SF-6D, and Health Utilities Index (HUI) Mark 2 (HUI2) and Mark 3 (HUI3) overall utility scores. Results: Ninety-eight of 124 (79%) patients completed the 6-month follow-up. Change scores of the EQ-Index, HUI2, and HUI3 were strongly correlated with changes in the Barthel Index and MRS, while the EQ-5D VAS had higher correlation with CES-D change scores than the other measures. The SF-6D, HUI3, and EQ-Index were generally more responsive than the HUI2 and EQ-5D Visual analogue scale (EQ-VAS). QALY estimates based on the EQ-5D index and HUI3 were twice as large as estimates based on the SF-6D and HUI2. Conclusions : The results of this study may assist in informing the selection of a preference-based generic HRQOL measure, although choice will also depend on study goals and context. We would caution against the generalization of the study results on responsiveness to conditions when more subtle change is expected.     

Measurement Properties of the EQ VAS Around the Globe: A Systematic Review and Meta-Regression Analysis

ObjectivesThis study aimed to synthesize and evaluate published evidence on the measurement properties of the EQ VAS, a component of all EQ-5D questionnaires.MethodsThis systematic review followed the Consensus-Based Standards for the Selection of Health Measurement Instruments guidelines. Five electronic databases were searched for EQ-5D-3L and EQ-5D-5L validation articles published from January 1, 2009, to November 5, 2019. Evidence for construct validity, test–retest reliability, and responsiveness was extracted from individual studies before being aggregated for evaluation of the populations represented by the studied samples. Multivariable logistic meta-regression was conducted to explore the effects of potential covariates on construct validity.ResultsA total of 50 articles containing 488 studies, using samples drawn from 12 different populations, were identified. Generally, the quality of evidence was high for construct validity studies (n = 397) but only moderate for both test–retest reliability studies (n = 21) and responsiveness studies (n = 70). “Sufficient” construct validity of EQ VAS was found in 8 of 12 populations, “sufficient” test–retest reliability was found in 3 of 11 populations, and “sufficient” responsiveness was found in 5 of 12 populations. Meta-regression analyses suggested that construct validity studies from the Asian-Pacific region were more likely to show a negative rating compared with studies from Europe and North America.ConclusionThe EQ VAS exhibits “sufficient” construct validity, “inconsistent” test–retest reliability, and “inconsistent” responsiveness across a broad range of populations. Additional studies are needed to explore the suboptimal validity of the EQ VAS in the Asian-Pacific region, whereas more high-quality validation studies are needed to assess its reliability and responsiveness.     

Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer

Background The assessment of health-related quality of life (HRQL) for patients with hormone-refractory prostate cancer (HRPC) is of paramount importance because new treatments have a modest impact on survival but side effects of treatment and disease symptoms can significantly impact HRQL. Methods This was an observational, non-interventional, multi-center, multi-national cohort study of patients with metastatic HRPC. Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30), the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the EQ-5D index. Mean changes from baseline to month 3, 6, and 9 were computed and tested using paired t-tests. Results FACT-P PCS, EQ-5D index and 10 of 14 EORTC domains were statistically significantly lower (P < 0.05) than the baseline scores at the 3, 6 and 9 month visits. The domains that did not reach statistical significance were cognitive functioning, insomnia, diarrhea and financial difficulties. Conclusions These data demonstrate that patients with metastatic HRPC experience rapid, significant deterioration in HRQL, highlighting the need for effective palliative therapy for men with HRPC.     

A comparison of the responsiveness of different generic health status measures in patients with asthma

Generic health status has been recommended to be measured separately from disease-specific health status, because they can yield complementary information. In particular, generic health status can provide comprehensive health ratings across various disorders. However, the weakness with generic measures is that they may be less responsive to clinical changes than disease-specific ones. Therefore, when using generic health status as an endpoint in clinical trials, the instrument to be used is a problem with respect to responsiveness. In the present study, we investigated and compared the responsiveness of health status measures during asthma treatment using three different generic instruments: the Medical Outcomes Study Short Form 36-items Health Survey (SF-36), the Nottingham Health Profile (NHP) and the EQ5D (EuroQoL), as well as one disease-specific instrument, the Asthma Quality of Life Questionnaire (AQLQ). Fifty-four new patients with asthma who consulted our clinic were recruited. The health status measurements were performed on the initial visit, and at 3 and 6 months. All subscales of the SF-36 showed a significant improvement during the first 6 months. Each dimension of the EQ5D showed stronger ceiling effects than the SF-36. With respect to the responsiveness indices, the SF-36 was regarded as more responsive than the NHP or EQ5D utility. The changes in the SF-36 had a weak to moderate correlation with the changes in the AQLQ. In conclusion, the SF-36 had a higher responsiveness for asthma as a generic measure than the NHP or EQ5D, and evaluated different aspects from the AQLQ. The SF-36 can be used effectively in asthma clinical trials.     

Responsiveness of the EQ-5D Health-Related Quality-of-Life Instrument in Assessing Low Back Pain

ObjectiveTo compare the responsiveness of the EuroQol five-dimensional questionnaire (EQ-5D) generic quality-of-life instrument with that of specific instruments—the Brief Pain Inventory (BPI) and the Oswestry Disability Index (ODI)—in assessing low back pain.MethodsData were obtained from a group of patients receiving epidural steroid injections. We assessed responsiveness by using correlation, by estimating standardized response means, by receiver operating characteristic curve analysis, and by comparing the minimum clinically important differences peculiar to each of the instruments.ResultsODI, BPI, and EQ-5D index scores, and changes in scores, were found to be correlated. Estimated standardized response means and receiver operating characteristic curve analysis suggested lower responsiveness for the EQ-5D index score. Clinically significant categories of mild, moderate, and severe BPI pain intensity translated into progressively and significantly lower mean EQ-5D index scores. An increase or a decrease in severity level reported on any of the five EQ-5D dimensions was associated with significant changes (with appropriate signs) in the condition-specific scores. No change in severity in any EQ-5D dimension was associated with no change in the specific scores. Significant changes in the EQ-5D index scores were associated with clinically important changes in the ODI and BPI scores. Correlation between index scores and responses on EQ-5D’s visual analogue scale was only moderate.ConclusionsThe EQ-5D index is less responsive than instruments specific to pain measurement, although it is capable of indicating clinically important changes. The lower responsiveness arises from EQ-5D’s more limited gradation of severity and its multidimensionality.     

Validity and reliability of the Health-Related Quality of Life Instrument with 8 Items (HINT-8) in Korean breast cancer patients

ObjectivesThis study evaluated the validity and reliability of the Health-Related Quality of Life Instrument with 8 Items (HINT-8) in postoperative breast cancer patients in South Korea.MethodsThe study included 300 breast cancer patients visiting a tertiary hospital. We measured health-related quality of life (HRQoL) using the HINT-8, the 5-level EQ-5D version (EQ-5D-5L), and the Functional Assessment of Cancer Therapy-Breast (FACT-B). Discriminatory ability, known-group validity, and convergent validity were assessed. Reliability was evaluated with the Cohen kappa, weighted kappa, and intraclass correlation coefficient (ICC).ResultsThe EQ-5D-5L indexes (p<0.001) and EQ visual analogue scale (VAS) scores (p<0.001) were significantly higher in subjects with no problems in each item of the HINT-8 than in those with problems. The FACT-B total scores were also higher in subjects without problems on the HINT-8. Older age, lower education level, and comorbidities were associated with a lower HINT-8 index. The HINT-8 index was correlated with the EQ-5D-5L index and the EQ VAS, with correlation coefficients of 0.671 (p<0.001) and 0.577 (p<0.001), respectively. The correlation coefficients between the HINT-8 and the FACT-B ranged from 0.390 to 0.714. The ICC was 0.690 (95% confidence interval, 0.580–0.780).ConclusionThe HINT-8 showed appropriate validity for capturing HRQoL in postoperative breast cancer patients.     

The determinants of self-reported health-related quality of life in a culturally and socially diverse South African community

OBJECTIVE: To determine factors predictive of the score on the visual analogue scale (VAS) of the EQ-5D questionnaire. METHODS: The responses of 1159 residents of a socially and ethnically diverse suburb of Cape Town, South Africa, to the EQ-5D questionnaire were analysed using forward stepwise multiple regression. The variables entered included ethnic group, religious affiliation (Christian or Muslim), income level, unemployment, recent illness or disability and each level of the five EQ-5D domains. FINDINGS: The model developed accounted for an adjusted r(2) of 0.234 and included 11 variables. In addition to the EQ-5D domains, the presence of a disability, an income of less than 420 US dollars per month, unemployment and age in years were significant predictors of VAS score. CONCLUSION: The substantial contribution of health state to the VAS indicates that it is a valid measure of health-related quality of life (HRQoL) across population groups. However, the subjects with lower social status reported a worse HRQoL than their health state alone warranted and this variable might need to be taken into account if the VAS is to be used to compare health states across populations. This paper provides empirical evidence of how HRQoL is perceived by different socioeconomic, cultural, ethnic and religious communities within a developing country.     

Reply from Drs. Newmark and Lupton

The relationship between weight loss, appetite, the inflammatory response, and quality of life in patients with advanced gastrointestinal cancer was examined. Height, weight, and skinfold anthropometry were measured in 119 patients. Blood was taken for analysis of C‐reactive protein and albumin. Appetite, performance status, and quality of life were assessed using EuroQol EQ‐5D and EORTC QLQ‐C30 questionnaires. Weight loss was >5% (median 17.1%) of their preillness weight in 97 patients; the remaining 22 patients were weight stable. Anthropometric measurements and circulating albumin concentrations were significantly lower (p < 0.01) and circulating concentrations of C‐reactive protein were significantly higher in the weight‐losing than in the weight‐stable group (p < 0.001). Appetite scores, performance status, and EuroQol EQ‐5D and EORTC QLQ‐C30 scores were also lower in the weight‐losing group (p < 0.01). When the weight‐losing cancer patients were divided on the basis of whether they had a marked inflammatory response, albumin concentrations, appetite, and Karnofsky performance status were significantly lower (p < 0.05) in the group with a marked inflammatory response. The results of the present study are consistent with weight loss, reduction of appetite, and an elevated inflammatory response being important related factors in lowering the quality of life of gastrointestinal cancer patients.     

Responsiveness of the EQ-5D in breast cancer patients in their first year after treatment

Background/aim  

The EQ-5D is a generic health-related quality of life (HRQoL) measure that is used for the purpose of economic evaluations of health interventions. Therefore, it has to be responsive to meaningful changes in health in the patient population under investigation. The aim of this study was to investigate the responsiveness of the EQ-5D in breast cancer patients in their first year after treatment.     

Acromegaly Quality of Life Questionnaire (AcroQoL)

Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D.     

Health-related quality of life of day-case surgery patients: a pre/posttest survey using the EuroQoL-5D

Aim This paper describes and compares the perceived health-related quality of life (HRQoL) of day-case surgery patients before and after their procedures and examines some associated patient-related factors. Method A pre/posttest survey design was employed to collect data from Finnish adult day-case surgery patients using participant-completed EuroQoL 5-Dimensional Classification Component Scores (EQ-5D) questionnaires given 2 weeks presurgery (n = 131) and 2 weeks postsurgery (n = 131) in 2004. Results No noticeable change after minor surgery was found using the EQ-5D. Using the EQ-5D index, patients perceived their HRQoL as high before and after surgery. Almost one fifth (17%) reported no pain or discomfort before the procedure compared with 40% after it. As measured by the EuroQol visual analogue scale (EQ_VAS), those patients who reported chronic illness before the operation had a lower perception of their HRQoL compared with those who did not. It was also found that self-care and usual activities were more disturbed after surgery. Conclusions Although there were increases and decreases within items of the EQ-5D, overall, there was no improvement on EQ-5D scores. More research is needed to explore the sensitivity and responsiveness of the EQ-5D measure in day-case surgery patients.