The added value of the cognition, dining, gastrointestinal problems, sleep and tiredness bolt-on dimensions to the EQ-5D-5L in patients with coeliac disease.

OBJECTIVES: Multiple studies suggest that the EQ-5D may overestimate health-related quality of life (HRQoL) in patients with coeliac disease (CD). We aimed to develop and psychometrically test potentially relevant bolt-on dimensions to improve the measurement performance of the EQ-5D-5L in CD patients. METHODS: The development and selection of bolt-ons were informed by a literature review on HRQoL in CD, expert and patient input. A cross-sectional online survey was conducted amongst 312 adult CD patients. Respondents completed the EQ-5D-5L, two condition-specific bolt-ons newly-developed for the present study [dining (DI) and gastrointestinal problems (GI)] and three existing bolt-ons [cognition (CO), sleep (SL) and tiredness (TI)]. The following psychometric properties were tested: ceiling, informativity, convergent and known-group validity, and dimensionality (confirmatory factor analysis). RESULTS: Adding the TI, SL, GI, DI and CO individual bolt-ons reduced the ceiling of the EQ-5D-5L (39%) to 17%, 23%, 24%, 26% and 37%, respectively. GI excelled with strong convergent validity with the Gastrointestinal Symptom Rating Scale total score (rs=0.71) and improved the discriminatory power for all known-groups. GI was the only bolt-on loading on a different factor from the five core dimensions, whereas the other four bolt-ons loaded onto the same 'psychosocial health' factor as the EQ-5D-5L anxiety/depression dimension. CONCLUSION: The DI, GI, SL and TI bolt-ons, especially the GI, enhance the validity of EQ-5D-5L in patients with CD, suggesting their value in capturing important HRQoL aspects potentially missed by the five core dimensions. These bolt-ons can be used in sensitivity analyses supporting health technology assessments and subsequent resource allocation decisions.

Where do measures of health, social care and wellbeing fit within a wider measurement framework? Implications for the measurement of quality of life and the identification of bolt-ons.

BACKGROUND: There is variability across studies in the dimensionality i.e., set of latent variables to which health, social care and wellbeing measures relate. This variability may impact the development of new measures and the identification of bolt-on dimensions. We examine the dimensionality of commonly used measures and identify a set of potential bolt-ons for the EQ-5D-5L. METHODS: We used the OMS dataset, an online survey of health, social care and wellbeing measures in patients and members of the general public. A content analysis provided a theoretical framework for results interpretation. Quantitative analyses were based on a pool of 79 items from 7 measures. Confirmatory factor analysis was used to assess health, social care and wellbeing measures dimensionality and their contribution to quality of life. The relationship between EQ-5D-5L items and the identified factors was used for bolt-ons identification. RESULTS: The dimensionality comprised of seven factors, namely physical functioning, psychological symptoms, energy/sleep, physical pain, social functioning, needs and satisfaction. Health measures covered five of the seven factors identified, wellbeing measures three and the social care measure one. A list of candidate bolt-on items for the EQ-5D-5L was presented e.g., cognition, energy, dignity. CONCLUSIONS: This study provides evidence on the dimensionality of health, social care and wellbeing measures and presents a list of candidate bolt-ons for the EQ-5D-5L.

Criteria for developing, assessing and selecting candidate EQ-5D bolt-ons.

PURPOSE: 'Bolt-on' dimensions are additional items added to multi-attribute utility instruments (MAUIs) such as EQ-5D that measure constructs not included in the core descriptive system. The use of bolt-ons has been proposed to improve the content validity and responsiveness of the descriptive system in certain settings and health conditions. EQ-5D bolt-ons serve a particular purpose and thus satisfy a certain set of criteria. The aim of this paper is to propose a set of criteria to guide the development, assessment and selection of candidate bolt-on descriptors. METHODS: Criteria were developed using an iterative approach. First, existing criteria were identified from the literature including those used to guide the development of MAUIs, the COSMIN checklist and reviews of existing bolt-ons. Second, processes used to develop bolt-ons based on qualitative and quantitative approaches were considered. The information from these two stages was formalised into draft development and selection criteria. These were reviewed by the project team and iteratively refined. RESULTS: Overall, 23 criteria for the development, assessment and selection of candidate bolt-ons were formulated. Development criteria focused on issues relating to i) structure, ii) language, and iii) consistency with the existing EQ-5D dimension structure. Assessment and selection criteria focused on face and content validity and classical psychometric indicators. CONCLUSION: The criteria generated can be used to guide the development of bolt-ons across different health areas. They can also be used to assess existing bolt-ons, and inform their inclusion in studies and patient groups where the EQ-5D may lack content validity.

Selecting Bolt-On Dimensions for the EQ-5D: Examining Their Contribution to Health-Related Quality of Life.

BACKGROUND: Generic preference-based measures may miss dimensions important for the health-related quality of life (HRQOL) of patients. When this happens, a possible solution is to add bolt-ons. Finch et al. (Finch AP, Brazier JE, Mukuria C, Bjorner JB. An exploratory study on using principal component analysis and confirmatory factor analysis to identify bolt-on dimensions: the EQ-5D case study. Value Health 2017;10:1362-75) have recently shown that bolt-ons can be systematically identified using factor analysis. Nevertheless, because for each bolt-on option a complete re-evaluation may be required, methods to select between them are needed. OBJECTIVES: To investigate the possibility of selecting bolt-ons using their ability to predict differences in HRQOL. It tests six factors (energy/vitality, satisfaction, relationships, hearing, vision, and speech), and 37 items loading on them, using the EuroQol five-dimensional questionnaire as a case study. METHODS: Data were obtained from the Multi-Instrument Comparison study, an online survey on health and well-being measures carried out in six countries. Two tests were performed. In the first test, linear regressions were fitted to determine whether different bolt-ons helped explain variations in HRQOL as measured by the Health visual analogue scale. The upper anchor (100) of this scale represents excellent physical, mental, and social health, and the lower anchor (0) represents death. Bolt-on relevance was judged comparing the strength, direction, and statistical significance of unadjusted ß coefficients. In the second test, linear regressions were fitted to further investigate whether different factors and items helped explain the negative effect of six chronic conditions on HRQOL. A reduction in the coefficients for the chronic condition dummies meant that the factor or item detected the effect. RESULTS: Energy/vitality, relationships, and satisfaction reported substantially larger coefficients than did speech, vision, and hearing. Also, items loading on energy/vitality, relationships, and satisfaction generally presented larger coefficients than did those loading on speech, vision, and hearing. The second test did not detect consistent decrements in the coefficients for chronic conditions when testing factors, but it generally did detect consistent decrements when testing items. CONCLUSIONS: The first test appeared useful for bolt-on selection. Further research is needed before using the second test.