The business case developed in Phase I for a new generic measure of care-related quality of life for people with long-term conditions (LTCs) presented some arguments about the limitations of an approach based only on the EQ-5D HRQOL measure. There are also important arguments in favour of using existing measures, such as EQ-5D, particularly bearing in mind the considerable validated use of these instruments to date and the breadth of the evidence base which incorporates them.
We therefore believe further investigation is warranted, particularly to assess alternative strategies for developing indicators which reflect a holistic picture of the health-related quality of life outcomes of people with LTCs. These options could include:
- using existing indicators (e.g. EQ-5D)
- developing a new outcome indicator
- exploring whether a better alternative to a completely new measure might be to develop a composite indicator that uses EQ-5D and one or more additional measures
There are numerous ways to assess quality of life outcome indicators in LTCs. Over recent years there has been a shift to patient-centred outcomes. This is because traditional clinical outcomes, such as improvements in physical health, are not as informative to help monitor outcomes in people with LTCs. One useful way to measure patient-centred outcome indicators is to look at what is important to patients directly. Patient-reported outcome measures (PROMs) were created to assess outcomes from the perspective of patients. These self-report questionnaires are fast, easy to administer and allow us to directly understand what is important to patients.
There are two types of PROMs: generic measures and disease specific measures. Each have strengths and limitations. Generic outcome measures are applicable across populations but do not always capture all outcomes of importance in LTCs. Generic measures may also not be sensitive enough to capture change in outcomes. On the other hand, disease-specific measures capture more specific aspects of every disease or condition, but the scores cannot be compared across different LTCs populations. These measures may also not be able to capture high-level outcomes across various conditions. Our initial analyses suggested that the EQ-5D is highly focused on personal functioning, being sensitive to measuring the impact of interventions that restore functioning or alleviate impairment, but is less sensitive for interventions that help people manage the consequences of long-term limiting conditions. There is a need for a questionnaire that directly measures outcome indicators across different LTCs.
Aims and methods
The project includes three strands:
Strand 1. Assessing the potential of existing measures
Strand 1 involved scoping reviews and stakeholder consultation. This phase consisted of conducting extensive literature reviews on PROMs for LTCs, interviewing professional and lay stakeholders to discuss the opinions of PROMs for LTCs, and interviewing individuals with LTCs with the purpose of understanding the impact of LTCs on people’s lives and what people want and need from different services. This phase ran from July 2013 until January 2015.
Strand 2. Development of a preliminary new generic LTC measure or the foundations of such a measure
Strand 2 involved the development of a self-report questionnaire for LTCs (LTCQ). This phase involved questionnaire item development and drafting the initial LTCQ. Cognitive interviews with individuals with various LTCs were also conducted. This phase also involved patient and public (PPI) consultation regarding the draft questionnaire. Further professional stakeholder consultation, translatability assessment and further cognitive testing of a second draft of the questionnaire took place during this phase. This phase ran from January 2015 until May 2015.
Strand 3. Testing and validating the new generic LTC measure or the foundations of such a measure
Strand 3 aims to validate the newly-developed long-term conditions questionnaire (LTCQ) among individuals with LTCs. The overall aim is to explore whether the LTCQ is valid and acceptable for individuals with single or multiple LTCs, including those who receive social care services. As such, we aim to validate the LTCQ, a 20-item self-report measure, by administering the LTCQ to a large and diverse sample of people with LTCs, including those who receive social services. Strand 3 is running from May 2015 onwards.
The objectives are to:
- To identify the structure of the LTCQ as an outcome measure for LTCs
- To explore whether the number of items in the LTCQ could be reduced
- To assess whether the LTCQ is valid for use in people with LTCs
- To assess whether the LTCQ is a reliable measure
Participants are being recruited through both primary care and social care services.
The data collection for the primary care survey and the social care survey will run simultaneously. Ethical and HRA approval was obtained first for the primary care survey (REC reference 15/EM/0414). We have obtained a favourable opinion from the East Midlands – Derby Research Ethics Committee (REC reference 15/EM/0414) for the social care survey. We also have ADASS approval for the social care survey.
Primary care survey
The aim of the primary care survey is to validate the LTCQ in a sample of people with a range of LTCs. The aim is to invite 3000 individuals with either a single LTC or multiple LTCs.
Fifteen primary care practices in several geographical areas in England will serve as Patient Identification Centres and select people with different long-term conditions who fit the provided inclusion/exclusion criteria. This will be reviewed by a GP or a nurse, and they will remove anyone who is not eligible. Every patient not eligible will be replaced by an eligible patient randomly selected from the database search in order to make sure that the specified number of questionnaires is sent per long-term condition.
Data collection is currently underway and is due to be completed in Summer 2016. More information about the primary care survey can be found here:
Social care survey
For the social care survey, the aim is to validate the LTCQ in a sample of people with a range of long-term conditions who receive social care support services. We aim to invite a minimum of six local authorities. Research governance approval will be obtained for each participating local authority for their involvement with the social care survey.
The recruitment of local authorities is currently underway, and we are in the process of inviting interested local authorities to help take part with the study. More information about the project can be found here:
Ray Fitzpatrick, Michele Peters, Caroline Potter, Laura Kelly, Louise Geneen, Elizabeth Gibbons, Crispin Jenkinson Angela Coulter at the University of Oxford; Julien Forder, Karen Jones, Laurie Batchelder and Diane Fox at PSSRU Kent; Jennifer Bostock and Matthew Baker from the QORU Public Involvement Implementation Group