Going beyond health related quality of life - towards a broader QALY measure for use across sectors

The NHS has a limited budget and so deciding to spend money on an expensive drug means less is available for other services. NICE helps the NHS by providing guidance on whether new medicines should be made available to patients based on the 'value for money' of the new treatment compared to what will be forgone. The value for money of a new treatment is decided by looking at the cost per gain in health from the treatment. However, there are concerns that the measure used to assess health gain (known as EQ-5D) does not pick up important benefits of the treatment that are not to do with health. At the same time, different measures are used in health care, social care and public health making it difficult to compare across these sectors, which is important when thinking about the wider government budget.

We are proposing to look at developing a new measure that includes aspects of life that people think are important to their quality of life. This includes their social life, aspects related to their emotions and mental health as well as other how they feel about their lives alongside questions that have been asked in the past about physical and role functioning. We have done some work with service providers who have already identified that the existing measures do not allow for comparisons across sectors or cover all that they think is important for service users. The next step will be to generate a long list of questions asking people about their quality of life and asking a sample (n=50) of the public and service users to tell us what they think about them. On the basis of this the items will be revised for the next phase.

We will then conduct a survey with around 2000 users of services in general practice, mental health and social care and informal carers and ask them to complete the long list of questions (up to 50). Their answers will be used to test out the questions to see which ones would be best to use in a smaller final version of the measure.

The next stage develops a way of scoring people's answers to these questions on a scale from zero to one, where zero is for someone whose quality of life is so bad that it is as bad as being dead up to one for best imaginable quality of life, with all scores in between. These scores are obtained from asking members of the general public to undertake a series of choices between living in poorer quality of life for longer or a shorter period in the full quality of life, a method called time trade off. These data will be analysed in various ways to help estimate the scores for the quality of life measure and to understand how people's values vary on the basis of who they are. We will also use a different method that allows members of the general public who work with NICE (i.e. members of NICE Citizen's Council) to provide values for the new measure using an approach that involves more discussion. These values will be compared to those generated by the TTO method to see if there are differences in values and to explore where and why they occur.

The final part of this study will look at how to apply this measure to assess value for money of interventions across different areas of public services, including health care, social care and public health. This will involve re-scoring the existing health and social care measures in terms of the new quality of life measure and testing the impact using these re-weighted measures to compare existing interventions. Throughout the project, we will be working closely with NICE and other policy makers who might consider using the new measure and providing guidance on how to apply it in health, social care and public health. We will also work with the provider of the EQ-5D, the Euroqol group, which is the main measure used by NICE, in order to draw from their experience as well as on-going studies on developing and promoting the new measure.

The aim of this project is to develop a measure of quality of life that is valued on the zero to one scale necessary to calculate Quality Adjusted Life Years (QALYs) for use in economic evaluation, which gives due recognition to the impact of clinical, public health and social care interventions on physical and mental health and broader emotional health and wellbeing on service users and their families/carers.

To achieve this aim we will develop a classification system that reflects the impact of clinical, public health and social care interventions on physical and mental health and broader emotional health and wellbeing on service users and their families/carers using a full range of evidence with full public involvement in all stages. This will be based on a mixed methods study. Qualitative review of the literature and interviews will be used to generate core themes which will be combined with quantitative psychometric analysis of a large data set. Items will be generated for the core themes and face validity tested through interviews (n=50) with patients, social service users and their carers, and psychometric testing on data from a large general population and service user survey (n=2000) in order to select the final items for a classification system.

The classification system will be valued in two general population samples using time trade off (n=600) and a deliberative approach (n=20). Values from the two approaches will be compared.

The weights for the new measure will be used to re-weight the EQ-5D in order to examine the impact the new measure is likely to have on decision making priorities.

The most immediate beneficiaries of this research are those who make decisions about the allocation of resources or provide guidance for those who do. The National Institute of Health and Care Excellence (NICE) is a key beneficiary of this research. It currently uses a measure of health related quality of life, the EQ-5D, to assess the cost-effectiveness of new health care technologies. In some areas of medical care this is thought to be inadequate and fails to capture key benefits. The development of a broader QOL measure provides a method for making comparisons across the sectors of health care, social care and public health that currently use different outcome measures. The new measure will also provide a broader basis for assessing the benefits of the different sectors and so enable evaluations to capture some wider societal benefits currently excluded from existing methods. The immediate impact of this research will be to present to decision makers a viable alternative measure to the EQ-5D that incorporates aspects currently not covered, and show them the impact the use of this measure would have on current decisions

Other agencies in the UK (Scottish Medicines Consortium, All Wales Medicines Strategy Group) and around the world are also heavily influenced by how NICE performs economic evaluations. The Industrial Collaboration with the EuroQol group will provide a large partner organisation who can help promote the output of the work around the world through their large network of researchers, industry and policy makers.

Development of a generic measure will also be useful to other sectors in the UK not covered by health and social care. Another key national agency is Public Health England that is making recommendations about public health interventions that have an impact well beyond health and again will benefit from being able to explore more fully the use of a broader measure. Other key national policy makers such as NHS England and DH in England will also benefit from having a broader QoL measure appropriate for use in economic evaluation. NHS England supports the joint commissioning of services through Clinical Commissioning Groups in health care and local authorities in social care and public health. The joint commissioning infrastructure of the Better Care Fund Partnerships is integral to the planning and implementation of coordinated approaches to maintaining independence, particularly for older people. Whilst these agencies are not able to apply the same rigorous frameworks as NICE, they are increasingly interested in the impact of their decisions on the broader QoL of the community, and the CLAHRC YH (Brazier leads its Health Economic and Outcome Measurement theme) is working with NHS England to instigate an infrastructure to include evaluation capacity in these partnerships. Using a broader QoL measure as part of this infrastructure can support this. Local providers, including the third sector, will also benefit from having a generic QoL measure that can be used to assess overall effectiveness.

In the health care sector, industry would also benefit from having a broader based measure of the benefits of their new and innovative products before they come to market. There has been a concern that EQ-5D is not adequate for demonstrating the value of innovative products, and the broader QoL provides an alternative means of examining this concern and examine the implications for cost-effectiveness.

There are potentially other uses of a broader QoL instrument that would be of value to both government and non-governmental organisations. The descriptive system of the measure could potentially be used in large surveys to measure the population QoL and how this is related to factors such as crime and social amenities which can be influenced by government policy.

The ultimate beneficiaries in the longer term, however, should be the recipients of services that are better directed to improving their wellbeing.