After successfully completing a pilot phase of interviewer training and data collection at the end of 2022, we are pleased to announce that the first participant in the new UK EQ-5D-5L valuation study was interviewed on 29 January 2023. Interviewer data will be collected online and face-to-face, to allow as many people to participate as possible.

To date approximately 125 interviews of the 1200 planned interviews have been collected in the valuation study and the expected end of data collection is end of summer 2023. The first interim analysis for in-depth checking of data quality and modelling results by the independent Quality Control team is pre-scheduled for Mid-March. This important study is being led by Professor Donna Rowen and is supported by the EuroQol Research Foundation.

Following the emergence of the COVID-19 pandemic, the Steering Group discussed the feasibility of undertaking the EQ-5D-5L valuation study for the United Kingdom during the COVID-19 pandemic. The question was whether the EQ-VTv2 TTO interviews could be conducted remotely using online videoconferencing software (such as Zoom or Microsoft Teams), and whether the results would be comparable with regular face-to-face interviews. Available evidence at the time suggested that experienced interviewers can do EQ-VT interviews face-to-face or remotely, with comparable results. However, none of these studies had a dedicated design to compare face-to-face versus videoconferencing in a controlled way. It was therefore decided to conduct a study to formally compare the feasibility, acceptability and equivalence of these two interviewing methods to collect TTO data (hereafter, ‘the equivalence study’), before starting the new UK valuation study. Following a delay to the start of the equivalence study, due to another lockdown in the UK, the Steering Group agreed to a proposal to run a parallel equivalence study in Australia or New Zealand, as the COVID-19 situation was different in that part of the world. Both studies were funded by EuroQol Research Foundation.

While the equivalence studies were starting, the study team and Steering Group focussed on ensuring that the protocol for the new study would address the concerns raised during the quality assurance of the Devlin et al. (2018) value set (these reviews are available on the NICE website, comprising an and reports from 4 independent experts). To this end the study team compiled a checklist summarizing the criticisms of the Devlin et al. value set and how the new study will address these criticisms - and provided rationale for any design elements that were previously criticised but that have not been changed in the new study. The statistical analysis plan was also informed by a review of published EQ-5D-5L value sets by Rowen et al. (2022).

In early 2022 Donna Rowen presented the results of the UK equivalence study. The results demonstrated that video and in-person TTO interviews are feasible and acceptable. Both interviewing modes generated good-quality data. A notable finding was that the characteristics of people preferring video interviews differed significantly from those preferring in-person interviews. Therefore, both modes will be used in the UK valuation study, with respondents being able to choose their preferred interviewing mode, to make the study more inclusive and maximise sample .

Finally, in line with Step 30 of the study governance document, the QC team has performed a
formal quality control (QC) of the study protocol and statistical analysis plan. QC findings were shared with the study team and the Steering Group, who provided their own feedback. Updates of these documents were discussed in the Steering Group. The study protocol and analysis plan were reviewed and approved for funding by EuroQol’s Executive Committee in June 2022. The Steering Group signed off on the study protocol and the statistical analysis plan in July 2022. The study protocol, including explanation of how the protocol has been designed to resolve quality assurance concerns with a previous English valuation, is being submitted for journal publication.

We are delighted to announce the start date of the new EQ-5D-5L valuation study for the United Kingdom. The study proposal and statistical analysis plan were approved for funding by EuroQol’s Executive Committee in June and have also now been signed off by the study’s Steering Group. The study team aim to start sample recruitment in October with the goal of undertaking 1,200 interviews in a representative sample of people living in England, Scotland, Northern Ireland and Wales. Data collection will be undertaken using the cTTO component from the latest version of the international standard valuation study protocol (EQ-VT).

Due to the global COVID-19 pandemic the launch of the new EQ-5D-5L valuation study for the United Kingdom, which had planned to use face-to-face interviews to collect time trade-off (TTO) data, was delayed. We are pleased to announce that the study protocol has now been adapted and tested to ensure that data can be collected safely and reliably in the light of COVID-19.

Below you find a series of updates on the study and the various teams involved.

Several expressions of interest were received for joining the Steering Group of the new UK EQ-5D-5L valuation study. At their meeting of 11MAR2020 the initial members of the Steering Group decided to appoint three academic experts to join the Steering Group:

• Charles Manski, Department of Economics, Northwestern University, Evanston, USA;
• Mark Sculpher, Centre for Health Economics, University of York;
• Anne Spencer, College of Health and Medicine, University of Exeter Medical School, University of Exeter.

The Steering Group now consists of nine members. Listed below you find the other six members:

• Kristina Secnik Boye, Eli Lilly and Company, Indianapolis, USA (EuroQol member);
• Jan Busschbach, Department of Psychiatry, Erasmus University Medical Center Rotterdam, The Netherlands (EuroQol member);
• Daniel Law, Department of Health and Social Care, London;
• Rosie Lovett, National Institute for Health and Care Excellence, Manchester;
• Danny Palnoch, NHS England and NHS Improvement, London;
• Bernhard Slaap, EuroQol Research Foundation, Rotterdam (Steering Group Chair).

The Steering Group is currently reviewing the expressions of interest for principle investigator and site investigator roles in the study team.

February 12, 2020

On 24 October 2019 EuroQol and NICE announced that a new EQ-5D-5L valuation study will be undertaken in the UK, following NICE’s decision not to use the EQ-5D-5L value set for England (Devlin et al 2018). This new study will be funded and managed by EuroQol. NICE, the Department of Health and Social Care and NHS England will advise on the study. Researchers are hereby invited to express their interest in participating in this new EQ-5D-5L valuation study in the UK.

Features of the new study

The new study will be funded by the EuroQol Research Foundation. The study team will be responsible for writing the study protocol and analysis plan, obtaining ethical approval, collecting the data, modelling the data to produce a value set, and writing publications and communications material. This work will be overseen by a Steering Group, which currently includes representatives from EuroQol, NICE, the Department of Health and Social Care, and NHS England.

The arrangements for study governance are described in a separate document.

Regarding study personnel and funding:

• The study will be undertaken by a Research Consortium (the “study team”) led by a principal investigator (PI).
• Researchers interested in applying for the study should be knowledgeable regarding the EQ-5D and have significant experience in managing field-work data collection and modelling valuation data.
• Once the study team has been appointed the EuroQol EQ-VT support team will work with the study team to write the study protocol and analysis plan. They will also help the study team to come up with a realistic study budget and timeline estimates. The EuroQol budget guidelines will be used for the study. Funding decisions will be made by the Executive Committee of the EuroQol Group.
• Each participating institute in the Research Consortium is eligible to have at least one author contributing to the value set publication. Final decisions on authorship and authorship ordering will rest with the Steering Group, in consultation with the PI and will depend on contribution to the project. All other individual consortium members will be listed in the article by-line.

The data collection is expected to begin in late 2020 and the value set is expected to be created by late 2021.

Study design

The Steering Group has already agreed on several key aspects of the study design:

• The time trade-off (TTO) module of the latest version of the international standard valuation study protocol (EQ-VT v2.1) will be used. The latest protocol has been shown to be effective in controlling interviewer effects and has been used in at least seventeen countries.
• The fieldwork will be conducted by trained members of the study team. A small interview team will be used, in order to minimise the impact of interviewer effects.
• The EuroQol EQ-VT support team will provide support to the study team to monitor interview quality, as is standard in EQ-VT v2.1.
• Subject recruitment will occur in England, Wales, Scotland and Northern Ireland. Recruitment will not be determined by postcode, but by using quota sampling. The quotas will be set, for example, by age, gender, socioeconomic status, location and any other characteristics determined important by the study team.
• Only time trade-off (TTO) data will be collected. The rationale is that TTO-only models are more readily interpretable than hybrid models (which combine TTO and discrete-choice experiment data).
• Independent Quality Control (QC) will be built in at every stage, with a QC review of at least 4 study milestones: study protocol (including data modelling plan), interim analyses, the final data set, and the final value set.

The Steering Group has not yet agreed the sample size and coverage (that is, the selection of health states to be valued). These aspects of study design were commented on during quality assurance and expert review of the first English 5L valuation study. The study team may propose to use the standard EuroQol sample size and coverage, or to increase the sample size and coverage.

Call for expression of interest

We invite expressions of interest from researchers to participate in the new EQ-5D-5L valuation study for the UK. Broadly, there are three ways for researchers to participate:

• Become the principal investigator. Researchers in the UK can apply to become PI, who will lead a team within his/her institution and will oversee the work of collaborating centres in the Consortium.
• Become the site investigator of a collaborating centre. Ideally around 4 centres in the UK will participate; the site investigator of a collaborating centre will need to make scientific staff available for the fieldwork, and/or the analysis and reporting.
• Become a member of the Steering Group. The Steering Group has a formal decision-making role and will provide advice and guidance to the study team. Their involvement will encompass the study period and beyond, to include discussion around implementation of the value set with policy-makers in the UK. Currently, representatives from NICE, NHS England, the Department of Health and Social Care and EuroQol are on the Steering Group. We would like to add two members to the Steering Group who have a strong background in health-state valuation studies and/or valuation-data modelling. The Steering Group will meet in person several times over the course of the study, with further input via teleconferences and email. Membership of the Steering Group is open to researchers from the UK and abroad.

Please note that researchers do not have to be members of the EuroQol Group to participate in this study.

Selection process

If you are interested in participating in the new UK EQ-5D-5L valuation study please download the application form here. After completion you can send the form with attachments to SteeringGroup@euroqol.org.

All applications received before the deadline will be discussed by the existing Steering Group, which will first appoint the additional two Steering Group members. The full Steering Group will then appoint the PI and the collaborating centres. Thus, applicants need to choose either to apply to be on the Steering Group or to be PI/chief investigator of a collaborating centre – they cannot apply for both.

Timings

The deadline for applications is March 4th 2020.
Steering group members will need to be available for a short telephone call between 16 and 20 March and to have time to shortlist applications between 20 March and 3 April. Further meetings will be arranged in due course.

Contact details

If you have any comments or questions, or when you want to apply for a role in the study, please send an email to: SteeringGroup@euroqol.org