Table 1 summarizes the main characteristics of the three protocols. The MVH and Paris protocols were developed in sequence for valuation of the EQ-5D-3L health states using conventional TTO. These protocols reflected the state of the art in TTO-based valuation at the time (1993 and 2009, respectively). The EQ-VT protocol is built on the experience obtained from the earlier protocols and on a set of multinational pilot studies [15]. It was launched in 2012. All three protocols feature warm-up exercises to familiarize the respondent with the EQ-5D health states and the TTO technique. In all three protocols, the respondent is first asked to classify their own health with EQ-5D to introduce them to the concept of health states. In the MVH and Paris protocols, the respondent is then asked to rank a set of health states and then to value these using a VAS. In the EQ-VT protocol, the warm-up tasks do not involve ranking or VAS valuation, but focus on practicing the valuation of health states using composite TTO prior to formal valuation tasks. All three protocols feature study designs capable of providing the necessary data for modelling using a multitude of regression techniques. For example, all three require each respondent to value ten or more different health states using TTO, allowing for individual-level models such as random-effects models. In addition, all protocols include a second valuation technique. The MVH and Paris protocols use VAS valuation prior to the TTO task, whereas the EQ-VT protocol includes a DCE after the TTO tasks [15]. For the purposes of this paper, we concentrate on the trade-off framework, iteration procedure and its mode and method of administration, training and quality control measures when describing the EuroQol protocols.
Table 1 Summary of the characteristics of EuroQol protocols
The MVH Protocol
The MVH protocol was developed in 1993 for eliciting the utility values of EQ-5D-3L health states from a general UK population sample [13]. The conventional TTO using a fixed time horizon of t = 10 years was adopted. The two anchor states used are the best health state defined by EQ-5D-3L (health state ‘11111’, i.e. no problems in any of the five dimensions) and immediate death. The iteration procedure of the MVH protocol uses a mix of three algorithms: bisection for the first three steps followed by an upward/downward titration procedure. The respondent is first asked to choose between 10 years in 11111 (life A) and 10 years in the target state (life B). Second, he or she is asked to choose between 0 years in good health (life A), i.e. immediate death, and 10 years in the target state (life B). Depending on the choice in the second task, the length of life A uses the mid-point of the BTD or the WTD scale (5 years in both cases) in the third task.
Following the third choice, the procedure continues with 1-year incremental changes to life A, followed by a 6-month correction at preference reversal. If life B is considered BTD, the third choice will compare 5 years in full health (life A) with 10 years in the target state (life B), followed by one-year adjustments. If x denotes the length of life A at the point of indifference, the value of the target state h is calculated as U(h) = x/10. If life B is considered WTD, a different task is presented. In this case, the respondent is faced with a choice between a composite life A, which begins with t − x years in the target state h, followed by x years in ‘11111’, for a fixed total of t = 10 years, and a life B of 0 years (immediate death). In the third choice question, life A is described as 5 years in h, followed by 5 years in ‘11111’. If life A is preferred, life A will be altered to 6 years in h, followed by 4 years in ‘11111’. If life B is preferred, the time in h will be decreased to 4 years, followed by 6 years in ‘11111’. If 10 − x is the number of years in the WTD state, and x is the number of years in full health, the value of the target state is U(h) = –x/(10 − x) when indifference is achieved. The iteration terminates when the respondent states preferential indifference, or when the point of indifference could be inferred to lie between two life ‘A’s differing by 6 months in length, at which the mid-point is assumed to be the point of indifference. The full iteration scheme is illustrated in Appendix Fig. 5a.
The MVH protocol is designed for use in one-on-one, face-to-face interviews. A data-collection form incorporated with step-by-step instructions and a standardized script [30] is prepared for trained interviewers to strictly follow the above-mentioned elicitation technique. A specially designed visual aid called a ‘time board’ is prepared for the interviewer to present the anchor and target states and explain the valuation tasks. As illustrated in Fig. 3, there are two horizontal graduated bars on side A of the time board representing the two hypothetical lives for valuing BTD states; a similar bar with two sections on side B is used to illustrate life A for valuing WTD states. All health states are presented by attaching cards to the time board, and the different lengths of life A are presented using a sliding pointer. The MVH protocol includes neither specific quality control components nor training guidelines for interviewers.
As stated previously, there are many different options with respect to the details of the TTO. All of these have their own pros and cons. Since there is no ‘gold standard’ for valuation, it is unavoidable that, when designing a TTO protocol, some decisions are not based on empirical evidence, such as the decision to use a fixed 10-year time horizon.
Several issues of concern became apparent from the use of the MVH protocol, including within-respondent logical inconsistency in valuation [31, 32], great variance among respondents [18, 33], interviewer effects [33] and a non-continuous value distribution [18, 33, 34]. Also, it should be noted that the MVH protocol was not officially standardized or recommended. Many studies used MVH-like protocols that were similar but not identical, thus hampering the comparability of the resultant value sets. TTO-based valuation studies using these protocols are reviewed elsewhere [35].
The Paris Protocol
The Paris protocol is an updated version of the MVH protocol for valuation of the EQ-5D-3L health states, refined to improve the data-collection process [14]. The main difference between the two protocols is that the Paris protocol uses a simplified iteration procedure and a different selection of health states. In the Paris protocol, iteration is terminated either when indifference is stated or, if indifference is not stated, when the interval surrounding the indifference point is narrowed to 1 year. This means that only integer years are used as x values in the iteration procedure. As illustrated in Appendix Fig. 5b, the number of x values is half of that for the MVH protocol. Accordingly, the interview and the data-collection forms are less complex than those of the MVH protocol. The rationale for using the simplified iteration procedure is to improve efficiency. Increasing the unit of measurement from 6 months to 1 year would not be expected to have a major effect on the mean and standard deviation of observed values for health states given the wide variations in values across individual respondents.
The Paris protocol has been used in a number of EQ-5D-3L valuation studies [36–40] since being proposed in 2009, but we are not aware of any empirical research on the comparative merits of the Paris and MVH protocols.
The EQ-VT Protocol
The EQ-VT protocol adopts the composite TTO. The iteration procedure is built on that of the MVH protocol: initial comparison to 10 years in full health, separation into BTD/WTD, bisection of the BTD/WTD scales, and 1-year incremental adjustments followed by a 6-month correction at preference reversal. Unlike the MVH and Paris protocols, the composite TTO task does not terminate until the respondent states indifference, allowing endless adjustments by 1-year increments, followed by 6-month corrections whenever the direction of preference is reversed. The EQ-VT protocol also allows easy variation of the x values within and across the BTD/WTD scales. The possible utility value ranges from −1 to 1, with the smallest difference between values being 0.05 (see Appendix Fig. 5c).
The EQ-VT protocol is designed for use in computer-assisted personal interviews. A visual aid similar to those in the MVH protocol is presented on the screen to illustrate the composite TTO questions (Fig. 4). All components of the protocol, including an interviewer guide, were developed to provide standardized interview conduct. Multiple training and quality control components are included in the EQ-VT protocol. First, a recommended interviewer-training procedure has been developed. Second, a training task is incorporated into the interview to make sure the respondent understands the concept of TTO. The interviewer first shows how TTO works using as an example the state of being ‘in a wheelchair’. This training task is followed by three practice tasks where the respondent is asked to value EQ-5D-5L health states of varying severity of problems.
The EQ-VT protocol was informed by a multi-country, multi-stage research program [41]. Two major aspects of the design in the EQ-VT protocol were based on empirical research. The composite TTO was adopted after scientific investigation of several TTO variants, including conventional TTO, lead-time TTO and lag-time TTO [27], using differing visualizations and time horizons. Furthermore, the decision to use face-to-face interviews was made after testing internet surveys and group interviews [28]. Empirical studies were also conducted to inform decisions on other aspects of the protocol design such as the visual aid [26] and the anchor state ‘full health’ [42].
A number of EQ-5D-5L valuation studies have used the EQ-VT protocol since its first version (version 1.0) became available in 2012. While those studies showed that the protocol is feasible, reliable and sensitive to variations in EQ-5D-5L health states, some issues have also emerged. Protocol adherence by the interviewers and data distribution were two areas worthy of attention. Analyses of interviews performed using the protocol indicated the presence of interviewer effects, with respect to both protocol compliance and TTO values obtained [43]. To address these issues, quality control software (QC tool) was developed and implemented in the second version of the protocol, which allows for real-time monitoring of protocol compliance and interviewer performance from the start of interviewer training and during the entire data-collection process. Interviewers failing to follow the protocol can be identified and retrained during data collection or removed from the study.
As stated previously, the EQ-VT includes a DCE in addition to the TTO task. When the development of the EQ-VT started, it was recognized that TTO as a valuation technique has its limitations and that other valuation techniques might be needed to replace or to be used in conjunction with TTO to make the valuation studies more affordable and feasible. Based on the promising results of a pilot study [44], DCE, which is rooted in random utility theory, became one of the main candidates. In a DCE, respondents are shown multiple (usually two) EQ-5D health states and asked to indicate which one they prefer, arguably making the valuation task easier to understand for respondents than TTO. However, this reduction in task complexity comes with a cost: health state values based on DCEs are on an arbitrary scale based on the relative distances between health states and not on a scale anchored at 0 (death) and 1 (full health) as is required by the QALY model. Until this anchoring problem is properly resolved, DCE as a standalone technique is not viable for generating utilities for use in QALY calculations and therefore cannot replace the TTO.
However, both DCE and TTO attempt to measure the same concept in different ways and both types of data seem to contain information relevant to this concept (i.e. the utility function). Therefore, the data resulting from the two elicitation techniques could be seen as complementary rather than competing. Put another way, the assumption is that respondents have a unique utility function that generates both types of responses. This leads to the idea of combining the TTO and DCE data into a single modelling framework: the hybrid model. The hybrid model is a maximum likelihood model where the ‘hybrid likelihood’ is the product of the likelihoods of the TTO data and the DCE data. The β’s of the TTO model and those of the DCE model are connected via a link function to account for the differences between the scales [43]. A hybrid model maximizes the use of the available data from a valuation study using the EQ-VT protocol.