Abstract
It is important that patient-reported outcome (PRO) measures used to assess cancer therapies adequately capture the benefits and risks experienced by patients, particularly when adverse event profiles differ across therapies. This study explores the case for augmenting preference-based utility measures to capture the impact of cancer treatment-related symptoms. Additional cancer treatment-related items could be specific (e.g., rash) or global. While specific items are easier to describe and understand, their use may miss rarer symptoms and those that are currently unknown but will arise from future medical advancements. The appropriate number of additional items, the independence of those items, and their impact on the psychometric properties of the core instrument require consideration. Alternatively, a global item could encompass all potential treatment-related symptoms, of any treatments for any disease. However, such an item may not be well understood by general public respondents in valuation exercises. Further challenges include the decision about whether to generate de novo value sets for the modified instrument or to map to existing tariffs. The fluctuating and transient nature of treatment-related symptoms may be inconsistent with the methods used in conventional valuation exercises. Fluctuating symptoms could be missed by sub-optimal measure administration timing. The addition of items also poses double-counting risks. In summary, the addition of treatment-related symptom items could increase the sensitivity of existing utility measures to capture known and unknown treatment effects in oncology, while retaining the core domains. However, more research is needed to investigate the challenges, particularly regarding valuation.
Highlights
For many years, chemotherapy, surgery and radiotherapy have been the most common forms of cancer treatment available
When a preference-based measure of health is required, an additional layer of complexity is cast upon the acknowledged strengths and limitations of generic and disease-specific measures
Adapting existing generic preference-based measures by adding treatment-related symptoms items potentially improves their sensitivity to health-related changes/differences in cancer patients, whilst retaining a degree of consistency with the original measures
Summary
Chemotherapy, surgery and radiotherapy have been the most common forms of cancer treatment available. The adaptation should improve the psychometric properties of the measure, i.e., it should address existing concerns about its content or face validity amongst the relevant patient population, and should matter to people to the extent that it would make a difference to utility values (though there are challenges involved in assessing this; see below) and to cost-effectiveness estimates Psychometric methods such as principal component analysis can be used to identify gaps and identify candidate bolt-on dimensions for measures [48]. Fixed-duration recall periods may be problematic in the context of health state valuation, using techniques such as time trade-off which posit that the health state in question is experienced for a specified duration that differs from the measurement recall period (conventionally 10 years in many valuation protocols [58]) For this reason, when valuing the preference-based QLU-C10, all 10 dimensions are framed in the present tense, in contrast to the corresponding QLQ-C30 items. It would need to be demonstrated that the incidence rates of these side effects are sufficiently high, and their expected impact on quality-adjusted life years is sufficiently great, so as to justify their inclusion in the measure
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