It’s a question we have been asking ourselves this week at Vitaccess as we monitor our adaptive patient registries – all of which collect patient-reported outcome (PRO) data to measure the impact of a disease or treatment on patient’s lives.

Both the generic (can be used across a wide variety of diseases) and disease-specific PRO measures we use in our registries contain questions that relate to areas of people’s lives that, according to both personal and media reports, may be impacted for both Covid-19 patients and, perhaps more importantly, the general public.

Take, as an example, the EuroQol Group’s EQ-5D, a widely used instrument which measures health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The mental health charity Mind have indicated that mental health conditions including anxiety may be impacted as a result of social restrictions and concern about the impact of the virus. It is also reasonable to think that many people will be unable to carry out their usual activities, including the work, study, housework, family or leisure activities given as examples in the EQ-5D. Social restrictions may impact how people interpret the term walking about which is used in two of the mobility dimension response options; in the current situation this may be taken to mean walking outside the house. Suffering from the symptoms of COVID-19 itself has the potential to impact all five dimensions.

I, like many others around the world, am currently self-isolating at home with my son and husband (my sympathies are with fellow parents of toddlers!). I am generally physically and mentally well and last week would have reported no problems in relation to the questions in the EQ-5D (referred to as a score of 11111).

However, through self-isolation alone and in the space of a week I have felt an impact on my ability to complete my usual activities, an increased level of anxiety and problems with mobility, certainly with walking about, depending on how this question is interpreted in the current climate. This merely reflects what, at this point, we all already know and experience: COVID-19 and everything about living under COVID-19 can affect nearly every part of our daily lives, whether we have an illness or not.

In general, and by design, the impact of external influences (not related to disease or treatment under observation) on individual patients in studies collecting PRO data tend to have a minimal impact on the study data as a whole. Questions are specifically to instruct people to consider impairments ‘due to your condition’. But people are also… people. Will 100% of survey participants actually be able to parse their anxiety into something attributable to cystic fibrosis, something attributable to living with cystic fibrosis and social distancing, and just quotidian anxiety that many of us are feeling?

If we continue to administer these instruments in our longitudinal studies, there is a possibility that we will see a change in the pattern of PRO data across whole cohorts during this pandemic that is not related to the disease or treatment under observation. We feel it is therefore critical to collect additional situational data from our study participants that may be relevant to the pandemic, such as reported symptoms that may relate to the viral infection or periods of self-quarantine. This will then facilitate incorporation of these factors into the subsequent analysis of any seemingly obvious changes in the data patterns. This is not something that can be corrected post hoc with later data.

By Catherine Bottomley

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