Measuring the burden of COVID–19 

Vitaccess’ adaptive patient registries collect patient-reported outcome data to measure the impact of a disease or treatment on patients’ lives. PRO data collected in our studies may have been impacted by the COVID-19 pandemic. These effects could be multi-level, for example the physical impact of contracting COVID-19, the psychological effects of national restrictions, or the consequences of disruption to routine care and treatment. 

We are partnering with a pharmaceutical company on an international, patient-centric real-world evidence study to identify and increase understanding of the impact of living with a rare autoimmune, neuromuscular disease. Discussions with patient advocacy groups and key opinion leaders indicated that the pathophysiology of this disease, particularly immune system involvement, may make patients more susceptible to COVID-19. As the literature on this topic was sparse, amending the study protocol to explore this question was both urgent and important. 

• To introduce questions into the study to capture participants’ experience with COVID-19, including whether the participant has been infected with COVID-19, their treatment if so, whether they have been vaccinated against COVID-19, and the impact of the pandemic on their care and mental health. 

• Scope: International (11 countries across Europe, North America, and Japan). 

• Vitaccess was responsible for the design and implementation of these bespoke surveys, including:

(i)Developing COVID-19 questions with the input of the pharmaceutical partner, KOLs, and PAGs  

(ii) Localizing questions into the study’s 11 languages

(iii) Submitting questions in an ethics amendment to the relevant committees

(iv) After ethical approval, building and implementing the survey in the study app.

When COVID-19 vaccines became widely available, an additional ethics amendment was conducted to include two further questions concerning whether participants have been vaccinated against COVID-19 and, if so, the number of doses received. 

• Study protocol amendments in the respective countries 

• Bespoke 14-item COVID-19 survey questions 

Given that literature on this topic is sparse, the data from this survey is incredibly important to the indication’s community, participants, PAGs, and KOLs, and has potential to be used in future publications. The data collected will also likely be valuable in future health technology assessment submissions.  

Due to the adaptive, flexible nature of the Vitaccess Real™ platform, we were able to react quickly to an unprecedented pandemic and, following approval, expedite updates to the study app. The additional questions were introduced in all study countries and languages, providing broad coverage of the impact of COVID-19 across geographies with varying rates of infection.