Sarah E. Hughes, PhD
Centre for Patient Reported Outcome Research (CPROR), University of Birmingham

Karen Matthews
Public Contributor, LongCovidSOS on behalf of the Therapies for Log COVID (TLC) Study Team

“Having a questionnaire that takes into account the relapsing and remitting nature of Long COVID is hugely important. Those using the SBQ™-LC will hopefully see the understanding of Long COVID’s nature that is brought by people with Long COVID being involved in its design.”

 – Karen Matthews, Public Contributor

For an estimated 100 million people worldwide, the symptoms of coronavirus (COVID-19) can persist for months after the original infection has gone. This is known as post-COVID-19 condition or “Long COVID”. Long COVID has been linked to over 200 symptoms, including breathlessness and fatigue, that affect many different organ systems in the body. These long-term symptoms affect people differently and may come and go.

Funded by the National Institute for Health and Care Research and UK Research and Innovation (UKRI), the Therapies for Long COVID (TLC) Study is a major clinical study that is currently underway at the University of Birmingham. The TLC Study aims to characterise the symptoms of Long COVID through the collection of patient-reported outcomes (PROs) – a measurement of a patient’s health that comes directly from the patient – and wearables. To do this, we needed a PRO instrument capable of capturing Long COVID’s numerous, diverse symptoms. We reviewed several PROs, including generic and COVID-specific instruments as well as symptom measures developed for other conditions. Feedback from the TLC study’s patient and public involvement group suggested that the data collected using these measures were missing a level of understanding of what is happening to the person completing the questionnaire.

To address the need for a suitable PRO in the TLC study, we decided to develop The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC). We developed the SBQ™-LC by building an item pool based on symptoms reported in systematic reviews of scientific articles on Long COVID. We conducted cognitive debriefing interviews with patients to confirm these questions captured symptoms of importance and to check they were easy to understand. Guided by patients’ feedback, we modified the question wording to improve clarity and added or removed questions to ensure comprehensive symptom coverage. We worked with Medtech company Aparito Ltd to deliver the SBQ™-LC as an electronic PRO made available via iOS, Android and a web platform. Lastly, we field tested the draft questionnaire in a larger group of patients recruited through social media. We used Rasch analysis, a psychometric model for analyzing questionnaire responses, with our data to construct the SBQ™-LC’s scales and to evaluate their measurement properties. Overall, the SBQ™-LC satisfied the requirements of the Rasch measurement model, although further validation in a clinically confirmed, representative sample is needed to confirm these findings.

The result of this study was a novel, multi-domain item bank and modular PRO instrument measuring the symptom burden of Long COVID. The SBQ™-LC has 16 independent scales measuring over 100 symptoms of Long COVID. Each scale measures a different symptom domain (e.g., breathing, circulation) and an “interference” scale measures the impact of a person’s symptoms on everyday life. Researchers and clinicians wishing to use the SBQ™-LC may select specific scales or administer the full instrument for a comprehensive overview of a person’s symptoms.

We hope the SBQ™-LC will help researchers and clinicians better understand the burden of Long COVID and the complexity of its symptoms. We believe it could be used to help design new treatments and to test whether these treatments are safe and effective. The SBQ™-LC could help patients discuss their symptoms with their healthcare provider, inform clinical decision-making, and support treatment monitoring to ensure receipt of safe, high-quality care. The SBQ™-LC is available through the University of Birmingham and details of its development may be found online.

Funding Statement
This work is independent research jointly funded by the National Institute for Health and Care Research (NIHR) and UK Research and Innovation (UKRI) (Therapies for Long COVID in non-hospitalised individuals: From symptoms, patient reported outcomes and immunology to targeted therapies (TLC Study), COV-LT-0013). The views expressed in this publication are those of the author(s) and not necessarily those of NIHR, The Department of Health and Social Care, or UKRI.

This newsletter editorial represents the views of the author and does not necessarily reflect the views of ISOQOL. 

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