Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis

Abstract

Objective: To describe the development and validation of a novel patient reported outcome measure for symptom burden from long covid, the symptom burden questionnaire for long covid (SBQ-LC).

Design: Multiphase, prospective mixed methods study.

Setting: Remote data collection and social media channels in the United Kingdom, 14 April to 1 August 2021.

Participants: 13 adults (aged ≥18 years) with self-reported long covid and 10 clinicians evaluated content validity. 274 adults with long covid field tested the draft questionnaire.

Main outcome measures: Published systematic reviews informed development of SBQ-LC's conceptual framework and initial item pool. Thematic analysis of transcripts from cognitive debriefing interviews and online clinician surveys established content validity. Consensus discussions with the patient and public involvement group of the Therapies for Long COVID in non-hospitalised individuals: From symptoms, patient reported outcomes and immunology to targeted therapies (TLC Study) confirmed face validity. Rasch analysis of field test data guided item and scale refinement and provided initial evidence of the SBQ-LC's measurement properties.

Results: SBQ-LC (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden. After rating scale refinement and item reduction, all scales satisfied the Rasch model requirements for unidimensionality (principal component analysis of residuals: first residual contrast values <2.00 eigenvalue units) and item fit (outfit mean square values within 0.5 -1.5 logits). Rating scale categories were ordered with acceptable category fit statistics (outfit mean square values <2.0 logits). 14 item pairs had evidence of local dependency (residual correlation values >0.4). Across the 17 scales, person reliability ranged from 0.34 to 0.87, person separation ranged from 0.71 to 2.56, item separation ranged from 1.34 to 13.86, and internal consistency reliability (Cronbach's alpha) ranged from 0.56 to 0.91.

Conclusions: SBQ-LC (version 1.0) is a comprehensive patient reported outcome instrument developed using modern psychometric methods. It measures symptoms of long covid important to people with lived experience of the condition and may be used to evaluate the impact of interventions and inform best practice in clinical management.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: SEH receives funding from the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands and UK Research and Innovation (UKRI) and declares personal fees from Aparito and Cochlear outside the submitted work. MJC is director of the Birmingham Health Partners Centre for Regulatory Science and Innovation and director of the Centre for Patient Reported Outcomes Research and is an NIHR senior investigator. MJC receives funding from the NIHR, UKRI, NIHR Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK SPINE, European Regional Development Fund-Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GlaxoSmithKline, and Gilead. MJC has received personal fees from Astellas, Aparito, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, and the Patient-Centered Outcomes Research Institute outside the submitted work. In addition, a family member owns shares in GlaxoSmithKline. OLA receives funding from the NIHR Birmingham Biomedical Research Centre, NIHR ARC West Midlands, UKRI, Health Foundation, Janssen, Gilead, and GlaxoSmithKline. He declares personal fees from Gilead Sciences, Merck, and GlaxoSmithKline outside the submitted work. JC is a lay member on the UK National Institute for Health and Care Excellence COVID expert panel, a citizen partner to the COVID-END Evidence Synthesis Network, patient and public involvement lead on the NIHR CICADA ME Study, patient representative at the EAN European Neurology Autonomic Nervous Systems Disorders Working Group, a member of the Medical Research Council/UKRI Advanced Pain Discovery Platform, and external board member of Plymouth Institute of Health. She also reports contracts with GlaxoSmithKline and Medable. CM receives funding from NIHR Surgical Reconstruction and Microbiology Research Centre, UKRI, and declares personal fees from Aparito. KM is employed by the NIHR. SH receives funding from NIHR and UKRI.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Fig 1

Development of symptom burden questionnaire for long covid (SBQ-LC)

Fig 2

Conceptual framework showing scales (domains) of symptom burden questionnaire for long covid (SBQ-LC, version 1.0)