BACKGROUND: To investigate a patient-level single imputation approach for patient reported outcomes (PROs) that express similar contents or associated PROs, where a PRO whose value is missing at a particular timepoint is substituted by another PRO whose value is available at the same timepoint. METHODS: We performed a simulation study on registry-based spondyloarthritis data to explore the potential interchangeability between the patient pain (PPA) and fatigue (PFA) assessment scores and relevant Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) individual questions, and between PPA, PFA and patient global assessment (PGA). Performance was assessed per imputation method in terms of relative bias and coverage. Sample size, level of missingness and missing data pattern were included as parameters in the simulations. RESULTS: All applied scenarios to interchange PPA with BASDAI question 2 (axial pain), BASDAI question 3 (peripheral joint pain/swelling) or their average failed. Interchangeability between PFA and BASDAI question 1 (fatigue/tiredness) was acceptable for partially (up to 50%) missing data. When interchanging patient assessment scores (PPA, PFA and PGA), we observed inconsistent results in terms of performance. The performance of the applied methods depended on the sample size and the level of missingness, but not heavily on the underlying missing data pattern. CONCLUSIONS: Interchanging PFA and the BASDAI fatigue question was justified for partially missing data, while interchangeability between PPA, PFA and PGA, and between PPA and the BASDAI pain questions was not advised. Our findings suggest that registering patient assessment scores and BASDAI questions is recommended.

Aberdeen Centre for Arthritis and Musculoskeletal Health University of Aberdeen Aberdeen UK

Amsterdam Rheumatology Immunology Center Reade and Amsterdam UMC Amsterdam Netherlands

Center for Treatment of Rheumatic and Musculoskeletal Diseases Diakonhjemmet Hospital Oslo Norway

Centre for Rheumatology Research Landspitali University Hospital Reykjavik Iceland

Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet Stockholm Sweden

Copenhagen Center for Arthritis Research Center for Rheumatology and Spine Diseases Centre for Head and Orthopaedics Rigshospitalet Glostrup Denmark

Department of Clinical Medicine Aarhus University Aarhus Denmark

Department of Clinical Medicine University of Copenhagen Copenhagen Denmark

Department of Clinical Sciences Lund Rheumatology Skåne University Hospital Lund University Lund Sweden

Department of Internal Medicine Dermatology and Psychiatry Universidad de La Laguna La Laguna Spain

Department of Rheumatology 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Rheumatology Aarhus University Hospital Aarhus Denmark

Department of Rheumatology and Clinical Immunology Amsterdam University Medical Center Amsterdam Netherlands

Department of Rheumatology and Clinical Immunology and Department of Experimental Immunology Amsterdam UMC Amsterdam Institute for Infection and Immunity University of Amsterdam Amsterdam Netherlands

Department of Rheumatology Geneva University Hospital Geneva Switzerland

Department of Rheumatology Hospital Garcia de Orta Almada Portugal

Department of Rheumatology Hospital General Universitario Gregorio Marañón Madrid Spain

Department of Rheumatology Kuopio University Hospital Kuopio Finland

Department of Rheumatology University Hospital Zurich University of Zurich Zurich Switzerland

Department of Rheumatology University Medical Centre Ljubljana Ljubljana Slovenia

Division of Rheumatology Department of Internal Medicine Dokuz Eylul University School of Medicine Izmir Turkey

Division of Rheumatology Department of Internal Medicine School of Medicine Kocaeli University Kocaeli Turkey

EpiDoC Unit CEDOC Nova Medical School Lisbon Portugal

Faculty of Medicine Complutense University of Madrid Madrid Spain

Faculty of Medicine University of Iceland Reykjavik Iceland

Faculty of Medicine University of Ljubljana Ljubljana Slovenia

Institute of Rheumatology Prague Czech Republic

Instituto Medicina Molecular Faculdade de Medicina da Universidade de Lisboa Centro Académico de Medicina de Lisboa Lisbon Portugal

Research Unit Sørlandet Hospital Kristiansand Norway

Rheumatology Inflammation Center Helsinki University Hospital University of Helsinki Helsinki Finland

Rheumatology Service Hospital Universitario de Canarias La Laguna Spain

Rheumatology Unit Hospital dos Lusíadas Lisbon Portugal

Statistics Group Swiss Clinical Quality Management Foundation Zurich Switzerland

The DANBIO Registry Copenhagen Denmark

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