Impact of speeding on the validity of patient-reported outcome measures. An analysis of psychometric properties stratified by response times

Background Randomised trials and meta-evidence increasingly rely on patient-reported outcome measures (PROMs). The psychometric properties of patient-reported outcome measures PROMs, including validity, reliability, and responsiveness, are typically established using high-quality datasets, which may not reflect the data quality in clinical trials. Increasing survey burden and fatigue may lead to issues with short response times that can reflect insufficient engagement. This phenomenon, often referred to as ‘speeding’ can lead to random, patterned, or otherwise invalid responses.

This study aims to investigate how response times influence the psychometric properties of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain domain in patients with chronic postsurgical pain.

The study is based on responses to the 5-item Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain domain (Likert-scale, version 3.1) from 2,031 patients who underwent total hip arthroplasty (THA), 2,172 patients who underwent total knee arthroplasty (TKA), and 870 patients who underwent unicompartmental knee arthroplasty (UKA) more than one year previously. Each of the three datasets, containing patients who have undergone THA, UKA and TKA, are individually stratified into response time deciles. For each of the deciles, we will evaluate if the data fit a congeneric measurement model, i.e. a model that assumes that the set of observed items all measure the same underlying latent factor. This evaluation of construct validity is done using Item Response Theory (IRT) and Confirmatory Factor Analysis (CFA). Perspective The results will be submitted for publication in a peer-reviewed journal. We will seek to make the report freely available, either by open-access publication or through publication on a preprint server, e.g. www.medrxiv.org. Competing Interest Statement The authors have declared no competing interest. Funding Statement This work was supported by the Michaelsen foundation (kahlke.dk/fonde/michaelsen-fond). The funding sources had no influence on the planning, execution, or publication of this study. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee of the Capitol Region of Denmark waived ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes jens.holm.laigaard{at}regionh.dk saber.muthanna.saber.aljuboori{at}regionh.dk soeren.overgaard{at}regionh.dk kach{at}sund.ku.dk Funding: This work was supported by the Michaelsen foundation (kahlke.dk/fonde/michaelsen-fond). The funding sources had no influence on the planning, execution, or publication of this study. Data availability statement The data used in this study are available from their primary sources upon reasonable request. Please see the original publications for details.