Development and Assessment of SCI Model Systems Complicated UTI Consensus Guidelines: A Psychometrically Designed Mixed-Methods Protocol

Abstract

Background Complicated UTI (cUTI) is highly prevalent among people with spinal cord injury and disease (SCI/D), but neither consistent nor evidence-based guidelines exist. Objectives We propose a two-phase, mixed-methods study to develop consensus around diagnostic and decision-making criteria for cUTI among people with SCI/D and the clinicians who treat them. Methods In phase 1 (qualitative), we will engage Spinal Cord Injury Model Systems (SCIMS) clinicians in focus groups to refine existing cUTI-related decision making using three reliable and validated Urinary Symptom Questionnaires for Neurogenic Bladder (USQNBs; intermittent catheterization, indwelling catheterization, and voiding) as points of departure, and then we will conduct a Delphi survey to explore and achieve consensus on cUTI diagnostic criteria among a nationally representative sample of clinicians from physical medicine and rehabilitation, infectious disease, urology, primary care, and emergency medicine. We will develop training materials based on these new guidelines and will deploy the training to both clinicians and consumers nationally. In phase 2 (quantitative), we will assess clinicians’ uptake and use of the guidelines, and the impact of the guidelines training on consumers’ self-management habits, engagement with the health care system, and antibiotic use over the 12 months after training. Results The output of this study will be diagnostic guidelines for cUTI among people with neurogenic lower urinary tract dysfunction (NLUTD) due to SCI/D, with data on uptake (clinicians) and impact (patients). Conclusion This mixed-methods protocol integrates formal psychometric methods with large-scale evidence gathering to derive consensus around diagnostic guidelines for cUTI among people with NLUTD due to SCI/D and provides information on uptake (clinicians) and impact (patients).