1. Protocol for PRImary care Management of lower Urinary tract Symptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (The PriMUS Study)
- Author
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Tom Schatzberger, Michael Drinnan, Calie Dyer, Kerenza Hood, Emma Thomas-Jones, Christopher Harding, Bethan Pell, Samantha Clarke, Harron Ahmed, A Joy Allen, Lucy Marsh, Jonathan J Deeks, Natalie Joseph-Williams, Adrian Edwards, Yemisi Takwoingi, Alison Bray, Richard Pickard, Marcus J. Drake, Sarah Milosevic, and Ridhi Agarwal
- Subjects
Protocol (science) ,medicine.medical_specialty ,Research ethics ,business.industry ,General Medicine ,Primary care ,medicine.disease ,Clinical decision support system ,Poor quality ,Patient management ,primary care ,03 medical and health sciences ,Bladder outlet obstruction ,0302 clinical medicine ,Lower urinary tract symptoms ,medicine ,adult urology ,030212 general & internal medicine ,General practice / Family practice ,urology ,Intensive care medicine ,business ,030217 neurology & neurosurgery - Abstract
IntroductionLower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life. General practitioners (GPs) currently have no easily available assessment tools to help effectively diagnose causes of LUTS and aid discussion of treatment with patients. Men are frequently referred to urology specialists who often recommend treatments that could have been initiated in primary care. GP access to simple, accurate tests and clinician decision tools are needed to facilitate accurate and effective patient management of LUTS in primary care.Methods and analysisPRImary care Management of lower Urinary tract Symptoms (PriMUS) is a prospective diagnostic accuracy study based in primary care. The study will determine which of a number of index tests used in combination best predict three urodynamic observations in men who present to their GP with LUTS. These are detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity. Two cohorts of participants, one for development of the prototype diagnostic tool and other for validation, will undergo a series of simple index tests and the invasive reference standard (invasive urodynamics). We will develop and validate three diagnostic prediction models based on each condition and then combine them with management recommendations to form a clinical decision support tool.Ethics and disseminationEthics approval is from the Wales Research Ethics Committee 6. Findings will be disseminated through peer-reviewed journals and conferences, and results will be of interest to professional and patient stakeholders.Trial registration numberISRCTN10327305.
- Published
- 2020
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