1. PRI mary care M anagement of lower U rinary tract S ymptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (the PriMUS study).
- Author
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Pell B, Thomas-Jones E, Bray A, Agarwal R, Ahmed H, Allen AJ, Clarke S, Deeks JJ, Drake M, Drinnan M, Dyer C, Hood K, Joseph-Williams N, Marsh L, Milosevic S, Pickard R, Schatzberger T, Takwoingi Y, Harding C, and Edwards A
- Subjects
- Cohort Studies, Humans, Lower Urinary Tract Symptoms etiology, Male, Urinary Bladder Neck Obstruction diagnosis, Urinary Bladder Neck Obstruction etiology, Urinary Bladder Neck Obstruction therapy, Urinary Bladder, Overactive diagnosis, Urinary Bladder, Overactive etiology, Urinary Bladder, Overactive therapy, Urinary Bladder, Underactive diagnosis, Urinary Bladder, Underactive etiology, Urinary Bladder, Underactive therapy, Urodynamics physiology, Decision Support Systems, Clinical, Lower Urinary Tract Symptoms diagnosis, Lower Urinary Tract Symptoms therapy, Primary Health Care
- Abstract
Introduction: Lower 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 Analysis: PRImary 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 Dissemination: Ethics 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 Number: ISRCTN10327305., Competing Interests: Competing interests: One of the index tests, Flowtaker, was developed by a team from Newcastle upon Tyne Hospitals (NuTH) and Newcastle University, including two individuals who are grant co-applicants, members of the study management team and co-authors (AB and MiD). In 2014, the device was licensed to MMS (Enschede, the Netherlands) and royalties from the sale of the device were paid to NuTH (not to the individuals). MMS was subsequently acquired by Laborie who removed Flowtaker from the market in January 2018., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2020
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