R01DK130963

Enhanced Clinical Decisions for Management of Benign Prostatic Hyperplasia Using Patient-Reported Outcomes - Project Summary

The American Urological Association Symptom Index (AUA-SI) has been the primary patient-reported outcome (PRO) used in men with benign prostatic hyperplasia (BPH) for decades. However, it is not a comprehensive assessment of lower urinary tract symptoms that may present with BPH because it lacks items on urinary incontinence and bladder pain.

The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) developed general-use multidimensional symptom questionnaires in order to address the complex needs of the urology clinic, but these tools have yet to be validated in specific clinical populations.

The overarching goal of this project is to use these questionnaires and other PROs to enhance clinical decision-making in men with BPH. This will be achieved by:

1. Integration of PRO assessments into the evaluation and management of patients with BPH.
2. Determination of clinically meaningful differences in LURN symptom indices in men with BPH receiving known effective treatment.
3. Creation of care-coordination recommendations to facilitate using PROs in order to match evidence-based treatments to patients with persistent symptoms.

PROs are a cost-effective strategy that, combined with advances in electronic medical health record technology, can improve patient care by allowing for more real-time surveillance and intervention, including the monitoring of both the core urologic symptoms of BPH and common comorbid symptoms such as sleep disturbance and depression.

In order to effectively determine meaningful symptom changes in response to treatment, minimally important differences specific to men with BPH must be established. Moreover, previously demonstrated convergent validity of the questionnaires must be confirmed in this population.

In addition to using PROs to assess treatment response, they can also be used to monitor short-term side effects and comorbid conditions over the course of treatment, a practice that can facilitate care coordination that will increase quality of care and quality of life for men with BPH.

In Aim 1, we will use statistical methods to predict changes in urologic symptoms and assess associations between lower urinary tract symptoms and measures of sleep disturbance, depression, and pain, among others.

In Aim 2, we will assess test-retest reliability and other psychometric properties of the LURN symptom indices, using a triangulation of methods to determine minimally important differences.

In Aim 3, we will engage stakeholders, including patients and clinicians, and use qualitative methods to create care coordination checklists intended for physician extenders to follow up with patients undergoing treatment, including via telehealth. Aim 3 will also enhance the recovery and routine monitoring of men with BPH after surgery, who can experience distressing side effects and complications such as urinary leakage and pain.

The ultimate result of this work will be a better understanding of the associations between comorbid sleep disturbance, depression, anxiety, etc., with urinary symptoms in men with BPH, and improved care and reduced symptom burden through the integration of robust and validated PROs into multiple phases of urologic care.

University Of Chicago

NOT APPLICABLE

93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [HHS - NIH]

Chicago, Illinois 606375418 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 360% from $715,094 to $3,287,977.