Perspectives on the role of industry in informatics research and authorship.

Objectives: Advances in informatics research come from academic, nonprofit, and for-profit industry organizations, and from academic-industry partnerships. While scientific studies of commercial products may offer critical lessons for the field, manuscripts authored by industry scientists are sometimes categorically rejected. We review historical context, community perceptions, and guidelines on informatics authorship.

Demonstrating an approach for evaluating synthetic geospatial and temporal epidemiologic data utility: results from analyzing >1.8 million SARS-CoV-2 tests in the United States National COVID Cohort Collaborative (N3C).

Objective: This study sought to evaluate whether synthetic data derived from a national coronavirus disease 2019 (COVID-19) dataset could be used for geospatial and temporal epidemic analyses.

Materials And Methods: Using an original dataset (n = 1 854 968 severe acute respiratory syndrome coronavirus 2 tests) and its synthetic derivative, we compared key indicators of COVID-19 community spread through analysis of aggregate and zip code-level epidemic curves, patient characteristics and outcomes, distribution of tests by zip code, and indicator counts stratified by month and zip code. Similarity between the data was statistically and qualitatively evaluated.

Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials.

Aims: To assess the efficacy and tolerability of fesoterodine 8 mg versus tolterodine extended release (ER) 4 mg in subjects with overactive bladder (OAB) stratified by age (<65, 65-74, and ≥75 years).

Methods: This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo.

The effect of elective sham dose escalation on the placebo response during an antimuscarinic trial for overactive bladder symptoms.

Purpose: We analyzed the effects of baseline symptom severity and placebo response magnitude on the decision to dose escalate in a 12-week, randomized, double-blind, flexible dose antimuscarinic trial of subjects with overactive bladder symptoms.

Materials And Methods: Data from the placebo arm of the trial were used for this post hoc analysis. Subjects could elect dose escalation at week 2.

Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder.

Aims: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study.

Methods: Subjects were randomized to fesoterodine 4  mg or placebo. At week 2, subjects could remain on 4  mg (non-escalators) or choose to increase to 8  mg (escalators) for the remaining 10 weeks (sham escalation for placebo).

Early onset of fesoterodine efficacy in subjects with overactive bladder.

Objective: To assess the onset of efficacy of fesoterodine 4 mg once daily on overactive bladder (OAB) symptoms after 1 week of treatment.

Patients And Methods: This was a prespecified analysis of data collected during the first week of a 12-week, open-label, single-arm, flexible-dose study of fesoterodine. Eligible subjects were adult men and women (aged ≥ 18 years) who reported urinary frequency (eight or more micturitions per 24 h) and urgency (three or more episodes per 24 h) in 5-day bladder diaries at baseline, and dissatisfaction with previous tolterodine or tolterodine extended-release treatment received within 2 years of screening.

Patient-optimized doses of fesoterodine improve bladder symptoms in an open-label, flexible-dose study.

Objective: To assess changes in overactive bladder (OAB) symptoms and patient-reported outcomes in a post hoc analysis in which subjects from a 12-week, open-label, flexible-dose fesoterodine study were stratified according to whether they opted for dose escalation.

Patients And Methods: Subjects with OAB (eight or more micturitions and three or more urgency episodes per 24 h) who reported dissatisfaction with tolterodine within 2 years of screening received fesoterodine 4 mg once daily for 4 weeks, with an optional dose increase to 8 mg after week 4 based on discussion of efficacy and tolerability between the subject and investigator. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12, and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12.

Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head-to-head placebo-controlled trial.

Objective: To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended-release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).

Patients And Methods: In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms for > or = 3 months and recorded > or = 8 voids and > or = 1 urgency urinary incontinence (UUI) episode per 24 h in 3-day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo).

Efficacy of fesoterodine over 24 hours in subjects with overactive bladder.

Objective: Fesoterodine is an antimuscarinic agent indicated for the treatment of overactive bladder (OAB) symptoms. The objective of this study was to evaluate the efficacy of fesoterodine versus placebo over selected intervals during a 24-hour period in subjects with OAB.

Research Design And Methods: In a post hoc analysis, data were analyzed from two randomized, double-blind, placebo-controlled 12-week phase III trials in which subjects with a history of OAB symptoms for >or=6 months were treated with morning doses of fesoterodine 4 mg, fesoterodine 8 mg, or placebo.

Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder.

Objectives: To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB).

Methods: In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo).

Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence.

Objective: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI).

Research Design And Methods: This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =6 months.

Efficacy and tolerability of fesoterodine in women with overactive bladder.

Introduction And Hypothesis: We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB).

Methods: This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12.

Continued symptom improvement in sexually active women with overactive bladder and urgency urinary incontinence treated with tolterodine ER for 6 months.

Improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) were assessed during a 24-week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). A 12-week, double-blind, randomized, placebo-controlled trial was followed by a 12-week open-label phase. Sexually active women reported symptoms for >or=3 months.

Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women.

We evaluated overactive bladder (OAB) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence (UUI) treated with tolterodine extended release (ER). Sexually active women with OAB symptoms were randomized to placebo or tolterodine ER. Five-day bladder diaries, Sexual Quality of Life Questionnaire-Female (SQOL-F), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), and Hospital Anxiety and Depression Scale (HAD) were completed at baseline and week 12.