Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109: Secondary Analysis of a Randomized Clinical Trial.

Importance: Recurrent Clostridioides difficile infection (CDI) is a debilitating disease leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. The potential association of treatment with HRQOL has not been well evaluated.

Objectives: To explore the association of SER-109 compared with placebo on HRQOL in patients with recurrent CDI up to week 8.

Validation of a Health-Related Quality of Life Questionnaire in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Phase 3 Randomized Trial.

Background: Debilitating symptoms of recurrent Clostridioides difficile infection (rCDI) often lead to long-term effects on health-related quality-of-life (HRQOL). In ECOSPOR III, SER-109, an investigational oral microbiome therapeutic, was superior to placebo in reducing rCDI. We investigated the validity, reliability, and responsiveness of a 32-item, CDI-specific questionnaire-the Clostridium difficile Quality of Life Survey (Cdiff32)-across mental, physical, and social domains in patients with rCDI.

Feasibility of an online mindfulness program for stress management--a randomized, controlled trial.

Background: Chronic stress affects many Americans. Stress management programs may be prohibitively expensive or have limited access.

Purpose: This study aims to determine feasibility of an 8-week Internet-based stress management program (ISM) based on mindfulness principles in reducing stress in a 12-week, parallel, randomized, controlled trial.

Asthma patients prefer Respimat Soft Mist Inhaler to Turbuhaler.

Device satisfaction and preference are important patient-reported outcomes to consider when choosing inhaled therapy. A subset of adults (n = 153) with moderate or severe asthma participating in a randomized parallel-group, double-dummy trial that compared the efficacy and safety of 12 weeks' treatment with budesonide delivered via Respimat Soft Mist Inhaler (SMI) (200 or 400 microg bd) or Turbuhaler dry powder inhaler (400 microg bd), completed a questionnaire on patient device preference and satisfaction (PASAPQ) as part of a psychometric validation. As the study used a double-dummy design to maintain blinding, patients used and assessed both devices, rating their satisfaction with, preference for, and willingness to continue using each device.

Botulinum toxin A improves the quality of life of patients with neurogenic urinary incontinence.

Objective: To evaluate the impact of botulinum toxin type A (BoNTA) on health-related quality of life in patients with neurogenic urinary incontinence (UI) using the Incontinence Quality of Life questionnaire (I-QOL).

Methods: Randomized, double-blind, multicenter, placebo-controlled study involving eight centers across Belgium, France, and Switzerland. Patients (n = 59) with UI due to neurogenic detrusor overactivity (spinal cord injury, n = 53; multiple sclerosis, n = 6) who were inadequately managed on oral anticholinergics received a single dose of BoNTA (200U or 300U, Botox) or placebo.

Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence.

Objective: To assess the reliability, validity, responsiveness, and minimally important difference (MID) of the Incontinence Quality of Life (I-QOL) questionnaire in patients with urinary incontinence due to neurogenic detrusor overactivity.

Design: Randomized, double-blind, multicenter, placebo-controlled study.

Setting: Eight centers across Belgium, France, and Switzerland.

The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW.

Objective: This study evaluated the validity of three single-item, patient-rated, interviewer-administered, global assessments of treatment benefit, satisfaction with treatment and willingness to continue treatment, collectively referred to as the BSW.

Methods: The BSW, micturition diaries, the Overactive Bladder Questionnaire (OAB-q) and the King's Health Questionnaire (KHQ) were included in part or in total in three OAB clinical trials. Discriminant validity for full and dichotomized responses was assessed with anovas models and correlations were used to evaluate construct validity.

Development and validation of a patient satisfaction and preference questionnaire for inhalation devices.

Introduction: The Patient Satisfaction and Preference Questionnaire (PASAPQ) is a multi-item measure of respiratory inhalation device satisfaction and preference designed to be easily understood and administered to patients with asthma and COPD. This study assessed its validity, reliability and responsiveness and explored the between-group difference in PASAPQ scores that is meaningful.

Methods: The field test version was developed using literature, focus groups and expert opinion.

How much is enough and who says so?

Background: One of the challenges of health-related quality of life research is to translate statistically significant health-related quality of life changes into interpretable clinical or medically important ones.

Objective: To calculate the minimal important difference of the King's Health Questionnaire, a condition-specific health-related quality of life questionnaire for the assessment of men and women with lower urinary tract dysfunction.

Methods: The King's Health Questionnaire was administered to patients suffering from overactive bladder enrolled in two multinational studies.

Screening, prevention and socioeconomic costs associated with the treatment of colorectal cancer.

Colorectal cancer (CRC), the third most prevalent cancer worldwide, imposes a significant economic and humanistic burden on patients and society. One study conservatively estimated the annual expenditures for colorectal cancer to be approximately dollars US 5.3 billion in 2000, including both direct and indirect costs.

Multinational study of reliability and validity of the King's Health Questionnaire in patients with overactive bladder.

Objective: Overactive bladder (OAB) has substantial impact on health-related quality of life (HRQoL). The purpose of this research was to evaluate the psychometric properties of the King's Health Questionnaire (KHQ).

Methods: The KHQ (n = 1284) was administered at baseline and 12 weeks post-treatment in a multinational, double-blind, randomized clinical trial of tolterodine for treatment of OAB.

Long-term health-related quality of life of patients receiving extended-release tolterodine for overactive bladder.

Objective: To evaluate the long-term effects of tolterodine on the health-related quality of life (HRQoL) of patients diagnosed with overactive bladder with incontinence.

Methods: Patients who completed a 12-week randomized, double-blind, safety and efficacy trial comparing tolterodine with placebo were invited to enroll in a 12-month open-label continuation trial to assess the long-term safety and efficacy of tolterodine. This study reports the HRQoL results from the King's Health Questionnaire (KHQ) and the Short Form-36 (SF-36) that were administered at baseline, at the end of the 12-week trial, and 3 and 12 months following open-label treatment with tolterodine.

Health-related quality of life of patients receiving extended-release tolterodine for overactive bladder.

Objective: To compare the health-related quality of life (HRQoL) of overactive bladder (OAB) patients foilowing treatment with tolterodine extended-release (ER) 4 mg once daily versus placebo.

Study Design: Multinational, placebo-controlled, randomized, double-blind 12-week study.

Population: Patients with urinary frequency ( > or = 8 micturitions/24 hours over a 7-day period), urge incontinence ( > or = 5 episodes/week), and symptoms of OAB for at least 6 months were eligible for inclusion.

The economic impact of opioids on postoperative pain management.

Study Objective: To evaluate the consequences of opioid use for postoperative pain management and the degree to which these consequences may be reduced or minimized with opioid-sparing or opioid-replacement techniques.

Design: Literature review relating to the economics of postoperative pain management. Comparisons between opioids and opioid-sparing techniques were identified and selected for study.