Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL).

Antibiotic treatment and factors influencing short and long term outcomes of acute exacerbations of chronic bronchitis.

Background: The MOSAIC study compared moxifloxacin with three standard antibiotic regimens in patients with Anthonisen type 1 acute exacerbations of chronic bronchitis (AECB). Further exploratory analyses were performed to identify prognostic factors of short and long term clinical outcomes and their value for clinical research.

Methods: Outpatients aged > or =45 years were screened between AECB episodes, randomised to treatment upon presenting with an AECB, assessed 7-10 days after study treatment, and followed monthly until a new AECB or for up to 9 months.

Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis.

Study Objectives: To compare the effectiveness of oral moxifloxacin with standard antibiotic therapy in acute exacerbation of chronic bronchitis (AECB).

Design: Multicenter, multinational, randomized, double-blind study of two parallel treatment arms.

Patients: Outpatients >or= 45 years old with stable chronic bronchitis, smoking history of >or= 20 pack-years, two or more AECBs in the previous year, and FEV(1) < 85% of predicted value.

An economic evaluation of sequential i.v./po moxifloxacin therapy compared to i.v./po co-amoxiclav with or without clarithromycin in the treatment of community-acquired pneumonia.

Study Objective: To evaluate costs, clinical consequences, and cost-effectiveness from a German and French health-care system perspective of sequential i.v./po moxifloxacin monotherapy compared to co-amoxiclav with or without clarithromycin (AMC +/- CLA) in patients with community-acquired pneumonia (CAP) who required parenteral treatment.

Validity of the St George's respiratory questionnaire at acute exacerbation of chronic bronchitis: comparison with the Nottingham health profile.

The purpose of the study is to compare a generic and a specific quality of life (QoL) instrument in the assessment of QoL in chronic bronchitis. Data from 320 patients were collected at acute exacerbation of chronic bronchitis (AECB), and from 230 patients during a subsequent stable phase (non-AECB), utilising both the specific St George's respiratory questionnaire (SGRQ) and the generic Nottingham health profile (NHP). Patients (maximum n = 200) reported significantly poorer QoL at AECB than at non-AECB for all domains except the SGRQ symptom domain (SRM = 0.

Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia.

Based on recent guidelines for the management of community-acquired pneumonia, this study was designed to evaluate the effectiveness of a new fluoroquinolone compared with standard antimicrobial regimens, in conditions relating as closely as possible to the real world setting. In this study, 564 patients were randomised to either oral moxifloxacin (400 mg o.d.

Intravenous and oral antibiotics in respiratory tract infection: an international observational study of hospital practice.

Background: Hospitalised patients with respiratory tract infections (RTI) frequently receive intravenous (i.v.) antibiotics followed by a short course of oral treatment.

The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia.

Study Objective: s: To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP).

Design: A psychometric study within an international, prospective, randomized, double-blind study. The CAP-symptom questionnaire (CAP-Sym) is a new, 18-item, patient-reported outcome measure that evaluates the bothersomeness of CAP-related symptoms during the past 24 h using a 6-point Likert scale.

Predictive factors of acute hospitalization in 134 patients with Alzheimer's disease: a one year prospective study.

Objective: To evaluate the frequency of and determine predictive factors for acute hospitalization in a prospective study of patients with Alzheimer's disease (AD).

Design: A one year prospective study.

Participants: 134 patients recruited from the memory clinic in Toulouse University Hospital, with AD diagnosed using the NINCDS-ADRDA criteria.

Pilot testing of the 'Haemo-QoL' quality of life questionnaire for haemophiliac children in six European countries.

In a multinational working group, an instrument (Haemo-QoL) to assess quality of life in children/adolescents with haemophilia and their parents has been developed. In co-operation with haemophilia treatment centres in six European countries, approximately 10 children/adolescents with haemophilia per country and their parents were asked to participate in the pilot-testing. Both self-reported and parent-reported questionnaires were provided for two age-groups of children (4-16 years).

Quality of life in acute exacerbation of chronic bronchitis: results from a German population study.

This study reports on data from a study conducted in the Federal Republic of Germany examining the quality of life (QoL) of patients with chronic bronchitis (CB) and its acute exacerbations (AECB). Data from 320 patients were collected at AECB and subsequently during a stable phase (non-AECB) utilizing the St George's Respiratory Questionnaire (SGRQ) and the Nottingham Health Profile (NHP). As expected, the QoL of CB patients was poor, even at non-AECB, with patients reporting lower scores than patients with other chronic conditions.

The impact of metrifonate therapy on caregivers of patients with Alzheimer's disease: results from the MALT clinical trial. Metrifonate in Alzheimer's Disease Trial.

Objective: To assess the impact on burden reported by caregivers of patients with mild to moderate Alzheimer's disease (AD) who were treated with metrifonate during a randomized double blind clinical trial.

Design: Randomized clinical trial, with a 2-week screening period and a 26-week double blind, placebo controlled, treatment phase. Caregivers were assessed at baseline, at 12 weeks, and at end of trial.

Health-related quality of life associated with lower urinary tract symptoms in four countries.

Objectives: To describe health-related quality of life (HRQL) associated with lower urinary tract symptoms (LUTS) assessed by validated questionnaires in four countries.

Methods: More than 6000 men, recruited by using community- or population-based sampling in four countries, completed questionnaires soliciting information about urinary symptom frequency, bother, degree of interference with daily activities, and other measures of HRQL.

Results: In all countries, disease-specific HRQL worsened with increasing age.

The relationship between sexual life and urinary condition in the French community.

As part of a large, nationwide community-based study in France on health and urinary condition, involving 2011 men aged between 50 and 80 years, information was collected on sexual life factors (e.g., frequency of sexual desires and sexual relations, and the frequency of having difficulties with erection and ejaculation) in addition to an assessment of overall sexual life satisfaction.

International comparison of the community prevalence of symptoms of prostatism in four countries.

We conducted an international comparison of the prevalence of urinary symptoms of prostatism in 4 countries, using a community-based random sampling of subjects, similar study procedures, and a single definition of cases that was based on a standardized symptom questionnaire. In Scotland 1,994 medically eligible men aged 40-79 years agreed to participate from 3 communities of the Forth Valley. In France, a nation-wide survey was conducted cross-sectionally in a representative sample of 2,011 French men aged 50-84 years.

Determinants of treatment-seeking behaviour for urinary symptoms in older men.

Objective: To determine the factors associated with seeking treatment for urinary symptoms among older men in a European population.

Subjects And Methods: A community survey involving a representative nationwide sample of 2011 French men aged between 50 and 80 years was performed and information collected using an interviewer-administered questionnaire.

Results: Visiting a doctor for urinary symptoms was associated with the perceived bothersomeness of urinary symptoms, in addition to and independently of the level of symptom severity.

A brief male sexual function inventory for urology.

Objectives: To develop a brief questionnaire to measure male sexual function.

Methods: An initial set of questions was refined and reduced through cognitive testing and two serial validation studies. In each study, men were recruited from a sexual dysfunction clinic and a general medicine practice to complete the instrument.

Impact of symptoms of prostatism on level of bother and quality of life of men in the French community.

The impact of symptoms of prostatism on level of bother and quality of life of French men was assessed nationwide, in a representative community sample of 2,011 subjects 50 to 84 years old. Bothersome level and quality of life associated with 12 urinary symptoms were assessed by face-to-face interviews, using a previously validated questionnaire for benign prostatic hyperplasia (BPH). The international prostate symptom score and the American Urological Association (AUA) bothersome index were also computed.

[Adaptation and validation in the French language of the International Score of Symptoms of Benign Prostatic Hypertrophy].

The International Prostate Symptom Score, which was proposed during the First Consultation on Benign Prostatic Hyperplasia in June 1991, was culturally adapted and linguistically validated in French. In a first step, the English version, adapted from the questionnaire developed by the American Urological Association, was translated into French. In a second step, the French version was submitted to a multidisciplinary group who made linguistic improvements.

Results of an epidemiological survey using a modified American Urological Association symptom index for benign prostatic hyperplasia in France.

The prevalence of urinary symptoms associated with benign prostatic hyperplasia was studied in a community-based, nationwide, representative sample of 2,011 French men 50 to 80 years old. Symptoms were assessed by the American Urological Association symptom index. After exclusion of patients with prostate cancer, 6.

[Evidences for genetic transmission of pulse arterial pressure].

Systolic (PS), diastolic (PD), and pulse (PULS) arterial blood pressure were examined in 151 French-West-Indies families. After adjustment for sex, age, Na/K urinary ratio, alcohol consumption, use of anti-hypertensive drug, the distributions of PS and PD were correctly fitted by two commingled normal distributions, one of them including 5% of the highest values of blood pressure which have to be compared to the high prevalence of hypertension in this population (10 to 20%). By performing segregation analyses under Lalouel et al.

Genealogical and genetical African admixture estimations, blood pressure and hypertension in a Caribbean community.

This study examines the relationships between blood pressure, prevalence of hypertension, and the degree of black African admixture in the population of the Caribbean Island of La Désirade which is homogeneous with respect to the environmental factors and for which the socioeconomical stratification does not match racial origin. The degree of admixture was estimated by using both genealogical information and genetic markers. Blood pressure was repeatedly measured using an automatic sphygmomanometer.