Dennis D. Gagnon

• MA, MABE
• Retired at Home

See source contribution for original English version - supplementary file: French version of the Information Toolkit on Violent Extremism

In a recent randomised, double-blind, phase III clinical trial among 1195 patients with metastatic castration-resistant prostate cancer (mCRPC) who had failed docetaxel chemotherapy, abiraterone acetate was shown to significantly prolong overall survival compared with prednisone alone. Here we report on the impact of abiraterone therapy on the heal...

9617 Background: HRQL was evaluated as part of COU-AA-301, a randomized phase 3 trial of AA + prednisone (P) vs placebo + P in mCRPC patients (pts) post-docetaxel, where AA + P demonstrated significant benefits over P in numerous HRQL measures. Here we report post hoc analyses investigating the role of disease progression (px) in mediating the HRQL...

9618 Background: The COU-AA-301 phase 3 trial showed that AA + prednisone (P) improved overall survival in mCRPC patients (pts) post-docetaxel. Compared with P alone, AA + P also had significant benefits on patient-reported pain. Here we describe post hoc sensitivity analyses of pain data from that trial, using different methods to compensate for t...

Background Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo and prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients after d...

Background: Bone metastases are a major cause of morbidity in metastatic castration-resistant prostate cancer. Abiraterone acetate potently disrupts intracrine androgen receptor signalling pathways implicated in the progression of the disease, including bone metastases. We assessed data for pain control and skeletal-related events prospectively co...

OBJECTIVES: In a simulated dataset, evaluate incremental cost-effectiveness ratios (ICERs) adjusted for covariates and missing data using three different regression models. The regression parameter of interest is the incremental net monetary benefit (INMB). Models are ANCOVA, mixed effects (ME), and joint mixed effects and log time-to-dropout (joi...

Relapse prevention and maintenance of social functioning are important treatment objectives in the long-term management of schizophrenia. However, relatively little is known about measuring maintenance of social functioning to assess treatment benefit in relapse prevention clinical trials or as a tool to predict relapse in clinical practice. This s...

The safety and efficacy of paliperidone extended-release tablets (paliperidone ER) in patients with acute symptoms of schizophrenia have been described in 3 randomized, double-blind, 6-week, placebo-controlled, fixed-dose, Phase III clinical trials. The validity and reliability of the Personal and Social Performance (PSP) scale, both in patients wi...

To describe the measurement properties of the Personal and Social Performance scale (PSP), a clinician-reported measure of severity of personal and social dysfunction, in subjects with acute symptoms of schizophrenia. Pooled data from three paliperidone extended-release clinical studies (n = 1665) and data from a separate noninterventional, cross-s...

This report describes the measurement properties of the Personal and Social Performance scale (PSP), a clinician-reported measure of severity of personal and social dysfunction, in an outpatient population with stabilized schizophrenia. Pooled data from two similar antipsychotic clinical studies were analyzed (n=411). The PSP showed good test-retes...

To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self-reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single-item measures, a profile, and an index score. Data were from men participating in observational studies in the USA (PE, 207 men; non-PE, 1380) and Europe (PE...

To characterize premature ejaculation (PE) in five European countries using intravaginal ejaculatory latency time (IELT) and the Premature Ejaculation Profile (PEP). This 8-wk, multicenter, observational study enrolled men >or=18 yr of age and their female partners. Clinicians diagnosed PE using the DSM-IV-TR criteria and at least moderate, subject...

Objective: To evaluate the impact of premature ejaculation (PE) on female partners of men with PE compared with female partners of men without PE in a large European observational study. Methods and materials: This was an 8-week, multicentre, European observational study which enrolled men ≥ ≥18 years of age and their female partners. Clinicians di...

A recent observational study characterized intravaginal ejaculatory latency time and single item patient reported outcome measures in a large population of males with and without premature ejaculation, as well as their female partners. In the current analysis we assessed the relative influence of those measures in identifying premature ejaculation...

Premature ejaculation is characterized by short ejaculatory latency, inability to control ejaculation and resultant overall decreased sexual satisfaction for the man and his partner. Diagnostic criteria typically include aspects of psychological well-being. To motivate and justify treatment for premature ejaculation a more comprehensive understandi...

Incomplete data are inevitable in quality-of-life (QoL) studies involving cancer patients, since a proportion of patients will not complete the trial. Traditional analyses assume that such data are missing at random, but this assumption may be incorrect. We therefore applied mixed-effects statistical models to determine the effects of non-random mi...

Anaemia is an important factor in the fatigue experienced by many patients receiving chemotherapy. A recent large-scale, randomised, placebo-controlled trial has shown that treatment with epoetin alfa raises haemoglobin levels, reduces fatigue and improves overall quality of life (QoL). In order to examine the relationship between anaemia and QoL m...

Assessment of health-related quality of life (QOL) has become increasingly common in clinical trials. Because QOL has multiple dimensions and is assessed repeatedly over time, multiple comparisons and missing data must be addressed in the design and analysis of these trials. While the development of an analysis plan will be a continuous process, de...

Quality of life (QOL) endpoints from a randomized, placebo-controlled trial of anemic cancer patients treated with nonplatinum-containing chemotherapy who received epoetin alfa or placebo were subjected to a sensitivity analysis. Three QOL instruments were used: the Functional Assessment of Cancer Therapy-Anemia (FACT-An), the Cancer Linear Analog...

Health-related quality of life (HrQOL) assessments are gaining importance as outcome measures in cancer clinical trials. A recently published clinical trial reported statistically significant (P<0.001) increases in haemoglobin (Hb) levels and significantly (P<0.01) increased HrQOL scores following the administration of recombinant human erythropoie...

The Diabetic Foot Ulcer Scale (DFS) provides comprehensive measurement of the impact of diabetic foot ulcers on patients' QOL through self-administration of 64 items comprising 15 subscales. To develop and evaluate a short form of the DFS (DFS-SF) to reduce patient burden and the number of outcome measures, and to improve sensitivity to change in c...

A number of new antiepileptic agents have been introduced within a short period of time. Direct comparisons are not available, and information about the balance between costs and effects for these new therapies is lacking. To introduce a first approximation of the cost effectiveness of the new therapeutic agents (topiramate and lamotrigine) for epi...

In a multinational trial of anaemic patients with cancer receiving nonplatinum-containing chemotherapy, epoetin-alfa effectively increased haemoglobin levels, reduced red blood cell transfusion requirements, and improved QOL. Although the study was not designed or powered to evaluate survival, a survival trend was noted favouring epoetin-alfa compa...

Anemia, highly common among cancer patients, is often an underlying cause of cancer-related fatigue and other quality-of-life (QOL) deficits. Although randomized clinical trials have shown that treatment with epoetin alfa increases hemoglobin levels, reduces fatigue, lessens transfusion requirements, and improves overall QOL, cancer-related anemia...

Cancer-related anaemia is associated with a wide spectrum of symptoms that can negatively affect quality of life. Because epoetin alfa has demonstrated efficacy in correcting cancer-related anaemia, the impact of this treatment on quality of life was evaluated in a multinational, randomised, double-blind, placebo-controlled trial in 375 anaemic can...

The diabetic foot ulcer scale (DFS) questionnaire is a specific instrument designed to assess the impact of foot ulcers and their treatment on quality of life in people with diabetes. Based on the results of semi-structured interviews and focus-group discussions with foot ulcer patients and caregivers, the DFS consists of 58 items grouped into 11 d...

BACKGROUND: In a multinational trial designed to determine the efficacy of epoetin alfa in chemotherapy-induced anemia, patients receiving non-platinum chemotherapy having a hemoglobin 10.5 g/dL or less, or a decline in hemoglobin of 1.5 g/dL or greater were randomized (2:1) to epoetin alfa or placebo. A total of 375 patients (251 epoetin alfa, 124...

Objectives. To compare the quality of life (QOL) of persons enrolled and not enrolled in formal weight- loss programs over 12 weeks and to examine important QOL correlates of weight change, including demo- graphic characteristics, bothersomeness of weight- related symptoms, and depressive symptomatology. Methods. Two groups of overweight persons we...

In multivariate analysis, WTP varied with fear of transfusion and education level, as expected. The probability of purchasing Epoetin-continuously decreased with price in 10 of 12 observations. CONCLUSIONS: Our findings indicate high internal consistency of the survey. Patients indicated considerable WTP for Epoetin-to reduce the risk of allogeneic...

Understanding the relationship between seizure frequency, seizure type and scores obtained from quality of life (QOL) measures is important if the incorporation of QOL measures into epilepsy clinical trials is to become standard practice. There is also a need to consider cross-cultural differences obtained from QOL measures, particularly in the con...

The relationship between seizure frequency and both health care costs and quality of life (QOL) was investigated in a retrospective, cross-sectional, multicenter study in France, Germany, and the United Kingdom. Three hundred outpatients with stable partial epilepsy were approximately evenly distributed among five seizure-frequency groups, ranging...

The objective of this study was to report U.S. validation of two measures specific to obesity and weight loss: the Obesity and Weight-Loss Quality-of-Life Instrument (OWLQOL) and Weight-Related Symptom Measure (WRSM), including measure- ment model, psychometric properties and burden. Two groups were recruited: 160 obese enrollees in diet, exercise,...