Demonstrating the burden of hypoglycemia on patients' quality of life in diabetes clinical trials: measurement considerations for hypoglycemia.

Objectives: To evaluate the association between hypoglycemia and health-related quality of life (HRQoL) in the context of a clinical trial using both an objectively confirmed and a patient-reported measure of hypoglycemia.

Methods: During a phase III, double-arm, randomized study, patients completed the short form 36 health survey (SF-36), a generic HRQoL questionnaire, at baseline and at weeks 24, 52, and 104. The objectively confirmed measure of hypoglycemia was based on a combination of plasma glucose measure and presence of hypoglycemia-related symptoms.

Validation of the Treatment Satisfaction Questionnaire for Medication in patients with cystic fibrosis.

Background: Our objective was to confirm the measurement properties of the Treatment Satisfaction Questionnaire with Medication (TQSM) in patients with cystic fibrosis (CF) receiving inhaled antibiotics.

Methods: The TSQM was included in the EAGER study, a clinical trial comparing a nebulized and a dry powder device for inhaled tobramycin in a CF population with chronic Pseudomonas aeruginosa (Pa) lung infection, aged 6 years and above (N=553). Reliability and validity of the questionnaire were investigated using Cronbach's α and multitrait-multimethod approach.

Burden of anemia in patients with osteoarthritis and rheumatoid arthritis in French secondary care.

Background: Arthritic disorders can be the cause of hospitalizations, especially among individuals 60 years and older. The objective of this study is to investigate associations between health care resource utilization in arthritis patients with and without concomitant anemia in a secondary care setting in France.

Methods: This retrospective cohort study utilized data on secondary care activity in 2001 from the Programme de Médicalisation des Systèmes d'Information database.

Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials.

Purpose: To evaluate psychometric properties of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire, a 47-item disease-specific instrument evaluating Health-Related Quality of Life (HRQL) in human immunodeficiency virus (HIV)-infected patients.

Methods: Treatment-experienced HIV-infected patients from two clinical programmes (N = 565; N = 1,096) completed the FAHI at Baseline and after 24 weeks of treatment. Psychometric properties of the FAHI were assessed in both trial populations, including minimal important differences (MIDs) calculations.

Measuring benefits and patients' satisfaction when glasses are not needed after cataract and presbyopia surgery: scoring and psychometric validation of the Freedom from Glasses Value Scale (FGVS).

Background: The purpose of this study was to reduce the number of items, create a scoring method and assess the psychometric properties of the Freedom from Glasses Value Scale (FGVS), which measures benefits of freedom from glasses perceived by cataract and presbyopic patients after multifocal intraocular lens (IOL) surgery.

Methods: The 21-item FGVS, developed simultaneously in French and Spanish, was administered by phone during an observational study to 152 French and 152 Spanish patients who had undergone cataract or presbyopia surgery at least 1 year before the study. Reduction of items and creation of the scoring method employed statistical methods (principal component analysis, multitrait analysis) and content analysis.

Effects of etravirine versus placebo on health-related quality of life in treatment-experienced HIV patients as measured by the functional assessment of human immunodeficiency virus infection (FAHI) questionnaire in the DUET trials.

Purpose: To study the effects of etravirine versus placebo on the health-related quality of life (HRQL) of HIV-infected patients.

Method: HRQL of HIV-infected patients was measured using the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire in two identically designed phase III clinical trials investigating efficacy and safety of etravirine as part of highly active antiretroviral therapy. Pooled analyses of covariance, adjusted for treatment group, baseline FAHI score, CD4 cell count, viral load, and enfuvirtide use helped investigate changes in FAHI scores between baseline and Week 24 in etravirine-treated (n = 599) and placebo-treated (n = 604) subjects.

Perception and acceptance of intradermal influenza vaccination: Patient reported outcomes from phase 3 clinical trials.

An intradermal trivalent inactivated influenza vaccine administered using a microinjection system has received European marketing authorization from the European Medicine Agency. We assessed clinical trial subjects' perception of injection site reactions (ISRs) and whether ISRs affected overall acceptability of vaccination and willingness to be vaccinated in the future. A validated, self-administered, patient reported outcome questionnaire was completed 21 days after intradermal or intramuscular vaccination by elderly and non-elderly adult participants in two European randomized, controlled, open-label phase 3 trials.

Scoring and psychometric properties of the Eye-Drop Satisfaction Questionnaire (EDSQ), an instrument to assess satisfaction and compliance with glaucoma treatment.

Background: The objective of this study was to ascertain the scoring and assess the psychometric properties of the Eye-Drop Satisfaction Questionnaire (EDSQ), a 43-item Patient-Reported Outcome instrument developed to assess patients' satisfaction and compliance with glaucoma treatment.

Methods: The EDSQ was administered during an observational, retrospective study to 184 French patients treated for glaucoma. The hypothesized structure, including six dimensions (patient-clinician relationship; patient experience; patient-treatment interaction; apprehension; patient knowledge; travel), was tested by assessing the internal consistency reliability (Cronbach's alpha) and construct-related validity (item convergent and discriminant validity).

Application of the disease-specific Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) questionnaire in a general population: results from a French panel study.

Objectives: To assess the psychometric properties of the disease-specific Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA) questionnaire in a general population, and collect French normative data.

Methods: A postal survey was conducted on 2900 adult panelists representative of the French population. The participants were asked to complete a questionnaire including the QoL-AGHDA and an evaluation of their overall health status (OHS).

Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients.

Background: Multinational clinical trials commonly include different language versions of patient-reported outcomes (PRO) instruments without considering the question of their cross-cultural validity. The inclusion of a PRO instrument, the Adult AIDS Clinical Trial Group Symptom Distress Module (SDM), in an multinational clinical trial in HIV-1 antiretroviral-naive patients offered an opportunity to explore the methods to assess cross-cultural validity of PRO instruments in the context of clinical trials.

Purpose: To assess the cross-cultural validity of the SDM across seven cultural groups in the setting of a multinational HIV clinical trial.

Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire.

Background: Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR).

Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial.

Background: Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available.