Catherine Acquadro

Catherine Acquadro
ICON Plc

MD

About

179
Publications
31,666
Reads
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4,940
Citations
Citations since 2017
22 Research Items
1680 Citations
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2017201820192020202120222023050100150200250300
2017201820192020202120222023050100150200250300
Introduction
With over 20 years of experience in PRO evaluation, Catherine Acquadro provides medical advice at Mapi Research Trust. She joined Mapi in 1991 to create the QOL Newsletter. In 1992, she was coordinating the IQOLA Project and was involved in the early development of linguistic validations. From 1997 to 2007, she was the coordinator of the ERIQA Group. From 2001 to 2006, she was co-convenor of the Cochrane Collaboration PRO Methods Group. Her medical thesis was about Inipi (Lakota sweat lodge).
Additional affiliations
January 1995 - present
Mapi Research Trust
Mapi Research Trust
Position
  • Consultant
April 1991 - present
Mapi
Position
  • Medical Professional

Publications

Publications (179)
Article
Full-text available
Background: Over the past 30 years, the healthcare industry has increasingly turned its attention to rare diseases. Regulators have emphasized the need for clinical research in this area to be patient-centered. However, there is a lack of evidence concerning whether this need is actually met. In this paper, we aim to address this gap. Methods: F...
Article
Full-text available
Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcateg...
Article
Background: Several instruments are widely used for assessing dependence, craving, withdrawal symptoms, and reinforcing effects in users of tobacco- and nicotine-containing products (TNP), including the Fagerström Test for Nicotine Dependence (FTND), Questionnaire of Smoking Urges, original (QSU) and brief (QSU-b) versions; Minnesota Nicotine Withd...
Article
Objective: Although several scores exist to assess psoriasis severity, most have marked limitations that rule out their use in routine clinical practice. A new score, the Simplified Psoriasis Index (SPI), has recently been developed and validated in adults in Britain for such use. It has separate components for current severity (SPI-s), psychosoci...
Article
Full-text available
The phenylketonuria - quality of life (PKU-QOL) questionnaire was developed to assess the impact of phenylketonuria (PKU) and its treatment on the health-related quality of life (HRQL) of patients and their caregivers. Available in four versions (child, adolescent, adult and parent), it was developed and validated in eight countries. The objective...
Article
Full-text available
INTRODUCTION Objective clinical assessments should include patient-reported outcome measures. VascuQoL is an established disease specific questionnaire assessing quality of life in patients with peripheral artery disease (PAD). Quality of life questionnaires require geographical localization and validation. OBJECTIVE The goal of this study was to v...
Article
Full-text available
Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to...
Article
Full-text available
Abstract With the growth of patient-reported outcome (PRO) measurement, questions arise regarding how copyright protection applies to PRO instruments in general and to their translations in particular. The main objectives of this reflection paper are: 1) to help authors of PRO instruments understand basic rules of intellectual property and copyrigh...
Article
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Background Patients with chronic conditions are required to take long-term treatments for their disease itself or to prevent any potential health risks. Measuring patient acceptance of their medication should help to better understand and predict patients’ behavior toward treatment. This study aimed to describe the level of patient acceptance towar...
Article
Full-text available
While it is important to treat symptoms, there is growing recognition that in order to help people with mental health problems lead meaningful and fulfilling lives, it is crucial to capture the impact of their conditions on wider aspects of their social lives. We constructed two versions of the Recovering Quality of Life (ReQoL) measure—ReQoL-10 an...
Conference Paper
Background The disability assessment component of the Health Assessment Questionnaire, the HAQ-DI,¹ developed in US English, assesses a patient‘s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Ther...
Article
Full-text available
This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-S...
Article
Full-text available
Background Phenylketonuria (PKU) is a rare genetic disorder caused by a defect in the metabolism of phenylalanine (PHE) resulting in elevated blood and brain PHE levels, and leading to cognitive, emotional, and psychosocial problems. The phenylketonuria – quality of life (PKU-QOL) questionnaire was the first self-administered disease-specific instr...
Conference Paper
Background: The BHQ is a new health-related quality of life questionnaire, developed in British English for patients with bronchiectasis. Objectives: The objectives of this study were to present the results of the translation of the BHQ into 11 languages, i.e., 9 Indo-European (Dutch for Belgium and The Netherlands, English for the USA, French for...
Article
Objectives: The objectives of this study were to finalize, develop the scoring, and explore the psychometric properties of the ACCEPTance by the Patients of their Treatment (ACCEPT©) questionnaire, as well as to provide the first elements for its interpretation and guidance for its future use. Methods: ACCEPT© was finalized according to referenc...
Article
Full-text available
Patient-reported outcomes (PROs) are any outcome evaluated directly by the patient himself and based on the patient's perception of a disease and its treatment(s). PROs are direct outcome measures that can be used as clinical meaningful endpoints to characterize treatment benefit. They provide unique and important information about the effect of tr...
Article
Full-text available
The Schizophrenia Caregiver Questionnaire (SCQ) was developed to provide a comprehensive view of caregivers' subjective experiences of the impacts of caring for someone with schizophrenia. The Caregiver Global Impression (CaGI) scales were designed to assess their perception of the severity of the schizophrenia symptoms, of change in schizophrenia...
Article
OBJECTIVES. 1) To identify orphan medicines indicated for lymphoproliferative disorders approved by the European Medicines Agency (EMA); (2) To identify medicines for which a PRO evaluation was performed; (3) To list those with a PRO labeling claim, and (4) To identify reasons for not granting a PRO claim. METHODS. The search was performed on the E...
Article
OBJECTIVES. According to the Federal, Food, Drug and Cosmetic Act (FD&C Act), prescription drug promotion must not be false or misleading, have fair balance, be consistent with the approved product labeling, and only include claims substantiated by adequate and well-controlled clinical studies. The Office of Prescription Drug Promotion (OPDP), form...
Article
OBJECTIVES. Feeling “lively” or “full of pep” are common items used in PRO measures. The Profile of Mood States (POMS) identifies and assesses six fluctuating mood or affective states: 1) Tension-Anxiety, 2) Vigour-Activity, 3) Depression-Dejection, 4) Fatigue-Inertia, 5) Anger-Hostility, and 6) Confusion-Bewilderment. “Lively” (item 7) and “full o...
Article
OBJECTIVES. Electronic Clinical Outcome Assessments (eCOAs) are increasingly being used in clinical trials and their use is encouraged by regulatory authorities. Licensing is a key issue for their appropriate utilization. The objective of this abstract is to make recommendations about eCOA licensing using lessons learned from the COA translation li...
Article
Objective. In 2002, PROQOLID was launched to provide an overview of existing PRO instruments. In October 2011, the term Clinical Outcome Assessments (COAs) was introduced to better reflect the importance of the source of information in measurements: patients (PROs), clinicians (ClinROs), and observers (ObsROs). In May 2013, a new category was added...
Article
Full-text available
DEVELOPMENT OF E-VERSIONS OF THE ASTHMA QUALITY OF LIFE QUESTIONNAIRE (STANDARDISED) [AQLQ(S)] IN 20 LANGUAGES FOR USE ON HANDHELD DEVICES Elizabeth F Juniper1, Géraldine Grataloup2, Catherine Acquadro3 1Dept. Clinical Epidemiology and Biostatistics, McMaster University, Canada. 2Mapi, Linguistic Validation, Lyon, France 3Mapi Research Trust, Lyon...
Article
Objectives. In July 2012, the European Medicines Agency (EMA) established the Pharmacovigilance and Risk Assessment Committee (PRAC). The PRAC recommends and advises on any questions of pharmacovigilance activities related to a medicine for human use and on risk management systems. This study describes PRAC’s activities to date. Methods. Meeting mi...
Article
Objectives. The Behavior Rating Inventory of Executive Function (BRIEF) is the most widely used questionnaire developed for parents and teachers of school-age children to assess executive function behaviors of children and adolescents in the school and home environments. It is composed of 86 items organized in eight clinical scales (Inhibit, Shift,...
Article
Objectives. (1) To identify products indicated for the treatment of rare diseases approved through the centralized procedure in Europe; and (2) To list the products which obtained a PRO labeling claim. Methods. The search was performed on the European Medicines Agency (EMA) website (11/12/2013). The European public assessment reports (EPARs) were...
Article
Objectives. The objective of this research was to review the role of patient-reported outcomes (PROs) in drug approval and labeling of products authorized for the treatment of cystic fibrosis (CF) in Europe and in the USA. Methods. This research was conducted through a systematic manual review of CF specific regulatory guidelines and product labeli...
Article
Full-text available
Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients' experiences with their condition and/or...
Article
Full-text available
The purpose of the study is to evaluate the extent to which a retrospectively conducted translatability assessment (TA) could identify the items previously singled out during the validation study as having poor content validity or poor measurement performance. This study was performed with the intent of supporting evidence of the usefulness of TA e...
Article
Objectives. (1) To identify products indicated for treatment of non-small-cell lung carcinoma (NSCLC) approved with a PRO labeling claim in Europe and the USA; and (2) to list the differences found in Europe vs. the USA in terms of products and labeling. Methods. The search was performed on the Food and Drug Administration (FDA) and European Medici...
Article
Objectives. (1) To identify antidiabetic products approved with a Patient-Reported Outcome (PRO) labeling claim in Europe and the USA; and (2) to list the differences found in Europe vs. the USA in terms of products and labeling. Methods. The search was performed on the FDA- and EMA-approved medicinal product labels (from 1995 to August 2012 inclus...