Biomedical subjects

Catherine Acquadro

Publications and source records attributed to Catherine Acquadro.

4 recordsLinked to original sources

PubMed2006

Translating overactive bladder questionnaires in 14 languages.

OBJECTIVES: Overactive bladder (OAB) affects millions of people worldwide. Identifying patients and measuring OAB's impact on symptom severity and patients' health-related quality-of-life is necessary to ensure proper treatment and facilitate communication among patients, clinicians, and caregivers. To accomplish this, the Overactive Bladder questionnaire (OAB-q) and its subsets instruments, the OAB-q Short-Form and the OAB-V8, were developed in U.S. English. To measure the impact of OAB cross-culturally, we performed the linguistic validation of these instruments in Danish, English (Canada), French (Canada and France), Italian (Switzerland), German (Switzerland), Korean, Norwegian, Polish, Portuguese (Brazil), Romanian, Swedish, and Turkish. The linguistic validation was conducted following a rigorous method to ensure conceptual equivalence between the original and its translations. METHODS: In each country, a specialist monitored the process, which included six steps: (1) two forward translations; (2) comparison and reconciliation of the translations; (3) back-translation; (4) comparison of the source and back-translation; (5) review by one urologist or gynecologist; and (6) a comprehension test using patients. RESULTS: The translation of symptom-related adjectives such as "uncomfortable," "sudden," "accidental," "uncontrollable" proved challenging. The subtle differences in the meaning of symptomatic items increased the difficulties to find equivalents. Issues regarding the appropriateness of certain concepts and idiomatic terms emerged during cognitive debriefing. The terms "urge," "desire," "urination," "commute," "drowsy," and "escape routes" were not retained literally and were replaced by colloquial expressions. CONCLUSIONS: The 14 versions of the OAB-q, OAB-q Short-Form, and OAB-V8 were successfully validated linguistically to facilitate data collection cross-culturally and the international comparison of symptom bother and health-related quality of life in patients with OAB.

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PubMed2005

Patient-reported outcome and quality of life instruments database (PROQOLID): frequently asked questions.

The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database), the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet.PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at http://www.proqolid.org. The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.). The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually.Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database.

Adult↗

PubMed2003

Quality of life in multiple sclerosis: translation in French Canadian of the MSQoL-54.

BACKGROUND: Multiple Sclerosis (MS) is a neurodegenerative disease which runs its course for the remainder of the patient's life frequently causing disability of varying degrees. Negative effects on Health-related quality of life (HRQOL) are well documented and a subject of clinical study. The Multiple Sclerosis QOL 54 (MSQOL-54) questionnaire was developed to measure HRQOL in patients with MS. It is composed of 54 items, and is a combination of the SF-36 and 18 disease-specific items. OBJECTIVE: The objective of this project was to translate the MSQOL-54 into French Canadian, and to make it available to the Canadian scientific community for clinical research and clinical practice. METHODS: Across all French speaking regions, there are occurrences of variation. They include the pronunciation, sentence structure, and the lexicon, where the differences are most marked. For this reason, it was decided to translate the US original MSQOL-54 into French Canadian instead of adapting the existing French version. The SF-36 has been previously validated and published in French Canadian, therefore the translation work was performed solely on the 18 MS specific items. The translation followed an internationally accepted methodology into 3 steps: forward translation, backward translation, and patients' cognitive debriefing. RESULTS: Instructions and Items 38, 43, 45 and 49 were the most debated. Problematic issues mainly resided in the field of semantics. Patients' testing (n = 5) did not reveal conceptual problems. The questionnaire was well accepted, with an average time for completion of 19 minutes. CONCLUSION: The French Canadian MSQOL-54 is now available to the Canadian scientific community and will be a useful tool for health-care providers to assess HRQOL of patients with MS as a routine part of clinical practice. The next step in the cultural adaptation of the MSQOL-54 in French Canadian will be the evaluation of its psychometric properties.

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PubMedDate not supplied

Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001.

BACKGROUND: The extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group. METHODS: Working with a member of the US Food and Drug Administration (FDA), four key issues requiring clarification were identified: how PROs are defined and put into operation for research purposes; the added value of PROs in the drug review and evaluation process; selected questions related to the PRO measurement and research methodology; and the interest and demand for PRO information by decision makers. On February 15, 2001, all members of the PRO Harmonization Group attended a meeting in Rockville, Maryland, to discuss these four issues further, and on February 16, 2001, a formal presentation was made to representatives from various departments and reviewing divisions of the FDA. These presentations are summarized in this report. RESULTS: All participants agreed that PROs are important for understanding the impact of treatment on patient functioning and well-being. They also stressed the need to communicate PRO information to key decision makers, including regulatory agencies, clinicians, patients and their families, and payers. Finally, the meeting resulted in plans for continuing the dialogue on PRO measurement and interpretation. SUMMARY: The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.

Advisory Committees↗