Bayer Biological Products Release: New Adult Hemophilia Quality Of Life Tool Now Available For Hemophilia Community
RESEARCH TRIANGLE PARK, N.C., Oct. 20 /PRNewswire-FirstCall/ -- Data validating the first and only available health-related quality of life (HRQL) instrument for adults with hemophilia were presented today at the World Federation of Hemophilia Congress in Bangkok, Thailand. Bayer Biological Products (BP) has supported the development and validation of Haemo-QoL-A in an effort to measure, in a meaningful way, health-related quality of life (HRQL) information for adults living with hemophilia. The new instrument will allow more complete evaluations of the effects of hemophilia care on people's lives, assisting clinicians, reimbursement agencies, and governments in their decisions regarding treatment options. Haemo-QoL-A builds on an earlier Bayer initiative to develop an international pediatric hemophilia- specific quality of life instrument, known as Haemo-QoL.
Results from this clinical study confirmed Haemo-QoL-A's internal consistency, reliability, reproducibility, and validity. Study findings also supported establishment of six subscales: physical functioning, role functioning, worry; consequences of bleeding, positive affect, and treatment concerns.
Haemo-QoL-A was able to detect differences among these subscales based on severity of disease, and presence of HIV. A difference also was detected in the physical functioning subscale when comparing patients utilizing on-demand vs. prophylaxis treatment regimens. Additionally, a symptom scale was developed as part of the project to measure the clinical severity of the disease from the patient's perspective.
"These results indicate this disease-specific HRQL instrument is a reliable and valid measure of the patient perspective on hemophilia-related quality of life," said Anne Rentz MSPH, research scientist at MEDTAP International, whose team collaborated with Bayer scientists and an international advisory committee of experts in hemophilia and outcomes research. "We are looking forward to additional research to confirm responsiveness, and to define what level of changes in patient HRQL is clinically meaningful."
Data were collected from 221 patients, aged 18 to 82, in the United States, Canada, Germany, and Spain with an instrument that utilized a six- point Likert-type scale. Questionnaire items were derived from the clinical literature, clinical input, and patient and treater focus groups in North America and Europe. Cultural adaptations ensured consistency of meaning in three languages and four cultures. The final instrument, based on the results of this study, contains 41 questions comprising the six subscales.
Responding to requests from the hemophilia community for a disease- specific instrument to effectively measure HRQL, Bayer BP Clinical Development has invested more than $600,000 to develop and validate Haemo-QoL-A. "Bayer's initiative in developing and validatingHaemo-QoL-A adds a significant new assessment tool to measure effects of treatment for hemophilia that goes beyond the traditional ways of measuring efficacy and safety," said Dr. Eduard Gorina, Global Clinical Projects Leader for Kogenate(R). "We now have one global instrument that can be used in international clinical trials, as well as in the clinical setting to assess outcomes from regimens such as primary prophylaxis or immune tolerance induction. Haemo-QoL-A also can be used to assess quality of care rendered in a particular hemophilia population, at a particular institution, or in a particular country. Such an instrument has been greatly needed by the hemophilia community for many years."
Michael Mathews, vice president, Global Strategic Marketing, Kogenate(R), commented on the importance of this work. "Haemo-QoL-A is the first validated instrument to measure the quality of life in adults with hemophilia. Responding to an unmet need of the hemophilia community, Bayer BP is the global leader in developing these instruments in adults and children so that treaters, institutions, reimbursement agencies, and governments can more fully evaluate the lives of persons with hemophilia. Among other uses, these instruments will now allow us, as a community, to assess and make funding decisions regarding treatment options that help people with hemophilia live more closely the lives they choose."
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Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.
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