Previous Research Projects
This research program in the field of Health-Related Quality of Life of elderly subjects living in nursing homes for dependent elderly people was initiated in 1999. The purpose of this program was to define guidelines for the evaluation and improvement of HRQoL of the elderly living in specialised institutions. A Health-Related Quality of Life Colloquium in Geriatrics was organized in Avignon, France (September 15, 2001) in which key players of the elderly institutions exchanged experiences and points of view and discussed the main directions of HRQoL research for this population.
In order to give a global satisfaction for dependent people who have lost, in most cases, their pleasure of living when they entered an institution, a consistent and rational program has to be developed to assess the well-being and HRQoL of institutionalized elderly people in France.
Survey of health care professionals’ views and attitudes
A survey (mail and e-mail) was conducted to assess how much PRO instruments are being used in clinical practice, with the purpose of identifying barriers and benefits to their utilization, as well as resources and solutions to overcome such barriers.
Outcomes are that physicians and nurses agree that health status questionnaires may be useful to facilitate the contact with the patients and may help monitoring a patient’s therapy. Physicians’ only regret is the time-consuming burden of PRO assessment under certain circumstances. However, nurses believe PROs help communicate and share a patient’s health status with other health care professionals.
Gene Therapy and Patient-Reported Outcomes
This research program, conducted in 2002-2003, aimed at evaluating the use of Patient-Reported Outcomes in Gene Therapy clinical trials and, identifying the PRO instruments used in such trials.
Since the ’80s, the number of clinical trials conducted using gene therapy techniques is up to 600 (66% in phase I and 2% in phase II/III), with the majority in the USA (80%) and 65% of these on cancer. The rate of successful gene therapy clinical trials is still reduced and the effects of this approach, as well as the real consequences on research clinical trials are still unknown.
As gene therapy clinical trials do not present great differences from general clinical trials, the existing generic or disease specific instruments should be appropriate to assess PRO in gene therapy clinical trials.
Results showed that although publications followed an exponential growth from the ’70s up to September 2002, only few articles mention gene therapy studies using PRO questionnaires: three protocols, one pilot study and two clinical trials. As gene therapy is a relatively new techinque, the lack of published references on successful clinical trials makes, for the time being, the evidence of PRO assessment in gene therapy a premature issue.
The International Diabetes Quality of Life and Economics Study (IDQOLES)
Mapi Research Trust conducted a survey of the diabetes literature and over 35 general and diabetes-specific HRQoL instruments. The main findings were discussed with an international panel of clinical experts. A consensus statement on the key considerations in HRQoL assessment in Type I and Type II diabetes mellitus was developed, including practical recommendations on the use of existing HRQoL instruments. A detailed final report was prepared for sponsors and prospective users.
Handicap International Research Project
Mapi Research Trust and Handicap International have been collaborating on various research projects for the evaluation of the health-related quality of life (HRQoL) of handicapped children over the past seven years. Two main projects were developed during this collaboration.
The development of a specific HRQoL questionnaire for adolescents and children who are victims of antipersonnel landmines
In collaboration with Drs Alice Dazord and Sabine Manificat from INSERM (Institut National de la Santé et de la Recherche Médicale – French National Institute for Health and Medical Research), a specific quality of life questionnaire was developed and adapted for use in former Yugoslavia for children who are victims of antipersonnel landmines. Evaluation of a school integration plan for handicapped children.
This study, carried out in France (2001/2002), aimed at assessing the school integration of handicapped children by evaluating their quality of life, specifically when this integration is accompanied by an auxiliary staff member. The children, their parents, and the teachers were interviewed using specific QoL questionnaires.