Portal de Periódicos da CAPES

PartecipaSalute, an Italian project to involve lay people, patients’ associations and scientific‐medical representatives in the health debate

2007; Wiley; Volume: 10; Issue: 2 Linguagem: Inglês

10.1111/j.1369-7625.2007.00444.x

1369-7625

Paola Mosconi, Cinzia Colombo, Roberto Satolli, Alessandro Liberati,

Patient-Provider Communication in Healthcare

Consumers and patients are increasingly demanding an active role in health-care access and quality, and associations and pressure groups are interacting directly with national health services and with researchers, doctors and scientific or professional societies.1–4 This article describes an Italian project aimed at creating a partnership among lay people, patients' associations and the scientific/medical community. In Italy, consumers are generally passive recipients of health information from various sources: doctors and health-care professionals, the health system, media, web and parents or peers. This information is often contradictory and non-evidence-based, leading to misunderstandings and confusion. The Di Bella case, the outcry about an alleged new cure for autism, and the increasing number of health awareness campaigns are all clear examples of the lack of an evidence-based culture among Italian consumers' and patients' associations (see Box 1). To cope with this, lay people must learn how to develop their scientific literacy, becoming familiar with clinical and epidemiological research and acquiring instruments to critically appraise and understand health information. Although these activities are in their infancy in Italy, there are some good examples of empowerment efforts (see Box 2). The number of consumer' and patients' associations is steadily growing: a survey in 2003 by the Italian National Statistical Institute5 identified about 21 000 non-profit organizations across the country, a 50% increase compared with a 1997 survey. These organizations cover a wide spectrum of activities corresponding to a broad definition of health, including psycho-social support and direct services, and the findings confirm the deeply rooted Italian tradition of mutual aid in the health-care field. In the last 10 years, consumers' and patients' associations have extended their interventions from self-help and care to advocacy, including important efforts to convey more information to the public, and organize awareness raising campaigns. In common with other European and American countries, patients' federations are emerging in Italy to boost the impact of individual organizations. Some now lobby at local, national and international level, drawing health authorities' attention to the need for improvement in a given area.6–10 This has led to the introduction of patients' charters and the mandatory presence of lay representatives on local ethics committees, yet the medical and scientific community still fails to see patients and consumer groups as partners with 'equal rights and weight'. Consumers, patients and their associations, on the other hand, often lack critical appraisal skills and they struggle to make their voice heard in the health-care debate. There are also very few opportunities for the medical community and patients' associations with meet and work together. Experiences of this kind are not collected and shared, so they are unlikely to be used in the development of new projects. In planning a project involving consumers' and patients' associations with the scientific and medical community, we reviewed consumer involvement initiatives in countries such as United States, United Kingdom and Australia (http://www.cochrane.org/consumers/homepage.htm, accessed on 27 October 2006).11 We were particularly inspired by: (i) the UK-based CASP initiative (Critical Appraisal Skills Programme) that offers courses for health-care professionals, for trainers and for consumers;12 (ii) the US-based LEAD initiative where a course developed by the National Breast Cancer Coalition empowers breast cancer activists to influence research and public policy13 and by courses and initiatives of the American Association for Cancer Research (http://www.aacr.org/home/survivors-advocates/about-the-survivor-and-patient-advocacy-program.aspx). We have also learned from the interesting James Lind Alliance in the United Kingdom, a coalition of patients' associations, researchers and clinicians working together to identify areas of uncertainty in medicine and define priorities for clinical research.14 The aim of this article was to present PartecipaSalute ('Participate in Health Care') a pilot project initiated at the end of 2003 following some 'pilot experiences' (http://www.pnlg.it, accessed on 8 May 2006).15,16 The project – funded by a non-profit bank foundation ('Compagnia San Paolo') – aims at involving patients' associations and is co-ordinated by the Mario Negri Institute, in collaboration with the Italian Cochrane Centre and the medical journalism agency Zadig. A multidisciplinary Scientific Committee, composed of representatives of consumer/patients' associations, medical associations, media, researchers and experts advises all the project activities. The project's main aim was to foster a strategic alliance between patients' groups and professional societies, with the goal of promoting better health and shared decision-making. Throughout its different phases PartecipaSalute involved patients, associations and lay people. The overall goal was to create the cultural and methodological conditions essential to support and increase shared initiatives between consumer/patients associations and scientific community. The project focused on the following main three areas. Championing the role of consumer/patients' associations in the health-care debate through a fact-finding exercise to unearth relevant experiences. Empowering patients, by launching a website and organizing courses for patients' representatives and lay members of ethics committees. Organizing collaborative initiatives between consumers/patients and representatives of the scientific and medical community. A survey was carried out in 2004 with the collaboration of 10 patients' federations in the cancer, cardiovascular and nervous system fields together with associations with a long grassroots tradition (AIDS, breast cancer). Building upon previous experiences15,16 a working group developed a semi-structured interview. Topics covered included: structure and organization (i.e. type of activity, capacity, distribution of the centres); training courses, information, sources and attitudes to and beliefs about information sources. Presidents of patients' federations were contacted by telephone and asked to participate in a one hour and half interview. Two researchers (PM and CC) conducted the interviews and analysed the data for open questions by extracting the principal themes and messages. The second survey targeted the Italian federation of medical societies (FISM). It was designed to assess medical societies' attitudes towards patients' involvement in research and health care and to find out about projects conducted in partnership with patients' associations. A questionnaire was developed based on a review of relevant literature and the previous experiences of working group members. Topics included: characteristics of each society's structure and organization, number and type of collaborations with patients' associations and opinions about patients' involvement in projects. All 204 medical associations belonging to FISM were contacted by e-mail with a covering letter explaining the survey. Non-respondents were sent a reminder. The survey was concluded in summer 2006 having obtained responses from 73 medical associations. Based on experience at the Mario Negri Institute, the Italian Cochrane Centre and Zadig, a training course was developed for patients' associations and lay member of ethics committees entitled 'Decision-making about clinical research and health care'. The course covered some of the topics requested by patients' associations during our preliminary interviews and meetings, such as technical aspects of clinical research and potential roles of voluntary organizations. The course was seen as an opportunity for the different associations with exchange information and foster collaborations. The course commenced in October 2005 and offered – within a 6-month period – a total of 9 days packaged in six modules dealing with: ABC of clinical research. Topics considered: critical aspects of clinical research on coxib drugs, flu vaccine, oncological screening, new oncological drugs and air pollution; developed through five working groups with plenary discussion, one lecture, two formal lessons, two debates. Uncertainty and conflict of interests in medicine. Topics considered: antibiotics for sore throat, cardiovascular risk cards, Prostate-specific Antigen; developed through three working groups with plenary discussion, three formal lessons and two debates. Strategies of health information. Topics considered: Hormonal replacement therapy, stem cells, lung cancer early diagnosis; developed through three working groups with plenary discussion, one formal lesson and one debate. Patients' associations: credibility and strengths. Topics considered: history, role, credibility and experiences of patients associations; developed through one working groups with plenary discussion, three formal lessons and one debate. Lay people's participation in ethic committees. Topics considered: history, regulations, role of lay people, informed consent; developed through three working groups with plenary discussion, one formal lesson and one debate. Ways to influence the research agenda. Topics considered: literature reviews, websites, independent research; developed through three working groups with plenary discussion, two lectures, three formal lesson and one debate. The faculty was made up of researchers, doctors, medical journalists, associations' representatives and activists. Throughout the course, we sought participants' opinions using assessment forms, similar to those used by the Italian Ministry of Health in the Continuing Medical Education courses. A website was launched in September 2004 to empower patients, lay people, their associations and health-care professionals to take an active part in health-care decisions. In Italy, as in other industrialized countries, there are several health-related websites; simply using the word 'health' reported in the URL address we found 873 000 pages in Italian (Google, 5 December 2005), most of them 'passive vehicles', offering reports and news without any attempt to appraise the content or to enable readers to evaluate the information. The PartecipaSalute website is based on the concept of active participation offering selected articles on debated health topics. It is organized in three main sections, analysing the topics from different aspects showing all possible implications of the medical news (see Box 3). The website offer guides and tools to critically appraise health information, to play an active role in health-care decisions, to understand the payoffs and limits of clinical research, and to collaborate with the medical-scientific community. The website is updated weekly; it does not accept any advertisements, and every 15 days a newsletter is e-mailed. In 2005, during the preparation of the Consensus Conference 'People with severe cerebral injury consequences (GCLA) and their relatives: needs for rehabilitation and assistance during the post-hospital period', PartecipaSalute co-ordinated a working group on 'Family's quality of life'. This conference was promoted by the Italian Society of Physical Medicine and Rehabilitation (SIMFER) in collaboration with some patients/families' associations. Three working groups were organized to deal with different research issues: (i) epidemiological data on long-term outcomes of cerebral injuries and the available health-care services; (ii) social and health-care needs of people with severe cerebral injury and their relatives, according to the severity of their condition and kinds of outcomes; (iii) critical aspects of social rehabilitation after injury, focusing on independence, social life, family role and quality of life. The PartecipaSalute multidisciplinary working group – involving relatives of patients with severe brain injury consequences, health-care professionals and GCLA patients' associations' representatives – identified two specific areas of interest investigated by ad hoc surveys. The first focussed on associations contacting all 68 Italian GCLA associations; the second targeted 453 families. The aim of the working group was to collect information on GCLA patients' and families' needs, and suggestions for quality improvements interventions. Further details about the procedures and areas investigated are shown in Box 4. In the first two years of the project, PartecipaSalute accomplished worthwhile results in terms of: knowledge of the role of patients' associations in health debate and decision-making; dissemination of critical medical information gathering practical tools to evaluate medical information thought the website, and organizing training course and growth of a sound group of patients/lay people' representatives working together with scientists in collaborative initiatives (courses, consensus, research projects, etc.). The findings from the patients' federation survey are presented in Table 1. The structure and organization of participants varied considerably in terms of number of members (associations or enrolled members), representativeness in the boards and existence of a scientific committee. 'Conflict of interest' emerged as an unfamiliar concept to patients' associations and transparency of fund raising is rarely discussed.17 When associations or federations were asked whether they had a policy on transparency towards the sponsor, or a document on competing interests, only five stated they had an explicit statement on transparency and only two had one on competing interests. In general, associations and federations have two main targets: patients and their families and the public, to increase awareness on a specific illness or health problem. Activities such as supporting and caring for patients and families, disseminating information on the disease (epidemiological burden, prognosis, disability, etc.), and on interventions are their main interest. Advocacy, increasing disease awareness, circulation of information on particular topics and lobbying are examples of the second type of activity. Almost every organization provides information for patients or families. Lobbying has grown in recent years and is nowadays the main activity of some organizations. This stems from the associations aim to strengthen their influence by achieving benefits for all their members. The associations consider the scientific literature as an important source of information, but, as most of them lack critical appraisal skills, they rely on clinical experts to appraise the quality of information. Patients' associations rarely get involved in research process, such as defining priorities or developing clinical trial protocols. There are only few examples of active collaboration, mainly assembling questionnaires for surveys, conducting qualitative surveys among patients or reviewing informed consent forms. Rarely are patients' and consumers' associations involved in debates about guidelines, consensus documents or clinical research. Challenges to medical and scientific dominance remain limited, as patients' associations depend on medical expert opinions to decide what part to play in health debates and how to organize the association's initiatives. They do not yet know how to assess the validity of health-care information using standards of critical evaluation. Most of associations had collaboration arrangements with scientific societies. Medical associations responding to the second survey varied widely in terms of year of activity, number of members and geographical distributions. Remarkably, 36 medical societies (49% of the total) had organized collaborative initiatives with patients/consumers associations during the last three years*. Among these, the most frequent were the preparation of written material for patients, organization of conferences or workshops and health awareness campaigns. Moreover, eight medical societies had published documents on patients' rights, but patients or their associations were involved in only 50% of these initiatives. The training course was challenging to organize given the lack of previous experience to build upon. Twenty-three representatives of different patients' associations (17) and lay members of Ethics Committees (6), of the 24 enrolled, attended the whole course. Participants' feedback about the quality and usefulness of the course are reported in Table 2. It was generally well received, although technical issues, such as basic statistical concepts, were deemed too difficult to follow more time and practical exercises were required. Participants also asked for more time for discussion and for exchanging their own views. More information is available at http://www.partecipasalute.it/attivita/cms/?q=node/58. The PartecipaSalute website registered monthly between April and October 2006 a mean of 14 000 contacts and an average of over 200 people a month subscribed to the weekly newsletter. Furthermore, every month the website receives about 40 comments and at least one new patients' association asks to be included in the website database. To our satisfaction we recently found out that when searching through Italian Google engine the words 'Incertezza in medicina' ('Uncertainty in medicine') PartecipaSalute is the first website listed from about 303 000 pages reported (accessed on 30 October 2006). Finally, in respect of our goal to 'foster a strategic alliance between patients' groups and professional societies', the Consensus Conference working group has represented an encouraging example of effective collaboration between clinicians, scientists and patients' associations. Briefly, the results (http://www.partecipasalute.it/attivita/conferenza-001.php, accessed on 8 May 2006) of the two surveys showed organizational shortcomings in the post-hospital/post-acute period, difficulties in finding clear information about rehabilitation and future conditions of patients, practical, economic and bureaucratic difficulties faced by families and, finally, the heavy impact on family's quality of life. These data – as underlined by the Jury during the Consensus Conference held on June 2005 – provided a broader picture of the consequences of severe cerebral injury, focusing on the true needs of patient and family for rehabilitation and assistance during the post-hospital period. To our knowledge, this is the first project fully involving patient and public advocates and the scientific community in Italy. Participation in the surveys, satisfaction with the empowerment activities, the valuable results of collaborative initiatives and, finally, the large number of PartecipaSalute website visitors, show that interest in public involvement is increasing in Italy. Considering the debate about consumer involvement (http://www.cochrane.org/consumers/homepage.htm, accessed on 27 October 2006),4,14 and the monitoring of advocates about strength and impact (http://www.cancerworld.org/CancerWorld/moduleStaticPage.aspx?id=754&id_sito=5&id_stato=1, accessed on 27 October 2006)18 we believe that the PartecipaSalute project has in concrete terms evolved into a new voice in the Italian panorama. However, during the development of PartecipaSalute several critical issues have emerged: consumers' and patients' associations are still not fully accepted as active players by health professionals or clinicians; their experiences and collaboration are still under valued in health debate; the involvement of consumer and patients associations with health-care institutions is still unsatisfactory; consumer and patients' associations should promote participation in the health-care debate following the principles of 'Evidence-based advocacy',19 but this is still too rarely an integral part of the discussion within consumers' and patients' associations; opportunities for training members of consumers' and patients' associations should become routine in order to create groups equipped to participate in meetings, discussions or research projects; when members of patients' associations are involved in working groups, the extent to which they felt enabled to actively participate should be assessed and explicit criteria that consumer and patients' associations should meet, in order to qualify as truly representative and independent representative bodies, are urgently needed in order to increase the transparency of their inclusion in working groups. As recently discussed in a consensus study on principles of successful consumer involvement in research,11 these critical points represent a challenge for future initiatives in Italy. PartecipaSalute will now offer a second edition of its training course specifically targeted at consumers' and patients' associations and at non-medical members of ethics committees, and will continue to develop the website. During 2007 research activities will be concentrated on the development of the 'Spazio Parita', a patient-oriented clinical research group. Following the James Lind Alliance14 example, we are organizing a multidisciplinary working group that will build upon unanswered questions (drugs or health care) identified by consumers/patients and their associations together with the scientific community. In order to start this new activity readers of PartecipaSalute website, in particular consumer and patients' associations, are invited to answer two questions regarding the priority of clinical research, relatively to pathology of their interest. PartecipaSalute is supported by Compagnia di San Paolo, Torino, Italy.