Patient input and involvement in health and medical care and research

Five case studies at national level

Input from patients and the public, and their influence over health and medical care as well as health-related research has been an increasing focus in recent years, and one trend could be said to be a shift from supply-oriented services to services with a clearer customer and individual perspective.

One driving factor in this context is the huge advances within bio­medical research, which have resulted in a much wider range and more complex options, with decisions often needing to be made in consultation between patients, relatives and care personnel. An increased focus on public health and preventative measures, where commitment and awareness from patients and the general public is key, is also significant in the effort to achieve increased patient involvement. Other reasons presented as impor­tant for largely viewing patients as resources rather than as passive recipients of care include the increased need for resource efficiency in care, the aim to achieve better quality of care, and the need for the patient’s perspective when identifying research issues and for research methods. A further argument for increased patient involvement that sometimes is presented is the need for greater transparency, and thereby increased public confidence in the care and research systems. Taken together, these factors contribute, in many countries, to the pressure for increased involvement of patients in processes, decision-taking and/or in advisory functions.

The trend towards greater patient involvement is also largely about strength­ening the rights of patients and their relatives, as well as their possibilities to influence their own care, the care system and research. Both the British National Institute for Health Research (NIHR) and the Patient Centered Outcomes Research Institute (PCORI) in the United States ensure that patients are part of the selection committees and processes. This type of partici­pation is seen as key, not least to emphasize research issues that are important to patients, to improve research methods and to strengthen the recruitment of individuals for clinical studies. The NIHR also requires that a plan be in place for patient involvement in all research projects that are funded.

The analysis indicates that it is within the translational, clinical and care research areas that the patient perspective is regarded as particular­ly important. This is due to the fact that these areas are close to the patients’ and their families’ realities and needs. Within pre­clinical biomedical research, patient involvement is less common and often more indirect. However, examples can be found in the form of advisory groups, consultation processes and similar. A challenge that sometimes is mentioned is the difficulties in educating patients and the general public about the significance of basic research.

This report discusses trends in the USA, England, the Netherlands, Denmark and Japan. The focus is on patient input and influence; in other words, not on ‘passive’ patient partici­pation in research or care activities. Among these countries, the USA and England stand out as being those who have progressed the furthest. The heterogeneous USA often shows a relatively distinct customer perspective in which patient influence and involvement is seen as self-evident. In some cases patient representatives are even employed on a commer­cial basis. The PCORI, a result of the President’s healthcare reform, is perhaps the most important example of patient influence on research priorities at the federal level. The rapid progress in recent years in England has largely been driven by the need to: increase confi­dence in the care system, increase resource efficiency, increase the quality of care, as well as a desire for greater integration of health-related research into care activities. The Netherlands and Denmark occupy an intermediate position, with interesting initiatives at various levels, and a development inspired by other countries such as England and Canada. In Japan, patient input is not particularly well developed, partly due to a low confidence in patient-reported data, a lack of standards for cooperation, splintered and small-size patient organisations plus insufficient support at the political level. However, several initiatives for patient involvement are in place also in Japan, partly at the regulatory level, but in order for patient participation in the country to make any serious headway, a national strategy with explicit political support is probably required. In several of the countries, a greater evidence base is being sought regarding how patient input influences research and care. Actors in Denmark, England and the Netherlands, amongst other countries, highlight the importance of gathering experiences and good examples of patient involvement, not least in order to educate healthcare professionals and researchers.

Patient involvement is an extremely heterogeneous area and can take many different forms. Involvement can, for instance, occur through panels for research priorities, as support in the formu­lation of research methods, in advisory groups and committees for regulatory authorities, in health-oriented charity organisations, at hospitals or in local environments where patients can participate in inspections of care environments. In other words, the mechanisms for patient participation and influences vary considerably, and in the Nether­lands there is discussion of a spectrum of patient involvement – from being “informed” to the patient/patients having decision rights in the relevant issue. Patient involvement may involve direct representation by individuals, representation via patient associations, or occur in other ways.

There are a number of significant players for patient involvement, and the political level is naturally of major importance, particularly in countries with publicly funded care. The state and government can act as drivers of change, for example by defining the desired focus, developing strategies, incorporating issues of patient input in commissions, changing organisation and setting aside funds. This is, amongst other things, a clear lesson from the development in the UK where the creation of NIHR (1996) as part of the care system was particularly important for the integration between clinical research, care and patient involvement. It is also central that the relevant authorities problematize issues of patient participation. It is indisputable that such influences can contribute positively to both healthcare and research, but the issues are also complex – for example, it is not obvious that bio­medical basic research always benefits by a strong direct influence from patients. Also, patient involvement is clearly just one part of a balanced equation, together with influences from care staff, researchers and other stakeholders.

Public research funding organizations are clearly important for patient involvement in research by developing requirement specifications, processes and forms of collaboration (the latter together with care providers, research organizations etc.). Integration of the patients’ perspective can be achieved by, for example, incorporating patients in groups that define research issues, in assessment panels and in processes for research design, in adviso­ry groups and consultation proce­dures. Research funders, higher education institu­tions and care providers can contribute to an increased cooperation with patients by requiring that they are included in decisions and processes in a more active way. For patient participation in care and research, a lesson from several countries is that care providers need to include patient participation processes into operations, as well as setting aside resources and time for this.

The above-mentioned patient associations are often crucial for promoting the patients’ interests. The lack of strong patient associations is a factor that in Japan is seen as worry­ing for patient input, and there are also examples of when patient organisations have been in direct competition with each other. In addition, research-funding charity organisations like Cancer Research UK (CRUK) are also important, and sometimes use patient input in their operations. Such organisations – together with patient organisations – also contribute to the education of patients and care staff on the subject of participation.

It is not uncommon to see a certain level of scepticism regarding patient involvement and some challenges have been identified, for example concerning representation and impacts on regulatory processes. However, a number of actors point out that a too limited level of patient involvement means lost opportunities for adapted and efficient care, and that the patients’ perspective on research is particularly important in clinical and care research. Patient participation may involve shifting boundaries, for example, in respect of acceptable side-effects, and only patients participating in research can talk about how their involve­ment was experienced.

Some researchers doubt the benefits of patient involvement in research, which is linked to the belief that patient participation is time-consuming and resource-intensive, and that patients generally don’t have the scientific knowledge required for many research questions. However, experience from England, the USA and elsewhere shows that many researchers who had previously been sceptical found patient input to be positive and rewarding. In order to stimulate increased patient involvement where it has the greatest positive effects, it is key to gather evidence and experiences, as well as to develop tools for participation. The British organisation INVOLVE is of particular interest here, and has developed tools and gathered evidence on patient involvement in research.

Teaching and information efforts aimed at patients, researchers and care staff alike are considered to be very significant, not least to highlight the advantages of patient involve­ment, creating initiatives for the integration of patients’ perspectives, and to catalyse long-term changes in attitude. In Denmark, and some other countries, it has been proposed that issues of patient participation should be included in care training to a greater extent, and also that such issues should be included in instructions to care personnel. To spread know­ledge to wider target audiences, and for example, encourage increased patient participa­tion, different types of ambassadors with experience of patient involvement could be an interesting component.

As already mentioned, patient representation can be achieved in different ways, such as through individuals participating in different forums, or through the care of patient organisations. It is of course important to aim for a patient representation that is as repre­sentative as possible for the patient group in question. However, it is often the case that one particular group is over-represented, and it can be a challenge to bring about a truer representation. Also in this case, one method to improve the situation may be that indivi­duals, who have been or are engaged, act as ambassadors to stimulate a broader patient participation. This, together with other campaigns, may also contribute to more people becoming interested in clinical studies.

All the countries studied present interesting initiatives for patient involvement in various forms. At the same time, the situation is not optimal in any case and patient participation can be characterised generally as an area under development. In this project we have not undertaken any detailed analysis regarding the situation concerning patient involvement in Sweden. There are however a number of interesting initiatives with regard to patient involve­ment in research, dissemination of information, quality registries, patient safety, authorities’ advisory bodies, care services etc. Nevertheless, the impression is that some of the countries examined are further ahead in this field. Unfortunately, few or no evaluations of specific initiatives have been identi­fied in any of the countries studied, which make the situation difficult to assess.

From all of the countries studied, there are lessons to be learned. Sweden should be able to learn both from and with others, and an exchange of information on best practices and obstacles is important. One observation is that patient involvement in both care and re­search may be strengthened by having a clear Champion (principal and/or spokes­person/­organisation) with a strong mandate to implement actions. Another lesson is that research funders who are linked to the care system, and who sets clear standards for patient involvement, seem to be a success factor. Clear political expressions of will, earmarked funds and strategies for patient involvement in care and research are also important.

Patient input and involvement in health and medical care and research Five case studies at national level

Serial number: PM 2015:07

Reference number: 2014/260

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