When I became committed to becoming a consumer representative and patient advocate in 2000 my sights were not just on my own care in Australia but included an international perspective. I had been a pharmacology researcher and worked for a number of years in England, travelling to other countries as part of my work, before returning to Australia. I was also married to someone who grew up and was educated in another country and of a different culture.
Evidence in healthcare research
We are a relatively small population in Australia and research and healthcare evidence is international. A major part of the evidence on the effectiveness of clinical interventions is generated overseas (and for new interventions or healthcare indications in large multicentre clinical trials). This is separate to health service research and how health care is funded and delivered within one country, such as Australia. Health care is not an exact science and healthcare interventions are not equally effective in all people who receive them. Different medical researchers can report different results or with a wide spread of results on the end benefit using the same healthcare intervention. Health and medical clinical trials need to be verified – by different researchers, in different health services, countries, in different populations and with possibly differing severity of disease. People of different age groups or with accompanying health problems may or may not be included. When one looks for the evidence supporting a medical service or treatment it is important that results from different clinical trials are looked for, compared and synthesised – for size of effect and any possible adverse effects. Restrictions in participation and other identifiable differences between trials are some of the limitations in the overall evidence.
My experiences with Cochrane
The huge person power required to synthesise the evidence from clinical trials in systematic reviews requires an international effort. Australians make strong contributions in Cochrane, an independent international collaboration that develops systematic reviews of best evidence (generally randomised controlled trials) on healthcare interventions. These reviews become part of the online Cochrane Library. Having this synthesised evidence available in one place can help a researcher avoid undertaking repetitive, wasteful research, research that does not add to the usable knowledge base of a healthcare treatment or service.
When I became a consumer representative, it was because I wanted better information to be available to patients on the outcomes of treatment, possible complications or adverse events as well as time-frames for recovery.
I became involved as a consumer with Cochrane, contributing over time to more than one review group. Review groups are disease or condition-based, or in different areas of health care such as pregnancy or neonatal health care. Consumers can be asked to comment on both the protocols setting out how systematic reviews are to be conducted and the completed reviews.
When I became a consumer representative, it was because I wanted better information to be available to patients on the outcomes of treatment, possible complications or adverse events as well as time-frames for recovery. This was not just for the ideal patient, but from a broader perspective. Everyone has different starting places for treatment and propensities for complications. I wanted to understand the possible causes of those complications and how to reduce or avoid them. Such knowledge can provide people with the information necessary for informed consent to healthcare procedures.
Some review groups provide more opportunity than others to involve people who have experienced the health condition in question, either as a patient or carer. Consumer participants are able to comment on the review topic or question, trial design, including who the trial participants were, their age and general health, what outcomes of treatment were looked at, if they were relevant to patients and their families, and when they were assessed after the intervention (particularly important for chronic or long-term diseases). Consumers can also give input on the description of the health problem and its treatment, the conclusions of the review, and how easy it was to read the protocol or review. Over time, each review included a plain language summary to explain in lay terms the content of the review and the conclusions drawn. Because systematic reviews are complex documents that follow well-defined research pathways, training and mentoring consumers are a key component.
An international consumer
I found that as a member of the Cochrane Consumer Network I had become part of an international community. I had the opportunity to apply for travel grants to attend annual conferences, meet other consumers, form working relationships with members of the review groups that I was part of. I became part of the management and governance of the UK based organisation. By being at the annual conferences and getting to know people I had the opportunity to be involved in research projects and to have a role as a patient partner in Outcome Measures in Rheumatology (OMERACT) and to attend conferences held by other organisations such as Guidelines International Network (GIN) as part of their patient and public involvement. I also had opportunities to participate in and help run workshops and meet other people working in patient and public involvement in healthcare research and policy development for evidence-based, person-centred health care. In 2011 I became involved with the Health Technology Assessment International Patient and Citizen Involvement Interest Group.
Consumers are not an intervention (like a new treatment) that needs to be evaluated.
What I have learned
The place of consumers
There is much talk about the need to evaluate and measure the impact of patient and public involvement in healthcare research and policy. This is without building standards for what that involvement could look like and how it is developed and supported. However, strong arguments can be put forward that consumers have a vital role in health care and that they have the right and should be included in the decision making; that is, their place is ‘at the table’. Consumers are not an intervention (like a new treatment) that needs to be evaluated. Building collaborative relationships that are genuine and underpinned by honesty, respect, co-learning and equity are important values to be applied to improve medical research, healthcare quality, reporting and accountability. Providing the knowledge base and experience to contribute in a meaningful way, and providing necessary support for both consumers and researchers are key elements. Best practices and standards for consumer engagement and reporting help to address patient-relevant research questions; enhance study design so measured outcomes and the methods used are more acceptable and appropriate for consumers; improve reporting and sharing of knowledge to inform consumers – and avoid the potential for research waste.
Broadening my outlook
For me, an added benefit of working internationally has been exposure to different ways of approaching the same thing, and differences in thinking in different countries, cultures and with different values and priorities. Having the opportunity to work with a range of stakeholders has broadened my perspectives. England, for example, recognises the importance of social care in its health policy. Bioethics is an important consideration in Scandinavian countries; and has also exposed me to literature on the hierarchical ranking of diseases and medical specialities.
Patient reported outcomes designed in partnership with patients [and accepted by regulators], trial design, early access to new medicines, use of digital technologies and large datasets are some of the enabling areas of development that help to empower consumers.
The availability of relevant information on new drugs, before market access, is restricted by codes of practice and regulations yet consumers and patient support organisations are being asked to give their perspectives on those new drugs. I have learned at first-hand what one country has done to overcome these barriers. Important projects are funded by the European Union Innovative Medicines Initiative (EU Commission and the European Pharmaceutical Industry) to upskill patient representatives and involve them in drug development; and by the Patient-Centered Outcomes Research Institute (PCORI) and others in the United States to develop person-centred outcome measures.
Much research is needed with its implementation supported by policy development to manage health conditions, their prevention and treatment. We need to increase our knowledge and experience in terms of measuring and evaluating the burden of health conditions and their treatment options, natural progression and the different severities over time. This work is most effectively achieved by working with patients and consumers.