Kupu Taurangi Hauora o Aotearoa

Health and Disability Consumer Representative Training MODULE THREE Evidence base

Welcome and introductions Who you are Where you’re from What you want to get out of the training today Allow time for each participant to (re)introduce themselves and what their expectations are of the day including what they hope to get out of the training. Again, if participants have not attended the previous module training, introducie yourself and give some background to your own involvement in health or disability. Explain the housekeeping points such as where the fire exit/s are, the location of toilets, when morning and afternoon tea and lunch will be. Establish ground rules – ask participants to give you any they have but include, confidentiality and respecting each others views.

Health and disability context Inequities Research Clinical trials Leadership Co-design Peer support Your experience Roles & responsibilities Meetings The NZ health and disability environment Defining consumers Quality improvement Consumer engagement 1. Health and disability context 2. Experience base 3. Evidence base 4. Partnership Again, if participants were not at the previous training explain the modular framework and the individual module content.

Health and disability context Evidence base Inequities Research Clinical trials Health and disability context Experience base Evidence base Partnership Explain that today’s module is about evidence based health and disability that includes: The definitions of inequity and inequality Health and disability research and how consumer representatives can be involved The reasons for clinical trials and benefits for consumers

Goals for the day To understand the cultural context and equity issues for different socioeconomic and ethnic groups in New Zealand’s health and disability sector. To increase your knowledge about research in health and disability sector as the evidence base for change and improvement. To learn the processes of clinical trials and how you can be involved in these.

Definitions (New Zealand Medical Association, nd) Health equality A description of ‘sameness’ in health Health equity The absence of systematic disparities in health between groups with different levels of advantage/disadvantage Health inequity The presence of systematic disparities in health between groups These definitions come from the New Zealand Medical Association’s position paper on equity. This can be found on - www.closingthegap.org – an Income Equity Project. Draw participants to this page (write the website on the board) – its aim is to raise public awareness of the benefits of a more equal society.

Health inequities in New Zealand Health inequities are defined as: ‘... differences which are unnecessary and avoidable… and are considered unfair and unjust. They do not occur naturally and are not random but are the result of social and economic policy and practices.’ (Ministry of Health 2004) Group discussion: Ask participants if 1. they agree or disagree with this and the previous definitions and, 2. What other ways can they see there are health inequities. Note: there are many determinants in health that are outside the direct influence of health – such as housing, education and socioeconomic factors – although government agencies are now working closer together to try and address these issues.

Health inequalities in New Zealand There are significant inequalities in health between socioeconomic groups, ethnic groups, people living in different geographical regions and males and females. (Reid & Robson 2007) Ethnic identity is an important dimension of health inequities. Māori and Pacific peoples experience lower life expectancy and health disadvantage across most mortality and morbidity indicators compared with pākehā. (Harris 2012) Note the references which can be found in the References page of the Guide. Morbidity is defined as disease or illness, Mortality is death. Hand out the Blakely and Simmers article on “Health Inequalities and Action fact sheets”. Ask the participants why they believe there is this disparity – write up responses on the whiteboard.

Inequities in health for Māori and Pacific peoples Māori populations still have higher levels of unmet need for GP care than non-Māori and receive a lower quality of care under treatment for some conditions. (Ministry of Health 2010) Compared with the total New Zealand population, Pacific peoples have poorer health status across a wide variety of measures, including child and youth health, risk factors leading to poor health and long-term conditions. (Ministry of Health 2010)

Health inequalities for migrant, refugee and Asian communities New Zealand’s migrant, refugee and Asian populations are increasing and facing increasing health issues. (www.moh.govt/asian) Group workshop: What are the barriers (if any) to accessing health services for these population groups? See Facilitator’s Guide for running this workshop. Examples of barriers can include but are not limited to: language barriers, lack of knowledge of the health care system which can hinder early detection of diseases or illness, gambling issues, change in diet (eg. high in fats/sugars).

Addressing inequalities The district health boards have a statutory responsibility under the New Zealand Public Health and Disability Act 2000 to: reduce health inequalities in their regions. improve outcomes for Māori. Group discussion: ask how these can be addressed. Some examples: A ‘for Māori by Māori’ service A service that integrates Māori expertise and advice with mainstream services A service that is established within a Maori settings (eg. Marae)

Health and disability research Next three topics Health and disability research Clinical trials Consumer involvement Give participants a 5 minute break before going on with the next three topics.

Health and disability research The Health Research Council of New Zealand is a Government agency responsible for managing the Government’s investment in health research. (www.hrc.govt.nz)

Ethics of including consumers in research The Health Research Council (HRC) is committed to ensuring that all research involving human participants is based on good science, meets ethical standards and complies with international best practice.  To achieve this: all health and disability research involving human participants funded by the HRC requires appropriate ethical approval from an approved ethics committee in New Zealand HRC-funded clinical trials, innovative treatment evaluation or community intervention studies are adequately monitored, to ensure the safety of participants and the integrity of the collected data are protected. (www.hrc.govt.nz/ethics-and-regulatory) Discuss this topic with the group asking if any of them have been involved in research, either as a participant or as a researcher and if they wish to share that.

Accessing research funds Health and disability researchers can access funds from a range of organisations including: District health boards Cancer Society of New Zealand New Zealand Breast Cancer Foundation drug companies private organisations, such as the Hugh McKenzie Trust Lottery Grants There are a number of different mechanisms through which health and disability researchers access funds to undertake research. As a consumer you may be part of a research team and have input into proposals in a role such as co-investigator. The Royal Society of NZ has comprehensive information about research funding. Write on the board its website: www.royalsociety.org.nz/programmes/funds

Examples of funded research ‘Mechanisms of obesity and type 2 diabetes; insights from bariatric surgery’ 12 months, $83,333, University of Otago ‘Health housing index and Māori health’ 4 months, $5000, Massey University 3. ‘Towards a Pacific Island definition of deliberate self harm’ 10 months, $10,000, University of Auckland Advise participants these examples come from the Health Research Council of New Zealand and researchers were recipients from the 2014 funding application round. Explain that ‘bariatric’ surgery means a branch of medicine that treats the control and treatment of obesity and allied diseases. For example, surgery on the stomach and/or intestines to help a person with extreme obesity lose weight.

Cochrane Consumer Network This website has three very good videos about consumer involvement in health research and evidence-based care consumers.cochrane.org/introduction-consumer-involvement-collaboration See note in Facilitator’s Guide. These videos are an excellent way to lead into the next area of research and consumer involvement – particularly the 7 minute video on Consumers United for Evidence-based health care (CUE).

Consumer involvement in research Active involvement by consumers: must include informed and explicit consent benefits: the quality and direction of research itself the research development process people affected by health and disability issues. Group Exercise: See Facilitator Guide Direct participants to the website: www.sciencedirect.com. This website currently highlights a book entitled: “Partners in Projects: Preparing for public involvement in health and social care research” (2014) that participants may be interested to look up.

Consumer involvement in research ‘Consumer involvement in research relates to an active relationship between consumers and researchers in the research process and leads to research of greater quality and clinical relevance due to the unique perspective that consumers bring to a research project.’ (Boote et al 2002) This is a quote from researchers looking at a critical review of the policy of consumer involvement in health research and the need to evaluate and measure the contribution consumers can make to the research process. Provide participants with copies of Saunders and Girgis (2010) article: “Status, challenges and facilitators of consumer involvement in Australian health and medical research policy and systems”

Why is the consumer voice important to health research? Helps promote reliable, relevant research important to consumers and carers. Presents the needs and views of consumers to the research community. Encourages research questions to include social and emotional aspects of health often missing from clinically led research. Ensures issues important to consumers are identified and prioritised. Ask participants if they have been involved in research projects and discuss. What other reasons for including consumers in health research?

Clinical trials A clinical trial is defined as a prospective scientific experiment usually conducted to assess the safety and effectiveness of an intervention in groups of subjects. Interventions can be: diagnostic, preventative or therapeutic, and can include drugs, biologics, medical devices or methods of screening, or procedures to improve the quality of life. (www.researchreview.co.nz) If possible, have a clinical/medical researcher speak to the slides on clinical trials. Note: Biologics means a medicinal preparation made from living organisms and their products, such as a serum or vaccine. Check with the participants if any of them have been involved in clinical trials and if they wish to share their experience. Note again, it is important that consumers give their informed consent and understand the processes of the trial.

Randomised control trials Patients are assigned at random either to receive a new drug (the standard treatment for that disease), or a placebo (that is, a sugar pill which has no effect). These are followed up in exactly the same way in terms of care and treatment received (for example, procedural tests, outpatient visits) and then compared. Randomisation helps to ensure the groups in the trial have similar characteristics, making it easier to compare outcomes between groups. (www.researchreview.co.nz) Again, check if any participants have been involved in a randomised control trial and if they wish to share their experience. Hand out the article: Research Review: Educational Series and give time for participants to read. Draw their attention to Phases of Clinical Trials in the article.

Benefits to consumers Access to a novel treatment before it is widely available or access to the global standard comparator (which may not be freely available in New Zealand). Close medical oversight and regular access to study nurse and physician. Close scrutiny of adverse events. Provision of care within a health care facility committed to improving best practice. (www.roche.co.nz)

Example of a clinical trial The Australia and New Zealand Breast Cancer Trials Group conducts an independent, collaborative breast cancer clinical trials research programme. Consumers with an interest in breast cancer clinical trials research are encouraged to join IMPACT – Improving Participation and Advocacy for Clinical Trials. (www.anzbctg.org) Note: this group is for breast cancer consumers. Advise participants if they are interested in becoming a member as a consumer they can contact the email address: impact@bcia.org.au

Two examples of clinical trials in New Zealand These are currently being conducted worldwide, including in NZ by Roche NZ: A study of a drug for patients with uncontrolled asthma on inhaled corticosteroids. A study to compare subcutaneous versus intravenous administration of a drug for patients with moderate to severe active rheumatoid arthritis.

Summary Not everyone gets treated the same or has equal access to health and disability support services, and this can result in inequalities for Māori, Pacific peoples, Asian and other minority groups. Health science is complex and ever-changing, with new research contributing to new treatments. Consumer involvement in setting up research is important and so is the opportunity to be offered the choice to give informed consent to participate in clinical trials.

Questions? Comments? Evaluation Hand out the Evaluation sheet to all the participants and ask them to fill it in. Explain that this can be helpful for future programme developments.