The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display "45 and up" open access version of this article for non-commercial purposes provided that: For commercial re-use, please contact journals. In common with virtually all industrialized countries and many less developed nations, Australia is facing rapid population ageing.
The challenges presented by the ageing of the population are far reaching. Discussions have tended to focus on its likely health and economic consequences; however, few aspects of society will remain unaffected by the issue.
45 and up an urgent need for reliable evidence to inform policy to support healthy ageing. The concept of healthy ageing encompasses traditional ideas relating to freedom from disease, as well as broader considerations including independence, quality of life, management of disability, participation in society and the workforce and productivity.
A comprehensive investigation of the determinants of healthy ageing must incorporate assessment of disease risk, quality of life and other indices, in to a very wide range of possible exposures, and with consideration of how these exposures might interact "45 and up" one another. Research needs to be of a sufficient scale to provide specific
45 and up on the major diseases and health problems experienced in later life.
This is because reliable assessments of risk factor—disease relationships require a substantial degree of pathological homogeneity of outcome and appropriate consideration of confounding. At the same time, research needs to be able to assess the broad risks and benefits of particular exposures, to allow meaningful conclusions to be reached about suitable public health interventions. Finally, it needs to be large and long term enough to track the impact of health interventions and policies at the population level.
Australia has some unique characteristics that will impact on healthy ageing and provide particular challenges in delivering health care. For example, it has: Excellent population-level databases relating to use of health services and medications, and registers of cancers and deaths, are available for statistical linkage with research data sets.
There is therefore a need for 45 and up that addresses issues specific to the Australian population and makes use of the unique features of the Australian setting, giving the 45 and up to provide insights of international relevance. The 45 and Up Study was conceived as a long-term collaborative resource to investigate healthy ageing, in response to the gaps in existing knowledge and the needs of researchers. Initial discussions among interested researchers resulted in the formation of a Scientific Steering Group in to oversee the development of the Study.
The Study is auspiced by the Sax Institute, which also provided funding for its development. The Sax Institute is an independent organization with core funding from the state government of New South Wales, Australia's most populous state.
Its mission is to improve health through facilitating high-quality research and increasing the impact of this research on health policy and services; it has membership from public health and health service research centres and universities across New South Wales. Workshops, meetings and consultations with individual researchers were held to identify research priorities for the Study and researchers were invited to become 45 and Up Study Collaborators. There were collaborators at the time of writing see www.
The protocol for the Study 45 and up completed in latethe Scientific Director was appointed inthe Study materials, methods and governance framework were developed in and and recruitment of participants started early in These were later joined by beyondblue: Competitive funding for a range of research projects has been secured and researchers using Study data for their projects support the Study through contributions to cost recovery and Study sustainability.
The 45 and Up Study is a large-scale Australian cohort study of individuals aged 45 and over aiming to provide researchers with timely "45 and up" reliable information on a wide range of exposures and outcomes of public health importance for the ageing population. At the same time as addressing specific research questions, the Study is also designed as a framework for a range of future research activities.
Priority areas for the Study are:. The 45 and Up Study is in the process of recruiting men and women aged 45 and over from the general population of the state of New South Wales, Australia Figure 1. Individuals aged 45 and over and resident in New South Wales randomly sampled from the Medicare Australia enrolment database.
This is the database 45 and up which national healthcare is administered and includes all citizens and permanent residents of Australia, as well as some temporary residents and refugees.
Eligible individuals are mailed an invitation to take part, an information leaflet, the study questionnaire and consent form and a reply paid envelope available at www. The data included in the baseline questionnaire are listed in Table 1. Participants join the study by completing the questionnaire and consent form and mailing them to the Study coordinating centre. Completed questionnaires are then scanned electronically and stored as images and data are double-entered.
The study over-samples, by a factor of two, individuals aged 80 years and over and people resident in
45 and up areas; all residents of remote areas are sampled. People may also volunteer to join the by calling the study helpline and requesting an invitation pack.
Recruitment into the 45 and Up Study commenced in February ; since then 36 men and women have joined the study. By the end ofparticipants will have joined the study, with the full recruited by the end of The current overall response rate to the mailed invitations to join the study is estimated to be In addition to the 36 The demographic characteristics of the first 36 members of the cohort are shown in Table 2.
Participants range in age from 45 to years, with a mean age of Socio-demographic characteristics of the first 36 participants joining the 45 and Up Study. Lifestyle and social factors in the first 36 participants joining the 45 and Up Study. "45 and up" and surgical history and functional capacity of the first 36 participants joining the 45 and Up Study.
Further details of the responses to the 45 and Up Study baseline questionnaire are available in the study preliminary data book, at www. The data that will be collected for the 45 and Up Study include a baseline questionnaire, 5-yearly repeat questionnaires, linkage to routinely collected health data, biological samples and more intensive measures from sub-studies conducted within the cohort.
The baseline questionnaire for the study broadly includes: A pilot study conducted in July established the feasibility of the recruitment methods and allowed the refinement of a number of questions. Repeat questionnaires to all cohort members to update exposure data and health status are planned at 5-yearly intervals. Questionnaire data from study participants are linked with routinely collected data from a range of population databases and registers. These include information on use of prescription medication, use of general practice services and updated address details, through Medicare Australia, and routine linkage to deaths, cancer registrations and hospitalizations, through the New South Wales Centre for Health Record Linkage see www.
Linkage is both retrospective and prospective, with the time period covered dependent on the properties of the specific data set. A range of additional data sets e. A number of more detailed sub-studies are already underway within the framework of the 45 and Up Study cohort, enhancing the information available on selected participants.
For example, the first participants will receive an additional questionnaire to provide more information on social, environmental and economic factors and health status. It is planned that biological samples, including blood for genotyping and examination of a range of analytes, will be collected on as many participants as possible as the Study progresses and funding becomes available.
Blood samples will be centrifuged and aliquotted, and stored long term in ultra low temperature freezers, with procedures in place for retrieval samples for specific projects. 45 and up protocol for collection of samples is currently being developed and collection is planned to commence in Following initial analyses of cross-sectional data, the main means of investigating relationships between exposure and outcome will be through cohort analyses and nested case—control studies.
For conditions yielding at least incident cases or deaths during the first 10 years of follow-up e. With the same power, significance and ratio of cases to controls, for outcomes with or more events e.
The 45 and Up Study has sought to establish an approach that will make optimal 45 and up of the data. Data from the study are accessible to local researchers for approved research projects. First, we have sought to encourage local 45 and up to use data from the Study by involving a large number of leading researchers, from across a range of institutions, in its management and design from the outset. A policy framework has been established for the Study that addresses issues including use of and access to the data, intellectual property, protecting the privacy and confidentiality of participants and charges for data use.
We have convened a Community and Ethical Oversight Committee, which includes community leaders among its members. At the time of writing, 18 applications had been made to the Scientific Advisory Committee for access to Study data for research projects and funding applications. Six projects, spanning cancer risk factors, oral health, health economics, functional capacity and psychological distress, are underway.
Second, to encourage use of the Study for research that will directly inform the planning and provision of services, we have convened a policy roundtable. This includes representation from major government and non-government agencies and private sector organizations that have responsibility for providing health and aged care services. The roundtable serves to generate ideas and opportunities for new policy-relevant research using the Study. It has been funded by the MBF Foundation a non-profit charitable institution.
When recruitment is complete, the 45 and Up Study will be the largest population-based cohort study in and, to our knowledge, in the Southern Hemisphere. It is unique among large-scale cohorts internationally, 45 and up terms of the scope of its ongoing linkage, even for those participants who are otherwise lost
45 and up follow-up, with a large number of routinely collected databases and registers that 45 and up virtually complete capture of use of a wide range of health services, as well as cancer registration and deaths.
The combination of large numbers of participants with individual prospective information on exposures and additional linked exposure and follow-up information will provide a valuable resource for the investigation of many different causes of morbidity, mortality and of patterns of use of health and aged care services. The addition of biological samples to the study over time
45 and up further increase its usefulness.
The study does not at present have the levels of funding required to collect biological samples on participants, so this is being introduced gradually, as funding is secured. A limitation of the study is the lack of large-scale clinical data on measures such as blood pressure, spirometry, anthropometry and cognition; it intended that many of these will be gathered as part of sub-studies within the cohort. The study population is relatively heterogeneous, with a good spread of responses across most variables.
The oversampling of people 80 years and over with no upper age limit to participation and from rural areas will enable a particular focus on these groups. The Study will provide a good basis for the investigation of aetiological research questions, based on internal comparisons within the cohort.
Although derived from the general population, the relatively low response rate means that the cohort is unlikely to be directly representative of the general population. Formal comparisons of the cohort with the general population will be conducted in due course.
The questionnaire is currently only available in English, limiting the participation of people with insufficient literacy in English. Having said this, 45 and up is likely to be one of the most inclusive large-scale cohort studies conducted to date and the results from cohort studies based on internal comparisons remain generalizable even when the cohort is from a selected group.
The Study is accessible to local and collaborating researchers for high "45 and up" policy-relevant research that is in the public interest. Details of the data access policy and procedures are available at www. The authors thank the men and women participating in the 45 and Up Study. National Center for Biotechnology InformationU. Published online Sep For a list of the 45 and Up Study Collaborators 45 and up go to www.
Author information Copyright 45 and up License information Disclaimer.
This article has been cited by other articles in PMC. How did the study come about? What does it cover? We included participants without prior stroke/MI from the New South Wales 45 and Up Study.
"45 and up" categorized baseline psychological distress. Participants were recruited through Medicare.
•men and women aged 45 years and over completed questionnaire about life and health in More than a quarter of a million people — one in 10 45 and up men and women aged over 45 — are participants in our 45 and Up Study, the largest ongoing study of.