2015 Summit Report
21-22 April 2015, AMREP Education Centre,
Alfred Medical Research and Education Precinct,
Alfred Hospital, Melbourne
Generously supported by
Arthritis Australia, Arthritis and Osteoporosis Victoria, Arthritis South Australia, Arthritis and Osteoporosis Tasmania, Australian Rheumatology Association, Australian Orthopaedic Association, Australian Physiotherapy Association, Cabrini Institute and Monash University
Goals of the Summit
There were four goals of the summit.
- To bring together all stakeholders with an interest in investigator-initiated musculoskeletal clinical trials to garner support for an international, multidisciplinary, collaborative musculoskeletal clinical trials network;
- To develop an agreed vision and mission statement and a set of values for ANZMUSC;
- To clearly identify achievable goals for the next year; and
- To develop a plan for how these goals will be realised.
Attendees at the Summit
There were 100 participants at the Summit. Participants were affiliated with 22 Universities in Australia and New Zealand as well as various research institutes and hospitals, consumer organisations, professional societies, NHMRC, Departments of Health (NSW, WA), Australian Commission on Safety & Quality in Health Care, Australian Clinical Trials Alliance (ACTA) and health insurers (Medibank Private). This suggests that our first goal was achieved.
Professors Alan Silman (UK) and John Zalcberg OAM (VIC) facilitated the two-day summit.
Professor Silman is an epidemiologist and a rheumatologist. He was Director of the UK’s Arthritis Research Epidemiology Unit in Manchester from 1988-2006. He then became Arthritis Research UK’s first Medical Director, a post he held from 2007 until the end of 2014. Currently he is Professor of Musculoskeletal Health in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Disease at Oxford University.
Professor John Zalcberg OAM was the Director, Division of Cancer Medicine, at the Peter MacCallum Cancer Centre in Melbourne, Australia for 17 years prior to recently taking up the position of Head, Cancer Research Program in the School of Public Health and Preventative Medicine at Monash University. He is a founding member of the Australasian Gastrointestinal Trials Group (AGITG) and is immediate past Chair of The Board after serving in this role for over 15 years. He is the Interim Chair of the Australian Clinical Trials Alliance (ACTA), an organization that is involved in advocating for embedding clinical research into routine clinical practice in order to improve the quality of health care delivery.
The program comprised a mix of talks and small group break out and feedback sessions. Over the two days we considered the value proposition of a network and how this is likely to greatly enhance our ability to perform large high quality multicentre studies focused on addressing the most important clinical questions. We heard about the outstanding achievements of other Australia and New Zealand clinical trial networks and the views of consumer and policy maker representatives. We presented the results of a survey that obtained the views of Australia and New Zealand musculoskeletal trialists and invited discussion in two small group breakout sessions and several feedback sessions devoted to considering the vision, mission, scope, values and structure of ANZMUSC, and the initial goals and how these can be achieved.
Summary of Invited Presentations: Day 1 (Tuesday April 21st)
In the first session on Day 1, Mr Tony Kingdon, Acting Chief Executive Officer, NHMRC outlined the NHMRC’s strong support for investigator-initiated clinical trials. The Clinical Trial Action Group (CTAG) report (2011) recommended that greater support for clinical trials networks in priority health areas be provided through the NHMRC. He outlined the steps that have been taken towards this goal, including identification of networks that exist in Australia and facilitating national coordination and encouraging collaboration across academia, clinical medicine and industry. The NHMRC are working with ACTA to better understand Australia’s Clinical Trials Networks and their contributions to the health system. In addition they have initiated strategies to improve staff training such as website resources (see www.australianclinicaltrials.gov.au) and development of competencies and are working towards a nationally consistent approach to clinical trials through redevelopment of the Ethics Application Form; pilot Clinical Trial web portal; and ‘good practice’ site assessment and authorisation of clinical trials.
Professor Alan Silman presented the value proposition of the ANZMUSC Clinical Trials Network. He outlined three major shortages – funding, clinical trial expertise and patients. He described the importance of determining the best clinical question in terms of which patients (e.g. severity, sub type, demographics, previous therapy), what intervention (e.g. dose, duration, comparator and co-therapies) and what outcomes (e.g. which measures, time point and consideration of ability to detect important between-group differences). He outlined the many barriers to performing trials that answered the important questions.
Professor John Zalcberg presented the quality agenda of investigator-initiated clinical trial networks. He emphasised that investigator-led networks are the most effective mechanism to undertake important public-good research. They can provide evidence that guides decision-making by clinicians, patients and policymakers, lead to improved health outcomes or cost savings, or both, and are integral to improving the quality of the healthcare system. Local networks not only add to the evidence base, they can change practice outside of clinical trials, address local patterns of care, increase accessibility to new agents and improve outcomes for patients involved in research.
The strengths of a network include the extensive access to expertise and corporate knowledge that is generated, access to large pool of patients for large trials, and the creation of infrastructure as well as a culture of research. Networks are typically run by clinicians who understand what is relevant to clinicians. They are responsible to, and representative of members, and can act to mentor and train the next generation, develop effective partnerships with similar international networks and facilitate the translation of research into practice by generating a community of clinicians who have a strong interest in the trials’ results.
Australia has about 35 established national clinical trials networks in Australia including 13 collaborative cancer groups. These networks are global leaders across many disciplines and have produced numerous examples of high-impact trials that have changed practice, improved outcomes and saved money. The Australian Clinical Trials Alliance (ACTA) (www.clinicaltrialsalliance.org.au) is promoting effective and cost‐effective health care in Australia through investigator‐initiated clinical trials. It has written a white paper that estimates the health and economic returns of investing in public-good clinical trials and clinical quality registries.
Professor Rachelle Buchbinder outlined the global burden of musculoskeletal disease, which accounts for 6.8% of the total burden of disease (including both death and disability). In Australia, musculoskeletal conditions have the second greatest impact on the health of the population after cancer (15.3% vs 16.2% of overall disease burden). Low back pain contributes most to years lived with disability, followed by major depressive disorder, other musculoskeletal, neck pain and falls, with osteoarthritis ranked 11th. In New Zealand low back pain also contributes most to years lived with disability, followed by major depressive disorder, neck pain, anxiety disorders and falls, with osteoarthritis also ranked 11th.
She summarised the results of a scoping review, undertaken at the end of 2013 that determined the current state of musculoskeletal trials in Australia. For the five-year interval 2009 to 2013, NHMRC funded 29 musculoskeletal randomised controlled trials at a cost of $17,612,303 (~ 5.8 per year). This represents ~1% of all project grants and project grant funding for those five years (3,631 grants, total funding $2,076,132,819) and 4.9% of all NHMRC clinical trial funding (total funding $354,394,863). Only one program grant for musculoskeletal conditions was funded over the same period (>$7m funding) from which 8 trials are registered and/or planned. 128 Australian-initiated randomised controlled trials were registered in a clinical trials registry in 2011 or 12. In two-thirds of these the sample size was less than 100. Of 565 investigator-initiated randomised controlled trials published in 37 leading journals in 2011 or 2012, 30 (or 1 in 20) were Australian investigator-initiated trials.
While the scoping review demonstrated that Australian musculoskeletal trialists are productive and internationally competitive, current funding is suboptimal and starkly disproportionate with the MSK global burden. In addition, current trials are small and may not be focused upon the most important clinical questions. She suggested that a collaborative network might be the only viable and sustainable model to address these shortcomings. A network is able to facilitate funding and resource acquisition, facilitate the conduct of trials, create and manage the network brand and create a culture. The ANZMUSC Clinical Trials Network could transform the current ad hoc approach to Australian musculoskeletal clinical trials and formulate a national research agenda and funding plan that would focus on most critical gaps in evidence and gaps between evidence and practice.
Finally, Dr Sam Whittle presented the results of the ANZMUSC clinical trialist Internet survey. Invitations were sent to 243 clinical trialists and 112 completed the survey (response rate 46%). Respondents were from all states and territories other than Northern Territory in Australia and 15% were from New Zealand. A wide variety of disciplines were represented with the largest group being physiotherapists. There were a wide variety of interests and also a diversity of opinions regarding how priorities for trials should be established. Most respondents (107/112) were either interested in ANZMUSC membership or were as yet undecided. Respondents indicated a wide variety of potential benefits of ANZMUSC membership which could be summarised into six themes: collaboration/networking; funding; learning/gaining experience/peer review; priority setting; advocacy for musculoskeletal disease/research; and avoidance of duplication.
In the second session on Day 1, Professor Silman discussed top down versus bottom up network models and Professor Zalcberg discussed different types of network models. Networks can be sub-entities of a parent body or an independent legal entity. Networks that are part of a professional society or other body cannot receive funds in own name and are ultimately responsible to the parent body. There may be greater support, lower costs and greater reach, compared with independent entities, but this may be at the expense of reduced independence and autonomy. Sub-entities of parent bodies are the most common structure for non-cancer networks. Independent legal entities are most commonly an incorporated public company or association. They have a Board of Directors and report to ASIC/ACNC (registered charities & not-for-profits). They are ultimately responsible to their members. They can receive funds in own name and have fiduciary responsibilities. While they have greater independence and autonomy, they may have less support, greater costs and variable reach. Most cancer networks are independent legal entities.
There are many governance issues that will need to be resolved. This includes ownership of the network; defining an agreed vision, mission, values and aims; transparency of rules and terms of reference; representation of members and an understanding that the Group is for the members not about the executive or the Chair; responsibility to members; turnover of leadership; executive office / administration; regular meetings; and communication. In the early stages it is often heavily reliant on a Chair + Executive Officer. Special Interest Groups and/or Working Groups can facilitate stakeholder engagement, diversify expertise and share workload. Other considerations that will require thought include trial management (central or devolved), identifying questions, designing trials, peer review, endorsing trials, whether or not we will sponsor trials, coordinating or running trials, investigator-initiated +/- industry trials; fundraising, and training, mentoring and education. It should also consider the opportunity to meet face to face at least once a year, selection of principal investigators, day-to-day management of the group, succession planning and engagement of all professional sub-disciplines.
The first in a series of talks showcasing the outstanding achievements of other Australia and New Zealand clinical trial networks was given by Associate Professor Craig French, Vice-Chair of the Vice Chair, Australian & New Zealand Intensive Care Society Clinical Trials Group (ANZICS). The ANZICs group was formed in 1994. Early studies built the network, infrastructure and track record and were largely unfunded. The principal investigators did much of the work and there was no formal management committee. There are now 73 ICU members of ANZICS and between them they have enrolled more than 30,000 patients in observational studies and more than 30,000 patients into controlled clinical trials. They have completed or are currently conducting more than 100 projects. They have published over 120 manuscripts; 11 in the New England Journal of Medicine and papers in BMJ, JAMA and Lancet. Craig attributed the success of the group to a combination of science, organisation and passion. He outlined the importance of the culture of collaboration and the need for enthusiasm, fun, organisation, pragmatism, a culture of questioning, collegiality, cooperation, hard work, group over individual and no hierarchy. He also outlined the importance of having a clear vision, mission, values and terms of reference which cover structure and governance, membership, procedures and policies, process of study endorsement, publication policy, meetings and email communication.
Ms Rhiannon Tate, Executive Officer of the Australian Clinical Trials Alliance, gave the final talk in the second session. She presented preliminary results from the National Survey of Clinical Trials Networks, which comprised a 50-question online survey, as well as data on all current, and all published studies in the last decade. This was commissioned by NHMRC and aims to provide a comprehensive snapshot report on Australia’s investigator-initiated clinical trials networks, including their structure, activities, achievements and contribution to the health system. 34/36 networks invited to participate responded (94% response rate) and over 1000 published studies from the networks have been identified and entered into a database (~17,000 data points).
Sixty-one percent (19/31) of the networks have a dedicated physical office, 80% (25/31) have a dedicated Executive Officer or Senior Manager and 77% (24/31) have paid staff responsible to the network (median of 2.0 FTE staff). Staff spends time on network administration and direct management of research projects, education and training, fundraising and consumer engagement. Network functions are numerous and include most commonly collaborative development of studies (82%), peer review of study protocols and designs (73%), scientific meetings (70%), education and training programs (61%), site selection or acquisition (61%), protocol development (61%), grant writing (58%), consumer liaison (52%), trial management (52%), trial oversight (52%) and formal study endorsement (52%). About a third are also involved in DSMB (36%), liaison with commercial entities (33%), formal mentoring programs (33%), formal manuscript endorsement (33%), advocacy (30%) and charitable fundraising (30%). A fifth (21%) are also concerned with clinical guideline development. The cost of administration in the last year ranged from nil (no administration staff) to $5mill with a median cost of $250,000 per annum. A wide range of sources funds administration including membership fees (7%), charitable (10%), state government (16%), NHMRC (36%), parent body (10%), industry (13%), MRI (3%), university (3%), philanthropic (3%), and ‘other’ (58%). Over half (58%: 52% no fees and 6% with fees) have formal membership, while 39% have informal membership.
In the final session of the first day, Ms Ainslie Cahill, Chief Executive Officer of Arthritis Australia presented her thoughts on the consumer perspective and how consumers can contribute. She acknowledged that while there is little published empirical evidence into the effects of consumer involvement in research or healthcare decision-making, organisations that utilise a patient and public involvement (PPI) model believe wholeheartedly in consumer involvement but have different ways of doing it. A 2014 review found that the most common activities undertaken by health consumers in the UK were steering committee membership and reviewing consumer information sheets.
Ainslie noted that tokenism is the biggest risk to consumer involvement. There is a perception in some quarters that consumers are parachuted in merely to tick a box, are ill informed and they bring nothing constructive to the decision-making process. She disagreed with this notion but emphasised the importance of creating clear terms of reference and advised that consumers be recruited in the early stages, so that they may contribute to the structure and operation of what’s required of consumer involvement.
Experience shows that consumers can bring important and sometimes novel insights that complement or contrast to those of health professionals, researchers and funders. She noted the many advantages of consumer involvement including:
- The consumer voice encourages democracy and transparency;
- The consumer perspective can help reinforce the concept of relevance to research decision-making;
- Consumers can bring common sense to the design of clinical studies. For example: feasibility and practicality and the impacts some study design factors may have on recruitment and retention (e.g. expecting participants to undergo multiple blood tests, travel, study duration);
- Such insights can assist in ensuring that the intended endpoints will be delivered in a timely and costly way. Recruitment and retention are absolutely crucial to the success of clinical trials, so listening to consumer views makes sense;
- Consumers can bring valuable insights into how to implement research findings into everyday practice;
- Visible involvement of consumers into the prioritisation and design of clinical studies may help to improve recruitment of study subjects;
- Consumer input may help to soften researcher or funder bias or steer organisations away from sinking substantial funding into areas that are of little concern to consumers;
- Consumers bring accountability, particularly when public funding is involved;
- Involvement of consumers may raise the public profile of musculoskeletal clinical research which is important for advocacy efforts and could help to improve government support of currently ill-served services for people with musculoskeletal disorders; and
- Consumer involvement ha the potential to improve fundraising efforts from the community as well as government.
The downside of consumer involvement can be the resources required, i.e. time and money. However, a properly trained and experienced consumer panel can be a long-term asset, advising on both broad strategy and multiple individual trials. It would be inappropriate to have consumers comment on the scientific feasibility of laboratory research. However, they are well-qualified to comment on the relevance and importance of all types of research in terms of potential benefits to patients.
Ainslie congratulated the ANZMUSC Steering Committee for their efforts in coordinating MSK research. She suggested there should be at least one consumer on the ANZMUSC Steering Committee and offered to assist in consumer recruitment via the Arthritis Australia network.
Associate Professor Alex Collie, Chief Executive Officer, Institute for Safety, Compensation and Recovery Research (ISCRR) discussed how to build relationships with policy makers. He noted that policy needs are different to evidence gaps and ‘gold standard’ research is not always necessary for policy action. A survey of 372 policy staff from Worksafe and the TAC found that academic research evidence was the least used form of information. He emphasised the need for researchers to accept and even embrace the validity of differing world views, the care needed with language, which can alienate or engage, and the need to be patient, to work hard on relationships and to identify opportunities. He outlined that the engagement mechanism is a critical decision for a new organisation. He presented data demonstrating that positive impacts of the work of ISCRR.
Ms Amanda Mulcahy, Senior Program Officer, Implementation Support, Australian Commission on Safety and Quality in Health Care discussed the work of Commission in identifying variations in care and opportunities for clinical trials to address them. She focused upon knee arthroscopy and the findings of the Australian Atlas of Healthcare Variation that found a large variation in arthroscopy rates across Australia with South Australia having the highest rates. Eighty percent of arthroscopies are performed in the private sector. She noted that the OECD had identified eight policy options for improving appropriateness of care including public reporting, setting targets at regional levels, reallocation of resources to alter resource supply in regions with low (or high) utilisation rates, establishment and implementation of clinical guidelines, provider-level reporting and feedback, changes in payment systems, measurement of health outcomes and utilisation of patient decision aids. She suggested that ANZMUSC could consider involvement in clinical guidelines. While there are issues with implementation, they do provide a clear description of best practice. She also highlighted that unrealistic patient expectations of the benefits and harms of interventions can influence decision-making and may be contributing to increasing intervention uptake and health care costs. This would be another area that could be considered by ANZMUSC.
Summary of Invited Presentations: Day 2 (Wednesday April 22nd)
In the first session on Day 2, Associate Professor Meredith Temple-Smith, Academic Lead, Australian Primary Care Research Network (APCReN) talked about how to get clinicians research ready focusing on general practice. She described how general practices go about setting up for clinical research, and what infrastructure support is required for this to be successful. She explained what the APCReN is doing to build practice based research networks (PBRNs) and a research culture within the local context of general practice. They involve practitioners as well as academics and generate research that is collaborative and ‘close to practice’ with the objective of producing research that changes practice. It is important to recognise that up until now, research is not a usual part of a GP’s work, there is a shortage of GPs and short consultation times, patients often doctor-shop and each GP practice is a small business and is different. They are each complex adaptive systems that include the staff and patients, patient care and organisational operations. To be successful in the clinic a research protocol needs to be ‘normalised’ (routinely embedded) otherwise it is likely to be either adopted only when remembered or rejected due to staff disregard, subversion or refusal. It must not disrupt daily usual activities. Setting up a clinic to be research-ready requires consideration of all the staff, software, reimbursement and performance feedback. There needs to be an easy method for identifying eligible patients such as an automated GP pop-up alert – this may vary across practices. Incentives include education for CME points, value for the patient and review of own performance. She explained that the role of APCReN is to facilitate research in primary care by building linkages between existing PBRNs, providing advocacy for PBRNs, supporting the establishment of new PBRNs and sharing PBRN knowledge and resources. APCReN can provide advice to non-primary care researchers on appropriate methods for research based in primary care, proven methods for GP recruitment for research, and appropriate costings.
Ms Linda Martin, Chief Executive Officer of Arthritis and Osteoporosis Victoria followed with her thoughts on how to get consumers research ready. She outlined the body of literature describing the many barriers and enablers to consumer participation in research. However it is known that people living with musculoskeletal conditions want evidence based information and services, trusted information, consistent information that is the best available for their conditions and their individual circumstances, health professionals to implement best practice and to communicate with each other about evidence-based practice, and they want to make informed decisions. There therefore appears to be a conceptual and pathway gap between consumers’ needs, wants and expectations for research and its translation into practice.
Similar to the first speaker of the day, Linda noted that research should not be a stand alone or isolated activity and it needs to be integrated at every level into our models of care, practice and consumer engagement. She advocated for people with musculoskeletal conditions being involved at every stage in the research process from concept development, and identifying the research questions to research design, implementation and review. She also noted that research accountability should extend beyond completion of a single research project and include connection to the key stakeholders, sharing results and translating research into practice.
On a positive note, she believes that trusted organisations with a strong consumer engagement and advocacy focus are well placed to recruit consumers, train them to be ‘research ready’ and support their participation in research. We need to understand what motivates consumers to be involved in research and how to inform and support them for optimal engagement. She highlighted the importance of taking an active role in explaining the research process to improve “research literacy”. Consumer organisations such as AOV could play an important role in translating research methods and outcomes into language and information that consumers can orient with, and more importantly, use; working with consumers to understand their motivation and develop frameworks for decision making about participation including consideration of value and risks; supporting consumers in research training; working with consumers to identify what research questions are relevant to them; and supporting consumers to negotiate fair compensation for associated costs.
The second in a series of talks showcasing the outstanding achievements of other Australia and New Zealand clinical trial networks was given by Professor Paul Myles, Founding member of the Australian and New Zealand College of Anaesthetists (ANZCA) Clinical Trials Group. He gave an inspiring presentation outlining the history of the group and its many successes. The group began as the MASTER Trial Group in 1996 (to evaluate effects of epidural anaesthesia and analgesia on the outcome of major surgery) and was formalised as the trial network within ANZCA in 2002. Its academic home at the Department of Epidemiology and Preventive Medicine, Monash University was formalised in 2008 with a Memorandum of Understanding with ANZCA. Paul outlined the current structure and governance of the network and the public availability of policy documents including its constitution and strategic plan. The network is led by both Paul, as head of the Monash University academic depart, and the Chair of the ANZCA Clinical Trial Network; and there is central coordination of all trials. At Monash there are four network coordinators (with another 20 based around Australia) whose role is to centrally coordinate the clinical trials, oversee ANZCA surveys, endorse clinical trials and fund pilot grants. They receive some NHMRC infrastructure funds. Successful research funding is dependent upon having an important clinical/scientific question, an updated systematic review (meta-analysis), an expert team (“the best in the country”), practice survey (to understand what is currently being done), pilot studies. The ANZCA CTN have had outstanding success in terms of major practice changing trials involving thousands of patients and an almost perfect record of major grant success.
The third and final talk in the series of talks showcasing the outstanding achievements of other Australia and New Zealand clinical trial networks was given by Associate Professor Ed Oakley, who is the chief investigator for the Paediatric Emergency Medicine Centre of Research Excellence and the Paediatric Research in Emergency Departments International Collaborative (PREDICT), a multicentre research network in paediatric emergency medicine. This group was founded in 2004 and its structure and regulations borrowed heavily from existing international research networks. There were 11 founding sites and 4 newer sites, a mix of tertiary paediatric and larger mixed EDs that are geographically spread across Australia and New Zealand. They received initial seed funding for meetings and then set about trying to develop a track record and set a research agenda. They had their first NHMRC success to conduct a 7-centre RCT in 2009 (after a failed attempt in 2008). A CRE was successfully funded in 2013 to provide infrastructure and development support including training of clinician researchers, a PhD program and mentoring program by overseas experts and large scale data management. Several large studies including a knowledge translation trial are underway. Their priorities have been to get research infrastructure at most sites, get protection of research time, link with other groups for knowledge transfer, maximise the CRE infrastructure and find a funding stream past the CRE.
In terms of success, they have developed a functional high quality research network from scratch in 10 years, established a good track record, collaboration with multiple specialties and craft groups and are engaging in global research and research groups. Their challenges include lack of ongoing infrastructure support; lack of assured funding and sustainability into the future (no ongoing funding stream and no research stream for clinicians and postdoctoral fellows); development of paediatric emergency medicine as a credible academic discipline; and knowledge translation (including the tension between times for research versus practice change).
Break out sessions
Break out session 1: Vision, mission and values of ANZMUSC and its structure
Professor Jane Latimer outlined the plans for the breakout session on Day 1. Each small group was asked to consider the overarching vision for ANZMUSC, which should be aspirational (where we want to be) and inspirational (stimulate action); our mission or how we plan to achieve our vision in a short series of statements with due consideration of scope; and what values or principles or standards of behaviour we would consider important for ANZMUSC. They were also asked to consider the ANZMUSC structure, for example this could be simple, acknowledging the early stage of ANZMUSC, a more formalized structure that includes key ANZMUSC committees and external partners, or a new structure suggested by the group. She emphasised the need for good governance that would ensure network primacy over individuals, transparency of rules, an executive that is representative of members (multidisciplinary), is responsible to its members, and turns over at regular intervals.
In the reporting back session, spokespeople from each group reported back on the small group discussions. All groups considered that there was a genuine need for a collaborative musculoskeletal clinical trials network. There appeared to be fairly consistent themes across groups that the primary aim should be to perform high quality research that would maximally improve the quality of health care and patient outcomes. There was discussion about whether or not the network should only do clinical trials or whether it could also include other study designs recognising that preliminary work might be needed before being ready for a trial. Mentoring and training were considered important. The ideas of all groups were recorded as statements and the working group undertook to synthesise these into a draft vision, mission and values statement for summit feedback on Day 2.
On Day 2, the draft vision, mission and values of the ANZMUSC Clinical Trials Network were presented to the summit attendees for consideration. The final version that was accepted by the majority of those present is shown below.
To optimise musculoskeletal health through high quality, collaborative clinical research.
- To identify the key clinical research questions relevant to musculoskeletal health.
- To improve the scientific quality of musculoskeletal research and its translation into policy and practice.
- To facilitate and endorse clinical research based on scientific quality and potential to improve health outcomes.
- Advocate for musculoskeletal research support.
- Foster collaboration between research groups and stakeholders.
- Advance the understanding of research through mentoring and education.
- Altruistic (generous, benevolent)
- Scientific integrity
- Mutual respect
- Health consumer centred
Break out session 2: Initial Goals and how these can be achieved
Professor Ian Harris outlined the plans for the breakout session on Day 2. Participants were asked to consider what needs to be achieved before the next annual meeting to set up the future success and sustainability of the group. They were asked to identify the most important goals. For each proposed goal they should consider its relevance, its necessity and whether it is achievable; they should precisely state the goal and how it will be achieved including who would be involved and any barriers to overcome. Finally they were asked to rank them in order of priority.
In the reporting back session, spokespeople from each group reported back on the small group discussions. Again there were similar themes noted. The following summarises the agreed one-year goals.
One year Goals
1. Structure and Governance
Clear and transparent structure and governance in place in 12 months
· Caretaker working group in short term
· Expand working group size and membership to include representative from New Zealand and consumer representative (skills based))
· Appoint Executive Officer
· Undertake stakeholder mapping
2. Define Key Functions of ANZMUSC
Develop policy and processes regarding how ANZMUSC will function
· Facilitate high quality research
· Link researchers answering same questions
· Multi-site recruitment, contribution, national, international collaboration
· Methodology input, mentorship, peer review
· Define priorities
· Endorse any high quality trial (not just priority area trial). No limitation on this.
· Funding longer term
Seed funding options depend upon available funding
· Executive officer (FT/PT) appointed early to enable us to move forward
· Consultancy firm?
· Prioritise how this money will be spent
· Implement structure and governance
· Goal amount $200,000 – $250,000??
4. Establishing and Expanding Membership
· Who can be a member – process for membership (individual); separate category for consumer membership?; and company membership?
· Nomination and seconder, board has final approval
· Know who our members are
· Relevant registration information to be recorded, easy website process
5. Plan future meeting and communication strategy
· Next meeting during ACTA Sydney, Oct 7-10, 2015
· Plan full meeting for April 2016
· Communication via anzmusc.org website
· Summary of meeting for those who could not attend including agreed vision, mission and values to be placed on the website
· Funders stakeholder meeting (consumer and professional organisation etc.) to discuss ways of establishing 5 year infrastructure support
· Apply for ANZMUSC CRE funding
2016 Annual Scientific Meeting Report
Wednesday April 27th – Thursday April 28th 2016
The Darlington Centre at the University of Sydney, 174 City Road, Darlington, NSW
Generously supported by
Monash University and Cabrini Health (Foundation Sponsors) and The George Institute and University of Sydney (2016 Annual Scientific Meeting Sponsors)
Goals of the Meeting
Following on from the successful 2015 inaugural summit, ANZMUSC held its second ASM and pre-meeting workshop on consumer engagement in clinical research (conducted by Ms Anne McKenzie AM from the University of Western Australia). The aims of the meeting were to:
- establish the foundations of ANZMUSC through agreement on ANZMUSC structure, governance and endorsement processes
- conduct the networks’ first open-forum sessions for the presentation, discussion and development of musculoskeletal research proposals for potential ANZMUSC endorsement
Attendees at the Summit
There were 66 participants at the Summit. Participants were affiliated with 12 Universities in Australia and New Zealand as well as various research institutes and hospitals, consumer organisations and professional societies.
Professor Vlado Perkovic, Executive Director George Institute Australia and George Clinical
Vlado Perkovic is Executive Director of The George Institute, Australia, Professor of Medicine at The University of Sydney, and a Staff Specialist in Nephrology at the Royal North Shore Hospital. His research focus is in clinical trials and epidemiology, in particular in preventing the progression of kidney disease and its complications. He leads several major international clinical trials, serves on the Steering Committees of several others, and has led the development of George Clinical, the global clinical trials arm of The George Institute. He has been involved in developing Australian and global guidelines in kidney disease, cardiovascular risk assessment and blood pressure management.
Professor Jonathan Craig, Associate Dean of Research in the Faculty of Medicine and Course Director of the Clinical Epidemiology, University of Sydney
Jonathan holds a Personal Chair in Clinical Epidemiology at the University of Sydney, and is a Senior Staff Specialist at the Children’s Hospital at Westmead. He is internationally recognised clinician-scientist, with more than 550 publications focussed on improving the health of well being of people with chronic kidney disease, especially children and Indigenous people. His awards include International Distinguished Medal of the National (US) Kidney Foundation (2010), TJ Neale Award for Outstanding Contribution to Nephrological Science, and Honorary Membership of the Italian Society of Nephrology (2004). He is a past Chair of the Steering Group of the Cochrane Collaboration, is a member of NHMRC Expert Advisory Group: Structural review of NHMRC funding, and NHMRC Advisory Group on the Synthesis and Translation of Research Evidence, a member of the Pharmaceutical Benefits Advisory Committee, and Medicare Services Advisory Committee.
Our meeting commenced with a plenary session regarding the conduct of major multi-centre clinical trials in 2016. This included presentations by Professor John Myburgh AO,(George Institute of Global Health) Associate Professor Laurent Billot (George Institute for Global Health) and Ms Amanda Jubb (George Clinical) focusing on ethics, recruitment, data management, statistics and monitoring requirements and strategies. We also fortunate enough to have 2 insightful presentations by Professor Jonathan Craig (University of Sydney) regarding the priority setting process and a discussion about what things ANZMSUC might consider in doing its own priority setting. We also held an early career breakfast featuring presentations by Associate Professor Christine Lin (George Institute for Global Health), Dr Chris Williams (Hunter New England Local Health District), Dr Saraid Billards (Director of the Research Grants team, NHMRC) and Ms Nicola Garrett (Co-founder and Editorial Director at the limbic).
The major achievement of the meeting was the discussion and agreement on the ANZMUSC structure and governance procedures and policies facilitated by Professor Vlado Perkovic. Over 2 sessions, the group worked to together to discuss the ‘ins’ and ‘outs’ of how ANZMUSC will function, and the alterations to the policies and procedures needed to ensure that ANZMUSC functions in a way that its members approve of. At the end of the 2 sessions, we had 96% agreement on the structure of ANZMUSC, 96% agreement on the membership policy, 100% agreement of the Consumer Advisory Group Terms of Reference, 85% agreement on the endorsement process and 83% agreement on the publication policy. A summary of the proposed changes to each of the documents is available here.
A second major achievement was the running of 4 open-forum proposal sessions for (potential) ANZMUSC endorsed trials. We heard a variety of research protocols ranging from trials that had been fully developed (and funded) through to new research ideas only in their infancy. These proposals were presented by senior researchers through to less experienced researchers. Each proposal was reviewed prior to the meeting by an ANZMUSC member and a member of the ANZMUSC Working group, who orally presented the summed review feedback in order to stimulate collegiate discussion and questioning to help improve the scientific rigour of the project.
We are pleased to announce that following the meeting, the Working group has endorsed 2 trials:
- A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE). CIA Professor Ian Harris AO
- Targeting pro-nociception to prevent chronic pain after whiplash injury. CIA Michele Sterling
2nd Year Goals
We also came up with some second year goals for the group including:
- Appointment Executive Officer
- Finalise ANZMUSC policies and procedures
- Appoint Scientific Advisory Group
- Appoint Consumer Advisory Group
- Conduct priority setting literature review in preparation for priority setting meeting
2017 Annual Scientific Meeting Report
10-11 May 2017, SAHMRI, Adelaide, SA
Generously supported by
Cabrini Health and Monash University (Foundation Members)
Goals of the meeting
Following the second successful ANZMUSC meeting in 2016, the 2017 meeting aimed to provide ANZMUSC members with an update on ANZMUSC activities and future goals and provide members the opportunity to discuss research proposals for potential endorsement. The meeting also had sessions on rapidly translating evidence into policy and practice and contained presentations by MSK investigators involved in the conduct of high quality MSK trials recently published in high impact journals.
The 2017 meeting was attended by 62 delegates from across Australia and New Zealand representing 36 Universities and research institutes as well as various research institutes, professional associations and consumer organisations. Also in attendance for the first time were members of the ANZMUSC CAG; Ms Suzie Edward May (WA), Ms Charlotte Hewson (NZ), Ms Linda Spurrier (ACT) and Ms Annie McPherson (VIC).
Day 1 Presentations
Session 1: ANZMUSC Clinical Trials Network Update
Dr Sheila Cyril, ANZMUSC EO, provided an overview and update on ANZMUSC activities to date including the finalised ANZMUSC structure and governance policies, the establishment and activities of the Scientific Advisory Committee (SAC), the Consumer Advisory Group (CAG), the administrative office, the External Advisory Group (for the CRE) and the Funders Group. She also updated us on the growth of ANZMUSC with 177 members including 8 consumer advisory (CAG) members from various states in Australia and New Zealand. Other goals set by ANZMUSC at the 2016 meeting including the endorsement of 2 trials and the commencement of the priority setting activities was mentioned along with additional achievements such as the establishment of a Chiropractic Australia and COCA Research Pty Ltd funded PhD scholarship in partnership with ANZMUSC and the Consumer Research Registry,
Dr Allison Bourne, Research Fellow, Monash Department of Clinical Epidemiology, provided an update on the ANZMUSC systematic review of priority settings for Arthritis and MSK conditions currently being undertaken as part of the ANZMUSC priority setting project. The systematic review aims to synthesise existing priority statements for clinical research for arthritis and MSK conditions available in the published literature and summarise the methods used to generate these priorities. The search strategy includes the Ovid Medline database, Cochrane priority setting methods group, the James Lind Alliance website, the Cochrane Musculoskeletal and Cochrane Back Groups review priority list, the US National Guidelines Clearinghouse and the Guidelines International Network. Screening of titles and abstracts of 5000+ articles have been completed. Data extraction of included articles is underway.
Ms Ornella Clavisi, CAG Chair, Research & Knowledge Manager, MOVE muscle bone and joint health, Victoria, summarised the function of the CAG and provided an update on the Consumer Research Registry (CRR). The CAG provides a mechanism for consumer input on ANZMUSC trials by reviewing trial proposals, advising on research priorities, reviewing and informing ANZMUSC policies and procedures and participating in working groups and reviewing participant materials of endorsed trials. The CRR provides an opportunity for consumers to function as research partners and provides a platform for researchers and consumers to communicate effectively. Discussions following her presentation highlighted the importance of education and resources to train consumers in research, clinician involvement in research and the role of qualitative research in ANZMUSC. The ability of the CRR to articulate with Twitter and other social networking platforms, as well as the reporting of clinical trials in a form that consumers could easily understand was also discussed, as was the need for plain language summaries of trial results based on consumer feedback. The audience discussed the possibilities of the CRR to enable consumers’ involvement in the latest research and trials taking place in hospitals. Consumer involvement in ATSI groups and the role of infograms (e.g. informing consumers on prostate cancer) in MSK research was also discussed.
Following this, we heard from two consumer members of the CAG. Ms Suzie Edward May, Director, Giving Voice Australia, Deputy Chair Eastern Metropolitan Health Service, WA, discussed the importance of using qualitative research methods and consumer partnerships to incorporate the “true patient voice” in ANZMUSC research. She described her own experiences around the lack of information for consumers regarding arthritis medications and pregnancy and detailed the qualitative research she conducted across five countries to inform her book ‘Arthritis, pregnancy and the path to parenthood’. The book is now available in 14 countries and is recommended reading for GPs by the RACG http://www.givingvoice.com.au/book. She concluded her presentation by highlighting the need for research findings to be presented in ways that are accessible to consumers at all levels of health literacy and acknowledged the immense collaborative opportunity the partnership between consumers and researchers in musculoskeletal research provides by producing research that is relevant to both consumers and clinicians.
Ms Annie McPherson, President and founding member, Ankylosing Spondylitis Victoria (AS Vic), provided an account of what is needed in the formation of peer support groups and the challenges such groups face. She likened the concept of establishing a peer support group to mixing a large cake, with many layers and ingredients such as skills in internet, email, member subscriptions, banking, newsletter writing, social event coordination and seminar preparation and production. She briefed us on the support provided by MOVE, muscle bone and joint health Victoria, in establishing AS Victoria and providing ongoing education in community support and activities. Currently, AS Victoria members provide support and patient talks in the Physiotherapy based exercise program at Caulfield Community Health in Alfred Health’s Caulfield campus, Victoria. Finally, she discussed the eagerness of consumers to know what research is being conducted and highlighted the ability of patient advocacy groups to be involved in the spreading the word about clinical research.
Session 2: Rapidly translating evidence into policy and practice
Professor Maria Makrides Theme Leader Health Mother, Babies and Children, SAHMRI, discussed the challenges and lessons learned in the STEP trial which aimed to trial whether the incidence of egg allergy is reduced by early, regular egg exposure from 4 – 6.5 months compared with delaying egg introduction. The trial results found no increase in allergy as a result of early introduction and was consistent with other trials (including the STAR, BEAT< EAT and HEAP) investigating food allergy and exposure during infancy. Maria highlighted the challenges with converting research findings such as the STEP trial into practice given the challenges in setting a concrete deadline for the age at which exclusive breast feeding should end given the benefits of breast feeding. To address this issue, Maria described a stakeholder summit that was conducted to produce a harmonised guidance statement and concluded her presentation with a discussion about the infographics information sheet being produced to assist with consumer communication.
Following Maria’s presentation, Professor Steve Wesselingh, Executive Director SAHMRI, gave a presentation about the power of Advanced Health and Research Translation Centres to improve the speed of research translation. He highlighted some of the problems with existing health research models including money and entrenched practice, time poor practitioners, lack of financial incentives and difficulty in behaviour change. He also highlighted the current structural issues including dichotomy of funding streams leading to lack of coordination between research funding and health service delivery and the issue of hospital KPIs being based on procedures not on patient outcomes or whether research has been moved into health care.
To overcome these issues, the NHMRC has accredited 4 Advanced Health Research and Translation Centres (AHRTC); Alfred Health and Monash Health Partners, Melbourne Health Partners, South Australian Health Partners and Sydney Health Partners. These centres have the state-wide involvement of primary care, Aboriginal Health, universities and local health networks. The SA Health Centre is chaired by Prof Steve Wesselingh and focuses on 7 priority areas:
- Aboriginal health
- Colorectal cancer
- Cardiac rehabilitation
- Translation of evidence (arthroscopy, hysterectomy, c-section, diabetic amputation)
- Evidence-based pathways (eg. stroke, diabetes)
- Translation pipeline (clinical trials, commercialisation).
- Data access and delivery
He concluded his presentation by highlighting the major opportunity these centres have to embed evaluation, research and workforce development in health services, and how they will improved health outcomes, evidence-based models of care, evidence-based health promotion and prevention, shared data collection and evaluation and consumer engagement by promoting health services to embrace research and training.
Session 4: Australian MSK trials in high impact journals
Day 1 concluded with a session on recent MSK trials published in high impact journals. The first presentation by Dr Xingzhong Jin described his RCT investigating the effect of Vitamin D supplementation on tibial cartilage volume and knee pain among patients with symptomatic knee osteoarthritis (Xingzhong Jin, MD; Graeme Jones, MD, PhD; Flavia Cicuttini, MD, PhD et al JAMA. 2016;315(10):1005-1013. Doi:10.1001/jama.2016.1961). This double-blind placebo-controlled multi-centre RCT concluded that there were no significant differences in annual change of tibial cartilage volume and WOMAC pain score over 2 years and overall does not support the use of vitamin D supplementation for preventing tibial cartilage loss or decreasing pain in patients with knee osteoarthritis. This result contrasts with other studies that have found a small but significant benefit and a systematic review that suggested Vitamin D may promote structural changes in OA. Dr Jin concluded his presentation by highlighting the difficulties in publishing negative trial results and the need to carefully consider primary and secondary end outcomes to ensure the most relevant outcome is measured.
For the final presentation of day 1, Professor Stephen Nicholls, Heart Disease Research Theme Leader, SAHMRI discussed the strengths and weaknesses of surrogate markers that he’d witnessed in cardiometabolic clinical trials. He outlined the numerous benefits of using surrogate markers in clinical trials including; the ability to perform smaller and faster trials; provide potential mechanistic effects; give early no/no-go signal; inform optimal dosing for larger trials and the potential for inclusion in regulatory filings. He also outlined the risks associated with surrogate markers including; a lack of information on safety and cost-effectiveness and a limited capacity to prove comparative effectiveness. He also discussed the need for any changes in surrogate measures to be predictive of the relevant clinical outcome and for them to capture the effect of the intervention on the clinical outcome. He gave several examples of biomarkers used in cardiovascular and diabetes trials that may be inefficient markers including LDL and Glycated Haemoglobin and concluded with the acknowledgement that although surrogate markers play an important role in testing new therapies, they ultimately cannot replace clinical outcomes.
Day 2 Presentations
Session 1: Australian MSK trials in high impact journals continued
Day 2 began with the presentation of more MSK trials recently published in high impact journals. Associate Professor Christin Lin, Senior Research Fellow, University of Sydney, began the session with a summary of her groups trial about the effectiveness of Pregabalin for acute and chronic sciatica (Mathieson S, Maher CG, McLachlan AJ, Latimer J, Koes BW, Hancock MJ, Harris I, Day RO, Billot L, Pik J, Jan S, Lin CC. N Engl J Med. 2017 Mar 23;376(12):1111-1120. doi: 10.1056/NEJMoa1614292). This randomised, double-blind, placebo-controlled trial found that over a course of 8 weeks, treatment with Pregabalin did not significantly reduce leg pain caused by sciatica or improve any of the secondary outcomes compared to the placebo group. Additionally there was a higher rate of adverse events in the intervention group overall, arguing against the use of Pregabalin for the management of sciatica.
Following this, Professor Rana Hinman, Professor of Physiotherapy, University of Melbourne, presented the results of a clinical trial aiming to test whether using appropriate footwear to reduce knee overload is effective for the self-management of knee osteoarthritis (Hinman RS, Paterson KL, Wrigley TV, Bennell KL. Ann Intern Med. 2017 Feb 21; 166(4):312. Doi: 10.7326/L16-0630). In partnership with a shoe company, the group created a shoe that showed reduction in external knee adduction but failed to find a difference in pain with walking and on other outcomes measured in this randomised control trial. Treatment outcome modifiers and limitations around the ability of improved biomechanics to improve clinical symptoms were raised as potential reasons why no difference was found.
Next Associate Professor Justine Naylor, Senior Principal Research Fellow, Orthopaedics, South Western Sydney Local Health District, presented the outcomes of an RCT evaluating the effect of inpatient rehabilitation vs a monitored home- based program on mobility in patients with total knee arthroplasty (HIHO) recently published in JAMA. (Buhagiar MA, Naylor JM, Harris IA, Xuan W, Kohler F, Wright R, Fortunato R.JAMA. 2017 Mar 14;317(10):1037-1046. doi: 10.1001/jama.2017.1224). Overall the study showed no significant difference between the inpatient and home-based groups across a range of outcomes at 10, 26 and 52 weeks after surgery. Justine also discussed the barriers and enablers to changing practice following this study including geographical barriers to inpatient rehabilitation, variations between clinician and patient preferences for rehabilitation and cost-effectiveness of rehab programs. On a positive note, a newspaper report from The Australian (15/3/2017) stated that private insurers support the conclusions of HIHO and advocated for the need for more transparency around the cost-effectiveness of rehab programs to enable consumers make informed decisions around their healthcare and private hospitals (including Cabrini Health) are discouraging clinicians from using inpatient rehab. The group will be conducting a similar trial following hip arthroplasty.
Session 3: Update from ANZMUSC endorsed clinical trials
In Session 3, we heard an overview and update on the progress on the 2 endorsed ANZMUSC trials. Professor Michele Sterling, Director, NHMRC Centre of Research Excellence in recovery Following Road Traffic Injuries, discussed her study on targeting pro-nociception to prevent chronic pain after whiplash injury. Specifically, this study aims to trial whether early consumption of Pregabalin in acute whiplash, prevents chronic pain that develops in 50% of people after a whiplash injury via a double blind, randomised, placebo-controlled trial to be conducted at 2 centres on the Gold Coast. A study protocol describing the strict inclusion and exclusion criteria has been developed and published for the study. Primary and secondary outcomes have been defined and the group has commenced enrolling participants at the Gold Coast University Hospital and plans to start recruiting at Ipswich Hospital shortly to boost recruitment rates. Other challenges including the cost of after-hour patient consultation for nurses and physiotherapists, and flexibility in RA hours have been identified and are being addressed.
Professor Ian Harris AM, Director, Whitlam Orthopaedic Research Centre, provided an update on the ANZMUSC endorsed study “A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly – CROSSFIRE”. This multicentre randomised comparative effectiveness trial aims to determine whether surgical intervention (plating) leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and old. An investigator video has been developed available at youtube.com/watch?v=DBx89JQHvRY&t=4s. Participant video incorporating consumer input is currently underway. Currently, the trial is running in 7 sites including Mackay Base Hospital, Liverpool Hospital, JHH, Canberra Hospital, Nambour Hospital, RAH, POWH, Epworth Healthcare, Townsville Hospital and Wellington Hospital. The trial has been registered on the ANZCTR and 15 participants have been recruited (5 randomised: 10 observational). The protocol has been accepted for publication in BMJ Open.
Session 4: CRE and building and developing capacity in ANZMUSC Network
During the last session of the meeting, we heard from Professor Chris Maher, Director, Musculoskeletal Health Sydney, University of Sydney, on the CRE ANZMUSC submitted late last year in order to help ANZMUSC build a workforce of trained musculoskeletal clinical trialists by providing the infrastructure, financial support, methodological leadership and research outcome incentives to encourage clinicians from different disciplines to become actively involved in research. A number of initiatives were included in the CRE application including clinical research fellowships, research project seed funds, summer research scholarships, consumer training workshops, investment in personnel to coordinate ANZMUSC, recruiting/supporting PhD students, postdoctoral fellows and clinician researchers, and providing expert mentoring for their CRE supervisors. The CRE also aims to develop large-scale project management processes to streamline all aspects of the trial process, reduce duplication of effort, and embed trials in routine care. Discussion following the presentation also raised the possibility of ANZMUSC being involved in a national biobank for Rheumatoid Arthritis which is already in the process of being established.
Following on from this, Associate Professor Will Taylor, University of Otago, NZ, provided an overview and update on the ANZMUSC Priority setting project. The project aims to a) develop a framework to determine the importance of a research question and to generate a set of researchable questions; b) develop a non-exhaustive ranked list of musculoskeletal research questions that will enable ANZMUSC to determine if projects meet the ANZMUSC endorsement criterion 1. ANZMUSC prioritisation will involve creating explicit criteria by which a question is considered important, such that new ideas can be immediately rated. The project will deliver a list of research questions that are ranked by importance by ANZMUSC, and includes the following steps
- Lit review (criteria and methods for prioritisation suggested by others) (underway)
- Delphi survey (on what ANZMUSC members think makes a research question important) (underway)
- Consensus workshop (to agree on a manageable set of the most important questions)
- Weighting workshop (to assign meaningful numeric scores to each question) (via discrete choice experiment)
- Application to initial questions, membership survey, document review
The first Delphi survey has been completed by 66 ANZMUSC members including researchers, clinicians, policymakers and consumers and has generated 5 main themes: potential for impact, population need, nature of the intervention, broad appeal, whether the project is able to be delivered/ implementability.
The final presentation of the meeting was from Professor Sally Green, Co-Director of Cochrane Australia, who presented on promoting effective transfer of research outcomes into health policy and practice. Transferring research findings into policy offers ANZMUSC the opportunity to further the science of research translation of MSK conditions (performing implementation trials to check what works for translation into policy, developing living systematic reviews and living guidelines); and effectively disseminating and translating the results of the CRE through external advisory boards, clinical researchers, media and communications plans. She also discussed the “new evidence ecosystem’ which involves linked data repositories, living systematic reviews and living guidelines to support decision making in health practice and highlighted the challenges in generating evidence (Elliot JH, Turner T, Clavisi O, Thomas J, et al. (2014) PLoS Med 11(2): e1001603) as well as the various challenges in current guideline development.
Sally then went on to talk about projects within the Cochrane group including the Cochrane Crowd who identify RCTs and the Cochrane Evidence pipeline which automatically identifies the study design, review group and PICO. She also talked about living (continuously updated) systematic reviews and noted that nesting living systematic reviews in a trials network is a perfect opportunity to identify important evidence-practice gaps, conduct trials, feed the results into guidelines, and conduct implementation trials (Elliott JH, Turner T, Clavisi O, Thomas J, Higgins JPT, Mavergames C, et al. (2014) Living Systematic Reviews: An Emerging Opportunity to Narrow the Evidence-Practice Gap. PLoS Med 11(2): e1001603 https://doi.org/10.1371/journal.pmed.1001603). It was also noted that guidelines could be more efficient if they were ‘living’ as well.