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Last Revised 22 September 2O16      
 
Innovation This paper discusses ways in which principles of "innovation management" guide the diffusion of new knowledge. The paper (repeated and expanded upon here) was developed by Peter Sullivan in conjunction with the 14th Annual Scientific Meeting of the Australasian College of Phlebology in Melbourne, Australia, in March 2011. For a number of years Peter (a person with MS) was a member of a national judging panel that recognised and fostered innovation across a range of disciplines. Topics discussed include
 
   1. What is Innovation?   7.  Text Books Rewritten
   2. What is the connection between Innovation and MS?    8.  Adapting to Change
   3. Simplicity in communication -The basic truth is simple    9. The 6 Key Result Areas
    4. About patient centred care - A Reference Group   10. Action Strategy
    5. Early Feedback - The 34 Position Points   11. Parliamentary Dialogue
    6. Treatment Delayed is Treatment Lost   12. Parliamentary Recognition
     
  WHAT IS INNOVATION?
 
Innovation Innovation is the process that renews something that exists and not, as is commonly assumed, the introduction of something new. Often the outcomes of innovation cause us to think about old things in new ways. The central meaning of innovation relates to renewal. For renewal to take place it is necessary for people to change the way they make decisions , they must choose to do things differently and make choices outside of their norm. .
  True innovation changes the values on which a system is based. When people change their value systems the old systems frequently struggle to make room for the new. When that happens innovation has occurred. Innovation is something that does, not something that is
  INNOVATION MANAGEMENT
  The process of innovation management (sometimes referred to as diffusion) recognises five broad groupings of stakeholders who influence (either positively or negatively) the paths through which innovation progresses. Key players comprise a series of 'interest groups'' broadly described as Innovators. Early Adopters, Early Majority, Late Majority and Laggards. Innovation does not ''go away'' - but progresses through the ''paths of least resistance'' often at significant cost to organisations (and nations) who do not identify the fostering of innovation as a strategic priority  - more about innovation management.
   RESISTANCE TO CHANGE
  Eminent physicist and Nobel Prize winner for his work on quantum theory, Max Planck (1858-1947) once commented: “A scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die and a new generation grows up that is familiar with it”. Hence, it is not surprising that new concepts often meet with great hostility. As illustrated in December 2015, by Professor Bernhard Juurlink, in a publication titled 'Time to Revisit Non-Pharmacological Research Approaches to Ameliorate Multiple Sclerosis Symptoms', Multiple Sclerosis is no exception.
  A SHIFT IN EMPHASIS - COLLABORATIVE PATIENT-CENTRED DECISION MAKING
  The 21st century transition of the Agricultural/Industrial societies of Planck's era to a significantly Knowledge Based society (and economy) brings with it a shift in emphasis from somewhat rigid nation/state/professional/boundaries to collaborative relationships that focus on the needs of the individual - whereby health services are developed  with patients not for patients. A process sometimes referred to as patient-centred or consumer-directed care.  At the same time,  easily accessible,  but powerful ''decision support'' research technologies are helping to further equalise potential power imbalances at a host of different and divergent levels. These changes are not necessarily welcomed by all.
   WHAT IS THE MULTIPLE SCLEROSIS ''INNOVATION CONNECTION''?
 
This connection stems from an ongoing range of developments whereby it is being found that many of the most common symptoms of multiple sclerosis (MS) are frequently alleviated through long standing, minimally invasive, vascular procedures and practices. .
  While vascular associations with MS have long been referenced in the literature it was not until 2009, when Professor Zamboni reported on the outcomes of treating MS patients with venoplasty, that the significant associations between blood flow irregularities and MS (and some other neurological disorders) began to attract increased global attention. This vascular disorder is known as chronic cerebrospinal venous insufficiency (CCSVI).
  During the course of the following 5 years it was regularly demonstrated that many of the most common disabilities experienced by those with MS improved/disappeared following treatment for CCSVI conditions, which are experienced by around 80% of those with MS. These beneficial outcomes  being welcomed by thousands of families living with MS.  Notwithstanding, there remains an underlying body of scepticism that potentially distracts from the significance of what is being learnt.
   INNOVATION OF A HIGH ORDER
 
When commenting on these seemingly divergent views Peter said ''such divergency is one of the hallmark of true innovation whereby different stakeholders, rightly or wrongly, seek to defend and support investments in the status quo''.
  At its most basic level, CCSVI, per se, is recognised as a vascular disorder in its own right that can contribute to a range of symptoms frequently associated with MS. At another level it has become the cornerstone for a myriad of previously uncontemplated medical explorations about the long term impact of vascular and lymphatic irregularities not only in relation to MS progression but also other neurologically based disorders. Peter went on to say "this  paradigm shift in thinking, and reactions thereto are being shown to challenge and change many of the significant values on which MS is understood and treatment based. This ranks this contribution (originating in the field of MS) as innovation of a high order".
  AUSTRALIANS ARE AT THE MS INNOVATION FOREFRONT
 
Testament to this view is the selection (13 October 2015) of ÇCSVI Australia (also known as Neurovascular Research Australia} as a finalist in Melbourne Australia's 2015 awards for ''Innovative organisations, iconic institutions and outstanding individuals''.
  Despite receiving no government funding, their fundraising allowed them to commission an internationally recognised and endorsed medical trial of the removal of jugular vein obstructions in people with Multiple Sclerosis (MS) to relieve MS symptoms. The trial has attracted global interest, funding and talent to The Alfred Hospital, and placed The Alfred at the forefront of medical research, with world-renowned scientists and medical specialists visiting to collaborate - find out more.
  SIMPLICITY IS THE CHALLENGE
  Simplicity is one of the keys to successful innovation. But simplicity is not the same as having simple ideas. Rather, it’s about taking sophisticated ideas and design and being able to reduce them down to a simple explanation. It’s about reducing the complex into something that is easy to understand. It’s about resisting the temptation of being clever and instead, focusing on creating a message that will resonate with the masses.
 
Communication An excellent example in relation to CCSVI is Kerri Cassidy's video library. This library follows Kerri's journey over more than 5 years since her treatment. Topics covered are: In the beginning "I had a doppler scan yesterday" - The journey begins (good starting point) - treatment (part1) - treatment (part2) - Treatment outcomes after:- 7 days - eight months - one year - three years - four years - 5 years. Other interesting discussions by Kerri relate to the role of Hope and her role as CEO of CCSVI Australia.
  A further example is a radio interview conducted in Melbourne Australia with Jennifer Robinson, a person diagnosed with MS, wherein she discusses her personal CCSVI experiences and expectations leading to her joining the Board of CCSVI Australia.  If you are not all that familiar with the CCSVI story then  take a few minutes to hear from Kerri or Jennifer.
 

PATIENT CENTRED FEEDBACK IS VITAL

Feedback (since 2011) from more than 2,700 families, friends, carers and service providers has also inspired the development of a Parliamentary Open Letter on this topic. About this Open Letter. More broadly, longitudinal studies involving increasing numbers of people with MS treated with venoplasty for CCSVI conditions, are reporting significant and enduring relief from a wide range of disorders associated with MS - especially for those with relapsing/remitting forms of MS where improvements are described as "significantly good'' - find out more.

  ADDRESSING THE CHALLENGES
For all of the foregoing reasons it is important for Australia to continue to foster environments that support the advancement of CCSVI medical knowledge while, at the same time, addressing the ''here and now'' needs of Australians with seriously debilitating CCSVI related vascular disorders. In short, to encourage the innovation influence, support (and learn from) the early adopters, promote broader awareness with those most likely to benefit, and protect the vulnerable.

While much is being achieved by the remarkable Alfred Hospital ‘’patient centred’’ innovation there is significant scope to accelerate this iconic research. Given that an estimated 200,000 Australians are associated with families living with MS better targeted government policies and programs readily spring to mind. The very recent emphasis by Prime Minister Turnbull identifying the importance of fostering Australian innovation accentuates this need.
  A PATIENT CENTRED PERSPECTIVE
 
During  2010 a Reference Group, drawn from the Australian MS community, was established with the aim of identifying, highlighting and progressing issues impacting upon the ability of the Australians with MS to access CCSVI vascular screening and possible treatment and, in consequence, to develop a draft Australian CCSVI Implementation Strategy.
  Participation by such a group is consistent with decisions (2010) by all Australian Health Ministers to transition to a patient-centred approach to the planning, delivery, and evaluation of health care that is grounded in mutually beneficial partnerships among healthcare providers, patients, and families. Superior organizational leadership is identified as key to these aims. Attachment 1 summarises early feedback received by this Group in response to a widely distributed discussion paper.
  THE BASIC TRUTH IS SIMPLE
  The Group found that while the basic truth concerning CCSVI is simple, all too frequently institutional systems and/or potentially competing agendas make it complex. The key question, as evidenced by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) is:
  "Does Percutaneous Venoplasty make a difference in relieving the symptoms of multiple sclerosis by improving cerebrospinal venous drainage"?
  HealthPACT went on to describe Percutaneous Venoplasty as "an established, routine procedure, with a proven safety and efficacy" and highlighted early research in relation to MS whereby "this procedure "significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up". It stressed the importance of further research before the procedure can be widely adopted.
  THE SIX KEY RESULT AREAS
  On an ongoing basis the Reference Group is proactive in creating awareness of these issues across a broad spectrum of platforms and stakeholders. The group commenced this process by putting forward for discussion a draft for an Australian CCSVI Action Strategy. This evoked wide ranging feedback - which serves as a valuable planning resource. Appendix 1 highlights 34 key "position points" that reflect this feedback. Six Key Result Areas were subsequently identified to guide future direction.
  TREATMENT DELAYED IS TREATMENT LOST
 
In July 2015 the Reference Group provided a report  titled 'Treatment Delayed is Treatment Lost''. The Executive Summary says ‘’It seems extraordinary that, after five years, less than 3% of the Australian MS population has been able to gain access to treatment - something is seriously wrong. Apart from potentially providing significant relief to seriously ill people, substantial economic benefits are being forgone'' - access this report
 
The translation of new thinking into improved practice is sometimes described as a process that 'makes the strange familiar and the familiar strange' . During this 'communication process' new ideas are not necessarily evaluated from a scientific standpoint; rather, subjective perceptions of the innovation influence. The process occurs over time. Social systems determine diffusion, norms on diffusion, roles of opinion leaders and change agents, types of innovation decisions, and innovation consequences.  Read more about the activities of the Reference Group..
 
  ADAPTING TO CHANGE - PRINCIPLES OF INNOVATION MANAGEMENT
 
Adaption The diffusion environment is one that recognises the key players as comprising a series of 'interest groups' broadly described as Innovators. Early Adopters, Early Majority, Late Majority and Laggards.
  Each group plays a significant, but different, role in the diffusion process. People's roles will differ according to the nature of a specific innovation and the ways, if any, that it may impact on their lives. The characteristics of the five adopter categories are as follows:
  Figure A - The Diffusion of Innovation - click on the Social System Category to learn about how this model is playing out in Australia in relation to the treatment of people with multiple sclerosis for CCSVI related vascular irregularities - click on the Support Strategy to learn more about the various stages in the diffusion process.
 
Social System Category   Category
Percentage
Characteristics Support Strategy
'In a word'
Innovators 2.5%

Innovators are the agents of change. They instinctively know that the vast majority of new ideas are not original but are adapted from something else. Most great ideas are really combinations of other ideas. Innovators often cause us to see 'old things in new ways'

Encourage
Early Adopters  13.5%

Early adopters are often opinion leaders, and serve as role-models for many other members of the social system. Their active involvement and feedback is critical to positioning innovation in a 'real world' environment

Support
    ----------------------------------  Critical Mass  ----------------------------------  
Early majority  34%

Opinion leaders in the early majority tend to be cautious, until they are confident it is safe to act. They judge innovations on reliability and longevity, not just effectiveness.

Show
Late majority 34%

The late majority know the idea is there or become aware of it through their early majority neighbours. They will put off adopting it until it has been developed as far as possible and is as easy as possible to adopt.

Inform
Laggards 16%

Laggards resist to the end. When they hear of the idea they will think that it is too much trouble to adopt or just plain wrong. They are happy with what they have and avoid having to change. Where the diffusion of innovation is perceived to threaten established 'power bases' i.e political or bureaucratic power, monopolistic practices, technological change or entrenched 'belief systems' then the euphemism  'Laggards' is sometimes replaced by the more colourful terms  of  'Saboteurs' or 'Luddites'.  

Tell
 
 

A December 2011 interview on the ABC 7.30 report brings together a number of the CCSVI early adopters along with others who are more cautious and/or less enthusiastic. A good discussion starter for students of innovation management.

 
  THE CRITICAL MASS 
  Crucial to this concept is the critical mass, which occurs at the point at which enough individuals have adopted an innovation whereby the innovation's further rate of adoption becomes self-sustaining. The concept of the critical mass implies that support strategies should be concentrated on getting the use of the innovation to the point of critical mass. These efforts should be focused on the early adopters, the 13.5 percent of the individuals in the system to adopt an innovation after the innovators have introduced the new idea into the system.
  THE "UNLEARNING BIT" IS THE HARDEST
  Because true innovation changes the values on which a system is based people can struggle to make room for the new - the "unlearning bit" is the hardest
 
David Brock in an IBM business presentation (November 2013) said 'Unlearning is different. It’s a structured conscious act. It takes courage and discipline to unlearn. It requires letting go of many of our preconceived notions. It may require us to let go of much of what has made us successful in the past". David went on to say " It requires thoughtfulness to evaluate new alternatives, approaches, strategies, and methods. Determining what we need to unlearn, then opening ourselves to learning something new and embracing it, enables us to move forward" - more about this presentation. 
  In the light of David's observations it is perhaps not surprising that the CCSVI phenomena has given rise to a range of quite different, and at times opposing, reactions. The hallmarks of successful innovation management include open-mindedness, suspension of judgment and identifying problem resolution as a shared goal. Find out more about managing patient centred innovation.
 
  ATTACHMENT 1
  PARLIAMENTARY RESPONSES - SOME FURTHER EXAMPLES
 
Responses In September 2011 the Reference Group advanced political awareness of these issues by providing all of Australia's 225 Federal Parliamentary representatives with a Parliamentary Briefing Note (PBN) that sought action by the Australian Parliament to:
 
Australian Government "Put in place policies, programs and practices to support the advancement of CCSVI medical knowledge while, at the same time, addressing the ongoing CCSVI needs of Australians living with MS"
  PRIME MINISTER SEEKS GUIDANCE ABOUT MULTIPLE SCLEROSIS AND CCSVI
  In consequence the Prime Minister sought the advice of Australia's National Health and Medical Research Council (NHMRC). Some of the issues were also addressed by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT). HealthPACT comprises representatives from all State and Territory health departments, the Australian Department of Health and Ageing, the Medical Services Advisory Committee (MSAC), the New Zealand Ministry of Health and the New Zealand District Health Boards.
  CLARIFYING KEY ISSUES
 
About HealthPACT  In November 2011 HealthPACT published a guidance Brief relating to the role of Percutaneous Venoplasty in treating vascular irregularities experienced by people with multiple sclerosis. In doing this it observed that "percutaneous venoplasty (per se) is an established, routine procedure, with a proven safety and efficacy" and went on to highlight the importance of randomised, controlled, clinical trials, to formally assess Percutaneous Venoplasty in the treatment of CCSVI in patients with MS, before the procedure can be widely adopted.
  Both NHMRC and HealthPACT stressed the importance of properly designed clinical trials.  Recommendations by the Reference Group for screening for possible vascular irregularities during the diagnostic stages of MS and the development of a national monitoring system, to capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS were referenced.
 

AUSTRALIAN PARLIAMENT HOUSE BRIEFING

  A briefing was conducted at Parliament House, Canberra on Monday 25 June 2012 with the aim of building upon the aforementioned developments by establishing "common ground". Organised by MS Australia, in collaboration with CCSVI Australia, and under the auspices of Senator Kate Lundy, it was agreed to progress this issue on a bipartisan basis. Laura Smyth MP committed to meet with Janelle Saffin MP on what to present to the Parliament's Health Committee with the aim of obtaining agreement from the Health Minister and NHRMC to fast track appropriate action. MSA and CCSVI Australia agreed to produce a 'united statement' for them to use in their work. MS Australia was represented by their President, Rob Hubbard and Robert Pask. CCSVI Australia was represented by Kerri Cassidy and Helena Webb. An excellent clinical overview of CCSVI and MS was provided by Doctor Paul Thibault. All in all an important step forward - find out more. 
   
 
  APPENDIX 1
 
Summations Details of some of the responses and issues underpinning the aforementioned developments follow. Figure 1 overviews the ways in which some of the key players responded to the Reference Groups representations.  Figure 2 highlights the then prevailing Australian MS environment. Figure 3 and subsequent provide more detailed information
  THE 34 POSITION POINTS - A FOUNDATION TO BUILD UPON
  The tables that follow identify the 34 'position points'. Figure 1 highlights the 7 'key responses' and is cross referenced to associated position points.  Details of feedback from CCSVI Australia and involvement by MS Australia (see earlier) are included.  A commentary is provided by the Network of Care primarily about the extent to which individual responses address the issues raised in the September 2011 Parliamentary Briefing Note. At this stage formal feedback from key CCSVI players in the vascular profession has not been sought but may be referenced where it is otherwise available in the public domain. Informal feedback is that their views correspond with those summarised at Figure 3
  An abridged 'snapshot' of these responses is included in the document "CCSVI - An Australian Parliamentary Perspective". This document provides an overview of  what has, and has not happened in progressing Parliamentary awareness of CCSVI issues in Australia. In September 2012 the Multiple Sclerosis Network of Care, Australia provided an Executive Overview of major developments from the perspective of many people with MS. It includes a Quick Reference Guide to a representative cross section of emerging CCSVI understandings, On 24 July 2015 the key issues flowing from these position point underpinned a joint submission to the Australian Parliament.
 
Figure 1 - Overview of Key Responses to the September 2011 Parliamentary Briefing (as at December 2011)
   The Key Responses to the September 2011 Parliamentary Briefing Note: Summation by Multiple Sclerosis Network of Care Australia
* Australia has no NHMRC endorsed clinical guidelines for the primary and secondary care of people with multiple sclerosis - position points 1, 2, 3, and 4
* That Percutaneous Venoplasty is an established, routine procedure, with a proven safety and efficacy. In saying this HealthPact went on to say that the outcomes of from randomised, controlled, clinical trials with long term follow up of patients will need to be evaluated before the procedure can be widely adopted. Such trials to also formally assess Percutaneous Venoplasty in the treatment of CCSVI in patients with MS - position point 5.
* Research that the reestablishment of a normal cerebrospinal venous return through percutaneous venoplasty significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up, in MS patients diagnosed with CCSVI. At this stage this research is limited to low level case series studies and that outcomes over longer term studies are not yet available.- position point 6 and 10
* That the outcomes from (additional) randomised, controlled, clinical trials with long-term follow-up of patients will need to be evaluated before this procedure can be widely adopted -  position points 9, 10
* That properly designed clinical trials will help answer this question - position points 10, 17, 21, 24, 91
* That Australia has no such trials as at November 2011 - position points 12, 13, 20, 21, 24, 91
* That the Canadian Government is funding the development of a national monitoring system, to capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS - position point 11
Click here to browse the expanded summaries
  Network of Care Summation
  The absence of any NHMRC endorsed clinical guidelines for the primary and secondary care of people with multiple sclerosis is a disgrace - The Network's more detailed summation is at Figure 2

Confirmation is welcome (by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) that "Percutaneous Venoplasty (per se) is an established, routine procedure, with a proven safety and efficacy" as is the advice highlighting early research that this procedure "significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up, in MS patients diagnosed with CCSVI". Given that this research is limited to low level case series studies and that outcomes over longer term studies are not yet available, it is important that these observations be read in consideration with other sections of the Brief and the intent of the Brief as a whole - read the Brief

Similarly welcome is the importance placed upon ongoing monitoring ''to capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS". Information of this sort will support the formal adoption of Percutaneous Venoplasty as a routine procedure to alleviate many of the most common symptoms of MS. Properly designed clinical trials were identified as one means to 'help answer this question". More broadly, reference is made to funding by the Canada government for "the development of a national monitoring system" - more about developments in Canada

In relation to Australian trials it is noted that, early in 2010, CCSVI Australia's involvement was pivotal in attracting $95,700 in donations from the MS community to support a clinical trial at the Alfred Hospital, Melbourne.
This trial received approval to proceed in February 2012 under the guidance of Professor Ken Thomson. More such research is needed with a specific focus on the benefits of Percutaneous Venoplasty in the relief of many of the most common MS symptoms - a good example. It is anticipated  that examples like this, the HealthPACT report and associated comments by NHMRC will underpin the initiation of such trials by other vascular specialists.


What ever data gathering strategies (or combinations thereof) are adopted for Australians with MS it is imperative that they reflect the 'real world' CCSVI environment whereby many hundreds of pwMS, have already undergone (or are undergoing) CCSVI screening and treatment. The outcomes of which are not currently being systematically monitored to capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS.

Examples of such data gathering techniques are here (MEM-net) and here (University of Milan). CCSVI Australia is also developing a database (searchable via HoriZonsSCAN) that includes references to the qualitative CCSVI experiences of many Australians.
 
It needs to be stressed that Percutaneous Venoplasty i
s not necessarily a 'once only' process - the reestablishment of normal blood flow may necessitate several treatments over time supplemented by vascular related medication. The fact that many of those who have already been treated are currently being denied access to essential follow up procedures is untenable.

It is the Network's (2011) view that the primary underlying national strategy involves following Canada's lead by putting in place a
national monitoring system that includes retrospective opportunities for the registration/recognition of those that have/are being treated and captures relevant information. The data arising from this process to become an additional research resource and an aid for monitoring and supporting the ongoing care of those involved. It is essential that such a system also assists in monitoring and supporting those where CCSVI treatment may not be practicable as well as those with negative/inconclusive screening. Second opinions are important. There is also a case to embrace vascular screening in the diagnostic stages of MS in this process.

Of most importance is the need to ensure that such processes are specifically benchmarked against improvements in the most common (research based) symptoms associated with MS. A 2001
study of 2618 pwMS in NSW may be useful. An understanding of factors influencing Quality of Life perceptions when living with MS is essential.

On 24 July 2015 a joint submission (submission 15) encompassing the foregoing principles was provided to an Australian Parliamentary Inquiry.

  The proactive participation of Australia's vascular profession in achieving these outcomes is fundamental
  ABSENCE OF NHMRC ENDORSED CARE GUIDELINES FOR AUSTRALIANS WITH MULTIPLE SCLEROSIS
  The September 2011 Parliamentary Briefing Note (PBN) also drew the attention of the Australian Parliament to an apparent lack of endorsed Australian clinical guidelines for the primary and secondary care of people with multiple sclerosis in the following terms: "This Briefing Note would fall short if it did not also highlight that, unlike many other countries, especially the United Kingdom, it is understood that Australia has never formally adopted comprehensive national guidelines for managing the primary and secondary care of people with multiple sclerosis. Without benchmarks that establish a right to specific aspects of care, enormous pressure is placed on people with MS, their families and all of those entrusted with their care"
  On 25 November 2011 the National Health and Medical Research Council (NHMRC), Australia's peak body for supporting health and medical research including clinical trials and developing health advice for the Australian community, health professionals and governments, advised as follows:
 
Figure 2 - The Current Australian MS Environment
   NHMRC advised as follows:
.1 Australia has no NHMRC endorsed clinical guidelines for the primary and secondary care of people with multiple sclerosis
.2 It is not aware of any plans for their development.
.3 Starting points' to initiate the development of such guidelines could include the State Chief Health Officers, the CEO of NHMRC or Australia's Chief Medical Officer.
.4 Funding is always an issue, so if there is a funding source, that makes it easier
  Network of Care Summation
  With all of the resources directed to MS support/research in Australia over the years it is hard to believe that there is no uniform baseline from which the relevance and effectiveness of service delivery and associated research can best be evaluated. Whatever the future holds, pwMS deserve the comfort of knowing that guidelines of this type are in place - read more about this issue. 
  The impending introduction of a National Disability Insurance Scheme and structural changes stemming from the associated Productivity Commission Report have the potential to significantly improve the well being of families living with MS. The absence of endorsed MS national guidelines to underpin this review process is a major concern. While there is a commonality of needs across a range of disabilities there are many situations whereby support needs are illness specific - MS is no exception.
  Such guidelines also need to ensure, inter alia, the rights of pwMS to gain proper and ongoing access to vascular (including CCSVI) screening and treatment along with a range of other conditions increasingly reported as being associated with and/or misdiagnosed as MS - Chlamydia pneumoniaecm Lyme Disease and the newly discovered genetic disorder HDLS are examples. 
   As an interim step, details of the NHMRC advice have been passed on to a range of people and organisations with an indicated interest in the effectiveness of strategies for the care and support of pwMS - including MS Australia (Alan Blackwood), Senators Humphries and Lundy and Janelle Saffin, MP. With vascular issues rapidly becoming more strategic this may be something for the Vascular Profession to also reflect upon.  Such guidelines may also may be relevant in monitoring the outcomes of Percutaneous Venoplasty procedures.
healthpact
  HealthPACT RESPONSE TO CCSVI DEVELOPMENTS
  November 2011 also saw the publication of a Brief by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) on the use of Percutaneous Venoplasty to relieve the symptoms of Multiple Sclerosis by improving Cerebrospinal Venous Drainage. HealthPACT is a sub committee of Australian Health Ministers’ Advisory Council (AHMAC) and a body that comprises representatives from health departments in all States and Territories, the Australian and New Zealand governments. It is understood that the ongoing representations by the Australian MS community to Australian Parliamentary representatives (from every Australian State and Territory) may have been a factor in the commissioning this Brief  - which, inter alia, referenced aspects of the PBN.
  This brief was prepared by Dr Prema Thavaneswaran from the Australian College of Surgeons as related to the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) in providing quality and timely assessments of new and emerging surgical technologies and techniques. While key elements of the HealthPact Brief are summarised below it is important that they be read in consideration with other sections of the Brief and the intent of the Brief as a whole. - read the Brief
 
Figure 3 - The Diffusion of New Knowledge about Relieving MS Symptoms
  The HealthPACT report highlighted:
.5 The evidence that Percutaneous Venoplasty is an established, routine procedure, with a proven safety and efficacy. In saying this HealthPact went on to say that the outcomes of from randomised, controlled, clinical trials with long term follow up of patients will need to be evaluated before the procedure can be widely adopted. Such trials to also formally assess Percutaneous Venoplasty in the treatment of CCSVI in patients with MS - subsequent developments,.
.6 Research that the reestablishment of a normal cerebrospinal venous return through percutaneous venoplasty significantly reduced chronic fatigue perception at 12 months follow-up, and improved the rate of relapse-free patients, quality of life, and neurological function at 18 months follow-up, in MS patients diagnosed with CCSVI. At this stage this research is limited to low level case series studies and that outcomes over longer term studies are not yet available - subsequent developments,
.7 That the cost-effectiveness of percutaneous venoplasty for this new indication cannot be determined at this time; however, it is unlikely that the costs associated with performing this procedure for the new indication would differ significantly from the cost of existing percutaneous venoplasty procedures - subsequent developments,.
.8 That it is still unclear what proportion of the MS patient population meets the diagnostic criteria for CCSVI, and would therefore benefit from this procedure.-subsequent developments
.9 The outcomes from (additional) randomised, controlled, clinical trials with long-term follow-up of patients will need to be evaluated before this procedure can be widely adopted - subsequent developments
10

There are a number of ongoing clinical trials assessing the use of percutaneous venoplasty for the relief of symptoms in MS patients with CCSVI being conducted in Italy (NCT01371760 - known as Brave Dreams -some results expected November 2016), Poland (NCT01264848 - since completed) and the US (NCT01089686 - since terminated, NCT01201707 - since terminated and NCT01205633 - recruitment temporarily suspended).

11

That in Canada the National Government has announced that it will provide funding, through the Public Health Agency of Canada, to support the development of a national monitoring system, which will capture information to help identify disease patterns and track CCSVI treatments and long-term outcomes for people living with MS -  subsequent developments-

12 That searches of clinical trials registers failed to identify any ongoing trials in Australia.- subsequent developments
13 That MS Australia has reported actively encouraging Australian researchers to pursue research into CCSVI; however, this has resulted in only two small scale projects - subsequent developments
  Diffusion Strategies
14 HealthPACT drew attention to recommendations by the MS Network of Care,  in particular:
 
That there is strong evidence that testing for possible CCSVI irregularities should be mandatory during the diagnostic stages of MS and that the Australian government could tie its immunotherapy subsidies for MS to requirements that information be provided to individual patients about possible vascular irregularities in MS, and vascular (including CCSVI) screening be undertaken. Authorising general practitioners to refer patients for Doppler ultrasound CCSVI screening may be a key step in achieving this.
  In relation to this suggestion HealthPACT observed "Given that an estimated 1000 patients are newly diagnosed with MS each year in Australia, the potential cost impact of routine Doppler ultrasound screening during the diagnostic stages of MS will need to be considered' - see now the July 2015 submission to the Australian Parliaments Health Committee
   Network of Care Summation
  These HealthPACT findings are consistent with the spirit of the issues raised by the Australian MS Network of Care in its September 2011 Parliamentary Briefing Note (PBN). By providing an impartial overview of the role of Percutaneous Venoplasty in the relief of many of the most common MS symptoms and issues they provide a strong foundation to underpin the further development of the Network's draft CCSVI action strategy. They also serve to strengthen the Australian and New Zealand Parliament's understanding of this aspect of CCSVI.

Regarding Safety. On 28 March 2011, researchers at the Society of Interventional Radiology’s 36th Annual Scientific Meeting in Chicago, in releasing details of a study of 231 patients treated for CCSVI conditions, said "Angioplasty, the nonsurgical procedure of threading a thin tube into a vein or artery to open blocked or narrowed blood vessels, is a safe treatment.  Our study will provide researchers the confidence to study it as an MS treatment option for the future and encourage additional studies for its use as a treatment option for individuals with multiple sclerosis. Angioplasty is a process used by Interventional radiologists to widen the veins in the neck and chest to improve blood flow" - read the study or watch a video about this research. These findings build upon and confirm earlier research by Dr Simka from Poland in a study involving 347 patients

Regarding CCSVI association with MS. There is ongoing fact finding about the prevalence of CCSVI conditions in pwMS as compared to the general community. Commencing around October 2011 details of the outcomes of this fact finding began to appear in the literature. In summary, these findings (that primarily relate to screening of jugular veins via doppler ultrasound) identify a CCSVI prevalence in the range 70% to 86% amongst MS populations and 10% to 14% in the general community. A need for more comprehensive operator training was cited as an important factor in these fluctuations. While these findings provide a very important 'baseline' it is important to remember that CCSVI can occur elsewhere in the vascular system requiring more extensive testing -  find out more

Regarding Evidence of Outcomes in Australia. While no formalised clinic trials have been conducted in Australia (as at 31 December 2011) several hundred people have been tested and treated in what is an ongoing process. Unfortunately all of the outcomes of this groundbreaking work are not being tracked as part of a national CCSVI registry reporting system. Were such a system in place Australia would have an extremely important research resource - more information.

Australia's first clinical trial at the Alfred Hospital in Melbourne received final approval to proceed early in February 2012 under the guidance of
Professor Ken Thomson. CCSVI Australia have strongly advocated for this trial in respect of which they were pivotal in raising $95,700 in donations from the MS community. Details of this trial are currently being recorded in Australian New Zealand Clinical Trials Registry established at the NHMRC Clinical Trials Centre, University of Sydney,  More such trials are needed with a specific focus on the benefits of Percutaneous Venoplasty in the relief of many of the most common MS symptoms..

One of the major reasons that uniformly consistent data relating to CCSVI prevalence is yet to emerge relates to shortfalls in training relating to doppler ultrasound screening of the jugular vein area. Also the outcomes of jugular vein testing are indicative only - the 'gold standard' involves more comprehensive  testing via Catheter Venography.  

Re Point 14 -  The 'ball park' annual costs of such a program could be in the general range of $200,000 to $500,000 before Medicare Rebates. Given that the envisaged screening may well need to go beyond what may currently be construed as CCSVI related conditions the costs may be at the higher end of things. For example, in a case in the Northern Rivers Region the comprehensive screening process identified one MS patient with six previously undetected holes in the heart requiring surgery. There is also a recommendation that screening to eliminate other conditions is needed.


What is not yet clear are the processes by which HealthPACT will become aware of the outcomes of the aforementioned (and other relevant research) for the purposes of supporting the wide adoption of Percutaneous Venoplasty for the relief of MS symptoms/issues. Advice on this matter will be sought.
  Click here to read the full report
  NHMRC RESPONSE TO THE BRIEFING NOTE
 

On 17 November 2011 Australia's National Health and Medical Research Council (NHMRC) responded to the PBN on behalf of the Prime Minister (the Hon Julia Gillard MP) and the Minister for Mental Health and Ageing (the Hon Mark Butler MP). The NHMRC is Australia's peak body for supporting health and medical research including clinical trials and developing health advice for the Australian community, health professionals and governments. In summary the NHMRC advice is as follows:

 
Figure 4 - The Role NHMRC in Guiding CCSVI Trials in Australia
  NHMRC advised as follows:
15 NHMRC acknowledges the importance of the MS Network of Care as a source of information for individuals living with MS and their families.
16 Although CCSVI treatment may show promise for the relief of MS symptoms, the success or otherwise of this treatment is still unknown
17  Properly designed clinical trials will help answer this question
18 Over the past decade NHMRC has contributed $40 million to projects studying various aspects of MS
19 $1.5 million is committed to projects commencing in 2012 #
20 These projects do not include clinical trials for CCSVI
21 NHMRC recognises the importance of conducting clinical trials but (with the exception of a limited number of targeted calls for research) does not request that specific trials be established
  Click here to read the NHMRC advice
  Network of Care Summation
  In some respects this response is disappointing in that it does not address the the desired outcome identified in the PBN or the associated question "when will the Australian Government and/or individual parliamentary parties confirm a policy of following the lead of the United Kingdom and Canadian Parliaments by asking Australia's National Health Advisory Body to guide the introduction of CCSVI clinical trials in Australia? - the longer that this is delayed the more that people will continue to suffer" - read the Briefing Note
  Similarly disappointing is the lack of cited evidence to support the observation that "the success or otherwise of this treatment is still unknown" - at first glance this observation seems inconsistent with finding by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) - see point 6
  Clarification will be helpful of the criteria for "a limited number of targeted calls for research"
  # The website of MS Research Australia suggests that this figure should read $5.1 million. To be clarified by NHMRC
  THE NEED FOR  COLLABORATION
  The PBN highlights the importance of drawing upon the advice of those recognised as being at the forefront of CCSVI understanding, diagnosis and treatment in Australia, including members of the Australian MS Community.  CCSVI Australia is an important catalyst in this process. Headed by Kerri Cassidy, CCSVI Australia is establishing ongoing dialogue with and between a range of stakeholders including vascular specialists, Australian parliamentary representatives, MS Australia and the media. A snapshot of the contributions by CCSVI Australia follows:
 
Figure 5 - Contributions by CCSVI Australia
   CCSVI Australia Contributions include:
22  Providing an internet based Australia wide support and information service relating to CCSVI
23 Providing Opportunities for the voice of the MS community to be heard via a petition to the Prime Minister, the Health Minister and MS Australia
24 Raising (early in 2010) $88,000 in private funding to support a CCSVI clinical trial at the Alfred Hospital, Melbourne.  This trial received approval to proceed  in February 2012 under the guidance of Professor Ken Thomson. More such trials are needed with a specific focus on the benefits of Percutaneous Venoplasty in the relief of many of the most common MS symptoms
25 Providing speakers for CCSVI professional development/awareness programs
26 Establishing, in partnership with Network of Care, ongoing dialogue with State and Federal Parliamentary representatives relating to Multiple Sclerosis and CCSVI related issues.
27 Providing feedback about CCSVI procedures performed in Australia
28 Undertaking research that also supports the ongoing development of the Australian Road Map to MS Support Services
29 Liaising with the media in creating public awareness of CCSVI issues - Click here for examples of Australian Television coverage
30 Expressing concern about an apparent lack of an independent umpire to investigate complaints about the extent to which perceived (and sometimes not publicly disclosed) conflicting interests may be impacting on the well being of Australian families living with MS.  While Medicines Australia has a strong regulatory role relating to the advertising of medicines a broader umbrella is needed.
31 Monitoring research about the effectiveness and safety of many of the pharmaceutical based interventions frequently associated MS, including Copaxone, Rebif, Avonex, Betaferon, Movectro, Tysabri (more info about each of these) and more recently Gilenya
32 Observing that the provision of CCSVI information to the broader MS community is highly fragmented across a wide range of outlets across Australia often resulting in the provision of factually unreliable or dated information. The observation is made that organisations such as MS Australia and Neurologists face the possibility of becoming increasingly irrelevant if they cannot understand the impact of open information in the hands of the people they are mandated to care for.
33 Suggesting the establishment of a single nationally accessible 1800 centralised service, appropriately staffed (and perhaps associated with a national CCSVI registry), as one possible means of addressing issue of this type
34 In association with the Network of Care approached MS Australia about reviewing the wording of a March 2011 advice titled 'CCSVI - Your Questions Answered'  provided by MS Australia in response to CCSVI enquiries. As a minimum, this advice needs to be upgraded to properly reflect the findings of November 2011 report by Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT).
  Network of Care Summation
  CCSVI Australia plays an important role in complementing the aim of the Australian Multiple Sclerosis Network of Care to provide an effective Voice for People Affected by MS. The many hundreds of individuals that comprise CCSVI Australia epitomise the rapidly emerging MS 'information generation'. They are knowledgeable and receptive, highly focussed and open minded but above all they understand what Quality of Life when living with MS really means.

On a positive note, a briefing was conducted at Parliament House, Canberra on Monday 25 June 2012 with the aim of building common ground. Organised by MS Australia, in collaboration with CCSVI Australia, and under the auspices of Senator Kate Lundy, it was agreed to progress this issue on a bipartisan basis. Laura Smyth MP committed to meet with Janelle Saffin MP on what to present to the Parliament's Health Committee with the aim of obtaining agreement from the Health Minister and NHRMC to fast track appropriate action. MSA and CCSVI Australia agreed to produce a 'united statement' for them to use in their work. MS Australia was represented by their President, Rob Hubbard and Robert Pask. CCSVI Australia was represented by Kerri Cassidy and Helena Webb. An excellent clinical overview of CCSVI and MS was provided by Doctor Paul Thibault. All in all an important step forward.


Point 30 is well made. The influence of pharmaceutical companies is a case in point. This may be something that a Health Care Ombudsman could be empowered to oversight  - more broadly, the establishment of a Judicial Enquiry into this issue may ultimately be needed to establish benchmarks
.

Re Points 32 and 33. There is a wealth of reliable up to date information on this topic available via the web, including that assembled by the Network of Care. In November 2011, Australia's National Health and Medical Research Council (NHMRC)
commented "NHMRC acknowledges the importance of the MS Network of Care as a source of information for individuals living with MS and their families".

What ever emerges in relation CCSVI much can be learnt from the ways that CCSVI Australia goes about its task. It prompts the question "what types of organisations/leadership and motivations are best suited to addressing the future needs of people with MS?
".

    
  FIND OUT MORE 
  An abridged 'snapshot' of these responses is included in the document "CCSVI - An Australian Parliamentary Perspective". This document provides an overview of  what has, and has not happened in progressing Parliamentary awareness of CCSVI issues in Australia. In September 2012 the Multiple Sclerosis Network of Care, Australia provided an Executive Overview of major developments from the perspective of many people with MS. It includes a Quick Reference Guide to a representative cross section of emerging CCSVI understandings

 

Facts Sheet RM1678MS
Road Map Reference