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Summary of Issues Raised by ESOs

Issues and responses collated from edited transcripts of the RMA Forum
March 2004

RMA Processes

Basis for Removing a Factor

ISSUE
Please clarify, when removing a SOP factor, the basis of sound medical-scientific evidence (SMSE) and how the new SMSE supports the removal of a particular factor?

RESPONSE
Professor Donald explained that the issue is that new studies emerge and those studies often contradict previous studies. They are sometimes better studies or bigger studies with more power than the ones that were previously in the literature. They sometimes cause the RMA to revise its opinion because of the quality of the studies or the size of the result, or all of those things. The whole body of evidence is taken into account when removing a factor.

Pearce Report Recommendations

ISSUE
What is the progress of the Pearce Report recommendations? In relation to recommendation 2, has the RMA considered the question of military experience as a desirable selection criterion for future appointments to the RMA?

RESPONSE
Professor Donald replied that the Minister of the day endorsed 18 of the 20 recommendations and the RMA has addressed all of those within its remit. The issue of how the RMA is constructed was outside the remit of the RMA. Mr Bill Maxwell (DVA) said that the government response had been to factor in the matter of military experience as a criterion but not to make it a prerequisite. However, there may be other means by which Defence experience could be brought into the process. There is already an established procedure where Departmental staff attend the informal part of the RMA meeting and comment upon the operationalisation of the draft SOPs. Some Defence Health people might be able to do something similar. Professor Donald agreed that this might be an appropriate approach, especially in light of the MRC Act and its applicability to current serving members. He undertook to take the matter up with the Commission.

ESO Response Time

ISSUE
Time allowed for ESO response time when asked to comment on RMA papers.

RESPONSE
Professor Donald said that the usual time given to response is about six to eight weeks but it depends on the RMA meeting schedule. The RMA is aware that there are sometimes delays by peak organisations in getting the papers out to individual ESOs. Viv Quinn (RSL) explained that the consultation process within their organisation can take longer than six weeks. Mrs Carole Friedrichs (RMA secretariat) responded that it was also necessary to recognise that a longer response time would delay the making of the instrument, which might also include changes that positively affect veterans. It was agreed to undertake further consultation with ESOs in relation to response time and electronic distribution.

RMA Protocols

ISSUE
What are the RMA Protocols for administration and management?

RESPONSE
Professor Donald answered that the RMA outlined its processes in this forum and the previous Forum in 1988. These processes are documented in the proceedings of the 1998 forum.

Expediting Reviews of SOPs

ISSUE
What (early) options are available when a genuine claim is restricted by a SOP in its current format?

RESPONSE
Professor Donald said that at the moment the answer is that there are no quick options, although there are sometimes other factors in a SOP which the veteran could look at. Mr John O'Connor Whyte (Specialist Medical Review Council) made the point that there is only a three month window to appeal a decision in respect of a SOP to the SMRC, although he warned that the Council's processes also take some time. Professor Donald explained that even though there are over 50 investigations listed, but the RMA can prioritise some investigations if they bear on a number of claims. There was a suggestion from Dr Keith Horsley (DVA) that an amendment to the legislation such that a single factor could be reviewed might make the RMA's processes more efficient and responsive. Professor Donald agreed but said that there would need to be some caveats around that and there would need to be Government support for amending the legislation.

The Specialist Medical Review Council

ISSUE
If the SMRC decides that there is sufficient evidence to include a factor that the RMA has rejected, does the RMA take that at face value or do you have to review it again?

RESPONSE
Professor Donald replied that the SMRC can ask the RMA to do a review or they can instruct it to put a factor in. They have instructed the RMA to put a factor in only once, in relation to chronic lymphatic leukemia and electromagnetic fields. The RMA did as instructed. In relation to job strain and hypertension they asked the RMA to do a review. The RMA looked at it and decided that on the whole of the evidence available the proposition wasn't sustained. However, the SOP factors put in by the SMRC are no more permanent than the SOP factors put in by the RMA. All of the SOPs are subject to review and as the scientific literature changes, they may change.

MRC Act

ISSUE
The passing of the MRC Act means that the SOPs will be used to relate service to compensation claims for serving Defence Force members. How will this affect the relationship of the RMA with the Defence Force? How will the RMA consult with the Defence community?

RESPONSE
Professor Donald noted that the legislation is new and will require careful reading, but that the process of making SOPs will not change. The RMA has foreseen a need to make some new SOPs in relation to overuse injuries and has advertised investigations into a selection of overuse syndromes. There will also be a need to consider diseases that affect younger people because of extension of coverage to school cadets.

Members of the RMA are observers on the Medical Advisory Panel and so are kept informed of current discussions between Defence and DVA in relation to occupational health and safety issues. In the past the RMA has visited troops on deployment in Timor and Bouganville to gain an understanding of conditions of service and may do so again. The RMA is looking at developing other mechanisms for consultation with the ADF.

Professor Andrew Wilson added that in addition to looking at specific conditions, there may also be specific exposures relevant to serving personnel that need to be thought about. The Centre for Military and Veterans' Health which is being launched in May is going to be an important resource for looking at these issues.

Professor Donald agreed but pointed out that health and mortality studies of groups of veterans often document exposures poorly. There are plans within ADF and DVA to overcome this problem by developing a prospective health surveillance program which will monitor exposures during deployment of small groups of soldiers.

Supporting documentation for requests

ISSUE
A request for a review of a SOP requires supporting information which may be difficult for a small organisation or individual to collect, especially when material on the internet is not peer reviewed. Section 196CA allows the Authority to refuse a request for review when there is insufficient new evidence. What is the quality and quantity of information required by the RMA in support of a request?

RESPONSE
Professor Donald explained that when the RMA first started it was important to get enough SOPs out there working so that the system would function. To that end, the Authority would sometimes just look at a particular factor. Subsequently it had legal advice that if a SOP is to be opened for investigation, it is necessary to look at the whole SOP, not just one factor. That meant that reviewing a SOP is a major task, sometimes taking many months. A mechanism was needed to be able to prioritise SOPs that had to be reviewed as against the ones where there was not a significant case for them to be reviewed.

When the RMA receives a request for review a medical officer will check the literature to see if there is anything new that would make a difference since the SOP was last made. Even if a minimal amount of information is supplied, staff of the secretariat will attempt to pursue it and identify relevant articles. The length of time since the SOP was last reveiwed is taken into consideration. Members of the RMA sometimes also know of new activities in the area under consideration. There is a process for deciding whether there is anything which would suggest to the Authority that it is reasonable to review the SOP, we don't just say "no" simply because of the lack of information provided. Section 196CA is a safety valve so that the RMA can priortise what really needs to be done.

Andrew Leiboff (medical research officer) added that the request must nominate a disease and a risk factor so that a search of the published evidence can be made. Internet searches are not dismissed as a source of information, but if the information is nothing but opinions then the quality of the evidence may be questionable.

Professor Andrew Wilson reinforced the point that it is not the internet per se that is the problem but the quality of the information that comes from it. The web is a major source for published peer reviewed literature and there are some fully peer reviewed journals that are only published on the web.

Documentation of Previous Studies

ISSUE
Why is it so time consuming to review earlier scientific studies when these would presumably have been documented from previous investigations?

RESPONSE
Professor Donald agreed that there is a document available, that being a submission to the Authority of the critical appraisal of the literature, at the time the SOP was made previously. There are two issues with such documentation. One is that if a SOP is reviewed it is important to make sure that there were no mistakes. That requires having a significant look at that previous critical appraisal and maybe even re-reading some of the papers. The second thing is, if new papers have been published, then the question is what do they do to the balance of the evidence. In other words, how do they fit into the context of the balance of evidence in the previous study. Sometimes one good study will critically alter the balance of evidence and lead to a different conclusion.

Professor John Kaldor further explained that the previous submission does summarise the evidence, but it is a judgement, not a one dimensional summary. You don't come up with some score to which you can just add a further computation if a new paper comes along. You might, for example, have the situation of twenty studies that were done in the past but they all had major methodological flaws of different kinds and then one terrific study comes along that has got over that flaw. You have to have a look at the overall body of evidence in order to put the new study in context.

Guidelines for Critical Appraisal

ISSUE
Is there an international convention that defines the factors that are important in the analysis and appraisal of reports? Does that make it much easier to draw out the information?

RESPONSE
Professor Kaldor replied that there are a number of different sets of guidelines that have been put in place for doing a critical appraisal. The Cochrane collaboration, for example, is one very well known structure that recommends that reviews be done in a certain way, primarily in the therapeutics area. Various learned institutions or individuals have promulgated guidelines. You could not say there is one standard but there's a great deal in common among the different types of standards that are used. The sort of categories that the RMA uses are the ones in general use. Professor Kaldor explained that internally at the RMA there is an attempt to summarise information, not necessarily paper by paper, but in a way that combines the information with an awareness of those key categories.

Professor Donald added that most of the studies are done on "free-ranging human beings" who are pretty hard to round up. This limits the quality of evidence from epidemiological studies. You just cannot get a dose response sometimes because people, in doing the studies, have been unable to structure it in such a way that you could even calculate a dose response.

ESO Consultation to Inform Decision Making

ISSUE
Epidemiological studies vary in quality and it is sometimes difficult to find evidence. Previously the RMA had a lot of consultation and communication between ex-Service organisations and the Department of Veterans' Affairs so that the RMA could take into account a far wider view of the clinical evidence in relation to causality. Now there appears to be a greater emphasis on documentary evidence.

RESPONSE
Professor Donald responded that the RMA always has the option of exercising clinical judgement. He explained that probably nearly all of the straightforward decisions were made in those first three years and what is left is the matters which are less clear, matters which are in contention and matters in which the literature is sometimes very extensive. Professor Donald acknowledged that the issues have become more difficult and that it is time once again to have more face to face communication. The RMA intends to recommence holding meetings interstate.

Professor Kaldor further clarified the meaning of clinical judgement. Clinical judgment or "common sense" is distinct from or complementary to epidemiological data. He emphasised that those processes come in after the RMA has gone through a very comprehensive review of what is available. Clinical judgements are a mechanism of interpretation of the data and resolving ambiguities that cannot be resolved with the available data. They are not a substitute or an alternative pathway for that analysis.

Issues Relating To Particular Factors

Class of Veterans

ISSUE
Although you have stated that the legislation is not based on classes of veterans, there is a factor for 30 days service in Vietnam, so what is the difference?

RESPONSE
Professor Donald acknowledged that the Vietnam factor was a class of veteran factor but it came in about 1994/95 and the RMA has had advice that it cannot repeat that sort of factor. It was based on the fact that although there was some published literature, it was very difficult to untangle what the real exposures were. Not every soldier in Vietnam, for example, had the same exposure to Agent Orange. The 30 days was chosen because that was what was required to get the Vietnam Medal for active service. Similarly, for radiation the RMA has gone away from class of veteran factors to doses of radiation.

Professor Donald added that it is also important that the factors retain scientific credibility. The SOP system was introduced because the Auditor General advised parliament that the old system was inconsistent and lacking in credibility. The RMA must be able to point to a convincing link to the science. Furthermore, inclusion of a factor must be based on the entire body of evidence, not just on one published paper out of many.

DDT

ISSUE
DDT is not recognised in the SOPs yet there are studies which indicate damage to bird eggs.

RESPONSE
Dr Keith Horsley (DVA) agreed that DDT was banned because it was making eggshells too thin and the American Bald Eagle was becoming extinct. He noted however that DDT is in fact recognised in the SOPs because exposure to DDT is a factor in the SOP for pancreatic cancer. Professor Donald explained that the RMA has studied the effects of DDT extensively but there have only been two studies of significance, the one which allowed the RMA to include it in the SOP for cancer of the pancreas and another which showed that it protected African-American women from breast cancer.

Definition of METs

ISSUE
It is difficult for widows to substantiate the factor for "inability to undertake more than a mildly strenuous level of physical activity" because the definition uses METs as the unit of measurement.

RESPONSE
Professor Donald said that the RMA understands that it is often difficult for widows to remember details but this is a problem for the Department as it relates to the evidence. There is some guidance from the Department at two levels. The GARP documents provide some guidance on how to translate activity levels into METS. The Decision Support Unit also distributes explanatory bulletins.

Brigadier Bill Rolfe (VRB) explained that there is an evidentiary onus to put forward some material that relates in a positive way to the particular contention. The VRB takes into account a lack of records due to the passage of time but without some material it is difficult to make a case.

Lifting and Carrying Factors

ISSUE
Can you clarify the application of lifting and carrying factors in SOPs for cervical, thoracic and lumbar spondylosis?

RESPONSE
Professor Donald said that the load and the frequency of carrying or lifting are used to calculate the cumulative total. If heavy loads are lifted or carried more frequently, the total will be reached more quickly. Both picking up and putting down count as a single operation. The instrument for cervical spondylosis only has a carrying factor because the SMSE relates to carrying heavy loads on the head. Carrying implies an initial lift hence the same formula as for lifting can be used.

Dr Kym Hickey (RMA medical officer) added that it is just a matter of multiplying the weight of the load by how many times you lift it to get the cumulative loads.

Solar UV Formula

ISSUE
What are the results of recent RMA meetings concerning the Solar UV Formula?

RESPONSE
Professor Donald stated the background to this issue, that is, a potential problem with running the UV formula program on the Department's new computer system and a wish expressed by ex-Service organisations not to make any changes to the formula based factor. After much discussion over several meetings the RMA has decided to try to develop a new factor but retain the formula. The new factor will probably be a sort of screening factor based on the amount of time and the latitude where the veteran served. If the veteran does not succeed under the new factor then he or she can go to the formula for a more detailed examination. Mr Norm Clarke (Legacy) supported this proposal because it would take the guesswork out of trying to obtain a detailed lifetime history from war widows about their husband's clothing.

Stress and Stressors

Stress of Perceived Failure

ISSUE
Quite often a member of the defence force or veteran may experience stress from failure or perceived failure.

RESPONSE
Professor Beverley Raphael agreed with this statement and added that in combat situations your time sense is often distorted, and you think you had time to do things when in fact you didn't. In the Granville disaster people's sense of frustration about not being able to fulfil their functions and the stress of that became apparent. Those issues come up in the consideration of stressor exposures. The issue for the RMA is what does the scientific literature say and how does it delineate those stressors.

Response to Judges' Interpretations

ISSUE
When cases come to court, judges often provide their interpretation on the words in the SOP, for example in relation to intense fear, helplessness and horror. Does the RMA review those psychiatric conditions when that happens?

RESPONSE
Professor Raphael responded that the RMA does take note of issues that are brought up from individual cases. The RMA will look back and see what it based the wording on, and how that's reflected in the literature. One of the limitations is what the literature shows, even though the RMA tries to dissect out these things, sometimes the literature doesn't dissect them out at all.

Severe Stressor Definition

ISSUE
Some SOPs specify that a stressor be extreme or severe and there are many situations in which a veteran does not remember a severe stressor despite being in a combat situation for quite some time.

RESPONSE
Professor Raphael agreed that in the circumstances of combat there is a range of stressors, not all of which would meet the definition of a catastrophic stressor. The question that has come up for the RMA is does there have to be an actual or objective threat or is it sufficient for there to be a perception of it. That is a complex boundary. Nobody would argue that in combat there is actual threat of death. Less severe stressors may result in other conditions which are covered by the SOPs.

Lack of Evidence of Exposure to a Stressor

ISSUE
We see cases of veterans with a psychiatric disability but no incident or evidence of real stress, apart from service itself. The SOPs don't seem to apply to these cases. Are you looking at that area? Shouldn't the principle of beneficiality apply?

RESPONSE
Professor Raphael explained that it certainly could come up in what the RMA is looking at because there's an evolving literature in the whole aetiology of a range of psychiatric disorders. She pointed out that at least one in five of the Australian community has a diagnosable psychiatric disorder. The years of being a soldier or being in the services are the years in which these disorders come on, so there is also potentially a coincidental effect. There are a great many people in the ages of 18 to 40 who develop significant and disabling psychiatric illnesses who have never had exposure to combat. So that's what complicates understanding whether the service has contributed in this particular circumstance. While the RMA is open to looking at the issues, there has to be an identified causal chain.

Professor Donald added that the principle of beneficiality applies at a number of levels in the system. In the evidentiary area where there is reverse standard of proof, then certainly you would expect that it would apply. At the reasonable hypothesis level, the evidence that is needed to put in a causal factor is in fact a very generous interpretation of the literature. It's not really a question of whether the generous nature of the legislation can be applied here. The problem for the RMA is that the issue is so complex that simple solutions that can be sustained are very difficult to find. Finding the evidence in the literature to sustain or underpin those simple solutions is very difficult because the literature is very complicated indeed.

Professor Raphael further added that the literature is becoming more sophisticated so it may become more obvious in future how to distinguish between service and other aspects of life. Also, it may be that a system of management might be more clearly linked to care than compensation.

Prolonged or Cumulative Stress

ISSUE
In respect of the severe stressor, the statement of principle for PTSD specifies an actual event, one single event, as opposed to someone who has been involved with prolonged stress or cumulative stress in a combat zone. For example, there is the veteran who has had the fear of being attacked or overrun for his whole period of service in Vietnam. There doesn't seem to be a window of opportunity for that veteran who may be suffering from PTSD.

RESPONSE
Professor Raphael replied that there is not the intent to exclude a veteran who has had exposure to that sort of stress but the fact is that in the literature a lower level of stress that is chronic may be more associated with anxiety and depressive disorders than with PTSD per se. So, sometimes the different definitions are reflective of that. Generally, if a person has been exposed to the sort of life threat continuously in combat, he would have had at least one event like that, so it shouldn't exclude him from being eligible for PTSD if that's the condition that he has. This is a matter for ongoing consideration by the RMA.

Stress from Natural Disasters

ISSUE
What is the literature in relation to stress from natural disasters such as Cyclone Tracy and the Brisbane floods and how can it be applied to military settings?

RESPONSE
Professor Raphael responded that the RMA does take the general disaster literature into account as well as military studies. Studies of disasters world-wide have shown impacts from the acute stressor exposure as well as from the chronic stressors of the aftermath.

Health Studies

Separating Out Multiple Deployments

ISSUE
There is an overlap between Korean War veterans and veterans of other conflicts; some Korean War veterans went on to serve in Vietnam and some had already served in the British atomic test program or World War II. How is this taken into account?

RESPONSE
Dr Keith Horsely replied that work is being done to separate these groups. There were about 30% of Korean War veterans who were World War II veterans and19% who were also Vietnam War veterans. An analysis of the veterans who only went to Korea is planned. It will be difficult to construct a comparison group because nearly all the active army went to Korea. A comparison with older Australian men is being undertaken. Mr Bill Maxwell (DVA) added that the phenomenon of soldiers going on multiple deployments is also a feature of more recent deployments.

Dealing With Findings of Excess Symptoms

ISSUE
There are some diseases that may not have been identified from previous health studies. How can the system deal with the findings of excess symptoms being identified by these studies? Is it within the authority of the RMA to make recommendations to the Department?

RESPONSE
Professor Donald responded that there was no easy answer to that problem, which is also likely to unfold when the F111 health study is completed. Further investigation may be necessary to discover whether a new disease is being uncovered. The RMA has to work with the legislation. With health studies there is sometimes an unrealistic expectation that the RMA will be able to act upon the findings when in fact it will not produce an outcome that fits into the legislation.

Professor Donald added that the RMA does make recommendations to the Commission. The RMA has been advocating for prospective surveillance and ongoing systematic record keeping for nearly ten years. The RMA also has the opportunity to make suggestions or comments through the Medical Advisory Panel.

Mr Bill Maxwell (DVA) explained that the VEA does not require a person to lodge a claim for a diagnosed medical condition. It requires them to lodge a claim for the acceptance of incapacity, which can be described in terms of a range of symptoms. The department has to investigate the claim, establish the medical conditions present and then apply the relevant SOPs. If no label for those symptoms can be identified, the claim can be dealt with as a non-SOP condition. Dr Keith Horsley (DVA) added that it is DVA policy to provide treatment until such time as a label is applied to those symptoms.

Professor Wilson pointed out that retrospective health studies can help identify constellations of symptoms which might go to form a new syndrome. The advantage of prospective studies is that they provide the opportunity to study the exposures that actually contribute in some way to those symptoms or syndromes.

RMA Response to F111 Health Study

ISSUE
What action has the RMA taken in regards to the findings of the F111 Health Study and any other DVA/Defence Study?

RESPONSE
Professor Donald said that the RMA has been watching the F-111 study carefully. The Principle Medical Officer attends the meetings of the Steering Committee and the RMA gets the minutes of that meeting. The RMA has advertised an investigation into toxic encephalopathy which is specifically aimed at determining whether there is a disease under which some of the F111 deseal/reseal people would fit. Some of them may be covered by the existing psychiatric SOPs. However, there will potentially be people who were involved in the reseal/deseal process who do not fit into the categories that a SOP would cover.

The RMA did obtain a copy of the chemical composition of the materials that were used and were staggered by the list of chemicals. Dr Ian Gardner (Defence) pointed out that the study is not specifically about the use of chemicals, but also about deseal/reseal processes. Professor Donald further explained that it was recognised right up front that it would be impossible to identify the contribution of this huge range of chemicals, most of which had very poorly described toxicological principles. Therefore the study is really basically looking at the processes and asking the question, "Is there an association between working on these processes and adverse health outcomes?"

Mr Andrew Leiboff (medical research officer) added that the members of the RMA and Secretariat have been made aware of the chemicals which were used by this group and will routinely look for evidence of a causal link between those chemicals and the disease under investigation.


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