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Statement of Principles

concerning

RESTLESS LEGS SYNDROME

No. 21 of 2014

for the purposes of the

Veterans’ Entitlements Act 1986

and

Military Rehabilitation and Compensation Act 2004

Title

1. This Instrument may be cited as Statement of Principles concerning restless legs syndrome No. 21 of 2014.

Determination

2. The Repatriation Medical Authority under subsection 196B(3) and (8) of the Veterans’ Entitlements Act 1986 (the VEA):

(a) revokes Instrument No. 34 of 2003 concerning restless legs syndrome; and

(b) determines in its place this Statement of Principles.

Kind of injury, disease or death

3. (a) This Statement of Principles is about restless legs syndrome and death from restless legs syndrome.

(b) For the purposes of this Statement of Principles, "restless legs syndrome" means a sensorimotor, neurological disorder characterised by all of the following criteria:

An urge to move the legs, usually accompanied by or in response to uncomfortable and unpleasant sensations in the legs, characterised by all of the following:

(i) The urge to move the legs begins or worsens during periods of rest or inactivity;

(ii) The urge to move the legs is partially or totally relieved by movement; and

(iii) The urge to move the legs is worse in the evening or at night than during the day, or occurs only in the evening or at night; and

B. The symptoms in Criterion A occur at least three times per week and have persisted for at least three months; and

C. The symptoms in Criterion A are accompanied by significant distress or impairment in social, occupational, educational, academic, behavioural or other important areas of functioning; and

D. The symptoms in Criterion A are not attributable to another medical condition (e.g., arthritis, leg oedema, peripheral ischaemia, leg cramps) and are not better explained by a behavioural condition (e.g., positional discomfort, habitual foot tapping).

Basis for determining the factors

4. On the sound medical-scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that restless legs syndrome and death from restless legs syndrome can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the Military Rehabilitation and Compensation Act 2004 (the MRCA).

Factors that must be related to service

5. Subject to clause 7, at least one of the factors set out in clause 6 must be related to the relevant service rendered by the person.

Factors

6. The factor that must exist before it can be said that, on the balance of probabilities, restless legs syndrome or death from restless legs syndrome is connected with the circumstances of a person’s relevant service is:

(a) having diabetes mellitus at the time of the clinical onset of restless legs syndrome; or

(b) having iron deficiency at the time of the clinical onset of restless legs syndrome; or

(d) having radiculopathy or peripheral neuropathy, involving the lower limbs, at the time of the clinical onset of restless legs syndrome; or

(e) having a spinal cord lesion at the time of the clinical onset of restless legs syndrome; or

(f) being treated with a drug or a drug from a class of drugs from the specified list, which cannot be ceased or substituted, at the time of the clinical onset of restless legs syndrome; or

(g) smoking at least ten pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical onset of restless legs syndrome, and where smoking has ceased, the clinical onset of restless legs syndrome has occurred within five years of cessation; or

(h) being obese within the two years before the clinical onset of restless legs syndrome; or

(i) having multiple sclerosis for at least the one year before the clinical onset of restless legs syndrome; or

(j) having a clinically significant psychiatric condition as specified for at least the one year before the clinical onset of restless legs syndrome; or

(k) having a specified sleep disorder at the time of the clinical onset of restless legs syndrome; or

(l) being pregnant at the time of the clinical onset of restless legs syndrome; or

(m) having diabetes mellitus at the time of the clinical worsening of restless legs syndrome; or

(n) having iron deficiency at the time of the clinical worsening of restless legs syndrome; or

(o) having chronic renal failure at the time of the clinical worsening of restless legs syndrome; or

(p) having radiculopathy or peripheral neuropathy, involving the lower limbs, at the time of the clinical worsening of restless legs syndrome; or

(q) having a spinal cord lesion at the time of the clinical worsening of restless legs syndrome; or

(r) being treated with a drug or a drug from a class of drugs from the specified list, which cannot be ceased or substituted, at the time of the clinical worsening of restless legs syndrome; or

(s) smoking at least ten pack-years of cigarettes, or the equivalent thereof in other tobacco products, before the clinical worsening of restless legs syndrome, and where smoking has ceased, the clinical worsening of restless legs syndrome has occurred within five years of cessation; or

(t) being obese within the two years before the clinical worsening of restless legs syndrome; or

(u) having multiple sclerosis for at least the one year before the clinical worsening of restless legs syndrome; or

(v) having a clinically significant psychiatric condition as specified for at least the one year before the clinical worsening of restless legs syndrome; or

(w) having a specified sleep disorder at the time of the clinical worsening of restless legs syndrome; or

(x) being pregnant at the time of the clinical worsening of restless legs syndrome; or

(y) inability to obtain appropriate clinical management for restless legs syndrome.

Factors that apply only to material contribution or aggravation

7. Paragraphs 6(m) to 6(y) apply only to material contribution to, or aggravation of, restless legs syndrome where the person’s restless legs syndrome was suffered or contracted before or during (but not arising out of) the person’s relevant service.

Inclusion of Statements of Principles

8. In this Statement of Principles if a relevant factor applies and that factor includes an injury or disease in respect of which there is a Statement of Principles then the factors in that last mentioned Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

Other definitions

9. For the purposes of this Statement of Principles:

"a clinically significant psychiatric condition as specified" means one of the following disorders of mental health, which is of sufficient severity to warrant ongoing management, which may involve regular visits (for example, at least monthly) to a psychiatrist, counsellor or general practitioner:

(a) major depressive disorder; or

(b) persistent depressive disorder;

"a drug or a drug from a class of drugs from the specified list" means:

(a) atypical antipsychotics, including olanzapine and risperidone;

(b) duloxetine;

(d) mianserin;

(e) mirtazapine;

(f) selective serotonin re-uptake inhibitors, including citalopram, escitalopram, fluoxetine, paroxetine and sertraline;

(g) tramadol; or

(h) venlafaxine;

"a specified sleep disorder" means:

(a) narcolepsy; or

(b) sleep apnoea;

"being obese" means an increase in body weight by way of fat accumulation which results in a Body Mass Index (BMI) of thirty or greater.

The BMI = W/H2 and where:

W is the person’s weight in kilograms; and

H is the person’s height in metres;

"chronic renal failure" means having a glomerular filtration rate of less than 60 mL/min/1.73 m2 for a period of at least three months, or the presence of irreversible kidney damage;

"death from restless legs syndrome" in relation to a person includes death from a terminal event or condition that was contributed to by the person’s restless legs syndrome;

"iron deficiency" means having a serum ferritin level of less than 20 micrograms per litre;

"pack-years of cigarettes, or the equivalent thereof in other tobacco products" means a calculation of consumption where one pack-year of cigarettes equals twenty tailor-made cigarettes per day for a period of one calendar year, or 7 300 cigarettes. One tailor-made cigarette approximates one gram of tobacco or one gram of cigar or pipe tobacco by weight. One pack-year of tailor-made cigarettes equates to 7.3 kilograms of smoking tobacco by weight. Tobacco products mean cigarettes, pipe tobacco or cigars, smoked alone or in any combination;

"radiculopathy" means a disease of the nerve roots resulting in symptoms of weakness, pain or loss of sensation;

"relevant service" means:

(a) eligible war service (other than operational service) under the VEA;

(b) defence service (other than hazardous service and British nuclear test defence service) under the VEA; or

"terminal event" means the proximate or ultimate cause of death and includes:

(a) pneumonia;

(b) respiratory failure;

(d) circulatory failure; or

(e) cessation of brain function.

Application

10. This Instrument applies to all matters to which section 120B of the VEA or section 339 of the MRCA applies.

Date of effect

11. This Instrument takes effect from 26 March 2014.

Dated this fourteenth day of March 2014

The Common Seal of the )

Repatriation Medical Authority )

was affixed to this instrument )

in the presence of: )

PROFESSOR NICHOLAS SAUNDERS AO

CHAIRPERSON