Statement of Principles concerning CHRONIC PRURITUS ANI (Reasonable Hypothesis) (No. 31 of 2019) The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(2) of the Veterans' Entitlements Act 1986. Dated 1 March 2019 The Common Seal of the Repatriation Medical Authority was affixed to this instrument at the direction of: Professor Nicholas Saunders AO Chairperson Contents 1 Name 2 Commencement 3 Authority 4 Repeal 5 Application 6 Definitions 7 Kind of injury, disease or death to which this Statement of Principles relates 8 Basis for determining the factors 9 Factors that must exist 10 Relationship to service 11 Factors referring to an injury or disease covered by another Statement of Principles Schedule 1 - Dictionary 1 Definitions 1 Name This is the Statement of Principles concerning chronic pruritus ani (Reasonable Hypothesis) (No. 31 of 2019). 2 Commencement This instrument commences on 25 March 2019. 3 Authority This instrument is made under subsection 196B(2) of the Veterans' Entitlements Act 1986. 4 Repeal The Statement of Principles concerning chronic pruritus ani No. 75 of 2010 (Federal Register of Legislation No. F2010L02314) made under subsection 196B(2) of the VEA is repealed. 5 Application This instrument applies to a claim to which section 120A of the VEA or section 338 of the Military Rehabilitation and Compensation Act 2004 applies. 6 Definitions The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument. 7 Kind of injury, disease or death to which this Statement of Principles relates (1) This Statement of Principles is about chronic pruritus ani and death from chronic pruritus ani. Meaning of chronic pruritus ani (2) For the purposes of this Statement of Principles, chronic pruritus ani means intense itching of more than six weeks duration affecting the perianal skin. Death from chronic pruritus ani (3) For the purposes of this Statement of Principles, chronic pruritus ani, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's chronic pruritus ani. Note: terminal event is defined in the Schedule 1 – Dictionary. 8 Basis for determining the factors The Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence that indicates that chronic pruritus ani and death from chronic pruritus ani can be related to relevant service rendered by veterans, members of Peacekeeping Forces, or members of the Forces under the VEA, or members under the MRCA. Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary. 9 Factors that must exist At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting chronic pruritus ani or death from chronic pruritus ani with the circumstances of a person's relevant service: (1) an inability to maintain adequate anal hygiene for at least the four weeks before the clinical onset of chronic pruritus ani; Note: adequate anal hygiene is defined in the Schedule 1 - Dictionary. (2) undertaking excessive cleansing of the perianal area for at least the four weeks before the clinical onset of chronic pruritus ani; Note: excessive cleansing of the perianal area is defined in the Schedule 1 - Dictionary. (3) having daily episodes of diarrhoea for at least the seven days before the clinical onset of chronic pruritus ani; Note: diarrhoea is defined in the Schedule 1 - Dictionary. (4) having faecal incontinence for at least the four weeks before the clinical onset of chronic pruritus ani; Note: faecal incontinence is defined in the Schedule 1 - Dictionary. (5) having a condition from the specified list of rectal, anal and perianal conditions at the time of the clinical onset of chronic pruritus ani; Note: specified list of rectal, anal and perianal conditions is defined in the Schedule 1 - Dictionary. (6) having a perianal or anal infection from the specified list of infections, at the time of the clinical onset of chronic pruritus ani; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (7) having a perianal or anal infestation with an agent from the specified list of infestations, at the time of the clinical onset of chronic pruritus ani; Note: specified list of infestations is defined in the Schedule 1 - Dictionary. (8) having a pathological vaginal discharge at the time of the clinical onset of chronic pruritus ani; Note: pathological vaginal discharge is defined in the Schedule 1 - Dictionary. (9) having a dermatological disease from the specified list of dermatological diseases affecting the perianal or anal region at the time of the clinical onset of chronic pruritus ani; Note: specified list of dermatological diseases is defined in the Schedule 1 - Dictionary. (10) having a systemic disease from the specified list of systemic diseases at the time of the clinical onset of chronic pruritus ani; Note: specified list of systemic diseases is defined in the Schedule 1 - Dictionary. (11) undergoing a course of therapeutic radiation for cancer, where the perianal region was in the field of radiation, within the 30 days before the clinical onset of chronic pruritus ani; (12) having corticosteroid-related atrophy of the perianal skin at the time of the clinical onset of chronic pruritus ani; (13) an inability to maintain adequate anal hygiene for at least the four weeks before the clinical worsening of chronic pruritus ani; Note: adequate anal hygiene is defined in the Schedule 1 - Dictionary. (14) undertaking excessive cleansing of the perianal area for at least the four weeks before the clinical worsening of chronic pruritus ani; Note: excessive cleansing of the perianal area is defined in the Schedule 1 - Dictionary. (15) having daily episodes of diarrhoea for at least the seven days before the clinical worsening of chronic pruritus ani; Note: diarrhoea is defined in the Schedule 1 - Dictionary. (16) having faecal incontinence for at least the four weeks before the clinical worsening of chronic pruritus ani; Note: faecal incontinence is defined in the Schedule 1 - Dictionary. (17) having a condition from the specified list of rectal, anal and perianal conditions at the time of the clinical worsening of chronic pruritus ani; Note: specified list of rectal, anal and perianal conditions is defined in the Schedule 1 - Dictionary. (18) having a perianal or anal infection from the specified list of infections, at the time of the clinical worsening of chronic pruritus ani; Note: specified list of infections is defined in the Schedule 1 - Dictionary. (19) having a perianal or anal infestation with an agent from the specified list of infestations, at the time of the clinical worsening of chronic pruritus ani; Note: specified list of infestations is defined in the Schedule 1 - Dictionary. (20) having a pathological vaginal discharge at the time of the clinical worsening of chronic pruritus ani; Note: pathological vaginal discharge is defined in the Schedule 1 - Dictionary. (21) having a dermatological disease from the specified list of dermatological diseases affecting the perianal or anal region at the time of the clinical worsening of chronic pruritus ani; Note: specified list of dermatological diseases is defined in the Schedule 1 - Dictionary. (22) having a systemic disease from the specified list of systemic diseases at the time of the clinical worsening of chronic pruritus ani; Note: specified list of systemic diseases is defined in the Schedule 1 - Dictionary. (23) undergoing a course of therapeutic radiation for cancer, where the perianal region was in the field of radiation, within the 30 days before the clinical worsening of chronic pruritus ani; (24) having corticosteroid-related atrophy of the perianal skin at the time of the clinical worsening of chronic pruritus ani; (25) inability to obtain appropriate clinical management for chronic pruritus ani. 10 Relationship to service (1) The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person. (2) The factors set out in subsections 9(13) to 9(25) apply only to material contribution to, or aggravation of, chronic pruritus ani where the person's chronic pruritus ani was suffered or contracted before or during (but did not arise out of) the person's relevant service. 11 Factors referring to an injury or disease covered by another Statement of Principles In this Statement of Principles: (1) if a factor referred to in section 9 applies in relation to a person; and (2) that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(2) of the VEA; then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time. Schedule 1 - Dictionary Note: See Section 6 1 Definitions In this instrument: adequate anal hygiene means the personal maintenance of cleanliness of the perianal area by wiping with paper or washing with water. chronic pruritus ani—see subsection 7(2). chronic renal failure means: (a) having a glomerular filtration rate of less than 15 mL/min/1.73 m2 for a period of at least three months; or (b) a need for renal replacement therapy (dialysis or transplantation) for treatment of complications of decreased glomerular filtration rate which would otherwise increase the risk of morbidity and mortality; or (c) undergoing chronic dialysis. diarrhoea means predominantly liquid faecal discharge. excessive cleansing of the perianal area means vigorous scrubbing of the perianal skin resulting in mechanical trauma to the skin, or the excessive use of soap or wipes containing alcohol or other astringents, irritants or allergens. faecal incontinence means the involuntary discharge of liquid or solid faeces. Note: Causes of faecal incontinence include, but are not limited to, constipation with overflow, laxative effects of drugs, and abnormalities of the anal sphincter muscles, rectum, puborectalis muscle, pudendal nerve, central nervous system, spinal cord and autonomic nervous system. iron deficiency means having a serum ferritin level of less than 20 micrograms per litre. MRCA means the Military Rehabilitation and Compensation Act 2004. pathological vaginal discharge means a discharge of fluid from the vagina due to one of the following diseases: vulvovaginal candidiasis, trichomonal vaginitis, bacterial vaginosis, Chlamydia trachomatis cervicitis or gonorrhoea of the lower genitourinary tract. radiation recall dermatitis means an acute inflammatory skin reaction in an area that has undergone a course of therapeutic radiation at least seven days earlier, and develops following the administration of a systemic antineoplastic agent or other drug. relevant service means: (a) operational service under the VEA; (b) peacekeeping service under the VEA; (c) hazardous service under the VEA; (d) British nuclear test defence service under the VEA; (e) warlike service under the MRCA; or (f) non-warlike service under the MRCA. Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary. specified list of dermatological diseases means: (a) acanthosis nigricans; (b) allergic contact dermatitis; (c) atopic dermatitis; (d) hidradenitis suppurativa; (e) irritant contact dermatitis; (f) lichen planus; (g) lichen sclerosus; (h) neurodermatitis; (i) psoriasis; (j) radiation dermatitis; (k) radiation recall dermatitis; (l) seborrhoeic dermatitis; or (m) systemic contact dermatitis. Note 1: Various forms of contact dermatitis may be precipitated by irritants or allergens, including, but not limited to, foods, chemicals, drugs and faeces. Note 2: Neurodermatitis is also known as lichen simplex chronicus. Note 3: systemic contact dermatitis and radiation recall dermatitis are also defined in the Schedule 1 - Dictionary. specified list of infections means: (a) Candida albicans; (b) Corynebacterium spp.; (c) Epidermophyton spp., Microsporum spp. or Trichophyton spp. (tinea); (d) herpes simplex virus; (e) human papilloma virus; (f) molluscum contagiosum virus; (g) Neisseria gonorrhoeae (gonorrhoea); (h) Staphylococcus spp.; (i) Streptococcus spp.; or (j) Treponeum pallidum (syphilis). specified list of infestations means: (a) Enterobius vermicularis (pin worm); (b) Phthirus pubis or Pediculus humanus (lice); (c) Sarcoptes scabiei (scabies); (d) Strongyloides stercoralis (strongyloides); or (e) Taenia saginata or Taenia solium (tapeworm). specified list of rectal, anal and perianal conditions means: (a) anal fissure; (b) anal fistula; (c) anal skin tag; (d) anal sphincter incompetence; (e) familial adenomatous polyposis; (f) haemorrhoid; (g) inflammatory bowel disease; (h) perianal wart; (i) perianal abscess; (j) proctitis; (k) rectal prolapse; or (l) any benign or malignant neoplasm of the rectum, anus, anal canal or perianal skin. specified list of systemic diseases means: (a) aplastic anaemia; (b) cholestatic liver disease; (c) chronic renal failure; (d) diabetes mellitus; (e) hyperbilirubinaemia; (f) hyperthyroidism; (g) hypothyroidism; (h) human immunodeficiency virus; (i) iron deficiency; (j) leukaemia; (k) lymphoma; or (l) polycythaemia vera. Note: chronic renal failure and iron deficiency are also defined in the Schedule 1 - Dictionary. systemic contact dermatitis means an inflammatory skin condition in a person who has experienced allergic contact dermatitis from cutaneous contact with an allergen at the affected site, and subsequently experiences a reactivation at that site following systemic exposure to that same allergen or a cross-reacting allergen. Note: Systemic contact dermatitis may occur following systemic exposure to a range of contact allergens, including, but not limited to, chemicals and drugs found in topical medications. terminal event means the proximate or ultimate cause of death and includes the following: (a) pneumonia; (b) respiratory failure; (c) cardiac arrest; (d) circulatory failure; or (e) cessation of brain function. VEA means the Veterans' Entitlements Act 1986.