Other AreasFen-Phen

AHP SettlementEndnotes (22-30)

In defining the "Levels of Severity " which qualify class members for matrix compensation benefits, the Settlement requires the application of a standardized methodology or protocol. Endnotes have been used in the description of levels of valvular heart disease to indicate reference to a standardized methodology or protocol. The referenced methodologies or protocols, together with the corresponding endnote, are as follows: (Also see endnotes 1-21)

22. See Id.

23. See Id.

24. See The American Heart Association Stroke Outcome Classification, approved by the American Heart Association Science Advisory and Coordinating Committee, Stroke 29: 1274-80 (1998):

The AHA Stroke Outcome Classification (AHA.SOC) score classifies the severity and extent of neurological impairments that are the basis for disability. The classification also identifies the level of independence of stroke patients according to basic and more complex activities of daily living both at home and in the community. The classification score is meant to describe the limitations resulting from the current stroke. It is not an evaluation of disabilities caused by other neurological events. Furthermore, it is a summary score.

Stroke Outcome Classification

AHA.SOC SCORE: (Number of Domains) (Severity) (Function)

Number of Neurological Domains Impaired
Score Domains Impaired Neurological Domains
0 0 domains impaired Motor
Sensory
Vision
Affect
Cognition
Language
1 1 domain impaired
2 2 domains impaired
3 >2 domains impaired

Severity of Impairment

Level A: No/minimal neurological deficit due to stroke in any domain

Level B: Mild/moderate deficit due to stroke in =1 domain(s)

Level C: Severe deficit due to stroke in =1 domain(s)

Function

Level I: Independent in Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL) activities and tasks required of roles patient had before the stroke. Patient is able to live alone, maintain a household, and access the community for leisure and/or productive activities such as shopping, employment, or volunteer work.

Level II: Independent in BADL but partially dependent in routine IADL. Patient is able to live alone but requires assistance/supervision to access the community for shopping and leisure activities. Patient may require occasional assistance with meal preparation, household tasks, and taking medications.

Level III: Partially dependent in BADL (<3 areas) and IADL. Patient is able to live alone with substantial daily help from family or community resources for more difficult BADL tasks such as dressing lower extremities, bathing, or climbing stairs. Patient requires assistance with such IADL tasks as meal preparation, home maintenance, community access, shopping, handling finances, and/or taking medications.

Level IV: Partially dependent in BADL ( >3 areas). Patient is unable to live alone safely and requires assistance with IADL except for simple tasks such as answering the telephone.

Level V: Completely dependent in BADL (>5 areas) and IADL. Patient is unable to live alone safely andrequires full-time care.

25. See Id.

26. See Id.

27. E. Braunwald, supra note 9 at 1433-34:

Endomyocardial Fibrosis. EMF occurs most commonly in tropical and subtropical Africa, particularly Uganda and Nigeria. It is typified by fibrous endocardial lesions of the inflow portion of the right or left ventricle or both and often involves the AV valves, resulting in regurgitation (citation omitted).

Pathology. A pericardial effusion, which may be quite large, may be present. The heart is normal in size or slightly enlarged, but massive cardiomegaly does not occur. The right atrium is often dilated, and in patients with severe right ventricular involvement there may be massive enlargement of this chamber. Indentation of the right border of the heart above the apex as a result of apical scarring may occur (citation omitted). Combined right and left ventricular disease occurs in about half the cases, with pure left ventricular involvement occurring in 40 per cent and pure right ventricular involvement in the remaining 10 per cent of patients who are examined post mortem (citation omitted).

Left ventricular involvement is similar, with fibrosis extending from the apex up the inflow portion of the left ventricle to the posterior mitral valve leaflet. The anterior leaflet of the mitral valve and the outflow portion of the left ventricle are usually spared. Thrombi often overlie the endocardial lesions, and widely distributed endocardial calcific deposits may occur. The coronary arteries are uninvolved, as is the remainder of the body (citation omitted).

Left Ventricular EMF. With predominant left-sided involvement, the endomyocardial fibrosis invades the apex of the ventricle and usually the chordae tendineae or the posterior mitral valve leaflet as well, leading to mitral valve regurgitation. The murmur may be confined to late systole, as is characteristic of the papil-lary muscle dysfunction type of murmur, or it may be pansystolic. Findings of pulmonary hypertension may be prominent. A protodiastolic gallop is commonly heard (citation omitted).

28. See American Heart Association Stroke Outcome Classification, supra note 24.

29. Braunwald supra note 9, at 796-98.

30. See G. Adelman, Encyclopedia of Neuroscience, 268 (1987):

The vegetative state is the condition wherein arousal (i.e., sleep-wake cycles) returns or remains but appropriate testing measures elicit no evidence of the person's cognitive awareness of self or environment.

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