8. Non-AIDS defining events

8.1 Non-AIDS-defining malignomas (any malignancy)

8.2 Cardiovascular events including vein diseases
8.2.1 Myocardial infarction
8.2.2 Cerebral infarction
8.2.3 Cerebral hemorrhage
8.2.4 Deep vein thrombosis
8.2.5 Pulmonary embolism

8.3 Metabolic events
8.3.1 Diabetes mellitus

8.7 Bacterial Pneumonia

8.8 Pancreatitis

8.1 Non-Aids defining malignomas

Diagnosis of cancer (other than: AIDS defining (non-Hodgkin's lymphoma, Kaposi's sarcoma ), or invasive cervical cancer); and other than basal and squamous cell skin cancers):

A. In a pathology report that established the diagnosis

B. In a hospital discharge summary or consultation note from the hospitalization or clinic visit during which the diagnosis was established

C. In the absence of A or B: strong suspicion of cancer supported by

(i) evidence from radiological or other imaging technique,
(ii) or biochemical assay

confirmed malignancy: A or B
probable malignancy: C

These diagnoses are systematically documented since January 2002.

8.2 Cardiovascular events including vein diseases

8.2.1 Myocardial infarction

Acute myocardia infarction, definitive

i) definitive* electrocardiogram (ECG), or
ii) symptoms* together with probable* ECG and abnormal enzymes (or troponine)*, or
iii) typical symptoms*, abnormal enzymes* and ischaemic/non-codable/not available* ECG, or
iv) fatal cases with naked-eye appearance of fresh MI and/or recent coronary occlusion found at necropsy.

1 ECG typical
2 ECG probable and enzymes elevated and symptoms typical, atypical or not interpretable
3 ECG ischaemic, uncodable or not available and enzymes elevated and symptoms typical

Acute myocardial infarction, possible
Living patients with typical symptoms* whose ECG* and enzymes* do not place them as myocardial infarction and in whom there is no conclusive evidence for another diagnosis for the attack.

ECG any Enzymes any Symptoms typical

ECG typical The development in serial records of a diagnostic Q wave -AND/OR-an ST segment elevation lasting more than one day
ECG probable Evolution of repolarisation changes (ST-segment depression or elevation, T wave inversion)
Note: Unlike the criteria for definite ECG, the evolution in this class can go in either direction, that is the codes can get better or worse
ECG ischaemic Ischaemic abnormalities without evolution
Symptoms typical chest pain lasting for at least 20 minutes and no other pathology known which could explain these symptoms

8.2.2 Cerebral infarction

Definitive
Rapidly developed clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours (unless interrupted by surgery or death), with no apparent cause other than a cardiovascular origin. Secondary stroke caused by trauma should be excluded.
The differentiation between infarction and haemorrhage should be based on results of cerebral scanning or necropsy.

Presumptive
Findings of cerebral scanning uncertain

8.2.3 Cerebral hemorrhage

8.2.4 Deep vein thrombosis

Definitive
Confirmed by ultrasonography, or CT scan, or MRI, or venography

Presumptive
Elevated D-dimer plus >3 points on the Wells Clinical Prediction Rule for deep venous thrombosis plus absence of alternative diagnosis.
Wells clinical prediction rule (1 point for each of the following):

Active cancer;
paralysis, paresis, or plaster immobilization of lower extremities;
recently bedridden for more than 3 days, or major surgery, within 4 weeks;
localized tenderness along distribution of the deep venous system;
entire leg swollen;
calf swelling by more than 3 cm when compared with the asymptomatic leg (measured 10 cm below tibial tuberosity):
pitting edema (greater in the symptomatic leg);
collateral superficial veins (non-varicose).

(Adapted from: Wells PS et al. Lancet 1997;350:1796)

8.2.5 Pulmonary embolism

Definitive
Symptoms compatible with pulmonary embolism plus confirmation by CT scan, or MRI, or angiography, or ventilation-üerfusion scintigraphy, or confirmed on autopsy.

Presumptive
Symptoms compatible with pulmonary embolism plus confirmation of deep venous thrombosis on venography or ultrasound or other imaging studies and exclusion of an alternative etiology for the cardio-pulmonary symptoms.

8.3 Metabolic events

8.3.1 Diabetes mellitus

fasting plasma glucose >= 7 mmol/l on two consecutive occasions (fasting means > 8 hours without caloric intake) or
typical symptoms, plasma glucose >= 11.1mmol/l or
venous plasma glucose >= 11.1 mmol/l, 2 hours after oral intake of 75g glucose
Hb1Ac >= 6.5%

Report also gestational diabetes

8.4 Liver-related events
(definitions from December 2008)

8.4.1 Bleeding from gastric or esophageal varices

Endoscopy verified

8.4.2 Spontaneous bacterial peritonitis

Detection od ascites, and no evidence of secondary peritonitis

8.4.3 Hepatic encephalopathy stage III or IV

Precoma or coma in a patient with signs and symptoms of liver failure and no other explanation for precoma or coma.
Stage III = pre-coma; stage IV = coma

8.4.4 Hepatorenal syndrome

Acute renal failure in patient with existing severe chronic liver disease, and no evidence of obstructive or parenchymal kidney disease.

8.4.5 Liver cirrhosis

Pathology report documenting cirrhosis (cirrhotic nodules and broad collagen bands corresponding to Metvir F4).

8.4.6 NASH (Non-alcoholic steatosis hepatis)

Definitive
Elevated liver enzymes plus histology of fatty liver disease in a patient without any other identifiable cause, i.e. exclusion of alcohol use, hepatitis virus infections and other known causes of liver diseases.

Presumptive
Elevated liver enzymes plus findings in ultrasonography or other imaging methods indicating fatty liver disease in a patient without any other identifiable cause, i.e. exclusion of alcohol use, hepatitis virus infections and other known causes of liver diseases.

8.4.7 Portal hypertension

Endoscopically documented oesophageal varices
or
portal pressure gradient (the difference in pressure between the portal vein and the hepatic veins) of 5mmHg or greater.

8.4.8 Ascites

Clinical identifiable and detectable ascites confirmed by imaging with no other known non-liver related cause.

8.5 Kidney-related events

8.5.1 Permanent dialysis

Indicate start date. Hemodialysis or peritoneal dialysis expected to last at least one month, documented in a clinical note.

8.6 Bone-related events

8.6.1 Avascular necrosis femoral head

Synonyms
Avascular necrosis of the femoral head, osteonecrosis of the femoral head, ischemic necrosis of the femoral head, bone necrosis of the femoral head, bone infarct of the femoral head, idiopathic bone necrosis of the femoral head, nontraumatic avascular necrosis of the femoral head, traumatic avascular necrosis of the femoral head, subchondral avascular necrosis.

Diagnosis
Confirmed by MRI or histology

8.6.2 Avascular necrosis other bone

as above

8.6.3 Diagnosis of osteoporosis

Osteoporosis
Bone mass that is 2.5 SD or more below the young adult mean bone mass

Diagnosis
confirmation by DEXA scan or by rheumatologist based on imaging techniques in a patient with or without fracture

8.6.4 Fracture with adequate trauma

Fracture is plausible

8.6.5 Low trauma fracture

A fracture that resulted from a fall from standing height or less, at walking speed or less, without additional trauma/impact (i.e. a fracture while riding bicycle, during sports, falling down stairway is NOT a low trauma fracture).

8.7 Bacterial pneumonia

Definitive
Signs and symptoms suggestive of bacterial pneumonia plus documented abnormality in chest x-ray or CT scan of lung compatible with bacterial pneumonia plus identification of a bacterial pathogen by blood culture, bronchoalveolar lavage or detection of Legionella or pneumococcal antigen in urine.

Presumptive
Signs and symptoms suggestive of bacterial pneumonia plus documented abnormality in chest x-ray or CT scan of lung compatible with bacterial pneumonia.

8.8 Pancreatitis

Definitive
Signs and symptoms suggestive of pancreatitis plus elevated pancreas enzymes plus documented structure abnormality in CT scan or MRI or other imaging techniques; or confirmed by histology.

Presumptive
Signs and symptoms suggestive of pancreatitis plus elevated pancreas enzymes without other explanation.