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Table 1 Definitions and criteria used to identify and classify the different endpoints in the CAPAMIS Study.

From: Rationale and design of the CAPAMIS study: Effectiveness of pneumococcal vaccination against community-acquired pneumonia, acute myocardial infarction and stroke

OUTCOMES

DEFINITIONS

A. Community-acquired pneumonia (CAP)*

Pneumonia will be considered when a new radiological infiltrate is identified in a patient with one major criterion (cough, expectoration or fever) or two minor criteria (dyspnea, pleuritic pain, altered mental status, pulmonary consolidation on auscultation and leukocytosis).

   A1. Hospitalised CAP

Will be considered those pneumonia cases identified on the basis of the listed primary diagnosis codes in hospital discharge databases (ICD-9-CM codes for pneumonia: 480 to 487.0).

   A2. Outpatient CAP

Will be considered those CAP cases non-hospitalised, and they will be identified from primary care or emergency visits (not hospitalised) with a code registered for pneumonia in the Emergency Unit discharge codes databases (ICD-9-CM codes: 480 to 487.0) or Primary Care Centers diagnosis database (ICD-10 codes: J10.9, J11.9 and J12 to J18).

B. Pneumococcal CAP**

Defined as a patient with CAP from whom Streptococcus Pneumoniae is identified by blood culture, sputum culture or urinary antigen.

   B1. Bacteremic pneumococcal CAP

Will be considered when S. pneumoniae was isolated from blood specimens or other sterile sites.

   B2. Nonbacteremic pneumococcal CAP

Will be considered when the patients have a typical clinical syndrome of pneumonia without bacteremia (negative or not performed blood culture), but they have a sputum culture that yielded pneumococci with no other likely bacterial pathogens and/or they have positive Binax-NOW Streptococcus pneumoniae urinary antigen test.

C. Acute myocardial infarction (AMI)

Defined as a patient hospitalised with diagnosis of acute or recurrent episode of myocardial infarction. Cases will be identified on the basis of the primary and secondary listed diagnosis codes in the hospital discharge database (ICD-9-CM code for AMI: 410). All initially identified cases of AMI will be further validated by checking hospital medical records, and each case will be classified as related or nonrelated with a prior episode of CAP.

   C1. CAP-related episode of AMI

Defined as AMI ocurring within the first 30 days after the onset of an episode of CAP.

   C2. CAP-nonrelated episode of AMI

Case of AMI ocurring more than 30 days after an episode of CAP or in a patient without history of prior CAP.

D. Hospitalisation for stroke

Defined as a patient admitted to hospital with a diagnosis of stroke, ictus or cerebral infarction. Cases will be identified on the basis of the primary and secondary listed diagnosis codes in the hospital discharge databases (ICD-9-CM codes for stroke: 430 to 437). Haemorragic strokes (codes 430 to 432) and ischaemic strokes will be considered (codes 433, 434, 436 or 437), but transient ischaemic attacks (code 435) will be excluded for the analyses. All cases initially identified of stroke will be further validated by checking hospital medical records, and each case will be classified as related or nonrelated with a prior episode of CAP.

   D1. CAP-related episode of stroke

Defined as an episode of stroke ocurring within the first 30 days after the onset of CAP.

   D2. CAP-nonrelated episode of stroke

Defined as an episode of stroke ocurring more than 30 days after an episode of CAP or in a patient without history of a prior episode of CAP.

E. All-cause death

It includes patients who died for any cause during the study period. Cases will be identified from primary care information system of each participating PCC.

   E1. Death from CAP

Defined as a patient who died (in hospital or not) within the first 30-days after the onset of CAP.

   E2. Death from AMI

Defined as a patient who died within hospital stay or within the first 30-days after the diagnosis of AMI.

   E3. Death from stroke

Defined as a patient who died within hospital stay or within the first 30 days after the onset of the stroke.

  1. * All cases of CAP (hospitalised and outpatient) must be radiographically confirmed and validated by checking the clinical record with the use of a standardized data-collection instrument. CAP will be considered if, on conclusion of the medical record review, the physician reviewer verified this diagnosis and it was not a readmission, nosocomial pneumonia or another diagnosis.
  2. ** Pneumococcal CAP will initially be identified on the basis of ICD-9-CM codes for pneumococcal bacteraemia (codes 038.0, 038.2, 041.0, 041.2) or pneumococcal pneumonia (code 481) in the Hospitals and Emergency discharge diagnosis databases and ICD-10 code for pneumococcal pneumonia (code J13) in the Primary Care visits diagnosis databases. Laboratory records will also be used to identify cases of pneumococcal infections not detected in ICD-9-CM or ICD-10 discharge codes.