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Table 2 Study variables for the evaluation of the COPD PROCESS

From: Assessment of a primary and tertiary care integrated management model for chronic obstructive pulmonary disease

Group

Variables

Social and demographic characteristics:†‡

Primary care clinic assignment; date of birth; sex.

Patient and lung function characteristics:

Weight; height; spirometry performed in the past year.

 

Spirometry results after bronchodilator (Datospir 120, model A, SIBEL, S.A, Barcelona, Spain; after calibration, with daily maintenance by expert nurses, and quality assurance).

 

Carbon monoxide in expired air; pulse oximetry; COPD stage (GOLD criteria); year COPD was diagnosed.

Clinical status (last 6 months):†‡

Smoking (frequency, pack-years, cessation phase, enrollment in a cessation program, adherence to recommended preventive measures); exercise (type of activity, duration in minutes and days per week); adherence to any medical advice that has been given; Charlson comorbidity index [43]; dyspnea severity (Medical Research Council Breathlessness scale [44]).

Medication:

Active principle and pharmaceutical class, dosage.

 

Inhalers: number of inhaler devices used in the last month, level of handling expertise (correct performance of 3 actions for a specific inhaler type).

 

Oral medications (glucocorticosteroids, theophylline, antioxidants) and their agreement between the patient's report and the medical record.

 

Supplemental oxygen therapy; mechanical ventilation; annual vaccination or in the previous winter (flu, pneumococcus)

 

Attendance at COPD management training sessions or specific sessions related to medication type.

 

Deviations from the PROCESS model (lack of agreement between drugs taken and those recommended for the recorded GOLD severity stage).

Exacerbations in the last year:†‡

Defined as the worsening of respiratory symptoms requiring treatment with antibiotics or oral corticosteroids or both (moderate exacerbation) or hospitalization (severe exacerbation) or a combination of the two degrees of severity (based on [45])

Complications and potential complications:

Primary care nursing diagnosis (according to the Catalan Health Institute's adaptation of the North American Nursing Diagnosis Association (NANDA), February 2003).

Health care in the past year:†‡

Primary care clinic visits for any reason (including the general practitioner, the nurse or the respiratory medicine specialist); number of home visits made in the past year; number of visits to hospital (outpatient, emergency, admissions).

Quality of life:

Respiratory-disease related quality of life (Chronic Respiratory Questionnaire [46])

Systemic inflammatory status:

C-reactive protein (capillary blood levels: QuikRead® CRP 101. Orion Diagnostica, Espoo, Finland)

Other:†‡

Exitus

  1. Measures evaluating the health-care dimension of the COPD PROCESS model. Information will be gathered on the population of patients with chronic obstructive pulmonary disease in each of the two study areas (clinical and administrative data from the databases of the participating centers).
  2. Measures to evaluate the clinical dimension of the COPD PROCESS model. Information will be gathered on patients in the intervention and control cohorts by consulting patient medical records and arranging for patient visits in each of the centers.