Kingston Chronic Obstructive Pulmonary Disease (COPD) Cohort
Kingston Chronic Obstructive Pulmonary Disease (COPD) Cohort
Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic
 complex patient. Their follow up can sometimes be difficult and challenging (1). There are
 patients with recurrent exacerbations that put an enormous burden on health care resources
 (2). They also have multiple comorbidities (3) that can sometimes make their management
 difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have
 numerous essential resources to take care of COPD patients like the nurse navigators, nurse
 practitioners and the pulmonary rehabilitation program. These programs provide an excellent
 support to the clinical activity of Respirologists and other health care providers.

 Rationale: The main rationale for the development of the Kingston COPD cohort is to translate
 that highly demanding clinical activity in a teaching and research oriented activity that
 could be used by clinicians, medical students, residents and fellows. Having a guideline
 complained established protocol in COPD patients that are usually follow at KGH and HDH could
 help in not only in unified the way COPD patients are seeing (preserving the importance of
 the personalized approach) but most importantly established a multidimensional (clinical,
 physiological, radiological, laboratory) database. This could help us know not only the
 results of our clinical activity but also have a long term (>5yrs) database for clinical
 research projects in collaboration with national and international research groups. Therefore
 this proposal is important because it will help us translate our busy daily clinical work in
 a highly productive teaching and research activity.
Aims: establish a long term multidimensional follow up of a large COPD cohort of COPD
 patients in Kingston, Ontario.

 Specific Objectives: 1. established a simple and easy to apply follow up protocol in COPD
 patients. 2. Hire a research assistant 3. Set up the database.

 Data source: Patients included in the present cohort will be those usually follow at the
 Respirology clinic at Hotel Dieu Hospital in Kingston Ontario.

 Inclusion Criteria: 1. Patients ages between 40-85 years old. 2. Smoking history of at least
 10 pack year history 3. Active of former smokers 4. Diagnosis of COPD according to the GOLD
 definition (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other
 associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or
 Interstitial Lung Disease. 5. Ability to perform all study procedures (complete pulmonary
 function tests, six minute walking test (6MWT) and chest computed tomography) and
 provide/sign informed consent.

 Exclusion criteria: 1. Patients not willing to sign the consent form 2. Patients with a life
 expectancy of less than 3 yrs. 3. Patients in palliative care. 4. Patients with chronic
 airway obstruction ie: FEV1/FVC≤0.70 of other etiology and without a smoking history of less
 than 10 packs year history. 5. Patients unable ort not able to perform the pulmonary function
 test, the 6MWT or the chest CT.

 Data elements: this will include clinical, laboratory, physiological and radiological data.

 Clinical: baseline and yearly evaluation. The following information will be collected and
 registered: Age, gender, history of prematurity and low weight at birth, maternal smoking
 during pregnancy, history of infections or wheezing during infancy, pack year history: (age
 of smoking initiation, years smoking, packs per day, age of quitting if quit), active or
 former smokers, use of vaping or marihuana?, registration of Comorbidities using the Copd
 cOmorbidiTy indEx COTE index, use of medications: LABA, LAMA, dual, LABA/ICS, ICS,
 Roflumilast, Erithromycin, NAC, etc, use of O2 at home: lt/min and duration, CPAP and BiPAP
 and pressures, degree of dyspnea measure by the Medical Research Council scale, height,
 weight, Body Mass Index, Free Fat Mass Index determined by electrical bioimpedance, handgrip,
 abdominal and pelvic girth.

 Laboratory: baseline and yearly The following information from the patient chart will be
 collected and registered: CBC (including differential specifically eosinophilia), CRP,
 baseline alfa 1 AT levels (only baseline), fibrinogen, basal ABG.

 Physiological information: yearly evaluation The following information will be collected and
 registered: FEV1, FVC, FEV1/FVC, TLC, IC/TLC, RV/TLC, DLCO, KCO. MIP, MEP, 6MWD with and
 without O2 in those O2 Sat 90% or lower. In a sample of interest full Cardiopulmonary
 exercise test.

 Radiological information: Yearly Low dose chest CT The following information will be
 registered from the final reports of the chest CT: Emphysema presence, type, extent and
 localization, PulmArt/Ao diameter ratio measurement, presence of bronchiectasis (type and
 localization), presence of air trapping, presence (type and localization) of interstitial
 changes, presence of coronary calcifications, presence of osteoporosis, presence of lung
 nodules---- Lung cancer.

 Data storage and identification Data will be stored in an encrypted file behind a firewall in
 a KGH server. For research purpose patient's information will be anonimized by using a study
 ID number that will be linked to the CR number of every patient in a different encrypted
 file. There will be no personal identifiable information during the entire process of each of
 the proposed studies.

 Statistical analysis plan The description of the characteristics of the participants will
 follow the following methodology: qualitative data will be described using relative
 frequencies. We will use the Kolmogorov-Smirnov test (K-S) to determine if a quantitative
 variable has a normal distribution. Quantitative data with a normal distribution will be
 expressed using the mean and the standard deviation (SD).

 When comparison between groups is planned the following methodological plan will be applied:
 quantitative data with non-normal distribution will be described with the median and the
 interquartile range (IQR). Differences will be compared with chi square for qualitative data
 or student t test and Mann-Whitney U test for quantitative data according to each variable
 distribution.
Inclusion Criteria:

 1. Patients ages between 40-85 years old. 2. Smoking history of at least 10 pack year
 history 3. Active of former smokers 4. Diagnosis of COPD according to the GOLD definition
 (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other associated
 respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung
 Disease. 5. Ability to perform all study procedures (complete pulmonary function tests, six
 minute walking test (6MWT) and chest computed tomography) and provide/sign informed
 consent.

 Exclusion Criteria:

 1. Patients not willing to sign the consent form 2. Patients with a life expectancy of less
 than 3 yrs. 3. Patients in palliative care. 4. Patients with chronic airway obstruction ie:
 FEV1/FVC≤0.70 of other etiology and without a smoking history of less than 10 packs year
 history. 5. Patients unable ort not able to perform the pulmonary function test, the 6MWT
 or the chest CT.