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cohort &#40;clinicaltrials&#46;gov <a href="ctgov:NCT03485690">NCT03485690</a>&#41; is a single-center&#44; prospective cohort study aimed at evaluating COPD patients prospectively using tools normally used in the clinic&#46; The study starts from the hypothesis that is possible to identify different patient types with different clinical behavior who show a different response to treatment by using common clinical tools available at all health centers attending patients with respiratory diseases&#46; The protocol has been approved by the Local Ethical Health Authorities &#40;Portal de &#201;tica de la Investigaci&#243;n Biom&#233;dica de Andaluc&#237;a&#44; approval actas 08&#47;2015 and 07&#47;2017&#41;&#46; Due to the observational and non-interventional nature of the study&#44; an informed consent was waived&#46; The ethical committee was notified of this circumstance and approved the procedure clearly recorded in the protocol&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The objective of the study is to accomplish three specific aims&#58; &#40;1&#41; to describe the variation over time of different clinical variables and the results of the complementary tests routinely used in the clinic&#44; &#40;2&#41; to define the different behavior patterns of the disease&#44; and &#40;3&#41; to evaluate the impact of different therapeutic approaches on this behavior in the different patient types in terms of lung function improvement&#44; perception of symptoms and exacerbation frequency&#46; The primary endpoint is survival&#46; The secondary endpoints include dyspnea&#44; measured by modified Medical Research Council scale&#44; the number of moderate or severe exacerbations&#44; forced expiratory volume in one second &#40;FEV<span class="elsevierStyleInf">1</span>&#41; annual decline&#44; forced expiratory flow at 25&#8211;75&#37; of expiration&#44; peak expiratory flow&#44; peripheral blood eosinophils count&#44; serum alpha1-antitrypsin&#44; total IgE&#44; bronchial colonization&#44; and inhaled and oral COPD-related medication use&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The study population is composed solely of COPD patients recruited from specialized COPD-dedicated outpatient clinics in a tertiary university hospital&#46; Estimated sample size was 1440 cases&#46; Adult patients with a diagnosis of COPD according to current guidelines<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> receiving routine follow-up in our dedicated COPD outpatient clinic have been selected for inclusion&#46; The protocol does not pre-specify any exclusion criteria&#44; except for the complete reversibility of lung function testing during follow-up&#46; The inclusion of patients was piloted study since 2012&#44; a procedure that was completed in 2015&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">After identification of cases&#44; the patients are followed up at yearly visits <span class="elsevierStyleItalic">sine die</span> until they die or are lost to follow-up&#46; The study is guided by a Steering Committee&#44; consisting of six academic respiratory physicians who attend patients regularly&#46; All the subjects receive their prescribed medication and therapeutic interventions throughout the study with any changes in medication being ordered by the physician in charge&#44; according to the patient&#39;s clinical status&#46; During the yearly visits&#44; clinical&#44; functional&#44; radiological and analytical information is recorded using a standardized questionnaire&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">All the clinical variables were obtained from the patient and included&#58; socio-demographics &#40;gender&#44; age&#41;&#44; tobacco history&#44; comorbidities&#44; clinical presentation during the previous year in a stable state &#40;including dyspnea evaluation&#44; cough and sputum production&#44; color of the sputum if present&#44; wheezing and symptoms suggestive of asthma&#41;&#44; exacerbations and hospitalization in the previous year&#44; current pharmacological and non-pharmacological treatment&#46; Complementary tests&#44; included&#44; at least&#44; chest radiology&#44; pre- and post-bronchodilator spirometry and analytical results &#40;blood eosinophils&#44; alpha1-antitrypsin&#44; total IgE&#41;&#46; With this information&#44; the patients are initially categorized according to the different versions of the Global Initiative of Obstructive Lung Disease &#40;GOLD&#41; document<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> and the Spanish national guidelines for COPD &#40;GesEPOC&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a> and the classification is adapted to the successive updates of these documents during the follow-up&#44; whenever possible&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Asthma-like symptoms are also recorded&#44; including the presence of rhinitis&#44; variability of respiratory symptoms during the year and worsening of respiratory symptoms when exposed to non-specific triggers&#46; The comorbidities are recorded following different comorbidity composite scores&#44; including the Charlson comorbidity index&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a> the COPD specific comorbidity test &#40;COTE&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> the COMorbidities in Chronic Obstructive Lung Disease &#40;COMCOLD&#41; index&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> and the Functional Comorbidity Index&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Exacerbations are recorded at each yearly clinical visit&#46; For the present study&#44; an exacerbation is defined as any increase in perceived respiratory symptoms which requires additional medication to control them&#46; To consider two exacerbations as different episodes&#44; a time lapse between episodes of at least 4 weeks from the end of the exacerbation or 6 weeks from the beginning is required&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> The information provided by the patient regarding exacerbation frequency is matched with the information in the clinical record&#46; Emergency ward visits and hospital admissions due to exacerbations are also noted&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Non-pharmacological treatments over the previous year are noted at every visit&#44; including the persistence of active smoking&#44; daily exercise&#44; and influenza and pneumococcal vaccinations&#46; Oral and inhaled pharmacological therapies for COPD are also noted&#44; as is the use of home-based therapies&#44; including home mechanical ventilation&#44; long-term oxygen therapy and nebulizers&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Spirometries are performed so far with a Masterlab Pneumatic Tachograph &#40;Erich Jaeger GHBH&#44; W&#252;rzburg&#44; Germany&#41;&#46; The spirometer is calibrated daily&#44; and the results adjusted by the atmospheric conditions&#46; Patients are instructed to withhold their inhaler medication on the day of the test&#44; in order to record pre- and post-bronchodilator spirometry&#46; If this is not the case&#44; then the spirometry is considered post-bronchodilator&#46; The bronchodilator test is performed after the administration of 400<span class="elsevierStyleHsp" style=""></span>&#956;g of salbutamol via a pressured metered dose inhaler with a chamber&#46; The spirometry is performed according to current standards assessing the quality of the results&#46; Parameters recorded in absolute values and percentage predicted values are forced vistal capacity &#40;FVC&#41;&#44; FEV<span class="elsevierStyleInf">1</span>&#44; FEV<span class="elsevierStyleInf">1</span>&#47;FVC ratio&#44; peak expiratory flow&#44; and forced expiratory flow between 25&#37; and 75&#37; of the FVC&#46; The main limitation is in relation to the non-use of advanced diagnostic techniques beyond those recommended for clinical practice&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">TRACE is a prospective cohort study is an opportunity to identify specific patients who have a specific response to various treatments using tools available to any clinician&#46; Their results may provide new information on how to make a more personalized medicine in real clinical practice&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Final declarations</span><p id="par0060" class="elsevierStylePara elsevierViewall">Funding&#46; TRACE is funded by an unrestricted grant from Gebro Pharma laboratories&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">JLLC has received honoraria during the last 3 years for lecturing&#44; scientific advice&#44; participation in clinical studies or writing for publications for &#40;alphabetical order&#41;&#58; AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; CSL Behring&#44; Esteve&#44; Ferrer&#44; Gebro&#44; GlaxoSmithKline&#44; Grifols&#44; Menarini&#44; Novartis&#44; Rovi&#44; and Teva&#46;</p></span></span>"
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Scientific Letter
Time-based Register and Analysis of COPD Endpoints (TRACE) Project: Methodology and Workflow
Registro y análisis en el tiempo de resultados clínicos en EPOC (Proyecto TRACE): metodología y procedimiento
Laura Carrasco Hernándeza, Candela Caballero Erasoa,b, María Abad Arranza, Eduardo Márquez Martína, Carmen Calero Acuñaa,b, Jose Luis Lopez-Camposa,b,
Corresponding author
lopezcampos@separ.es

Corresponding author.
a Unidad Médico-Quirúrgica de Enfermedades Respiratorias. Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocio/Universidad de Sevilla, Spain
b CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Over the last few decades&#44; several observational prospective cohorts have added to our understanding of the clinical presentation and the progression of chronic obstructive pulmonary disease &#40;COPD&#41;&#46; Although the different studies available have provided valuable information on specific aspects of the disease over a fixed period of time&#44;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">1&#44;2</span></a> its direct implications for daily clinical practice have been less profound than expected partly due to the use of specific advanced diagnostic tools&#44; which are not always routinely available in clinical practice&#46; Accordingly&#44; it would be desirable to conduct a prospective observational cohort study evaluating the tools normally available to the clinician in their daily clinical practice&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The <span class="elsevierStyleItalic">Time-based Register and Analysis of COPD Endpoints</span> &#40;TRACE&#41; cohort &#40;clinicaltrials&#46;gov <a href="ctgov:NCT03485690">NCT03485690</a>&#41; is a single-center&#44; prospective cohort study aimed at evaluating COPD patients prospectively using tools normally used in the clinic&#46; The study starts from the hypothesis that is possible to identify different patient types with different clinical behavior who show a different response to treatment by using common clinical tools available at all health centers attending patients with respiratory diseases&#46; The protocol has been approved by the Local Ethical Health Authorities &#40;Portal de &#201;tica de la Investigaci&#243;n Biom&#233;dica de Andaluc&#237;a&#44; approval actas 08&#47;2015 and 07&#47;2017&#41;&#46; Due to the observational and non-interventional nature of the study&#44; an informed consent was waived&#46; The ethical committee was notified of this circumstance and approved the procedure clearly recorded in the protocol&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The objective of the study is to accomplish three specific aims&#58; &#40;1&#41; to describe the variation over time of different clinical variables and the results of the complementary tests routinely used in the clinic&#44; &#40;2&#41; to define the different behavior patterns of the disease&#44; and &#40;3&#41; to evaluate the impact of different therapeutic approaches on this behavior in the different patient types in terms of lung function improvement&#44; perception of symptoms and exacerbation frequency&#46; The primary endpoint is survival&#46; The secondary endpoints include dyspnea&#44; measured by modified Medical Research Council scale&#44; the number of moderate or severe exacerbations&#44; forced expiratory volume in one second &#40;FEV<span class="elsevierStyleInf">1</span>&#41; annual decline&#44; forced expiratory flow at 25&#8211;75&#37; of expiration&#44; peak expiratory flow&#44; peripheral blood eosinophils count&#44; serum alpha1-antitrypsin&#44; total IgE&#44; bronchial colonization&#44; and inhaled and oral COPD-related medication use&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The study population is composed solely of COPD patients recruited from specialized COPD-dedicated outpatient clinics in a tertiary university hospital&#46; Estimated sample size was 1440 cases&#46; Adult patients with a diagnosis of COPD according to current guidelines<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> receiving routine follow-up in our dedicated COPD outpatient clinic have been selected for inclusion&#46; The protocol does not pre-specify any exclusion criteria&#44; except for the complete reversibility of lung function testing during follow-up&#46; The inclusion of patients was piloted study since 2012&#44; a procedure that was completed in 2015&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">After identification of cases&#44; the patients are followed up at yearly visits <span class="elsevierStyleItalic">sine die</span> until they die or are lost to follow-up&#46; The study is guided by a Steering Committee&#44; consisting of six academic respiratory physicians who attend patients regularly&#46; All the subjects receive their prescribed medication and therapeutic interventions throughout the study with any changes in medication being ordered by the physician in charge&#44; according to the patient&#39;s clinical status&#46; During the yearly visits&#44; clinical&#44; functional&#44; radiological and analytical information is recorded using a standardized questionnaire&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">All the clinical variables were obtained from the patient and included&#58; socio-demographics &#40;gender&#44; age&#41;&#44; tobacco history&#44; comorbidities&#44; clinical presentation during the previous year in a stable state &#40;including dyspnea evaluation&#44; cough and sputum production&#44; color of the sputum if present&#44; wheezing and symptoms suggestive of asthma&#41;&#44; exacerbations and hospitalization in the previous year&#44; current pharmacological and non-pharmacological treatment&#46; Complementary tests&#44; included&#44; at least&#44; chest radiology&#44; pre- and post-bronchodilator spirometry and analytical results &#40;blood eosinophils&#44; alpha1-antitrypsin&#44; total IgE&#41;&#46; With this information&#44; the patients are initially categorized according to the different versions of the Global Initiative of Obstructive Lung Disease &#40;GOLD&#41; document<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> and the Spanish national guidelines for COPD &#40;GesEPOC&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a> and the classification is adapted to the successive updates of these documents during the follow-up&#44; whenever possible&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Asthma-like symptoms are also recorded&#44; including the presence of rhinitis&#44; variability of respiratory symptoms during the year and worsening of respiratory symptoms when exposed to non-specific triggers&#46; The comorbidities are recorded following different comorbidity composite scores&#44; including the Charlson comorbidity index&#44;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a> the COPD specific comorbidity test &#40;COTE&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> the COMorbidities in Chronic Obstructive Lung Disease &#40;COMCOLD&#41; index&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> and the Functional Comorbidity Index&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Exacerbations are recorded at each yearly clinical visit&#46; For the present study&#44; an exacerbation is defined as any increase in perceived respiratory symptoms which requires additional medication to control them&#46; To consider two exacerbations as different episodes&#44; a time lapse between episodes of at least 4 weeks from the end of the exacerbation or 6 weeks from the beginning is required&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> The information provided by the patient regarding exacerbation frequency is matched with the information in the clinical record&#46; Emergency ward visits and hospital admissions due to exacerbations are also noted&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Non-pharmacological treatments over the previous year are noted at every visit&#44; including the persistence of active smoking&#44; daily exercise&#44; and influenza and pneumococcal vaccinations&#46; Oral and inhaled pharmacological therapies for COPD are also noted&#44; as is the use of home-based therapies&#44; including home mechanical ventilation&#44; long-term oxygen therapy and nebulizers&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Spirometries are performed so far with a Masterlab Pneumatic Tachograph &#40;Erich Jaeger GHBH&#44; W&#252;rzburg&#44; Germany&#41;&#46; The spirometer is calibrated daily&#44; and the results adjusted by the atmospheric conditions&#46; Patients are instructed to withhold their inhaler medication on the day of the test&#44; in order to record pre- and post-bronchodilator spirometry&#46; If this is not the case&#44; then the spirometry is considered post-bronchodilator&#46; The bronchodilator test is performed after the administration of 400<span class="elsevierStyleHsp" style=""></span>&#956;g of salbutamol via a pressured metered dose inhaler with a chamber&#46; The spirometry is performed according to current standards assessing the quality of the results&#46; Parameters recorded in absolute values and percentage predicted values are forced vistal capacity &#40;FVC&#41;&#44; FEV<span class="elsevierStyleInf">1</span>&#44; FEV<span class="elsevierStyleInf">1</span>&#47;FVC ratio&#44; peak expiratory flow&#44; and forced expiratory flow between 25&#37; and 75&#37; of the FVC&#46; The main limitation is in relation to the non-use of advanced diagnostic techniques beyond those recommended for clinical practice&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">TRACE is a prospective cohort study is an opportunity to identify specific patients who have a specific response to various treatments using tools available to any clinician&#46; Their results may provide new information on how to make a more personalized medicine in real clinical practice&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Final declarations</span><p id="par0060" class="elsevierStylePara elsevierViewall">Funding&#46; TRACE is funded by an unrestricted grant from Gebro Pharma laboratories&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">JLLC has received honoraria during the last 3 years for lecturing&#44; scientific advice&#44; participation in clinical studies or writing for publications for &#40;alphabetical order&#41;&#58; AstraZeneca&#44; Boehringer Ingelheim&#44; Chiesi&#44; CSL Behring&#44; Esteve&#44; Ferrer&#44; Gebro&#44; GlaxoSmithKline&#44; Grifols&#44; Menarini&#44; Novartis&#44; Rovi&#44; and Teva&#46;</p></span></span>"
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ISSN: 03002896
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