Variability in adherence to clinical practice guidelines and recommendations in COPD outpatients: a multi-level, cross-sectional analysis of the EPOCONSUL study
Calle Rubio et al. Respiratory Research
Variability in adherence to clinical practice guidelines and recommendations in COPD outpatients: a multi-level, cross-sectional analysis of the EPOCONSUL study
Myriam Calle Rubio 0 1 4
José Luis López-Campos 1 2 3
Juan J. Soler-Cataluña 1 8
Bernardino Alcázar Navarrete 1 7
Joan B. Soriano 1 6
José Miguel Rodríguez González-Moro 1 5
Manuel E. Fuentes Ferrer 1 9
Juan Luis Rodríguez Hermosa 0 1 4
On behalf of the EPOCONSUL Study 1
0 Pulmonary Department, Research Institute of Hospital Clínico San Carlos (IdISSC), Faculty of Medicine, University Complutense of Madrid , C/ Martin Lagos s/n, 28040 Madrid , Spain
1 Appendix 4 Participants investigators in EPOCONSUL study Andalucía: Jose Luis Rojas Box, H. de Alta Resolución de Écija, Sevilla. Jose Domingo Garcia Jimenez, H. de Alta Resolución de Utrera, Sevilla. Adolfo Domenech del Rio, Ana Muñoz. H. Carlos Hayas, Málaga. Antonia Soto Venegas, H. San Juan de la Cruz, Úbeda, Jaén. Aurelio Arnedillo Muñoz. H. U. Puerta del Mar, Cádiz. Agustín Valido Morales. H. Virgen de Macarena. Sevilla. Jose Velasco Garrido, Carlos Rueda Ríos, Macarena Arroyo Varela H. Virgen de la Victoria. Málaga. Francisco Ortega Ruiz, Eduardo Marquez Martin, Carmen Calero Acuña, H. Virgen del Rocio, Sevilla. Francisco Luis Garcia Gil, H. U Reina Sofia, Córdoba. Aragón: Joaquin Carlos Costan Galicia, H. Clínico U. Lozano Blesa, Zaragoza. Ana Boldova Loscertales, H. Royo Villanova, Zaragoza. Asturias: Cristina Martinez González, Rosirys Guzman Taveras, H. U. Central de Asturias, Oviedo. Murcia: Juan Luis De la Torre Alvaro, H. U Santa Lucia, Cartagena, Ma Jesus Avilés Ingles, H. General U. Reina Sofia, Murcia. Rubén Andújar Espinosa, H.U. Virgen de la Arrixaca, Murcia. Canarias: Juan Manuel Palmero Tejera, Juan Marco Figueira Conçalves, H.U. Nuestra Señora de la Candelaria , Santa Cruz de Tenerife
2 CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III , Madrid , Spain
3 Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad of Sevilla , Sevilla , Spain
4 Pulmonary Department, Research Institute of Hospital Clínico San Carlos (IdISSC), Faculty of Medicine, University Complutense of Madrid , C/ Martin Lagos s/n, 28040 Madrid , Spain
5 Pulmonary Department, H. Universitario Príncipe de Asturias, Alcalá de Henares , Madrid , Spain
6 Research Institute of Hospital University La Princesa (IISP), University Autónoma of Madrid , Madrid , Spain
7 Pulmonary Department, Hospital of Alta Resolución de Loja , Granada , Spain
8 Pulmonary Department, Hospital of Arnau de Villanova , Valencia , Spain
9 UGC de Medicina Preventiva, Research Institute of Hospital Clínico San Carlos (IdISSC), Hospital Clínico San Carlos, Faculty of Medicine, University Complutense of Madrid , Madrid , Spain
Background: Clinical audits have reported considerable variability in COPD medical care and frequent inconsistencies with recommendations. The objectives of this study were to identify factors associated with a better adherence to clinical practice guidelines and to explore determinants of this variability at the the hospital level. Methods: EPOCONSUL is a Spanish nationwide clinical audit that evaluates the outpatient management of COPD. Multilevel logistic regression with two levels was performed to assess the relationships between individual and disease-related factors, as well as hospital characteristics. Results: A total of 4508 clinical records of COPD patients from 59 Spanish hospitals were evaluated. High variability was observed among hospitals in terms of medical care. Some of the patient's characteristics (airflow obstruction, degree of dyspnea, exacerbation risk, presence of comorbidities), the hospital factors (size and respiratory nurses available) and treatment at a specialized COPD outpatient clinic were identified as factors associated with a better adherence to recommendations, although this only explains a small proportion of the total variance. Conclusion: To be treated at a specialized COPD outpatient clinic and some intrinsic patient characteristics were factors associated with a better adherence to guideline recommendations, although these variables were only explaining part of the high variability observed among hospitals in terms of COPD medical care.
Chronic obstructive pulmonary disease; Clinical audit; Medical care; Clinical practice guidelines; Adherence to recommendations
Chronic obstructive pulmonary disease (COPD) is one
of the most frequent reasons for seeking medical
attention and accounts for 10% of primary care and
30% of outpatient respiratory care visits [
with this condition have a high morbidity and
]. For these reasons, there are a number of
clinical practice guidelines (CPG) aimed to systemize
medical care for COPD [
]. However, the real-life
implementation of these CPG is low [
Clinical audits have emerged as an overarching tool to
measure the adequacy of clinical practice and feedback is
being used to improve health care [
]. For more than 12 years,
some countries have been auditing the quality of their
inhospital COPD management in a systematic way [
However, we have less evidence regarding outpatient care,
and the few existing studies only explored certain aspects,
such as the diagnosis or the prescription pattern, showing us
outpatient care is far from perfect [
] with considerable
variability in COPD medical care and frequent
inconsistencies with CPG recommendations.
The EPOCONSUL study is the first national audit to
evaluate the adequacy of medical care according to
CPG in Spain in COPD patients treated at outpatient
respiratory clinics. The study confirmed significant
variations in adherence to CPG recommendations
between centers [
]. The objective of our work has
been analyze the variability and to identify factors
associated with adherence to current recommendations
for COPD clinical practice guidelines for outpatients
The methodology of the EPOCONSUL audit has been
extensively described elsewhere [
]. Briefly, the
COPD audit promoted by the Spanish Society of
Pneumology and Thoracic Surgery (SEPAR) was
designed to evaluate clinical practice as well as clinical
and organizational factors related to managing
patients with COPD across Spain. It was designed as an
observational non-interventional cross-sectional
study. Recruitment was intermittent during the year
(May 2014–May 2015). Every 2 months each
investigator recruited clinical records of the first 10 patients
identified as diagnosed with COPD and seen in the
outpatient respiratory clinic. Subsequently, patients
identified were reevaluated to determine if they met
the inclusion/exclusion criteria described in Appendix
1. The sampling process was detailed in an
epidemiology flow chart and described in Appendix 2.
The information collected was historical in nature
for the clinical data of the last and previous visits, and
the information about hospital resources was
As described in the methodological research paper
], in order to evaluate the degree of current CPG
implementation of the main statements according to
the 2012 Spanish National Guidelines for COPD care
(GesEPOC) and the 2013 Global initiative for chronic
Obstructive Lung Disease (GOLD), we established
fulfilling ≥ 50% of criteria for good clinical practice
evaluated in each category (clinical evaluation of the
patient, COPD evaluation and therapeutic
intervention) as the cut-off point.
From the 175 public hospitals in the National Health
System invited from the Spanish Society of
Pneumology and Thoracic Surgery, 59 participated (33.3%).
The estimated reference population for the
EPOCONSUL study was 18,104,350 inhabitants, representing
39% of the Spanish population. The distribution of
hospitals in the different regions and the population
covered by those hospitals are detailed in Appendix 3
and participating investigators are included in
In order to compare hospitals, these were divided in two
types of center according to their size (small or large) as
measured by: the number of beds per center ≥ 500, the
number of inpatient respiratory beds ≥ 20, the number of
pulmonology staff members ≥ 5, and the number of
annual outpatient respiratory visits ≥ 10,000. All the
criteria are necessary to be considered large.
The protocol was approved by the Ethics Committee
of the Hospital Clínico San Carlos (Madrid, Spain;
internal code 14/030-E). Additionally, according to
current research laws in Spain, the ethics committee
at each participating hospital evaluated and agreed to
the study protocol. The need for informed consent
was waived because ours is a clinical audit, beside the
non-interventional nature of the study, the
anonymization of data and the need to blindly evaluate the
clinical performance. This circumstance was clearly
explained in the protocol, and the ethical committees
approved this procedure. To avoid modifications to
the usual clinical practice and preserve the blinding of
the clinical performance evaluation, the medical staff
responsible for the outpatient respiratory clinic was
not informed about the audit. Data was entered
remotely at each participating location to a
Descriptive results are presented both at the patient
and hospital level. Qualitative variables were
summarized by their frequency distribution as well as
quantitative variables by their median, interquartile range
(IQR) and minimum–maximum. The differences
between hospital resources and characteristics according
to size (small vs large) were evaluated using χ2 tests
for categorical data, while the non-parametric
MannWhitney test was used for continuous data.
Significance of variability by area/hospital was explored by
the Kruskal–Wallis or chi-square tests.
With regard to missing data, after performing data
cleansing to identify and correct missing and extremely
unlikely values, the data was included in the analysis as
Three dependent variables were generated to evaluate
the degree of CPG implementation; criteria of good
clinical practice were categorized into: fulfilling three
criteria at the clinical evaluation, fulfilling four criteria at
the COPD evaluation, and fulfilling three criteria at the
The association between each independent variable
(patient characteristics, hospital resources and work
organization) and each of the dependent variables was
assessed by calculating the crude odds ratio (OR) via
multilevel bivariate regression analysis. Each
multilevel analysis included two levels: the individual or
patient level (level 1), and the hospital level (level 2).
It was developed in four consecutive steps: (1) Model
1 (empty model) which included only the dependent
variable and the hospital-cluster effect; (2) random
effects Model 2, which included the hospital variables;
(3) random effects Model 3, which included the
patient variables; (4) random effects Model 4, which
included the patient and hospital variables in order to
obtain an overall multivariable model. Candidate
predictors with a value of p < 0.10 in the univariate
analysis were accepted for inclusion in the multivariate
analysis in model 2 and 3. Variables were removed
from the model when the p-value exceeded 0.10 and
were kept in the final model when less than 0.05. The
independent predictor variables included in Model 4
were those selected in the last step in Models 2 and 3.
The coefficients of the predictor variables were
transformed into OR, with 95% confidence intervals (CI).
The hospital cluster effect was evaluated and
quantified by two indicators: 1) the intra-cluster correlation
coefficient (ICC) which represents the proportion of the
variance attributable to the clustering effect and 2) the
median odds ratio (MOR). The MOR can be interpreted
as the median increased odds of reaching the outcome if
an individual was admitted to another hospital with a
greater risk of that outcome.
All analyses were performed using STATA 12.0
software. Statistical significance was assumed as p < 0.05.
A total of 17,893 clinical records of patients treated in
outpatient respiratory clinics were evaluated during the
study period and 5726 clinical records of patients
presumably diagnosed with COPD were selected. Of them,
4508 patients were audited from 59 hospitals, for having
all the inclusion criteria and none of the exclusion
criteria. The sampling process was detailed in an
epidemiology flow chart and described in Appendix 2.
The hospital characteristics and respiratory unit
resources are summarized in Table 1. Large hospitals
constituted 54% of centers. The majority participating
centers were public (93.2%), university hospitals
(83.1%) and had a pulmonary resident available
(67.8%). Although the larger hospitals had more staff,
the length of the outpatient follow-up visit was
similar. There were few centers with a specialized COPD
outpatient clinic (47.5%) and outpatient respiratory
nursing clinic (45.8%), regardless of hospital size.
Audited patient characteristics and clinical conditions
The main characteristics of the patients evaluated are
presented in Table 2.
Adequacy of medical care according to CPG
Adherence to the main CPG statements is summarized
in Table 3. There was a significant variation between
hospitals, with a better adherence to the statements in
the clinical evaluation category, with three out of six
criteria fulfilled in 65.5% of the patients.
Adherence to CPG recommendations based on patient and center characteristics
The bivariate association between adherence to the main
CPG statements and the variables related to hospital and
patient characteristics is summarized in Appendix 5. A
major number of the patient-level variables were
associated with adherence, whereas the majority of
centerlevel variables were not.
Multilevel variability analysis of adherence to CPG recommendations
For the adherence to the statements in the clinical
evaluation category, fulfillment of at least three criteria,
the percentage of the total variability attributable to the
hospital-cluster effect was 36%. The empty model
exhibited a significant cluster effect (ICC = 0.36) and
cluster heterogeneity (MOR = 3.73). In the adjusted model,
being an active smoker, having a Charlson index ≥ 3,
undergoing ≥ 1 hospitalization for COPD in the past
year and being treated at a specialized COPD
outpatient clinic was positively associated. Only one
variable linked to the hospital level (large hospital) was
retained in the model as a predictor, but was
unfavorable (Table 4). The inclusion of all predictors further
reduced the residual between-hospital cluster
variability. The ICC and MOR dropped to 0.31 and 3.26,
respectively (Table 4). Some unrecorded values (COPD
phenotype missing) showed significant associations,
which is naturally open to interpretation.
For COPD evaluation category, fulfillment of at least
four criteria, the empty model displayed an ICC of 0.30
and a MOR of 3.13 (Table 4). In the adjusted model, an
age of ≤ 55 years, FEV1 < 50%, dyspnea ≥ 2 MRC-m and
being treated at a specialized COPD outpatient clinic
were positively associated with better adherence to
CPG recommendations. However, being male and
having a Charlson index ≥ 3 were retained as predictors of
worse adherence. Some unrecorded values (COPD
phenotype missing, dyspnea missing, or level of
dyspnea not referred to) showed a significant negative
association. Only one variable linked to the hospital
level (i.e. respiratory ward availability) was retained as a
predictor of better adherence. The inclusion of this
predictor further reduced the between-hospital cluster
variability. The ICC and MOR dropped to 0.24 and
Number of participating hospitals, n
Public hospital (%)
University hospital (%)
Beds per center ≥ 500 (%)
Beds per center, median (P25–75)
Hospital with a respiratory ward (%)
Number of inpatient respiratory beds ≥ 20 (%)
Number of pulmonology staff members ≥ 5 (%)
Number of pulmonology staff members, median (P25–75)
Pulmonology residents available (%)
Number of annual outpatient respiratory visits, median (IQR)
Number of annual outpatient respiratory visits ≥ 10,000 (%)
≥ 15 min of follow-up at general outpatient respiratory visit (%)
Specialized COPD outpatient clinic available (%)
≥ 15 min of follow-up at specialized COPD outpatient visit (%)
Outpatient respiratory nursing clinic availability (%)
Functional respiratory laboratory available (%)
- Spirometry 100 100 100
- Diffusing capacity 100 100 100
- Plethysmography 100 100 100
- Respiratory muscle strength 84.7 66.7 100
- 6MWT available 94.9 88.9 100
- Cardiopulmonary exercise testing available 62.7 40.7 81.3
Inhalation technique educational program available (%) 30.5 15.6 48.1
Respiratory rehabilitation program available (%) 74.6 66.7 81.3
- Hospital-based 61.4 61.1 61.5
- Home-based 6.8 11.1 3.8
- Mixed 31.8 27.8 34.6
Data are presented as median (CI 95%), unless stated otherwise. Dichotomous variables are expressed as number and/or percent. p† calculated by the
Kruskal–Wallis or Chi-square test, depending on the nature of the variable
For therapeutic intervention category, fulfillment of at
least three criteria, the empty model displayed an ICC of
0.52 and a MOR of 6.09. A Charlson index ≥ 3,
undergoing ≥ 1 hospitalizations in the past year, being treated at
a specialized COPD outpatient clinic, and outpatient
respiratory nursing clinic availability were associated with
better adherence to the recommendations. Meanwhile,
being male, being ≤ 55 years old and being a university
hospital were all associated with worse adherence. The
inclusion of these predictors further reduced the
between-hospital cluster variability. The ICC and MOR
dropped to 0.44 and 4.74, respectively (Table 4).
The present study constitutes one of the few research
papers in the literature that analyze the variability in
adherence to current recommendations for COPD clinical
practice guidelines for outpatients in Spain. In our
analysis, we aimed to study the variables associated with this
This study shows that accounting for the hospital cluster
effect, the patient-level and hospital-level predictor
variables, partly reduced the unexplained between-hospital
variation in adherence. Additionally, it identified a number
of variables as predictors of better adherence at the
patient and hospital levels. Most predictors were linked to
patient characteristics (patient-level) and the type of
respiratory clinic in which the patient was treated (general
clinic or specialized COPD outpatient clinic).
Being treated at a specialized COPD outpatient
clinic was associated with a higher likelihood of
adherence to guidelines in the three categories
evaluated, and was considered to be of greater importance,
compared with the cluster effect, in explaining the
between-hospital outcome variations. This is an
interesting result, since less than half of the centers
had specialized COPD outpatient clinics. In addition,
the time available at specialized COPD outpatient
clinics to treat the patient was the same as the
general outpatient respiratory visit and there was no
support nurse. Consequently, this could be considered a
proxy for the experience, knowledge and interest of
department physicians in the management of COPD
Also, some unrecorded values (COPD phenotype
missing and level of dyspnea missing) showed a statistically
significant negative association, which are naturally open
The clinical COPD phenotype according to the
Spanish National Guideline for COPD (GesEPOC) was
collected in 46.3% of the audited patients.
Only 2 (outpatient respiratory nursing clinic and a
respiratory ward availability) of the 46 hospital-level
variables examined were retained in the model
associated with a higher likelihood of implementing CPG
recommendations. On the contrary, being a university
hospital or large hospital were negatively associated
factors. Nevertheless, given the small amount of
cluster variability left unexplained in the analysis, it is
unlikely that relevant hospital-level variables were not
revealed. It’s possible that this finding is the result of a
relative small hospital sample size (N = 59). Thus,
medical care in COPD does not require complex
interventions and the majority of respiratory units
offered a functional respiratory laboratory. We must
consider the fact that this study did not include
information about work organization such as COPD
clinical management protocol availability or electronic/
digital information availability. It also did not include
the number of respiratory physicians or respiratory
nurses available in the area around the clinic or the
professional experience of treating physicians, which
might explain a proportion of the total variance due to
the center effect.
Our findings are similar to those of previous studies
that have demonstrated significant variability in the
processes of COPD care. In the European COPD
], a considerable variability in
recommendation guideline suitability was described and only
hospital characteristics were related to a minority of
indicators. The adherence to guidelines also varied
with hospital size, but the differences were small and
inconsistent. Previous studies have shown adherence
to clinical guidelines was a strong predictor of a
favorable outcome. Roberts et al. [
] have suggested that a
1: included variables in the final center model: large hospital and outpatient respiratory nursing clinic available
2: included variables in the final patient model: active smokers, Charlson index ≥3, number of hospital admissions
in the last year ≥1, to be taken care in specialized COPD outpatient clinic and GesEPOC phenotype exacerbator.
Adherence to good clinical practice criteria in COPD evaluation (≥4 criteria fulfilling)
Treatment at a specialized COPD outpatient clinic
1: variables included in the final center model: university hospital and outpatient respiratory nursing clinic availability
2: variables included in the final patient model: age ≤ 55, gender (male), Charlson index ≥3, number of hospital admissions
in the last year ≥1, GesEPOC exacerbator phenotype and being treated in specialized COPD outpatient clinic
hospital’s resources are potential components of the
unexplained variation in outcomes. A greater number
of medical and nursing staff was identified as a
protective factor for intra-hospital mortality. In
AUDIPOC Spain [
], the large hospital COPD
volume and the number of COPD patients admitted to
the hospital the year prior to admission was identified
as a predictor of a favourable outcome.
In our study, a large component of center-related
variance remained unexplained, suggesting that the clinical
profile of patients included in the study also varied
markedly among hospitals. It is important to remember
that recommendation guidelines are evidence-based and
aimed to systemize medical care, but the clinical
presentation of COPD is variable [
Our study has several strengths and limitations. The
main strength is its sample size that accounts for 39%
of the Spanish population. Nevertheless, the
limitations to be considered are the fact that the selection of
participating centers was not random and hospital
participation was voluntary based on their interest to
participate. Also, clinical records were used as the
data source, so some missing and inconsistent values
were unavoidable. Despite these limitations, we
believe that this dataset represents the largest
available comparative survey of Spanish centers.
High variability was observed among hospitals in terms
of medical care. Some of the patient’s characteristics
(airflow obstruction, degree of dyspnea, exacerbation risk,
presence of comorbidities) and the type of respiratory
clinic in which the patient was treated (specialized
COPD outpatient clinic) were identified as factors
associated with a better adherence to recommendations,
though a great part of the variability among center
cannot be explained. This suggests that there is a significant
inconsistency among centers in the implementation of
This information must be accounted for by health care
professionals and administrators, in order to establish
better clinical practice by means of the medical care in
the specialized COPD outpatient clinic and the
implementation of evidence-based best clinical practice
guidelines that could facilitate a uniform approach to COPD
patients as outpatients, thereby both improving patient
outcomes and optimizing medical resources.
- lack of follow-up for at least 1 year in a respiratory outpatient clinic
- participating in a clinical trial
Valencia: Carmen Aguar Benito, H. de Arnau de
Villanova, Valencia. Pablo Catalán Serra, H. de
Requena, Requena. Eusebi Chiner Vives. H. U. de San
Juan, Alicante. Juan Antonio Royo Prats. H. General de
Castellón, Castellón de la Plana. Cristina Sabater Abad,
Esther Verdejo Mengual, H. General Universitario de
Valencia. Eva Martínez- Moragon, H. Universitario Dr.
Extremadura: Francisca Lourdes Marquez Perez, H. U
Santa Cristina, Badajoz.
Galicia: Alberto Fernandez Villar, Cristina Represas
Represas, Ana Priegue Carrera, Complejo hospitalario de
Vigo. Marina Blanco Aparicio, Pedro Jorge Marcos
Rodriguez, H. U. Juan Canalejo, La Coruña.
Baleares: Federico Gonzalo Fiorentino, Mª Magdalena
Pan Naranjo, H. Son Espases, Palma de Mallorca. Antonia
Fuster Gomila, H. Sant Llatzer, Palma de Mallorca.
Madrid: German Peces Barba, Felipe Villar Alvarez,
Fundación Jimenez Diaz, Madrid. Carlos Jose Álvarez
Martinez, H. 12 de Octubre, Madrid. Juan Luis
Rodriguez Hermosa, J.L. Álvarez Sala-Walther, Juan
Rigüal Bobillo, Gianna Vargas Centanaro, H. Clinico San
Carlos, Madrid. José Andrés García Romero de Tejada,
H. U. Infanta Sof ía, San Sebastián de los Reyes, Madrid.
Javier Jareño, Sergio Campos Tellez. H. Central de la
Defensa, Madrid. Raul Galera Martinez, H. La Paz. Rosa
Mar Gómez Punter, Emma Vázquez Espinosa, H. La
Princesa, Madrid. Esther Alonso Peces, H. Principe de
Asturias, Alcalá de Henares, Madrid. Juan Manuel Diez
Piña, Raquel Pérez Rojo, H. U. de Móstoles, Madrid.
Luis Puente Maestu, Julia Garcia de Pedro. H. U.
Gregorio Marañón, Madrid. Soledad Alonso Viteri, H. U
de Torrejón, Torrejón de Ardoz, Madrid.
Navarra: Maria Hernandez Bonaga, Complejo
Hospitalario de Navarra, Pamplona.
País Vasco: Maria Milagros Iriberri Pascual, H de
Cruces, Baracaldo. Myriam Aburto Barrenechea, H de
Galdakano. Sophe Garcia Fuika, Hospital Santiago
Apostol, Vitoria. Patricia Sobradillo Ecenarro, Hospital
Table 7 Logistic regression bivariate analysis (adherence to good clinical practice criteria in three categories: clinical evaluation of
the patient, COPD evaluation and therapeutic interventions)
Patients Clinical evaluation p Centers Clinical evaluation p
≥ 3 criteria fulfilled ≥ 3 criteria fulfilled
OR (95%CI) OR (95% CI)
Age (≤55 years) 1.01 (0.78–1.31) 0.89 Large hospital 0.44 (0.21–0.89)
Therapeutic intervention p
≥3 criteria fulfilled
Therapeutic intervention p
≥3 criteria fulfilled
No aplicable (Anyone who contributed towards the article who does not
meet the criteria for authorship).
This study has been promoted and sponsored by the SEPAR. We thank
Boehringer Ingelheim for its financial support to carry out the study. The
financing entities did not participate in the design of the study, data
collection, analysis, publication or preparation of this manuscript.
Availability of data and materials
The datasets used and/or analysed during the current study are available
from the corresponding author on reasonable request.
The protocol was approved by the Ethics Committee of the Hospital Clínico
San Carlos (Madrid, Spain; internal code 14/030-E). According to current
research laws in Spain, the ethics committee at each participating hospital
evaluated and agreed to the study protocol. The need for informed consent
was waived due to the non-interventional nature of the study, the
anonymization of data and the need to blindly evaluate the clinical
performance. This circumstance was clearly explained in the protocol,
and the ethical committees approved this procedure.
MCR, JLLC, BAN, JBS, JJSC, JMRG form the study’s Scientific Committee.
MEFF carried out the statistical analysis. JRH contributed substantially to data
analysis and results interpretation. MCR designed the study and wrote the
manuscript. The rest of the authors recruited patients and reviewed the
manuscript. All authors contributed to data analysis, drafting and revising
the paper, and agree to be accountable for all aspects of the work.
Consent for publication
No aplicable (does not contain any individual persons data and does not
report on or involve the use of any animal or human data or tissue).
The authors declare that they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
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