Ethics approval and consent to participate
The study protocol was approved by the CRECs of all participant centres (study code in the coordinating centre [Hospital Universitari de Bellvitge] CREC: EPA032/16; [Hospital Germans Trias i Pujol] CREC: PI-16-120 ; [Hospital Clínic de Barcelona] CREC: HCB/2019/0528; [Hospital Universitari Vall d'Hebron] CREC: EPA(AG)55/2016(4967); [Hospital de la Santa Creu i Sant Pau] CREC: 16/156(OBS); [Hospital Universitario Ramón y Cajal] CREC: ALIMAR-C2; [Hospital Universitario Fundación Jiménez Díaz] CREC: EOH 2016-37; [Hospital Clínico San Carlos] CREC: 16/326-E; [Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol] CREC: P16/105, and [Gerencia Asistencial de Atención Primaria] CREC:43/16. All CRECs accept a waiver for participant consent, taking into account the characteristics of the study.
The ALIMAR-C2 study was entered in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register Number: EUPAS13969, June 2016) and received approval from the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) (http://www.encepp.eu/encepp/viewResource.htm?id=14215).
Regarding the data contained in the databases, and according to Spanish legislation on the confidentiality and protection of data (Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales), data included in this study consist of the identification of incident cases of LA in hospitals and some specific information from primary healthcare. In order to link this information, the same identity code is needed for each patient. A coding system was used to link this information while keeping the identity of the patients anonymous.
Consent for publication
Not applicable.
Availability of data and materials
The datasets used and analysed during the current study are available from the corresponding author on reasonable request.
Conflict of interest
The authors declare that they have no conflict of interest.
Funding
The project received a research grant from the Carlos III Institute of Health, Ministry of the Economy and Competitiveness (Spain), in 2015 (reference PI15/00764) under the Health Strategy Action 2015, within the Technical, Scientific and Innovation Research National Plan 2013–2016 (Co-funded by the European Regional Development Fund or ERDF). The funders had no role in the study design, data collection or analysis, the decision to publish or the preparation of the manuscript. Our study protocol has also undergone a peer-review through the Carlos III Institute of Health.
Author contributions
SV is the principal investigator. CP was actively involved in the conception and design of the study. MA, MM, RM, and AG are members of the coordinating group and were also involved in the conception and design of the study.
MA, SV, CP, AG, OP and RM drafted the manuscript. All authors made contributions to the design of the study, critically reviewed the manuscript and approved the final version.
Acknowledgements
The authors would like to acknowledge the following investigators for their contribution, who participated in the preliminary stage of designing the study and critically reviewing the study proposal: Josep Maria Arnau (Hospital Universitari de Bellvitge), Miquel Hueso (Nephrology Department, Hospital Universitari de Bellvitge), María Giner (Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol)), Jordi Cortés (Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol)), Hoi Tong (Hospital Universitario La Paz), Antonio Carcas (Hospital Universitario La Paz), Mª Ángeles Lobo (Hospital Universitario Virgen del Rocío), Jaume Torelló (Hospital Universitario Virgen del Rocío), Judith Sanabria (Hospital Universitario Virgen de la Victoria), Mikel Castaño (Hospital Universitario Cruces), Lorena Codesido (Hospital Universitario Donostia), Mª Teresa Rodrigo (Hospital Universitario Donostia), Ana Aldea (Hospital Universitario de Canarias), David Gualteros (Clinical Research and Clinical Trials Unit, Institut d'Investigació Biomédica de Bellvitge [IDIBELL]), María Angeles Quijada (Clinical Research and Clinical Trials Unit. Institut d'Investigació Biomédica de Bellvitge [IDIBELL]), Cristina Mustata (Unitat d’Estudis del Medicament, Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol)). We would also like to thank the CERCA Programme / Generalitat de Catalunya for the institutional support provided.
ALIMAR-C2 Study Group
Members of the ALIMAR-C2 Study Group: Consuelo Pedrós (Clinical Pharmacology Unit. Consorci Hospital General Universitari de València), Mónica Ávila (Clinical Research and Clinical Trials Unit. Bellvitge Biomedical Research Institute [IDIBELL]), Marcela Manríquez (Clinical Research and Clinical Trials Unit. Bellvitge Biomedical Research Institute [IDIBELL]), Sebastián Videla (Clinical Pharmacology Department. Bellvitge University Hospital. Bellvitge Biomedical Research Institute [IDIBELL]), Rosa Morros (Unitat d’Estudis del Medicament. Institut Universitari d'Investigació en Atenció Primària [IDIAP] Jordi Gol). Departament de Farmacologia, Terapèutica i Toxicologia. Universitat Autònoma de Barcelona), Ainhoa Gómez-Lumbreras (Unitat d’Estudis del Medicament. Institut Universitari d'Investigació en Atenció Primària [IDIAP] Jordi Gol), Oriol Prat Vallverdú (Unitat d’Estudis del Medicament. Institut Universitari d'Investigació en Atenció Primària [IDIAP] Jordi Gol), Inmaculada Fuentes (Servicio de Farmacología Clínica, Hospital Universitari Vall d'Hebron. Vall d’Hebron Institut de Recerca), Angélica Valderrama (Vall d’Hebron Institut de Recerca, Barcelona), Cristina Aguilera (Servicio de Farmacología Clínica, Hospital Universitari Vall d'Hebron), Ana María Barriocanal (Clinical Research and Clinical Trials Unit-UPIC. Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol), Joaquín Sáez-Peñataro (Servicio de Farmacología Clínica, Área del Medicamento, Hospital Clínic de Barcelona; Universitat de Barcelona), Rosa Antonijoan (Servicio de Farmacología Clínica, Hospital de la Santa Creu i Sant Pau), Claudia E. Delgado (Clinical Research and Clinical Trials Unit, Sant Pau Biomedical Research Institute), Lucía Llanos (Clinical Research and Clinical Trials Unit, Fundación Jiménez Díaz, Health Research Institute), Leonor Laredo (Servicio de Farmacología Clínica, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos IdISSC), Mónica Aguilar (Clinical Pharmacology Unit. Ramón y Cajal Hospital. IRyCIS), Teresa Sanz (Unidad de Apoyo a la Investigación. Gerencia Asistencial de Atención Primaria de Madrid), Montserrat Hernández (Gerencia Adjunta de Procesos Asistenciales. Asistencial de Atención Primaria de Madrid), José C. Estévez (Unidad de Apoyo Técnico. Gerencia Asistencial de Atención Primaria de Madrid), Sergio Ruiz (Gerencia Adjunta de Procesos Asistenciales. Gerencia Asistencial de Atención Primaria de Madrid), Lluís Murgui (Subdirectorate for Information Systems. Bellvitge University Hospital), Xavier Corbella (Internal Medicine Department. Bellvitge University Hospital. Bellvitge Biomedical Research Institute [IDIBELL]), Xavier Fulladosa (Nephrology Department. Bellvitge University Hospital. Bellvitge Biomedical Research Institute [IDIBELL]), Manuel Pérez-Maraver (Endocrinology Department. Bellvitge University Hospital. Bellvitge Biomedical Research Institute [IDIBELL]), Virginia Alonso (Intensive Medicine Department. Bellvitge University Hospital. Bellvitge Biomedical Research Institute [IDIBELL]), Manel Mata-Cases (CAP La Mina. Institut Català de la Salut. USR Barcelona, Institut Universitari d'Investigació en Atenció Primària [IDIAP] Jordi Gol. GEDAPS).