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Clinical Trial Report

Disease awareness in patients with COPD: measurement and extent

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Pages 1-11 | Published online: 17 Dec 2018
 

Abstract

Background

Patient awareness of COPD refers to knowledge and acceptance of the disease and its treatment. Although it is relevant to management and outcomes, the disease awareness of patients is poorly investigated, and no validated questionnaires are currently available. We aimed to develop the novel Disease Awareness in COPD Questionnaire (DACQ), which was validated in relation to demographic and clinical features, in patients participating in the SATisfaction and Adherence to COPD Treatment (SAT) study.

Methods

DACQ was developed according to a list of items regarding the patient’s knowledge, acceptance, and perception of COPD as well as of treatment needs. The questionnaire was validated by assessing internal structure and consistency, correlations with other patient-reported outcomes, and stability over time. Furthermore, the extent of disease awareness of patients enrolled in the SAT study was assessed by using DACQ, and correlations with demographic and clinical features were evaluated.

Results

DACQ was composed of four domains. Overall reliability and stability over time were adequate; correlations between DACQ and other tools measuring different constructs (ie, treatment satisfaction, illness perception, impact of COPD symptoms on daily life, and dyspnea severity) were, as expected, more limited. In the enrolled patient sample, a suboptimal level of disease awareness (<70%) was detected, especially in terms of disease acceptance and perception. Disease knowledge was positively associated with COPD severity, while the impact of symptoms on daily life was negatively associated with disease acceptance, awareness of treatment needs, and overall awareness.

Conclusion

DACQ proved to be a reliable tool to assess awareness in COPD patients. Awareness of COPD patients need to be improved.

Clinical trial registration

ClinicalTrials.gov ID# NCT2689492.

Acknowledgments

Medical writing assistance was provided by Luisa Granziero, appointed by MediNeos Observational Research, Modena, Italy. Luisa Granziero declares no potential competing interests related to her assistance. We acknowledge the participants of the SAT study group for collecting data. This study was supported by Boehringer Ingelheim S.p.A, Italy. The SAT study group: Steering Committee: Fulvio Braido, A.O.U. IRCCS San Martino (Genova); Marco Contoli, A.O.U. Sant’Anna (Cona); Angelo Guido Corsico, Fondazione IRCCS San Matteo (Pavia); Fabiano Di Marco, Ospedale San Paolo (Milano); Paola Rogliani, Policlinico Tor Vergata (Roma); Pierachille Santus, Istituti Clinici Scientifici Maugeri-SpA SB (Milano); Nicola Scichilone, A.O. V. Cervello (Palermo). Participating centers: Rita Raccanelli, Dejan Radovanovic, Istituti Clinici Scientifici Maugeri-SpA SB (Milano); Angelo Guido Corsico, Erica Gini, Fondazione IRCCS San Matteo (Pavia); Vincenzo Patella, Giovanni Florio, Ospedale S. Maria della Speranza (Battipaglia); Fulvio Braido, Silvia Garuti, A.O.U. IRCCS San Martino (Genova); Marco Contoli, Giacomo Forini, A.O.U. Sant’Anna (Cona); Nicola Scichilone, Alida Benfante, A.O. V. Cervello (Palermo); Giuseppe Fiorentino, Antonella Marotta, A.O. dei Colli P.O. Monaldi (Napoli); Fabiano Di Marco, Fausta Alfano, Ospedale San Paolo (Milano); Paola Rogliani, Francesco Cavalli, Policlinico Tor Vergata (Roma); Roberto Piro, Patrizia Ruggiero, Arcispedale S. Maria Nuova IRCCS (Reggio Emilia); Mauro Carone, Maria Aliani, ICS Maugeri (IRCCS Cassano Murge); Antonio Iannaccone, Alessandro Izzo, A.O. San G. Moscati (Avellino); Biago Polla, Ospedale SS Antonio Biagio e Cesare e Arrigo (Alessandria); Riccardo Sarzani, Francesco Spannella, Ospedale INRCA (Ancona); Claudio Micheletto, Ospedale Mater Salutis (Legnago); Rigoletta Vincenti, Ospedale Civico (Livorno); Laura Maugeri, Carlo Gulotta – A.O.U. San Luigi Gonzaga (Orbassano); Roberto Tazza, Azienda Unità Sanitaria Locale Umbria n.2 (Terni); Luigi Di Re, Paolo Mimotti, Ospedale Mazzini (Teramo); Roberto Carbone, Rodolfo Riva, Ospedale Reg. Parini (Aosta). Project management, statistical analyses, and data management: Giovanni Fiori, Stefano Viaggi, Alessandra Ori, Lucia Simoni, Christian Amici, Fabio Ferri, Barbara Roncari, Saide Sala, Francesca Trevisan, Nicole Lanci (MediNeos Observational Research, Modena, Italy).

Disclosure

The following authors report personal fees for scientific consultation from Boehringer Ingelheim related to the study: FB, IB, AGC, MC, FDM, GM, PR, NS, and PS. FB has received honoraria for lectures at national and international meetings from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Dompè, Guidotti/Malesci, GlaxoSmithKline, Menarini, Novartis, Lallemand Pharma, Biofutura, Levante Pharma, Merck Sharp and Dohme, and Zambon. He has served as consultant for AstraZeneca, Chiesi Farmaceutici, Novartis, Glaxo Smith Kline, Boehringer Ingelheim, Guidotti/MalesciZambon, and CSL Behring. MC reports grants for research from AstraZeneca and Chiesi and reports personal fees for scientific consultations and/or lectures at national and international meetings from Chiesi, Novartis, AstraZeneca, Glaxo Smith Kline, Boehringer Ingelheim, Menarini, and Zambon, which are not related to the submitted manuscript. FDM has received honoraria for lectures at national and international meetings from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Dompe, Guidotti/Malesci, GlaxoSmithKline, Menarini, Novartis, and Zambon. He has served as consultant for AstraZeneca, Chiesi Farmaceutici, Novartis, and Zambon, and he has received financial support for research from Novartis and Boehringer Ingelheim. PR has participated as a lecturer, speaker, and advisor in scientific meetings and courses under the sponsorship of Almirall, AstraZeneca, Biofutura, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Menarini Group, Mundipharma, and Novartis. Her department has received funding from Almirall, Boehringer Ingelheim, Chiesi, Novartis, and Zambon. She has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. PL and CS are employees of Boehringer Ingelheim Italy. FF is an employee of MediNeos Observational Research, Modena, Italy. He received payment from Boehringer Ingelheim Italy for the following activities related to the submitted work: scientific support, clinical operations, data management, statistical analysis, and manuscript preparation. MC, GF, and VP do not report any competing interests. The authors report no other conflicts of interest in this work.

Author contributions

All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.