EUROPEAN COPD AUDIT European COPD Audit: Design, Organisation of Work and Methodology
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Eur Respir J 2013; 41: 270–276 DOI: 10.1183/09031936.00021812 CopyrightßERS 2013 EUROPEAN COPD AUDIT European COPD Audit: design, organisation of work and methodology Jose Luis Lo´pez-Campos*,#, Sylvia Hartl", Francisco Pozo-Rodriguez#,+, and C. Michael Roberts1, on behalf of the European COPD Audit teame ABSTRACT: Clinical audit has an important role as an indicator of the clinical practice in a given AFFILIATIONS community. The European Respiratory Society (ERS) chronic obstructive pulmonary disease *Unidad Medico-Quirugica de Enfermedades Respiratorias, Instituto (COPD) audit was designed as a pilot study to evaluate clinical practice variability as well as clinical de Biomedicina de Sevilla (IBiS), and organisational factors related to outcomes for COPD hospital admissions across Europe. Hospital Universitario Virgen del The study was designed as a prospective observational noninterventional cohort trial, in which Rocı´o, Seville, # 422 hospitals from 13 European countries participated. There were two databases: one for CIBER de Enfermedades Respiratorias (CIBERES), Instituto de hospital’s resources and organisation and one for clinical information. Salud Carlos III, Madrid, and The study was comprised of an initial 8-week phase during which all consecutive cases +Hospital 12 de Octubre, Instituto de admitted to hospital due to an exacerbation of COPD were identified and information on clinical Investigacio´ni+12, Madrid, Spain. " practice was gathered. During the 90-day second phase, mortality and readmissions were Ludwig Boltzmann Institute of COPD and Respiratory Epidemiology, recorded. Patient data were anonymised and encrypted through a multi-lingual web-tool. As there Vienna, Austria. is no pan-European Ethics Committee for audits, all partners accepted the general ethical rules of 1Barts and The London School of the ERS and ensured compliance with their own national ethical requirements. Medicine and Dentistry, Queen Mary This paper describes the methodological issues encountered in organising and delivering a University of London, London, UK. eFor details of the members of the multi-national European audit, highlighting goals, barriers and achievements, and provides European COPD Audit team, please valuable information for those interested in developing clinical audits. see the Acknowledgements section. KEYWORDS: Chronic obstructive pulmonary disease, clinical audit, exacerbation, hospital CORRESPONDENCE J.L. Lo´pez-Campos admission, outcomes Hospital Universitario Virgen del Rocı´o Avda. Manuel Siurot hronic obstructive pulmonary disease different hospitals and between different countries, s/n (COPD) is a significant cause of morbidity and is frequently not consistent with published 41013 Seville C and mortality in Europe and a major guidelines. Additionally, the organisation and Spain consumer of resources in both primary and resource provision for COPD varies considerably E-mail: [email protected] secondary healthcare [1, 2]. The disease has an from unit to unit, and there is no mechanism for Received: increasingly high profile with health authorities, either identifying or disseminating examples of Feb 04 2012 health insurance companies and healthcare pro- high-quality care or innovation in service delivery. Accepted after revision: viders. In this regard, clinical audit is potentially a In this context, it remains unknown which national March 23 2012 vital tool in assessing clinical practice in this systems deliver the best practice for different First published online: chronic debilitating disease. Audits of patient care aspects of patients care. In all likelihood, we can May 17 2012 have been extended to measure the organisation of all improve the care of COPD patients if we have care and the resources dedicated to COPD care in better knowledge of our performance and gain acute units. Over the last 10 yrs, several audits understanding of the factors associated with better have been carried out in individual countries patient outcomes. However, there is not yet a highlighting important information about the culture of participation in audits across and within delivery of care to COPD patients and the most European countries to provide a basis for such structure of the hospitals serving them. The first comparisons. Notwithstanding, the technology to national COPD audit was developed in the UK in facilitate an audit of this kind is available and large 1997 [3]. Others have followed, including Spain quantities of relevant data could be collected and [4], Scandinavian countries [5] and Australia [6]. reported to clinicians. European Respiratory Journal These audits provide growing evidence that the Being aware of this scenario, the European Print ISSN 0903-1936 quality of COPD patient care varies widely between Respiratory Society (ERS) developed the first Online ISSN 1399-3003 270 VOLUME 41 NUMBER 2 EUROPEAN RESPIRATORY JOURNAL J.L. LO´PEZ-CAMPOS ET AL. COPD European COPD Audit as a pilot study to evaluate clinical about the project to all members through the Forum of European practice as well as clinical and organisational factors related to Respiratory Societies. Two major conditions were set for national outcomes for COPD admissions across Europe. In the present societies to participate: 1) the logistic capacity to provide the article, we describe the methodology used to perform this audit administrative structure for a national organisation of local and the challenges of auditing across differing healthcare investigators; and 2) the financial resource to support the national systems and countries. audit process. The national societies of 13 countries agreed to participate in the audit (table 1). A further 11 national societies METHODS that expressed an interest but were not in a position to participate The audit was designed as a prospective, observational, non- were invited to meetings as observers. All participants were not- interventional cohort trial over a defined time period, in which for-profit organisations with a legal status without profitable 13 European countries participated. interests and were independent of industry, commercial and business or other conflicting interests. Participant national Governance societies held the responsibility to organise data collection within The ERS managed the audit, named a steering committee, which their own territory following the decisions made by the expert reported to the ERS executive committee, to oversee the process panel. Each national society was responsible for selecting the and assigned a project manager to help the steering committee participant hospitals in that particular country. develop the audit. The steering committee was formed by three respiratory physicians with expertise in COPD and clinical Data item selection audits from three different countries: C.M. Roberts (UK), S. Items for the organisational database were selected by the Hartl (Austria) and J.L. Lo´pez-Campos (Spain). Each national steering committee based upon those that had previously been society named one or two national experts to coordinate the used and validated in the Spanish and UK national audits audit in that particular country and to represent their views. (table 2) [3, 5]. A number of terms had to be consensually Altogether, the steering committee, the project manager and all defined, as there was no shared meaning across Europe and national experts formed the expert panel, an operational group were considered key concepts for the audit. that was responsible for ensuring the success of the data collection and which provided feedback on the process and Items for the clinical database were selected by the expert panel suggested improvements through regular face-to-face meetings through a two-round modified Delphi process. The steering and teleconferences. Within each national participating society a committee circulated a list of potential variables based upon number of investigators were appointed, each operating at an items that had previously been used in the Spanish and UK individual hospital level and responsible for local data collec- national audits [3, 5], and included process issues matched to tion on patients and organisation of care (fig. 1). guidelines and those considered relevant by national experts. The aim was to select a relatively small group of items that were Funding relevant to clinical practice and were easy to collect across the Central funding of the project was entirely granted by the ERS participating healthcare systems. All potential clinical variables covering all costs at a European level. Expenses at a national were organised in a spreadsheet and sent to national experts for level were not covered. The project gave freedom to national their evaluation. Each national expert graded items using one of experts to raise funds to cover expenditure to develop the project three following options according to their importance: high in their own country according to their ethical regulations. relevance (five points), medium relevance (three points) or low relevance (one point). Thus, each item could be scored from 10 Selection of the participant countries to 50 points. Those with .30 points were selected for the second During 2009, contact with National Respiratory Societies across round of the Delphi process. In the second round, the initial Europe was established by the steering committee with a scoring was fed back to participants as a group mean allowing proposal to participate. Those interested attended a meeting that for a second voting