Patient Perception, Preference and ParticipationPatient participation in a Clinical Guideline Development for Systemic Lupus Erythematosus
Introduction
Systemic lupus erythematosus (SLE) is a complex chronic and multisystem disease in which various cell types and immunological pathways are deregulated explaining its variable clinical presentations, course, and prognosis. SLE affects over half a million people in Europe and a quarter of a million people in the USA, based on a prevalence rate of 30–50 per 100,000 [1]. Because of the systemic nature of SLE, several medical specialties are involved in the care of those affected. To reduce medical practice variations, the unwanted effects of care fragmentation, and optimizing clinical management of SLE patients, the European League Against Rheumatism (EULAR) Task Force developed in 2008 a set of 12 key evidence-based clinical recommendations to guide clinical decision making [1]. Two other guidelines for SLE were developed in 2011 [2] and 2013 [3] in Spain and Chile, respectively, with a lower degree of methodological transparency.
The complexity of SLE together with the challenge of the required clinical coordination among several medical specialties, the recent devolvement of new and expensive drugs for its treatment, the limited spectrum of clinical questions included in the EULAR recommendations, as well as the need of bringing up to date these evidence based recommendations [1], justify the decision of the Spanish Ministry of Health to support the development of a Clinical Practice Guideline (CPG) for SLE management. The CPG was commissioned to the Planning & Evaluation Unit of the Canary Islands Health Service (SESCS) as part of the Spanish Network of Agencies for Health Technology Assessment in the National Health System.
According to the 2011 definition developed by the Institute of Medicine of the USA, CPGs are statements that include recommendations intended to optimize patient care that are informed by a systematic review (SR) of the evidence, and an assessment of the benefits and harms of alternative care options [4]. CPGs have the potential to facilitate decision-making, improve patient care and optimize the use of available resources. Many studies recommend active patient participation in the process of CPG development to make guidelines more patient-centered [5]. Patients can identify issues that may be overlooked by health professionals and highlight areas where the patient's perspective differs from the views of health professionals, ensuring that key issues of concern to those affected are considered. Patient engagement in CPG development could also improve its translation into clinical practice. The CPGs Program supported by the Spanish Ministry of Health (http://portal.guiasalud.es/web/guest/informacion-pacientes) promotes patient involvement in the CPG development process as a preliminary step for patient empowerment and informed decision making. Earlier, this participative and instrumental approach had been adopted by countries such as Australia, the United Kingdom, and the Netherlands among other countries [6], [7], [8], [9], [10].
This paper describes both the process used and the outcomes obtained by involving patients in the development of a CPG for SLE management from the earlier steps of identification and priority setting of topics and clinical questions that should be answered by the CPG. Patient involvement was addressed to identify the main health problems and needs of care related to SLE to warrant that the contents of the CPG are really patient-centered.
Section snippets
Methods
Three different but complementary activities were performed. First, a SR of the international literature focused on health problems and perceived health care needs by SLE patients. Second, in order to receive feedback from people living with SLE in Spain, a consultative and consensus process was carried out. Third, a patient representative was recruited for the guideline development group (GDG) from the beginning to the end of the CPG development process. This study was approved by the Ethics
Systematic review
The results of the search and the selection of studies process are shown in Fig. 1. From 980 potentially relevant references initially identified, 19 studies (involving more than 2187 participants) that met the pre-established selection criteria were finally selected [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32]. The studies, published from 1988 to 2011, were conducted across 10 countries, mainly United Kingdom, USA, Australia,
Discussion
This study describes the process of obtaining key information from SLE patients about self-perceived health problems, needs and expectations with care and the obtained outcomes to guide the design and development of a CPG for SLE in Spain. The process used three different but complementary activities: first, a SR of the international literature; second, a consultation to SLE patients in Spain; and third, the inclusion of a patients’ representative as a member of the GDG from the beginning of
Competing interest
The authors have no conflict of interest with the subject matter or materials discussed in the manuscript.
We confirm all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story.
Funding sources
This work was supported by the Ministry of Health, Social Affairs and Equality of Spain in cooperation with the Instituto de Salud Carlos III, the “Fundación Canaria de Investigación Sanitaria” (FUNCANIS) and the Spanish Network of Health Services Research for Chronic Diseases (REDISSEC), in the framework of the Spanish Network of Health Technology Assessment and Clinical Guideline Development.
Acknowledgments
We gratefully acknowledge the cooperation of Mrs. Pilar Pazos, President of the Spanish Federation of Patient Associations of Systemic Lupus Erythematosus (FELUPUS) and of all participant patients affected by SLE in Spain.
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See Appendix A for the members of the Spanish SLE CPG Development Group.