The use of aerosol drugs in the treatment of respiratory disease has become widely generalized since their introduction in the 1970s. Inhaled administration is today the method of choice for drugs that need to act directly on the bronchial tree, particularly bronchodilator and anti-inflammatory agents. Consequently, standard clinical practice guidelines recommend the use of inhaled therapies for the treatment of obstructive respiratory diseases.1–3 Their main drawback is that a large proportion of patients who use them do so incorrectly, which can cause a lack of therapeutic efficacy and insufficient control of the disease.4,5 This requires clinicians to make an extra effort in order to educate and adequately train patients in the correct use of inhalers. All the clinical practice guidelines for asthma and COPD dedicate special attention to said activity, which is a basic axis of their education programs.1–3 As medical professionals are responsible for the education of their patients, this requires the physicians and nurses who are usually involved in the clinical management of respiratory patients to be familiarized with the details of inhaled therapies and devices for their administration. Nevertheless, the reality is disappointing. Several studies6,7 done over the last 20 years have consistently shown that the majority of doctors who prescribe inhalers, regardless of the type of device considered, were unaware of their correct usage. And what is even worse is that it has recently been confirmed that said lack of awareness does not seem to have improved recently8–10 despite the educational efforts made by scientific societies and workgroups to improve the situation.11,12

In a recent survey of 1514 Spanish doctors from different specialties, it was confirmed that up to 86% of those interviewed showed an insufficient level of knowledge about inhaled therapy.10 Given the severity and the persistence of the deficiencies observed, the members of the Scientific Committee of said study (made up of a multidisciplinary group of physicians specialized in the subject—Annex 1) decided to promote an educational project in order to improve knowledge and understanding of inhaled therapies and inhalers among Spanish medical professionals: the Inhaled Therapy Project. As proof that this problem is also current on an international level, said initiative coincided in objective and in time with the recent publication of the consensus report by the European Respiratory Society and the International Society for Aerosols in Medicine (ERS/ISAM Task Force Report),13 which updates global understanding of aerosol use. Among other actions, the Inhaled Therapy Project prepared a specific monographic document about the subject,14 which included the recommendations for clinical practice made by the authors of each chapter. The aim of the Consensus Statement is to present information to Spanish medical professionals about the appropriate management of inhaled therapies that may lead to future improvement in the treatment provided by both physicians and nursing staff. This present study was created with the objective to validate the recommendations with the Delphi method by a group of experts who did not participate in drafting the aforementioned monographic document.

The mean age of the 59 expert panelists was 50.3, with a majority of males (83%). All of them were clinicians who were actively working in public health-care services (simultaneously in private practice in 16% of the cases), mostly hospitals (82%), with an average of 21.6 years of professional experience. They represented all the autonomous communities (provinces) of the country and came from different specialties, including pulmonology (85%), allergology, internal medicine, family medicine and pediatrics.

The experts consulted completed the two rounds of evaluation and they proposed no new items. In the first round, consensus was reached for 35 of the 40 recommendations analyzed according to the pre-established evaluation criteria. The consensus for these 35 items was of group agreement (acceptance) with the questions posed. Out of the 5 remaining items that were proposed for reconsideration by the experts in the second round, a consensus was reached for 4 more, also with group agreement with the item in question. Considered as a whole, the panel reached consensus for 97.5% of the recommendations proposed. Among the observed results were that 8 (20%) of the items reached unanimous consensus (100% acceptance) from the experts. Out of these 8 items, 3 belonged to the “general aspects” group (items 1, 3 and 4), 2 to “inhaled drugs” (items 10 and 11) and 3 to the “aspects related with compliance and education” (items 36, 38 and 40).

Table 1 compiles the values obtained in each of the items or proposals made with their corresponding statistics, indicating for each item the median and mean scores as well as the distribution of the participants in each of the consensus regions (agreement, undecided or disagreement with the item).

There was only one item, number 14, which did not reach a consensus, either for agreement or disagreement. After the two rounds, it still continued to have an indeterminate level of consensus among the panelists (lack of agreement or disagreement according to pre-established criteria). Said item affirmed that “pressurized metered-dose inhalers (pMDI) are the most efficient (cost-effective) and, consequently, should be considered the inhaler of choice”. Although this was an opinion shared by most of the panelists (65.4%), a small but significant subgroup of experts (13.5%) manifested their opinion to the contrary, while the remaining participants (21.1%) declared having doubts.

The external assessment by experts in inhaled therapies from the different specialties that have made up the panel in the present study shows a high level of agreement with the proposed recommendations (97.5%). This external acceptance gives credit to the previous task of recompilation carried out by the writers of the document “Inhaled Therapy: theory and clinical practice” and to the task of agglutination and synthesis by the members of the Executive Committee of the project who drafted the recommendations. It should be highlighted that the majority (35 out of 40) of these reached consensus in the first round of the Delphi survey, and that the scores of the evaluations emitted by the experts for each of the items were at very high levels. In fact, for 8 recommendations the agreement was unanimous. In general terms, the high level of agreement observed is situated above what is usually reported in studies with similar characteristics.21,22 And, this is of special interest when, in this present analysis, the panel of experts was comprised of professionals from different origins, both corporate and geographical, with different responsibilities and health-care activities.

The results of this study endorse the recommendations of experts that make up the present Consensus on Inhaled Therapies. In our setting, there is no similar precedent, and therefore this consensus of clinical recommendations is the first text on inhaled therapies and inhalation devices to be completed in Spain. The high number of participating experts (78) in the Project, their prestige and multidisciplinary origin contribute to the credibility of the document. The high degree of consensus observed among the members of the panel in the majority of the items examined leads us to believe that these clinical recommendations and criteria are supported by the unanimous professional opinion of Spanish experts. This aspect, in addition to the endorsement of the Consensus, may be considered an interesting contribution to be diffused and followed by health-care professionals. This would promote its practical application in reducing the unjustified variability found among these professionals. Among the causes of the poor compliance with clinical practice guidelines are the different criteria and lines of action seen from specialty to specialty, causing excessive variability in clinical practice. For this reason, it is possible that in the future the Consensus may become a common reference text for inhaled therapies in our setting, which physicians may turn to and cite in order to support his/her own considerations or recommendations, regardless of the specialty in question. The initiative concurs with other similar initiatives recently done in the United States12 and in Europe.13

The result of the non-consensus observed with item 14 (about whether pressurized cartridges are the most cost-effective devices available) merits comment. First of all, the lack of consensus does not mean that the item was rejected, because in that case we could have witnessed agreement in its being rejected. Instead, the fragmentation observed in the responses given by the experts (65.4% agreed, 13.5% disagreed and 21.1% were on the fence) meant that consensus was not reached after two rounds. Second, this lack of consensus neither invalidates nor rules out its affirmation; it may simply translate either the lack of scientific evidence to promote a categorical opinion, or that such evidence is too heterogeneous, with conflicting results seen in the literature. As a consequence, the situation leads one to reflect upon the need to develop well-designed cost-efficiency studies that could shed light on the question. This would allow us to later, in light of future results, unify professional opinions, either by accepting or rejecting the initial pending recommendation.

Considerable efforts have been made in education in recent years in order to improve the level of knowledge about aerosols and their correct administration among health-care professionals in our country. In spite of this, the situation unfortunately continues to be less than optimal,10 and this circumstance seems to be universal.8,9 The causes of this phenomenon should be investigated and new educational strategies should be designed and implemented to efficiently resolve this shortcoming. In this context, and with the ambitious intention of making a contribution to mitigate these mentioned deficiencies, the Inhaled Therapy Project was born. It is basically an educational initiative that is locally based in the Spanish setting, whose aim is to update the understanding in this material among health-care professionals. It unites different complementary actions which have been occurring since 2010. In addition to publishing the aforementioned monographic document entitled “Inhaled Therapies: theory and clinical practice”14 and the OPTIM-Test study,10 the Project has designed, together with the sponsor of the initiative, a series of training meetings and debates in smaller groups of professionals from different specialties distributed all over Spain during 2011 and 2012. Among the objectives of these meetings, the most important, without a doubt, is to disseminate the 39 recommendations embodied in the Consensus on Inhaled Therapies for clinical hat were validated in the present study. We are certain that all these efforts made will result in an improvement in the training and performance of our professionals, which will consequently translate into better patient use of inhalers, ultimately providing them optimal control of their disease and a better quality of life. This is the raison d’être as well as the main objective of the Inhaled Therapy Project.

Among the possible design limitations of this study is the method used for selecting the members of the panel of experts who participated in the validation of the consensus recommendations. Even though there could be a certain (but not deliberate) bias of choice, there was no better alternative, particularly if what we intended was for it to be comprised of experts. On the contrary, among its strengths are the high number of participants, their territorial representation and a certain multidisciplinary participation. Although most were pulmonologists, other specialists also participated from the areas of allergology, primary care and internal medicine.

In short, the study demonstrated the validation, with excellent levels of agreement among experts, of a group of practical recommendations created to improve the understanding and use of inhaled therapies. The resulting test is the first Consensus on Inhaled Therapies done in our country to date. The diffusion of said document could contribute to increasing the degree of knowledge of health-care professionals about the use of inhalers for treating obstructive respiratory diseases.

The study received unconditional help from Chiesi Farmaceutici, which did not intervene in the data collection, analysis or interpretation of the results or in the drafting of the manuscript.

The authors present no conflict of interests with regards to this article.