Documents
Present status of rhinosinusitis in Spain:
the Prosinus Study
MONTSERRAT J.
Hospital Sant Pau. Barcelona.
Current Vision of Rhinosinusitis
and recent progress in advanced sinonasal endoscopic surgery
Medical forum. Valencia, March 2007
Keywords of Current Vision of Rhinosinusitis 2007 - PDF
LECTURES
The PROSINUS study is a PROspective epidemiological study of the diagnosis and therapeutic management of acute rhinoSINUSitis in otorhinolaryngology offices in Spain and includes an assessment of the disease’s socioeconomic impact. Approximately 300 specialists and 2,400 patients will take part in this study, which is currently in the development phase. As Dr. Montserrat said, “it is a prospective observational study of outcomes so the factor under discussion is not a medicine but a disease.”
The study’s primary goal is to evaluate the diagnostic, treatment and clinical monitoring procedures applied in acute rhinosinusitis in usual clinical practice. The secondary goals include the following: describe the biodemographic and clinical profile of the patient with acute rhinosinusitis, determine the prevalence of acute rhinosinusitis, assess the level of implementation of European consensus guidelines in the Spanish health system, determine the prevalence of complications associated with acute rhinosinusitis, assess the health-related quality of life of patients with acute rhinosinusitis, and analyse the patients’ treatment compliance. In addition, a pharmacoeconomic goal has been established, studying the socioeconomic impact of acute rhinosinusitis (determine the relationship between resources used and the diagnosis, treatment and evolution of acute rhinosinusitis).
The study is clearly justified. It is a disease with a high level of morbidity and a significant impact on the patient’s quality of life, entailing substantial social and financial costs. Furthermore, according to the EP3OS document, before a suitable treatment can be given, it is first necessary to identify correctly the type of rhinosinusitis. It is estimated that there are more than 88 million cases/year of common cold or viral rhinosinusitis, 0.5-2% of which may suffer complications and lead to non-viral acute rhinosinusitis. The incidence of non-viral acute rhinosinusitis ranges between 440,000 and 1,760,000 cases/year.
The study includes adult patients of both sexes diagnosed with acute rhinosinusitis.
Antibiotics are the treatment that has been used most often by patients for their acute rhinosinusitis at the first visit in the PROSINUS study (50%), followed by mucolytics (46%), saline solutions (34%), nasal decongestants (32%), antihistamines (25%), natural products (25%) and topical nasal corticoids (24%).
Subjects diagnosed with chronic rhinosinusitis, recurrent disease requiring medication that may interfere with the sinonasal disease, patients who pose monitoring problems or who have a high risk of dropping out from the study before completion are excluded. The primary assessment variables are duration of the condition, diagnostic resources, number of visits, medication used and impact of the disease on the patient’s work activity. Other secondary variables such as the patients’ epidemiological characteristics, treatment compliance, occurrence of complications and degree of patient satisfaction have been analysed. Although diagnosis of this disease is eminently clinical, supplementary tests may be used such as endoscopy, 6rhinoscopy, secretion cultures, plain X-rays, computerised tomography and/or the allergy questionnaire or allergy tests. To determine the patients’ treatment compliance, the Morisky-Green test (a simple test with four questions) has been used.
PRELIMINARY RESULTS
PROSINUS is the first epidemiological study on rhinosinusitis that is based on the considerations set forth in the EP3OS document, which gives it added value. At present, only information obtained from the first visit, corresponding to the first phase of the study, is available. This visit has provided useful information, such as epidemiological data and risk factors, previous diseases, selection criteria, informed consent, concurrent therapies, otorhinolaryngological background, diagnostic tests, severity assessment (using the VAS scale), supplementary tests and the treatment currently being received by the 7tients for their rhinosinusitis, the impact of rhinosinusitis on daily or work activities, general health and baseline quality of life assessment (using the SNOT-16 scale). With 139 subjects assessed to date (at their first visit), it is seen that the majority of patients are women (55% vs 45%) and the average age is 42.4 years. Most work (68%) and live (88%) in adequately climatised environments.
With 139 subjects assessed to date (at their first visit), it is seen that the majority of patients are women (55% vs 45%) and the average age is 42.4 years. Most work (68%) and live (88%) in adequately climatised environments.
None of the patients analysed to date had a prior diagnosis of chronic rhinosinusitis, 52% reported a previous episode of rhinosinusitis and 46% did not. The average number of previous episodes in the last 12 weeks is 0.5. In terms of clinical symptoms in the current episode, a high percentage of cases report nasal obstruction (96%) and nasal secretion (94%), with a smaller percentage of subjects reporting facial pain or tension (78%) and impaired or non-existent sense of smell (60%).
More than half of the patients report a need to blow their nose, with constant and copious nasal secretion. 44% of the patients experience headache and 37% experience facial pressure or pain. The patients also report other symptoms that prevent them from leading a normal life.
Regarding the present episode of rhinosinusitis that has induced the patient to see the specialist, the average duration is 9.2 days. The average severity (according to the VAS scale, from 0 to 10) is 7.1. The average number of medical appointments for acute rhinosinusitis before the first study visit is 1.6.
Among the diagnostic tests carried out for the present episode of acute rhinosinusitis and described in the first visit in the PROSINUS study, the most commonly performed are sinus X-rays (41%), rhinoscopy or nasal endoscopy (33%), and allergy tests (14%). The average number of tests performed is 1.6.
Antibiotics are the treatment that has been used most often by patients for their acute rhinosinusitis at the first visit in the PROSINUS study (50%), followed by mucolytics (46%), saline solutions (34%), nasal decongestants (32%), antihistamines (25%), natural products (25%) and topical nasal corticoids (24%). The average duration of the treatment before attending the first visit was 8.3 days. The average duration of the medication received varies depending on the type of drug administered; the antihistamines and the topical nasal corticoids are the treatments taken for longest (16.5 and 11.5 days, respectively).
The analysis of these preliminary data also shows the significant impact that rhinosinusitis has on the patients’ daily and work activities. The average number of hours of 8work lost in the previous week was 4.4 (the average number of hours worked per week is 35.2). The VAS assessment of the lower performance during the previous week gives a score of 6.1 (scale from 0 to 10) and the VAS assessment of the reduced ability to perform routine tasks during the previous week is 5.8. Up to 15.11% of the patients have had to be replaced in their routine unremunerated tasks during the previous week.
The SNOT-16 quality of life test also shows the deterioration that these patients experience in the main health-related quality of life parameters, with a mean score per patient of 2.4 in this test (0-5). More than half of the patients report a need to blow their nose, with constant and copious nasal secretion. 44% of the patients experience headache and 37% experience facial pressure or pain. The patients also report other symptoms that prevent them from leading a normal life.
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