Documents
Results of the Prospective Epidemiological Study of
the Diagnosis and Management of Acute Rhinosinusitis
in ENT offices in Spain. Socioeconomic Impact.
Prosinus study
MONTSERRAT J.
Head of the Rhinology Section.
ENT Department. Hospital de la
Santa Creu i Sant Pau. Barcelona
Present and Future of the Management of Sinonasal Disesase.
Madrid, 11 November 2007.
Keywords Present and Future of the Management of Sinonasal Disesase - PDF
INTRODUCTION
The PROSINUS study has been designed in response to the shortage of epidemiological data in Spain on the diagnosis and treatment of acute rhinosinusitis (ARS). The name PROSINUS refers to a prospective epidemiological study whose purpose is to analyse the diagnosis and treatment of this disease in ENT offices in Spain and also to assess its socioeconomic impact.
However, 550 were subsequently excluded because they had chronic rhinosinusitis and a further 77 had a probable diagnosis of chronic rhinosinusitis. Of the 1,233 patients with a confirmed diagnosis of ARS, 1,172 have completed visit 1 of the study and 788 have also reached visit 2. Most of the patients (approx. 90%) initially had a moderate or severe disease, according to the VAS.
The definition of acute rhinosinusitis given in the 2005 EP3OS guidelines has been used for the study. At present, the diagnosis of rhinosinusitis is basically clinical; the main symptoms are nasal obstruction/congestion, impaired sense of smell, anterior or posterior rhinorrhoea, and facial pain/pressure; at least two symptoms are required to determine the presence of rhinosinusitis.
However, a further condition has been added in that the symptoms must be associated with suggestive endoscopic findings (polyps, rhinorrhoea and oedema) or changes in the sinonasal mucosa that can be identified by computerised tomography (CT).
In the review of the EP3OS position paper performed this year (Fokkens et al., 2007), it was proposed to reclassify the severity of rhinosinusitis by quantifying it on a visual analogue scale graded from 0 to 10.
Under this new classification, a patient is considered to have mild disease when the score on the visual analogue scale does not exceed 4 and moderate/severe disease when at least one symptom attains a score between 4 and 10. As regards the duration of the rhinosinusitis, it is defined as acute or intermittent when disease duration is less than 12 weeks and chronic or persistent if it continues beyond 12 weeks.
Acute rhinosinusitis is further subdivided into two clinical conditions: acute viral rhinosinusitis or common cold and acute/intermittent non-viral rhinosinusitis.
In viral rhinosinusitis, symptom duration is less than 10 days, while acute/intermittent non-viral rhinosinusitis is defined as an increase in symptom severity after 5 days or persistence of symptoms beyond 10 days after symptoms began. In both cases, symptom remission is complete within 12 weeks.
METHODOLOGY AND OBJECTIVES
PROSINUS is an prospective, observational, epidemiological study of health outcome in which the exposure factor is not a medicine but a disease. As the speaker stressed, “it is not drug efficacy and/or tolerance that is being assessed but the evolution of a disease from initial diagnosis to final cure.”
Before the first visit, information was obtained on the treatment received by the patient in the non-ENT primary care system, while the management approach applied during specialist care was examined after the first visit. The study’s primary goal is to assess the diagnostic, treatment and clinical monitoring procedures available for acute rhinosinusitis in usual practice.
The secondary goals include the following: describe the bio-demographic and clinical profile of the patient with acute rhinosinusitis, assess the degree to which the European position papers (EP3OS) are applied in the Spanish health system, determine the prevalence of complications of acute rhinosinusitis, analyse the health-related quality of life of patients with acute rhinosinusitis, and assess their treatment compliance.
Certain pharmacoeconomic goals have also been set: study the socioeconomic impact of acute rhinosinusitis, evaluating the ratio-optimization of the resources used to control the disease, and the impact on work life.
The primary study variables are: disease duration, diagnostic resources used or number of visits; the secondary variables are concerned with epidemiological data, treatment compliance (Morisky-Green test), and degree of satisfaction.
The study is structured in two phases. At present, only the data for the first phase are available. This phase includes the baseline visit and visit 2 (week 2-4). The second phase assesses chronification of the disease (week 12).
RESULTS OF THE FIRST VISIT
At visit 1, the following assessments were performed: epidemiological data and risk factors, previous rhinosinusitis events, the current event, severity, visits to the doctor and diagnostic tests performed prior to the study, prior medication, impact of the rhinosinusitis on work or daily life activities, and the patient’s health-related quality of life (SNOT-16).
At the first PROSINUS visit, it is seen that there are slightly more women (49.74% vs. 45.22%), the participants’ mean age is 42.1 years, and most patients’ work and home environment (68% and 87.1%) is adequately climate-controlled. 44.37% of the patients had reported a prior ARS and the most commonly experienced symptoms were nasal secretion (100%), facial pain or pressure (95.48%), nasal obstruction (91.89%), and impaired or lost sense of smell (64.25%).
Mean duration of the current event is 11.3 days and the mean severity is 7.3 points on the VAS. On average, the patients had been to see their doctor 1.4 times for their ARS before this first visit. As regards the diagnostic tests used, the high rate of sinus Xrays (48.98%) compared with rhinoscopy (28.92%), sinus CT scan (6.48%), and allergy tests (5.63%) is striking; on average, each patient underwent 1.1 tests.
The most commonly prescribed medications before the first PROSINUS visit include antibiotics (56.74%), mucolytics (47.01%), nasal decongestants (35.24%) and saline solutions (34.30%). The rate of use of other resources (such as topical corticoids, antihistamines or natural products) is less. Mean treatment duration for the current ARS event is 8.8 days, ranging from 11.4 days for antihistamines or 10.5 days for saline solutions to 7 days for antibiotics.
As regards the ARS’s impact on work activity, it is seen that during the week prior to inclusion in the study, the average number of hours not worked because of this disease is 5.4 h/patient while 9.13% of the patients have needed replacement for an average of 12.5 h/patient during the last week in carrying out routine, non-remunerated tasks. The SNOT-16 quality of life test confirms that, as a general rule, the patients perceive a clear deterioration of their health-related quality of life.
The average score in this test is 2.5 (0-5). This score increases to 3.7 when only the average score obtained for the 5 highest- scoring items is assessed. The most significant events reported by the patients are constant nasal secretion, headache, need to blow one’s noise, abundant nasal secretion,and facial pain or pressure.
RESULTS OF THE SECOND VISIT
At the second visit (made between 2 and 4 weeks after the 1st visit), the patients’ progress is analysed after they have been seen by an ENT specialist (n=788). Among other aspects, the persistence or cure of the disease, the clinical symptoms, the severity of the rhinosinusitis, visits to the doctor since the 1st visit, diagnostic tests performed during this period, medication received and the quality of life are assessed.
At this visit, up to 82.87% of the ARS events have been cured, with a mean symptom duration of 22.4 days. Only 16.93% of the events have not been cured. The average score on the VAS is 5.1 points. A substantial increase is also seen in the frequency of use of the main diagnostic tests of choice, such as rhinoscopy or nasal endoscopy (70.30%) or CT (13.58%), with a decrease in the frequency of use of X-rays (33.63%); the mean number of tests performed is low (1.2).
As regards the medication given, the significant increase in the use of natural products or phytotherapy is particularly striking (51.44% vs. 20.22% at the first visit), together with the decrease in the frequency of use of antibiotics (42.51% vs. 56.74%) and mucolytics (25.63% vs. 47.01%). This trend is found with all medicines except phytotherapy. Treatment duration is 11.1 days, with an increase in the duration of treatment with antibiotics (mean, 9 days) or topical corticoids (15.4 days).
As regards the complications documented at this second visit, the only findings are a slight increase in the incidence of bleeding (2.79%), conjunctival hyperaemia (1.14%) and headache (1.14%).
The Morisky-Green test shows that up to 22.59% of the patients forget to take the medication and that 10.66% do not take it when they should. It is estimated that the percentage of non-complying patients is greater than 30%; most of the patients stop taking the treatment because of unpleasant side effects (62%) or because they experience a clear improvement in their symptoms (22%).
Up to 95.49% of the patients are satisfied with the treatment prescribed and 92.26% are satisfied with the follow-up of the disease by the ENT specialist.
At the second visit, the average score in all 16 items of the SNOT-16 quality of life scale is much lower than that recorded in the first visit (1.1 on a scale from 0 to 5), although the average score of the 5 items that are most important for the patient remains stable (3.7).
Summarising the main findings obtained from this study to date, Dr. Montserrat said that “this is the first Spanish prospective epidemiological study of the diagnostic and therapeutic management of ARS. This study has shown that the ARS is cured in 82.87% of the cases within 4 weeks after the disease process has started. ENT specialists prescribe antibiotics less but for longer than GPs and less plain X-rays are performed. The quality of life is significantly impaired during ARS and treatment compliance is 67.77%.”
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