Documents
Current status of rhinosinusitis in Spain.
The PROSINUS study
MONTSERRAT J.
ENT Department. Hospital de la Santa
Creu i Sant Pau. Barcelona
New Horizons in the Non-Invasive Management of Sinonasal Disorders.
International ENT Medical Summit.
Barcelona, 19 September 2007.
Keywords of New Horizons in the Non-Invasive management of sinonasal disorders - PDF
INTRODUCTION
The PROSINUS study is being carried out with the primary goal of assessing the impact of acute or intermittent rhinosinusitis in Spain (in accordance with the classification given in the EP3OS 2005 guidelines).
This a PROspective epidemiological study of the diagnosis and therapeutic management of acute rhinoSINusitis by ENT specialists in Spain, and also includes an evaluation of the disease’s socioeconomic impact. About 300 specialists are taking part in the study, and 1,531 patients have been assessed. This is an observational study in which the exposure factor is not a medicine but a disease.
The primary goal is to assess the diagnostic, therapeutic and clinical monitoring procedures for acute rhinosinusitis in current clinical practice. The secondary goals are to describe the biodemographic and clinical profile of the acute rhinosinusitis patient, evaluate the prevalence of acute rhinosinusitis, assess the degree to which the European consensus guidelines are applied in the Spanish health system, determine the prevalence of complications of acute rhinosinusitis, evaluate the health-related quality of life of acute rhinosinusitis patients and analyse patients’ treatment compliance.
In addition, a pharmacoeconomic goal has been established, consisting of studying the socioeconomic impact of acute rhinosinusitis (evaluate the relationship between resources used and the diagnosis, treatment and evolution of acute rhinosinusitis).
This study, as Dr. Montserrat stated, “is absolutely necessary, particularly considering the disease’s high morbidity and considerable impact on the patient’s quality of life, which translates into significant social and economic costs.”
The study includes patients of either sex, diagnosed with acute rhinosinusitis and over 18 years of age. Subjects diagnosed with chronic rhinosinusitis, with an intercurrent disease requiring medication that could interfere with the sinonasal disease, and patients who are difficult to monitor or have a high risk of withdrawing prematurely from the study are excluded.
The primary end-points are disease duration, diagnostic resources, number of visits, medication used and the disease’s impact on the patient’s work activity. Other secondary end-points have been analysed, such as the patients’ epidemiological features, treatment compliance, occurrence of complications and the patients’ degree of satisfaction.
Although diagnosis of this disease is eminently clinical, endoscopy, rhinoscopy, secretion cultures, plain X-rays, computerised tomography and/or the allergy questionnaire or allergy tests can be used as complementary tests. Morisky-Green’s test has been used to assess the patients’ treatment compliance.
PRELIMINARY RESULTS. FIRST VISIT
PROSINUS is the first epidemiological study of rhinosinusitis that is based on the considerations included in the EP3OS document, which gives it added value. At present, only information obtained from the first phase of the study (with a baseline visit and another after 2-4 weeks) is available. In the first visit, relevant information such as epidemiological data and risk factors, previous diseases, selection criteria, informed consent, concurrent therapies, ORL background, diagnostic tests, determination of severity using the visual analogue scale (VAS), complementary tests, and the treatment currently being received by the patients for rhinosinusitis is recorded (Figure 1), together with the disease’s impact on work activity or daily tasks, the general state of health and the baseline assessment of the quality of life (using the SNOT-16 scale).
In the second visit, the clinical symptoms (if they persist), the diagnostic tests that have been necessary, the VAS, the clinical data on the rhinosinusitis at that time, the complementary tests, the treatment proposed by the otorhinolaryngologist, the presence of complications, treatment compliance and a second quality of life test are analysed.
Of the 1531 patients evaluated to date (at their first visit), it is seen that there are more women (50% vs 45%), the average age is 43 years, the average weight is 70.8 kg, and the average height is 168.9 cm. Most work in an adequately heated and ventilated work atmosphere (63%) and their home is also suitably heated and ventilated in most cases (87%).
51% of the patients analysed report a prior episode of acute rhinosinusitis. The average number of prior episodes in the last 12 weeks is 0.8. Regarding the clinical symptoms of the current episode, a high percentage report nasal obstruction (95%) and nasal secretion (92%), with less people reporting facial pain or pressure (74%) and impaired or lost sense of smell (59%).
With respect to the current episode of rhinosinusitis that has led to the patients seeing the specialist, the average number of days that have elapsed since the episode started to being seen by the otorhinolaryngologist is 11.3 days. The average severity (according to the VAS, 0-10) is 7.1 (which is a very high score).
The average number of visits to the GP for this episode of acute rhinosinusitis before the first visit to the specialist is 1.5. Among the diagnostic tests performed for the present episode of acute rhinosinusitis and which were described at the first visit in the PROSINUS study (that is, those that have been performed prior to referral to the specialist), the most common are the plain sinus X-ray (44%), rhinoscopy or nasal endoscopy (28%) and allergy tests (5%). The average number of tests performed is 1.2.
Antibiotics are the treatment prescribed most frequently to patients for their acute rhinosinusitis at the first visit of the PROSINUS study (52%), followed by mucolytics (44%), nasal decongestants (33%), saline solutions (32%), antihistamines (25%), nasal topical corticoids (25%) and natural products (20%). The average duration of the treatment for the acute rhinosinusitis before the first visit is 8.7 days.
The average duration of the medication received varies depending on the type of drug given; the nasal topical corticoids and the antihistamines are the treatments given for longest (11.6 and 10.7 days, respectively).
In the light of this data, Dr. Montserrat said that he was “disappointed, particularly by the high rate of use of antibiotics in primary care to treat these episodes of acute rhinosinusitis.”
The analysis of this preliminary data also shows the significant impact of rhinosinusitis on the patients’ daily activities and work life. The average hours of work lost during the last week is 5 (the average number of hours worked per week is 36.1). The VAS score for the reduced performance during the last week gives a figure of 6.5 (on a scale of 0-10) and the VAS score of the reduced capacity for performing routine tasks during the last week is 6.1. Up to 10.97% of the patients needed to be replaced in their routine, non-remunerated tasks during the last week (the average number of hours in which they have been replaced is greater than 12).
The quality of life test SNOT16 also shows the deterioration experienced by these patients in the main health-related quality of life parameters, with an average 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 abundant nasal secretion. 44% of the patients reported headache and 37% reported facial pain or pressure. The patients also report other symptoms that prevent them from leading a normal life (waking up at night, diminished concentration, tiredness,...).
The analysis of this preliminary data also shows the significant impact of rhinosinusitis on the patients’ daily activities and work life.
PRELIMINARY RESULTS. SECOND VISIT
At the second visit, other relevant data were examined in more detail, basically determining the persistence or not of the symptoms after 2-4 weeks (with the patients now under Specialist Care).
At this second visit, a drastic reduction in the patients’ clinical symptoms is observed. 22.7% of the cases have nasal obstruction (a 76% decrease compared with the first visit), nasal secretion persists in 31.9% of the patients (a 65% decrease), facial pain or pressure is reported only by 9.2% of the subjects (an 88% reduction), and impaired or lost sense of smell now only affects 11.6% of the patients (an 81% reduction compared with the first PROSINUS visit).
In a large part of the population analysed, the disease has been cured by this second visit (82.3%); the average symptom duration is 22.8 days. 15.8% of the patients still have symptoms and remain under treatment, with an average score on the VAS scale of 4.3 (the severity of the symptoms is significantly reduced compared with the first visit).
The diagnostic tests most commonly used by the otorhinolaryngologist are rhinoscopy or nasal endoscopy (66.8%), plain X-rays of the sinuses (36.5%) and CT scans of the sinuses (14.6%). The average number of tests performed is 1.3. As regards the treatments given, 39% of the patients have been prescribed antibiotics (a 25% reduction compared with the first visit), 29% have received topical nasal corticoids (a 13% increase) and 21.6% have received antihistamines (a 15% decrease).
There is also a decrease in the use of other drugs, such as nasal decongestants, mucolytics, saline solutions, but there is a considerable increase in the prescription of phytotherapy (Figure 2). The average treatment duration for acute rhinosinusitis in the second visit is 11.5 days, with particularly long treatment periods for nasal topical corticoids (an average of 16.1 days) and antibiotics (9 days).
No significant complications are reported in these patients. The most noteworthy are some isolated cases of bleeding (2.16%).
Treatment compliance, as determined from the analysis of the Morisky-Green test, is relatively high. It is estimated that 22.8% of the patients forget to take the medication, 11.1% do not take it at the times prescribed by their doctor, and about 23% drop the treatment. It is concluded that the percentage of non-compliant patients is 31%.
The degree of patient satisfaction with the treatment prescribed by the doctor is very high (52% are highly satisfied and 16.2% are very highly satisfied), as also with the monitoring of the disease (92% are satisfied).
The SNOT 16 test shows a clear improvement in the patients’ quality of life at the second visit (compared with the first visit), with an average score of 1 (scale of 0-5 points).
By way of conclusion, Dr. Montserrat called attention to the fact that “PROSINUS is the first prospective, observational, epidemiological study of the management, diagnosis and treatment of acute rhinosinusitis in Spain. Among other findings, it has been found that 82% of the episodes of acute rhinosinusitis assessed are cured within 4 weeks after diagnosis. It is also seen that the specialists prescribe less antibiotics (although perhaps for longer periods) and use less plain X-rays of the sinuses and more CT scans.
The effect on these patients’ quality of life is substantial. As regards treatment compliance, it is calculated that it is 68.9% at the second visit.”
By way of conclusion, Doctor Montserrat called attention to the fact that “PROSINUS is the first prospective, observational, epidemiological study of the management, diagnosis and treatment of acute rhinosinusitis in Spain.
CONCLUSIONS
- It is the first prospective, observational, epidemiological study of the management, diagnosis and treatment of acute rhinosinusitis.
- 82% are cured with the first 4 weeks after diagnosis
- ENT specialist use less antibiotics but for longer periods
- ENT specialist perform less X-Rays
- Acute rhinosinusitis has a marked effect on patient's quality of life
- Treatment compliance is 68.9%
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