Monday, October 8, 2012

Current status of rhinosinusitis in Spain. The PROSINUS study

Current status of rhinosinusitis in Spain. The PROSINUS study

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 rhino sinuusitis 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.

  • It is the first prospective, observational, epidemiological study of the management, diagnosis and treatment of acute rhinosinusitis
  • 82% are cured within the first 4 weeks after diagnosis
  • ENT specialists use less antibiotics but for longer periods
  • ENT specialists perform less X-rays
  • Acute rhinosinusitis has a marked effect on patients’ quality of life
  • Treatment compliance is 68.9%
“The analysis of this preliminary data also shows the significant impact of rhinosinusitis on the patients’ daily activities and work life”

Spech by Dr. J. Montserrat 
ENT Department. Hospital de la Santa Creu i Sant Pau. Barcelona

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