Outcomes assessment refers to the measurement of health and medical results toward the goal of improving care. Although outcomes assessment in itself is not controversial, controversy arises when attempts are made to standardize methodology. There are several valid ways to approach outcomes assessment and management in sinus surgery. The best means to eliminate controversy is for the reader to understand that the relevant criteria for choosing an outcomes management system should be based on the individual needs of a particular practice or a particular study and the performance characteristics (e.g., type of measure, reliability, ease of use) of the available measures and staging systems.
Sinusitis is an increasingly common cause for patient visits to the doctor in the United States and is the prinicipal diagnosis in nearly 2% of all patient visits. Surgery for the treatment of chronic sinusitis is performed more than 200,000 times per year in the United States alone, making sinusitis both a common and, in aggregate, an expensive illness.
Sinusitis is a predominantly ambulatory disease that afflicts a working-age population. In many ways, sinusitis is a model to explain the practical steps necessary in developing outcomes management systems for chronic ambulatory diseases as well as the information that can be obtained and used from an effective program. The elements of an outcomes management system for sinus surgery include staging and stratification, process measurement, outcomes measures, and feedback.
Staging and Stratification
The challenge of developing outcomes management systems rests in adequately defining and stratifying starting points and in accurately quantifying endpoints. In sinusitis, for example, a great deal of attention has been focused on the appropriate method to stage a preoperative computed tomography (CT) scan of the paranasal sinuses. Yet, the factors that comprise a good staging system (i.e., validity, reliability, statistical distribution, comprehensiveness, and the ability to predict outcome) are rarely considered or objectively evaluated. In two studies of clinician-based staging systems,1, 2 we have found wide variations in reliability (both intra-rater and inter-rater) and the lack of substantial correlations to postoperative outcome. Nevertheless, for consistency in reporting results, it is necessary to choose a staging system. Table 18-1 describes several proposed staging systems that have been evaluated. In the comprehensive evaluation by Metson et al.,2 which included staging systems by Kennedy,3 Friedman et al.,4 and May et al.,5 the Harvard system6 and the Lund–MacKay staging systems7 were found to be the most reliable, whereas the Harvard system was the easiest to use. In 1996, in a report of the Rhinosinusitis Task Force Committee Meeting, Drs. Lund and Kennedy recommended the modified Lund–MacKay staging system for further outcomes research.8 Ultimately, the best staging system will be chosen by evaluating outcomes studies to determine which factors are most predictive of the result. That will not be possible until additional data are collected.
Outcomes Measures
Assessing endpoints or outcomes is the next step in developing outcomes management systems. Although traditional endpoints such as complications and mortality rates are important, they are imprecise for nonmorbid disease processes such as sinusitis. Therefore, these measures must be supplemented by more precise and useful measurements. Unlike hearing or vision loss, patients with sinusitis suffer in ways that are less easily measured but that certainly affect their functioning and well-being. Therefore, it is clear that patient-based quality-of-life measures should be a vital element of any studies in patients with sinusitis. The recommended elements of a quality-of-life outcomes monitor for sinusitis include a general health assessment, which is a global view of the patient’s well-being as well as a disease-specific assessment that focuses more narrowly on the disease entity and that is usually more sensitive to clinical change with treatment.6, 9, 10
Probably the most widely tested instrument used for general health assessment today is the SF-36 Health Survey, or some form of it.11 This 36-item survey measures 8 domains of general health grouped into physical and mental health areas. In a study of 165 patients presenting to otolaryngologists with chronic sinusitis, patients with chronic sinusitis demonstrated significant decrements from expected normative levels of functioning when tested with this survey in such areas as physical role functioning, bodily pain, general health, vitality, and social functioning.10 Whenever a quality-of-life measurement is reported, it is important to put it into perspective. For example, the vitality score reported in chronic sinusitis refractory to medical therapy can be thought of as indicating that one-fourth of these patients would be expected to report that they are tired most or all of the time. As a generic measure, the SF-36 also permits comparisons between diseases, to understand the relative health impact of chronic sinusitis as compared with other chronic illnesses. Such comparisons show that patients with chronic sinusitis have SF-36 scores in domains such as general health and vitality similar to scores of patients with other chronic illnesses, such as chronic obstructive pulmonary disease. Using generic health measures in this way gives us a better understanding of the relative public health impact of one illness versus another.
| Stage | Description | |
| Staging system proposed by Kennedya | ||
| 0 | Normal | |
| I | Anatomic abnormalities, all unilateral sinus disease, bilateral disease limited to ethmoidal sinuses | |
| II | Bilateral ethmoidal disease with involvement of one dependent sinus | |
