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Abstract

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

Although sinusitis is one of the most common chronic illnesses in this country, relatively little is known about the effect of this disease or its treatment on quality of life. In a series of studies utilizing both disease-specific and general health instruments, patients with chronic sinusitis were found to have significant decrements in several subscales of general health, including bodily pain and social functioning (P < .05), compared with the general US population. Surgery for sinus disease was shown to result in significant reduction in both symptoms and medication usage (P < .05) after 12 months. These same outcome instruments can be used by health care providers to document clinical outcomes in similar populations of patients with chronic sinusitis.


INTRODUCTION

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

Chronic sinusitis is one of the most prevalent illnesses in the United States. It affects as many as 30 million Americans 1 and is the principal diagnosis in almost 2% of all office visits to physicians. Although there is a plethora of literature on clinical trials assessing the efficacy of various medical and surgical interventions for chronic sinusitis, outcome studies measuring the quality of life (QOL) of patients suffering this debilitating disease and the effectiveness of these interventions on such quality remain limited.

Whereas the precise definition of QOL remains debatable, it is clear that the best information to measure such quality is obtained directly from the patient. Improvements in the methodologic science of survey construction have allowed the development of reliable and valid questionnaires for the purpose of accumulating such data. Collectively, these instruments have been called QOL measures. The elements of a QOL outcomes monitor include both a general health assessment and a disease-specific health assessment. 2

OUTCOME INSTRUMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

The most widely tested and used instrument for general health assessment is the Medical Outcomes Study Short-form 36-item Health Survey (SF-36). 3 This 36-question survey measures eight domains of general health status (Table I), including physical functioning (PF), role-functioning physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-functioning emotional (RE), and mental health (MH).

Table Table 1.. Eight Subscales of General Health Comprising the SF-36 Patient Survey. 8
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PF = physical functioning; RP = role-functioning physical; BP = bodily pain; GH = general health; VT = vitality; SF = social functioning; RE = role-functioning emotional; MH = mental health.

The Chronic Sinusitis Survey (CSS) is a six-item, duration-based monitor of sinusitis-specific outcomes (Table II) that has demonstrated statistical reliability and validity. 4 It is divided into a symptom-based section and a medication-based section. The symptom-based section asks questions about the duration of symptoms during a 2-month period. The symptoms assessed are sinus headaches, facial pain or pressure, nasal drainage or postnasal drip, and nasal congestion or obstruction. The medication-based section assesses usage of antibiotics, prescription nasal sprays, and over-the-counter sinus medications. In patients with chronic sinusitis, the CSS is very sensitive to clinical change over time. The sensitivity to longitudinal change, or responsiveness, makes it a particularly valuable tool to assess patients with chronic sinusitis during their course of treatment. 5

Table Table 2.. Chronic Sinusitis Survey.
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Chronic Sinusitis Survey © Clinical Outcomes Research Unit, Massachusetts Eye and Ear Infirmary, Harvard Medical School.

Although this report describes the authors' results using the CSS, it is important to note that other authors have developed and validated outcomes tools that can also be used for chronic sinusitis patients. The Rhinosinusitis Outcome Measure is a comprehensive 31-item questionnaire that is mainly directed at sinusitis-specific symptoms but also includes some general health assessments. 6 These items are divided into seven domains: nasal symptoms, eye symptoms, sleep, ear symptoms, general symptoms, practical problems, and emotional consequences. Each item is rated and weighted by patients in relation to their magnitude and importance. The Rhinoconjunctivitis Quality of Life Questionnaire is directed at patients with seasonal allergic rhinosinusitis. 7 It was developed from 91 questions related to local symptoms, systemic symptoms, and general psychosocial disturbance. The final questionnaire, constructed on the basis of frequency and importance rated by the patients, contains six domains and 28 items. Four items are related to nasal symptoms, three to sleep, six to emotion, and six to practical problems.

HEALTH IMPACT OF CHRONIC SINUSITIS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

Mean SF-36 scores of general health in 108 patients with chronic sinusitis are presented in Figure 1 along with normative data from the US general population. 8,9 It is apparent that chronic sinusitis patients have large and measurable changes in general health status as assessed by this survey. The most severe decrements compared with the published norms are seen in the BP and SF subscores, followed by the GH, RP, and VT subscores. All five subscales are significantly different from their corresponding normative values (P < .05). PF, such as climbing stairs or vigorous activity, is not affected, nor is RE. The differences in these subscores from normative data are even more striking considering that the sinusitis population in this study is on average 20 years younger than the Medical Outcomes Study sample used to generate the normal data.

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Figure Fig. 1.. Chronic sinusitis patients versus US general population normative data for eight subscales of the SF-36 Health Survey. Differences with the US population data shown were statistically significant (P < .05) for role-functioning physical (RP), bodily pain (BP), general health (GH), vitality (VT), and social functioning (SF). PF = physical functioning; RE = role-functioning emotional; MH = mental health. Reprinted with permission from Gliklich and Metson. 8

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Use of published normative data for other disease states allows a comparison that helps us to understand the relative burden of chronic sinusitis versus other chronic diseases. 8 The disease cohorts presented include patients with congestive heart failure, chronic obstructive pulmonary disease, angina pectoris, and back pain or sciatica. The most significant differences between these populations were seen in the BP (Fig. 2A) and SF (Fig. 2B) scales. Patients with chronic sinusitis had significantly lower BP scores (more pain) than any of the other cohorts, including angina and back pain/sciatica (P < .05). In the measurement of SF, patients with chronic sinusitis were significantly more limited by their health in their social activities than patients with any of the other chronic diseases (P < .05).

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Figure Fig. 2.. Comparison of chronic sinusitis cohort to congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), angina, and back pain/sciatica disease cohorts for individual subscales of the SF-36 General Health Survey. Chronic sinusitis cohort demonstrates significantly lower mean scores (P < .05) for BP (A) and SF (B) than comparison groups. Asterisk over bar indicates that cohort mean score is significantly different from sinusitis cohort at P < .05. Reprinted with permission from Gliklich and Metson. 8

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EFFECTS OF SINUS SURGERY

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

Comparison of the SF-36 subscale scores before and after surgery demonstrates a significant improvement in six subscales—PF, RP, BP, SF, VT, and MH (P < .05)—as shown in Table III. 10 The largest improvement was seen in the RP score, which increased by 22%. Several mean SF-36 subscale scores for this population reached the published age-adjusted normative levels, and RE remained at this level (Fig. 3). No significant differences were identified between scores on the SF-36 at the 3-, 6-, and 12-month postoperative testings.

Table Table 3.. Chronic Sinusitis Survey (CSS) and Medical Outcomes Study Short-form 36-Item Health Survey (SF-36): Preoperative and 12-Month Postoperative Scores (n = 108). 10
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NS = not significant at .05 level.

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Figure Fig. 3.. Mean scores on SF-36 before and 6 months after sinus surgery. Improvement in mean subscale score was significant (P < .05) for PF, RP, BP, SF, VT, and MH. RP does not reach the published mean normative value. Reprinted with permission from Gliklich and Metson. 10

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Patients demonstrated significant improvements (P < .001) on all items of the CSS (Table III and Fig. 4). The mean CSS symptom score improved 95%, the mean CSS medication score improved 36%, and the mean CSS total score improved 58%. The average change in the total CSS score was 22.5 points. A change in CSS score of 8 points requires a 50% reduction in the duration of symptom or medication usage. We used an increase of 8 points or more to indicate clinical improvement. On the basis of this definition, 82% of patients improved, 11% worsened, and 7% remained unchanged 12 months after sinus surgery. 10

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Figure Fig. 4.. Mean scores for Chronic Sinusitis Survey (CSS). Changes between all preoperative and postoperative scores were significant (P < .0001). No significant differences were found between 3- and 6-month postoperative scores. Mean level for each subscale in normal population is shown (N). Reprinted with permission from Gliklich and Metson. 10

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We have collected normative data for the CSS in patients with no history of nasal or sinus disease. 10 The mean normative score is 89.7, and the interquartile range (25th to 75th percentile) is 83.3 to 100. Before surgery none of the patients in the sinusitis study group was at or above the mean normative score, and only 1 patient was within the interquartile range. After surgery 14 (13%) patients had scores within the normative interquartile range. No significant differences in CSS scores were measured at the 3-, 6-, and 12-month postoperative intervals.

Endoscopic surgery for frontal rhinosinusitis resulted in significant improvements in both sinusitis-specific and general health status. 11 The CSS symptoms scores improved 37% 1 year after surgery. The CSS medication scores improved by 25%, indicating a significant reduction in the use of medications after surgery. These improvements are less than those previously reported for surgery of the ethmoid, maxillary, and sphenoid sinuses, 10,12 confirming clinical suspicion that disease of the frontal sinus is more refractory to therapy than that of the other paranasal sinuses. Nevertheless, the improvements seen in this cohort of patients with frontal sinusitis are both statistically and clinically significant (P < .05).

COMMENTS

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY

Quality of life measures are a relatively new tool for the evaluation of treatment efficacy. Information obtained from disease-specific and general health surveys provides valuable insight into a patient's well being and ability to function in society. Such measures are particularly applicable in diseases such as chronic sinusitis, in which a patient's poor QOL, as demonstrated through symptom severity and prolonged medication usage, often leads to the decision to proceed with surgical intervention. Therefore such information allows health care providers to better inform their patients about the implications of treatment choices.

For these reasons, health-related QOL must be considered an important outcome in evaluation of the efficacy of sinus surgery. In this study 82% of patients who underwent surgery for chronic sinusitis demonstrated statistically significant clinical improvement in their sinusitis-specific health status on the CSS. This information, however, is incomplete as a QOL measurement without concurrent measurement of general health assessment. The SF-36 evaluates global patient function and provides a means to examine the relative impact of comorbidities. It also allows for identification of potential benefits or trade-offs in well being between treatments that may otherwise appear equally efficacious by the sinusitis-specific measure.

It has been shown that general health status in selected patients with chronic sinusitis is poor relative to the status in normative populations. This study demonstrated significant improvement in six of eight general health categories 12 months after sinus surgery. The greatest improvement was seen in the score for physical role functioning, which describes limitations with work or other daily activities as a result of physical health. However, even when comorbidities were controlled for, this population failed to achieve the expected normative level for this subscale. In fact, the mean score for this domain places it below the reported lowest 30th percentile for the US population. Longer follow-up will be needed to determine whether further improvement in general health status lags behind sinusitis-specific status or whether these findings represent the ultimate outcome for this population.

Predictor analysis with a multiple logistic regression method demonstrated the preoperative CSS score to be most predictive for ultimate patient outcome. Interestingly, the CSS symptom and medication subscores were each independently predictive of outcome. Other clinical factors such as age, polypoid disease, septal deviation, and computed tomography stage were not found to be predictive of outcome. These findings suggest that preoperative CSS score should be considered in the future development of a staging system for chronic sinusitis.

BIBLIOGRAPHY

  1. Top of page
  2. Abstract
  3. INTRODUCTION
  4. OUTCOME INSTRUMENTS
  5. HEALTH IMPACT OF CHRONIC SINUSITIS
  6. EFFECTS OF SINUS SURGERY
  7. COMMENTS
  8. BIBLIOGRAPHY