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Impact of endoscopic sinus surgery on global health perception: An outcomes study
Impact of endoscopic sinus surgery on global health perception: An outcomes study WELBY WINSTEAD, MD, and SUSAN N. BARNETT, MSSW, Louisville, Kentucky
The Medical Outcome Study Short-Form 36-item Health Survey (SF-36) was used to prospectively assess outcomes after endoscopic sinus surgery. Our study found that chronic rhinosinusitis has a significant adverse impact on patient-perceived functional status and quality of life. Endoscopic sinus surgery resulted in statistically significant improvement in both disease-specific symptoms and patient-perceived global health status at 6 and 12 months of follow-up. The SF-36 is recommended for use as the global health monitor in outcomes evaluation for chronic rhinosinusitis. (Otolaryngol Head Neck Surg 1998;119:486-91.)
Chronic rhinosinusitis is a prevalent chronic disease and one of the most common reasons for patients seeking care from a physician.1 A recent study of physician prescribing behavior suggests that its incidence may be increasing.2 The cost to society is high in terms of use of health care resources, loss of productivity, and absenteeism from the workplace. Endoscopic sinus surgery (ESS) has become the treatment of choice for chronic sinus disease that does not respond to medical management. Numerous studies have reported clinical success after ESS; however, comparison of results is limited by the lack of uniform reporting criteria. Rice3 reported results of ESS in 100 consecutive patients with 2-year follow-up. He noted symptom resolution or improvement in 93%, but his assessment criteria were not specified. Levine4 reported resolution of symptoms in 84% of patients with chronic rhinosinusitis who were followed up for a mean of 17 months after ESS, but his outcome assessment criteria also were not specified. Kennedy5 prospectively collected radiographic and endoscopic data on patients undergoing ESS. Follow-up included detailed objective endoscopic findings and a subjective results question-
naire. Kennedy’s criteria for a successful outcome was normal endoscopic appearance of the nose and sinuses. He found no correlation between patient symptom improvement and endoscopic appearance of the sinuses after surgery. Lund et al,6 recognizing the need for standardized criteria to assess outcome, used a battery of physiologic tests and subjective sinus symptom scores. They reported a significant increase in ciliary beat frequency in the study population 3 months after surgery. They also found that the sinus symptoms most significantly improved after ESS were nasal obstruction, headache, and facial pain. In a results-oriented study that used patient-perceived improvement in sinus symptoms and overall health benefit as criteria for success, Hoffman et al7 used a self-administered questionnaire in a retrospective assessment of ESS. Sinus symptom improvement was reported in 91%, and an overall health benefit of the surgery was reported in 88%. Gliklich and Metson8 used the Medical Outcome Study (MOS) Short-form 36-item Health Survey (SF-36) to assess the impact of chronic rhinosinusitis on overall function and well-being in patients referred for otolaryngologic care. They found that patient-perceived well-being or quality of life was adversely affected by chronic rhinosinusitis far more than previously appreciated. Their results demonstrate that chronic rhinosinusitis affects health in a more global manner than indicated by a traditional sinus symptom monitor alone. They conclude that an accurate assessment of patient outcome after ESS requires the traditional sinus symptom monitor, as well as an overall or global health assessment.9 Hoffman et al10 used a portfolio of monitors, including the SF-36, to study patient outcomes after surgical treatment for chronic rhinosinusitis. Their study demonstrated that data collection for outcomes assessment can be easily and economically integrated into community-based practices. OBJECTIVES
From the Division of Otolaryngology–Head and Neck Surgery, University of Louisville School of Medicine. Reprint requests: Welby Winstead, MD, Division of Otolaryngology– Head and Neck Surgery, University of Louisville School of Medicine, Myers Hall, Louisville, KY 40292. Copyright © 1998 by the American Academy of Otolaryngology– Head and Neck Surgery Foundation, Inc. 0194-5998/98/$5.00 + 0 23/1/86476 486
The primary purpose of this study was to assess outcome after ESS from the perspective of patient-perceived quality of life. We prospectively administered SF-36 to patients with chronic rhinosinusitis scheduled to undergo ESS. The SF-36 was developed as a practical tool for monitoring patient outcomes in a clinical setting.11 Large population studies have documented
Otolaryngology– Head and Neck Surgery Volume 119 Number 5
that it provides reproducible, valid, reliable data on global health perceptions, overall function, and quality of life.12,13 It is brief, easy to use, and can be selfadministered. The SF-36 measures 8 dimensions or subscales of general health shown in Table 1. Our secondary objective was to determine whether the SF-36 was suitable for routine use as a global health monitor in clinical practice. Adoption of standardized tools for outcomes evaluation would allow critical evaluation of the medical literature and comparison of therapeutic modalities so that we can provide patients and payers with objective information on the effectiveness of different treatment options. METHODS The population for this study included consecutive patients seen in the senior author’s (W.W.) practice during the enrollment period of December 1993 through December 1995 who were scheduled to undergo ESS. All subjects had medically unresponsive chronic rhinosinusitis, which was defined as more than 3 months of facial pressure, pain, headache, or recurring episodes of acute rhinosinusitis associated with abnormalities on CT and/or nasal endoscopic examination. When these diagnostic criteria were met, surgery was presented to the patient as a treatment option to consider if symptoms were severe, failed to respond to medical management to their satisfaction, and were having a major impact on quality of life and/or productivity. This approach allowed the patient to play a major role in the decision to proceed with surgical intervention. Excluded from the study were individuals with cystic fibrosis and those undergoing ESS for drainage of subperiosteal orbital abscess, repair of cerebrospinal fluid fistulas, or excision of inverted papilloma. All subjects had comprehensive nasal endoscopy and coronal, high-resolution CT scans. Every effort was made to scan subjects after adequate medical treatment and a reasonable interval free of acute exacerbation. Radiologic and clinical staging of the extent of disease was performed. All surgical procedures were performed on an outpatient basis with patients under general anesthesia. Surgical technique in all patients was uniform with strict adherence to the functional concepts of Stammberger.14 Dissection was limited to deformities and anatomic variations that resulted in mucosal impaction or ostial occlusion. The middle turbinate was preserved intact except in those patients with concha bullosa, in whom the lateral lamella was resected. Maxillary sinus endoscopy was rarely performed; antral disease was addressed, to the extent possible, by creating and enlarging a middle meatal antrostomy. Septal surgery was performed when needed for endoscopic access to the ethmoid, in the presence of symptomatic airway obstruction or an impacted spur. By rigorously avoiding aspirin and other nonsteroidal antiinflammatory drugs for 3 weeks before surgery, patients
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Table 1. SF-36 subscales of global health Subscale
Abbreviation
Physical functioning
PF
Role physical
RP
Bodily pain
BP
Social functioning
SF
Mental health
MH
Role emotional
RE
Vitality General health perception
VT GH
Definition
Problems performing all physical activities including bathing or dressing Problems with work or other daily activities as a result of physical health Intensity of body pain or limitation because of body pain Interference with normal social activities because of physical or emotional problems Problems with psychological stress or temperament Problems with work or other daily activities as a result of emotional problems Level of energy Perception of current health and health outlook
rarely required nasal packing after surgery. We did not routinely use any splints or stents after surgery. Prophylactic antibiotics were given for 10 days after surgery, and frequent debridements were routinely performed. There were no orbital or central nervous system complications during the course of this study, and no patients required transfusion. Consent was obtained from study subjects to complete the SF-36 as part of a portfolio of monitors used to assess patient outcomes. Demographic data and a detailed history regarding health conditions were also obtained. The Technology of Patient Experience (TyPE) specification form developed by the Health Outcomes Institute (Bloomington, MN) was used to assess sinus-specific symptoms. All data were collected through a self-administered format. Enrollment questionnaires were collected when the patient returned for the first postoperative debridement. Follow-up surveys were mailed with a self-addressed envelope 6 and 12 months after surgery. The follow-up survey included both the SF-36 and the sinusspecific symptom questionnaire. We modified the 6-month, sinus-specific symptom TyPE questionnaire to reflect the interval “since your sinus surgery” and the 12-month questionnaire “in the past 6 months” from the preoperative instrument, which assessed symptoms during “the 8 weeks prior to seeking medical help.” The extent of disease was staged for each subject by use of the preoperative CT scan. We used the staging system recommended by Kennedy,5 in which stage I includes anatomic abnormalities, all unilateral sinus disease and bilateral disease limited to the ethmoid sinuses; stage II is bilateral ethmoid disease with involvement of 1 dependent sinus; stage III is bilateral ethmoid disease with involvement of 2 or more dependent sinuses on each side; and stage IV is diffuse
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Fig 1. Mean sinus-specific symptom scores before and 6 and 12 months after ESS.
Fig 2. Mean SF-36 subscale standard scores for rhinosinusitis subjects before and 6 and 12 months after ESS. Mean score for the general population is set at zero for each subscale.
sinonasal polyposis. The type and extent of the surgical procedure performed and postoperative complications were recorded for each subject. All data were stored in a relational database and transferred to the Statistical Package for the Social Science for analysis. SF-36 scores were tabulated according to published algorithms for comparison with US general population normative data, available from the Medical Outcomes Trust (Boston, MA). Statistical significance (P < 0.05) was determined by comparison of the study group preoperative subscale mean scores with the 95% confidence interval of the corresponding MOS subscale scores. Preoperative mean scores were compared with 6- and 12-month postoperative scores by 2-tailed paired Student’s t tests. Analysis of variance (ANOVA) was used to study CT stage and comorbidity as predictors of SF-36 scores and clinical outcomes. RESULTS
During the study period 125 of 143 eligible patients were enrolled. Follow-up data were available for 84 patients at 6 months and 43 at 12 months. The mean age
Otolaryngology– Head and Neck Surgery November 1998
of the study population was 34 years (range 8 to 63 years). The population was 35% male and 65% female. Previous sinus surgery was reported by 17% of the population. Allergy was reported by 76%, asthma 18%, depression 22%, and diabetes mellitus 1.5%. Current or former tobacco use was reported by 37% of the subjects. The average duration of sinus problems was 4.2 years, with 60% of the subjects reporting symptoms for 7 or more years. The most frequently reported symptoms were headache, facial pain, pressure, 98%; nasal congestion, 90%; significant post nasal discharge, 87%; sinus infection, 81%; nasal obstruction, 81%; and toothache, 55%. Radiologic staging based on extent of disease showed a distribution of stage I, 23%; stage II, 26%; stage III, 43%; and stage IV, 7%. Concha bullosa was present in 18% of the subjects. Concomitant septal surgery, performed in 41% of the subjects, was frequently limited to endoscopic removal of an impacted spur. The extent of disease required sphenoidotomy in only 12% of the subjects. Preoperative and 6- and 12-month postoperative mean scores from the sinus-specific symptom monitor are shown in Fig 1. There was a statistically significant (P < 0.05) improvement in sinus-specific symptoms 6 months after surgery, with an additional degree of improvement found at 12 months after surgery. Preoperative mean SF-36 subscale scores and standard deviations for the study group and corresponding normative values for the general population from the MOS are presented in Table 2. Statistically significant (P < 0.05) differences between patients with rhinosinusitis and the general population were found for all subscales except physical functioning. The greatest health impacts of chronic rhinosinusitis were in the domains of role physical, bodily pain, social functioning, and vitality. Table 3 presents SF-36 subscale scores and standard deviations for the study group before and 6 and 12 months after surgery. These data are presented as standard scores in Fig 2. Standard scores were calculated by dividing the difference between the scores for each subscale in the study group and those of the general population by the standard deviation of the general population, according to the methods of Garratt et al13 Statistically significant (P < 0.05) improvement in mean scores was found at both the 6- and 12-month follow-ups for all subscales. The SF-36 subscale’s mean scores 6 and 12 months after ESS did not deviate significantly from corresponding values from the general population. ANOVA demonstrated that the presence of asthma or allergy had an adverse impact on vitality and general health perception compared with rhinosinusitis alone.
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Fig 3. ANOVA of mean SF-36 subscale standard scores according to CT stage. Mean score for the general population is set at zero for each subscale. Results are shown for before and 6 and 12 months after ESS.
However, subjects with these comorbidities had no statistically significant differences in postoperative SF-36 scores from those with rhinosinusitis alone. ANOVA in SF-36 scores based on CT staging is shown in Fig 3. Preoperative data demonstrated a trend toward lower scores for patients with stage IV disease. At 6 months after surgery no statistically significant difference was found between subjects with stage I, II, or III disease and MOS population norms. In contrast, 6-month postoperative scores for stage IV subjects had variance from MOS norms that was statistically significant (P < 0.05) in the domains of role physical, general health perception, vitality, bodily pain, and social functioning. At 12 months stage IV data showed overall improvement in subscale scores with the exception of general health perception, which remained significantly depressed. DISCUSSION
A large volume of literature deals with treatment success and clinical outcome after ESS for chronic rhinosinusitis. The lack of uniform criteria for defining a successful outcome makes critical comparison of results difficult. Postoperative success has been based on pathologic observations made on endoscopy or CT scans, physiologic measures, patient symptoms, or a combination of these criteria made at varying time intervals. Chronic rhinosinusitis is a complex multifactorial disease or group of diseases that have similar clinical symptoms. Current understanding suggests that ostiomeatal obstruction is an important, but not the only, etiologic factor. Nonobstructive mechanisms, not generally thought to be affected by surgical intervention, are oper-
ative to some degree in most patients. The relative contribution to disease by nonobstructive mechanisms such as allergy and other immune system diseases, genetic predisposition, mucosal sensitivities to environmental pollutants, neurogenic inflammation, and other poorly understood processes cannot be quantified with currently available diagnostic techniques. Until we have a better understanding of these nonobstructive mechanisms, control rather than cure of this complex multifactorial disease may be all that can reasonably be expected from a surgical procedure designed to relieve ostial occlusion and mucosal impaction. Given these limitations, a realistic treatment goal may be the reduction or elimination of symptoms to the extent that they interfere little if any with function and quality of life of the patient. In this study the SF-36 was administered before and at intervals after ESS to assess outcome from the functional status and quality-of-life perspective. The preoperative mean SF-36 scores in this study were significantly (P < 0.05) lower for all domains of global health except physical functioning. Chronic rhinosinusitis had its greatest adverse impact in the domains of role physical, bodily pain, social functioning, and vitality. Our findings confirm those reported by Gliklich and Metson,8 who also found significant decrements in multiple domains of global health among rhinosinusitis patients. This substantial impact on patient-perceived functional status and quality of life illustrates the importance of assessing global health status in outcome studies for chronic rhinosinusitis. After ESS, our study subjects had statistically significant (P < 0.05) improvement in sinus-specific symptom scores. The degree of improvement in sinus symp-
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Table 2. Preoperative SF-36 subscale scores for rhinosinusitis: Subjects versus MOS population norms Preoperative scores (n = 125) SF-36 subscale
Mean
Physical functioning Role physical Bodily pain Social functioning Mental health Role emotional Vitality General health perception
82.78 43.5* 53.92* 65.42* 64.19* 65.35* 45.39* 61.47*
MOS norms (n = 2474)
SD
Mean
SD
22.02 43.94 25.03 28.09 21.41 42.66 23.78 23.4
84.15 80.96 75.15 83.28 74.74 81.26 60.86 71.95
23.28 34 23.69 22.69 18.05 33.04 20.96 20.34
*Statistically significant difference (P < 0.05) from MOS norms.
Table 3. SF-36 subscale scores for rhinosinusitis subjects: Scores before surgery versus those 6 and 12 months after surgery Before (n = 125) SF-36 subscale
Physical functioning Role physical Bodily pain Social functioning Mental health Role emotional Vitality General health perception
Mean
SD
82.78 43.5 53.92 65.42 64.19 65.35 45.39 61.47
22.02 43.94 25.03 28.09 21.41 42.66 23.78 23.4
6 mo after (n = 84) Mean
90.72* 76.37* 72.98* 83.06* 76.87* 85.79* 58.95* 70.34*
SD
17.25 35.88 19.03 21.95 15.39 31.3 18.08 21.99
12 mo after (n = 43) Mean
91.18* 81.67* 73.17* 79.39* 73.75* 82.4* 56.17* 70.57*
SD
19.02 31.29 25.22 23.42 16.77 35.17 19.7 22.98
*Statistically significant difference (P < 0.05) from preoperative value.
toms seen at 6 months was well maintained at 12 months. ESS also resulted in statistically significant (P < 0.05) improvement in all SF-36 subscales of global health. Mean subscale scores at both 6 and 12 months after surgery showed no significant variance from MOS population norms. This marked improvement in perceived global health occurred despite incomplete resolution of sinus symptoms. Having suffered the extreme morbidity that often accompanies chronic rhinosinusitis, affected individuals may have a different reference standard on which their perception of health and quality of life is based. These results suggest that patients with chronic rhinosinusitis are able to live with their residual symptoms with a perceived health impact no greater than that of the general population and an effective outcome greater than that predicted by assessment of sinus symptom scores alone. ANOVA demonstrated that preoperative SF-36 data in subjects with rhinosinusitis and asthma or allergy closely paralleled data in those subjects with rhinosinusitis alone, suggesting that rhinosinusitis is the major factor responsible for decrements in global health per-
ception. Subjects with these comorbidities, not unexpectedly, have a poorer perception of their general health than those with rhinosinusitis alone. The presence of asthma or allergy did not predict a poorer outcome after ESS than that seen in subjects with rhinosinusitis alone. ANOVA in SF-36 subscale scores based on CT staging suggests a poorer prognosis after ESS in subjects with stage IV disease. The relatively small sample size for the dependent variables in our 12-month data leaves the prognostic value of CT staging open to further study. Our initial experience supports preliminary adoption of the SF-36 as the global health monitor in outcomes evaluation for chronic rhinosinusitis. It provides reproducible, valid, objective data concerning functional status and quality of life, the dimensions of health most valued by patients and payers. We found the SF-36 to be acceptable to patients and easy to use. The self-administered questionnaire, distributed by medical assistants, had little impact on office flow or physician time, suggesting suitability for community-based practices. The SF-36 is a practical first step to establish health out-
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comes assessment as a routine part of the care of the rhinosinusitis patient. Recognizing the need to track and evaluate health outcomes routinely, the American Academy of Otolaryngology–Head and Neck Surgery is currently developing services to assist its membership in the management and analysis of outcomes data (Personal communication, June 4, 1997). To be accurate and comprehensive, outcomes evaluation should include the SF-36 used in conjunction with a disease-specific symptom monitor, and clinical and radiographic staging systems, all tracked at appropriate intervals after various interventions. Current research is focused on the development of a comprehensive sinusspecific symptom questionnaire that monitors sinusrelated problems including olfactory dysfunction and primary headache syndromes such as migraine. Efforts are also under way to come to consensus regarding clinical and radiographic staging systems and to determine the most appropriate intervals for outcomes assessment. Adoption of a uniform set of measurement techniques to accurately assess outcomes would enable meaningful comparison of results of different treatment modalities, identification of variables affecting treatment success, and refinements in patient selection criteria. Once outcomes evaluation is established as a routine part of patient care, data can be pooled and analyzed for clues that may result in improved diagnostic accuracy and a better understanding of the pathophysiologic mechanisms causing chronic rhinosinusitis. The data generated would also enable us to meet the challenge of today’s cost-conscious health care environment for objective information regarding the result of medical interventions in terms of relative cost, safety, effectiveness, and the quality of life that they provide. CONCLUSION
This outcomes study found that ESS is safe and effective in medically unresponsive chronic rhinosinusitis. Statistically significant improvements in both sinus-specific symptoms and global health perceptions were reported by subjects 6 and 12 months after surgery. We believe that a uniform set of measurement techniques to assess outcomes after ESS should be adopted and applied widely. Outcomes evaluation should include
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interval measurement of disease-specific symptoms as well as global health perceptions in conjunction with clinical and radiographic staging. Our initial experience supports adoption of the SF-36 for use as the global health monitor in outcomes evaluation for chronic rhinosinusitis. Widespread use of standardized instruments for outcomes evaluation would allow critical analysis of the literature, enable objective documentation of the effectiveness of treatment, and generate more accurate prognostic information for patients and payers. Special thanks to Sanford R. Hoffman, MD, whose advice and encouragement were invaluable in the design of this study. REFERENCES 1. Benson V, Marano MA. Current estimates from the National Health Interview Survey. Vital Health Stat 10 1994;189:1-269. 2. McCaig LF, Hughes JM. Antimicrobial drug prescribing by U.S. physicians. JAMA 1995;273:214-9. 3. Rice DH. Endoscopic sinus surgery: results at 2-year followup. Otolaryngol Head Neck Surg 1989;101:476-9. 4. Levine HL. Functional endoscopic sinus surgery: evaluation, surgery, and follow-up of 250 patients. Laryngoscope 1990;100: 79-84. 5. Kennedy DW. Prognostic factors, outcomes and staging in ethmoid sinus surgery. Laryngoscope 1992;102(Suppl 57):1-18. 6. Lund VJ, Holmstrom M, Scadding GK. Functional endoscopic sinus surgery in the management of chronic rhinosinusitis. An objective assessment. J Laryngol Otol 1991;105:832-5. 7. Hoffman SR, Dersarkissian RM, Buck SH, et al. Sinus disease and surgical treatment: a results oriented quality assurance study. Otolaryngol Head Neck Surg 1989;100:573-7. 8. Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg 1995;113:104-9. 9. Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope 1995;105:387-90. 10. Hoffman SR, Mahoney MC, Chmiel JF, et al. Conducting outcomes research in a community-based practice setting. Am J Rhinol 1994;8:193-200. 11. Ware JE, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83. 12. Brazier JE, Harper R, Jones NMB, et al. Validating the SF-36 Health Survey Questionnaire: new outcome measure for primary care. BMJ 1992;305:160-4. 13. Garratt AM, Ruta DA, Abdalla MI, et al. The SF-36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ 1993;306:1440-4. 14. Stammberger H. Endoscopic endonasal surgery—concepts in treatment of recurring rhinosinusitis. Part II. Surgical Technique. Otolaryngol Head Neck Surg 1986;94:147-56.
The Medical Outcome Study Short-Form 36-item Health Survey (SF-36) was used to prospectively assess outcomes after endoscopic sinus surgery. Our study found that chronic rhinosinusitis has a significant adverse impact on patient-perceived functional status and quality of life. Endoscopic sinus surgery resulted in statistically significant improvement in both disease-specific symptoms and patient-perceived global health status at 6 and 12 months of follow-up. The SF-36 is recommended for use as the global health monitor in outcomes evaluation for chronic rhinosinusitis. (Otolaryngol Head Neck Surg 1998;119:486-91.)
Chronic rhinosinusitis is a prevalent chronic disease and one of the most common reasons for patients seeking care from a physician.1 A recent study of physician prescribing behavior suggests that its incidence may be increasing.2 The cost to society is high in terms of use of health care resources, loss of productivity, and absenteeism from the workplace. Endoscopic sinus surgery (ESS) has become the treatment of choice for chronic sinus disease that does not respond to medical management. Numerous studies have reported clinical success after ESS; however, comparison of results is limited by the lack of uniform reporting criteria. Rice3 reported results of ESS in 100 consecutive patients with 2-year follow-up. He noted symptom resolution or improvement in 93%, but his assessment criteria were not specified. Levine4 reported resolution of symptoms in 84% of patients with chronic rhinosinusitis who were followed up for a mean of 17 months after ESS, but his outcome assessment criteria also were not specified. Kennedy5 prospectively collected radiographic and endoscopic data on patients undergoing ESS. Follow-up included detailed objective endoscopic findings and a subjective results question-
naire. Kennedy’s criteria for a successful outcome was normal endoscopic appearance of the nose and sinuses. He found no correlation between patient symptom improvement and endoscopic appearance of the sinuses after surgery. Lund et al,6 recognizing the need for standardized criteria to assess outcome, used a battery of physiologic tests and subjective sinus symptom scores. They reported a significant increase in ciliary beat frequency in the study population 3 months after surgery. They also found that the sinus symptoms most significantly improved after ESS were nasal obstruction, headache, and facial pain. In a results-oriented study that used patient-perceived improvement in sinus symptoms and overall health benefit as criteria for success, Hoffman et al7 used a self-administered questionnaire in a retrospective assessment of ESS. Sinus symptom improvement was reported in 91%, and an overall health benefit of the surgery was reported in 88%. Gliklich and Metson8 used the Medical Outcome Study (MOS) Short-form 36-item Health Survey (SF-36) to assess the impact of chronic rhinosinusitis on overall function and well-being in patients referred for otolaryngologic care. They found that patient-perceived well-being or quality of life was adversely affected by chronic rhinosinusitis far more than previously appreciated. Their results demonstrate that chronic rhinosinusitis affects health in a more global manner than indicated by a traditional sinus symptom monitor alone. They conclude that an accurate assessment of patient outcome after ESS requires the traditional sinus symptom monitor, as well as an overall or global health assessment.9 Hoffman et al10 used a portfolio of monitors, including the SF-36, to study patient outcomes after surgical treatment for chronic rhinosinusitis. Their study demonstrated that data collection for outcomes assessment can be easily and economically integrated into community-based practices. OBJECTIVES
From the Division of Otolaryngology–Head and Neck Surgery, University of Louisville School of Medicine. Reprint requests: Welby Winstead, MD, Division of Otolaryngology– Head and Neck Surgery, University of Louisville School of Medicine, Myers Hall, Louisville, KY 40292. Copyright © 1998 by the American Academy of Otolaryngology– Head and Neck Surgery Foundation, Inc. 0194-5998/98/$5.00 + 0 23/1/86476 486
The primary purpose of this study was to assess outcome after ESS from the perspective of patient-perceived quality of life. We prospectively administered SF-36 to patients with chronic rhinosinusitis scheduled to undergo ESS. The SF-36 was developed as a practical tool for monitoring patient outcomes in a clinical setting.11 Large population studies have documented
Otolaryngology– Head and Neck Surgery Volume 119 Number 5
that it provides reproducible, valid, reliable data on global health perceptions, overall function, and quality of life.12,13 It is brief, easy to use, and can be selfadministered. The SF-36 measures 8 dimensions or subscales of general health shown in Table 1. Our secondary objective was to determine whether the SF-36 was suitable for routine use as a global health monitor in clinical practice. Adoption of standardized tools for outcomes evaluation would allow critical evaluation of the medical literature and comparison of therapeutic modalities so that we can provide patients and payers with objective information on the effectiveness of different treatment options. METHODS The population for this study included consecutive patients seen in the senior author’s (W.W.) practice during the enrollment period of December 1993 through December 1995 who were scheduled to undergo ESS. All subjects had medically unresponsive chronic rhinosinusitis, which was defined as more than 3 months of facial pressure, pain, headache, or recurring episodes of acute rhinosinusitis associated with abnormalities on CT and/or nasal endoscopic examination. When these diagnostic criteria were met, surgery was presented to the patient as a treatment option to consider if symptoms were severe, failed to respond to medical management to their satisfaction, and were having a major impact on quality of life and/or productivity. This approach allowed the patient to play a major role in the decision to proceed with surgical intervention. Excluded from the study were individuals with cystic fibrosis and those undergoing ESS for drainage of subperiosteal orbital abscess, repair of cerebrospinal fluid fistulas, or excision of inverted papilloma. All subjects had comprehensive nasal endoscopy and coronal, high-resolution CT scans. Every effort was made to scan subjects after adequate medical treatment and a reasonable interval free of acute exacerbation. Radiologic and clinical staging of the extent of disease was performed. All surgical procedures were performed on an outpatient basis with patients under general anesthesia. Surgical technique in all patients was uniform with strict adherence to the functional concepts of Stammberger.14 Dissection was limited to deformities and anatomic variations that resulted in mucosal impaction or ostial occlusion. The middle turbinate was preserved intact except in those patients with concha bullosa, in whom the lateral lamella was resected. Maxillary sinus endoscopy was rarely performed; antral disease was addressed, to the extent possible, by creating and enlarging a middle meatal antrostomy. Septal surgery was performed when needed for endoscopic access to the ethmoid, in the presence of symptomatic airway obstruction or an impacted spur. By rigorously avoiding aspirin and other nonsteroidal antiinflammatory drugs for 3 weeks before surgery, patients
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Table 1. SF-36 subscales of global health Subscale
Abbreviation
Physical functioning
PF
Role physical
RP
Bodily pain
BP
Social functioning
SF
Mental health
MH
Role emotional
RE
Vitality General health perception
VT GH
Definition
Problems performing all physical activities including bathing or dressing Problems with work or other daily activities as a result of physical health Intensity of body pain or limitation because of body pain Interference with normal social activities because of physical or emotional problems Problems with psychological stress or temperament Problems with work or other daily activities as a result of emotional problems Level of energy Perception of current health and health outlook
rarely required nasal packing after surgery. We did not routinely use any splints or stents after surgery. Prophylactic antibiotics were given for 10 days after surgery, and frequent debridements were routinely performed. There were no orbital or central nervous system complications during the course of this study, and no patients required transfusion. Consent was obtained from study subjects to complete the SF-36 as part of a portfolio of monitors used to assess patient outcomes. Demographic data and a detailed history regarding health conditions were also obtained. The Technology of Patient Experience (TyPE) specification form developed by the Health Outcomes Institute (Bloomington, MN) was used to assess sinus-specific symptoms. All data were collected through a self-administered format. Enrollment questionnaires were collected when the patient returned for the first postoperative debridement. Follow-up surveys were mailed with a self-addressed envelope 6 and 12 months after surgery. The follow-up survey included both the SF-36 and the sinusspecific symptom questionnaire. We modified the 6-month, sinus-specific symptom TyPE questionnaire to reflect the interval “since your sinus surgery” and the 12-month questionnaire “in the past 6 months” from the preoperative instrument, which assessed symptoms during “the 8 weeks prior to seeking medical help.” The extent of disease was staged for each subject by use of the preoperative CT scan. We used the staging system recommended by Kennedy,5 in which stage I includes anatomic abnormalities, all unilateral sinus disease and bilateral disease limited to the ethmoid sinuses; stage II is bilateral ethmoid disease with involvement of 1 dependent sinus; stage III is bilateral ethmoid disease with involvement of 2 or more dependent sinuses on each side; and stage IV is diffuse
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Fig 1. Mean sinus-specific symptom scores before and 6 and 12 months after ESS.
Fig 2. Mean SF-36 subscale standard scores for rhinosinusitis subjects before and 6 and 12 months after ESS. Mean score for the general population is set at zero for each subscale.
sinonasal polyposis. The type and extent of the surgical procedure performed and postoperative complications were recorded for each subject. All data were stored in a relational database and transferred to the Statistical Package for the Social Science for analysis. SF-36 scores were tabulated according to published algorithms for comparison with US general population normative data, available from the Medical Outcomes Trust (Boston, MA). Statistical significance (P < 0.05) was determined by comparison of the study group preoperative subscale mean scores with the 95% confidence interval of the corresponding MOS subscale scores. Preoperative mean scores were compared with 6- and 12-month postoperative scores by 2-tailed paired Student’s t tests. Analysis of variance (ANOVA) was used to study CT stage and comorbidity as predictors of SF-36 scores and clinical outcomes. RESULTS
During the study period 125 of 143 eligible patients were enrolled. Follow-up data were available for 84 patients at 6 months and 43 at 12 months. The mean age
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of the study population was 34 years (range 8 to 63 years). The population was 35% male and 65% female. Previous sinus surgery was reported by 17% of the population. Allergy was reported by 76%, asthma 18%, depression 22%, and diabetes mellitus 1.5%. Current or former tobacco use was reported by 37% of the subjects. The average duration of sinus problems was 4.2 years, with 60% of the subjects reporting symptoms for 7 or more years. The most frequently reported symptoms were headache, facial pain, pressure, 98%; nasal congestion, 90%; significant post nasal discharge, 87%; sinus infection, 81%; nasal obstruction, 81%; and toothache, 55%. Radiologic staging based on extent of disease showed a distribution of stage I, 23%; stage II, 26%; stage III, 43%; and stage IV, 7%. Concha bullosa was present in 18% of the subjects. Concomitant septal surgery, performed in 41% of the subjects, was frequently limited to endoscopic removal of an impacted spur. The extent of disease required sphenoidotomy in only 12% of the subjects. Preoperative and 6- and 12-month postoperative mean scores from the sinus-specific symptom monitor are shown in Fig 1. There was a statistically significant (P < 0.05) improvement in sinus-specific symptoms 6 months after surgery, with an additional degree of improvement found at 12 months after surgery. Preoperative mean SF-36 subscale scores and standard deviations for the study group and corresponding normative values for the general population from the MOS are presented in Table 2. Statistically significant (P < 0.05) differences between patients with rhinosinusitis and the general population were found for all subscales except physical functioning. The greatest health impacts of chronic rhinosinusitis were in the domains of role physical, bodily pain, social functioning, and vitality. Table 3 presents SF-36 subscale scores and standard deviations for the study group before and 6 and 12 months after surgery. These data are presented as standard scores in Fig 2. Standard scores were calculated by dividing the difference between the scores for each subscale in the study group and those of the general population by the standard deviation of the general population, according to the methods of Garratt et al13 Statistically significant (P < 0.05) improvement in mean scores was found at both the 6- and 12-month follow-ups for all subscales. The SF-36 subscale’s mean scores 6 and 12 months after ESS did not deviate significantly from corresponding values from the general population. ANOVA demonstrated that the presence of asthma or allergy had an adverse impact on vitality and general health perception compared with rhinosinusitis alone.
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Fig 3. ANOVA of mean SF-36 subscale standard scores according to CT stage. Mean score for the general population is set at zero for each subscale. Results are shown for before and 6 and 12 months after ESS.
However, subjects with these comorbidities had no statistically significant differences in postoperative SF-36 scores from those with rhinosinusitis alone. ANOVA in SF-36 scores based on CT staging is shown in Fig 3. Preoperative data demonstrated a trend toward lower scores for patients with stage IV disease. At 6 months after surgery no statistically significant difference was found between subjects with stage I, II, or III disease and MOS population norms. In contrast, 6-month postoperative scores for stage IV subjects had variance from MOS norms that was statistically significant (P < 0.05) in the domains of role physical, general health perception, vitality, bodily pain, and social functioning. At 12 months stage IV data showed overall improvement in subscale scores with the exception of general health perception, which remained significantly depressed. DISCUSSION
A large volume of literature deals with treatment success and clinical outcome after ESS for chronic rhinosinusitis. The lack of uniform criteria for defining a successful outcome makes critical comparison of results difficult. Postoperative success has been based on pathologic observations made on endoscopy or CT scans, physiologic measures, patient symptoms, or a combination of these criteria made at varying time intervals. Chronic rhinosinusitis is a complex multifactorial disease or group of diseases that have similar clinical symptoms. Current understanding suggests that ostiomeatal obstruction is an important, but not the only, etiologic factor. Nonobstructive mechanisms, not generally thought to be affected by surgical intervention, are oper-
ative to some degree in most patients. The relative contribution to disease by nonobstructive mechanisms such as allergy and other immune system diseases, genetic predisposition, mucosal sensitivities to environmental pollutants, neurogenic inflammation, and other poorly understood processes cannot be quantified with currently available diagnostic techniques. Until we have a better understanding of these nonobstructive mechanisms, control rather than cure of this complex multifactorial disease may be all that can reasonably be expected from a surgical procedure designed to relieve ostial occlusion and mucosal impaction. Given these limitations, a realistic treatment goal may be the reduction or elimination of symptoms to the extent that they interfere little if any with function and quality of life of the patient. In this study the SF-36 was administered before and at intervals after ESS to assess outcome from the functional status and quality-of-life perspective. The preoperative mean SF-36 scores in this study were significantly (P < 0.05) lower for all domains of global health except physical functioning. Chronic rhinosinusitis had its greatest adverse impact in the domains of role physical, bodily pain, social functioning, and vitality. Our findings confirm those reported by Gliklich and Metson,8 who also found significant decrements in multiple domains of global health among rhinosinusitis patients. This substantial impact on patient-perceived functional status and quality of life illustrates the importance of assessing global health status in outcome studies for chronic rhinosinusitis. After ESS, our study subjects had statistically significant (P < 0.05) improvement in sinus-specific symptom scores. The degree of improvement in sinus symp-
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Table 2. Preoperative SF-36 subscale scores for rhinosinusitis: Subjects versus MOS population norms Preoperative scores (n = 125) SF-36 subscale
Mean
Physical functioning Role physical Bodily pain Social functioning Mental health Role emotional Vitality General health perception
82.78 43.5* 53.92* 65.42* 64.19* 65.35* 45.39* 61.47*
MOS norms (n = 2474)
SD
Mean
SD
22.02 43.94 25.03 28.09 21.41 42.66 23.78 23.4
84.15 80.96 75.15 83.28 74.74 81.26 60.86 71.95
23.28 34 23.69 22.69 18.05 33.04 20.96 20.34
*Statistically significant difference (P < 0.05) from MOS norms.
Table 3. SF-36 subscale scores for rhinosinusitis subjects: Scores before surgery versus those 6 and 12 months after surgery Before (n = 125) SF-36 subscale
Physical functioning Role physical Bodily pain Social functioning Mental health Role emotional Vitality General health perception
Mean
SD
82.78 43.5 53.92 65.42 64.19 65.35 45.39 61.47
22.02 43.94 25.03 28.09 21.41 42.66 23.78 23.4
6 mo after (n = 84) Mean
90.72* 76.37* 72.98* 83.06* 76.87* 85.79* 58.95* 70.34*
SD
17.25 35.88 19.03 21.95 15.39 31.3 18.08 21.99
12 mo after (n = 43) Mean
91.18* 81.67* 73.17* 79.39* 73.75* 82.4* 56.17* 70.57*
SD
19.02 31.29 25.22 23.42 16.77 35.17 19.7 22.98
*Statistically significant difference (P < 0.05) from preoperative value.
toms seen at 6 months was well maintained at 12 months. ESS also resulted in statistically significant (P < 0.05) improvement in all SF-36 subscales of global health. Mean subscale scores at both 6 and 12 months after surgery showed no significant variance from MOS population norms. This marked improvement in perceived global health occurred despite incomplete resolution of sinus symptoms. Having suffered the extreme morbidity that often accompanies chronic rhinosinusitis, affected individuals may have a different reference standard on which their perception of health and quality of life is based. These results suggest that patients with chronic rhinosinusitis are able to live with their residual symptoms with a perceived health impact no greater than that of the general population and an effective outcome greater than that predicted by assessment of sinus symptom scores alone. ANOVA demonstrated that preoperative SF-36 data in subjects with rhinosinusitis and asthma or allergy closely paralleled data in those subjects with rhinosinusitis alone, suggesting that rhinosinusitis is the major factor responsible for decrements in global health per-
ception. Subjects with these comorbidities, not unexpectedly, have a poorer perception of their general health than those with rhinosinusitis alone. The presence of asthma or allergy did not predict a poorer outcome after ESS than that seen in subjects with rhinosinusitis alone. ANOVA in SF-36 subscale scores based on CT staging suggests a poorer prognosis after ESS in subjects with stage IV disease. The relatively small sample size for the dependent variables in our 12-month data leaves the prognostic value of CT staging open to further study. Our initial experience supports preliminary adoption of the SF-36 as the global health monitor in outcomes evaluation for chronic rhinosinusitis. It provides reproducible, valid, objective data concerning functional status and quality of life, the dimensions of health most valued by patients and payers. We found the SF-36 to be acceptable to patients and easy to use. The self-administered questionnaire, distributed by medical assistants, had little impact on office flow or physician time, suggesting suitability for community-based practices. The SF-36 is a practical first step to establish health out-
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comes assessment as a routine part of the care of the rhinosinusitis patient. Recognizing the need to track and evaluate health outcomes routinely, the American Academy of Otolaryngology–Head and Neck Surgery is currently developing services to assist its membership in the management and analysis of outcomes data (Personal communication, June 4, 1997). To be accurate and comprehensive, outcomes evaluation should include the SF-36 used in conjunction with a disease-specific symptom monitor, and clinical and radiographic staging systems, all tracked at appropriate intervals after various interventions. Current research is focused on the development of a comprehensive sinusspecific symptom questionnaire that monitors sinusrelated problems including olfactory dysfunction and primary headache syndromes such as migraine. Efforts are also under way to come to consensus regarding clinical and radiographic staging systems and to determine the most appropriate intervals for outcomes assessment. Adoption of a uniform set of measurement techniques to accurately assess outcomes would enable meaningful comparison of results of different treatment modalities, identification of variables affecting treatment success, and refinements in patient selection criteria. Once outcomes evaluation is established as a routine part of patient care, data can be pooled and analyzed for clues that may result in improved diagnostic accuracy and a better understanding of the pathophysiologic mechanisms causing chronic rhinosinusitis. The data generated would also enable us to meet the challenge of today’s cost-conscious health care environment for objective information regarding the result of medical interventions in terms of relative cost, safety, effectiveness, and the quality of life that they provide. CONCLUSION
This outcomes study found that ESS is safe and effective in medically unresponsive chronic rhinosinusitis. Statistically significant improvements in both sinus-specific symptoms and global health perceptions were reported by subjects 6 and 12 months after surgery. We believe that a uniform set of measurement techniques to assess outcomes after ESS should be adopted and applied widely. Outcomes evaluation should include
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interval measurement of disease-specific symptoms as well as global health perceptions in conjunction with clinical and radiographic staging. Our initial experience supports adoption of the SF-36 for use as the global health monitor in outcomes evaluation for chronic rhinosinusitis. Widespread use of standardized instruments for outcomes evaluation would allow critical analysis of the literature, enable objective documentation of the effectiveness of treatment, and generate more accurate prognostic information for patients and payers. Special thanks to Sanford R. Hoffman, MD, whose advice and encouragement were invaluable in the design of this study. REFERENCES 1. Benson V, Marano MA. Current estimates from the National Health Interview Survey. Vital Health Stat 10 1994;189:1-269. 2. McCaig LF, Hughes JM. Antimicrobial drug prescribing by U.S. physicians. JAMA 1995;273:214-9. 3. Rice DH. Endoscopic sinus surgery: results at 2-year followup. Otolaryngol Head Neck Surg 1989;101:476-9. 4. Levine HL. Functional endoscopic sinus surgery: evaluation, surgery, and follow-up of 250 patients. Laryngoscope 1990;100: 79-84. 5. Kennedy DW. Prognostic factors, outcomes and staging in ethmoid sinus surgery. Laryngoscope 1992;102(Suppl 57):1-18. 6. Lund VJ, Holmstrom M, Scadding GK. Functional endoscopic sinus surgery in the management of chronic rhinosinusitis. An objective assessment. J Laryngol Otol 1991;105:832-5. 7. Hoffman SR, Dersarkissian RM, Buck SH, et al. Sinus disease and surgical treatment: a results oriented quality assurance study. Otolaryngol Head Neck Surg 1989;100:573-7. 8. Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg 1995;113:104-9. 9. Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope 1995;105:387-90. 10. Hoffman SR, Mahoney MC, Chmiel JF, et al. Conducting outcomes research in a community-based practice setting. Am J Rhinol 1994;8:193-200. 11. Ware JE, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83. 12. Brazier JE, Harper R, Jones NMB, et al. Validating the SF-36 Health Survey Questionnaire: new outcome measure for primary care. BMJ 1992;305:160-4. 13. Garratt AM, Ruta DA, Abdalla MI, et al. The SF-36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ 1993;306:1440-4. 14. Stammberger H. Endoscopic endonasal surgery—concepts in treatment of recurring rhinosinusitis. Part II. Surgical Technique. Otolaryngol Head Neck Surg 1986;94:147-56.