Richard E Gliklich

The Health Impact of Chronic Sinusitis in Patients Seeking Otolaryngologic Care

Although chronic sinusitis is an increasingly common diagnosis in the United States, the health burden of this disorder relative to the general population and to other chronic diseases has not been previously evaluated. One hundred fifty-eight patients with chronic sinusitis and no prior surgery underwent cross-sectional evaluation by use of the Medical Outcome Study Short-form 36-Item Health Survey. These patients were all referred for otolaryngologic care, and more than 80% subsequently underwent sinus surgery. Mean scores were compared from the eight subscales of general health assessment with similarly derived data for the United States general population. Significant differences (p < 0.05) were seen in several domains, including bodily pain, general health, vitality, and social functioning. Comparisons with other chronic diseases revealed significantly lower scores (p < 0.05) in measures of bodily pain and social functioning for sinusitis patients than in patients with congestive heart failure, angina, chronic obstructive pulmonary disease, and back pain. These findings suggest that the national health impact of chronic sinusitis is far greater than is currently appreciated.

EFFECT OF SINUS SURGERY ON QUALITY OF LIFE

Although sinus surgery may reduce the incidence of recurrent infection in patients with chronic sinusitis, little is known about the effect of such surgery on a patients quality of life. One hundred eight patients undergoing ethmoid sinus surgery were prospectively evaluated with statistically validated measures of sinusitis-specific and general health-related quality of life. Twelve months after surgery significant improvements were found in sinus-specific health status, including a reduction in symptoms (p < 0.001) and medication usage (p < 0.001). An overall improvement was found in 82% of patients, whereas 11% were worse, and 7% remained unchanged. Measures of general health status demonstrated preoperative decrements in five of eight subscales as compared with the normal population. Six months after surgery significant improvements were noted in six categories (p < 0.05), and most attained near-normative levels. Individuals with asthma demonstrated greater overall improvement in general health status than did other cohorts (p < 0.05). We conclude that patients with chronic sinusitis achieve large improvements in sinusitis-specific quality-of-life measures 12 months after sinus surgery, as well as improvements in general health status.

Why Observational Studies Should Be Among The Tools Used In Comparative Effectiveness Research

Doctors, patients, and other decision makers need access to the best available clinical evidence, which can come from systematic reviews, experimental trials, and observational research. Despite methodological challenges, high-quality observational studies have an important role in comparative effectiveness research because they can address issues that are otherwise difficult or impossible to study. In addition, many clinical and policy decisions do not require the very high levels of certainty provided by large, rigorous randomized trials. This paper provides insights and a framework to guide good decision making that involves the full range of high-quality comparative effectiveness research techniques, including observational research.

Validation of a Patient‐Graded Instrument for Facial Nerve Paralysis: The FaCE Scale

Objective To develop and validate a patient‐based instrument to measure both facial impairment and disability, the Facial Clinimetric Evaluation (FaCE) Scale.

A comparison of image guidance systems for sinus surgery

Objective: Intraoperative computed tomographic guidance systems are available which utilize either electromagnetic (radiofrequency) or optical (infrared) signals to localize instruments within the surgical field. The objective of this study was to compare the use of these two different image guidance technologies for sinus surgery. Study Design: Prospective cohort study. Methods: The electromagnetic‐based InstaTrak system (n = 24) and the optical‐based Stealth‐Station (n = 49) were compared in a series of 73 consecutive sinus series which utilized image guidance technology. Results: Both the electromagnetic and optical systems provided anatomic localization to within 2 mm during surgery. Intraoperative reregistration was effective in correcting for any anatomic drift. There were no intraoperative complications. Mean operative times were 156.3 ± 8.9 minutes for the electromagnetic and 139.2 ± 17.7 minutes for the optical system (P < .05). The average intraoperative blood loss did not differ significantly between groups (electromagnetic, 190.6 ± 28.7 mL; optical, 172.4 ± 23.0 mL). Each system was noted to have limitations. The presence of metallic objects in the operative field interfered with functioning of the electromagnetic system, whereas the optical system required a clear line of sight to be maintained between the infrared camera and surgical handpiece. Both systems required specialized headsets to be worn by patients during surgery to monitor head position. The electromagnetic system also required these headsets to be worn during the preoperative computed tomography scan. Conclusion: Although these two image guidance systems both proved valuable for anatomic localization during sinus surgery, individual preferences can be based on distinct differences in their design and operation.

Validation of a Voice Outcome Survey for Unilateral Vocal Cord Paralysis

Current methods to assess voice outcomes in patients with unilateral vocal cord paralysis (UVCP) are limited by expense, reliability, or lack of a true patient-relevant focus. The purpose of this study was to develop and validate a patient-based, disease-specific instrument, the Voice Outcome Survey (VOS), that is brief, reliable, and sensitive to real clinical change in patients with UVCP. Fifty-six consecutive patients with uncompensated UVCP and without complicating comorbid illness received the VOS, the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), and a voice laboratory analysis before and 6 months after type I thyroplasty. Overall, reliability of the VOS was excellent (r = 0.87, P< 0.0001). The VOS index was significantly (P < 0.05) correlated to subscales of the SF-36 including social functioning (SF) (r = 0.56) and physical role functioning (r = 0.35), as well as changes in objective voice measures such as phonation time (r = 0.51) and average intensity (r = 0.44). The VOS index was the most sensitive measure to clinical change after surgery (standardized response means: VOS, 1.92; phonation time, 0.68; SF, 0.58; physical role functioning, 0.53; intensity, 0.51). The VOS is a brief, valid, reliable, and highly sensitive measure of disease-specific health status in patients with UVCP.Current methods to assess voice outcomes in patients with unilateral vocal cord paralysis (UVCP) are limited by expense, reliability, or lack of a true patient-relevant focus. The purpose of this study was to develop and validate a patient-based, disease-specific instrument, the Voice Outcome Survey (VOS), that is brief, reliable, and sensitive to real clinical change in patients with UVCP. Fifty-six consecutive patients with uncompensated UVCP and without complicating comorbid illness received the VOS, the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), and a voice laboratory analysis before and 6 months after type I thyroplasty. Overall, reliability of the VOS was excellent (r = 0.87, P < 0.0001). The VOS index was significantly (P < 0.05) correlated to subscales of the SF-36 including social functioning (SF) (r = 0.56) and physical role functioning (r = 0.35), as well as changes in objective voice measures such as phonation time (r = 0.51) and average intensity (r = 0.44). The VOS index was the most sensitive measure to clinical change after surgery (standardized response means: VOS, 1.92; phonation time, 0.68; SF, 0.58; physical role functioning, 0.53; intensity, 0.51). The VOS is a brief, valid, reliable, and highly sensitive measure of disease-specific health status in patients with UVCP.

Techniques for outcomes research in chronic sinusitis

Accurate assessment of patient outcome after sinus surgery requires the collection of valid and reliable data. Symptom-based surveys were administered in a prospective manner to 104 patients with chronic sinusitis. Test-retest reliability for the Chronic Sinusitis Survey based on duration of symptoms (0.86, P<.0001) was superior to that for a similar survey based on severity of symptoms (0.57, P<.0001). Results of the Chronic Sinusitis Survey also correlated significantly with subscales of a general health assessment in the extent to which chronic sinusitis limits physical activity (0.40, P<.01), interferes with work or other activities (0.36, P<.01), and affects patient perception of bodily pain (0.46, P<.001). The Chronic Sinusitis Survey is an efficient and reliable method to follow health status and health-related quality of life outcomes in patients with chronic sinusitis

Longitudinal sensitivity of generic and specific health measures in chronic sinusitis

The utility of reliable health measures for longitudinal studies in chronic sinusitis depends on their ability to detect clinically relevant change. Sixtythree patients with chronic sinusitis were evaluated before and three months after ethmoid sinus surgery using the Chronic Sinusitis Survey (CSS) and the generic Short-Form 36-Item Health Survey (SF-36). Statistically significant improvement was found for several SF-36 subscales including physical functioning, role functioning-physical, bodily pain, vitality and all CSS subscales. However, the differences between the instruments in longitudinal sensitivity to change as measured by standardized response means (SRM) and effect sizes (ES) were large. For the SF-36, sensitivity to change ranged from minimal to small (SRM: 0.01–0.43; ES: 0.01–0.52) with bodily pain and role functioning-physical scores most sensitive. For the CSS, sensitivity to change ranged from moderate to large (SRM: 0.56–0.82; ES: 0.48–1.12) with symptom-based and total index scores most sensitive. Despite this, the SF-36 yielded useful information concerning the relative burden of chronic sinusitis and failure of these patients to achieve normal levels of general health 3 months after sinus surgery. We conclude that the disease-specific CSS was more sensitive to change than the SF-36 survey in patients following ethmoid sinus surgery.

The American Orthopaedic Association's “Own the Bone” Initiative to Prevent Secondary Fractures

BACKGROUND The American Orthopaedic Association initiated its Own the Bone pilot project in 2005 in order (1) to assess current orthopaedic practices for the prevention of secondary fractures in adult patients who have sustained a low-energy fracture (fragility fracture), (2) to pilot quality-improvement tools designed to improve the application of evidence-based strategies for the prevention of secondary fractures, and (3) to identify barriers to the broader implementation of the Own the Bone project and explore how to overcome them. METHODS The ten-month pilot project took place at fourteen sites (thirteen inpatient sites and one outpatient site) and involved 635 participants with a median age of seventy-seven years. The primary outcome measures were the percentages of patients who received (1) counseling on calcium and vitamin-D supplementation, weight-bearing exercise, smoking cessation, and fall prevention, (2) bone mineral density testing, and (3) pharmaceutical intervention to prevent or treat osteoporosis. Secondary outcome measures focused on improved information flow and included the percentage of patients whose physicians were sent a letter recommending the evaluation and treatment of the fracture and the percentage of patients who received a letter recommending that they see their primary-care physician for evaluation and treatment of osteoporosis associated with the fracture. RESULTS The intervention produced significant improvements (p < 0.0001) in patient counseling on calcium and vitamin-D supplementation, exercise, fall prevention, and communication with primary-care providers and the patients themselves. No improvements were shown in the ordering of bone mineral density testing or the prescription of pharmacotherapy. The most significant improvements (p < 0.0001) were in improved communication with primary-care physicians and in efforts to educate patients about their risk of future fracture. CONCLUSIONS The Own the Bone initiative offers tools to improve the prevention of secondary fractures and a structure to monitor physician compliance. The American Orthopaedic Association plans to use these quality-improvement tools to stimulate change in both physician and patient behavior following low-energy fractures.

Outcomes of septoplasty

A prospective nonrandomized study of consecutive patients presenting to the Massachusetts Eye and Ear Infirmary for septoplasty was conducted to evaluate patient-based outcome. Patients received statistically validated measures of general health status (Short Form-12) and nasal specific health (Nasal Health Survey) before and 6 and 12 months after surgery. Multiple perioperative patient- and surgeon-dependent treatment variables were also evaluated to determine the impact on outcome. A total of 161 patients were entered into the study, and 93 were available for statistical analysis. At 9 months the mean follow-up (range 6–12 months), both symptom and medication subscores of the Nasal Health Survey, and the total score demonstrated significant improvement (P < 0.05); 71% of patients had clinically significant improvement as determined by at least a 50% decrease in duration of nasal symptoms. Measures of general health did not differ significantly from normative values at baseline and did not change after surgical intervention. Predictor analysis revealed that female gender and a history of previous nasal surgery predicted worse outcome.