Characterizing patients initiating abaloparatide, teriparatide, or denosumab in a real-world setting: a US linked claims and EMR database analysis.

We characterized patients initiating abaloparatide (ABL), teriparatide (TPTD), or denosumab (DMAB) in a real-world clinical setting from a large medical and pharmacy claims database. Differences were noted in sex, age, pathologic fractures, comorbidity index, and prior bisphosphonate use for patients initiating ABL and TPTD compared with those receiving DMAB. INTRODUCTION: To characterize patients initiating abaloparatide (ABL), teriparatide (TPTD), or denosumab (DMAB) treatment in a real-world clinical setting. METHODS: Patients aged ≥ 18 years initiating ABL, TPTD, or DMAB between May 1, 2017, and September 24, 2018 (without receiving the same drug in the previous 12 months), were identified using the OM1 Data Cloud, which contains medical and pharmacy claims from approximately 200 million US patients. The index date was the date of initial prescription or dispensing for ABL, TPTD, or DMAB during the study period. RESULTS: During the study period, 2666 patients initiated ABL, 9210 TPTD, and 116,718 DMAB. Mean age (standard deviation) was 69.2 (10.6) years for the ABL cohort, 68.6 (11.3) for TPTD, and 72.1 (10.2) for DMAB (P < 0.001; ABL vs DMAB). Proportionally more patients initiating ABL were female (95.2% ABL, 86.9% TPTD, and 91.3% DMAB, P < 0.001 ABL vs TPTD or DMAB). Nearly twice as many patients initiating ABL (19.1%) and TPTD (18.8%) had a previous pathologic/fragility fracture vs DMAB (9.6%; P < 0.001 ABL vs DMAB). Fewer patients initiating ABL (36.3%) or TPTD (39.7%) had Charlson comorbidity index of ≥ 2 vs DMAB (48.4%; P < 0.001 ABL vs DMAB). Before initiating ABL, TPTD, or DMAB, 44.3%, 33.8%, and 33.9% of patients had prior osteoporosis treatment, respectively. Bisphosphonate use was more common before initiating ABL (19.2%) or TPTD (19.6%), than before initiating DMAB (16.6%; P < 0.001 ABL vs DMAB). CONCLUSIONS: Patients initiating ABL and TPTD differed in sex, age, pathologic fractures, comorbidity index, and prior bisphosphonate use compared with those initiating DMAB.

Tissue eosinophilia in chronic sinusitis: quantification techniques.

OBJECTIVE: To ascertain the reliability of a proposed method for quantifying tissue eosinophilia in sinus mucosa. DESIGN: Prospective cohort study. INTERVENTIONS AND OUTCOME MEASURES: Pathology slides from patients undergoing endoscopic sinus surgery for chronic rhinosinusitis were independently assessed by 2 reviewers. Using a proposed systematic counting method, the degree of tissue eosinophilia was quantified. Disease severity was assessed by computed tomographic (CT) staging. Intrarater, interrater, and intrapatient reliability was determined using correlational reliability analysis. The degree of correlation between tissue eosinophilia and CT stage was determined. RESULTS: One hundred thirty-two slides from 65 patients were reviewed. The mean (SD) eosinophil density was 23.4 (37.2) eosinophils per high-power field. Only 12 patients (18%) had no eosinophils on histopathologic analysis. Strong intrarater (r> or =0.91 for each rater, P<.001) and interrater reliability (r> or =0.82 between raters, P<.001) was noted for the quantification method. A moderate degree of correlation was found between CT scan stage and degree of tissue eosinophilia (Spearman rho = 0.62, P<.001). CONCLUSIONS: The proposed method for quantifying tissue eosinophilia in sinus mucosa is reliable and valid. A relatively strong correlation exists between CT scan stage and tissue eosinophilia in chronic rhinosinusitis.

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. STUDY DESIGN: Prospective instrument validation. METHODS: Eighty-six patients with a documented history of facial paralysis completed a preliminary, 51-item instrument (alpha FaCE Scale), as well as the previously developed Facial Disability Index (FDI) and the Medical Outcomes Study Short Form 36 Item Questionnaire (SF-36). Two weeks after completing these instruments, 76 patients again completed the alpha FaCE Scale. Forty-one of the patients were also evaluated using the House-Brackmann Grading System (HBGS) and the Facial Grading System (FGS). RESULTS: Exploratory principal component factor analysis grouped 15 FaCE Scale items into 6 impairment and disability categories (domains), forming the beta FaCE Scale. Overall, the test-retest reliability of the FaCE Scale was high (Spearman's correlation coefficient (r) = 0.88, P <.01), as were the reliability coefficients of the individual domains (r = 0.81-0.92, P <.01). The FaCE Scale domains showed appropriate correlation to global visual analogue scale questions posed on the original alpha FaCE Scale (r = 0.65-0.81, P <.01). Overall, the FaCE Scale showed significant correlation with HBGS and FGS scores (r = -0.55 and 0.57, respectively; P <.01). However, not all FaCE Scale domains correlated with the HBGS and FGS scores. CONCLUSIONS: A reliable and valid patient-based system to measure impairment and disability in facial paralysis has been developed. This system appears to be better than traditional, physician-graded scales for evaluating quality-of-life issues affected by facial disability.

The health impact of chronic recurrent rhinosinusitis in children.

OBJECTIVES: To report and quantify the health-related quality of life of children who require surgical intervention for chronic recurrent rhinosinusitis and to assess the perspective of the child vs that of the parent. DESIGN: Prospective, observational. PATIENTS AND INTERVENTION: Twenty-one of a consecutive sample of 35 children undergoing endoscopic sinus surgery for infectious indications completed, along with their parents, the Child Health Questionnaire. The Child Health Questionnaire measures in parallel both child and parent perceptions of health by means of separate parent proxy report (Child Health Questionnaire-Parent Form 50) and child self-report (Child Health Questionnaire-Child Form 87) questionnaires concerning physical and psychosocial functioning. MAIN OUTCOME MEASURES: Tabulated scores from both the Child Health Questionnaire-Parent Form 50 and Child Health Questionnaire-Child Form 87 were compared with published data from age-matched normative populations and several pediatric chronic disease groups. RESULTS: Significant decrements in the general health of children with chronic recurrent rhinosinusitis compared with a normative sample were observed for both child- and parent-reported data, particularly in the physical domains. Children with rhinosinusitis were perceived by their parents to have significantly more bodily pain (P<.001)and to be more limited in their physical activities (P<.05)than children with asthma, juvenile rheumatoid arthritis, and other chronic disorders. Parent-child perceptions did vary, with parents reporting more pain and general behavioral effects relative to their children's reports in these areas. CONCLUSION: The health impact of chronic recurrent rhinosinusitis as reported by the subjective evaluations of pediatric patients and their parents is severe.

Use of the radial forearm fasciocutaneous free flap and montgomery salivary bypass tube for pharyngoesophageal reconstruction.

BACKGROUND: Head and neck reconstructive surgeons involved in pharyngoesophageal reconstruction have several options available to repair the defect after partial or total laryngopharyngectomy. There is no uniform agreement among head and neck surgeons as to which of the most frequently used techniques offers the best results. METHODS: A retrospective study was performed on 20 consecutive patients who had undergone reconstruction of the hypopharynx and cervical esophagus using a radial forearm free flap with Montgomery salivary bypass tube at the Massachusetts Eye and Ear Infirmary in Boston, Massachusetts, and St. Louis University, Department of Otolaryngology-Head and Neck Surgery between 1992 and 1996. This reconstruction was used for primary reconstruction after total or partial laryngopharyngectomy with cervical esophagectomy, partial pharyngectomy sparing the larynx, and for reconstruction of the stenotic neopharynx after laryngectomy. RESULTS: The overall rate of pharyngocutaneous fistula was 20%, and the rate of postoperative stricture was 10%. Of patients reconstructed with this technique, 85% were able to resume oral alimentation, whereas 15% remained G-tube dependent. Of the 18 patients who did not have their larynges remain intact, 6 were able to develop useful tracheoesophageal speech. CONCLUSIONS: The results of this study show that the radial forearm fasciocutaneous free flap in combination with the Montgomery salivary bypass tube is extremely useful for reconstruction of partial and circumferential defects of the hypopharynx and cervical esophagus.

Health status in allergic rhinitis.

Although valid and reliable instruments exist to measure the quality of life of allergic rhinitis patients, a statistically sensitive and clinically meaningful way to evaluate patients undergoing immunotherapy has not been reported. A 21-site prospective, observational study was performed in a population of consecutive patients with allergic rhinitis. Baseline general health measures revealed significant (P < 0.05) decrements from reported normative levels in 8 domains for patients choosing to undergo immunotherapy and 5 domains for patients choosing not to undergo immunotherapy. The General Health Survey was less sensitive in detecting change than the Nasal Health Survey (Chronic Sinusitis Survey) and allergy-specific (Rhinoconjunctivitis Quality of Life Questionnaire and Allergy Outcome Survey) surveys. Severity of symptoms was associated with both the likelihood to choose immunotherapy and the likelihood for early improvement. We conclude that general and condition-specific measures can be used to observe patients after immunotherapy; however, obtaining baseline data and controlling for seasonality are important considerations.

Delayed orbital infection after endoscopic orbital decompression for dysthyroid orbitopathy.

OBJECTIVE: To present a delayed complication of endoscopic orbital decompression that has not been reported previously in the literature. DESIGN: Retrospective non-comparative small case series. PARTICIPANTS: Three patients with dysthyroid orbitopathy. INTERVENTION: The medical records of patients with dysthyroid orbitopathy who underwent endoscopic orbital decompression and subsequently developed orbital infection were reviewed. RESULTS: Three patients with dysthyroid orbitopathy developed orbital infection (cellulitis or abscess) originating from the frontal sinus more than 2 years after their endoscopic orbital decompression surgery. Management required drainage of the abscess, administration of antibiotics, and creation of adequate frontal sinus drainage. CONCLUSIONS: Delayed orbital infection can occur after endoscopic orbital decompression for dysthyroid orbitopathy when the frontal sinus ostium is obstructed by orbital fat or scar tissue. Infection within the frontal sinus can cause secondary orbital cellulitis or abscess. Early signs and symptoms of a frontal sinus infection can be easily misdiagnosed as progression of the patient's thyroid eye disease. Awareness of this possible complication followed by appropriate early intervention will prevent a potentially blinding condition. Furthermore, ever since this complication was observed, the authors' surgical technique of endoscopic decompression has been modified to leave the most anterosuperior portion of the lamina papyracea to prevent fat prolapse and scar formation into the region of the frontal recess.

Health status in patients with disturbed sleep and obstructive sleep apnea.

The health status of 435 consecutive patients with sleep disturbances necessitating polysomnography was investigated. Patients underwent overnight polysomnography and health status assessment, including the Medical Outcomes Study SF-36 Health Survey and the Pittsburgh Sleep Quality Index. Based on a respiratory distress index (RDI) greater than 10 to define apnea, patients with apnea were significantly (P < 0.05) more likely to be male, be older, and have higher body mass index and lower oxygen saturation levels than patients without apnea. Multiple domains of the SF-36 Health Survey and the Pittsburgh Sleep Quality Index were significantly worse (P < 0.05) for this population when normative data were compared. Although few differences were observed between the apneic and nonapneic patients when a cutoff point for apnea was defined as an RDI greater than 10 or 20, increasing RDI was significantly associated with worsening physical functioning scores. Overall, decrements in health status measures were more strongly correlated with the number of oxygen desaturations below 85% than with increasing RDI. We conclude that patients with sleep disturbances demonstrate significant decrements in general and sleep-specific health status, but these decrements are more closely associated with oxygen desaturation than RDI.

Validation of outcomes survey for adults with chronic suppurative otitis media.

Currently, there is no valid, disease-specific outcomes measure to evaluate health impact and treatment effectiveness for patients with chronic suppurative otitis media (CSOM). The Chronic Ear Survey (CES) is a new, disease-specific outcomes measure for CSOM that was administered in a prospective manner to 91 patients with CSOM. It was then validated according to established criteria for reliability, validity, and sensitivity to clinical change by correlation with objective data and self-assessment questionnaires such as the Hearing Handicap Inventory for Adults (HHIA) and the generic 36-Item Short-Form Health Survey (SF-36). Significant correlations between subscale scores of the CES and audiometric data and between subscale scores of the HHIA and SF-36 were found. The standardized response mean for the CES total score was 0.42, indicating moderate sensitivity to clinical change. Overall, results demonstrated that the CES is a reliable and valid instrument for investigation of health status and health-related quality-of-life outcomes.

Clinical outcomes in patients with chronic sinusitis.

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.

Outcomes assessment for chronic otitis media: the Chronic Ear Survey.

Analysis of outcomes in chronic otitis media has in the past been limited to audiological measurement or physical examination. The Chronic Ear Survey (CES) is an instrument to measure the impact of chronic otitis media and its treatment. The survey provides information regarding total ear-specific health, as well as subscore information regarding activity restriction, symptoms, and medical resource usage attributable to chronic otitis media Application of the CES to a prospective, nonrandomized series of 147 patients revealed that patients with chronic otitis media have significantly decreased CES scores compared with unaffected controls and that surgical intervention provides a significant improvement in ear-specific outcomes.

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.

Development of the allergy outcome survey for allergic rhinitis.

The Allergy Outcome Survey (AOS) is a reliable measure used to monitor patients with allergic rhinitis. It was developed for and included in the Outcomes Measures of Immunotherapy in Allergic Rhinitis (OMIAR-1) project, designed to study the benefits of immunotherapy in the treatment of allergic rhinitis. Preliminary results indicate that AOS is specific, brief, reliable, and easy to use. Also, it is useful for evaluating change with therapy and can be used alone as a performance metric or in combination with other measures as part of a more complete outcomes monitoring system. As the OMIAR-1 study progresses, more information will be available on the advantages and limitations of the AOS.

The role of image-guidance systems for head and neck surgery.

BACKGROUND: Although image-guidance systems have gained widespread acceptance for neurosurgical procedures, their role for extracranial surgery of the head and neck is yet to be defined. OBJECTIVES: To describe the authors' experience with image-guidance systems and to measure the effects of image-guided technology on the performance of minimally invasive otolaryngological procedures. DESIGN: Prospective cohort study. METHODS: Optical- and electromagnetic-based image-guidance systems were used during the performance of endoscopic surgery on patients with disease of the paranasal sinuses, orbit, skull base, and temporal bone (n = 79). Results were compared with those in control patients who underwent similar surgery without image guidance during the same period (n = 42). RESULTS: Intraoperative anatomical localization was accurate to within 2 mm at the start of surgery in all cases. Accuracy degraded by 0.89 +/- 0.20 mm (mean +/- SE) during the operative procedure. The use of an image-guidance system increased operating room time by a mean of 17.4 minutes per case (image-guidance group, 137.3 +/- 6.0 minutes [mean +/- SE]; control group, 119.9 +/- 5.7 minutes; P=.006) and increased hospital charges by approximately $496 per case. Intraoperative blood loss (image-guidance group, 178.4 +/- 18.0 mL [mean +/- SE]; control group, 149.4 +/- 20.1 mL) and complication rates (image-guidance group, 2.7%; control group, 4.7%) did not differ significantly between groups. CONCLUSIONS: Image-guidance systems can provide the head and neck surgeon with accurate information regarding anatomical localization in cases with poor surgical landmarks caused by extensive disease or prior surgery; however, the use of such systems is associated with increased operative time and expense.

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.

Clinical outcome of endoscopic surgery for frontal sinusitis.

OBJECTIVE: To determine the efficacy of endoscopic surgery for chronic frontal sinusitis. DESIGN: A prospective analysis of established measures of clinical outcome (Chronic Sinusitis Survey and Short Form 36) that was administered to patients before frontal sinus surgery and at intervals of 3 months, 6 months, and 1 year after surgery. INTERVENTIONS: For limited disease, the frontal recess was opened and the frontal ostium probed or enlarged. For more severe cases, a drill was used to resect the frontal sinus floor and interfrontal septum. SETTING: Private and institutional-based practices at an academic medical center. SUBJECTS: Eighty-seven patients who underwent endoscopic surgery for frontal sinusitis, including 24 patients with severe disease who underwent a frontal sinus drillout procedure. MAIN OUTCOME MEASURES: Scores on the Chronic Sinusitis Survey, Short Form 36, and surgical revision rate. RESULTS: Significant improvement in facial pain, nasal drainage, and congestion was observed 1 year after surgery (P<.01). Medication use was also significantly reduced during this period (P<.01). Quality-of-life measures showed greatest improvement in the domain of social functioning (P<.05). Three (12.5%) of 24 patients who underwent a frontal sinus drillout procedure did not respond to surgery secondary to restenosis of the frontal ostium. CONCLUSIONS: Although the long-term results of endoscopic surgery for frontal sinusitis are unknown, this approach appears to be effective for most patients and may provide a reasonable alternative to frontal sinus obliteration surgery in selected cases.

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.

Bilateral nasolacrimal duct obstruction managed with endoscopic techniques.

We present 3 cases of bilateral acquired nasolacrimal duct obstruction secondary to Wegener granulomatosis, sarcoidosis, and chronic lymphocytic leukemia. In all cases significant paranasal sinus and intranasal disease coincided with bilateral nasolacrimal duct obstruction. Surgical treatment of the nasolacrimal duct obstruction with dacryocystorhinostomy was more successful if the paranasal sinus disease was also treated. Nontraumatic bilateral nasolacrimal duct obstruction heralds unusual underlying systemic diseases, and coexisting paranasal sinus disease should be suspected. The simultaneous surgical treatment of both lacrimal and paranasal sinus disease through an endoscopic approach is advocated.

Paranasal sinus endoscopy and orbital fracture repair.

Although excellent results may be achieved in the management of many orbital floor injuries with standard transconjunctival or transcutaneous approaches, visualization of the posterior edge of the orbital floor or medial wall defect may be challenging at times. We describe our experience using endoscopic examination of the orbital floor through maxillary sinus approaches during the repair of selected orbital floor fractures. Owing to the posterosuperior angulation of the orbital floor, these approaches allow better visualization of the posterior edge of fractures involving the posterior portion of the orbital floor than do the standard transconjunctival approaches, and they facilitate confirmation that all orbital soft tissues have been elevated from the fracture site. We have used these techniques successfully in 9 patients with fractures involving either the posterior portion of the orbital floor or the medial wall or both.

Repair of orbital blow-out fractures with nasoseptal cartilage.

The goals of reconstruction in orbital blow-out fractures are to restore floor continuity, provide support of orbital contents, and prevent fibrosis of soft tissues. Although ease of use has popularized alloplasts, autogenous material provides greater biocompatibility and results in low rates of infection, extrusion, and migration. Nasoseptal cartilage is an easily accessible, abundant, autogenous source that provides support to the orbital floor and minimal donor site morbidity. Thirteen patients who presented with orbital blow-out fractures underwent reconstruction with nasoseptal cartilage. Follow-up at 3 months to 4 years shows one patient with persistent manifest enophthalmos requiring further augmentation. There were no recipient or donor site complications. Nasoseptal cartilage is an underutilized and superior material for reconstruction of orbital blow-out fractures.