Background: Joint swelling and tenderness are common in patients with systemic lupus erythematosu... more Background: Joint swelling and tenderness are common in patients with systemic lupus erythematosus (SLE). Swollen to tender joint count ratio (STR) is an index originally used in rheumatoid arthritis (RA) which assesses severity of disease activity based on 28 joint counts [1]. In RA, STR is a predictor of treatment response with a higher score indicating greater likelihood of responding. Objectives: To characterize SLE patients in a real-world cohort based on disease activity as defined by STR. Methods: The OM1 SLE Registry (OM1, Boston, MA) follows more than 37,000 SLE patients longitudinally with deep clinical data, including laboratory, patient-reported and disease activity information, and linked administrative claims, starting from 2013. Patients ≥16 years of age with swollen and tender joint counts based on 28 joints on the same encounter were included. STRs were calculated by inserting 1 if the denominator was 0 [2]. Patients were categorized by first available STR as having...
We characterized patients initiating abaloparatide (ABL), teriparatide (TPTD), or denosumab (DMAB... more 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.
The demand for real-world research (RWR) from many stakeholders has resulted in an increasing nee... more The demand for real-world research (RWR) from many stakeholders has resulted in an increasing need for well-trained professionals who understand how to perform and evaluate RWR and to interpret the results of such data. The Drug Information Association (DIA) Real World Outcomes Task Force (RWOTF) developed a survey to explore North American workforce and training needs in RWR for DIA’s
ABSTRACT Objectives: (1) Characterize contemporary utilization patterns of a stand-alone otolaryn... more ABSTRACT Objectives: (1) Characterize contemporary utilization patterns of a stand-alone otolaryngology emergency room (ER). (2) Assess the range of otolaryngologic complaints. (3) Determine characteristics of patients that require inpatient admission. (4) Provide a practical discussion about the utility of a specialized ER in otolaryngologic care.
The subcranial approach to the cranio-orbito-frontal junction allows direct access to the central... more The subcranial approach to the cranio-orbito-frontal junction allows direct access to the central anterior cranial base for repair of fractures, dural tears, and cerebrospinal fluid fistulae. It provides good visualization without brain retraction and is suitable in primary or delayed traumatic cases. For extended visualization, a portion of the frontal sinus may be removed and repositioned at the end of the procedure. Because the brain is not retracted, morbidity is low. Potential and active cerebrospinal fluid fistulae can be successfully managed with the use of free fascial grafts and often do not require a pericranial flap. Contraindications include parenchymal brain injury or bleeding that may require a more standard frontal craniotomy for management. The purpose of this report is to highlight the use of the subcranial approach to repair cerebrospinal fluid fistulae in immediate and delayed traumatic cases.
Archives of otolaryngology--head & neck surgery, 2001
To ascertain the reliability of a proposed method for quantifying tissue eosinophilia in sinus mu... more To ascertain the reliability of a proposed method for quantifying tissue eosinophilia in sinus mucosa. Prospective cohort study. 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. 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 quantific...
To present a delayed complication of endoscopic orbital decompression that has not been reported ... more To present a delayed complication of endoscopic orbital decompression that has not been reported previously in the literature. Retrospective non-comparative small case series. Three patients with dysthyroid orbitopathy. The medical records of patients with dysthyroid orbitopathy who underwent endoscopic orbital decompression and subsequently developed orbital infection were reviewed. 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. 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 symp...
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 1993
The World Health Organization has designated the teaching of otitis media management skills a &qu... more The World Health Organization has designated the teaching of otitis media management skills a "priority" status. Effective treatment of ear disease requires that the physician be both informationally educated as well as physically trained to use otoscopy. Little is known about how well this education can be provided in a short time and in a foreign country. To more objectively assess teaching effect, results of an education session for rural Mexican pediatric primary-care providers who were given an intensive otitis media lecture and otoscopy skills workshop in 1990 were evaluated. To test immediate cognitive impact, an anonymous written examination was given both before and after the teaching session. Average test scores after the educational sessions improved 24% (p < 0.001) over baseline scores before the sessions. To evaluate long-term impact on clinical practice, a follow-up telephone survey 2 years later was conducted. The use of an otoscope to diagnose otitis med...
Currently, there is no valid, disease-specific outcomes measure to evaluate health impact and tre... more 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 heal...
Analysis of outcomes in chronic otitis media has in the past been limited to audiological measure... more 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.
Although sinusitis is one of the most common chronic illnesses in this country, relatively little... more 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&lt;.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&lt;.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.
Background: Joint swelling and tenderness are common in patients with systemic lupus erythematosu... more Background: Joint swelling and tenderness are common in patients with systemic lupus erythematosus (SLE). Swollen to tender joint count ratio (STR) is an index originally used in rheumatoid arthritis (RA) which assesses severity of disease activity based on 28 joint counts [1]. In RA, STR is a predictor of treatment response with a higher score indicating greater likelihood of responding. Objectives: To characterize SLE patients in a real-world cohort based on disease activity as defined by STR. Methods: The OM1 SLE Registry (OM1, Boston, MA) follows more than 37,000 SLE patients longitudinally with deep clinical data, including laboratory, patient-reported and disease activity information, and linked administrative claims, starting from 2013. Patients ≥16 years of age with swollen and tender joint counts based on 28 joints on the same encounter were included. STRs were calculated by inserting 1 if the denominator was 0 [2]. Patients were categorized by first available STR as having...
We characterized patients initiating abaloparatide (ABL), teriparatide (TPTD), or denosumab (DMAB... more 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.
The demand for real-world research (RWR) from many stakeholders has resulted in an increasing nee... more The demand for real-world research (RWR) from many stakeholders has resulted in an increasing need for well-trained professionals who understand how to perform and evaluate RWR and to interpret the results of such data. The Drug Information Association (DIA) Real World Outcomes Task Force (RWOTF) developed a survey to explore North American workforce and training needs in RWR for DIA’s
ABSTRACT Objectives: (1) Characterize contemporary utilization patterns of a stand-alone otolaryn... more ABSTRACT Objectives: (1) Characterize contemporary utilization patterns of a stand-alone otolaryngology emergency room (ER). (2) Assess the range of otolaryngologic complaints. (3) Determine characteristics of patients that require inpatient admission. (4) Provide a practical discussion about the utility of a specialized ER in otolaryngologic care.
The subcranial approach to the cranio-orbito-frontal junction allows direct access to the central... more The subcranial approach to the cranio-orbito-frontal junction allows direct access to the central anterior cranial base for repair of fractures, dural tears, and cerebrospinal fluid fistulae. It provides good visualization without brain retraction and is suitable in primary or delayed traumatic cases. For extended visualization, a portion of the frontal sinus may be removed and repositioned at the end of the procedure. Because the brain is not retracted, morbidity is low. Potential and active cerebrospinal fluid fistulae can be successfully managed with the use of free fascial grafts and often do not require a pericranial flap. Contraindications include parenchymal brain injury or bleeding that may require a more standard frontal craniotomy for management. The purpose of this report is to highlight the use of the subcranial approach to repair cerebrospinal fluid fistulae in immediate and delayed traumatic cases.
Archives of otolaryngology--head & neck surgery, 2001
To ascertain the reliability of a proposed method for quantifying tissue eosinophilia in sinus mu... more To ascertain the reliability of a proposed method for quantifying tissue eosinophilia in sinus mucosa. Prospective cohort study. 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. 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 quantific...
To present a delayed complication of endoscopic orbital decompression that has not been reported ... more To present a delayed complication of endoscopic orbital decompression that has not been reported previously in the literature. Retrospective non-comparative small case series. Three patients with dysthyroid orbitopathy. The medical records of patients with dysthyroid orbitopathy who underwent endoscopic orbital decompression and subsequently developed orbital infection were reviewed. 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. 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 symp...
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 1993
The World Health Organization has designated the teaching of otitis media management skills a &qu... more The World Health Organization has designated the teaching of otitis media management skills a "priority" status. Effective treatment of ear disease requires that the physician be both informationally educated as well as physically trained to use otoscopy. Little is known about how well this education can be provided in a short time and in a foreign country. To more objectively assess teaching effect, results of an education session for rural Mexican pediatric primary-care providers who were given an intensive otitis media lecture and otoscopy skills workshop in 1990 were evaluated. To test immediate cognitive impact, an anonymous written examination was given both before and after the teaching session. Average test scores after the educational sessions improved 24% (p < 0.001) over baseline scores before the sessions. To evaluate long-term impact on clinical practice, a follow-up telephone survey 2 years later was conducted. The use of an otoscope to diagnose otitis med...
Currently, there is no valid, disease-specific outcomes measure to evaluate health impact and tre... more 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 heal...
Analysis of outcomes in chronic otitis media has in the past been limited to audiological measure... more 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.
Although sinusitis is one of the most common chronic illnesses in this country, relatively little... more 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&lt;.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&lt;.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.
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Papers by R. Gliklich