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Article ; Online: Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence.

Gliklich, Richard E / Leavy, Michelle B

Therapeutic innovation & regulatory science

2020 Volume 54, Issue 2, Page(s) 303–307

Abstract: The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use ... ...

Abstract	The use of real-world data and real-world evidence to inform health care decisions is increasing. Yet, the variable quality of these data and the lack of widely-accepted criteria by which to assess quality create uncertainty about how and when to use these data and the associated evidence in decision making. Patient registries are an important source of real-world data and real-world evidence. The good practices and evaluation criteria developed for patient registries are highly relevant to real-world data and real-world evidence and offer a foundation for a unified set of quality criteria that can be applied across sources of real-world data and real-world evidence intended for use in medical product evaluation.
Language	English
Publishing date	2020-01-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-019-00058-6
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Article ; Online: Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery.

Hoffman, Veena / Mortimer, Kathleen M / Mulder, Kyra / Topuria, Ia / Gliklich, Richard / Kallman, James E

Current medical research and opinion

2022 Volume 38, Issue 3, Page(s) 375–381

Abstract: Objective: To compare healthcare resource use (HCRU) in patients undergoing sinus surgery with or without steroid-eluting sinus implants.: Methods: A retrospective, observational cohort study using real-world evidence data (OM1, Inc, Boston, MA, USA) ...

Abstract	Objective: To compare healthcare resource use (HCRU) in patients undergoing sinus surgery with or without steroid-eluting sinus implants. Methods: A retrospective, observational cohort study using real-world evidence data (OM1, Inc, Boston, MA, USA) was conducted on adult patients with chronic rhinosinusitis (CRS) with or without nasal polyps who underwent endoscopic sinus surgery between 2014 and 2019 and had at least 18 months of data both before and after surgery. Patients receiving implants ("implant cohort") were matched to patients who did not receive implants ("non-implant cohort") based on a propensity score developed using baseline characteristics. Chi-square for binary variables and analysis of variance tests for continuous variables were applied to compare HCRU measures. Results: Comparison of the implant ( Conclusion: Patients with steroid-eluting sinus implants had lower HCRU over a post-operative period of 18 months. These findings support the contention that reductions in HCRU may be achieved using steroid-eluting implants during sinus surgery.What is known on this topicChronic rhinosinusitis (CRS) causes severe symptoms that lead to poor quality of life.Endoscopic sinus surgery (ESS) is 76-98% effective in improving CRS patients' symptoms.Surgical outcomes can be compromised in the immediate post-operative period by scarring, adhesion formation, and early polyp recurrence.Oral and topical corticosteroid therapy has become integral to the maintenance of successful surgical outcomes, the management of post-operative scarring and edema, and the prevention of nasal polyp recurrence.Steroid-eluting sinus implants have been shown in clinical trials to improve postoperative outcomes after ESS by delivering localized, sustained release of corticosteroids directly onto inflamed sinus tissue.What this study addsThis observational study is one of the first to use real-world evidence to assess the effect of steroid-eluting sinus implants on healthcare resource use (HCRU) in patients with chronic rhinosinusitis who underwent sinus surgery with or without implants.Use of implants significantly reduced HCRU, including all-cause outpatient visits (94.3% vs 96.6%,
MeSH term(s)	Adult ; Chronic Disease ; Cicatrix ; Delivery of Health Care ; Humans ; Nasal Polyps/drug therapy ; Quality of Life ; Retrospective Studies ; Rhinitis/drug therapy ; Rhinitis/surgery ; Sinusitis/drug therapy ; Sinusitis/surgery ; Steroids/therapeutic use ; Treatment Outcome
Chemical Substances	Steroids
Language	English
Publishing date	2022-01-20
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1080/03007995.2021.2022874
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Article ; Online: Techniques for outcomes research in chronic sinusitis.

Gliklich, Richard E / Metson, Ralph

The Laryngoscope

2015 Volume 125, Issue 10, Page(s) 2238–2241

MeSH term(s)	Chronic Disease ; History, 20th Century ; Humans ; Outcome Assessment (Health Care)/history ; Sinusitis/history
Language	English
Publishing date	2015-10
Publishing country	United States
Document type	Classical Article ; Historical Article ; Journal Article
ZDB-ID	80180-x
ISSN	1531-4995 ; 0023-852X
ISSN (online)	1531-4995
ISSN	0023-852X
DOI	10.1002/lary.25276
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Article: Texting while driving: the development and validation of the distracted driving survey and risk score among young adults.

Bergmark, Regan W / Gliklich, Emily / Guo, Rong / Gliklich, Richard E

Injury epidemiology

2016 Volume 3, Issue 1, Page(s) 7

Abstract: Background: Texting while driving and other cell-phone reading and writing activities are high-risk activities associated with motor vehicle collisions and mortality. This paper describes the development and preliminary evaluation of the Distracted ... ...

Abstract	Background: Texting while driving and other cell-phone reading and writing activities are high-risk activities associated with motor vehicle collisions and mortality. This paper describes the development and preliminary evaluation of the Distracted Driving Survey (DDS) and score. Methods: Survey questions were developed by a research team using semi-structured interviews, pilot-tested, and evaluated in young drivers for validity and reliability. Questions focused on texting while driving and use of email, social media, and maps on cellular phones with specific questions about the driving speeds at which these activities are performed. Results: In 228 drivers 18-24 years old, the DDS showed excellent internal consistency (Cronbach's alpha = 0.93) and correlations with reported 12-month crash rates. The score is reported on a 0-44 scale with 44 being highest risk behaviors. For every 1 unit increase of the DDS score, the odds of reporting a car crash increases 7 %. The survey can be completed in two minutes, or less than five minutes if demographic and background information is included. Text messaging was common; 59.2 and 71.5 % of respondents said they wrote and read text messages, respectively, while driving in the last 30 days. Conclusion: The DDS is an 11-item scale that measures cell phone-related distracted driving risk and includes reading/viewing and writing subscores. The scale demonstrated strong validity and reliability in drivers age 24 and younger. The DDS may be useful for measuring rates of cell-phone related distracted driving and for evaluating public health interventions focused on reducing such behaviors.
Language	English
Publishing date	2016-03-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2764253-7
ISSN	2197-1714
ISSN	2197-1714
DOI	10.1186/s40621-016-0073-8
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Article: Review of literature of saddle nose deformity reconstruction and presentation of vomer onlay graft.

Gadkaree, Shekhar K / Weitzman, Rachel E / Fuller, Jennifer C / Justicz, Natalie / Gliklich, Richard E

Laryngoscope investigative otolaryngology

2020 Volume 5, Issue 6, Page(s) 1039–1043

Abstract: Objective: Saddle nose deformity is a well-described condition that most commonly results from trauma or prior surgery. For larger saddle nose deformity defects, bone grafts are a reconstructive option that provide adequate structure for repair. One new ...

Abstract	Objective: Saddle nose deformity is a well-described condition that most commonly results from trauma or prior surgery. For larger saddle nose deformity defects, bone grafts are a reconstructive option that provide adequate structure for repair. One new technique for repair of these deformities is a vomerian bone onlay graft. We aim to provide a review of literature on autogenous repair of saddle nose deformities, as well as introduce a new technique in which the vomer bone is used as an onlay bone graft. Methods: Literature review and case series. Five cases in which vomer onlay grafts were used for repair of saddle nose deformity were reviewed between January 2013 and December 2015. Aesthetic outcomes and postoperative complications were evaluated at subsequent follow-up visits in clinic. Results: In all cases where vomer bone was harvested, the vomer onlay graft provided adequate structure to traverse the saddle nose deformity. No postoperative complications were observed in an 18 month follow-up period. Conclusion: Vomerian bone onlay grafts are a reconstructive option for saddle nose deformity and nasal dorsum defects. While septal cartilage is commonly used, and ethmoidal bone has been previously described as an option for composite graft reconstruction, vomer bone onlay grafting has not been well described in the literature. This method may be of use when previous nasal surgery has been performed and standard septal cartilage is not possible to harvest. The aesthetic outcomes following nasal dorsum reconstruction using onlay grafts are favorable, but long-term outcomes of these grafts require further study. Level of evidence: IV.
Language	English
Publishing date	2020-10-16
Publishing country	United States
Document type	Journal Article
ISSN	2378-8038
ISSN	2378-8038
DOI	10.1002/lio2.475
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Article ; Online: Voldemort deformity: nasolabial transposition technique for severe nasal inlet stenosis.

Kozin, Elliott D / Gliklich, Richard E

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery

2014 Volume 151, Issue 6, Page(s) 1078–1080

MeSH term(s)	Follow-Up Studies ; Humans ; Male ; Middle Aged ; Nasal Obstruction/diagnosis ; Nasal Obstruction/surgery ; Nasal Septum/abnormalities ; Nasal Septum/surgery ; Nasal Surgical Procedures/methods ; Nose/abnormalities ; Nose/surgery ; Reconstructive Surgical Procedures/methods ; Recovery of Function ; Severity of Illness Index ; Surgical Flaps ; Treatment Outcome
Language	English
Publishing date	2014-08-07
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	392085-9
ISSN	1097-6817 ; 0161-6439 ; 0194-5998
ISSN (online)	1097-6817
ISSN	0161-6439 ; 0194-5998
DOI	10.1177/0194599814545745
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Article ; Online: Using real-world evidence to support a changing paradigm for cancer screening: A commentary.

Leavy, Michelle B / Starzyk, Kathryn / Myers, Evan / Curhan, Gary / Gliklich, Richard

Pharmacoepidemiology and drug safety

2020 Volume 29, Issue 10, Page(s) 1312–1315

Language	English
Publishing date	2020-09-09
Publishing country	England
Document type	Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5104
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Zs.A 3395: Show issues

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Article ; Online: Patient-Reported Morbidity Instruments: A Systematic Review.

Oemrawsingh, Arvind / Swami, Nishwant / Valderas, José M / Hazelzet, Jan A / Pusic, Andrea L / Gliklich, Richard E / Bergmark, Regan W

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2020 Volume 23, Issue 6, Page(s) 791–811

Abstract: Objectives: Although comorbidities play an essential role in risk adjustment and outcomes measurement, there is little consensus regarding the best source of this data. The aim of this study was to identify general patient-reported morbidity instruments ...

Abstract	Objectives: Although comorbidities play an essential role in risk adjustment and outcomes measurement, there is little consensus regarding the best source of this data. The aim of this study was to identify general patient-reported morbidity instruments and their measurement properties. Methods: A systematic review was conducted using multiple electronic databases (Embase, Medline, Cochrane Central, and Web of Science) from inception to March 2018. Articles focusing primarily on the development or subsequent validation of a patient-reported morbidity instrument were included. After including relevant articles, the measurement properties of each morbidity instrument were extracted by 2 investigators for narrative synthesis. Results: A total of 1005 articles were screened, of which 34 eligible articles were ultimately included. The most widely assessed instruments were the Self-Reported Charlson Comorbidity Index (n = 7), the Self-Administered Comorbidity Questionnaire (n = 3), and the Disease Burden Morbidity Assessment (n = 3). The most commonly included conditions were diabetes, hypertension, and myocardial infarction. Studies demonstrated substantial variability in item-level reliability versus the gold standard medical record review (κ range 0.66-0.86), meaning that the accuracy of the self-reported comorbidity data is dependent on the selected morbidity. Conclusions: The Self-Reported Charlson Comorbidity Index and the Self-Administered Comorbidity Questionnaire were the most frequently cited instruments. Significant variability was observed in reliability per comorbid condition of patient-reported morbidity questionnaires. Further research is needed to determine whether patient-reported morbidity data should be used to bolster medical records data or serve as a stand-alone entity when risk adjusting observational outcomes data.
MeSH term(s)	Comorbidity ; Humans ; Morbidity ; Outcome Assessment, Health Care ; Patient Reported Outcome Measures ; Reproducibility of Results ; Risk Adjustment/methods ; Surveys and Questionnaires
Language	English
Publishing date	2020-05-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2020.02.006
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Article ; Online: A new approach to identifying patients with elevated risk for Fabry disease using a machine learning algorithm.

Jefferies, John L / Spencer, Alison K / Lau, Heather A / Nelson, Matthew W / Giuliano, Joseph D / Zabinski, Joseph W / Boussios, Costas / Curhan, Gary / Gliklich, Richard E / Warnock, David G

Orphanet journal of rare diseases

2021 Volume 16, Issue 1, Page(s) 518

Abstract: ... signals to make predictions and included both familiar symptoms associated with FD (e.g. renal ...

Abstract	Background: Fabry disease (FD) is a rare genetic disorder characterized by glycosphingolipid accumulation and progressive damage across multiple organ systems. Due to its heterogeneous presentation, the condition is likely significantly underdiagnosed. Several approaches, including provider education efforts and newborn screening, have attempted to address underdiagnosis of FD across the age spectrum, with limited success. Artificial intelligence (AI) methods present another option for improving diagnosis. These methods isolate common health history patterns among patients using longitudinal real-world data, and can be particularly useful when patients experience nonspecific, heterogeneous symptoms over time. In this study, the performance of an AI tool in identifying patients with FD was analyzed. The tool was calibrated using de-identified health record data from a large cohort of nearly 5000 FD patients, and extracted phenotypic patterns from these records. The tool then used this FD pattern information to make individual-level estimates of FD in a testing dataset. Patterns were reviewed and confirmed with medical experts. Results: The AI tool demonstrated strong analytic performance in identifying FD patients. In out-of-sample testing, it achieved an area under the receiver operating characteristic curve (AUROC) of 0.82. Strong performance was maintained when testing on male-only and female-only cohorts, with AUROCs of 0.83 and 0.82 respectively. The tool identified small segments of the population with greatly increased prevalence of FD: in the 1% of the population identified by the tool as at highest risk, FD was 23.9 times more prevalent than in the population overall. The AI algorithm used hundreds of phenotypic signals to make predictions and included both familiar symptoms associated with FD (e.g. renal manifestations) as well as less well-studied characteristics. Conclusions: The AI tool analyzed in this study performed very well in identifying Fabry disease patients using structured medical history data. Performance was maintained in all-male and all-female cohorts, and the phenotypic manifestations of FD highlighted by the tool were reviewed and confirmed by clinical experts in the condition. The platform's analytic performance, transparency, and ability to generate predictions based on existing real-world health data may allow it to contribute to reducing persistent underdiagnosis of Fabry disease.
MeSH term(s)	Algorithms ; Artificial Intelligence ; Fabry Disease/genetics ; Female ; Humans ; Infant, Newborn ; Kidney ; Machine Learning ; Male
Language	English
Publishing date	2021-12-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2225857-7
ISSN	1750-1172 ; 1750-1172
ISSN (online)	1750-1172
ISSN	1750-1172
DOI	10.1186/s13023-021-02150-3
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Article ; Online: Practice patterns and treatment changes for open-angle glaucoma: the RiGOR study.

Coleman, Anne L / Lum, Flora C / Velentgas, Priscilla / Su, Zhaohui / Gliklich, Richard E

Journal of comparative effectiveness research

2016 Volume 5, Issue 1, Page(s) 79–85

Abstract: Aims: The RiGOR study provides a current picture of the types of glaucoma treatment over 12 months.: Methods: Patients were identified and enrolled at the time of decision to proceed with laser surgery procedure or other procedure such as incisional ... ...

Abstract	Aims: The RiGOR study provides a current picture of the types of glaucoma treatment over 12 months. Methods: Patients were identified and enrolled at the time of decision to proceed with laser surgery procedure or other procedure such as incisional surgery or drainage device implantation, or initiation of a new or additional course of therapy with medication for glaucoma treatment. Results: The most frequent type of treatments were prostaglandin analogues (60%) among patients with additional medication, selective laser trabeculoplasty (87%) among patients with laser surgery and trabeculectomy (57%) among patients with incisional surgery. Conclusion: For 36% of patients, a treatment cascade involves two or more therapies over a year. This demonstrates the complex nature of open-angle glaucoma treatment.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Glaucoma, Open-Angle/drug therapy ; Glaucoma, Open-Angle/surgery ; Humans ; Laser Therapy/methods ; Male ; Middle Aged ; Practice Patterns, Physicians'/statistics & numerical data ; Prospective Studies ; Prostaglandins, Synthetic/therapeutic use ; Trabeculectomy/methods ; Young Adult
Chemical Substances	Prostaglandins, Synthetic
Language	English
Publishing date	2016-01
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, U.S. Gov't, P.H.S.
ISSN	2042-6313
ISSN (online)	2042-6313
DOI	10.2217/cer.15.57
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