Harmonized Outcome Measures for Use in Non-Small Cell Lung Cancer Patient Registries and Clinical Practice.

BACKGROUND: Lung cancer is the leading cause of cancer-related death in the United States and globally, and many questions exist about treatment options. Harmonizing data across registries and other data collection efforts would yield a robust data infrastructure to help address many research questions. The purpose of this project was to develop a minimum set of patient and clinician relevant harmonized outcome measures that can be collected in non-small cell lung cancer (NSCLC) patient registries and clinical practice. METHODS: Seventeen lung cancer registries and related efforts were identified and invited to submit outcome measures. Representatives from medical specialty societies, government agencies, health systems, health information technology groups, patient advocacy organizations, and industry formed a stakeholder panel to categorize the measures and harmonize definitions using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). RESULTS: The panel reviewed 66 outcome measures and identified a minimum set of 8 broadly relevant measures in the OMF categories of patient survival, clinical response, events of interest, and resource utilization. The panel harmonized definitions for the 8 measures through in-person and virtual meetings. The panel did not reach consensus on 1 specific validated instrument for capturing patient-reported outcomes. The minimum set of harmonized outcome measures is broadly relevant to clinicians and patients and feasible to capture across NSCLC disease stages and treatment pathways. A pilot test of these measures would be useful to document the burden and value of the measures for research and in clinical practice. CONCLUSIONS: By collecting the harmonized measures consistently, registries and other data collection systems could contribute to the development research infrastructure and learning health systems to support new research and improve patient outcomes.

Harmonized Outcome Measures for Use in Depression Patient Registries and Clinical Practice.

Major depressive disorder is a common mental health condition that affects an estimated 16.2 million adults and 3.1 million adolescents in the United States. Yet, a lack of uniformity remains in measurements and monitoring for depression both in clinical practice and in research settings. This project aimed to develop a minimum set of standardized outcome measures relevant to both patients and clinicians that can be collected in depression registries and clinical practice. Twenty-nine depression registries and related data collection efforts were identified and invited to submit outcome measures. Additional measures were identified through literature searches and reviews of quality measures. A multistakeholder panel representing clinicians; payers; government agencies; industry; and medical specialty, health care quality, and patient advocacy organizations categorized the 27 identified measures using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework. The panel identified 10 broadly relevant measures and harmonized definitions for these measures through in-person and virtual meetings. The harmonized measures represent a minimum set of outcomes that are relevant to clinicians and patients and appropriate for use in depression research and clinical practice. Routine and consistent collection of these measures in registries and other systems would support creation of a national research infrastructure to efficiently address new questions, improve patient management and outcomes, and facilitate care coordination.

Patient-Reported Morbidity Instruments: A Systematic Review.

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.

Harmonized outcome measures for use in asthma patient registries and clinical practice.

BACKGROUND: Asthma, a common chronic airway disorder, affects an estimated 25 million persons in the United States and 330 million persons worldwide. Although many asthma patient registries exist, the ability to link and compare data across registries is hindered by a lack of harmonization in the outcome measures collected by each registry. OBJECTIVES: The purpose of this project was to develop a minimum set of patient- and provider-relevant standardized outcome measures that could be collected in asthma patient registries and clinical practice. METHODS: Asthma registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of quality measures and consensus statements. Outcome measures were categorized by using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework. A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: Forty-six outcome measures, including those identified from 13 registries, were curated and harmonized into a minimum set of 21 measures in the Outcome Measures Framework categories of survival, clinical response, events of interest, patient-reported outcomes, resource utilization, and experience of care. The harmonized definitions build on existing consensus statements and are appropriate for adult and pediatric patients. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in asthma research and clinical practice. Routine and consistent collection of these measures in registries and other systems would support creation of a national research infrastructure to efficiently address new questions and improve patient management and outcomes.

Subspecialty emergency room as alternative model for otolaryngologic care: implications for emergency health care delivery.

PURPOSE: A dedicated otolaryngology emergency room (ER) represents a specialized surgical evaluation and treatment setting that may be an alternative triage pathway for acute otolaryngologic complaints. We aim to characterize practice patterns in this setting and to provide insight into the epidemiology of all-comer, urgent otolaryngologic complaints in the United States. METHODS AND METHODS: Electronic medical records were reviewed for all patients who registered for otolaryngologic care and received a diagnosis in the Massachusetts Eye and Ear Infirmary ER between January 2011 and September 2013. Descriptive analysis was performed to characterize utilization and diagnostic patterns. Predictors of inpatient admission were identified using multivariable regression. Geocoding analysis was performed to characterize catchment area. RESULTS: A total of 12,234 patient visits were evaluated with a mean age of 44.7. Auditory and vestibular problems constituted the most frequent diagnoses (50.0%). The majority of patients were discharged home (92.3%). Forty-three percent of patients underwent a procedure in the ER; the most common procedure was diagnostic nasolaryngoscopy (52%). Predictors of inpatient admission were post-operative complaint (odds ratio [OR] 7.3, P<0.0001), arrival overnight (OR 3.3, P<0.0001), and laryngeal complaint (OR 2.4, P<0.0001). Patients traveled farther for evaluation of hearing loss (11 miles) and less for common diagnoses including impacted cerumen (7.1 miles) (P<0.0001). CONCLUSION: In this report, we investigate practice patterns of a dedicated otolaryngology emergency room to explore an alternative to standard acute otolaryngologic health care delivery mechanisms. We identify key predictors of inpatient admission. This study has implications for emergency health care delivery models.

A new approach to identifying patients with elevated risk for Fabry disease using a machine learning algorithm.

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.

Harmonized outcome measures for use in degenerative lumbar spondylolisthesis patient registries and clinical practice.

OBJECTIVE: The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS: Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality's Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS: The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS: This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

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

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.

Review of literature of saddle nose deformity reconstruction and presentation of vomer onlay graft.

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.

Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice: Endorsed by the Heart Rhythm Society Board of Trustees.

BACKGROUND: Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization. OBJECTIVES: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice. METHODS: AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.

Comparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System.

RATIONALE AND OBJECTIVES: To compare outcomes associated with breast cancer screening with digital mammography (DM) alone versus in combination with digital breast tomosynthesis (DBT) in a large representative cohort. MATERIALS AND METHODS: A total of 325,729 screening mammograms from 247,431 women were analyzed, across two healthcare systems, from June 2015 to September 2017. Patient level demographic, calculated risk levels, and clinical outcomes were extracted from radiology information system and electronic medical records. Multivariable regression modeling adjusting for institution, age, breast density, and first exam was conducted to compare patient characteristics, recall rates, time to biopsy and final diagnosis, clinical outcomes, and diagnostic performance. Participating institutions and the Coordinating Center received Institutional Review Board approval for a waiver of consent to collect and link data and perform analysis. RESULTS: A total of 194,437 (59.7%) screens were DBT versus 131,292 (40.3%) with DM. Women with dense breasts and higher calculated risk were more likely to be screened with DBT. Recall rates were lower for DBT overall (8.83% DBT vs 10.98% DM, adjusted odds ratio, 95% confidence interval = 0.85, 0.83-0.87) and across all age groups, races, and breast densities, and at facilities that used predominantly DBT (8.05%) versus predominantly DM (11.22%), or a combination (10.73%). The most common diagnostic pathway after recall was mammography and ultrasound. Women recalled from DBT were more likely to proceed directly to ultrasound. The median time to biopsy (18 vs 22 days) and final diagnosis (10 vs 13 days) was shorter for DBT. The adjusted cancer rate, cancer detection rate, and specificity were higher for DBT. CONCLUSION: DBT demonstrated a more efficient screening pathway and improved quality measures with lower recall rates in all patient types, reduced diagnostic mammography and shorter time to biopsy and final diagnosis.

Assessment of Chinese-version voice outcome survey in patients with unilateral vocal cord paralysis.

BACKGROUND: To develop a Mandarin Chinese outcome measure for the assessment of quality of life among unilateral vocal cord paralysis (UVCP) patients. METHODS: Voice Outcome Survey (VOS) was translated into Mandarin Chinese using a parallel model. The Chinese (Taiwan) version of the VOS (CVOS) was administered to 48 patients with symptomatic UVCP in a prospective manner; the CVOS was validated according to established criteria for reliability, validity, and longitudinal sensitivity. RESULTS: CVOS demonstrates moderate test-retest reliability (r = 0.59, P < 0.001) and internal consistency (Cronbach's alpha = 0.63). CVOS significantly correlates with most of the subscales in the Mandarin Chinese (Taiwan) version of 36-Item Short-Form Health Survey (SF-36) with only two exceptions (GH, general health; VT, vitality). The standardized response mean for the CVOS total score is 1.91, indicating excellent sensitivity to detect clinical changes. CONCLUSIONS: Performance characteristics of the CVOS are equivalent to the English-version VOS. CVOS is a valid tool to evaluate adults with UVCP-related problems among Chinese-speaking populations.

Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation.

OBJECTIVES: To transcutaneously deliver intense ultrasound (IUS) energy to target the facial superficial musculoaponeurotic system (SMAS), to produce discrete thermal injury zones (TIZs) in the SMAS, and to demonstrate the relative sparing of adjacent nontargeted layers superficial and deep to the SMAS layer. METHODS: In 6 unfixed human cadaveric specimens, the SMAS layer was visualized and targeted using the ultrasound imaging component of the IUS device. Using 2 IUS handpieces, 202 exposure lines were delivered bilaterally in multiple facial regions by varying combinations of power and exposure time (0.5-8.0 J). Tissue was then excised and examined grossly and histologically for evidence of thermal injury using nitroblue tetrazolium chloride viability stain. RESULTS: Reproducible TIZs were produced selectively in the SMAS at depths of up to 7.8 mm, and sparing of surrounding tissue including the epidermis. Higher energy settings and high-density exposure line pattern produced a greater degree of tissue shrinkage. CONCLUSIONS: In human cadaveric facial tissue, IUS can noninvasively target and selectively produce TIZs of reproducible location, size, and geometry in the SMAS layer. The ability to produce focused thermal collagen denaturation in the SMAS to induce shrinkage and tissue tightening has not been previously reported and has significant implications for aesthetic facial rejuvenation.

Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues.

OBJECTIVE: To evaluate the clinical safety of intense ultrasound in the treatment of the dermis and subcutaneous tissues of the face and neck in terms of skin inflammation, pain, adverse events, and histologic features. DESIGN: In an open-label, phase 1 study, patients scheduled to undergo a rhytidectomy were enrolled into immediate (face-lift surgery within 24 hours of intense ultrasound treatment) and delayed (face-lift surgery 4-12 weeks after treatment) treatment groups. Intense ultrasound treatments were performed as a series of several linear exposures delivered 1.5 to 2.0 mm apart with the use of 1 of 3 available handpieces with different focal depths. Subject pain ratings and standardized digital photographs were obtained at uniform points. Photographs were blindly rated for inflammation. Histologic evaluation of treated tissues was performed with nitroblue tetrazolium chloride viability stain. RESULTS: Fifteen subjects with a mean +/- SD age of 53 +/- 7 years were enrolled. Seven subjects were nonrandomly assigned to the immediate group and 8 were in the delayed group. On histologic examination, thermal injury zones were consistently identified in the dermis at exposure levels greater than 0.5 J as focal areas of denatured collagen. At this threshold level or above, most patient exposures were associated with transient superficial skin erythema and slight to mild discomfort on a standardized pain scale. No other adverse effects were noted in any case. Thermal injury zones were produced in the expected linear pattern and were consistent in size and depth from zone to zone. Increasing source power did not increase the depth of the epicenter of the thermal injury zone. Epidermis was spared in all cases. CONCLUSION: In this first clinical study of intense ultrasound therapy to facial tissues, the intense ultrasound system allowed for the safe and well-tolerated placement of targeted, precise, and consistent thermal injury zones in the dermis and subcutaneous tissues with sparing of the epidermis.

Generic and specific quality-of-life measures in Taiwanese adults with sleep-disordered breathing.

OBJECTIVE: To investigate the quality-of-life status of Taiwanese adult patients with sleep-disordered breathing (SDB). STUDY DESIGN AND SETTING: A prospective, quality-of-life survey in a tertiary referral sleep center on 94 consecutive adult SDB patients. Patients were evaluated with polysomnogram, Medical Outcome Study SF-36 Health Survey, Snore Outcome Survey (SOS), and Epworth Sleepiness Scale (ESS). RESULTS: SDB patients have significantly lower scores in all 8 SF-36 subscales (P < 0.05) than do normative Taiwan adult population. Apnea patients have lower SOS (34.5 +/- 7.5 vs 40.1 +/- 10.3, P = 0.005) and higher ESS scores than do simple snorers (8.8 +/- 5.1 vs 11.7 +/- 5.2, P = 0.03). Patients with a higher degree of sleepiness show worse performance in all dimensions of their general health status (P values 0.0005 to 0.01). Deep sleep (stage 3 + 4) is predictive of SF-36 role: physical (beta = 1.63, P = 0.04), bodily pain (beta = 1.22, P = 0.01), vitality (beta = 1.05, P = 0.01), subscales scores (adjusted R(2) 0.005 to 0.1). CONCLUSION: SDB has considerable impact on a patient's global health status. SIGNIFICANCE: Daytime sleepiness, rather than apnea, is a major quality-of-life determinant. EBM RATING: B-2b.

Texting while driving: the development and validation of the distracted driving survey and risk score among young adults.

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.

The impact of surgical trainee participation on sinus surgery outcomes.

OBJECTIVES/HYPOTHESIS: To determine the effect of otolaryngology trainee participation on clinical outcomes in patients who undergo endoscopic sinus surgery (ESS) for chronic rhinosinusitis. STUDY DESIGN: Secondary analysis of prospectively collected data. METHODS: Patients enrolled in a sinus surgery outcomes study between May 2011 and March 2013 were stratified into two groups--those who were operated on by an attending alone and those operated on by an attending with a trainee present (resident, fellow, or both). Patients completed quality of life (QOL) surveys including the Chronic Sinusitis Survey (CSS), 22-item Sino-Nasal Outcome Test (SNOT-22), and EuroQol 5-dimension survey preoperatively and 1 year postoperatively. Operative time, estimated blood loss (EBL), complication rates, and survey scores were compared between groups. RESULTS: The study population consisted of 452 patients. The attending alone (n = 119) and trainee (n = 333) groups were statistically comparable in terms of patient demographics, disease severity, and extent of surgery. Mean operative time was significantly shorter in the attending-alone group (80.0 vs. 90.6 minutes, P < .01). Mean EBL (105 mL attending vs. 117 mL trainee, P = .39) and complication rates (3.3% attending vs. 0.6% trainee, P = .07) were similar between groups. Observed changes in QOL measures following ESS were comparable between groups, although absolute improvement in the SNOT-22 scores (19.0 attending vs. 24.5 trainee, P = .05) did show a trend toward greater improvement in the trainee group. CONCLUSIONS: Trainee participation in ESS is associated with prolongation in surgical time; however, such participation was not found to adversely affect patient safety or clinical outcomes. LEVEL OF EVIDENCE: 2b.

Impact of treatment strategies for open angle glaucoma on intraocular pressure: the RiGOR study.

AIMS: The RiGOR study's primary outcome measure was a 15% reduction in intraocular pressure (IOP) for patients with open-angle glaucoma at 1 year. METHODS: Patients received treatment according to the ophthalmologist's usual practice. RESULTS: A higher proportion of patients in the incisional and other surgery group achieved a 15% reduction in IOP than in the laser surgery or additional medication groups (82, 57, and 57% respectively). In multivariate regression analyses, incisional surgery patients were 2.7-times as likely as patients treated with additional medication to achieve a 15% reduction in IOP (odds ratio: 2.67; 95% CI: 2.01-3.57). CONCLUSION: Incisional and other surgical procedures are effective treatments. There were no differences in treatment response by race or ethnicity.

Quality of life and visual acuity outcomes in the Registry in Glaucoma Outcomes Research study.

AIMS: The RiGOR study evaluated the association of treatment and patient-reported outcomes for open-angle glaucoma patients. METHODS: The Glaucoma Symptom Scale (National Eye Institute-Visual Function Questionnaire (NEI-VFQ) and visual acuity (VA) were collected as quality of life measures. RESULTS: The proportion of patients with improvement of at least two lines of vision was highest in the incisional surgery group (14.2% compared with 9.9% for laser surgery and 10.9% for additional medication). CONCLUSION: No clinically relevant differences were seen in benefit for the laser surgery or incisional surgery groups compared with additional medications for the Glaucoma Symptom Scale or NEI-VFQ measures or subscales. Differences in quality of life by race need to be explored in further studies.

RiGOR: a prospective observational study comparing the effectiveness of treatment strategies for open-angle glaucoma.

AIMS: The RigOR study was designed to assess comparative effectiveness of medications, laser trabeculoplasty and incisional surgery in patients with open-angle glaucoma (OAG) in the community initiating a new or additional course of therapy as judged necessary by their ophthalmologist. This paper focuses specifically on demographic and clinical characteristics of OAG patients at enrollment. PATIENTS & METHODS: A total of 2597 with OAG already on medical therapy were enrolled from 45 community and academic practices throughout the USA. RESULTS: Overall, 784 (30%) patients were treated with laser surgery, 436 with other surgical procedures (17%), and 1377 with additional medication (53%). Patients had mild (35%) or moderate (31%) glaucoma, with 28% with severe glaucoma. CONCLUSION: The RiGOR study enrolled a diverse population and will provide valuable information regarding visual function and treatment patterns among different racial/ethnic populations. African-American and Hispanic patients entered the study with poorer visual acuity and more severe glaucoma.