Emulating VIEW 1 and VIEW 2 Clinical Trial Outcome Data Using the American Academy of Ophthalmology IRIS Registry.

BACKGROUND AND OBJECTIVE: A retrospective, noninterventional cohort study of the American Academy of Ophthalmology IRIS Registry, an electronic health record (EHR)-based comprehensive eye disease and condition registry, intended to assess whether the IRIS® Registry (Intelligent Research in Sight) could emulate the VIEW randomized clinical trials (VIEW RCTs) eligibility criteria, treatment protocol regimen, and primary endpoint. PATIENTS AND METHODS: Deidentified patients having an anti-VEGF injection of aflibercept or ranibizumab between January 1, 2013, and December 31, 2018, from the IRIS Registry. Patients were treated in accordance with one of three treatment regimens from the VIEW RCT: monthly intravitreal aflibercept injection (IAI 2Q4), intravitreal aflibercept every 2 months after 3 initial monthly doses (IAI 2Q8), or monthly ranibizumab (RQ4) injection. The main outcome measures are the number and proportion of patients meeting VIEW RCT eligibility and treatment group criteria, demographic, and clinical differences between IRIS Registry treatment groups, mean change in best documented visual acuity at one year, and evaluation of the primary endpoint of the VIEW RCT: difference in the proportion of patients maintaining vision. RESULTS: Among the 90,900 patients who met VIEW RCT eligibility criteria, 4,457 (4.85%) met treatment group criteria. The percentage of patients maintaining vision at one year was over 90%. No statistically significant difference was observed when comparing the proportion of patients maintaining vision among the RQ4 treatment group to the IAI 2Q4 or IAI 2Q8 treatment group. CONCLUSIONS: A small percentage of real-world patients met VIEW RCT study eligibility criteria and treatment protocol regimen. Among patients meeting all available criteria, the primary endpoint interpretation yielded by an observational EHR-based dataset suggested comparable results to the VIEW RCT. [Ophthalmic Surg Lasers Imaging Retina 2023;54:6-14.].

Use of Death Certificates to Identify Tuberculosis-Related Deaths in Washington State.

CONTEXT: Death certificates are routinely used to estimate tuberculosis (TB) mortality rates. The validity of International Classification of Diseases, Tenth Revision (ICD-10) codes and text cause of death data for this purpose is uncertain. OBJECTIVE: To evaluate the accuracy of ICD-10 coded and text cause of death data in identifying TB-related deaths in Washington State. DESIGN: Cross-sectional descriptive study comparing TB-related deaths detected through Washington State death certificates to TB-related deaths identified in the Washington State TB registry during 2009-2010. MAIN OUTCOME MEASURE(S): Sensitivity and positive predictive value of ICD-10 coded and text cause of death definitions in identifying TB-related deaths compared to the TB registry. RESULTS: All methods for identifying TB-related deaths using death certificate data overestimated the number of TB-related deaths compared to the tuberculosis registry. The positive predictive value ranged from 22% for a TB ICD-10 code as an underlying or multiple cause of death to 56% for TB listed in the direct cause of death text field. Seventeen (33%) of 51 subjects assigned with a TB ICD-10 code as an underlying or multiple cause of death had no evidence of TB on the death certificate and were not present in the TB registry. CONCLUSIONS: Death certificates were not highly predictive of TB-related deaths. Use of the direct cause of death text field was the most accurate method to identify a TB-related death when using death certificates. Specific ICD-10 coding algorithms may misclassify subjects as having died from TB.