Role of real-world digital data for orthopedic implant automated surveillance: a systematic review

Dhalluin, Thibault; Fakhiri, Sara; Bouzillé, Guillaume; Herbert, Julien; Rosset, Philippe; Cuggia, Marc; Grammatico‐Guillon, Leslie

doi:10.1080/17434440.2021.1943361

Cited by 4 publications

(1 citation statement)

References 79 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Some studies have discussed how to use UDI to facilitate real-world medical device surveillance research. 5 , 6 However, for these studies, a big challenge remains regarding how to standardize and integrate medical device and electronic health record (EHR)-related data together, especially for studies that include multiple institutions. Meanwhile, a variety of common data models (CDMs) have been developed to provide a standardized approach to store and organize clinical research data.…”

Section: Introductionmentioning

confidence: 99%

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Jiang

Brandt

et al. 2023

JAMIA Open

View full text Add to dashboard Cite

The objective of this study is to describe application of the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to support medical device real-world evaluation in a National Evaluation System for health Technology Coordinating Center (NESTcc) Test-Case involving 2 healthcare systems, Mercy Health and Mayo Clinic. CDM implementation was coordinated across 2 healthcare systems with multiple hospitals to aggregate both medical device data from supply chain databases and patient outcomes and covariates from electronic health record data. Several data quality assurance (QA) analyses were implemented on the OMOP CDM to validate the data extraction, transformation, and load (ETL) process. OMOP CDM-based data of relevant patient encounters were successfully established to support studies for FDA regulatory submissions. QA analyses verified that the data transformation was robust between data sources and OMOP CDM. Our efforts provided useful insights in real-world data integration using OMOP CDM for medical device evaluation coordinated across multiple healthcare systems.

show abstract

Section: Introductionmentioning

confidence: 99%

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Jiang

Brandt

et al. 2023

JAMIA Open

View full text Add to dashboard Cite

show abstract

Register-based research and clinical studies

et al. 2023

View full text Add to dashboard Cite

Validation of the first computerized indicator for orthopaedic surgical site infections in France: ISO-ORTHO

Grammatico‐Guillon

Banaei-Bouchareb²,

Solomiac³

et al. 2023

Antimicrob Resist Infect Control

View full text Add to dashboard Cite

Background The French national authority for health (HAS) develops in-hospital indicators for improving quality of care, safety and patient outcome. Since 2017, it has developed a measurement of surgical site infections (SSI) after total hip or knee arthroplasty (TH/KA) by using a computerized indicator, called ISO-ORTHO, based on a hospital discharge database (HDD) algorithm. The aim of the study was to assess the performance of this new indicator . Methods The ISO-ORTHO performance was estimated via its positive predictive value (PPV) among adult patients having undergone a TH/KA between January 1st and September 30th 2018, based on the orthopaedic procedure codes. Patients at very high risk of SSI and/or with SSI not related to the in-hospital care were excluded. SSI were detected from the date of admission up to 90 days after the TH/KA using the ISO-ORTHO algorithm, based on 15 combinations of ICD-10 and procedure codes. Its PPV was estimated by a chart review in volunteer healthcare organisations (HCO). Results Over the study period, 777 HCO including 143,227 TH/KA stays were selected, providing 1,279 SSI according to the ISO-ORTHO indicator. The 90-day SSI rate was 0.89 per 100 TH/KA stays (0.98% for THA and 0.80% for TKA). Among the 448 HCO with at least 1 SSI, 250 HCO participated in reviewing 725 SSI charts; 665 were confirmed, giving a PPV of 90.3% [88.2-92.5%], 89.9% [87.1-92.8%] in THA and 90.9% [87.7-94.2%] in TKA. Conclusions The PPV of ISO-ORTHO over 90% confirms its validity for any use according to the HAS method. ISO-ORTHO and detailed information were provided in 2020 to HCO and used for quality assessment and in-hospital risk management.

show abstract

Role of real-world digital data for orthopedic implant automated surveillance: a systematic review

Cited by 4 publications

References 79 publications

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation

Register-based research and clinical studies

Validation of the first computerized indicator for orthopaedic surgical site infections in France: ISO-ORTHO

Contact Info

Product

Resources

About