Real-World Data Set Parameters and Synthesization for Matching Identity in Clinical Protocols

Author(s):  
Hanna Farah ◽  
Daniel Amyot ◽  
Khaled El Emam
2019 ◽  
Vol 10 (03) ◽  
pp. 409-420 ◽  
Author(s):  
Steven Horng ◽  
Nathaniel R. Greenbaum ◽  
Larry A. Nathanson ◽  
James C. McClay ◽  
Foster R. Goss ◽  
...  

Objective Numerous attempts have been made to create a standardized “presenting problem” or “chief complaint” list to characterize the nature of an emergency department visit. Previous attempts have failed to gain widespread adoption as they were not freely shareable or did not contain the right level of specificity, structure, and clinical relevance to gain acceptance by the larger emergency medicine community. Using real-world data, we constructed a presenting problem list that addresses these challenges. Materials and Methods We prospectively captured the presenting problems for 180,424 consecutive emergency department patient visits at an urban, academic, Level I trauma center in the Boston metro area. No patients were excluded. We used a consensus process to iteratively derive our system using real-world data. We used the first 70% of consecutive visits to derive our ontology, followed by a 6-month washout period, and the remaining 30% for validation. All concepts were mapped to Systematized Nomenclature of Medicine–Clinical Terms (SNOMED CT). Results Our system consists of a polyhierarchical ontology containing 692 unique concepts, 2,118 synonyms, and 30,613 nonvisible descriptions to correct misspellings and nonstandard terminology. Our ontology successfully captured structured data for 95.9% of visits in our validation data set. Discussion and Conclusion We present the HierArchical Presenting Problem ontologY (HaPPy). This ontology was empirically derived and then iteratively validated by an expert consensus panel. HaPPy contains 692 presenting problem concepts, each concept being mapped to SNOMED CT. This freely sharable ontology can help to facilitate presenting problem-based quality metrics, research, and patient care.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 180-180 ◽  
Author(s):  
A. Oliver Sartor ◽  
Sreevalsa Appukkuttan ◽  
Ronald E. Aubert ◽  
Jeffrey Weiss ◽  
Joy Wang ◽  
...  

180 Background: Radium-223 (RA-223) is the first FDA approved targeted alpha therapy that significantly improves overall survival (OS) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases. There is limited real world data describing RA-223 current use. Methods: A retrospective patient chart review was done of men who received at least 1 cycle of Ra-223 for mCRPC in 10 centers throughout the US (4 academic, 6 private practices). All pts had a minimum follow-up of 4 months, or placed in hospice or death. Descriptive analyses for clinical characteristics and treatment outcomes were performed. Results: Among the 200 pts (mean age-73.6 years, mean Charlson comorbidity index-6.9) RA-223 was initiated on average 1.6 years from mCRPC diagnosis (first line use (1L)=38.5%, 2L=31.5% and ≥3L=30%). 78% completed 5-6 cycles of RA-223 with mean therapy duration of 4.2 months. Among all pts, 43% received RA-223 as monotherapy (no overlap with other mCRPC therapies) while 57% had combination therapy with either abiraterone or enzalutamide. Median OS following RA-223 initiation was 21.2 months (95% CI 19.6- 29.2). Table provides the RA-223 utilization by type of clinical practice. Conclusions: Utilization of RA-223 in this real world data set was distinct from clinical trial data. Most patients received RA-223 in combination with abiraterone or enzalutamide, therapies that were unavailable when the pilot trial was conducted. Median survival was 21.2 months. Real world use of RA-223 has evolved as newer agents have become FDA approved in bone-metastatic CRPC. Academic and community patterns of practice were more similar than distinct. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18725-e18725
Author(s):  
Ravit Geva ◽  
Barliz Waissengrin ◽  
Dan Mirelman ◽  
Felix Bokstein ◽  
Deborah T. Blumenthal ◽  
...  

e18725 Background: Healthcare data sharing is important for the creation of diverse and large data sets, supporting clinical decision making, and accelerating efficient research to improve patient outcomes. This is especially vital in the case of real world data analysis. However, stakeholders are reluctant to share their data without ensuring patients’ privacy, proper protection of their data sets and the ways they are being used. Homomorphic encryption is a cryptographic capability that can address these issues by enabling computation on encrypted data without ever decrypting it, so the analytics results are obtained without revealing the raw data. The aim of this study is to prove the accuracy of analytics results and the practical efficiency of the technology. Methods: A real-world data set of colorectal cancer patients’ survival data, following two different treatment interventions, including 623 patients and 24 variables, amounting to 14,952 items of data, was encrypted using leveled homomorphic encryption implemented in the PALISADE software library. Statistical analysis of key oncological endpoints was blindly performed on both the raw data and the homomorphically-encrypted data using descriptive statistics and survival analysis with Kaplan-Meier curves. Results were then compared with an accuracy goal of two decimals. Results: The difference between the raw data and the homomorphically encrypted data results, regarding all variables analyzed was within the pre-determined accuracy range goal, as well as the practical efficiency of the encrypted computation measured by run time, are presented in table. Conclusions: This study demonstrates that data encrypted with Homomorphic Encryption can be statistical analyzed with a precision of at least two decimal places, allowing safe clinical conclusions drawing while preserving patients’ privacy and protecting data owners’ data assets. Homomorphic encryption allows performing efficient computation on encrypted data non-interactively and without requiring decryption during computation time. Utilizing the technology will empower large-scale cross-institution and cross- stakeholder collaboration, allowing safe international collaborations. Clinical trial information: 0048-19-TLV. [Table: see text]


1985 ◽  
Vol 22 (4) ◽  
pp. 462-467 ◽  
Author(s):  
Dennis H. Gensch

All disaggregate multiattribute choice models contain the assumption that the population is reasonably homogeneous with respect to the aggregate parameters estimated by the model. The author points out that one particular choice model, logit, has a structure that makes it particularly suited to test a data set for possible segments. A real-world data set is used to illustrate a simple procedure for testing the homogeneity assumption. The analysis provides a warning that managers may easily derive suboptimal or counterproductive strategies if they fail to test this assumption.


2018 ◽  
Vol 210 ◽  
pp. 04019 ◽  
Author(s):  
Hyontai SUG

Recent world events in go games between human and artificial intelligence called AlphaGo showed the big advancement in machine learning technologies. While AlphaGo was trained using real world data, AlphaGo Zero was trained using massive random data, and the fact that AlphaGo Zero won AlphaGo completely revealed that diversity and size in training data is important for better performance for the machine learning algorithms, especially in deep learning algorithms of neural networks. On the other hand, artificial neural networks and decision trees are widely accepted machine learning algorithms because of their robustness in errors and comprehensibility respectively. In this paper in order to prove that diversity and size in data are important factors for better performance of machine learning algorithms empirically, the two representative algorithms are used for experiment. A real world data set called breast tissue was chosen, because the data set consists of real numbers that is very good property for artificial random data generation. The result of the experiment proved the fact that the diversity and size of data are very important factors for better performance.


2002 ◽  
Vol 14 (1) ◽  
pp. 21-41 ◽  
Author(s):  
Marco Saerens ◽  
Patrice Latinne ◽  
Christine Decaestecker

It sometimes happens (for instance in case control studies) that a classifier is trained on a data set that does not reflect the true a priori probabilities of the target classes on real-world data. This may have a negative effect on the classification accuracy obtained on the real-world data set, especially when the classifier's decisions are based on the a posteriori probabilities of class membership. Indeed, in this case, the trained classifier provides estimates of the a posteriori probabilities that are not valid for this real-world data set (they rely on the a priori probabilities of the training set). Applying the classifier as is (without correcting its outputs with respect to these new conditions) on this new data set may thus be suboptimal. In this note, we present a simple iterative procedure for adjusting the outputs of the trained classifier with respect to these new a priori probabilities without having to refit the model, even when these probabilities are not known in advance. As a by-product, estimates of the new a priori probabilities are also obtained. This iterative algorithm is a straightforward instance of the expectation-maximization (EM) algorithm and is shown to maximize the likelihood of the new data. Thereafter, we discuss a statistical test that can be applied to decide if the a priori class probabilities have changed from the training set to the real-world data. The procedure is illustrated on different classification problems involving a multilayer neural network, and comparisons with a standard procedure for a priori probability estimation are provided. Our original method, based on the EM algorithm, is shown to be superior to the standard one for a priori probability estimation. Experimental results also indicate that the classifier with adjusted outputs always performs better than the original one in terms of classification accuracy, when the a priori probability conditions differ from the training set to the real-world data. The gain in classification accuracy can be significant.


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Nibha Jain ◽  
Ramasharan Laxminarayan ◽  
Arumugam Moorthy ◽  
Roshan Amarasena ◽  
Natasha Cleaton ◽  
...  

Abstract Background/Aims  Secukinumab is an interleukin-17 inhibitor has been found to be effective in the treatment of ankylosing spondylitis (AS) in studies, including phase 3 clinical trials, however these are conducted in highly selected patients and it is important to confirm the efficacy and safety in a real world data. Response to secukinumab should be assessed after 16-weeks and continued if there has been sufficient response to treatment according to the BASDAI and spinal VAS scores. Methods  This was a multicentre cross-sectional observational study in collaboration with Midland Ankylosing Spondylitis Collaboration. Consecutive baseline and 16th week data of all AS patients on Secukinumab from 2017 to 2019 were collected and analysed to assess treatment response. All data were compiled in excel sheets and analysed using Medcalc calculator. Data were collected from collaborative efforts of the Royal Wolverhampton NHS trust, Queen’s Hospital (Burton on Trent), Leicester Royal Infirmary and Robert Jones and Agnes Hunt hospital. Results  Total 92 patients with radiographic AS on standard dose of secukinumab were included at baseline and 88 were followed up till week 16. Mean age was 45.9(SD ± 15) (Median=44years) and 67% were male. Baseline Mean BASDAI was 7 (SD ± 1.7); Mean CRP was 16.6 (SD ± 11.2), Mean VAS was 7.6(SD ± 1.6). There was statistical significant change in BASDAI, VAS and CRP levels at week 16th. ΔBASDAI=2.2 (SD ± 2) (p = 0.002), ΔVAS=3.2 (SD ± 2.1) (p = 0.001), ΔCRP=6.9 (SD ± 17) (p = 0.03). At 16th week, 68% had clinical improvement while 4 patients discontinued therapy (2-colitis, 1-uveitis and 1-patient choice). 10% overall had some adverse effects with most common being upper respiratory tract infection. We also compared patients with previous anti-TNF exposure (TE) to Anti-TNF naïve (TN). 63% were in TE group vs 37% in TN. 69% of TE and 76% of TN showed clinical improvement at week 16.Mean ΔBASDAI was more in TN group vs TE (p = 0.01), however there was no difference in ΔVAS and ΔCRP levels. (p = 0.0 & p = 0.2 respectively). Conclusion  This multi-centre retrospective analysis found secukinumab to be clinically effective in 68% of patients with AS. There was significant improvement in BASDAI, VAS and CRP levels at week16. Compared to anti-TNF resistant patients, TNF-Naïve responded better to secukinumab, although both showed good clinical improvement. These findings support the use of secukinumab in the treatment of AS, as a first line therapy or for those who have failed anti-TNF therapy. Safety signals observed in the real-word data set were consistent with those seen in the clinical trials and the Summary of Product Characteristics. Disclosure  N. Jain: None. R. Laxminarayan: Honoraria; Honorarium from Novartis, Lilly, Pfizer and Abvie. A. Moorthy: Honoraria; Speaker and conference fee MSD, Novartis, Abbvie. R. Amarasena: None. N. Cleaton: None. G. Kakade: None. A. Gunawardane: None. T. Khan: None. H. Sapkota: None. N. Barkham: Grants/research support; research funding from Novartis, Eli Lilly, UCB.


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