clinical registries
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Author(s):  
Jeremy Adler ◽  
Sally J Eder ◽  
Acham Gebremariam ◽  
Christopher J Moran ◽  
Lee M Bass ◽  
...  

Abstract Background Endoscopic mucosal healing is the gold standard for evaluating Crohn’s disease (CD) treatment efficacy. Standard endoscopic indices are not routinely used in clinical practice, limiting the quality of retrospective research. A method for retrospectively quantifying mucosal activity from documentation is needed. We evaluated the simplified endoscopic mucosal assessment for CD (SEMA-CD) to determine if it can accurately quantify mucosal severity recorded in colonoscopy reports. Methods Pediatric patients with CD underwent colonoscopy that was video recorded and evaluated via Simple Endoscopic Score for CD (SES-CD) and SEMA-CD by central readers. Corresponding colonoscopy reports were de-identified. Central readers blinded to clinical history and video scoring were randomly assigned colonoscopy reports with and without images. The SEMA-CD was scored for each report. Correlation with video SES-CD and SEMA-CD were assessed with Spearman rho, inter-rater, and intrarater reliability with kappa statistics. Results Fifty-seven colonoscopy reports were read a total of 347 times. The simplified endoscopic mucosal assessment for CD without images correlated with both SES-CD and SEMA-CD from videos (rho = 0.82, P < .0001 for each). The addition of images provided similar correlation. Inter-rater and intrarater reliability were 0.93 and 0.92, respectively. Conclusions The SEMA-CD applied to retrospective evaluation of colonoscopy reports accurately and reproducibly correlates with SES-CD and SEMA-CD of colonoscopy videos. The SEMA-CD for evaluating colonoscopy reports will enable quantifying mucosal healing in retrospective research. Having objective outcome data will enable higher-quality research to be conducted across multicenter collaboratives and in clinical registries. External validation is needed.


2021 ◽  
Vol 30 (162) ◽  
pp. 210194
Author(s):  
Ruben J. Mylvaganam ◽  
Joseph I. Bailey ◽  
Jacob I. Sznajder ◽  
Marc A. Sala

Acute manifestations of SARS-CoV-2 infection continue to impact the lives of many across the world. Post-acute sequelae of coronavirus disease 2019 (COVID-19) may affect 10–30% of survivors of COVID-19, and post-acute sequelae of COVID-19 (PASC)-pulmonary fibrosis is a long-term outcome associated with major morbidity. Data from prior coronavirus outbreaks (severe acute respiratory syndrome and Middle East respiratory syndrome) suggest that pulmonary fibrosis will contribute to long-term respiratory morbidity, suggesting that PASC-pulmonary fibrosis should be thoroughly screened for through pulmonary function testing and cross-sectional imaging. As data accumulates on the unique pathobiologic mechanisms underlying critical COVID-19, a focus on corollaries to the subacute and chronic profibrotic phenotype must be sought as well. Key aspects of acute COVID-19 pathobiology that may account for increased rates of pulmonary fibrosis include monocyte/macrophage–T-cell circuits, profibrotic RNA transcriptomics, protracted elevated levels of inflammatory cytokines, and duration of illness and ventilation. Mechanistic understanding of PASC-pulmonary fibrosis will be central in determining therapeutic options and will ultimately play a role in transplant considerations. Well-designed cohort studies and prospective clinical registries are needed. Clinicians, researchers and healthcare systems must actively address this complication of PASC to minimise disability, maximise quality of life and confront a post-COVID-19 global health crisis.


Author(s):  
Sean Ming Sheng Ng ◽  
Rebecca Low ◽  
Annette K. Hoskin ◽  
Andres Rousselot ◽  
Dinesh Visva Gunasekeran ◽  
...  

10.2196/31288 ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. e31288
Author(s):  
Lingtong Min ◽  
Koray Atalag ◽  
Qi Tian ◽  
Yani Chen ◽  
Xudong Lu

Background The semantic interoperability of health care information has been a critical challenge in medical informatics and has influenced the integration, sharing, analysis, and use of medical big data. International standard organizations have developed standards, approaches, and models to improve and implement semantic interoperability. The openEHR approach—one of the standout semantic interoperability approaches—has been implemented worldwide to improve semantic interoperability based on reused archetypes. Objective This study aimed to verify the feasibility of implementing semantic interoperability in different countries by comparing the openEHR-based information models of 2 acute coronary syndrome (ACS) registries from China and New Zealand. Methods A semantic archetype comparison method was proposed to determine the semantics reuse degree of reused archetypes in 2 ACS-related clinical registries from 2 countries. This method involved (1) determining the scope of reused archetypes; (2) identifying corresponding data items within corresponding archetypes; (3) comparing the semantics of corresponding data items; and (4) calculating the number of mappings in corresponding data items and analyzing results. Results Among the related archetypes in the two ACS-related, openEHR-based clinical registries from China and New Zealand, there were 8 pairs of reusable archetypes, which included 89 pairs of corresponding data items and 120 noncorresponding data items. Of the 89 corresponding data item pairs, 87 pairs (98%) were mappable and therefore supported semantic interoperability, and 71 pairs (80%) were labeled as “direct mapping” data items. Of the 120 noncorresponding data items, 114 (95%) data items were generated via archetype evolution, and 6 (5%) data items were generated via archetype localization. Conclusions The results of the semantic comparison between the two ACS-related clinical registries prove the feasibility of establishing the semantic interoperability of health care data from different countries based on the openEHR approach. Archetype reuse provides data on the degree to which semantic interoperability exists when using the openEHR approach. Although the openEHR community has effectively promoted archetype reuse and semantic interoperability by providing archetype modeling methods, tools, model repositories, and archetype design patterns, the uncontrolled evolution of archetypes and inconsistent localization have resulted in major challenges for achieving higher levels of semantic interoperability.


2021 ◽  
Author(s):  
Kristina Gaietto ◽  
Megan Culler Freeman ◽  
Leigh Anne DiCicco ◽  
Sherry Rauenswinter ◽  
Joseph R Squier ◽  
...  

BACKGROUND: Most pediatric studies of asthma and COVID-19 to date have been ecological, which offer limited insight. We evaluated the association between asthma and COVID-19 at an individual level. METHODS: Using data from prospective clinical registries, we conducted a nested case-control study comparing three groups: children with COVID-19 and underlying asthma ("A+C" cases); children with COVID-19 without underlying disease ("C+" controls); and children with asthma without COVID-19 ("A+" controls). RESULTS: The cohort included 142 A+C cases, 1110 C+ controls, and 140 A+ controls. A+C cases were more likely than C+ controls to present with dyspnea and wheezing, to receive pharmacologic treatment including systemic steroids (all p<0.01), and to be hospitalized (4.9% vs 1.7%, p=0.01). In the adjusted analysis, A+C cases were nearly 4 times more likely to be hospitalized than C+ controls (adjusted OR=3.95 [95%CI=1.4-10.9]); however, length of stay and respiratory support level did not differ between groups. Among A+C cases, 8.5% presented with an asthma exacerbation and another 6.3% developed acute exacerbation symptoms shortly after testing positive for SARS-CoV-2. Compared to historic A+ controls, A+C cases had less severe asthma, were less likely to be on controller medications, and had better asthma symptom control (all p<0.01). CONCLUSIONS: In our cohort, asthma was a risk factor for hospitalization in children with COVID-19, but not for worse COVID-19 outcomes. SARS-CoV-2 does not seem to be a strong trigger for pediatric asthma exacerbations. Asthma severity was not associated with higher risk of COVID-19.


Surgeries ◽  
2021 ◽  
Vol 2 (3) ◽  
pp. 335-346
Author(s):  
Kengo Mukuda ◽  
Jun Watanabe

Punch incision is an alternative to elliptical excision for treating epidermal inclusion cysts, but its efficacy has not been systematically reviewed. This study assessed the efficacy and safety of punch incision versus elliptical excision for epidermal inclusion cysts. Randomized controlled trials published through January 2021 that evaluated the performance of punch incision versus elliptical excision on epidermal inclusion cysts were identified through electronic databases and clinical registries. Version 2 of the Cochrane risk-of-bias tool for randomized trials tool was used. Review Manager software was used for the meta-analysis. Two trials (100 participants) were identified. The primary outcomes were recurrence rate (risk ratio, 2.40; 95% confidence interval [CI], 0.37–15.60 [favoring elliptical excision]), mean operative time (mean difference [MD], −5.28; 95% CI, −12.72 to 2.16 [favoring punch incision]), and mean postoperative wound length (MD, −11.67; 95% CI, −20.59 to −2.76 [favoring punch incision]). The evidence was low to moderate due to the small sample size and its considerable heterogeneity. The use of punch incision shortened the mean postoperative wound length and had comparable safety to that of elliptical excision.


Author(s):  
Martina Vasakova ◽  
Martina Sterclova ◽  
Nesrin Moğulkoç ◽  
Katerzyna Lewandowska ◽  
Veronika Müller ◽  
...  

2021 ◽  
Vol 1 (1) ◽  
pp. 10-15
Author(s):  
A. V. Ivanov

The development of medical science requires a constant increase in the effectiveness and safety of treatment. Collection of real-world data (RWD) is one way of solving these problems. Clinical registries are one of the most important parts of this process. Clinical registries allow collecting data on the use of medical technologies and monitoring the results of therapy in real clinical practice. The introduction of patient registers and the collection of RWD data into widespread medical practice can help to optimize costs in the treatment of high-cost diseases and to better plan the budget.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
James Reeves Mbori Ngwayi ◽  
Jie Tan ◽  
Ning Liang ◽  
Kenedy Uzoma Obie ◽  
Daniel Edward Porter

Abstract Background Patient Reported Outcome Measures (PROMs) are widely used in Europe and North America in a variety of areas including research, clinical governance, clinical registries and insurance ascertainment. The aim of this study was to assess commonly used knee and hip PROMs among Chinese surgeons and to gain an insight into their impact on evaluation of clinical outcomes. Methods 1. A systematic literature search of databases Medline, EMBASE, CINAHL and CNKI was performed from the earliest records to 22/07/2020 for knee instruments and 22/08/2020 for hip instruments, to retrieve Chinese Mandarin cross culturally adapted and validated knee and hip PROMs. 2. An 11-item electronic questionnaire was then designed under four domain categories. The survey was distributed via a ubiquitous online social media platform to orthopaedic surgeons. Responses were collected and analyzed. Output from 1. was used to populate parts of the survey questionnaire. Results The systematic online search yielded a total of 41 evaluation instruments, (10 hip and 31 knee); all of which were incorporated as response options. 234 viable questionnaires were retrieved with the largest group representing attending surgeons. 59.0% were familiar with the concept of PROMs among which 78.4% reported to have used PROMs themselves. In order of frequency of use, PROMs were purposed for clinical assessment (55.6%), research (40.7%), health regulation policies (18.6%) and insurance service requirements (10.6%). Implementation was prompted by both departmental (43.4%) and institutional policy (34.5%). 89.4% of PROMs users reported difficulties in the use of PROMs, with major barriers including license fees, limited access, inadequate training and burden of fill-out time (all > 40%). Conclusion There is evidence of limited familiarity with knee and hip PROMs among orthopaedic surgeons. Barriers to their use are significant. Development of a Chinese language PROMs database would be helpful.


2021 ◽  
Author(s):  
Lingtong Min ◽  
Koray Atalag ◽  
Qi Tian ◽  
Yani Chen ◽  
Xudong Lu

BACKGROUND The semantic interoperability of health care information has been a critical challenge in medical informatics and has influenced the integration, sharing, analysis, and use of medical big data. International standard organizations have developed standards, approaches, and models to improve and implement semantic interoperability. The openEHR approach—one of the standout semantic interoperability approaches—has been implemented worldwide to improve semantic interoperability based on reused archetypes. OBJECTIVE This study aimed to verify the feasibility of implementing semantic interoperability in different countries by comparing the openEHR-based information models of 2 acute coronary syndrome (ACS) registries from China and New Zealand. METHODS A semantic archetype comparison method was proposed to determine the semantics reuse degree of reused archetypes in 2 ACS-related clinical registries from 2 countries. This method involved (1) determining the scope of reused archetypes; (2) identifying corresponding data items within corresponding archetypes; (3) comparing the semantics of corresponding data items; and (4) calculating the number of mappings in corresponding data items and analyzing results. RESULTS Among the related archetypes in the two ACS-related, openEHR-based clinical registries from China and New Zealand, there were 8 pairs of reusable archetypes, which included 89 pairs of corresponding data items and 120 noncorresponding data items. Of the 89 corresponding data item pairs, 87 pairs (98%) were mappable and therefore supported semantic interoperability, and 71 pairs (80%) were labeled as “direct mapping” data items. Of the 120 noncorresponding data items, 114 (95%) data items were generated via archetype evolution, and 6 (5%) data items were generated via archetype localization. CONCLUSIONS The results of the semantic comparison between the two ACS-related clinical registries prove the feasibility of establishing the semantic interoperability of health care data from different countries based on the openEHR approach. Archetype reuse provides data on the degree to which semantic interoperability exists when using the openEHR approach. Although the openEHR community has effectively promoted archetype reuse and semantic interoperability by providing archetype modeling methods, tools, model repositories, and archetype design patterns, the uncontrolled evolution of archetypes and inconsistent localization have resulted in major challenges for achieving higher levels of semantic interoperability.


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