scholarly journals An Informatics Consult approach for generating clinical evidence for treatment decisions

2021 ◽  
Author(s):  
Alvina G. Lai ◽  
Wai Hoong Chang ◽  
Constantinos A. Parisinos ◽  
Michail Katsoulis ◽  
Ruth M. Blackburn ◽  
...  
Keyword(s):  
Observational Studies ◽  
Large Scale ◽  
Stroke Risk ◽  
Meta Analysis ◽  
Return Of Results ◽  
Mendelian Randomisation ◽  
Vitamin K1 ◽  
Specific Patient ◽  
All Cause Mortality ◽  
Electronic Health

AbstractAn Informatics Consult has been proposed in which clinicians request novel evidence from large scale health data resources, tailored to the treatment of a specific patient, with return of results in clinical timescales. However, the availability of such consultations is lacking. We seek to provide an Informatics Consult for a situation where a treatment indication and contraindication coexist in the same patient, i.e., anti-coagulation use for stroke prevention in a patient with both atrial fibrillation (AF) and liver cirrhosis. We examined four sources of evidence for the effect of warfarin on stroke risk (efficacy) or all-cause mortality (safety) from: (i) randomised controlled trials (RCTs), (ii) meta- analysis of prior observational studies, (iii) trial emulation (using population electronic health records (N = 3,854,710) and (iv) genetic evidence (Mendelian randomisation). We developed prototype forms to request an Informatics Consult and return of results in electronic health record systems. We found 0 RCT reports and 0 trials recruiting for patients with AF and cirrhosis. We found broad concordance across the three new sources of evidence we generated. Meta-analysis of prior observational studies showed that warfarin use was associated with lower stroke risk (hazard ratio [HR] = 0.71). In a target trial emulation, warfarin was associated with lower all-cause mortality (HR = 0.61) and ischaemic stroke (HR = 0.27). Mendelian randomisation served as a drug target validation where we found that lower levels of vitamin K1 (warfarin is a vitamin K1 antagonist) are associated with lower stroke risk. A pilot survey with an independent sample of 34 clinicians revealed that 85% of clinicians found information on prognosis useful and that 79% thought that they should have access to the Informatics Consult as a service within their healthcare systems. We identified candidate steps for automation to scale evidence generation and to accelerate the return of results within clinical timescales.

scholarly journals An informatics consult approach for generating clinical evidence for treatment decisions

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Alvina G. Lai ◽  
Wai Hoong Chang ◽  
Constantinos A. Parisinos ◽  
Michail Katsoulis ◽  
Ruth M. Blackburn ◽  
...  
Keyword(s):  
Observational Studies ◽  
Stroke Risk ◽  
Meta Analysis ◽  
Treatment Decisions ◽  
Return Of Results ◽  
Mendelian Randomisation ◽  
Vitamin K1 ◽  
All Cause Mortality ◽  
Electronic Health ◽  
Evidence Generation

Abstract Background An Informatics Consult has been proposed in which clinicians request novel evidence from large scale health data resources, tailored to the treatment of a specific patient. However, the availability of such consultations is lacking. We seek to provide an Informatics Consult for a situation where a treatment indication and contraindication coexist in the same patient, i.e., anti-coagulation use for stroke prevention in a patient with both atrial fibrillation (AF) and liver cirrhosis. Methods We examined four sources of evidence for the effect of warfarin on stroke risk or all-cause mortality from: (1) randomised controlled trials (RCTs), (2) meta-analysis of prior observational studies, (3) trial emulation (using population electronic health records (N = 3,854,710) and (4) genetic evidence (Mendelian randomisation). We developed prototype forms to request an Informatics Consult and return of results in electronic health record systems. Results We found 0 RCT reports and 0 trials recruiting for patients with AF and cirrhosis. We found broad concordance across the three new sources of evidence we generated. Meta-analysis of prior observational studies showed that warfarin use was associated with lower stroke risk (hazard ratio [HR] = 0.71, CI 0.39–1.29). In a target trial emulation, warfarin was associated with lower all-cause mortality (HR = 0.61, CI 0.49–0.76) and ischaemic stroke (HR = 0.27, CI 0.08–0.91). Mendelian randomisation served as a drug target validation where we found that lower levels of vitamin K1 (warfarin is a vitamin K1 antagonist) are associated with lower stroke risk. A pilot survey with an independent sample of 34 clinicians revealed that 85% of clinicians found information on prognosis useful and that 79% thought that they should have access to the Informatics Consult as a service within their healthcare systems. We identified candidate steps for automation to scale evidence generation and to accelerate the return of results. Conclusion We performed a proof-of-concept Informatics Consult for evidence generation, which may inform treatment decisions in situations where there is dearth of randomised trials. Patients are surprised to know that their clinicians are currently not able to learn in clinic from data on ‘patients like me’. We identify the key challenges in offering such an Informatics Consult as a service.

scholarly journals Approaches for combining primary care electronic health record data from multiple sources: a systematic review of observational studies

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037405
Author(s):  
Daniel Dedman ◽  
Melissa Cabecinha ◽  
Rachael Williams ◽  
Stephen J W Evans ◽  
Krishnan Bhaskaran ◽  
...  
Keyword(s):  
Systematic Review ◽  
Primary Care ◽  
Electronic Health Record ◽  
Observational Studies ◽  
Meta Analysis ◽  
Data Sources ◽  
Health Record ◽  
Two Stage ◽  
One Stage ◽  
Electronic Health

ObjectiveTo identify observational studies which used data from more than one primary care electronic health record (EHR) database, and summarise key characteristics including: objective and rationale for using multiple data sources; methods used to manage, analyse and (where applicable) combine data; and approaches used to assess and report heterogeneity between data sources.DesignA systematic review of published studies.Data sourcesPubmed and Embase databases were searched using list of named primary care EHR databases; supplementary hand searches of reference list of studies were retained after initial screening.Study selectionObservational studies published between January 2000 and May 2018 were selected, which included at least two different primary care EHR databases.Results6054 studies were identified from database and hand searches, and 109 were included in the final review, the majority published between 2014 and 2018. Included studies used 38 different primary care EHR data sources. Forty-seven studies (44%) were descriptive or methodological. Of 62 analytical studies, 22 (36%) presented separate results from each database, with no attempt to combine them; 29 (48%) combined individual patient data in a one-stage meta-analysis and 21 (34%) combined estimates from each database using two-stage meta-analysis. Discussion and exploration of heterogeneity was inconsistent across studies.ConclusionsComparing patterns and trends in different populations, or in different primary care EHR databases from the same populations, is important and a common objective for multi-database studies. When combining results from several databases using meta-analysis, provision of separate results from each database is helpful for interpretation. We found that these were often missing, particularly for studies using one-stage approaches, which also often lacked details of any statistical adjustment for heterogeneity and/or clustering. For two-stage meta-analysis, a clear rationale should be provided for choice of fixed effect and/or random effects or other models.

scholarly journals Prognostic Value of Serum Magnesium in Mortality Risk among Patients on Hemodialysis: A Meta-Analysis of Observational Studies

2020 ◽  
pp. 1-10
Author(s):  
Hongwei Wu ◽  
Qiang Li ◽  
Lijing Fan ◽  
Dewang Zeng ◽  
Xianggeng Chi ◽  
...  
Keyword(s):  
Mortality Risk ◽  
Cardiovascular Mortality ◽  
Observational Studies ◽  
Prognostic Value ◽  
Meta Analysis ◽  
Serum Magnesium ◽  
Cochrane Library ◽  
Lower Serum ◽  
All Cause Mortality ◽  
End Stage

<b><i>Background:</i></b> Previous studies have reported that serum magnesium (Mg) deficiency is involved in the development of heart failure, particularly in patients with end-stage kidney disease. The association between serum Mg levels and mortality risk in patients receiving hemodialysis is controversial. We aimed to estimate the prognostic value of serum Mg concentration on all-cause mortality and cardiovascular mortality in patients receiving hemodialysis. <b><i>Methods:</i></b> We did a systematic literature search in PubMed, EMBASE, Cochrane Library, and Web of Science to identify eligible studies that reported the prognostic value of serum Mg levels in mortality risk among patients on hemodialysis. We performed a meta-analysis by pooling and analyzing hazard ratios (HRs) and 95% confidence intervals (CIs). <b><i>Results:</i></b> We identified 13 observational studies with an overall sample of 42,967 hemodialysis patients. Higher all-cause mortality (adjusted HR 1.58 [95% CI: 1.31–1.91]) and higher cardiovascular mortality (adjusted HR 3.08 [95% CI: 1.27–7.50]) were found in patients with lower serum Mg levels after multivariable adjustment. There was marked heterogeneity (<i>I</i><sup>2</sup> = 79.6%, <i>p</i> &#x3c; 0.001) that was partly explained by differences in age stratification and study area. In addition, subgroup analysis showed that a serum Mg concentration of ≤1.1 mmol/L might be the vigilant cutoff value. <b><i>Conclusion:</i></b> A lower serum Mg level was associated with higher all-cause mortality and cardiovascular mortality in patients receiving hemodialysis.

scholarly journals Characterization and selection of Japanese electronic health record databases used as data sources for non-interventional observational studies

2021 ◽  
Author(s):  
Yumi Wakabayashi ◽  
Masamitsu Eitoku ◽  
Narufumi Suganuma
Keyword(s):  
Electronic Health Record ◽  
Observational Studies ◽  
Large Scale ◽  
Data Sources ◽  
Flow Diagram ◽  
Health Record ◽  
Medical Institutions ◽  
Data Source ◽  
Electronic Health ◽  
Using Data

Abstract Background Interventional studies are the fundamental method for obtaining answers to clinical question. However, these studies are sometimes difficult to conduct because of insufficient financial or human resources or the rarity of the disease in question. One means of addressing these issues is to conduct a non-interventional observational study using electronic health record (EHR) databases as the data source, although how best to evaluate the suitability of an EHR database when planning a study remains to be clarified. The aim of the present study is to identify and characterize the data sources that have been used for conducting non-interventional observational studies in Japan and propose a flow diagram to help researchers determine the most appropriate EHR database for their study goals. Methods We compiled a list of published articles reporting observational studies conducted in Japan by searching PubMed for relevant articles published in the last 3 years and by searching database providers’ publication lists related to studies using their databases. For each article, we reviewed the abstract and/or full text to obtain information about data source, target disease or therapeutic area, number of patients, and study design (prospective or retrospective). We then characterized the identified EHR databases. Results In Japan, non-interventional observational studies have been mostly conducted using data stored locally at individual medical institutions (713/1463) or collected from several collaborating medical institutions (351/1463). Whereas the studies conducted with large-scale integrated databases (195/1463) were mostly retrospective (68.2%), 27.2% of the single-center studies, 46.2% of the multi-center studies, and 74.4% of the post-marketing surveillance studies, identified in the present study, were conducted prospectively. Conclusions Our analysis revealed that the non-interventional observational studies were conducted using data stored local at individual medical institutions or collected from collaborating medical institutions in Japan. Disease registries, disease databases, and large-scale databases would enable researchers to conduct studies with large sample sizes to provide robust data from which strong inferences could be drawn. Using our flow diagram, researchers planning non-interventional observational studies should consider the strengths and limitations of each available database and choose the most appropriate one for their study goals. Trial registration Not applicable.

scholarly journals Pregnancy-related complications and incidence of atrial fibrillation: a systematic review and meta-analysis

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
T Al Bahhawi ◽  
A Aqeeli ◽  
S L Harrison ◽  
D A Lane ◽  
I Buchan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Cohort Studies ◽  
Observational Studies ◽  
Large Scale ◽  
Data Extraction ◽  
Meta Analysis ◽  
Significant Heterogeneity ◽  
Random Effects Models ◽  
Increased Risk

Abstract Funding Acknowledgements Type of funding sources: None. Background Pregnancy-related complications have been previously associated with incident cardiovascular disease. However, data are scarce on the association between pregnancy-related complications and incident atrial fibrillation (AF). This systematic review examines associations between pregnancy-related complications and incident AF. Methods A systematic search of the literature utilising MEDLINE and EMBASE (Ovid) was conducted from 1990 to 6 April 2020. Observational studies examining the association between pregnancy-related complications including hypertensive disorders of pregnancy (HDP), gestational diabetes, placental abruption, preterm birth, low birth weight, small-for-gestational-age and stillbirth, and incidence of AF were included. Screening and data extraction were conducted independently by two reviewers. Inverse-variance random-effects models were used to pool hazard ratios. Results: Six observational studies met the inclusion criteria one case-control study and five retrospective cohort studies, with four studies eligible for meta-analysis.  Sample sizes ranged from 1,839-1,303,365. Mean/median follow-up for the cohort studies ranged from 7-36 years. Most studies reported an increased risk of incident AF associated with pregnancy-related complications. The pooled summary statistic from four studies reflected a greater risk of incident AF for HDP (hazard ratio (HR) 1.47, 95% confidence intervals (CI) 1.18-1.84; I2 = 84%) and from three studies for pre-eclampsia (HR 1.71, 95% CI 1.41-2.06; I2 = 64%; Figure). Conclusions The results of this review suggest that pregnancy-related complications particularly pre-eclampsia appear to be associated with higher risk of incident AF. The small number of included studies and the significant heterogeneity in the pooled results suggest further large-scale prospective studies are required to confirm the association between pregnancy-related complications and AF. Abstract Figure.

scholarly journals Prognostic Impact of Metabolic Syndrome in Patients With Heart Failure: A Meta-Analysis of Observational Studies

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhuo-Ming Huang ◽  
Wen-Rong Chen ◽  
Qi-Wen Su ◽  
Zhuo-Wen Huang
Keyword(s):  
Heart Failure ◽  
Metabolic Syndrome ◽  
Cardiovascular Mortality ◽  
Cardiovascular Events ◽  
Observational Studies ◽  
Meta Analysis ◽  
Prognostic Impact ◽  
The Metabolic Syndrome ◽  
All Cause Mortality ◽  
The Impact

Background: The metabolic syndrome (MS) is significantly associated with the risk of incident heart failure (HF). However, there are still great controversies about the impact of MS on the prognosis in patients with established HF. This meta-analysis aimed to ascertain the effect of MS on the prognosis in patients with HF.Methods: We searched multiple electronic databases, including PubMed, Opengrey, EMBASE, and Cochran Library, for potential studies up to February 15, 2021. Observational studies that reported the impact of MS on the prognosis in patients with established HF were included for meta-analysis.Results: Ten studies comprising 18,590 patients with HF were included for meta-analysis. The median follow-up duration of the included studies was 2.4 years. Compared with HF patients without MS, the risk of all-cause mortality and cardiovascular mortality was not increased in HF with MS (HR = 1.04, 95% CI = 0.88–1.23 for all-cause mortality; HR = 1.66, 95% CI = 0.56–4.88 for cardiovascular mortality, respectively). However, there was a significant increase in composited cardiovascular events in the HF patients with MS compared with those without MS (HR = 1.73, 95% CI = 1.23–2.45).Conclusions: In patients with established HF, the presence of MS did not show an association on the risk of all-cause mortality or cardiovascular mortality, while it may increase the risk of composite cardiovascular events.

scholarly journals Fish consumption and risk of all-cause and cardiovascular mortality: a dose–response meta-analysis of prospective observational studies

2018 ◽  
Vol 21 (7) ◽  
pp. 1297-1306 ◽  
Author(s):  
Ahmad Jayedi ◽  
Sakineh Shab-Bidar ◽  
Saragol Eimeri ◽  
Kurosh Djafarian
Keyword(s):  
Relative Risk ◽  
Dose Response ◽  
Fish Consumption ◽  
Regional Differences ◽  
Observational Studies ◽  
Meta Analysis ◽  
Asian Studies ◽  
Linear Dose ◽  
All Cause Mortality ◽  
Cvd Mortality

AbstractObjectiveThere are some indications of regional differences in the association between fish consumption and clinical outcomes. We aimed to test the linear and potential non-linear dose–response relationships between fish consumption and risk of all-cause and cardiovascular (CVD) mortality, and possible confounding by region.DesignSystematic review and dose–response meta-analysis.SettingSystematic search using PubMed and Scopus, from inception up to September 2016.SubjectsProspective observational studies reporting the estimates of all-cause and CVD mortality in relation to three or more categories of fish intake were included. Random-effects dose–response meta-analysis was conducted.ResultsFourteen prospective cohort studies (ten publications) with 911 348 participants and 75 451 incident deaths were included. A 20 g/d increment in fish consumption was significantly and inversely associated with the risk of CVD mortality (relative risk=0·96; 95 % CI 0·94, 0·98; I2=0 %, n 8) and marginally and inversely associated with the risk of all-cause mortality (relative risk=0·98; 95 % CI 0·97, 1·00; I2=81·9 %, n 14). Subgroup analysis resulted in a significant association only in the subgroup of Asian studies, compared with Western studies, in both analyses. Analysis of Western studies suggested a nearly U-shaped association, with a nadir at fish consumption of ~20 g/d in analysis of both outcomes. Meanwhile, the associations appeared to be linear in Asian studies.ConclusionsThere was potential evidence of regional differences in the association between fish consumption and mortality. It may be helpful to examine the associations by considering types of fish consumed and methods of fish preparation.

scholarly journals Brachial Pulse Pressure and Cardiovascular or All-Cause Mortality in the General Population: A Meta-Analysis of Prospective Observational Studies

2014 ◽  
Vol 16 (9) ◽  
pp. 678-685 ◽  
Author(s):  
Leilei Zhao ◽  
Yijuan Song ◽  
Pingshuan Dong ◽  
Zhijuan Li ◽  
Xuming Yang ◽  
...  
Keyword(s):  
General Population ◽  
Pulse Pressure ◽  
Observational Studies ◽  
Meta Analysis ◽  
All Cause Mortality

scholarly journals C-reactive protein for predicting all-cause mortality in patients with acute ischemic stroke: a meta-analysis

2019 ◽  
Vol 39 (2) ◽  
Author(s):  
Bo Yu ◽  
Ping Yang ◽  
Xuebi Xu ◽  
Lufei Shao
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Observational Studies ◽  
Meta Analysis ◽  
C Reactive Protein ◽  
Stroke Patients ◽  
Reactive Protein ◽  
Increased Risk ◽  
All Cause Mortality ◽  
Unit Increase

Abstract Studies on the association of C-reactive protein (CRP) with all-cause mortality in acute ischemic stroke patients have yielded conflicting results. The objective of this meta-analysis was to evaluate the prognostic value of CRP elevation in predicting all-cause mortality amongst patients with acute ischemic stroke. We searched the original observational studies that evaluated the association of CRP elevation with all-cause mortality in patients with acute ischemic stroke using PubMed and Embase databases until 20 January 2018. Pooled multivariate-adjusted hazard ratio (HR) with 95% confidence intervals (CI) of all-cause mortality was obtained for the highest compared with the lowest CRP level or per unit increment CRP level. A total of 3604 patients with acute ischemic stroke from eight studies were identified. Acute ischemic stroke patients with the highest CRP level were independently associated with an increased risk of all-cause mortality (HR: 2.07; 95% CI: 1.60–2.68) compared with the lowest CRP category. The pooled HR of all-cause mortality was 2.40 (95% CI: 1.10–5.21) for per unit increase in log-transformed CRP. Elevated circulating CRP level is associated with the increased risk of all-cause mortality in acute ischemic stroke patients. This meta-analysis supports the routine use of CRP for the death risk stratification in such patients.

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