scholarly journals Distributed Learning from Multi-Site Observational Health Data for Zero-Inflated Count Outcomes

2020 ◽  
Author(s):  
Mackenzie J. Edmondson ◽  
Chongliang Luo ◽  
Rui Duan ◽  
Mitchell Maltenfort ◽  
Zhaoyi Chen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Real World ◽  
Gold Standard ◽  
Meta Analysis ◽  
Distributed Learning ◽  
Privacy Preserving ◽  
Patient Data ◽  
Relative Bias ◽  
Serious Adverse Events ◽  
Hurdle Regression

AbstractBackgroundMulti-site studies facilitate the study of rare outcomes or exposures through integrating patient information from several distinct care sites. Due to patient privacy concerns, sharing of patient-level information among collaborating sites is often prohibited, suggesting a need for privacy-preserving data analysis methods. Several such methods exist, but have been shown to sometimes result in biased estimation or require extensive communication among sites.ObjectiveWe present a communication-efficient, privacy-preserving method for performing distributed regression on Electronic Health Records (EHR) data across multiple sites for zero-inflated count outcomes. Our approach is motivated by two real-world data problems: modeling frequency of serious adverse events and examining risk factors associated with pediatric avoidable hospitalization.MethodsWe use hurdle regression, a two-part (logistic-Poisson) regression model, to characterize the effects of risk factors on zero-inflated count outcomes. Further, we develop a one-shot algorithm for performing hurdle regression (ODAH) across multiple sites, using individual patient data at one site and aggregated data from all other sites to approximate the complete data log likelihood. We evaluate ODAH through extensive simulations and an application to EHR data from the Children’s Hospital of Philadelphia (CHOP) and the OneFlorida Clinical Research Consortium. We compare ODAH estimates to those from meta-analysis and pooled analysis (the gold standard in which all patient data are pooled together).ResultsIn simulations, ODAH estimates exhibited bias relative to the gold standard of less than 0.1% across several settings. In contrast, meta-analysis estimated exhibited relative bias up to 12.7%, largely dependent on the event rate. When applying ODAH to CHOP data, relative biases for estimates in both components of the hurdle model were less than 5.1%, while meta-analysis estimates exhibited relative bias as high as 63.6%. When analyzing OneFlorida data, ODAH relative biases were less than 10% for eight of the ten log relative risks estimated, while meta-analysis estimates again showed substantially greater bias.ConclusionsOur simulations and real-world applications suggest ODAH is a promising method for performing privacy-preserving distributed learning on EHR data when modeling zero-inflated count outcomes.

scholarly journals Implementing a hash-based privacy-preserving record linkage tool in the OneFlorida clinical research network

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 562-569 ◽  
Author(s):  
Jiang Bian ◽  
Alexander Loiacono ◽  
Andrei Sura ◽  
Tonatiuh Mendoza Viramontes ◽  
Gloria Lipori ◽  
...  
Keyword(s):  
Clinical Research ◽  
Open Source ◽  
Real World ◽  
Record Linkage ◽  
Gold Standard ◽  
Privacy Preserving ◽  
Research Network ◽  
Clinical Research Network ◽  
Real World Setting ◽  
Hash Codes

Abstract Objective To implement an open-source tool that performs deterministic privacy-preserving record linkage (RL) in a real-world setting within a large research network. Materials and Methods We learned 2 efficient deterministic linkage rules using publicly available voter registration data. We then validated the 2 rules’ performance with 2 manually curated gold-standard datasets linking electronic health records and claims data from 2 sources. We developed an open-source Python-based tool—OneFL Deduper—that (1) creates seeded hash codes of combinations of patients’ quasi-identifiers using a cryptographic one-way hash function to achieve privacy protection and (2) links and deduplicates patient records using a central broker through matching of hash codes with a high precision and reasonable recall. Results We deployed the OneFl Deduper (https://github.com/ufbmi/onefl-deduper) in the OneFlorida, a state-based clinical research network as part of the national Patient-Centered Clinical Research Network (PCORnet). Using the gold-standard datasets, we achieved a precision of 97.25∼99.7% and a recall of 75.5%. With the tool, we deduplicated ∼3.5 million (out of ∼15 million) records down to 1.7 million unique patients across 6 health care partners and the Florida Medicaid program. We demonstrated the benefits of RL through examining different disease profiles of the linked cohorts. Conclusions Many factors including privacy risk considerations, policies and regulations, data availability and quality, and computing resources, can impact how a RL solution is constructed in a real-world setting. Nevertheless, RL is a significant task in improving the data quality in a network so that we can draw reliable scientific discoveries from these massive data resources.

scholarly journals Serious Adverse Events with Bevacizumab or Ranibizumab for Age-Related Macular Degeneration: Meta-analysis of Individual Patient Data

2017 ◽  
Vol 1 (5) ◽  
pp. 375-381 ◽  
Author(s):  
Maureen G. Maguire ◽  
James Shaffer ◽  
Gui-shuang Ying ◽  
Usha Chakravarthy ◽  
Karina Berg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Macular Degeneration ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Age Related Macular Degeneration ◽  
Serious Adverse Events ◽  
Age Related

scholarly journals Efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy: a protocol for systematic review and individual patient data (IPD) meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027503 ◽  
Author(s):  
Makoto Saito ◽  
Rashid Mansoor ◽  
Kalynn Kennon ◽  
Rose McGready ◽  
François Nosten ◽  
...  
Keyword(s):  
Risk Factors ◽  
Treatment Failure ◽  
Falciparum Malaria ◽  
Treatment Efficacy ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Malaria In Pregnancy ◽  
Uncomplicated Falciparum Malaria ◽  
In Pregnancy

IntroductionPregnant women are more vulnerable to malaria leading to adverse impact on both mothers and fetuses. However, knowledge on the efficacy and safety of antimalarials in pregnancy is limited by the paucity of randomised control trials and the lack of standardised protocols in this special subpopulation. Pooling individual patient data (IPD) for meta-analysis could address in part these limitations to summarise accurately the currently available evidence on treatment efficacy and risk factors for treatment failure.Methods and analysisTo assess the treatment efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy, seven databases (Medline, Embase, Global Health, Cochrane Library, Scopus, Web of Science and Literatura Latino Americana em Ciências da Saúde) and two clinical trial registries (International Clinical Trials Registry Platform and ClinicalTrial.gov) were searched. Both interventional and observational cohort studies following up for at least 28 days will be included. IPD of the identified eligible published or unpublished studies will be sought by inviting principal investigators. Raw IPD will be shared through the web-based secure platform developed by the WorldWide Antimalarial Resistance Network using the established methodology. The primary objective is to compare the risk of PCR-corrected treatment failure among different treatments and to find the risk factors. One-stage IPD meta-analysis by Cox model with shared frailty will be conducted. A risk of bias assessment will be conducted to address the impact of unshared potential data and of the quality of individual studies. Potential limitations include difficulty in acquiring the IPD and heterogeneity of the study designs due to the lack of standard.Ethics and disseminationThis IPD meta-analysis consists of secondary analyses of existing anonymous data and meets the criteria for waiver of ethics review by the Oxford Tropical Research Ethics Committee. The results of this IPD meta-analysis will be disseminated through open-access publications at peer-reviewed journals. The study results will lead to a better understanding of malaria treatment in pregnancy, which can be used for clinical decision-making and conducting further studies.PROSPERO registration numberCRD42018104013.

scholarly journals Sex Difference and Rupture Rate of Intracranial Aneurysms: An Individual Patient Data Meta-Analysis

Stroke ◽  
2022 ◽  
Author(s):  
Charlotte C.M. Zuurbier ◽  
Rob Molenberg ◽  
Liselore A. Mensing ◽  
Marieke J.H. Wermer ◽  
Seppo Juvela ◽  
...  
Keyword(s):  
Risk Factors ◽  
Subarachnoid Hemorrhage ◽  
Sex Difference ◽  
Intracranial Aneurysms ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Aneurysmal Rupture ◽  
Rupture Rate ◽  
Related Risk

Background and Purpose: In previous studies, women had a higher risk of rupture of intracranial aneurysms than men, but female sex was not an independent risk factor. This may be explained by a higher prevalence of patient- or aneurysm-related risk factors for rupture in women than in men or by insufficient power of previous studies. We assessed sex differences in rupture rate taking into account other patient- and aneurysm-related risk factors for aneurysmal rupture. Methods: We searched Embase and Pubmed for articles published until December 1, 2020. Cohorts with available individual patient data were included in our meta-analysis. We compared rupture rates of women versus men using a Cox proportional hazard regression model adjusted for the PHASES score (Population, Hypertension, Age, Size of Aneurysm, Earlier Subarachnoid Hemorrhage From Another Aneurysm, Site of Aneurysm), smoking, and a positive family history of aneurysmal subarachnoid hemorrhage. Results: We pooled individual patient data from 9 cohorts totaling 9940 patients (6555 women, 66%) with 12 193 unruptured intracranial aneurysms, and 24 357 person-years follow-up. Rupture occurred in 163 women (rupture rate 1.04%/person-years [95% CI, 0.89–1.21]) and 63 men (rupture rate 0.74%/person-years [95% CI, 0.58–0.94]). Women were older (61.9 versus 59.5 years), were less often smokers (20% versus 44%), more often had internal carotid artery aneurysms (24% versus 17%), and larger sized aneurysms (≥7 mm, 24% versus 23%) than men. The unadjusted women-to-men hazard ratio was 1.43 (95% CI, 1.07–1.93) and the adjusted women/men ratio was 1.39 (95% CI, 1.02–1.90). Conclusions: Women have a higher risk of aneurysmal rupture than men and this sex difference is not explained by differences in patient- and aneurysm-related risk factors for aneurysmal rupture. Future studies should focus on the factors explaining the higher risk of aneurysmal rupture in women.

scholarly journals Comparative effectiveness of biological medicines in rheumatoid arthritis: systematic review and network meta-analysis including aggregate results from reanalysed individual patient data

BMJ ◽  
2020 ◽  
pp. m2288 ◽  
Author(s):  
Kirsten Janke ◽  
Katharina Biester ◽  
Dietmar Krause ◽  
Bernd Richter ◽  
Christoph Schürmann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Comparative Effectiveness ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
The Other ◽  
Serious Adverse Events ◽  
Low Disease Activity ◽  
Clinical Study Reports

Abstract Objective To assess the comparative effectiveness of biological medicines in rheumatoid arthritis in sufficiently similar patient populations, based on the current definitions of key outcomes. Design Systematic review and network meta-analysis including aggregate results from reanalysed individual patient data. Data sources Clinical study reports and aggregate results from reanalyses of individual patient data on key outcomes for rheumatoid arthritis provided by study sponsors for studies conducted up to 2017, and several databases and registries from inception up to February 2017. Eligibility criteria for selecting studies Randomised controlled trials investigating patient relevant outcomes in adults with rheumatoid arthritis treated with biological medicines in combination with methotrexate after methotrexate failure for at least 24 weeks. Results 45 eligible trials were identified. Combining data from clinical study reports and aggregate results from reanalyses of individual patient data allowed extensive analyses yielding sufficiently similar populations and homogeneous study results for network meta-analyses, including up to 35 studies on eight biological medicines combined with methotrexate. These analyses showed few statistically significant differences between the combination treatments. For example, anakinra showed less benefit than almost all the other seven biological medicines regarding clinical remission or low disease activity (clinical disease activity index ≤2.8 or ≤10, respectively) and certolizumab pegol showed more harm than the other seven biological medicines regarding serious adverse events or infections. Some outcomes had very wide 95% confidence intervals, potentially implying unidentified differences between the eight biological medicines, but wide 95% confidence intervals were less prominent for low disease activity, serious adverse events, and infections. Owing to a lack of head-to-head trials, results were mainly based on indirect comparisons with a limited number of studies, and recently approved Janus kinase inhibitors could not be included. Conclusions For patients with rheumatoid arthritis after methotrexate failure, only minor differences in benefits and harms were seen between biological medicines in combination with methotrexate. However, the analysis was hampered by a lack of long term direct comparisons. The substantial information gain achieved by the reanalysis of individual patient data calls for the routine availability of individual patient data.

scholarly journals Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis

2020 ◽  
Author(s):  
Tayler A Buchan ◽  
Behnam Sadeghirad ◽  
Nayeli Schmutz ◽  
Nicolai Goettel ◽  
Farid Foroutan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Individual Patient Data ◽  
Elective Surgery ◽  
Meta Analysis ◽  
Patient Data ◽  
Factors Associated ◽  
Increased Risk

Abstract Background: Early identification of patients at risk for postoperative delirium is essential because adequate well-timed interventions could reduce the occurrence of delirium and the related detrimental outcomes.Methods: We will conduct a systematic review and individual patient data (IPD) meta-analysis of prognostic studies evaluating the predictive value of risk factors associated with an increased risk of postoperative delirium in elderly patients undergoing elective surgery. We will identify eligible studies through systematic search of MEDLINE, EMBASE, and CINAHL from their inception to May 2020. Eligible studies will enroll older adults (≥ 50 years) undergoing elective surgery and assess pre-operative prognostic risk factors for delirium and incidence of delirium measured by a trained individual using a validated delirium assessment tool. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible studies. We will contact chief investigators of eligible studies requesting to share the IPD to a secured repository. We will use one-stage approach for IPD meta-analysis and will assess certainty of evidence using the GRADE approach.Discussion: Since we are using existing anonymized data, ethical approval is not required for this study. Our results can be used to guide clinical decisions about the most efficient way to prevent postoperative delirium in elderly patients.

Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis

2021 ◽  
Author(s):  
Carlos Taxonera ◽  
David Olivares ◽  
Cristina Alba
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Real World ◽  
Meta Analysis ◽  
Mucosal Healing ◽  
Incidence Rates ◽  
Serious Adverse Events ◽  
The Real ◽  
Rate Of Response

Abstract Background Knowledge of the real-world effectiveness and safety of tofacitinib for ulcerative colitis (UC) is relevant to confirm the benefit observed in clinical trials. Methods This systematic review and meta-analysis evaluated the real-world effectiveness of tofacitinib for moderate to severely active UC. The primary outcome was clinical remission evaluated at week 8, weeks 12 to 16, and month 6. Secondary outcomes were response, corticosteroid-free remission, mucosal healing, colectomy, and safety. Results Seventeen studies with a total of 1162 patients with UC were included. Remission (11 studies) was achieved in 34.7% of patients at week 8 (95% confidence interval [CI], 24.4%-45.1%), 47% at weeks 12 to 16 (95% CI, 40.3%-53.6%), and 38.3% at month 6 (95% CI, 29.2%-47.5%) at month 6 duplicated. Response was achieved in 62.1%, 64.2%, 50.8%, and 41.8% of patients at week 8, weeks 12 to 16, month 6, and month 12, respectively. Corticosteroid-free remission (5 studies) was achieved in 38.4%, 44.3%, 33.6%, and 31% of patients at week 8, weeks 12 to 16, month 6, and month 12, respectively. Mucosal healing was achieved in 48.3% and 45.3% of patients at week 8 and weeks 12 to 16, respectively. Patients who were biologic-naïve (11.6%) had a significantly higher rate of response at week 8 (1.38; 95% CI, 1.03-1.84). The incidence rates of serious adverse events and herpes zoster was 8.9 and 6.9 per 100 patient-years, respectively. Conclusions This meta-analysis of real-world studies confirms the effectiveness of tofacitinib in a highly refractory population of patients with moderate to severely active UC. Tofacitinib showed an acceptable safety profile. These findings were consistent with clinical trials and further support the use of tofacitinib in UC.

scholarly journals SHARP: Enabling generation of real-world evidence on a pan-European scale to improve the lives of individuals with severe asthma

2021 ◽  
pp. 00064-2021
Author(s):  
Job J.M.H. van Bragt ◽  
Susanne Hansen ◽  
Ratko Djukanovic ◽  
Elisabeth H.D. Bel ◽  
Anneke ten Brinke ◽  
...  
Keyword(s):  
Severe Asthma ◽  
Real World ◽  
Large Scale ◽  
Research Collaboration ◽  
Meta Analysis ◽  
National Registry ◽  
Patient Data ◽  
Local Analysis ◽  
Common Data Model ◽  
Real World Evidence

IntroductionReal world evidence is important to help unravel unanswered problems in severe asthma and is valuable to better understand the patient experience and common clinical practice.AimThe Severe Heterogeneous Asthma Registry, Patient-centred (SHARP) Clinical Research Collaboration (CRC) is created as a network of national registries and severe asthma centres that work together to perform registry based real world research and clinical studies on a pan-European scale.The CRCSuch collaboration requires a new, innovative design to overcome the many issues that arise with large-scale data collection across national borders. SHARP has developed a platform that offers a federated analysis approach where national registry data are transformed and integrated into a common data model (CDM). The CDM then allows a local analysis of de-identified patient data and subsequent aggregate (meta-)analysis. To facilitate an easily accessible way to set up new registries, SHARP enables new registries to take part in a central database, based on already proven technology. Next to being economical, this linkage ensures data from different SHARP central members to be comparable.The FutureTechnological advancements lead to an ever-expanding rate of patient data that will be collected; with the collective effort of the pan-European severe asthma research community SHARP hopes to ensure that they are well equipped to enter a new era of medical research, with the ultimate goal to positively impact the lives of patients with severe asthma.

scholarly journals Preoperative prognostic factors associated with postoperative delirium in older people undergoing surgery: protocol for a systematic review and individual patient data meta-analysis

2020 ◽  
Author(s):  
Tayler A Buchan ◽  
Behnam Sadeghirad ◽  
Nayeli Schmutz ◽  
Nicolai Goettel ◽  
Farid Foroutan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Elderly Patients ◽  
Postoperative Delirium ◽  
Individual Patient Data ◽  
Elective Surgery ◽  
Meta Analysis ◽  
Patient Data ◽  
Factors Associated ◽  
Increased Risk

Abstract Background: Early identification of patients at risk for postoperative delirium is essential because adequate well-timed interventions could reduce the occurrence of delirium and the related detrimental outcomes.Methods: We will conduct a systematic review and individual patient data (IPD) meta-analysis of prognostic studies evaluating the predictive value of risk factors associated with an increased risk of postoperative delirium in elderly patients undergoing elective surgery. We will identify eligible studies through systematic search of MEDLINE, EMBASE, and CINAHL from their inception to May 2020. Eligible studies will enroll older adults (³ 50 years) undergoing elective surgery and assess pre-operative prognostic risk factors for delirium and incidence of delirium measured by a trained individual using a validated delirium assessment tool. Pairs of reviewers will, independently and in duplicate, screen titles and abstracts of identified citations, review the full texts of potentially eligible studies. We will contact chief investigators of eligible studies requesting to share the IPD to a secured repository. We will use one-stage approach for IPD meta-analysis and will assess certainty of evidence using the GRADE approach.Discussion: Since we are using existing anonymized data, ethical approval is not required for this study. Our results can be used to guide clinical decisions about the most efficient way to prevent postoperative delirium in elderly patients. Systematic review registration: CRD42020171366

Sign in / Sign up

Export Citation Format

Share Document