The SMART Safety: An empirical dataset for evidence synthesis of adverse events.
Ontology highlight
ABSTRACT:
SUBMITTER: Fan S
PROVIDER: S-EPMC10589771 | biostudies-literature | 2023 Dec
REPOSITORIES: biostudies-literature
Publications
The SMART Safety: An empirical dataset for evidence synthesis of adverse events.
Fan Shiqi S Yu Tianqi T Yang Xi X Zhang Rui R Furuya-Kanamori Luis L Xu Chang C
Data in brief 20231004
Evidence synthesis serves an important role to promote informed decision-making in healthcare practice. A key issue of evidence synthesis is the approach to deal with rare adverse events and the methods to address bias of harm effects. Empirical data is essential to help methodologists and statisticians to solve the issues in evidence synthesis of adverse events. For this reason, we have established SMART Safety dataset, the largest empirical dataset of meta-analyses of adverse events. The datas ...[more]
Similar Datasets
Project description:BackgroundSafety is important in the assessment of health interventions, while the results of adverse events are often susceptive to potential effect modifiers since the event risk tends to be rare. In this study, we investigated whether the potential impact of the important effect modifiers on harmful effects was analyzed in meta-analyses of adverse events.MethodsSystematic reviews of healthcare interventions, had adverse events as the exclusive outcomes, had at least one meta-analysis, and published between 1st January 2015, and 1st January 2020 were collected. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. Six effect modifiers that are the most important for harmful effects were identified by a group discussion. The proportions of eligible systematic reviews that investigated the potential impact of the six effect modifiers on harmful effects were summarized.ResultsWe identified 279 systematic reviews eligible for this study. Except for the modifier of interventions/controls (70.61%, 197/279), most of the systematic reviews failed to investigate the potential impact of treatment duration (21.15%, 59/279), dosage (24.73%, 69/279), age (11.47%, 32/279), risk of bias (6.45%, 18/279), and source of funding (1.08%, 3/279) on harmful effects. Systematic reviews with meta-analyses containing more studies were more likely to investigate the potential impacts of these modifiers on the effects, but the proportion was still low (2.3% to 33.3%). Systematic reviews that developed a protocol were significantly more likely to investigate the potential impact of all these effect modifiers (e.g. treatment duration: odds ratio = 5.08, 95% CI: 2.76 to 9.35) on the results.ConclusionsCurrent systematic reviews rarely investigated the potential impact of the important effect modifiers on harmful effects. Methodological guidelines for meta-analysis of adverse events should consider "effect modifier" as one of the domains to help systematic review authors better investigate harmful effects.
| S-EPMC10142201 | biostudies-literature
Project description:BackgroundsZero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events.MethodsWe conducted a survey of systematic reviews published in two periods: January 1, 2015, to January 1, 2020, and January 1, 2008, to April 25, 2011. Databases were searched for systematic reviews that conducted at least one meta-analysis of any healthcare intervention and used adverse events as the exclusive outcome. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. We summarized the frequency of occurrence of zero-events studies in eligible systematic reviews and how these studies were dealt with in the meta-analyses of these systematic reviews.ResultsWe included 640 eligible systematic reviews. There were 406 (63.45%) systematic reviews involving zero-events studies in their meta-analyses, among which 389 (95.11%) involved single-arm-zero-events studies and 223 (54.93%) involved double-arm-zero-events studies. The majority (98.71%) of these systematic reviews incorporated single-arm-zero-events studies into the meta-analyses. On the other hand, the majority (76.23%) of them excluded double-arm-zero-events studies from the meta-analyses, of which the majority (87.06%) did not discuss the potential impact of excluding such studies. Systematic reviews published at present (2015-2020) tended to incorporate zero-events studies in meta-analyses than those published in the past (2008-2011), but the difference was not significant (proportion difference=-0.09, 95% CI -0.21 to 0.03, p = 0.12).ConclusionSystematic review authors routinely treated studies with zero-events in both arms as "non-informative" carriers and excluded them from their reviews. Whether studies with no events are "informative" or not largely depends on the methods and assumptions applied, thus sensitivity analyses using different methods should be considered in future meta-analyses.
| S-EPMC8204528 | biostudies-literature
Project description:ObjectivesTo investigate the validity of data extraction in systematic reviews of adverse events, the effect of data extraction errors on the results, and to develop a classification framework for data extraction errors to support further methodological research.DesignReproducibility study.Data sourcesPubMed was searched for eligible systematic reviews published between 1 January 2015 and 1 January 2020. Metadata from the randomised controlled trials were extracted from the systematic reviews by four authors. The original data sources (eg, full text and ClinicalTrials.gov) were then referred to by the same authors to reproduce the data used in these meta-analyses.Eligibility criteria for selecting studiesSystematic reviews were included when based on randomised controlled trials for healthcare interventions that reported safety as the exclusive outcome, with at least one pair meta-analysis that included five or more randomised controlled trials and with a 2×2 table of data for event counts and sample sizes in intervention and control arms available for each trial in the meta-analysis.Main outcome measuresThe primary outcome was data extraction errors summarised at three levels: study level, meta-analysis level, and systematic review level. The potential effect of such errors on the results was further investigated.Results201 systematic reviews and 829 pairwise meta-analyses involving 10 386 randomised controlled trials were included. Data extraction could not be reproduced in 1762 (17.0%) of 10 386 trials. In 554 (66.8%) of 829 meta-analyses, at least one randomised controlled trial had data extraction errors; 171 (85.1%) of 201 systematic reviews had at least one meta-analysis with data extraction errors. The most common types of data extraction errors were numerical errors (49.2%, 867/1762) and ambiguous errors (29.9%, 526/1762), mainly caused by ambiguous definitions of the outcomes. These categories were followed by three others: zero assumption errors, misidentification, and mismatching errors. The impact of these errors were analysed on 288 meta-analyses. Data extraction errors led to 10 (3.5%) of 288 meta-analyses changing the direction of the effect and 19 (6.6%) of 288 meta-analyses changing the significance of the P value. Meta-analyses that had two or more different types of errors were more susceptible to these changes than those with only one type of error (for moderate changes, 11 (28.2%) of 39 v 26 (10.4%) 249, P=0.002; for large changes, 5 (12.8%) of 39 v 8 (3.2%) of 249, P=0.01).ConclusionSystematic reviews of adverse events potentially have serious issues in terms of the reproducibility of the data extraction, and these errors can mislead the conclusions. Implementation guidelines are urgently required to help authors of future systematic reviews improve the validity of data extraction.
| S-EPMC9086856 | biostudies-literature
Project description:Background: Tripterygium wilfordii Hook F can cause adverse effects (AEs) in clinical application and may be harmful to human health. This study aim to summarize the AEs caused by T. wilfordii tgpolyglycoside (TWP), the most common preparation of T. wilfordii Hook F for clinical use. Methods: The Cochrane Library, EMBASE, PubMed, and Web of Science were searched to identify potential articles on this topic. All single-arm trials, controlled clinical trials, and randomized controlled trials were selected and summarized. Meta-regression was used to determine the sources of heterogeneity, and subgroups were used to identify factors leading to AEs. Results: Forty-six studies, comprising 25 randomized controlled trials, 13 controlled clinical trials, and 8 single-arm trials, were included in this meta-analysis, representing 2437 enrolled TWP-treated participants. Combined intervention, drug dosage, medication treatment, pharmaceutical manufacturers, and specific organ toxicity were identified as potential factors leading to TWP-induced AEs in this meta-analysis. In patients treated with TWP, the global incidence of AEs was 30.75% (95% confidence interval [21.18-40.33], I 2 = 97%), and that of severe grade AEs was 4.68% (95% confidence interval [0.00-12.72], I 2 = 53%). Organ-specific analyses indicated that TWP treatment elicited intestinal toxicity, reproductive toxicity, hepatotoxicity, nephrotoxicity, hematotoxicity, cutaneous toxicity, and other damages. The AEs analyzed in the subgroups of combined intervention, drug dosage, medication treatment, and pharmaceutical manufacturers were considered as primary outcomes, and organic-specific AEs were considered as secondary outcomes. Conclusions: The occurrence of TWP-induced AEs was systemic, organ-specific, and related to medication course, combined intervention, and drug dosage.
| S-EPMC6851843 | biostudies-literature
Project description:A COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) has recently been authorized for adolescents in the US. However, the impact of adverse events on adolescents after vaccination has not been fully investigated. To assess the safety of the COVID-19 vaccine in adolescents, the incidence of adverse events (AEs) in adolescents and adults was compared after vaccination. We included 6304 adolescents (68.14 per 100,000 people) who reported adverse events using vaccine adverse event reporting system (VAERS) data from 10 May 2021 to 30 September 2021. The mean age was 13.6 ± 1.1 years and women (52.7%) outnumbered men. We analyzed severe and common adverse events in response to the COVID-19 vaccine among 6304 adolescents (68.14 per 100,000 people; 52% female; mean age, 13.6 ± 1.1 years). The risk of myocarditis or pericarditis among adolescents was significantly higher in men than in women (OR = 6.61, 95% CI = 4.43 to 9.88; p < 0.001), with a higher frequency after the second dose of the vaccine (OR = 8.52, 95% CI = 5.79 to 12.54; p < 0.001). In addition, severe adverse events such as multisystem inflammatory syndromes, where the incidence rate per 100,000 people was 0.11 (n = 10), and the relative risk was 244.3 (95% CI = 31.27 to 1908.38; p < 0.001), were significantly higher in adolescents than in adults. The risk of the inflammatory response to the COVID-19 vaccine, including myocarditis, pericarditis, or multisystem inflammatory syndromes, was significantly higher in men than in women, with a higher frequency in adolescents than in adults. The inflammation-related AEs may require close monitoring and management in adolescents.
| S-EPMC9143867 | biostudies-literature
Project description:This study aims to investigate the factors that perceive citizens' intention to adopt smart city technologies in the Arab world. A self-administered questionnaire that included 312 end users as citizens in Amman, Jordan's capital city, was used in this study. This study uses advanced statistical techniques to test an expanded technology acceptance model (TAM) that incorporates the determinants of perceived usefulness, perceived ease of use, security and privacy, ICT infrastructure and inadequate Internet connectivity, social influence, and demographic profiles. Based on the results, perceived ease of use and ICT infrastructure and Internet connectivity showed positive association with the intention of citizens to adopt smart city services in Jordan. By recognizing the factors that predict citizens' adoption of smart city services, this study presents some theoretical implications and practical consequences related to smart city service adoption.
| S-EPMC10280567 | biostudies-literature
Project description:The potential of adoptive T-cell therapy in effecting complete and durable responses has been demonstrated in a number of malignant and infectious diseases. Ongoing progress in T-cell engineering has given cause for optimism in the broader clinical applicability of this approach. However, the development of more potent T cells is checked by safety concerns, highlighted by the occurrence of on-target and off-target toxicities that, although uncommon, have been fatal on occasions. Timely pharmacological intervention is effective in the management of a majority of adverse events but adoptively transferred T cells can persist long term, along with any unwanted effects. A recently validated cellular safety switch, inducible caspase 9 (iCasp9), has the potential to mitigate the risks of T-cell therapy by enabling the elimination of transferred T cells if required. In haematopoietic stem cell transplantation, iCasp9-modified donor T cells can be rapidly eliminated in the event of graft-versus-host disease. This review presents an overview of the risks associated with modern T-cell therapy and the development, clinical results and potential future application of the iCasp9 safety switch.
| S-EPMC4232067 | biostudies-literature
Project description:The dataset was formulated through field research in the Greek Municipalities. The survey was undertaken with an online questionnaire (available in Greek) and the contact person was the Chief Digital Officer or a person with similar responsibilities. The final sample is 252 out of a total of 325 Municipalities. Each respondent had to answer to 26 questions, including sub-questions, of different types (1) 5-point Likert scale, (2) rating scale, (3) closed type "Yes/no", (4) open-ended and (5) dropdown, and, depending on them, there are 3 types of variables (1) ordinal, (2) nominal, and (3) scale variables. The concepts included in the questionnaire are a) the level of integration and use of digital technologies, b) the difficulties and the challenges municipality authorities face when trying to implement a smart strategy and c) the level of diverse collaborations and partnerships which are necessary in order to develop a strategy. The data can be used to analyse the strategic capabilities of the Greek Municipalities under the three concepts evaluated in the questionnaire. The data's primary beneficiaries include researchers, public authorities, digital platforms entrepreneurs, smart city specialists and smart city entrepreneurs, as they can use the dataset to develop models against already known results, to identify factors important in an urban strategy and to further study the correlations between the different factors, design and draft an urban strategy on real data.
| S-EPMC8715129 | biostudies-literature
Project description:BackgroundFluoroquinolones have been widely used for a variety of Gram-positive and Gram-negative infections, and by 2002 they had become the most commonly prescribed class of antibiotics for adults in the United States. With widespread use, the class has become associated with a range of adverse events. Delafloxacin is a fluoroquinolone approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs). Delafloxacin is differentiated from other fluoroquinolones due to structural differences and in its activity against methicillin-resistant Staphylococcus aureus, including quinolone-resistant strains. This paper reviews the safety profile of delafloxacin across clinical studies with an emphasis on the incidence of adverse events of special interest that are associated with fluoroquinolones.MethodsData from 2 completed phase III studies of delafloxacin for the treatment of ABSSSIs were pooled and are the primary focus of this paper. Additional support from the full safety analysis set (30 completed phase I to phase III clinical studies) is included where applicable.ResultsFewer patients in the pooled delafloxacin group had AESIs than in the comparator group (7.0% vs 9.2%, respectively). Delafloxacin had a low rate of discontinuations due to treatment-related adverse events (<1%). Serious adverse events occurred at similar rates in patients treated with delafloxacin vs comparators.ConclusionsSerious adverse events occurred at similar rates in patients treated with delafloxacin vs nonquinolone comparators used to treat ABSSSIs.Clinicaltrialsgov identifierNCT01984684 and NCT01811732.
| S-EPMC6189306 | biostudies-literature
Project description:BACKGROUND:While clinical trials are considered the gold standard for detecting adverse events, often these trials are not sufficiently powered to detect difficult to observe adverse events. We developed a preliminary approach to predict 135 adverse events using post-market safety data from marketed drugs. Adverse event information available from FDA product labels and scientific literature for drugs that have the same activity at one or more of the same targets, structural and target similarities, and the duration of post market experience were used as features for a classifier algorithm. The proposed method was studied using 54 drugs and a probabilistic approach of performance evaluation using bootstrapping with 10,000 iterations. RESULTS:Out of 135 adverse events, 53 had high probability of having high positive predictive value. Cross validation showed that 32% of the model-predicted safety label changes occurred within four to nine years of approval (median: six years). CONCLUSIONS:This approach predicts 53 serious adverse events with high positive predictive values where well-characterized target-event relationships exist. Adverse events with well-defined target-event associations were better predicted compared to adverse events that may be idiosyncratic or related to secondary target effects that were poorly captured. Further enhancement of this model with additional features, such as target prediction and drug binding data, may increase accuracy.
| S-EPMC7191698 | biostudies-literature