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The Journal of Infectious Diseases Nov 2023HIV poses significant challenges for vaccine development due to its high genetic mutation and recombination rates. Understanding the distribution of HIV subtypes... (Meta-Analysis)
Meta-Analysis
Geographic and Population Distributions of Human Immunodeficiency Virus (HIV)-1 and HIV-2 Circulating Subtypes: A Systematic Literature Review and Meta-analysis (2010-2021).
BACKGROUND
HIV poses significant challenges for vaccine development due to its high genetic mutation and recombination rates. Understanding the distribution of HIV subtypes (clades) across regions and populations is crucial. In this study, a systematic review of the past decade was conducted to characterize HIV-1/HIV-2 subtypes.
METHODS
A comprehensive search was performed in PubMed, EMBASE, and CABI Global Health, yielding 454 studies from 91 countries.
RESULTS
Globally, circulating recombinant forms (CRFs)/unique recombinant forms (URFs) accounted for 29% of HIV-1 strains, followed by subtype C (23%) and subtype A (17%). Among studies reporting subtype breakdowns in key populations, 62% of HIV infections among men who have sex with men (MSM) and 38% among people who inject drugs (PWIDs) were CRF/URFs. Latin America and the Caribbean exhibited a 25% increase in other CRFs (excluding CRF01_AE or CRF02_AG) prevalence between 2010-2015 and 2016-2021.
CONCLUSIONS
This review underscores the global distribution of HIV subtypes, with an increasing prevalence of CRFs and a lower prevalence of subtype C. Data on HIV-2 were limited. Understanding subtype diversity is crucial for vaccine development, which need to elicit immune responses capable of targeting various subtypes. Further research is needed to enhance our knowledge and address the challenges posed by HIV subtype diversity.
Topics: Male; Humans; HIV Infections; Homosexuality, Male; HIV-1; HIV-2; Genetic Variation; Phylogeny; Sexual and Gender Minorities; Prevalence; Genotype
PubMed: 37592824
DOI: 10.1093/infdis/jiad327 -
Expert Review of Anticancer Therapy Jul 2024This study aimed to estimate the toxicities of PARP inhibitors (PARPis), based on randomized controlled trials (RCTs) and the FDA Adverse Event Reporting System (FAERS)... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
This study aimed to estimate the toxicities of PARP inhibitors (PARPis), based on randomized controlled trials (RCTs) and the FDA Adverse Event Reporting System (FAERS) database.
METHODS
Four electronic databases were searched from inception to 16 April 2024, for RCTs of approved PARPis. The primary and secondary outcomes were grade 3-5 adverse events (AEs) and grade 3-5 hematological AE, respectively. We conducted network meta-analyses to calculate the relative risks (RRs) and 95% confidence intervals (CIs) of outcomes. A disproportionality analysis was conducted to estimate the signals of hematological AEs associated with PARPis from the FAERS database.
RESULTS
Overall, 27 RCTs involving 11,067 patients with cancer were included. Olaparib had the best safety profile for any grade 3-5 AEs and hematological AEs among four approved PARPis. Olaparib did not increase the risk of thrombocytopenia (RR: 1.48; 95%CI: 0.64-3.39), but other PARPis did. Furthermore 14,780 hematological AE reports associated with PARPis were identified in the FAERS database, and all PARPis were associated with strong hematological AE signals. Hematological AEs mainly occurred within the first 3 months (80.84%) after PARPi initiation.
CONCLUSION
Olaparib had the best safety profile among five PARPis. PARPi-associated hematological AEs mainly occurred within the first 3 months.
REGISTRATION
PROSPERO (CRD42022385274).
Topics: Humans; Poly(ADP-ribose) Polymerase Inhibitors; Neoplasms; Randomized Controlled Trials as Topic; Pharmacovigilance; Hematologic Diseases; Adverse Drug Reaction Reporting Systems; Antineoplastic Agents; Databases, Factual; Phthalazines; Piperazines
PubMed: 38761169
DOI: 10.1080/14737140.2024.2357822 -
Kidney360 Jan 2024There is dramatic global variability in the prevalence of ESKD. Higher health care spending in each country is associated with increased delivery of care for ESKD.
KEY POINTS
There is dramatic global variability in the prevalence of ESKD. Higher health care spending in each country is associated with increased delivery of care for ESKD.
BACKGROUND
Approaches to treating ESKD may vary internationally on the basis of the availability of care and other factors. We performed a systematic review to understand the international variability in ESKD epidemiology, management, and outcomes.
METHODS
We systematically searched PubMed for population-based studies of CKD and ESKD epidemiology and management. Population-level data from 23 predesignated nations were eligible for inclusion if they pertained to people receiving dialysis or kidney transplant for ESKD. When available, government websites were used to identify and extract data from relevant kidney registries. Measures gathered included those related to the prevalence and mortality of ESKD; the availability of nephrologists; health care expenditures; and use of erythropoietin-stimulating agents.
RESULTS
We obtained data from the United States; seven nations in Eastern Europe; four each in Western Europe, Latin America, and Africa; and three in Asia. The documented prevalence of ESKD per million population varied from a high of 3600 (Malaysia) to a low of 67 (Senegal). The annual mortality associated with ESKD varied from 31% (Ethiopia and Senegal) to 10% (the United Kingdom). Nephrologist availability per million population varied from 40 (Japan) to <1 (South Africa) and was associated with health care expenditures.
CONCLUSIONS
The delivery of kidney care related to ESKD varies widely among countries. Higher health care spending is associated with increased delivery of kidney care. However, in part because documentation of kidney disease varies widely, it is difficult to determine how outcomes related to ESKD may vary across nations.
Topics: Humans; Kidney Failure, Chronic; Disease Progression
PubMed: 38055708
DOI: 10.34067/KID.0000000000000335 -
Daru : Journal of Faculty of Pharmacy,... Jun 2024Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the... (Meta-Analysis)
Meta-Analysis Review
Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis.
OBJECTIVES
Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance.
EVIDENCE ACQUISITION
A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270.
RESULTS
Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention.
CONCLUSION
EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.
Topics: Pharmacovigilance; Humans; Health Knowledge, Attitudes, Practice; Health Personnel; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38427161
DOI: 10.1007/s40199-024-00508-z -
Archivos de Bronconeumologia Aug 2023Home noninvasive ventilation (NIV), targeting a reduction of carbon dioxide with a combination of sufficient inspiratory support and backup-rate improves outcomes in... (Meta-Analysis)
Meta-Analysis
Effect of Intensity of Home Noninvasive Ventilation in Individuals With Neuromuscular and Chest Wall Disorders: A Systematic Review and Meta-Analysis of Individual Participant Data.
INTRODUCTION
Home noninvasive ventilation (NIV), targeting a reduction of carbon dioxide with a combination of sufficient inspiratory support and backup-rate improves outcomes in patients with chronic obstructive pulmonary disease. The aim of this systematic review with individual participant data (IPD) meta-analysis was to evaluate the effects of intensity of home NIV on respiratory outcomes in individuals with slowly progressive neuromuscular (NMD) or chest-wall disorders (CWD).
METHODS
Controlled, non-controlled and cohort studies indexed between January-2000 and December-2020 were sought from Medline, Embase and the Cochrane Central Register. Outcomes were diurnal PaCO, PaO, daily NIV usage, and interface type (PROSPERO-CRD 42021245121). NIV intensity was defined according to the Z-score of the product of pressure support (or tidal volume) and backup-rate.
RESULTS
16 eligible studies were identified; we obtained IPD for 7 studies (176 participants: 113-NMD; 63-CWD). The reduction in PaCO was greater with higher baseline PaCO. NIV intensity per se was not associated with improved PaCO except in individuals with CWD and the most severe baseline hypercapnia. Similar results were found for PaO. Daily NIV usage was associated with improvement in gas exchange but not with NIV intensity. No association between NIV intensity and interface type was found.
CONCLUSION
Following home NIV initiation in NMD or CWD patients, no relationship was observed between NIV intensity and PaCO, except in individuals with the most severe CWD. The amount of daily NIV usage, rather than intensity, is key to improving hypoventilation in this population during the first few months after introduction of therapy.
Topics: Humans; Noninvasive Ventilation; Thoracic Wall; Respiratory Insufficiency; Respiration, Artificial; Pulmonary Disease, Chronic Obstructive; Hypercapnia
PubMed: 37217384
DOI: 10.1016/j.arbres.2023.05.002 -
Journal of Internal Medicine Jul 2023Although a few case reports have shown that immune checkpoint inhibitors (ICIs) are potential inducers of capillary leak syndrome (CLS), an incidental finding cannot be...
BACKGROUND
Although a few case reports have shown that immune checkpoint inhibitors (ICIs) are potential inducers of capillary leak syndrome (CLS), an incidental finding cannot be ruled out. The aim of this study was to describe the clinical characteristics of ICI-induced CLS through a systematic review and to assess a potential safety signal.
METHODS
Medline/PubMed, Embase, and Reactions Weekly were screened, and a global disproportionality study was performed using the World Health Organization pharmacovigilance database through January 15, 2023. A signal of disproportionate reporting was defined as a Bayesian information component (IC) with a 95% credibility interval (CrI) lower boundary that exceeds 0.
RESULTS
A total of 47 cases of ICI-associated CLS were included, 14 from the systematic review (of 61 screened articles) and 33 from VigiBase (of 34,058,481 reports of adverse drug reactions). The median time to CLS onset from the start of ICI was 12 weeks (interquartile range 8-49, n = 24). A total of 57% (8/14) of patients experienced an immune-related adverse event (irAE) before CLS. A fatal outcome was reported in 23% (7/31) of patients. A significant overreporting of CLS was found with ICIs compared with all other drugs (IC 2.4, 95% CrI from 1.8 to 2.8).
CONCLUSION
This study showed a significant signal of disproportionality reporting for ICI-induced CLS, characterized by a long time to onset, and compared with the idiopathic form of the disease with a less abrupt onset and a less consistent hemoconcentration pattern.
Topics: Humans; Immune Checkpoint Inhibitors; Pharmacovigilance; Capillary Leak Syndrome; Bayes Theorem; Antineoplastic Agents, Immunological; Retrospective Studies; Drug-Related Side Effects and Adverse Reactions
PubMed: 37038359
DOI: 10.1111/joim.13641 -
Drug Safety Jul 2023Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic review showed the knowledge and attitudes of...
INTRODUCTION
Underreporting is a major limitation of the voluntary reporting system of adverse drug reactions (ADRs). A 2009 systematic review showed the knowledge and attitudes of health professionals were strongly related with underreporting of ADRs.
OBJECTIVE
Our aim was to update our previous systematic review to determine factors (sociodemographic, knowledge and attitudes) associated with the underreporting of ADRs by healthcare professionals.
METHODS
We searched the MEDLINE and EMBASE databases for studies published between 2007 and 2021 that met the following inclusion criteria: (1) published in English, French, Portuguese or Spanish; (2) involving health professionals; and (3) the goal was to evaluate factors associated with underreporting of ADRs through spontaneous reporting.
RESULTS
Overall, 65 papers were included. While health professional sociodemographic characteristics did not influence underreporting, knowledge and attitudes continue to show a significant effect: (1) ignorance (only serious ADRs need to be reported) in 86.2%; (2) lethargy (procrastination, lack of interest, and other excuses) in 84.6%; (3) complacency (the belief that only well tolerated drugs are allowed on the market) in 46.2%; (4) diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 44.6%; and (5) insecurity (it is nearly impossible to determine whether or not a drug is responsible for a specific adverse reaction) in 33.8%, and the absence of feedback in 9.2%. In this review, the non-obligation to reporting and confidentiality emerge as new reasons for underreporting.
CONCLUSIONS
Attitudes regarding the reporting of adverse reactions continue to be the main determinants of underreporting. Even though these are potentially modifiable factors through educational interventions, minimal changes have been observed since 2009.
CLINICAL TRIALS REGISTRATION
PROSPERO registration number CRD42021227944.
Topics: Humans; Adverse Drug Reaction Reporting Systems; Health Personnel; Attitude of Health Personnel; Drug-Related Side Effects and Adverse Reactions; Health Knowledge, Attitudes, Practice; Pharmacovigilance
PubMed: 37277678
DOI: 10.1007/s40264-023-01302-7 -
Journal of Virus Eradication Sep 2023Understanding the clinical potency of latency-reversing agents (LRAs) on the HIV-1 reservoir is useful to deploy future strategies. This systematic review evaluated the... (Review)
Review
INTRODUCTION
Understanding the clinical potency of latency-reversing agents (LRAs) on the HIV-1 reservoir is useful to deploy future strategies. This systematic review evaluated the effects of LRAs in human intervention studies.
METHODS
A literature search was performed using medical databases focusing on studies with adults living with HIV-1 receiving LRAs. Eligibility criteria required participants from prospective clinical studies, a studied compound hypothesised as LRA, and reactivation or tolerability assessments. Relevant demographical data, LRA reactivation capacity, reservoir size, and adverse events were extracted. A study quality assessment with analysis of bias was performed by RoB 2 and ROBINS-I tools. The primary endpoints were HIV-1 reservoir reactivation after LRA treatment quantified by cell-associated unspliced HIV-1 RNA, and LRA tolerability defined by adverse events. Secondary outcomes were reservoir size and the effect of LRAs on analytical treatment interruption (ATI) duration.
RESULTS
After excluding duplicates, 5182 publications were screened. In total 45 publications fulfilled eligibility criteria including 26 intervention studies and 16 randomised trials. The risk of bias was evaluated as high. Chromatin modulators were the main investigated LRA class in 24 studies. Participants were mostly males (90.1%). Where reported, HIV-1 subtype B was most frequently observed. Reactivation after LRA treatment occurred in 78% of studies and was observed with nearly all chromatin modulators. When measured, reactivation mostly occurred within 24 h after treatment initiation. Combination LRA strategies have been infrequently studied and were without synergistic reactivation. Adverse events, where reported, were mostly low grade, yet occurred frequently. Seven studies had individuals who discontinued LRAs for related adverse events. The reservoir size was assessed by HIV-1 DNA in 80% of studies. A small decrease in reservoir was observed in three studies on immune checkpoint inhibitors and the histone deacetylase inhibitors romidepsin and chidamide. No clear effect of LRAs on ATI duration was observed.
CONCLUSION
This systematic review provides a summary of the reactivation of LRAs used in current clinical trials whilst highlighting the importance of pharmacovigilance. Highly heterogeneous study designs and underrepresentation of relevant patient groups are to be considered when interpreting these results. The observed reactivation did not lead to cure or a significant reduction in the size of the reservoir. Finding more effective LRAs by including well-designed studies are needed to define the required reactivation level to reduce the HIV-1 reservoir.
PubMed: 37663575
DOI: 10.1016/j.jve.2023.100342 -
Journal of Biomedical Informatics Mar 2024An adverse drug event (ADE) is any unfavorable effect that occurs due to the use of a drug. Extracting ADEs from unstructured clinical notes is essential to biomedical... (Review)
Review
BACKGROUND
An adverse drug event (ADE) is any unfavorable effect that occurs due to the use of a drug. Extracting ADEs from unstructured clinical notes is essential to biomedical text extraction research because it helps with pharmacovigilance and patient medication studies.
OBJECTIVE
From the considerable amount of clinical narrative text, natural language processing (NLP) researchers have developed methods for extracting ADEs and their related attributes. This work presents a systematic review of current methods.
METHODOLOGY
Two biomedical databases have been searched from June 2022 until December 2023 for relevant publications regarding this review, namely the databases PubMed and Medline. Similarly, we searched the multi-disciplinary databases IEEE Xplore, Scopus, ScienceDirect, and the ACL Anthology. We adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement guidelines and recommendations for reporting systematic reviews in conducting this review. Initially, we obtained 5,537 articles from the search results from the various databases between 2015 and 2023. Based on predefined inclusion and exclusion criteria for article selection, 100 publications have undergone full-text review, of which we consider 82 for our analysis.
RESULTS
We determined the general pattern for extracting ADEs from clinical notes, with named entity recognition (NER) and relation extraction (RE) being the dual tasks considered. Researchers that tackled both NER and RE simultaneously have approached ADE extraction as a "pipeline extraction" problem (n = 22), as a "joint task extraction" problem (n = 7), and as a "multi-task learning" problem (n = 6), while others have tackled only NER (n = 27) or RE (n = 20). We further grouped the reviews based on the approaches for data extraction, namely rule-based (n = 8), machine learning (n = 11), deep learning (n = 32), comparison of two or more approaches (n = 11), hybrid (n = 12) and large language models (n = 8). The most used datasets are MADE 1.0, TAC 2017 and n2c2 2018.
CONCLUSION
Extracting ADEs is crucial, especially for pharmacovigilance studies and patient medications. This survey showcases advances in ADE extraction research, approaches, datasets, and state-of-the-art performance in them. Challenges and future research directions are highlighted. We hope this review will guide researchers in gaining background knowledge and developing more innovative ways to address the challenges.
Topics: Humans; Machine Learning; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Natural Language Processing; PubMed
PubMed: 38331081
DOI: 10.1016/j.jbi.2024.104603 -
Journal of Oncology Pharmacy Practice :... Jul 2024This systematic review and meta-analysis aimed to determine the safety of liposomal amphotericin B (L-AMB) compared to other antifungal agents for secondary prophylaxis. (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
This systematic review and meta-analysis aimed to determine the safety of liposomal amphotericin B (L-AMB) compared to other antifungal agents for secondary prophylaxis.
METHOD
We conducted a comprehensive search across international databases and reference lists of articles to compile all relevant published evidence evaluating the efficacy and safety of L-AMB versus other antifungals (NLAMB) for secondary prophylaxis against invasive fungal infections. Pooled estimates were calculated after data transformation to evaluate mortality, breakthrough infections, and the frequency of adverse effects, including hypokalemia and nephrotoxicity. Comparisons of breakthrough fungal infection and mortality between the L-AMB and NLAMB groups were performed.
RESULT
We identified 10 studies. The cumulative frequency of patients using L-AMB was 148, compared to 341 patients in the NLAMB group. The mortality rates in the L-AMB and NLAMB groups were 10% and 0%, respectively. However, based on the odds ratio, the mortality in the L-AMB group was lower than that in the NLAMB group. No significant difference was observed in breakthrough invasive fungal infections between the L-AMB and NLAMB groups. The frequencies of nephropathy and hypokalemia in the L-AMB group were 36% and 18%, respectively.
CONCLUSION
Our findings indicate a lower incidence of mortality in the L-AMB group compared to the NLAMB group. No statistically significant difference was observed in the incidence of breakthrough infection between the two groups. L-AMB administration is associated with nephropathy and hypokalemia. However, the refusal to continue treatment due to adverse effects is not significantly high.
Topics: Amphotericin B; Humans; Antifungal Agents; Invasive Fungal Infections; Mycoses; Secondary Prevention; Hypokalemia
PubMed: 38720564
DOI: 10.1177/10781552241241317