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Langén V, Winstén AK, Airaksinen KEJ, Teppo K. Clinical outcomes of atrial fibrillation screening: a meta-analysis of randomized controlled trials. Ann Med 2025; 57:2457522. [PMID: 39862317 DOI: 10.1080/07853890.2025.2457522] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2024] [Revised: 01/09/2025] [Accepted: 01/13/2025] [Indexed: 01/27/2025] Open
Abstract
BACKGROUND Several randomized controlled trials (RCTs) have investigated the benefits of atrial fibrillation (AF) screening. However, since none have shown a significant reduction in stroke rates, the impact of screening on clinical outcomes remains uncertain. MATERIALS AND METHODS We conducted a systematic review and meta-analysis of RCTs reporting clinical outcomes of systematic AF screening in participants without known AF. Pooled risk ratios (RRs) were computed for all-cause stroke or systemic embolism, major bleeding, and all-cause mortality, comparing screening with no screening. RESULTS Seven RCTs encompassing 76 458 participants were identified. One trial utilized implantable loop recorders for rhythm monitoring, while the others employed non-invasive screening methods. Pooled results indicated that AF screening was associated with a significant reduction in all-cause stroke or systemic embolism (RR 0.932, 95% CI 0.873-0.996, I2 = 0%, p = 0.037), but had no effect on major bleeding (RR 0.996, 95% CI 0.935-1.060, I2 = 0%, p = 0.876) or all-cause mortality (RR 0.987, 95% CI 0.945-1.031, I2 = 0%, p = 0.550). We estimated a number needed to screen of 148 to prevent one stroke or systemic embolism over a 10-year period in a population of 75-year-olds. When only non-invasive screening methods were considered, the reduction in strokes was not statistically significant (RR 0.942, 95% CI 0.880-1.008, I2 = 0%, p = 0.083). CONCLUSIONS Systematic AF screening is associated with a modest yet statistically significant 7% relative reduction in stroke and systemic embolism, with no observed impact on major bleeding or all-cause mortality.
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Affiliation(s)
- Ville Langén
- Division of Medicine, Turku University Hospital and University of Turku, Turku, Finland
| | - Aleksi K Winstén
- Faculty of Medicine, Department of Mathematics and Statistics, University of Turku, Turku, Finland
| | | | - Konsta Teppo
- Heart Centre, Turku University Hospital, Turku, Finland
- Biotechnology Unit, Department of Life Technologies, University of Turku, Turku, Finland
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Sinopoulou V, Shah E, Gordon M, Tony-Jimmy TE. Primary author contact for systematic reviews of randomized controlled trials: A systematic review. World J Methodol 2025; 15:95559. [DOI: 10.5662/wjm.v15.i3.95559] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2024] [Revised: 11/01/2024] [Accepted: 12/03/2024] [Indexed: 03/06/2025] Open
Abstract
BACKGROUND Systematic reviews (SRs) synthesize and evaluate data, mainly from randomized trials, which then guides the development of clinical recommendations in evidence-based medicine. However, the data and methodological information in the included papers can often be lacking or unclear, and reviewers usually need to contact the authors of included studies for clarifications. Contacting authors is recommended, but it is unclear how often SR teams do it, or what the level of response is.
AIM To investigate how often reviewers undertake contact with the authors of included randomized controlled trials (RCTs) for clarification on data and risk of bias concerns, to explore the factors that influence whether SR authors contact or do not contact the authors, and the content and level of responses.
METHODS We conducted a systematic electronic database search in MEDLINE using the search string “(systematic review)” AND “(RCT OR randomized OR trial)” for articles published between 1 January 2024 and 19 February 2024, without language restrictions. Screening and data extraction was done independently by two reviewers, and conflicts resolved by a senior author. Contact authors of included SRs were contacted for clarifications.
RESULTS Of the 329 included SRs, 38% (n = 125) explicitly mentioned contact with the authors of included studies. The remaining 62% (n = 204) did not. We attempted contact with all SR teams for clarifications and received 90 responses (19.4%). Of the 50 respondents who did not explicitly mention contact in their SRs, 25 (50%) replied that they did make contact. We received a total of 64 responses on the level and content of information sought. The mean ± SD contacts SR teams made were 10 (10), replies received 5 (6.7), and response waiting time 10.1 (28.3) weeks. Resources, time, poor previous experience, perceived likelihood of poor response and bias concerns were reported as barriers to attempting contact.
CONCLUSION The majority of SRs published in 2024 did not confirm seeking clarifying or missing information from primary study authors. However, SR teams reported that 50% of contacted primary authors respond. Additional research can clarify this rate of response and establish methods to increase the integration of this core methodological element in SRs.
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Affiliation(s)
- Vasiliki Sinopoulou
- Biomedical Evidence Synthesis and Translation to Practice Unit, School of Medicine, Preston PR1 7BH, United Kingdom
| | - Eshan Shah
- School of Medicine and Dentistry, University of Central Lancashire, Preston PR1 2HE, United Kingdom
| | - Morris Gordon
- Biomedical Evidence Synthesis and Translation to Practice Unit, School of Medicine, Preston PR1 7BH, United Kingdom
| | - Tonia E Tony-Jimmy
- School of Medicine and Dentistry, University of Central Lancashire, Preston PR1 2HE, United Kingdom
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Rolland P, Jutel A, Douget L, Naudet F, Roy JC. Incomplete reporting of adverse events in duloxetine trials: a meta-research survey of randomized controlled trials vs placebo. J Clin Epidemiol 2025; 180:111677. [PMID: 39826626 DOI: 10.1016/j.jclinepi.2025.111677] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/11/2024] [Revised: 12/09/2024] [Accepted: 01/09/2025] [Indexed: 01/22/2025]
Abstract
BACKGROUND AND OBJECTIVES Relying on published data alone might be insufficient for meta-analyses to be reliable and trustworthy since selective outcome reporting is common, especially for adverse events (AEs). We investigated the existence of selective reporting and its potential for bias in a case study exploring AEs of duloxetine in adults. STUDY DESIGN AND SETTING We systematically searched all previous meta-analyses/pooled analyses on duloxetine published on PubMed for seven indications approved by the American and European health authorities. We included all randomized controlled trials (RCTs) vs placebo. For each RCT, we extracted the number of serious adverse events (SAEs), AEs, drop-outs (DOs) and drop-outs for safety reasons (DOSRs) using four information sources: published articles, clinical study registries, clinical study reports and data available in meta-analyses/pooled analyses. To assess the range of differences resulting from these four extraction strategies, we performed 4 meta-analyses using random effect models as well as a complete meta-analysis combining all sources. RESULTS A total of 70 RCTs (including 24,330 patients) were included. Of those, SAEs were identified for 42 studies (61%) in published articles, 58 (84%) in study reports (8 study reports were not retrieved), 24 (34.7%) in registries, and 21 (30.4%) in meta-analyses/pooled analyses. For 2 (2.9%), 2 (2.9%), 2 (2.9%) and 1 (1.4%) studies, we found respectively no data on SAEs, AEs, DOs, and DOSRs in any sources. Discrepant results across sources were found in 24 (34.5%), 20 (28.5%), 13 (18.6%), and 9 (12.8%) studies, respectively for SAEs, AEs, DOs, and DOSRs. Despite variations in point estimates and their 95% confidence intervals, we did not find different results in the conclusions of meta-analyses depending on the different information sources used, except for DOs, for which no effect was found using results published in registries, in contrast to other information sources. CONCLUSION None of the four information sources provided complete retrieval of safety results for duloxetine in adults across various indications. However, we did not find strong evidence that this underreporting leads to different conclusions in meta-analyses. Nonetheless, this finding remains uncertain, as we were unable to obtain complete information for all studies despite extensive searches.
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Affiliation(s)
- P Rolland
- Adult Psychiatry Department, Rennes University Hospital, Rennes, France; Université de Rennes, University Rennes, CHU Rennes, Rennes, France
| | - A Jutel
- Université de Rennes, University Rennes, CHU Rennes, Rennes, France
| | - Le Douget
- Université de Rennes, University Rennes, CHU Rennes, Rennes, France
| | - F Naudet
- Adult Psychiatry Department, Rennes University Hospital, Rennes, France; Université de Rennes, University Rennes, CHU Rennes, Rennes, France; Centre d'investigation clinique de Rennes 1414, Service de pharmacologie clinique, Institut de recherche en santé, environnement et travail (IRSET), UMR S 1085, EHESP, Rennes, France; Institut Universitaire de France, Paris, France
| | - J C Roy
- Adult Psychiatry Department, Rennes University Hospital, Rennes, France; Université de Rennes, University Rennes, CHU Rennes, Rennes, France; Centre for Population Neuroscience and Stratified Medicine (PONS), Department of Psychiatry and Clinical Neuroscience, Charité Universitätsmedizin Berlin, Berlin, Germany.
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Afsharnejad B, Whitehorne Smith P, Bölte S, Milbourn B, Girdler S. A Systematic Review of Implicit Versus Explicit Social Skills Group Programs in Different Settings for School-Aged Autistic Children and Adolescents. J Autism Dev Disord 2024:10.1007/s10803-024-06657-z. [PMID: 39690375 DOI: 10.1007/s10803-024-06657-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/13/2024] [Indexed: 12/19/2024]
Abstract
This systematic review and meta-analysis aimed to identify and evaluate the quality of randomised controlled trials (RCTs), assessing the efficacy of Social Skills Group Programs (SSGPs) for primary and secondary school aged autistic children and adolescents exploring the influence of informant, setting characteristics and teaching strategies as moderating factors for social outcomes. A search of the electronic databases of Medline, ProQuest, CINAHL, Scopus, and Web of Sciences electronic databases was conducted for the period January 1, 2013 until December 31, 2023 for peer-reviewed RCT studies published in English, evaluating the efficacy of SSGPs for school-aged autistic children and adolescents (6-18 years). Included studies were assessed for methodological quality and efficacy using random effect meta-analysis. Informant analysis and moderator analyses were also conducted investigating the influence of informant, setting characteristics and teaching strategy utilised in the SSGPs on the participants social outcomes. Sixty-five studies were included in the systematic review with 49 studies included in the meta-analysis. Although most studies had strong or good methodological quality, a high possibility of publication bias was detected in the meta-analysis. After statistical adjustments for publication bias were made, findings revealed that SSGPs had no effect on the overall outcomes assessed by included studies on school-aged autistic children and adolescents. However, informant analysis revealed small effects reported by self-report, parent-proxy and researchers. Teaching strategies and setting characteristics were not significant moderators for the efficacy of SSGPs on the social outcomes of autistic children and adolescents. This review highlights the need for improvements in measurement frameworks for assessing social skills in autistic children and adolescents.
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Affiliation(s)
- Bahareh Afsharnejad
- Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia.
- Curtin University, The School of Population Health, Perth, Australia.
| | - Patrice Whitehorne Smith
- Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Curtin School of Allied Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
| | - Sven Bölte
- Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Curtin School of Allied Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Centre of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet & Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden
| | - Ben Milbourn
- Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Curtin School of Allied Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
| | - Sonya Girdler
- Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Curtin School of Allied Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia
- Centre of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet & Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden
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Bramley P, Hulman J, Wanstall H. Risk of bias and problematic trials: characterising the research integrity of trials submitted to Anaesthesia. Anaesthesia 2024; 79:1309-1316. [PMID: 39145890 DOI: 10.1111/anae.16411] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/17/2024] [Indexed: 08/16/2024]
Abstract
BACKGROUND There is some evidence for systematic biases and failures of research integrity in the anaesthesia literature. However, the features of problematic trials and effect of editorial selection on these issues have not been well quantified. METHODS We analysed 209 randomised controlled trials submitted to Anaesthesia between 8 March 2019 and 31 March 2020. We evaluated the submitted manuscript, registry data and the results of investigations into the integrity of the trial undertaken at the time of submission. Trials were labelled 'concerning' if failures of research integrity were found, and 'problematic' if identified issues would have warranted retraction if they had been found after publication. We investigated how 'problematic' trials were detected, the distribution of p values and the risk of outcome reporting bias and p-hacking. We also investigated whether there were any factors that differed in problematic trials. RESULTS We found that false data was the most common reason for a trial to be labelled as 'concerning', which occurred in 51/62 (82%) cases. We also found that while 195/209 (93%) trials were preregistered, we found adequate registration for only 166/209 (79%) primary outcomes, 100/209 (48%) secondary outcomes and 11/209 (5%) analysis plans. We also found evidence for a step decrease in the frequency of p values > 0.05 compared with p values < 0.05. 'Problematic' trials were all single-centre and appeared to have fewer authors (incident risk ratio (95%CI) 0.8 (0.7-0.9)), but could not otherwise be distinguished reliably from other trials. CONCLUSIONS Identification of 'problematic' trials is frequently dependent on individual patient data, which is often unavailable after publication. Additionally, there is evidence of a risk of outcome reporting bias and p-hacking in submitted trials. Implementation of alternative research and editorial practices could reduce the risk of bias and make identification of problematic trials easier.
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Affiliation(s)
- Paul Bramley
- Department of Anaesthesia, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- School of Medicine and Population Health, University of Sheffield, Sheffield, UK
| | - Joshua Hulman
- Department of Anaesthesia, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | - Helen Wanstall
- Emergency Department, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
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Xing X, Zhu J, Shi L, Xu C, Lin L. Assessment of inverse publication bias in safety outcomes: an empirical analysis. BMC Med 2024; 22:494. [PMID: 39456055 PMCID: PMC11515227 DOI: 10.1186/s12916-024-03707-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2024] [Accepted: 10/15/2024] [Indexed: 10/28/2024] Open
Abstract
BACKGROUND The aims of this study were to assess the presence of inverse publication bias (IPB) in adverse events, evaluate the performance of visual examination, and explore the impact of considering effect direction in statistical tests for such assessments. METHODS We conducted a cross-sectional study using the SMART Safety, the largest dataset for evidence synthesis of adverse events. The visual assessment was performed using contour-enhanced funnel plots, trim-and-fill funnel plots, and sample-size-based funnel plots. Two authors conducted visual assessments of these plots independently, and their agreements were quantified by the kappa statistics. Additionally, IPB was quantitatively assessed using both the one- and two-sided Egger's and Peters' tests. RESULTS In the SMART Safety dataset, we identified 277 main meta-analyses of safety outcomes with at least 10 individual estimates after dropping missing data. We found that about 13.7-16.2% of meta-analyses exhibited IPB according to the one-sided test results. The kappa statistics for the visual assessments roughly ranged from 0.3 to 0.5, indicating fair to moderate agreement. Using the one-sided Egger's test, 57 out of 72 (79.2%) meta-analyses that initially showed significant IPB in the two-sided test changed to non-significant, while the remaining 15 (20.8%) meta-analyses changed from non-significant to significant. CONCLUSIONS Our findings provide supporting evidence of IPB in the SMART Safety dataset of adverse events. They also suggest the importance of researchers carefully accounting for the direction of statistical tests for IPB, as well as the challenges of assessing IPB using statistical methods, especially considering that the number of studies is typically small. Qualitative assessments may be a necessary supplement to gain a more comprehensive understanding of IPB.
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Affiliation(s)
- Xing Xing
- Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
| | - Jianan Zhu
- Department of Biostatistics, School of Global Public Health, New York University, New York, NY, USA
| | | | - Chang Xu
- Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
| | - Lifeng Lin
- Department of Epidemiology and Biostatistics, University of Arizona, Tucson, AZ, USA.
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Xing X, Xu C, Al Amer FM, Shi L, Zhu J, Lin L. Methods for assessing inverse publication bias of adverse events. Contemp Clin Trials 2024; 145:107646. [PMID: 39084407 PMCID: PMC11392622 DOI: 10.1016/j.cct.2024.107646] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2023] [Revised: 06/06/2024] [Accepted: 07/27/2024] [Indexed: 08/02/2024]
Abstract
In medical research, publication bias (PB) poses great challenges to the conclusions from systematic reviews and meta-analyses. The majority of efforts in methodological research related to classic PB have focused on examining the potential suppression of studies reporting effects close to the null or statistically non-significant results. Such suppression is common, particularly when the study outcome concerns the effectiveness of a new intervention. On the other hand, attention has recently been drawn to the so-called inverse publication bias (IPB) within the evidence synthesis community. It can occur when assessing adverse events because researchers may favor evidence showing a similar safety profile regarding an adverse event between a new intervention and a control group. In comparison to the classic PB, IPB is much less recognized in the current literature; methods designed for classic PB may be inaccurately applied to address IPB, potentially leading to entirely incorrect conclusions. This article aims to provide a collection of accessible methods to assess IPB for adverse events. Specifically, we discuss the relevance and differences between classic PB and IPB. We also demonstrate visual assessment through contour-enhanced funnel plots tailored to adverse events and popular quantitative methods, including Egger's regression test, Peters' regression test, and the trim-and-fill method for such cases. Three real-world examples are presented to illustrate the bias in various scenarios, and the implementations are illustrated with statistical code. We hope this article offers valuable insights for evaluating IPB in future systematic reviews of adverse events.
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Affiliation(s)
- Xing Xing
- Department of Biostatistics, Johns Hopkins University, Maryland, MD, USA
| | - Chang Xu
- Clinical Transformation Center, Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai, China
| | - Fahad M Al Amer
- Department of Mathematics, College of Science and Arts, Najran University, Najran, Saudi Arabia
| | | | - Jianan Zhu
- Department of Biostatistics, School of Global Public Health, New York University, New York, NY, USA
| | - Lifeng Lin
- Department of Epidemiology and Biostatistics, University of Arizona, Tucson, AZ, USA.
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Xu L, Chen S, Cao H, Feng Z, Yang C. Efficacy of sorafenib plus transcatheter arterial chemoembolization in treating hepatocellular carcinoma with portal vein tumor thrombosis: A meta-analysis. ACTA PHARMACEUTICA (ZAGREB, CROATIA) 2024; 74:405-422. [PMID: 39279524 DOI: 10.2478/acph-2024-0019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 04/02/2024] [Indexed: 09/18/2024]
Abstract
This meta-analysis aimed to evaluate the efficacy of sorafenib plus transcatheter arterial chemoembolization (TACE) in treating hepato-cellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT). Twelve randomized controlled trials published until 28th Sep 2022 were finally included. Of the total 1746 patients, of whom 458 received sorafenib and TACE treatment (Group S+TACE), and 1288 only underwent TACE (Group TACE), were enrolled. Outcomes including time to progression (TTP), objective response rate (ORR), disease control rate (DCR), overall survival (OS), survival rate (SR), and adverse reactions, were extracted. The OS (HR: 0.596, 95 %CI: 0.507-0.685, p < 0.001; I2 = 0.0 %) and TTP (HR: 0.379, 95 %CI: 0.205-0.553, p < 0.001; I2 = 4.5 %) in the S+TACE group were longer than those in the TACE group. The ORR (RR: 2.101, 95 %CI: 1.555-2.839, p < 0.001; I2 = 0.0 %), DCR (RR: 1.547, 95 %CI: 1.126-2.126, p = 0.007; I2 = 79.6 %) and SR (RR: 1.416, 95 %CI: 1.183-1.694, p < 0.001; I2 = 83.8 %) in the S+TACE group were higher than those in the TACE group. Compared with the TCAE group, the higher odds of HFSR, oral ulcer, and diarrhea among patients with HCC complicated by PVTT were discovered in the S+TACE group. The marginal significance was found in ascites and gastrointestinal bleeding between the two groups. Sorafenib plus TACE has good efficacy and mild adverse reactions, which may be worthy of clinical promotion.
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Affiliation(s)
- Li Xu
- Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou 310000, China
| | - Shanshan Chen
- Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou 310000, China
| | - Haijun Cao
- Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou 310000, China
| | - Zemin Feng
- Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou 310000, China
| | - Chao Yang
- Department of Orthopedics 903rd Hospital of PLA Hangzhou 310000, China
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Sedhom R, Hamed M, Elbadawi A, Mohsen A, Swamy P, Athar A, Bharadwaj AS, Prasad V, Elgendy IY, Alfonso F. Outcomes With Limus- vs Paclitaxel-Coated Balloons for Percutaneous Coronary Intervention: Meta-Analysis of Randomized Controlled Trials. JACC Cardiovasc Interv 2024; 17:1533-1543. [PMID: 38986653 DOI: 10.1016/j.jcin.2024.04.042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/29/2024] [Revised: 04/08/2024] [Accepted: 04/24/2024] [Indexed: 07/12/2024]
Abstract
BACKGROUND Randomized controlled trials (RCTs) examining the outcomes with limus drug-coated balloons (DCBs) vs paclitaxel DCBs were small and underpowered for clinical endpoints. OBJECTIVES This study sought to compare the angiographic and clinical outcomes with limus DCBs vs paclitaxel DCBs for percutaneous coronary intervention (PCI). METHODS An electronic search of Medline, EMBASE, and Cochrane databases was performed through January 2024 for RCTs comparing limus DCBs vs paclitaxel DCBs for PCI. The primary endpoint was clinically driven target lesion revascularization (TLR). The secondary endpoints were late angiographic findings. Summary estimates were constructed using a random effects model. RESULTS Six RCTs with 821 patients were included; 446 patients received a limus DCB, and 375 patients received a paclitaxel DCB. There was no difference between limus DCBs and paclitaxel DCBs in the incidence of TLR at a mean of 13.4 months (10.3% vs 7.8%; risk ratio [RR]: 1.32; 95% CI: 0.84-2.08). Subgroup analysis suggested no significant interaction among studies for de novo coronary lesions vs in-stent restenosis (Pinteraction = 0.58). There were no differences in the risk of major adverse cardiovascular events, cardiac mortality, or target vessel myocardial infarction between groups. However, limus DCBs were associated with a higher risk of binary restenosis (RR: 1.89; 95% CI: 1.14-3.12), late lumen loss (mean difference = 0.16; 95% CI: 0.03-0.28), and a smaller minimum lumen diameter (mean difference = -0.12; 95% CI: -0.22 to -0.02) at late follow-up. In addition, late lumen enlargement occurred more frequently (50% vs 27.5%; RR: 0.59; 95% CI: 0.45-0.77) with paclitaxel DCBs. CONCLUSIONS Among patients undergoing DCB-only PCI, there were no differences in the risk of clinically driven TLR and other clinical outcomes between limus DCBs and paclitaxel DCBs. However, paclitaxel DCBs were associated with better late angiographic outcomes. These findings support the need for future trials to establish the role of new-generation limus DCBs for PCI.
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Affiliation(s)
- Ramy Sedhom
- Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA
| | - Mohamed Hamed
- Division of Cardiology, Florida Atlantic University, Boca Raton, Florida, USA
| | - Ayman Elbadawi
- Division of Cardiology, Christus Good Shepherd Medical Center, Longview, Texas, USA; Texas A&M School of Medicine, Bryan, Texas, USA
| | - Amr Mohsen
- Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA
| | - Pooja Swamy
- Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA
| | - Ahmed Athar
- Cardiology Section, Jerry L. Pettis Memorial Veteran's Hospital, Loma Linda, California, USA
| | - Aditya S Bharadwaj
- Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA
| | - Vinoy Prasad
- Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, USA
| | - Islam Y Elgendy
- Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, Kentucky, USA.
| | - Fernando Alfonso
- Cardiology Department, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, CIBER-CV, Madrid, Spain
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Goel H, Raheja D, Nadar SK. Evidence-based medicine or statistically manipulated medicine? Are we slaves to the P-value? Postgrad Med J 2024; 100:451-460. [PMID: 38330498 DOI: 10.1093/postmj/qgae012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2023] [Revised: 12/27/2023] [Accepted: 01/04/2024] [Indexed: 02/10/2024]
Abstract
First popularized almost a century ago in epidemiologic research by Ronald Fisher and Jerzy Neyman, the P-value has become perhaps the most misunderstood and even misused statistical value or descriptor. Indeed, modern clinical research has now come to be centered around and guided by an arbitrary P-value of <0.05 as a magical threshold for significance, so much so that experimental design, reporting of experimental findings, and interpretation and adoption of such findings have become largely dependent on this "significant" P-value. This has given rise to multiple biases in the overall body of biomedical literature that threatens the very validity of clinical research. Ultimately, a drive toward reporting a "significant" P-value (by various statistical manipulations) risks creating a falsely positive body of science, leading to (i) wasted resources in pursuing fruitless research and (ii) futile or even harmful policies/therapeutic recommendations. This article reviews the history of the P-value, the conceptual basis of P-value in the context of hypothesis testing and challenges in critically appraising clinical evidence vis-à-vis the P-value. This review is aimed at raising awareness of the pitfalls of this rigid observation of the threshold of statistical significance when evaluating clinical trials and to generate discussion regarding whether the scientific body needs a rethink about how we decide clinical significance.
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Affiliation(s)
- Harsh Goel
- Department of Medicine, St. Luke's University Hospital, 801 Ostrum St, Bethlehem, PA 18015, United States
- Lewis Katz School of Medicine, Temple University, 1801 N Broad St, Philadelphia, PA 19122, United States
| | - Divisha Raheja
- Lewis Katz School of Medicine, Temple University, 1801 N Broad St, Philadelphia, PA 19122, United States
- Department of Neurology, St. Luke's University Hospital, 801 Ostrum St. Bethlehem, PA 18015, United States
| | - Sunil K Nadar
- Department of Cardiology, Dudley Group of Hospitals NHS Trust, Pensnett Road, Dudley, DY1 2HQ United Kingdom
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11
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Evalen PS, Barnhardt EN, Ryu J, Stahlschmidt ZR. Toxicity of glyphosate to animals: A meta-analytical approach. ENVIRONMENTAL POLLUTION (BARKING, ESSEX : 1987) 2024; 347:123669. [PMID: 38460584 DOI: 10.1016/j.envpol.2024.123669] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Revised: 02/10/2024] [Accepted: 02/26/2024] [Indexed: 03/11/2024]
Abstract
Glyphosate (GLY)-based herbicides (GBHs) are the most commonly applied pesticide worldwide, and non-target organisms (e.g., animals) are now regularly exposed to GLY and GBHs due to the accumulation of these chemicals in many environments. Although GLY/GBH was previously considered to be non-toxic, growing evidence indicates that GLY/GBH negatively affects some animal taxa. However, there has been no systematic analysis quantifying its toxicity to animals. Therefore, we used a meta-analytical approach to determine whether there is a demonstrable effect of GLY/GBH toxicity across animals. We further addressed whether the effects of GLY/GBH vary due to (1) taxon (invertebrate vs. vertebrate), (2) habitat (aquatic vs. terrestrial), (3) type of biological response (behavior vs. physiology vs. survival), and (4) dosage or concentration of GLY/GBH. Using this approach, we also determined whether adjuvants (e.g., surfactants) in commercial formulations of GBHs increased toxicity for animals relative to exposure to GLY alone. We analyzed 1282 observations from 121 articles. We conclude that GLY is generally sub-lethally toxic for animals, particularly for animals in aquatic or marine habitats, and that toxicity did not exhibit dose-dependency. Yet, our analyses detected evidence for widespread publication bias so we encourage continued experimental investigations to better understand factors influencing GLY/GBH toxicity to animals.
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Affiliation(s)
- P S Evalen
- University of the Pacific, Stockton, CA, USA; University of Pennsylvania, Philadelphia, PA, USA
| | | | - J Ryu
- University of the Pacific, Stockton, CA, USA
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12
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Woodyard KC, Hogan E, Dembinski DR, Madzia J, Guyton L, Janowak CF, Pan BS, Gobble RM. A Review of Meta-Analyses in Plastic Surgery: Need for Adequate Assessment of Publication Bias. J Surg Res 2024; 296:781-789. [PMID: 37543495 DOI: 10.1016/j.jss.2023.06.052] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/11/2023] [Revised: 06/10/2023] [Accepted: 06/25/2023] [Indexed: 08/07/2023]
Abstract
INTRODUCTION Publication bias describes a phenomenon in which significant positive results have a higher likelihood of being published compared to negative or nonsignificant results. Publication bias can confound the estimated therapeutic effect in meta-analyses and needs to be adequately assessed in the surgical literature. METHODS A review of meta-analyses published in five plastic surgery journals from 2002 to 2022 was conducted. The inclusion criteria for meta-analyses were factors that demonstrated an obligation to assess publication bias, such as interventions with comparable treatment groups and enough power for statistical analysis. Acknowledgment of publication bias risk, quality of bias assessment, methods used in assessment, and individual article factors were analyzed. RESULTS 318 unique meta-analyses were identified in literature search, and after full-text reviews, 143 met the inclusion criteria for obligation to assess publication bias. 64% of eligible meta-analyses acknowledged the confounding potential of publication bias, and only 46% conducted a formal assessment. Of those who conducted an assessment, 49% used subjective inspection of funnel plots alone, while 47% used any statistical testing in analysis. Overall, only 9/143 (6.3%) assessed publication bias and attempted to correct for its effect. Journals with a higher average impact factor were associated with mention and assessment of publication bias, but more recent publication year and higher number of primary articles analyzed were not. CONCLUSIONS This review identified low rates of proper publication bias assessment in meta-analyses published in five major plastic surgery journals. Assessment of publication bias using objective statistical testing is necessary to ensure quality literature within surgical disciplines.
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Affiliation(s)
- Kiersten C Woodyard
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio; Division of Pediatric Plastic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
| | - Elise Hogan
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio
| | - Douglas R Dembinski
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio
| | - Jules Madzia
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio
| | - Lane Guyton
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio
| | - Christopher F Janowak
- Division of Trauma and Critical Care Surgery, University of Cincinnati, Cincinnati, Ohio
| | - Brian S Pan
- Division of Pediatric Plastic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
| | - Ryan M Gobble
- Division of Plastic and Reconstructive Surgery, University of Cincinnati, Cincinnati, Ohio.
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13
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Petkova E, Ciarleglio A, Casey P, Poole N, Kaufman K, Lawrie SM, Malhi G, Siddiqi N, Bhui K, Lee W. Positive thinking about negative studies. Br J Psychiatry 2024; 224:79-81. [PMID: 38174364 DOI: 10.1192/bjp.2023.155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/05/2024]
Abstract
The non-reporting of negative studies results in a scientific record that is incomplete, one-sided and misleading. The consequences of this range from inappropriate initiation of further studies that might put participants at unnecessary risk to treatment guidelines that may be in error, thus compromising day-to-day clinical practice.
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Affiliation(s)
- Eva Petkova
- NYU Grossman School of Medicine, New York University, New York, USA
| | - Adam Ciarleglio
- George Washington University School of Public Health and Health Services, Washington, DC, USA
| | - Patricia Casey
- Hermitage Medical Clinic, Dublin, Ireland; and Department of Psychiatry, University College Dublin, Dublin, Ireland
| | - Norman Poole
- Department of Neuropsychiatry, South West London and St George's Mental Health NHS Trust, London, UK
| | - Kenneth Kaufman
- Department of Psychiatry, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA; and Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK
| | - Stephen M Lawrie
- Department of Psychiatry, University of Edinburgh, Edinburgh, UK
| | - Gin Malhi
- Academic Department of Psychiatry, Kolling Institute, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia; CADE Clinic and Mood-T, Royal North Shore Hospital, Northern Sydney Local Health District, Sydney, New South Wales, Australia; and Department of Psychiatry, University of Oxford, Oxford, UK
| | - Najma Siddiqi
- Department of Health Sciences, Hull York Medical School, University of York, York, UK
| | - Kamaldeep Bhui
- Department of Psychiatry, Nuffield Department of Primary Care Health Science, University of Oxford, Oxford, UK; Wadham College, University of Oxford, Oxford, UK; East London and Oxford Health NHS Foundation Trusts, London, UK; and WPA Collaborating Centre Oxford, Oxford, UK
| | - William Lee
- Department of Liaison Psychiatry, Cornwall Partnership NHS Trust, Bodmin, UK
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14
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Grobusch MP, Ruiz Del Portal Luyten C, Visser BJ, de Jong HK, Goorhuis A, Hanscheid T. Overcoming publication and dissemination bias in infectious diseases clinical trials. THE LANCET. INFECTIOUS DISEASES 2024; 24:e189-e195. [PMID: 37837983 DOI: 10.1016/s1473-3099(23)00455-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/18/2023] [Revised: 07/13/2023] [Accepted: 07/14/2023] [Indexed: 10/16/2023]
Abstract
Non-timely reporting, selective reporting, or non-reporting of clinical trial results are prevalent and serious issues. WHO mandates that summary results be available in registries within 12 months of study completion and published in full text within 24 months. However, only a limited number of clinical trials in infectious diseases, including those done during the COVID-19 pandemic, have their results posted on ClinicalTrials.gov. An analysis of 50 trials of eight antiviral drugs tested against COVID-19 with a completion date of at least 2 years ago revealed that only 18% had their results published in the registry, with 40% not publishing any results. Non-timely and non-reporting practices undermine patient participation and are ethically unacceptable. Strategies should include obligatory reporting of summary results within 12 months in clinical trial registries, with progress towards peer-reviewed publication within 24 months indicated. Timely publication of research papers should be encouraged through an automated flagging mechanism in clinical trial registries that draws attention to the status of results reporting, such as a green tick for trials that have reported summary results within 12 months and a red tick in case of failure to do so. We propose the inclusion of mandatory clinical trial reporting standards in the International Conference on Harmonization Good Clinical Practice guidelines, which should prohibit sponsor contract clauses that restrict reporting (referred to as gag clauses) and require timely reporting of results as part of the ethics committees' clearance process for clinical trial protocols.
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Affiliation(s)
- Martin P Grobusch
- Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands; Institute of Tropical Medicine, German Centre for Infection Research (DZIF), University of Tübingen, Tübingen, Germany; Centre de Recherches Médicales en Lambaréné (CERMEL), Lambaréné, Gabon; Masanga Medical Research Unit (MMRU), Masanga, Sierra Leone; Institute of Infectious Diseases and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa.
| | - Claire Ruiz Del Portal Luyten
- Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
| | | | - Hanna K de Jong
- Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
| | - Abraham Goorhuis
- Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Division of Internal Medicine, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
| | - Thomas Hanscheid
- Instituto de Microbiologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
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15
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Shrestha S, Cummings G, Knopp-Sihota J, Devkota R, Hoben M. Factors influencing health-related quality of life among long-term care residents experiencing pain: a systematic review protocol. Syst Rev 2024; 13:49. [PMID: 38303055 PMCID: PMC10832087 DOI: 10.1186/s13643-024-02459-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/06/2023] [Accepted: 01/11/2024] [Indexed: 02/03/2024] Open
Abstract
BACKGROUND Pain is highly burdensome, affecting over 30% of long-term care (LTC) residents. Pain significantly reduces residents' health-related quality of life (HRQoL), limits their ability to perform activities of daily living (ADLs), restricts their social activities, and can lead to hopelessness, depression, and unnecessary healthcare costs. Although pain can generally be prevented or treated, eliminating pain may not always be possible, especially when residents have multiple chronic conditions. Therefore, improving the HRQoL of LTC residents with pain is a priority goal. Understanding factors influencing HRQoL of LTC residents with pain is imperative to designing and evaluating targeted interventions that complement pain management to improve residents' HRQoL. However, these factors are poorly understood, and we lack syntheses of available research on this topic. This systematic review protocol outlines the methods to identify, synthesize, and evaluate the available evidence on these factors. METHODS This mixed methods review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. We will systematically search Medline, EMBASE, PsycINFO, CINAHL, Scopus, Cochrane Database of Systematic Reviews and ProQuest Dissertation and Thesis Global from database inception. We will include primary studies and systematically conducted reviews without restrictions to language, publication date, and study design. We will also include gray literature (dissertation and reports) and search relevant reviews and reference lists of all included studies. Two reviewers will independently screen articles, conduct quality appraisal, and extract data. We will synthesize results thematically and conduct meta-analyses if statistical pooling is possible. Residents and family/friend caregivers will assist with interpreting the findings. DISCUSSION This proposed systematic review will address an important knowledge gap related to the available evidence on factors influencing HRQoL of LTC residents with pain. Findings will be crucial for researchers, LTC administrators, and policy makers in uncovering research needs and in planning, developing, and evaluating strategies in addition to and complementary with pain management to help improve HRQoL among LTC residents with pain. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42023405425.
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Affiliation(s)
- Shovana Shrestha
- Faculty of Nursing, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada.
| | - Greta Cummings
- Faculty of Nursing, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Jennifer Knopp-Sihota
- Faculty of Nursing, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
- Faculty of Health Disciplines, Athabasca University, Edmonton, Alberta, Canada
| | - Rashmi Devkota
- Faculty of Nursing, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
| | - Matthias Hoben
- Faculty of Nursing, College of Health Sciences, University of Alberta, Edmonton, Alberta, Canada
- School of Health Policy and Management, Faculty of Health, York University, Toronto, Ontario, Canada
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16
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Ishitsuka K, Piedvache A, Kobayashi S, Iwama N, Nishimura T, Watanabe M, Metoki H, Iwata H, Miyashita C, Ishikuro M, Obara T, Sakurai K, Rahman MS, Tanaka K, Miyake Y, Horikawa R, Kishi R, Tsuchiya KJ, Mori C, Kuriyama S, Morisaki N. The Population-Attributable Fractions of Small-for-Gestational-Age Births: Results from the Japan Birth Cohort Consortium. Nutrients 2024; 16:186. [PMID: 38257079 PMCID: PMC10820645 DOI: 10.3390/nu16020186] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2023] [Revised: 12/22/2023] [Accepted: 01/03/2024] [Indexed: 01/24/2024] Open
Abstract
A fetal growth restriction is related to adverse child outcomes. We investigated risk ratios and population-attributable fractions (PAF) of small-for-gestational-age (SGA) infants in the Japanese population. Among 28,838 infants from five ongoing prospective birth cohort studies under the Japan Birth Cohort Consortium, two-stage individual-participant data meta-analyses were conducted to calculate risk ratios and PAFs for SGA in advanced maternal age, pre-pregnancy underweight, and smoking and alcohol consumption during pregnancy. Risk ratio was calculated using modified Poisson analyses with robust variance and PAF was calculated in each cohort, following common analyses protocols. Then, results from each cohort study were combined by meta-analyses using random-effects models to obtain the overall estimate for the Japanese population. In this meta-analysis, an increased risk (risk ratio, [95% confidence interval of SGA]) was significantly associated with pre-pregnancy underweight (1.72 [1.42-2.09]), gestational weight gain (1.95 [1.61-2.38]), and continued smoking during pregnancy (1.59 [1.01-2.50]). PAF of underweight, inadequate gestational weight gain, and continued smoking during pregnancy was 10.0% [4.6-15.1%], 31.4% [22.1-39.6%], and 3.2% [-4.8-10.5%], respectively. In conclusion, maternal weight status was a major contributor to SGA births in Japan. Improving maternal weight status should be prioritized to prevent fetal growth restriction.
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Affiliation(s)
- Kazue Ishitsuka
- Department of Social Medicine, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan; (A.P.); (N.M.)
| | - Aurélie Piedvache
- Department of Social Medicine, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan; (A.P.); (N.M.)
| | - Sumitaka Kobayashi
- Center for Environmental and Health Sciences, Hokkaido University, Sapporo 060-0808, Japan; (S.K.); (H.I.); (C.M.); (R.K.)
| | - Noriyuki Iwama
- Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan; (N.I.); (M.I.); (T.O.); (S.K.)
- Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, 1-1, Seiryomachi, Sendai 980-8574, Japan
| | - Tomoko Nishimura
- Research Center for Child Mental Development, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan; (T.N.); (K.J.T.); (M.S.R.)
| | - Masahiro Watanabe
- Department of Sustainable Health Science, Center for Preventive Medical Sciences, Chiba University, Chiba 263-8522, Japan; (M.W.); (C.M.)
| | - Hirohito Metoki
- Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1, Fukumuro, Miyagino-ku, Sendai 983-8536, Japan;
| | - Hiroyoshi Iwata
- Center for Environmental and Health Sciences, Hokkaido University, Sapporo 060-0808, Japan; (S.K.); (H.I.); (C.M.); (R.K.)
| | - Chihiro Miyashita
- Center for Environmental and Health Sciences, Hokkaido University, Sapporo 060-0808, Japan; (S.K.); (H.I.); (C.M.); (R.K.)
| | - Mami Ishikuro
- Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan; (N.I.); (M.I.); (T.O.); (S.K.)
| | - Taku Obara
- Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan; (N.I.); (M.I.); (T.O.); (S.K.)
| | - Kenichi Sakurai
- Department of Nutrition and Metabolic Medicine, Center for Preventive Medical Sciences, Chiba University, Chiba 263-8522, Japan;
- Department of Bioenvironmental Medicine, Graduate School of Medicine, Chiba University, Chiba 263-8522, Japan
| | - Mohammad Shafiur Rahman
- Research Center for Child Mental Development, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan; (T.N.); (K.J.T.); (M.S.R.)
| | - Keiko Tanaka
- Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine, 10-13 Dogo-Himata, Matsuyama 790-8577, Japan; (K.T.); (Y.M.)
| | - Yoshihiro Miyake
- Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine, 10-13 Dogo-Himata, Matsuyama 790-8577, Japan; (K.T.); (Y.M.)
| | - Reiko Horikawa
- Division of Endocrinology and Metabolism, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan;
| | - Reiko Kishi
- Center for Environmental and Health Sciences, Hokkaido University, Sapporo 060-0808, Japan; (S.K.); (H.I.); (C.M.); (R.K.)
| | - Kenji J. Tsuchiya
- Research Center for Child Mental Development, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan; (T.N.); (K.J.T.); (M.S.R.)
| | - Chisato Mori
- Department of Sustainable Health Science, Center for Preventive Medical Sciences, Chiba University, Chiba 263-8522, Japan; (M.W.); (C.M.)
- Department of Bioenvironmental Medicine, Graduate School of Medicine, Chiba University, Chiba 263-8522, Japan
| | - Shinichi Kuriyama
- Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8573, Japan; (N.I.); (M.I.); (T.O.); (S.K.)
| | - Naho Morisaki
- Department of Social Medicine, National Center for Child Health and Development, 2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan; (A.P.); (N.M.)
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17
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Campaz-Landazábal D, Vargas I, Vázquez ML. Impact of coordination mechanisms based on information and communication technologies on cross-level clinical coordination: A scoping review. Digit Health 2024; 10:20552076241271854. [PMID: 39130524 PMCID: PMC11311193 DOI: 10.1177/20552076241271854] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2024] [Accepted: 07/04/2024] [Indexed: 08/13/2024] Open
Abstract
Background Coordination mechanisms based on information and communication technologies (ICTs) are gaining attention, especially since the pandemic, due to their potential to improve communication between health professionals. However, their impact on cross-level clinical coordination remains unclear. The aim is to synthesize the evidence on the impact of ICT-based coordination mechanisms on clinical coordination between primary care and secondary care (SC) doctors and to identify knowledge gaps. Methods A scoping review was conducted by searching for original articles in six electronic databases and a manual search, with no restrictions regarding time, area, or methodology. Titles and abstracts were screened. Full texts of the selected articles were reviewed and analysed to assess the impact of each mechanism, according to the cross-level clinical coordination conceptual framework. Results Of the 6555 articles identified, 30 met the inclusion criteria. All had been conducted in high-income countries, most (n = 26) evaluated the impact of a single mechanism - asynchronous electronic consultations via electronic health records (EHR) - and were limited in terms of design and types and dimensions of cross-level clinical coordination analysed. The evaluation of electronic consultations showed positive impacts on the appropriateness of referrals and accessibility to SC, yet the qualitative studies also highlighted potential risks. Studies on other mechanisms were scarce (shared EHR, email consultations) or non-existent (videoconferencing, mobile applications). Conclusions Evidence of the impact of ICT-based mechanisms on clinical coordination between levels is limited. Rigorous evaluations are needed to inform policies and strategies for improving coordination between healthcare levels, thus contributing to high-quality, efficient healthcare.
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Affiliation(s)
- Daniela Campaz-Landazábal
- Health Policy and Health Services Research Group, Health Policy Research Unit, Consortium for Health Care and Social Services of Catalonia, Barcelona, Spain
| | - Ingrid Vargas
- Health Policy and Health Services Research Group, Health Policy Research Unit, Consortium for Health Care and Social Services of Catalonia, Barcelona, Spain
| | - María-Luisa Vázquez
- Health Policy and Health Services Research Group, Health Policy Research Unit, Consortium for Health Care and Social Services of Catalonia, Barcelona, Spain
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18
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Almutairi MF, Gulden S, Hundscheid TM, Bartoš F, Cavallaro G, Villamor E. Platelet Counts and Risk of Severe Retinopathy of Prematurity: A Bayesian Model-Averaged Meta-Analysis. CHILDREN (BASEL, SWITZERLAND) 2023; 10:1903. [PMID: 38136105 PMCID: PMC10741847 DOI: 10.3390/children10121903] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/07/2023] [Revised: 12/04/2023] [Accepted: 12/07/2023] [Indexed: 12/24/2023]
Abstract
BACKGROUND We aimed to conduct a systematic review and Bayesian model-averaged meta-analysis (BMA) on the association between platelet counts and severe retinopathy of prematurity (ROP). METHODS We searched for studies reporting on platelet counts (continuous variable) or thrombocytopenia (categorical variable) and severe ROP or aggressive posterior ROP (APROP). The timing of platelet counts was divided into Phase 1 (<2 weeks) and Phase 2 (around ROP treatment). BMA was used to calculate Bayes factors (BFs). The BF10 is the ratio of the probability of the data under the alternative hypothesis (H1) over the probability of the data under the null hypothesis (H0). RESULTS We included 21 studies. BMA showed an association between low platelet counts and severe ROP. The evidence was strong (BF10 = 13.5, 7 studies) for phase 1 and very strong (BF10 = 51.0, 9 studies) for phase 2. Thrombocytopenia (<100 × 109/L) in phase 2 was associated with severe ROP (BF10 = 28.2, 4 studies). Following adjustment for publication bias, only the association of severe ROP with thrombocytopenia remained with moderate evidence in favor of H1 (BF10 = 4.30). CONCLUSIONS Thrombocytopenia is associated with severe ROP. However, the evidence for this association was tempered when results were adjusted for publication bias.
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Affiliation(s)
- Mohamad F. Almutairi
- Division of Neonatology, Department of Pediatrics, MosaKids Children’s Hospital, Maastricht University Medical Center (MUMC+), School for Oncology and Reproduction (GROW), Maastricht University, 6202 AZ Maastricht, The Netherlands
| | - Silvia Gulden
- Neonatal Intensive Care Unit, Sant’Anna Hospital, 22020 Como, Italy
| | - Tamara M. Hundscheid
- Division of Neonatology, Department of Pediatrics, MosaKids Children’s Hospital, Maastricht University Medical Center (MUMC+), School for Oncology and Reproduction (GROW), Maastricht University, 6202 AZ Maastricht, The Netherlands
| | - František Bartoš
- Department of Psychology, University of Amsterdam, 1001 NK Amsterdam, The Netherlands
| | - Giacomo Cavallaro
- Neonatal Intensive Care Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy
| | - Eduardo Villamor
- Division of Neonatology, Department of Pediatrics, MosaKids Children’s Hospital, Maastricht University Medical Center (MUMC+), School for Oncology and Reproduction (GROW), Maastricht University, 6202 AZ Maastricht, The Netherlands
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Dos Reis-Prado AH, Abreu LG, de Arantes LC, Dos Santos de Paula K, de Castro Oliveira S, Goto J, Viana ACD, Benetti F. Influence of sodium hypochlorite on cyclic fatigue resistance of nickel-titanium instruments: A systematic review and meta-analysis of in vitro studies. Clin Oral Investig 2023; 27:6291-6319. [PMID: 37704917 DOI: 10.1007/s00784-023-05243-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2022] [Accepted: 09/05/2023] [Indexed: 09/15/2023]
Abstract
OBJECTIVE This systematic review/meta-analysis investigated the influence of NaOCl on cyclic fatigue resistance of endodontic NiTi instruments. MATERIALS AND METHODS A systematic search until July 2022 in PubMed/MEDLINE, Embase, Scopus, Web of Science, SciELO, Cochrane Library, and grey literature was conducted. According to the PECOS strategy, only in vitro studies evaluating the effects of NaOCl on the cyclic fatigue resistance of NiTi instruments were eligible. Cyclic fatigue resistance was the primary outcome. A modified Joanna Briggs Institute's Checklist was used for risk of bias assessment. RESULTS Of the 2,445 records screened, 37 studies were included. Most studies used simulated canals made of stainless-steel block with severe to moderate curvatures. NaOCl concentration varied from 1-6%, mainly at 37 °C. Regarding fatigue resistance, 23 studies using 1.2% to 6% NaOCl showed a reduction in the resistance compared to the control groups, especially when pre-heated. Four meta-analyses were performed according to the tested NiTi systems. The meta-analyses indicated that the PTU F2 files had higher reduction of fatigue resistance after exposure to 5.25% NaOCl; no differences between NaOCl and no immersion were observed for Reciproc R25, WaveOne 25.08, and WaveOne Gold Primary files. Included studies had low risk of bias. CONCLUSION NaOCl appears to reduce cyclic fatigue resistance of certain NiTi files, especially when they are pre-heated, particularly in conventional NiTi files compared to some heat-treated instruments. It is possible that the temperature of the solution may have a greater influence on resistance than NaOCl itself. Important to note that an overall tendency toward no significant influence was observed among various systems. CLINICAL RELEVANCE Precautions are necessary when a pre-heated high-concentration NaOCl is used to enhance its properties during root canal preparation, mainly using conventional wire.
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Affiliation(s)
| | - Lucas Guimarães Abreu
- Department of Child's and Adolescent's Oral Health, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
| | - Lara Cancella de Arantes
- Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
| | - Kiani Dos Santos de Paula
- Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
| | - Sabrina de Castro Oliveira
- Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
| | - Juliana Goto
- Department of Restorative Dentistry, School of Dentistry, São Paulo State University (Unesp), Araçatuba, SP, Brazil
| | - Ana Cecília Diniz Viana
- Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
| | - Francine Benetti
- Department of Restorative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil
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Ding P, Chen P, Ouyang J, Li Q, Li S. Clinicopathological and prognostic value of epithelial cell adhesion molecule in solid tumours: a meta-analysis. Front Oncol 2023; 13:1242231. [PMID: 37664060 PMCID: PMC10468606 DOI: 10.3389/fonc.2023.1242231] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/18/2023] [Accepted: 07/27/2023] [Indexed: 09/05/2023] Open
Abstract
Background Malignant tumors, mainly solid tumors, are a significant obstacle to the improvement of life expectancy at present. Epithelial cell adhesion molecule (EpCAM), a cancer stem cell biomarker, showed widespread expression in most normal epithelial cells and most cancers. Although the clinical significance of EpCAM in various malignant solid tumors has been studied extensively, the latent relationships between EpCAM and pathological and clinical characteristics in solid tumors and differences in the roles of EpCAM among tumors have not been clearly determined. The destination point of this study was to analyze the value of EpCAM in solid tumors in clinicopathological and prognostic dimension using a meta-analysis approach. Method and materials A comprehensive and systematic search of the researches published up to March 7th, 2022, in PubMed, EMBASE, Web of Science, Cochrane library and PMC databases was performed. The relationships between EpCAM overexpression, clinicopathological characteristics, and survival outcomes were analyzed. Pooled hazard ratios (HRs) with 95% confidence intervals (CIs) and odds ratios (ORs) were estimated as indicators of the degree of correlation. This research was registered on PROSPERO (International prospective register of systematic reviews), ID: CRD42022315070. Results In total, 57 articles and 14184 cases were included in this study. High EpCAM expression had a significant coherence with a poorer overall survival (OS) (HR: 1.30, 95% CI: 1.08-1.58, P < 0.01) and a worse disease-free survival (DFS) (HR: 1.58, 95% CI: 1.28-1.95, P < 0.01), especially of gastrointestinal tumors' OS (HR: 1.50, 95% CI: 1.15-1.95, P < 0.01), and DFS (HR: 1.84, 95% CI: 1.52-2.33, P < 0.01). The DFS of head and neck tumors (HR: 2.33, 95% CI: 1.51-3.61, P < 0.01) was also associated with the overexpression of EpCAM. There were no positive relationships between the overexpression of EpCAM and sex (RR: 1.03, 95% CI: 0.99-1.07, P = 0.141), T classification (RR: 0.93, 95% CI: 0.82-1.06, P = 0.293), lymph node metastasis (RR: 0.85, 95% CI: 0.54-1.32, P = 0.461), distant metastasis (RR: 0.97, 95% CI: 0.84-1.10, P = 0.606), vascular infiltration (RR: 1.05, 95% CI: 0.85-1.29, P = 0.611), and TNM stage (RR: 0.93, 95% CI: 0.83-1.04, P = 0.187). However, the overexpression of EpCAM exhibited a significant association with the histological grades (RR: 0.88, 95% CI: 0.80-0.97, P < 0.01). Conclusion Based on pooled HRs, the positive expression of EpCAM was totally correlated to a worse OS and DFS in solid tumors. The expression of EpCAM was related to a worse OS in gastrointestinal tumors and a worse DFS in gastrointestinal tumors and head and neck tumors. Moreover, EpCAM expression was correlated with the histological grade. The results presented pointed out that EpCAM could serve as a prognostic biomarker for gastrointestinal and head and neck tumors. Systematic review registration https://www.crd.york.ac.uk/prospero, identifier CRD42022315070.
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Affiliation(s)
- Peiwen Ding
- Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
- Clinical School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Panyu Chen
- Operating Room, Sichuan University West China Hospital School of Nursing, Chengdu, China
| | - Jiqi Ouyang
- Department of Gastroenterology, China Academy of Chinese Medical Sciences Guang’anmen Hospital, Beijing, China
| | - Qiang Li
- Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
- Clinical School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
| | - Shijie Li
- Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China
- Clinical School, Chengdu University of Traditional Chinese Medicine, Chengdu, China
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21
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Li TF, Ke XY, Zhang YR, Zhan JH. The correlation between rs2501577 gene polymorphism and biliary atresia: a systematic review and meta-analysis. Pediatr Surg Int 2023; 39:206. [PMID: 37248361 DOI: 10.1007/s00383-023-05491-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/23/2023] [Indexed: 05/31/2023]
Abstract
IMPORTANCE Multiple studies indicate a possible correlation between ADD3 rs2501577 and biliary atresia susceptibility; however, a conclusive determination has yet to be made. OBJECTIVE Investigate the role of ADD3 rs2501577 in biliary atresia susceptibility across diverse populations. DATA SOURCES The study protocol has been registered on PROSPERO, an international platform for systematic review registration (PROSPERO ID: CRD42023384641). The following databases will be searched until February 1, 2023: PubMed, Embase, Cochrane, CBM, Web of Science, and CNKI. STUDY SELECTION Eight studies were selected from seven papers to assess the data. A total of 7651 participants were included, consisting of 1662 in the BA group and 5989 in the NC group. DATA EXTRACTION AND SYNTHESIS Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed while conducting the systematic reviews and meta-analyses. Two authors independently assessed the quality of the included studies using the Newcastle-Ottawa Quality Assessment Scale. The significance of the pooled odds ratio (OR) was evaluated with a Z test, and statistical heterogeneity across studies was assessed using the I2 and Q statistics. Publication bias was assessed using Egger's and Begg's tests. MAIN OUTCOME(S) AND MEASURE(S) The primary study outcome was the development of biliary atresia. Subgroup analysis was performed based on race, region, and assessment of Hardy-Weinberg equilibrium (HWE). RESULTS The studies indicate that the ADD3 rs2501577 susceptibility locus increases the risk of developing biliary atresia, regardless of allelic, homozygote, dominant, and recessive gene inheritance models. Furthermore, ADD3 has been found to be associated with apoptosis, cell cycle, and cell damage repair based on functional analysis. CONCLUSIONS AND RELEVANCE The ADD3 rs2501577 polymorphic locus is associated with an increased risk of biliary atresia, particularly in Asian populations. This study recommends further investigation of the ADD3 rs2501577 locus in Asian populations to validate its role in the diagnosis of biliary atresia.
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Affiliation(s)
- Teng-Fei Li
- Graduate School, Tianjin Medical University, Tianjin, 300070, China
- Department of General Surgery, Tianjin Children's Hospital, Tianjin, 300134, China
| | - Xing-Yuan Ke
- School of Basic Medical Sciences, Tianjin Medical University, Tianjin, 300070, China
| | - Yan-Ran Zhang
- School of Basic Medical Sciences, Tianjin Medical University, Tianjin, 300070, China
| | - Jiang-Hua Zhan
- Department of General Surgery, Tianjin Children's Hospital, Tianjin, 300134, China.
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Mayo-Wilson E, Qureshi R, Li T. Conducting separate reviews of benefits and harms could improve systematic reviews and meta-analyses. Syst Rev 2023; 12:67. [PMID: 37061724 PMCID: PMC10105415 DOI: 10.1186/s13643-023-02234-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/02/2022] [Accepted: 04/10/2023] [Indexed: 04/17/2023] Open
Abstract
Guidance for systematic reviews of interventions recommends both benefits and harms be included. Systematic reviews may reach conclusions about harms (or lack of harms) that are not true when reviews include only some relevant studies, rely on incomplete data from eligible studies, use inappropriate methods for synthesizing data, and report results selectively. Separate reviews about harms could address some of these problems, and we argue that conducting separate reviews of harms is a feasible alternative to current standards and practices. Systematic reviews of potential benefits could be organized around the use of interventions for specific health problems. Systematic reviews of potential harms could be broader, including more diverse study designs and including all people at risk of harms (who might use the same intervention to treat different health problems). Multiple reviews about benefits could refer to a single review of harms. This approach could improve the reliability, completeness, and efficiency of systematic reviews.
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Affiliation(s)
- Evan Mayo-Wilson
- Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC, 27599, USA.
| | - Riaz Qureshi
- Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Tianjing Li
- Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
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23
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Obande D, Young I, Gao JL, Pearl DL, Papadopoulos A. Systematic review and meta-regression of food safety knowledge and behaviour of primary food preparers for young children in the home setting. Food Control 2023. [DOI: 10.1016/j.foodcont.2022.109455] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
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24
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Zhang ZY, Ji HS, He JX, Huang LJ, Ding SC, Sun J, Li DY. A Meta-analysis of the Effects of High-Intensity Interval Training and Small-Sided Games on Sprint Performance in Adolescents. Strength Cond J 2023. [DOI: 10.1519/ssc.0000000000000773] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/09/2023]
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25
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Gómez-Ochoa SA, Pitton M, Valente LG, Sosa Vesga CD, Largo J, Quiroga-Centeno AC, Hernández Vargas JA, Trujillo-Cáceres SJ, Muka T, Cameron DR, Que YA. Efficacy of phage therapy in preclinical models of bacterial infection: a systematic review and meta-analysis. THE LANCET. MICROBE 2022; 3:e956-e968. [PMID: 36370748 DOI: 10.1016/s2666-5247(22)00288-9] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/30/2022] [Revised: 09/14/2022] [Accepted: 09/21/2022] [Indexed: 11/11/2022]
Abstract
BACKGROUND Antimicrobial resistance of bacterial pathogens is an increasing clinical problem and alternative approaches to antibiotic chemotherapy are needed. One of these approaches is the use of lytic bacterial viruses known as phage therapy. We aimed to assess the efficacy of phage therapy in preclinical animal models of bacterial infection. METHODS In this systematic review and meta-analysis, MEDLINE/Ovid, Embase/Ovid, CINAHL/EbscoHOST, Web of Science/Wiley, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar were searched from inception to Sept 30, 2021. Studies assessing phage efficacy in animal models were included. Only studies that assessed the efficacy of phage therapy in treating established bacterial infections in terms of survival and bacterial abundance or density were included. Studies reporting only in-vitro or ex-vivo results and those with incomplete information were excluded. Risk-of-bias assessment was performed using the Systematic Review Centre for Laboratory Animal Experimentation tool. The main endpoints were animal survival and tissue bacterial burden, which were reported using pooled odds ratios (ORs) and mean differences with random-effects models. The I2 measure and its 95% CI were also calculated. This study is registered with PROSPERO, CRD42022311309. FINDINGS Of the 5084 references screened, 124 studies fulfilled the selection criteria. Risk of bias was high for 70 (56%) of the 124 included studies; therefore, only studies classified as having a low-to-moderate risk of bias were considered for quantitative data synthesis (n=32). Phage therapy was associated with significantly improved survival at 24 h in systemic infection models (OR 0·08 [95% CI 0·03 to 0·20]; I2=55% [95% CI 8 to 77]), skin infection (OR 0·08 [0·04 to 0·19]; I2 = 0% [0 to 79]), and pneumonia models (OR 0·13 [0·06 to 0·31]; I2=0% [0 to 68]) when compared with placebo. Animals with skin infections (mean difference -2·66 [95% CI -3·17 to -2·16]; I2 = 95% [90 to 96]) and those with pneumonia (mean difference -3·35 [-6·00 to -0·69]; I2 = 99% [98 to 99]) treated with phage therapy had significantly lower tissue bacterial loads at 5 ± 2 days of follow-up compared with placebo. INTERPRETATION Phage therapy significantly improved animal survival and reduced organ bacterial loads compared with placebo in preclinical animal models. However, high heterogeneity was observed in some comparisons. More evidence is needed to identify the factors influencing phage therapy performance to improve future clinical application. FUNDING Swiss National Foundation and Swiss Heart Foundation.
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Affiliation(s)
- Sergio Alejandro Gómez-Ochoa
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; Research Center, Fundación Cardiovascular de Colombia, Bucaramanga, Colombia.
| | - Melissa Pitton
- Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland; Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Luca G Valente
- Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | | | - Jorge Largo
- Internal Medicine Department, Universidad Militar Nueva Granada, Bogotá, Colombia
| | | | | | | | - Taulant Muka
- Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; Epistudia, Bern, Switzerland
| | - David R Cameron
- Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Yok-Ai Que
- Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
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26
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Gartlehner G, Emprechtinger R, Hackl M, Jutz FL, Gartlehner JE, Nonninger JN, Klerings I, Dobrescu AI. Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis. BMJ Evid Based Med 2022; 27:345-351. [PMID: 35292534 PMCID: PMC9691824 DOI: 10.1136/bmjebm-2021-111846] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/07/2022] [Indexed: 11/04/2022]
Abstract
OBJECTIVES To assess the magnitude of reporting bias in trials assessing homeopathic treatments and its impact on evidence syntheses. DESIGN A cross-sectional study and meta-analysis. Two persons independently searched Clinicaltrials.gov, the EU Clinical Trials Register and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials. To determine whether registered trials were published and to detect published but unregistered trials, two persons independently searched PubMed, Allied and Complementary Medicine Database, Embase and Google Scholar up to April 2021. For meta-analyses, we used random effects models to determine the impact of unregistered studies on meta-analytic results. MAIN OUTCOMES AND MEASURES We report the proportion of registered but unpublished trials and the proportion of published but unregistered trials. We also assessed whether primary outcomes were consistent between registration and publication. For meta-analyses, we used standardised mean differences (SMDs). RESULTS Since 2002, almost 38% of registered homeopathy trials have remained unpublished, and 50% of published randomised controlled trials (RCTs) have not been registered. Retrospective registration was more common than prospective registration. Furthermore, 25% of primary outcomes were altered or changed compared with the registry. Although we could detect a statistically significant trend toward an increase of registrations of homeopathy trials (p=0.001), almost 30% of RCTs published during the past 5 years had not been registered.A meta-analysis stratified by registration status of RCTs revealed substantially larger treatment effects of unregistered RCTs (SMD: -0.53, 95% CI -0.87 to -0.20) than registered RCTs (SMD: -0.14, 95% CI -0.35 to 0.07). CONCLUSIONS Registration of published trials was infrequent, many registered trials were not published and primary outcomes were often altered or changed. This likely affects the validity of the body of evidence of homeopathic literature and may overestimate the true treatment effect of homeopathic remedies.
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Affiliation(s)
- Gerald Gartlehner
- Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems, Austria
- RTI International, Research Triangle Park, North Carolina, USA
| | - Robert Emprechtinger
- Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems, Austria
| | - Marlene Hackl
- Karl Landsteiner University of Health Sciences, Krems, Austria
| | | | | | | | - Irma Klerings
- Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems, Austria
| | - Andreea Iulia Dobrescu
- Department for Evidence-based Medicine and Evaluation, Danube University Krems, Krems, Austria
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Postpartum depression and ADHD in the offspring: Systematic review and meta-analysis. J Affect Disord 2022; 318:314-330. [PMID: 36096371 DOI: 10.1016/j.jad.2022.08.055] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2022] [Revised: 08/08/2022] [Accepted: 08/21/2022] [Indexed: 11/21/2022]
Abstract
BACKGROUND Postpartum depression (PPD) is a disorder that has a severe impact on a woman's mental state and mood after birth. Research has shown that postnatal levels of family adversity and maternal psychopathology are associated with Attention Deficit Hyperactivity Disorder (ADHD). This paper is intended to examine the association among maternal PPD and the risk of ADHD in the offspring. METHODS Keyword search was conducted for PsycINFO, PubMed, Google Scholar, and Embase up to Feb 28, 2021; studies in English were deemed eligible. Random-effects meta-analysis and meta-regression analysis took place. Subgroup analyses by study design, geographical region, level of adjustment and study setting were performed. RESULTS Nine cohort studies and two case-control studies published from 2003 to 2019 were included in the qualitative synthesis; among them, eight studies were synthesized in the meta-analysis. Overall, maternal PPD was associated with an increased risk of ADHD in the offspring (pooled relative risk, RR = 1.69, 95%CI: 1.27-2.26). Significant associations were noted in the subsets of cohort studies, studies implementing multivariate analyses and registry-based surveys. LIMITATIONS Overall, a larger number of studies of the field are needed. Data collection relied on self-report and attrition bias limited the validity of eligible studies. Studies from developing countries were underrepresented. There was significant publication bias (p = 0.035, Egger's test). CONCLUSIONS The relationship between PPD and ADHD in children was found to be significant in this systematic review and meta-analysis and reveals the need for further investigation in various geographical regions.
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Elbadawi A, Sedhom R, Gad M, Hamed M, Elwagdy A, Barakat AF, Khalid U, Mamas MA, Birnbaum Y, Elgendy IY, Jneid H. Screening for atrial fibrillation in the elderly: A network meta-analysis of randomized trials. Eur J Intern Med 2022; 105:38-45. [PMID: 35953337 DOI: 10.1016/j.ejim.2022.07.015] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2022] [Revised: 07/08/2022] [Accepted: 07/26/2022] [Indexed: 11/03/2022]
Abstract
BACKGROUND Randomized controlled trials (RCTs) investigating the optimal screening strategy for atrial fibrillation (AF) have yielded conflicting results. OBJECTIVE To examine the comparative efficacy of different AF screening strategies in older adults. METHODS We searched MEDLINE, EMBASE and Cochrane without language restrictions through January 2022, for RCTs evaluating the outcomes of non-invasive AF screening approaches among adults ≥65 years. We conducted a pairwise meta-analysis comparing any AF screening approach versus no screening, and a network meta-analysis comparing systematic screening versus opportunistic screening versus no screening. The primary outcome was new AF detection. RESULTS The final analysis included 9 RCTs with 85,209 patients. The weighted median follow-up was 12 months. The mean age was 73.4 years and men represented 45.6%. On pairwise meta-analysis, any AF screening (either systematic or opportunistic) was associated with higher AF detection (1.8% vs. 1.3%; risk ratio [RR] 2.10; 95% confidence interval [CI] 1.20-3.65) and initiation of oral anticoagulation (RR 3.26; 95%CI 1.15-9.23), compared with no screening. There was no significant difference between any AF screening versus no screening in all-cause mortality (RR 0.97; 95%CI 0.93-1.01) or acute cerebrovascular accident (CVA) (RR 0.92; 95%CI 0.84-1.01). On network meta-analysis, only systematic screening was associated with higher AF detection (RR 2.73; 95% CI 1.62-4.59) and initiation of oral anticoagulation (RR 5.67; 95% CI 2.68-11.99), but not with the opportunistic screening, compared with no screening. CONCLUSION Systematic AF screening using non-invasive tools was associated with higher rate of new AF detection and initiation of OAC, but opportunistic screening was not associated with higher detection rates. There were no significant differences between the various AF screening approaches with respect to rates of all-cause mortality or CVA events. However, these analyses are likely underpowered and future RCTs are needed to examine the impact of systematic AF screening on mortality and CVA outcomes. PRIMARY FUNDING SOURCE None.
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Affiliation(s)
- Ayman Elbadawi
- Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, USA
| | - Ramy Sedhom
- Division of Cardiology, Loma Linda University Health, Loma Linda, CA, USA
| | - Mohamed Gad
- Department of Internal Medicine, Cleveland Clinic, Cleveland, OH, United States
| | - Mohamed Hamed
- Division of Internal Medicine, Florida Atlantic University, Boca Raton, Florida, United States
| | - Amr Elwagdy
- Department of Internal Medicine, Rochester General Hospital, Rochester, NY, United States
| | - Amr F Barakat
- UPMC Heart and Vascular Institute, University of Pittsburgh, Pittsburgh, PA, United States
| | - Umair Khalid
- Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, USA
| | - Mamas A Mamas
- Keele Cardiovascular Research Group, Keele University, Keele, England; Institute of Population Health, University of Manchester, England
| | - Yochai Birnbaum
- Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, USA
| | - Islam Y Elgendy
- Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, KY, United States
| | - Hani Jneid
- Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, USA.
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Ademuyiwa AO, Adisa AO, Bach S, Bhangu A, Harrison E, Ingabire JCA, Haque PD, Ismail L, Glasbey J, Ghosh D, Kadir B, Kamarajah SK, Li E, Lillywhite R, Mann H, Martin J, Ramos de la Madina A, Moore R, Morton D, Nepogodiev D, Ntirenganya F, Pinkney T, Pockney P, Omar O, Simoes J, Smart N, Smith D, Tabiri S, Taylor E, Wilkin R. Alcoholic chlorhexidine skin preparation or triclosan-coated sutures to reduce surgical site infection: a systematic review and meta-analysis of high-quality randomised controlled trials. THE LANCET. INFECTIOUS DISEASES 2022; 22:1242-1251. [PMID: 35644158 DOI: 10.1016/s1473-3099(22)00133-5] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/16/2021] [Revised: 01/14/2022] [Accepted: 01/31/2022] [Indexed: 06/15/2023]
Abstract
BACKGROUND WHO and the UK's National Institute for Health and Care Excellence recommend alcoholic chlorhexidine skin preparation and triclosan-coated sutures to prevent surgical site infections (SSIs). Existing meta-analyses that include studies at high risk of bias, combined with the recent publication of large, randomised trials, justify an updated meta-analysis of high-quality randomised controlled trials (RCTs). We aimed to test the rates of SSI according to skin preparation solutions (ie, alcoholic chlorhexidine vs aqueous povidone-iodine) and types of sutures (ie, coated vs uncoated). METHODS In this systematic review and meta-analysis, we searched MEDLINE, Embase, Pubmed, and Cochrane Library databases, with no language restrictions, to identify high-quality RCTs testing either alcoholic chlorhexidine skin preparation (vs aqueous povidone-iodine) or triclosan-coated sutures (vs uncoated sutures), or both, published from database inception to Sept 1, 2021. Patients who received clean-contaminated, contaminated, or dirty surgery were included. We predefined the characteristics of a high-quality trial through an expert consensus process to develop an enhanced Cochrane risk of bias-2 tool specifically for RCTs with a primary outcome of SSI. Data were extracted from published reports. Meta-analysis was performed using a random-effects model and heterogeneity was assessed using the I2 statistic. This systematic review and meta-analysis was prospectively registered in PROSPERO, CRD42021267220. FINDINGS Of 942 studies identified, 933 were excluded. Four high-quality RCTs (n=7467 patients) were included that tested alcoholic chlorhexidine. No significant difference in SSI rates was noted between alcoholic chlorhexidine and aqueous povidone-iodine (17·9% [667 of 3723 patients] vs 19·8% [740 of 3744 patients]; odds ratio 0·84 [95% CI 0·65-1·06]; p=0·21, I2=53·1%). Five high-quality RCTs were included that tested triclosan-coated sutures (n=8619 patients), with no significant difference noted between triclosan-coated and uncoated sutures (16·8% [733 of 4360 patients] vs 18·4% [784 of 4259 patients]; OR 0·90 [95% CI 0·74-1·09]; p=0·29, I2=36·4%). INTERPRETATION Contrary to previous meta-analyses, this study did not show a benefit from either alcoholic chlorhexidine skin preparation or triclosan-coated sutures, both of which are more expensive than other readily available alternatives. Global and national guidance should be reconsidered to remove recommendations for their routine use. FUNDING National Institute for Health Research (NIHR) Global Health Research Unit.
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Adverse Effects of Angiotensin-Converting Enzyme Inhibitors in Humans: A Systematic Review and Meta-Analysis of 378 Randomized Controlled Trials. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2022; 19:ijerph19148373. [PMID: 35886227 PMCID: PMC9324875 DOI: 10.3390/ijerph19148373] [Citation(s) in RCA: 21] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/16/2022] [Revised: 07/06/2022] [Accepted: 07/06/2022] [Indexed: 11/29/2022]
Abstract
Background: Although angiotensin-converting enzyme (ACE) inhibitors are among the most-prescribed medications in the world, the extent to which they increase the risk of adverse effects remains uncertain. This study aimed to systematically determine the adverse effects of ACE inhibitors versus placebo across a wide range of therapeutic settings. Methods: Systematic searches were conducted on PubMed, Web of Science, and Cochrane Library databases. Randomized controlled trials (RCTs) comparing an ACE inhibitor to a placebo were retrieved. The relative risk (RR) and its 95% confidence interval (95% CI) were utilized as a summary effect measure. A random-effects model was used to calculate pooled-effect estimates. Results: A total of 378 RCTs fulfilled the eligibility criteria, with 257 RCTs included in the meta-analysis. Compared with a placebo, ACE inhibitors were associated with an significantly increased risk of dry cough (RR = 2.66, 95% CI = 2.20 to 3.20, p < 0.001), hypotension (RR = 1.98, 95% CI = 1.66 to 2.35, p < 0.001), dizziness (RR = 1.46, 95% CI = 1.26 to 1.70, p < 0.001), and hyperkalemia (RR = 1.24, 95% CI = 1.01 to 1.52, p = 0.037). The risk difference was quantified to be 0.037, 0.030, 0.017, and 0.009, respectively. Conclusions: We quantified the relative risk of numerous adverse events associated with the use of ACE inhibitors in a variety of demographics. This information can help healthcare providers be fully informed about any potential adverse consequences and make appropriate suggestions for their patients requiring ACE inhibitor therapy.
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Schwartz SM, Barpujari A, Finnerup NB, Raja SN. Pharmacologic therapies for neuropathic pain: an assessment of reporting biases in randomized controlled trials. Pain 2022; 163:795-804. [PMID: 34348355 PMCID: PMC8810900 DOI: 10.1097/j.pain.0000000000002426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2021] [Accepted: 07/22/2021] [Indexed: 11/26/2022]
Abstract
ABSTRACT Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7% to 8% of the population experiences neuropathic pain (NP), and established treatment guidelines are based predominantly on published clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for NP and assessed the relative proportions with statistically significant (ie, positive) and nonsignificant (ie, negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central NP. Positive studies were cited nearly twice as often as negative studies in the literature (P = 0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.
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Affiliation(s)
- Stefani M Schwartz
- Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, MD, United States
| | - Awinita Barpujari
- Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, MD, United States
| | - Nanna Brix Finnerup
- Danish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Srinivasa N Raja
- Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Hospital, Baltimore, MD, United States
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Devani RN, Kirubakaran A, Molokhia M. Digital health RCT interventions for cardiovascular disease risk reduction: a systematic review and meta-analysis. HEALTH AND TECHNOLOGY 2022; 12:687-700. [PMID: 35350665 PMCID: PMC8947848 DOI: 10.1007/s12553-022-00651-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2021] [Accepted: 02/19/2022] [Indexed: 11/16/2022]
Abstract
Heart disease is a leading cause of UK mortality. Evidence suggests digital health interventions (DHIs), such as smartphone applications, may reduce cardiovascular risk, but no recent reviews are available. This review examined the effect of DHIs on cardiovascular disease (CVD) risk scores in patients with increased CVD risk, compared to usual care alone. PubMed, Cochrane Database, Medline, and Google Scholar were searched for eligible trials published after 01/01/2010, involving populations with at least one CVD risk factor. Primary outcome was change in CVD risk score (e.g. QRISK3) between baseline and follow-up. Meta-analysis was undertaken using Revman5/STATA using random-effects modelling. Cochrane RoB-2 tool determined risk-of-bias. 6 randomised controlled trials from 36 retrieved articles (16.7%) met inclusion criteria, involving 1,157 patients treated with DHIs alongside usual care, and 1,127 patients offered usual care only (control group). Meta-analysis using random-effects model in STATA showed an inconclusive effect for DHIs as effective compared to usual care (Mean Difference, MD -0.76, 95% CI -1.72, 0.20), with moderate certainty (GRADEpro). Sensitivity analysis by DHI modality suggested automated email messaging was the most effective DHI (MD -1.09, 95% Cl -2.15, -0.03), with moderate certainty (GRADEpro). However, substantial study heterogeneity was noted in main and sensitivity analyses (I2 = 66% and 64% respectively). Quality assessment identified risk-of-bias concerns, particularly for outcome measurement. Findings suggest specific DHIs such as automated email messaging may improve CVD risk outcomes, but were inconclusive for DHIs overall. Further research into specific DHI modalities is required, with longer follow-up. Supplementary Information The online version contains supplementary material available at 10.1007/s12553-022-00651-0.
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Affiliation(s)
- Rohan Neil Devani
- Department of Life Sciences and Medicine, King’s College London, Great Maze Pond, London, SE1 1UL UK
| | - Arushan Kirubakaran
- Department of Life Sciences and Medicine, King’s College London, Great Maze Pond, London, SE1 1UL UK
| | - Mariam Molokhia
- Department of Life Sciences and Medicine, King’s College London, Great Maze Pond, London, SE1 1UL UK
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Hadi A, Asbaghi O, Kazemi M, Haghighian HK, Pantovic A, Ghaedi E, Abolhasani Zadeh F. Consumption of pistachio nuts positively affects lipid profiles: A systematic review and meta-analysis of randomized controlled trials. Crit Rev Food Sci Nutr 2021:1-14. [PMID: 34933637 DOI: 10.1080/10408398.2021.2018569] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effects of consuming pistachio nuts on lipid profiles (total cholesterol [TC], low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], and triglyceride [TG]). Databases of PubMed, Scopus, ISI Web of Science, and Cochrane Library were searched from inception to June 2019 to identify RCTs documenting the effects of consuming pistachio nuts on blood lipid profiles in adults. Effect sizes were reported as weighted mean difference (WMD) and 95% confidence interval (CI) using the random-effects models (DerSimonian-Laird method). Twelve eligible RCTs were included. Consumption of pistachio nuts decreased TC (WMD: -7.48 mg/dL; 95% CI, -12.62 to -2.34), LDL-C (WMD: -3.82 mg/dL; 95% CI, -5.49 to -2.16) and TG (WMD: -11.19 mg/dL; 95% CI, -14.21 to -8.17) levels. However, HDL-cholesterol levels (WMD: 2.45 mg/dL; 95% CI, -2.44 to 7.33) did not change following pistachio consumption. Consuming pistachio nuts may improve lipid profiles (TC, LDL-C, TG) in adults and may be protective against cardiometabolic diseases. However, further studies with larger sample sizes are required to confirm these results.
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Affiliation(s)
- Amir Hadi
- Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Omid Asbaghi
- Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Maryam Kazemi
- Human Metabolic Research Unit, Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA
| | - Hossein Khadem Haghighian
- Metabolic Diseases Research Center, Research Institute for Prevention of on-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran
| | - Ana Pantovic
- Faculty of Biology, University of Belgrade, Belgrade, Serbia
| | - Ehsan Ghaedi
- Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran
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Grin N, Rousson V, Darocha T, Hugli O, Carron PN, Zingg T, Pasquier M. Hypothermia Outcome Prediction after Extracorporeal Life Support for Hypothermic Cardiac Arrest Patients: Assessing the Performance of the HOPE Score in Case Reports from the Literature. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2021; 18:11896. [PMID: 34831650 PMCID: PMC8622062 DOI: 10.3390/ijerph182211896] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/05/2021] [Revised: 11/01/2021] [Accepted: 11/10/2021] [Indexed: 11/29/2022]
Abstract
Aims: The hypothermia outcome prediction after extracorporeal life support (ECLS) score, or HOPE score, provides an estimate of the survival probability in hypothermic cardiac arrest patients undergoing ECLS rewarming. The aim of this study was to assess the performance of the HOPE score in case reports from the literature. Methods: Cases were identified through a systematic review of the literature. We included cases of hypothermic cardiac arrest patients rewarmed with ECLS and not included in the HOPE derivation and validation studies. We calculated the survival probability of each patient according to the HOPE score. Results: A total of 70 patients were included. Most of them (62/70 = 89%) survived. The discrimination using the HOPE score was good (Area Under the Receiver Operating Characteristic Curve = 0.78). The calibration was poor, with HOPE survival probabilities averaging 54%. Using a HOPE survival probability threshold of at least 10% as a decision criterion for rewarming a patient would have resulted in only five false positives and a single false negative, i.e., 64 (or 91%) correct decisions. Conclusions: In this highly selected sample, the HOPE score still had a good practical performance. The selection bias most likely explains the poor calibration found in the present study, with survivors being more often described in the literature than non-survivors. Our finding underscores the importance of working with a representative sample of patients when deriving and validating a score, as was the case in the HOPE studies that included only consecutive patients in order to minimize the risk of publication bias and lower the risk of overly optimistic outcomes.
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Affiliation(s)
- Nolan Grin
- School of Medicine, Lausanne University, 1011 Lausanne, Switzerland;
| | - Valentin Rousson
- Center for Primary Care and Public Health (Unisanté), Lausanne University Hospital, 1010 Lausanne, Switzerland;
| | - Tomasz Darocha
- Severe Accidental Hypothermia Center, Department of Anaesthesiology and Intensive Care, Medical University of Silesia, 40-001 Katowice, Poland;
| | - Olivier Hugli
- Department of Emergency Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland; (O.H.); (P.-N.C.)
| | - Pierre-Nicolas Carron
- Department of Emergency Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland; (O.H.); (P.-N.C.)
| | - Tobias Zingg
- Department of Surgery, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland;
| | - Mathieu Pasquier
- Department of Emergency Medicine, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland; (O.H.); (P.-N.C.)
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Abstract
Digital health data are multimodal and high-dimensional. A patient's health state can be characterized by a multitude of signals including medical imaging, clinical variables, genome sequencing, conversations between clinicians and patients, and continuous signals from wearables, among others. This high volume, personalized data stream aggregated over patients' lives has spurred interest in developing new artificial intelligence (AI) models for higher-precision diagnosis, prognosis, and tracking. While the promise of these algorithms is undeniable, their dissemination and adoption have been slow, owing partially to unpredictable AI model performance once deployed in the real world. We posit that one of the rate-limiting factors in developing algorithms that generalize to real-world scenarios is the very attribute that makes the data exciting-their high-dimensional nature. This paper considers how the large number of features in vast digital health data can challenge the development of robust AI models-a phenomenon known as "the curse of dimensionality" in statistical learning theory. We provide an overview of the curse of dimensionality in the context of digital health, demonstrate how it can negatively impact out-of-sample performance, and highlight important considerations for researchers and algorithm designers.
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Schwab S, Kreiliger G, Held L. Assessing treatment effects and publication bias across different specialties in medicine: a meta-epidemiological study. BMJ Open 2021; 11:e045942. [PMID: 34521659 PMCID: PMC8442042 DOI: 10.1136/bmjopen-2020-045942] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/21/2020] [Accepted: 08/09/2021] [Indexed: 12/27/2022] Open
Abstract
OBJECTIVES To assess the prevalence of statistically significant treatment effects, adverse events and small-study effects (when small studies report more extreme results than large studies) and publication bias (over-reporting of statistically significant results) across medical specialties. DESIGN Large meta-epidemiological study of treatment effects from the Cochrane Database of Systematic Reviews. METHODS We investigated outcomes from 57 162 studies from 1922 to 2019, and overall 98 966 meta-analyses and 5534 large meta-analyses (≥10 studies). Egger's and Harbord's tests to detect small-study effects, limit meta-analysis and Copas selection models to bias-adjust effect estimates and generalised linear mixed models were used to analyse one of the largest collections of evidence in medicine. RESULTS Medical specialties showed differences in the prevalence of statistically significant results of efficacy and safety outcomes. Treatment effects from primary studies published in high ranking journals were more likely to be statistically significant (OR=1.52; 95% CI 1.32 to 1.75) while randomised controlled trials were less likely to report a statistically significant effect (OR=0.90; 95% CI 0.86 to 0.94). Altogether 19% (95% CI 18% to 20%) of the large meta-analyses showed evidence for small-study effects, but only 3.9% (95% CI 3.4% to 4.4%) showed evidence for publication bias after further assessment of funnel plots. Adjusting treatment effects resulted in overall less evidence for efficacy. CONCLUSIONS These results suggest that reporting of large treatment effects from small studies may cause greater concern than publication bias. Incentives should be created so that studies of the highest quality become more visible than studies that report more extreme results.
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Affiliation(s)
- Simon Schwab
- Center for Reproducible Science & Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
| | - Giuachin Kreiliger
- Master Program in Biostatistics, University of Zurich, Zurich, Switzerland
| | - Leonhard Held
- Center for Reproducible Science & Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
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Lazaru P, Bueschges S, Ramadanov N. Direct anterior approach (DAA) vs. conventional approaches in total hip arthroplasty: A RCT meta-analysis with an overview of related meta-analyses. PLoS One 2021; 16:e0255888. [PMID: 34428236 PMCID: PMC8384214 DOI: 10.1371/journal.pone.0255888] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2021] [Accepted: 07/26/2021] [Indexed: 01/02/2023] Open
Abstract
OBJECTIVES Several systematic reviews and meta-analyses on short-term outcomes between total hip arthroplasty (THA) through direct anterior approach (DAA) compared to THA through conventional (including anterior, anterolateral, lateral transgluteal, lateral transtrochanteric, posterior, and posterolateral) approaches (CAs) in treatment of hip diseases and fractures showed contradicting conclusions. Our aim was to draw definitive conclusions by conducting both a fixed and random model meta-analysis of quality randomized controlled trials (RCTs) and by comparison with related meta-analyses. DESIGN We performed a systematic literature search up to May 2020 to identify RCTs, comparing THA through DAA with THA through CAs and related meta-analyses. We conducted risk of bias and level of evidence assessment in accordance with the Cochrane's Risk of Bias 2 tool and with the guidelines of the Centre for Evidence-Based Medicine. We estimated mean differences (MD) with 95% confidence intervals (CI) through fixed and random effects models, using the DerSimonian and Laird method. Heterogeneity was assessed using tau-square (τ2). Our conclusions take into account the overall results from related meta-analyses. RESULTS Nine studies on THA through DAA met the criteria for final meta-analysis, involving 998 patients. Three studies were blinded RCTs with a level I evidence, the other 6 studies were non-blinded RCTs with a level II evidence. We came to the following results for THA through DAA compared to THA through CAs: operation time (I2 = 92%, p<0.01; fixed: MD = 15.1, 95% CI 13.1 to 17.1; random: MD = 18.1, 95% CI 8.6 to 27.5); incision length (I2 = 100%, p<0.01; fixed: MD = -2.9, 95% CI -3.0 to -2.8; MD = -1.1, 95% CI -4.3 to 2.0); intraoperative blood loss (I2 = 87%, p<0.01; fixed: MD = 51.5, 95% CI 34.1 to 68.8; random: MD = 51.9, 95% CI -89.8 to 193.5); VAS 1 day postoperatively (I2 = 79%, p = 0.03; fixed: MD = -0.8, 95% CI -1.2 to -0.4; random: MD = -0.9, 95% CI -2.0 to 0.15); HHS 3 months postoperatively (I2 = 52%, p = 0.08; fixed: MD = 2.8, 95% CI 1.1 to 4.6; random: MD = 3.0, 95% CI -0.5 to 6.5); HHS 6 months postoperatively (I2 = 0%, p = 0.67; fixed: MD = 0.9, 95% CI -1.1 to 2.9; random: MD = 0.9, 95% CI -1.1 to 2.9); HHS 12 months postoperatively (I2 = 0%, p = 0.79; fixed: MD = 0.7, 95% CI -0.9 to 2.4; random: MD = 0.7, 95% CI -0.9 to 2.4). We compared our findings with 7 related meta-analyses. CONCLUSIONS Considering the results of our meta-analysis and the review of related meta-analyses, we can conclude that short-term outcomes of THA through DAA were overall better than THA through CAs. THA through DAA had a shorter incision length, a tendency towards a lower pain VAS 1 day postoperatively and better early postoperative functional outcome than THA through CAs. The intraoperative blood loss showed indifferent results. THA through DAA had a longer operation time than THA through CAs.
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Affiliation(s)
- Philip Lazaru
- Center for Surgery, Evangelical Hospital Ludwigsfelde-Teltow, Ludwigsfelde, Germany
| | - Simon Bueschges
- Faculty of Medicine, Department of Statistics, University of Salamanca, Salamanca, Spain
| | - Nikolai Ramadanov
- Department of Emergency Medicine, University Hospital Jena, Friedrich Schiller University, Jena, Germany
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Casolino R, Paiella S, Azzolina D, Beer PA, Corbo V, Lorenzoni G, Gregori D, Golan T, Braconi C, Froeling FEM, Milella M, Scarpa A, Pea A, Malleo G, Salvia R, Bassi C, Chang DK, Biankin AV. Homologous Recombination Deficiency in Pancreatic Cancer: A Systematic Review and Prevalence Meta-Analysis. J Clin Oncol 2021; 39:2617-2631. [PMID: 34197182 PMCID: PMC8331063 DOI: 10.1200/jco.20.03238] [Citation(s) in RCA: 70] [Impact Index Per Article: 17.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2020] [Revised: 04/13/2021] [Accepted: 05/26/2021] [Indexed: 12/20/2022] Open
Abstract
PURPOSE To analyze the prevalence of homologous recombination deficiency (HRD) in patients with pancreatic ductal adenocarcinoma (PDAC). MATERIALS AND METHODS We conducted a systematic review and meta-analysis of the prevalence of HRD in PDAC from PubMed, Scopus, and Cochrane Library databases, and online cancer genomic data sets. The main outcome was pooled prevalence of somatic and germline mutations in the better characterized HRD genes (BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, RAD51, and the FANC genes). The secondary outcomes were prevalence of germline mutations overall, and in sporadic and familial cases; prevalence of germline BRCA1/2 mutations in Ashkenazi Jewish (AJ); and prevalence of HRD based on other definitions (ie, alterations in other genes, genomic scars, and mutational signatures). Random-effects modeling with the Freeman-Tukey transformation was used for the analyses. PROSPERO registration number: (CRD42020190813). RESULTS Sixty studies with 21,842 participants were included in the systematic review and 57 in the meta-analysis. Prevalence of germline and somatic mutations was BRCA1: 0.9%, BRCA2: 3.5%, PALB2: 0.2%, ATM: 2.2%, CHEK2: 0.3%, FANC: 0.5%, RAD51: 0.0%, and ATR: 0.1%. Prevalence of germline mutations was BRCA1: 0.9% (2.4% in AJ), BRCA2: 3.8% (8.2% in AJ), PALB2: 0.2%, ATM: 2%, CHEK2: 0.3%, and FANC: 0.4%. No significant differences between sporadic and familial cases were identified. HRD prevalence ranged between 14.5%-16.5% through targeted next-generation sequencing and 24%-44% through whole-genome or whole-exome sequencing allowing complementary genomic analysis, including genomic scars and other signatures (surrogate markers of HRD). CONCLUSION Surrogate readouts of HRD identify a greater proportion of patients with HRD than analyses limited to gene-level approaches. There is a clear need to harmonize HRD definitions and to validate the optimal biomarker for treatment selection. Universal HRD screening including integrated somatic and germline analysis should be offered to all patients with PDAC.
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Affiliation(s)
- Raffaella Casolino
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
- Department of Medicine, University and Hospital Trust of Verona, Verona, Italy
| | - Salvatore Paiella
- General and Pancreatic Surgery Unit, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy
| | - Danila Azzolina
- Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Padova, Italy
- Research Support Unit, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy
| | - Philip A. Beer
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
- Sanger Institute, Wellcome Trust Genome Campus, Cambridge, United Kingdom
| | - Vincenzo Corbo
- Section of Pathology, Department of Diagnostics and Public Health, University and Hospital Trust of Verona, Verona, Italy
- ARC-Net Research Centre, University of Verona, Verona, Italy
| | - Giulia Lorenzoni
- Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Padova, Italy
| | - Dario Gregori
- Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Padova, Italy
| | - Talia Golan
- The Oncology Institute, Sheba Medical Center at Tel-Hashomer, Tel Aviv University, Tel Aviv, Israel
| | - Chiara Braconi
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
- Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
| | - Fieke E. M. Froeling
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
| | - Michele Milella
- Section of Oncology, Department of Medicine, University and Hospital Trust of Verona, Verona, Italy
| | - Aldo Scarpa
- Section of Pathology, Department of Diagnostics and Public Health, University and Hospital Trust of Verona, Verona, Italy
- ARC-Net Research Centre, University of Verona, Verona, Italy
| | - Antonio Pea
- General and Pancreatic Surgery Unit, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy
| | - Giuseppe Malleo
- General and Pancreatic Surgery Unit, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy
| | - Roberto Salvia
- General and Pancreatic Surgery Unit, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy
| | - Claudio Bassi
- General and Pancreatic Surgery Unit, Pancreas Institute, University and Hospital Trust of Verona, Verona, Italy
| | - David K. Chang
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
- West of Scotland Pancreatic Unit, Glasgow Royal Infirmary, Glasgow, United Kingdom
| | - Andrew V. Biankin
- Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
- West of Scotland Pancreatic Unit, Glasgow Royal Infirmary, Glasgow, United Kingdom
- Faculty of Medicine, South Western Sydney Clinical School, University of NSW, Liverpool, Australia
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Cruz AJS, Abreu LG, Mendes SDR, de Castilho LS, de Abreu MHNG. Association of sociodemographic factors with the prescription pattern of opioids for dental patients: A systematic review protocol. PLoS One 2021; 16:e0255743. [PMID: 34352025 PMCID: PMC8341526 DOI: 10.1371/journal.pone.0255743] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2021] [Accepted: 07/20/2021] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION Oral health practitioners are responsible for a significant share of opioid prescriptions that seem to be influenced by many aspects, including sociodemographic factors. However, there is no consensus on the factors associated with opioid prescription in Dentistry. OBJECTIVE To identify whether patients' sociodemographic factors are associated with the prescription pattern of opioids in Dentistry. MATERIALS AND METHODS This systematic review will include observational studies (cross-sectional, case-control, and cohort). Electronic searches will be conducted in MEDLINE (PubMed), EMBASE, Scopus, Web of science, LILACS, SciELO, and Google Scholar. Grey literature will also be consulted. Two independent reviewers will screen all retrieved articles for eligibility, extract data, and assess the methodological quality of the included studies. The results will be presented as a narrative synthesis and, where possible, a meta-analysis will be conducted. Certainty of the evidence will be assessed with the Grading of Recommendations, Assessment, Development, and Evaluation approach. SYSTEMATIC REVIEW REGISTRATION NUMBER PROSPERO CRD42020211226.
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Affiliation(s)
- Alex Junio Silva Cruz
- Graduate Programme in Dentistry, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
| | - Lucas Guimarães Abreu
- Department of Child’s and Adolescent’s Oral Health, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
| | - Suellen da Rocha Mendes
- Graduate Programme in Dentistry, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
| | - Lia Silva de Castilho
- Department of Operative Dentistry, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
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Nagaoka M, Hashimoto Z, Takeuchi H, Sado M. Effectiveness of mindfulness-based interventions for people with dementia and mild cognitive impairment: A meta-analysis and implications for future research. PLoS One 2021; 16:e0255128. [PMID: 34339428 PMCID: PMC8328308 DOI: 10.1371/journal.pone.0255128] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2021] [Accepted: 07/10/2021] [Indexed: 11/18/2022] Open
Abstract
Objective To assess the effectiveness of mindfulness-based interventions on people with dementia and mild cognitive impairment. Methods We searched several electronic databases, namely Cochrane Library, EMBASE, and MEDLINE with no limitations for language or document type (last search: 1 February 2020). Randomized controlled trials of mindfulness-based interventions for people with dementia and mild cognitive impairment compared to active-control interventions, waiting lists, or treatment as usual were included. Predefined outcomes were anxiety symptoms, depressive symptoms, cognitive function, quality of life, mindfulness, ADL and attrition. We used the random effects model (DerSimonian-Laird method) for meta-analysis, reporting effect sizes as Standardized Mean Difference. Heterogeneity was assessed with the I2 statistics. Results Eight randomized controlled trials, involving 276 patients, met the eligibility criteria and were included in the meta-analysis. We found no significant effects for mindfulness-based interventions in either the short-term or the medium- to long-term on any outcomes, when compared with control conditions. The number of included studies and sample sizes were too small. Additionally, the quality of evidence was low for each randomized controlled trial included in the analysis. This is primarily due to lack of intent-to-treat analysis, high risk of bias, and imprecise study results. The limited statistical power and weak body of evidence prevented us from reaching firm conclusions. Conclusions We found no significant effects of mindfulness-based interventions on any of the outcomes when compared with control conditions. The evidence concerning the efficacy of mindfulness-based interventions in this population is scarce in terms of both quality and quantity. More well-designed, rigorous, and large-scale randomized controlled trials are needed.
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Affiliation(s)
- Maki Nagaoka
- Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan
| | - Zenta Hashimoto
- Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan
- Department of Neuropsychiatry, Yokohama Municipal Citizen’s Hospital, Yokohama, Kanagawa, Japan
| | - Hiroyoshi Takeuchi
- Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan
| | - Mitsuhiro Sado
- Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan
- Center for Stress Research, Keio University, Tokyo, Japan
- * E-mail:
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Bramley P, López-López JA, Higgins JPT. Examining how meta-analytic methods perform in the presence of bias: A simulation study. Res Synth Methods 2021; 12:816-830. [PMID: 34327842 DOI: 10.1002/jrsm.1516] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/25/2020] [Revised: 04/15/2021] [Accepted: 07/05/2021] [Indexed: 01/08/2023]
Abstract
Standard meta-analysis methods are vulnerable to bias from incomplete reporting of results (both publication and outcome reporting bias) and poor study quality. Several alternative methods have been proposed as being less vulnerable to such biases. To evaluate these claims independently we simulated study results under a broad range of conditions first with no bias, then introducing simulated publication bias, outcome reporting bias, and bias from poor study quality. We then implemented common and the proposed bias robust meta-analysis methods and compared the mean bias and mean squared error (MSE) for four estimates of effect and the coverage probability of seven confidence intervals. We found that no methods perform well in the presence of any substantial bias. A regression based extension to Egger's test gave an estimate of effect with lower mean bias than standard methods in the presence of publication bias or poor study quality, but had a substantially worse MSE except in very specific conditions. Coverage of all 95% confidence intervals was very poor with increasing numbers of studies in biased conditions, often falling below 50%. The Knapp-Hartung interval performed closest to nominal coverage with fewer than 10 studies in most conditions, and the Henmi-Copas interval generally performed best with more than 10 studies. There was no evidence that a multiplicative term for heterogeneity improved coverage. Multiple forms of bias remain problematic for all meta-analysis methods, with very poor performance under conceivable conditions.
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Affiliation(s)
- Paul Bramley
- Sheffield Teaching Hospitals NHS Foundation Trust and The School of Health and Related Research, University of Sheffield, Sheffield, UK
| | - José A López-López
- Department of Basic Psychology & Methodology, Faculty of Psychology, University of Murcia, Murcia, Spain
| | - Julian P T Higgins
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
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Côté P, Hartvigsen J, Axén I, Leboeuf-Yde C, Corso M, Shearer H, Wong J, Marchand AA, Cassidy JD, French S, Kawchuk GN, Mior S, Poulsen E, Srbely J, Ammendolia C, Blanchette MA, Busse JW, Bussières A, Cancelliere C, Christensen HW, De Carvalho D, De Luca K, Rose AD, Eklund A, Engel R, Goncalves G, Hebert J, Hincapié CA, Hondras M, Kimpton A, Lauridsen HH, Innes S, Meyer AL, Newell D, O'Neill S, Pagé I, Passmore S, Perle SM, Quon J, Rezai M, Stupar M, Swain M, Vitiello A, Weber K, Young KJ, Yu H. Response to Lawrence DJ: the global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature. Chiropr Man Therap 2021; 29:26. [PMID: 34284791 PMCID: PMC8290565 DOI: 10.1186/s12998-021-00380-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2021] [Accepted: 06/02/2021] [Indexed: 11/10/2022] Open
Affiliation(s)
- Pierre Côté
- Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada. .,Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada. .,Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. .,IHPME, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
| | - Jan Hartvigsen
- Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.,Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark
| | - Iben Axén
- Intervention & Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.,ELIB - et liv i bevegelse, Oslo, Norway
| | - Charlotte Leboeuf-Yde
- Department for Regional Health Research, University of Southern Denmark, Odense, Denmark
| | - Melissa Corso
- Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada.,Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada
| | - Heather Shearer
- Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada.,IHPME, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
| | - Jessica Wong
- Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada.,Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada.,Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
| | - Andrée-Anne Marchand
- Department de Chiropractique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada
| | - J David Cassidy
- Division of Epidemiology, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
| | - Simon French
- Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia
| | - Gregory N Kawchuk
- Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Edmonton, Canada
| | - Silvano Mior
- Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada.,Canadian Memorial Chiropractic College, Toronto, Canada
| | - Erik Poulsen
- Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
| | - John Srbely
- Department of Human Health & Nutritional Sciences, University of Guelph, Guelph, Canada
| | - Carlo Ammendolia
- IHPME, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.,Rebecca MacDonald Centre, Mount Sinai Hospital, Toronto, Canada
| | - Marc-André Blanchette
- Department de Chiropractique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada
| | - Jason W Busse
- Department of Health Research Methods, Evidence & Impact, Faculty of Health Sciences, McMaster University, Hamilton, Canada
| | - André Bussières
- Department de Chiropractique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.,School of Physical & Occupational Therapy, McGill University, Montreal, Canada
| | - Carolina Cancelliere
- Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada.,Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada
| | | | - Diana De Carvalho
- Faculty of Medicine, Memorial University of Newfoundland, St. John, 's, Canada
| | - Katie De Luca
- Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia
| | - Alister Du Rose
- Faculty of Life Sciences and Education University of South Wales, Cardiff, UK
| | - Andreas Eklund
- Intervention & Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
| | - Roger Engel
- Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia
| | | | - Jeffrey Hebert
- Faculty of Kinesiology, University of New Brunswick, Fredericton, Canada
| | - Cesar A Hincapié
- Department of Chiropractic Medicine, Faculty of Medicine, University of Zurich & Balgrist University Hospital, Zurich, Switzerland
| | - Maria Hondras
- Department of Anesthesiology, University of Kansas Medical Center, Kansas City, USA
| | | | - Henrik Hein Lauridsen
- Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
| | - Stanley Innes
- College of Science, Health, Engineering and Education, Murdoch University, Murdoch, Australia
| | | | | | - Søren O'Neill
- Department for Regional Health Research, University of Southern Denmark, Odense, Denmark.,Spine Center of Southern Denmark, University Hospital of Southern Denmark, Middelfart, Denmark
| | - Isabelle Pagé
- Department de Chiropractique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada
| | - Steven Passmore
- Faculty of Kinesiology & Recreation Management University of Manitoba, Winnipeg, Canada
| | - Stephen M Perle
- School of Chiropractic, University of Bridgeport, Bridgeport, USA
| | - Jeffrey Quon
- School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, Canada
| | - Mana Rezai
- Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada
| | - Maja Stupar
- Canadian Memorial Chiropractic College, Toronto, Canada
| | - Michael Swain
- Department of Chiropractic, Faculty of Science and Engineering, Macquarie University, Sydney, Australia
| | - Andrew Vitiello
- School of Health, Medical and Applied Sciences, CQ University, Sydney, Australia
| | - Kenneth Weber
- Stanford University School of Medicine, Stanford University, Stanford, USA
| | - Kenneth J Young
- School of Sport and Health Sciences, University of Central Lancashire, Preston, England
| | - Hainan Yu
- Faculty of Health Sciences, Ontario Tech University, Oshawa, Canada.,Centre for Disability Prevention and Rehabilitation at Ontario Tech University and CMCC, Oshawa, Canada
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Lawrence DJ. Letter to the editor: the global summit on the efficacy and effectiveness of spinal manipulative therapy for the prevention and treatment of non-musculoskeletal disorders: a systematic review of the literature. Chiropr Man Therap 2021; 29:25. [PMID: 34284790 PMCID: PMC8290599 DOI: 10.1186/s12998-021-00378-1] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2021] [Accepted: 06/02/2021] [Indexed: 11/10/2022] Open
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Ahmadzadeh YI, Schoeler T, Han M, Pingault JB, Creswell C, McAdams TA. Systematic Review and Meta-analysis of Genetically Informed Research: Associations Between Parent Anxiety and Offspring Internalizing Problems. J Am Acad Child Adolesc Psychiatry 2021; 60:823-840. [PMID: 33675965 PMCID: PMC8259118 DOI: 10.1016/j.jaac.2020.12.037] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2020] [Revised: 12/09/2020] [Accepted: 02/25/2021] [Indexed: 12/19/2022]
Abstract
OBJECTIVE Parent anxiety is associated with offspring internalizing problems (emotional problems related to anxiety and depression). This may reflect causal processes, whereby exposure to parent anxiety directly influences offspring internalizing (and/or vice versa). However, parent-offspring associations could also be attributable to their genetic relatedness. A systematic review and meta-analysis were conducted to investigate whether exposure to parent anxiety is associated with offspring internalizing after controlling for genetic relatedness. METHOD A literature search across 5 databases identified 429 unique records. Publications were retained if they used a quasi-experimental design in a general population sample to control for participant relatedness in associations between parent anxiety and offspring internalizing outcomes. Publications were excluded if they involved an experimental exposure or intervention. Studies of prenatal and postnatal anxiety exposure were meta-analyzed separately. Pearson's correlation coefficient estimates (r) were pooled using multilevel random-effects models. RESULTS Eight publications were retained. Data were drawn from 4 population cohorts, each unique to a quasi-experimental design: adoption, sibling-comparison, children-of-twins or in vitro fertilization. Cohorts were located in northern Europe or America. Families were predominantly of European ancestry. Three publications (Nfamilies >11,700; offspring age range, 0.5-10 years) showed no association between prenatal anxiety exposure and offspring internalizing outcomes after accounting for participant relatedness (r = .04; 95% CI: -.07, .14). Six publications (Nfamilies >12,700; offspring age range, 0.75-22 years) showed a small but significant association between concurrent symptoms in parents and offspring after accounting for participant relatedness (r = .13; 95% CI: .04, .21). CONCLUSION Initial literature, derived from homogeneous populations, suggests that prenatal anxiety exposure does not cause offspring internalizing outcomes. However, postnatal anxiety exposure may be causally associated with concurrent offspring internalizing via nongenetic pathways. Longitudinal stability, child-to-parent effects, and the role of moderators and methodological biases require attention.
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Affiliation(s)
| | | | | | | | | | - Tom A McAdams
- King's College London, United Kingdom; University of Oslo, Norway
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Matthay EC, Hagan E, Gottlieb LM, Tan ML, Vlahov D, Adler N, Glymour MM. Powering population health research: Considerations for plausible and actionable effect sizes. SSM Popul Health 2021; 14:100789. [PMID: 33898730 PMCID: PMC8059081 DOI: 10.1016/j.ssmph.2021.100789] [Citation(s) in RCA: 37] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2020] [Revised: 03/25/2021] [Accepted: 03/30/2021] [Indexed: 11/23/2022] Open
Abstract
Evidence for Action (E4A), a signature program of the Robert Wood Johnson Foundation, funds investigator-initiated research on the impacts of social programs and policies on population health and health inequities. Across thousands of letters of intent and full proposals E4A has received since 2015, one of the most common methodological challenges faced by applicants is selecting realistic effect sizes to inform calculations of power, sample size, and minimum detectable effect (MDE). E4A prioritizes health studies that are both (1) adequately powered to detect effect sizes that may reasonably be expected for the given intervention and (2) likely to achieve intervention effects sizes that, if demonstrated, correspond to actionable evidence for population health stakeholders. However, little guidance exists to inform the selection of effect sizes for population health research proposals. We draw on examples of five rigorously evaluated population health interventions. These examples illustrate considerations for selecting realistic and actionable effect sizes as inputs to calculations of power, sample size and MDE for research proposals to study population health interventions. We show that plausible effects sizes for population health interventions may be smaller than commonly cited guidelines suggest. Effect sizes achieved with population health interventions depend on the characteristics of the intervention, the target population, and the outcomes studied. Population health impact depends on the proportion of the population receiving the intervention. When adequately powered, even studies of interventions with small effect sizes can offer valuable evidence to inform population health if such interventions can be implemented broadly. Demonstrating the effectiveness of such interventions, however, requires large sample sizes.
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Affiliation(s)
- Ellicott C. Matthay
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
- Department of Epidemiology and Biostatistics, University of California, San Francisco, 550 16th Street, 2nd Floor, Campus Box 0560, San Francisco, CA, 94143, USA
| | - Erin Hagan
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
| | - Laura M. Gottlieb
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
| | - May Lynn Tan
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
| | - David Vlahov
- Yale School of Nursing at Yale University, 400 West Campus Drive, Room 32306, Orange, CT, 06477, USA
| | - Nancy Adler
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
| | - M. Maria Glymour
- Center for Health and Community, University of California, San Francisco, 3333 California St., Suite 465, Campus Box 0844, San Francisco, CA, 94143-0844, USA
- Department of Epidemiology and Biostatistics, University of California, San Francisco, 550 16th Street, 2nd Floor, Campus Box 0560, San Francisco, CA, 94143, USA
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Assessments and Interventions for Sleep Disorders in Infants With or at High Risk for Cerebral Palsy: A Systematic Review. Pediatr Neurol 2021; 118:57-71. [PMID: 33541756 DOI: 10.1016/j.pediatrneurol.2020.10.015] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Revised: 10/02/2020] [Accepted: 10/27/2020] [Indexed: 12/22/2022]
Abstract
BACKGROUND Children with cerebral palsy (CP) are five times more likely than typically developing children to have sleep problems, resulting in adverse outcomes for both children and their families. The purpose of this systematic review was to gather current evidence regarding assessments and interventions for sleep in children under age 2 years with or at high risk for CP and integrate these findings with parent preferences. METHODS Five databases (CINAHL, EMBASE, OVID/Medline, SCOPUS, and PsycINFO) were searched. Included articles were screened using preferred reporting items for systematic reviews and meta-analyses guidelines, and quality of the evidence was reviewed using best evidence tools by two independent reviewers at minimum. An online survey was conducted regarding parent preferences through social media channels. RESULTS Eleven articles met inclusion criteria. Polysomnography emerged as the only high-quality assessment for the population. Three interventions (medical cannabis, surgical interventions, and auditory, tactile, visual, and vestibular stimulations) were identified; however, each only had one study of effectiveness. The quality of evidence for polysomnography was moderate, while the quality and quantity of the evidence regarding interventions was low. Survey respondents indicated that sleep assessments and interventions are highly valued, with caregiver-provided interventions ranked as the most preferable. CONCLUSIONS Further research is needed to validate affordable and feasible sleep assessments compared to polysomnography as the reference standard. In the absence of diagnosis-specific evidence of safety and efficacy of sleep interventions specific to young children with CP, it is conditionally recommended that clinicians follow guidelines for safe sleep interventions for typically developing children.
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Fifer H, Lewis A, Perin G, Balasubramanian SP. Letter to the Editor: Outcomes of Laparoscopic Splenectomy for Treatment of Splenomegaly: A Systematic Review and Meta-analysis. World J Surg 2021; 45:2306-2307. [PMID: 33782731 DOI: 10.1007/s00268-021-06090-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/08/2021] [Indexed: 11/29/2022]
Affiliation(s)
- H Fifer
- General surgery, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, England.
| | - A Lewis
- The University of Sheffield, Sheffield, England
| | - G Perin
- General surgery, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, England
| | - S P Balasubramanian
- General Surgery, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England
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Yin L, Chen X, Lu X, An Y, Zhang T, Yan J. An updated meta-analysis: repetitive transcranial magnetic stimulation for treating tinnitus. J Int Med Res 2021; 49:300060521999549. [PMID: 33729855 PMCID: PMC7975580 DOI: 10.1177/0300060521999549] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Abstract
Objective To undertake an updated meta-analysis to obtain more evidence from randomized
controlled trials (RCTs) to assess the effect of repetitive transcranial
magnetic stimulation (rTMS) for the treatment of tinnitus. Methods PubMed®, Embase®, Web of Science, Cochrane Database of Systematic Reviews,
CBM, CNKI and Wanfang were searched for RCTs from inception up to March
2020. Studies meeting the eligibility criteria were included in the
meta-analysis. The mean difference was calculated and the effect size was
evaluated using a Z test. Results The analysis included 12 randomized sham-controlled clinical trials with a
total of 717 participants. Active rTMS was superior to sham rTMS in terms of
the short-term and long-term effects (6 months) on the tinnitus handicap
inventory scores, but an immediate effect was not significant. There was no
significant immediate effect on the tinnitus questionnaire (TQ) and Beck
depression inventory (BDI) scores. Conclusions This meta-analysis demonstrated that rTMS improved tinnitus-related symptoms,
but the TQ and BDI scores demonstrated little immediate benefit. Future
research should be undertaken on large samples in multi-centre settings with
longer follow-up durations.
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Affiliation(s)
- Lu Yin
- Department of Tuina, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
| | - Xiao Chen
- Department of Tuina, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
| | - Xingang Lu
- Department of Traditional Chinese Medicine, Shanghai Key Laboratory of Clinical Geriatric Medicine, HuaDong Hospital, FuDan University, Shanghai, China
| | - Yun An
- Department of Tuina, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
| | - Tao Zhang
- Department of Tuina, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
| | - Juntao Yan
- Department of Tuina, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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A Systematic review and meta-analysis of sensate versus non-sensate flaps for the prevention of pressure ulcer recurrence among individuals with spinal cord disease. Spinal Cord 2021; 59:463-473. [PMID: 33727678 DOI: 10.1038/s41393-020-00590-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2020] [Revised: 11/02/2020] [Accepted: 11/03/2020] [Indexed: 11/08/2022]
Abstract
STUDY DESIGN Systematic review and meta-analysis. OBJECTIVES To identify, critically appraise, and synthesize research findings on non-sensate versus sensate flaps among individuals with spinal cord disease and pelvic pressure ulcers, with pressure ulcer recurrence as primary outcome. METHODS PubMed, EMBASE, and Cochrane CENTRAL were screened for relevant studies. Data on surgical characteristics, ulcer recurrence, and sensory outcomes were retrieved and tabulated. Risk of bias was assessed with MINORS. The level of evidence was evaluated with GRADE. Meta-analysis was performed when possible. RESULTS Meta-analysis of 1794 non-sensate locoregional reconstructions indicated a recurrence rate of 34% within several years (95% CI, 27-42). Twenty-one articles provided data on 75 sensate reconstructions, performed in 74 individuals. Meta-analysis of the sensate reconstructions indicated a recurrence rate of 1% (95% CI, 0-8). Sensate reconstructions were not associated with an increase of wound complications (19%; 95% CI, 7-40) compared with non-sensate ones (34%; 95% CI, 27-42). A very low level of evidence was determined with use of GRADE. CONCLUSION Although of a very low-level, the present evidence suggests that restoration of sensory innervation may be an effective intervention for the prevention of pressure ulcer recurrence among individuals with spinal cord disease. A prospective RCT is needed to confirm or refute the results of this systematic review.
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van Wincoop M, de Bijl-Marcus K, Lilien M, van den Hoogen A, Groenendaal F. Effect of therapeutic hypothermia on renal and myocardial function in asphyxiated (near) term neonates: A systematic review and meta-analysis. PLoS One 2021; 16:e0247403. [PMID: 33630895 PMCID: PMC7906340 DOI: 10.1371/journal.pone.0247403] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2020] [Accepted: 02/08/2021] [Indexed: 01/20/2023] Open
Abstract
BACKGROUND Therapeutic hypothermia (TH) is a well-established neuroprotective therapy applied in (near) term asphyxiated infants. However, little is known regarding the effects of TH on renal and/or myocardial function. OBJECTIVES To describe the short- and long-term effects of TH on renal and myocardial function in asphyxiated (near) term neonates. METHODS An electronic search strategy incorporating MeSH terms and keywords was performed in October 2019 and updated in June 2020 using PubMed and Cochrane databases. Inclusion criteria consisted of a RCT or observational cohort design, intervention with TH in a setting of perinatal asphyxia and available long-term results on renal and myocardial function. We performed a meta-analysis and heterogeneity and sensitivity analyses using a random effects model. Subgroup analysis was performed on the method of cooling. RESULTS Of the 107 studies identified on renal function, 9 were included. None of the studies investigated the effects of TH on long-term renal function after perinatal asphyxia. The nine included studies described the effect of TH on the incidence of acute kidney injury (AKI) after perinatal asphyxia. Meta-analysis showed a significant difference between the incidence of AKI in neonates treated with TH compared to the control group (RR = 0.81; 95% CI 0.67-0.98; p = 0.03). No studies were found investigating the long-term effects of TH on myocardial function after neonatal asphyxia. Possible short-term beneficial effects were presented in 4 out of 5 identified studies, as observed by significant reductions in cardiac biomarkers and less findings of myocardial dysfunction on ECG and cardiac ultrasound. CONCLUSIONS TH in asphyxiated neonates reduces the incidence of AKI, an important risk factor for chronic kidney damage, and thus is potentially renoprotective. No studies were found on the long-term effects of TH on myocardial function. Short-term outcome studies suggest a cardioprotective effect.
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Affiliation(s)
- Maureen van Wincoop
- Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht and Utrecht University, Utrecht, The Netherlands
| | - Karen de Bijl-Marcus
- Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht and Utrecht University, Utrecht, The Netherlands
| | - Marc Lilien
- Department of Pediatric Nephrology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht and Utrecht University, Utrecht, The Netherlands
| | - Agnes van den Hoogen
- Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht and Utrecht University, Utrecht, The Netherlands
| | - Floris Groenendaal
- Department of Neonatology, Wilhelmina Children’s Hospital, University Medical Centre Utrecht and Utrecht University, Utrecht, The Netherlands
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