scholarly journals Adverse events associated with human papillomavirus vaccines: a protocol for systematic review with network meta-analysis incorporating all randomised controlled trials comparing with placebo, adjuvants and other vaccines

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026924 ◽  
Author(s):  
Jiro Takeuchi ◽  
Hisashi Noma ◽  
Yuta Sakanishi ◽  
Takashi Kawamura

IntroductionAdverse events following the injection (AEFIs) of human papillomavirus vaccine (HPVv) among female adolescents are still a major public health concern.MethodsAccording to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension statement for systematic reviews incorporating network meta-analyses, all prospective randomised trials will be included. The primary outcome for adverse events is topical pain during the observation period.We will mainly search 17 electronic databases from January 2000 through September 2019 with suitable Medical Subject Headings and text words for PubMed. Two reviewers will independently check the reports at the title/abstract level and identify potentially applicable studies. Then we will obtain their full texts and decide whether to include them based on the same eligible criteria.We will compare HPVv with placebo, HPVv with adjuvant and HPVv with other vaccines. Interstudy heterogeneity, publication biases or small study effects will be evaluated using conventional meta-analysis methods. The consistency of the network will be checked using tests for local and global inconsistency and the side-splitting method. To address the heterogeneity of treatment effects among the studies, we will use the multivariable random effect model.Ethics and disseminationThis pairwise or network meta-analysis does not require ethics approval. The data used here are not individual nor private. We will be able to determine which component of the vaccine induces adverse events, especially topical pain. This systematic review with network meta-analysis will provide valid answers regarding AEFIs for HPVv.PROSPERO registration numberCRD42018109265

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 127
Author(s):  
David Núñez-Fuentes ◽  
Esteban Obrero-Gaitán ◽  
Noelia Zagalaz-Anula ◽  
Alfonso Javier Ibáñez-Vera ◽  
Alexander Achalandabaso-Ochoa ◽  
...  

Balance problems are one of the most frequent symptoms in patients with Fibromyalgia Syndrome (FMS). However, the extent and nature of this balance disorder are not known. The objective of this work was to determine the best evidence for the alteration of postural balance in patients with FMS and analyze differences with healthy controls. To meet this objective, a systematic review with meta-analysis was performed. A bibliographical search was carried out in PubMed Medline, Scopus, Web of Science, CINAHL and SciELO. Observational studies that assessed postural balance in patients with FMS compared to healthy subjects in baseline conditions, were selected. In a random-effect model, the pooled effect was calculated with the Standardized Mean Difference (SMD) and its 95% confidence interval (CI). Nineteen studies reporting data of 2347 participants (95% female) were included. FMS patients showed poor balance with a large effect on static (SMD = 1.578; 95% CI = 1.164, 1.992), dynamic (SMD = 0.946; 95% CI = 0.598, 1.294), functional balance (SMD = 1.138; 95% CI = 0.689, 1.588) and on balance confidence (SMD = 1.194; 95% CI = 0.914, 1.473). Analysis of the Sensory Organization Test showed large alteration of vestibular (SMD = 1.631; 95% CI = 0.467, 2.795) and visual scores (SMD = 1.317; 95% CI = 0.153, 2.481) compared to healthy controls. Patients with FMS showed worse scores for different measures of postural balance compared to healthy controls. Concretely, FMS patients appear to have poor vestibular and visual scores with a possible somatosensory dependence.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniel Atlaw ◽  
Yohannes Tekalegn ◽  
Biniyam Sahiledengle ◽  
Kenbon Seyoum ◽  
Damtew Solomon ◽  
...  

Abstract Background Neural tube defects (NTDs) are a group of disorders that arise from the failure of the neural tube close between 21 and 28 days after conception. About 90% of neural tube defects and 95% of death due to these defects occurs in low-income countries. Since these NTDs cause considerable morbidity and mortality, this study aimed to determine the prevalence and associated factors of NTDs in Africa. Methods The protocol of this study was registered in the International Prospective Register of Systematic Reviews (PROSPERO number: CRD42020149356). All major databases such as PubMed/MEDLINE, EMBASE, CINAHL, Web of Science, African Journals Online (AJOL), and Google Scholar search engine were systematically searched. A random-effect model was used to estimate the pooled prevalence of NTDs in Africa, and Cochran’s Q-statistics and I2 tests were used to assess heterogeneity between included studies. Publication bias was assessed using Begg ’s tests, and the association between determinant factors and NTDs was estimated using a random-effect model. Results Of the total 2679 articles, 37 articles fulfilled the inclusion criteria and were included in this systematic review and meta-analysis. The pooled prevalence of NTDs in Africa was 50.71 per 10,000 births (95% CI: 48.03, 53.44). Folic acid supplementation (AOR: 0.40; 95% CI: 0.19–0.85), maternal exposure to pesticide (AOR: 3.29; 95% CI: 1.04–10.39), mothers with a previous history of stillbirth (AOR: 3.35, 95% CI: 1.99–5.65) and maternal exposure to x-ray radiation (AOR 2.34; 95% CI: 1.27–4.31) were found to be determinants of NTDs. Conclusions The pooled prevalence of NTDs in Africa was found to be high. Maternal exposure to pesticides and x-ray radiation were significantly associated with NTDs. Folic acid supplementation before and within the first month of pregnancy was found to be a protective factor for NTDs.


Author(s):  
Mary Obasi ◽  
Arielle Abovich ◽  
Jacqueline B. Vo ◽  
Yawen Gao ◽  
Stefania I. Papatheodorou ◽  
...  

Abstract Purpose Cardiotoxicity affects 5–16% of cancer patients who receive anthracyclines and/or trastuzumab. Limited research has examined interventions to mitigate cardiotoxicity. We examined the role of statins in mitigating cardiotoxicity by performing a systematic review and meta-analysis of published studies. Methods A literature search was conducted using PubMed, Embase, Web of Science, ClinicalTrials.gov, and Cochrane Central. A random-effect model was used to assess summary relative risks (RR), weighted mean differences (WMD), and corresponding 95% confidence intervals. Testing for heterogeneity between the studies was performed using Cochran’s Q test and the I2 test. Results Two randomized controlled trials (RCTs) with a total of 117 patients and four observational cohort studies with a total of 813 patients contributed to the analysis. Pooled results indicate significant mitigation of cardiotoxicity after anthracycline and/or trastuzumab exposure among statin users in cohort studies [RR = 0.46, 95% CI (0.27–0.78), p = 0.004, $${ }I^{2}$$ I 2  = 0.0%] and a non-significant decrease in cardiotoxicity risk among statin users in RCTs [RR = 0.49, 95% CI (0.17–1.45), p = 0.20, $$I^{2}$$ I 2  = 5.6%]. Those who used statins were also significantly more likely to maintain left ventricular ejection fraction compared to baseline after anthracycline and/or trastuzumab therapy in both cohort studies [weighted mean difference (WMD) = 6.14%, 95% CI (2.75–9.52), p < 0.001, $$I^{2}$$ I 2  = 74.7%] and RCTs [WMD = 6.25%, 95% CI (0.82–11.68, p = 0.024, $$I^{2}$$ I 2  = 80.9%]. We were unable to explore publication bias due to the small number of studies. Conclusion This meta-analysis suggests that there is an association between statin use and decreased risk of cardiotoxicity after anthracycline and/or trastuzumab exposure. Larger well-conducted RCTs are needed to determine whether statins decrease risk of cardiotoxicity from anthracyclines and/or trastuzumab. Trial Registration Number and Date of Registration PROSPERO: CRD42020140352 on 7/6/2020.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
I Giacchetta ◽  
M Chiavarini ◽  
G Naldini ◽  
R Fabiani

Abstract Background The probability of developing invasive cutaneous malignant melanoma (CMM) is higher in women than in men up until the age of 49. Several studies investigated the association between hormonal factors and CMM. The aim of this systematic review and meta-analysis is to summarize the evidence on the association between Oral Contraceptives (OC) and the risk of CMM. Methods This review and meta-analysis follow the PRISMA guidelines. A systematic literature search was conducted on Medline and Web of Science until December 2019. Studies were eligible if reported a risk estimate for the association between OC and CMM. Heterogeneity testing was performed using Cochran's Q and I2 statistics. Publication bias was assessed by Egger's test and Begg's test. Meta-analysis was performed using random effect model. Results The results of the pooled analysis of all 32 studies showed no significant association between OC and the risk of CMM (OR 1.02; 95% CI 0.94-1.11; I2=39.32%, p = 0.013). The stratified analyses by study design found no significant association between OC and the risk of CMM neither in the 18 case-control studies (OR 1.02; 95% CI 0.87-1.21; I2=56.91%, p = 0.002) nor in the 14 cohort studies (OR 1.04; 95% CI 0.98-1.11; I2=0.00%, p = 0.557). No significant publication bias could be detected by Egger's test or Begg's test. Conclusions This meta-analysis of available literature suggests no significant association between OC and the risk of developing CMM. Further investigations are needed to evaluate the possible relationship of OC use and other hormonal factors potentially contributing to the increased risk of CMM in women during their reproductive years. Key messages Oral contraceptives (OC) do not significantly contribute to the risk of Cutaneous Malignant Melanoma (CMM). Further studies are needed to investigate the potential role of other hormonal factors in the increased probability of developing CMM in women during their reproductive years.


2020 ◽  
Vol 30 (8) ◽  
pp. 3073-3083 ◽  
Author(s):  
Walid El Ansari ◽  
Ayman El-Menyar ◽  
Brijesh Sathian ◽  
Hassan Al-Thani ◽  
Mohammed Al-Kuwari ◽  
...  

Abstract Background This systematic review and meta-analysis searched, retrieved and synthesized the evidence as to whether preoperative esophagogastroduodenoscopy (p-EGD) should be routine before bariatric surgery (BS). Methods Databases searched for retrospective, prospective, and randomized (RCT) or quasi-RCT studies (01 January 2000–30 April 2019) of outcomes of routine p-EGD before BS. STROBE checklist assessed the quality of the studies. P-EGD findings were categorized: Group 0 (no abnormal findings); Group 1 (abnormal findings that do not necessitate changing the surgical approach or postponing surgery); Group 2 (abnormal findings that change the surgical approach or postpone surgery); and Group 3 (findings that signify absolute contraindications to surgery). We assessed data heterogeneity and publication bias. Random effect model was used. Results Twenty-five eligible studies were included (10,685 patients). Studies were heterogeneous, and there was publication bias. Group 0 comprised 5424 patients (56%, 95% CI: 45–67%); Group 1, 2064 patients (26%, 95% CI: 23–50%); Group 2, 1351 patients (16%, 95% CI: 11–21%); and Group 3 included 31 patients (0.4%, 95% CI: 0–1%). Conclusion For 82% of patients, routine p-EGD did not change surgical plan/ postpone surgery. For 16% of patients, p-EGD findings necessitated changing the surgical approach/ postponing surgery, but the proportion of postponements due to medical treatment of H Pylori as opposed to “necessary” substantial change in surgical approach is unclear. For 0.4% patients, p-EGD findings signified absolute contraindication to surgery. These findings invite a revisit to whether p-EGD should be routine before BS, and whether it is judicious to expose many obese patients to an invasive procedure that has potential risk and insufficient evidence of effectiveness. Further justification is required.


2021 ◽  
pp. 003435522110432
Author(s):  
Areum Han

Objective: Mindfulness- and acceptance-based intervention (MABI) is an emerging evidenced-based practice, but no systematic review incorporating meta-analyses for MABIs in stroke survivors has been conducted. The objective of this systematic review was to measure the effectiveness of MABIs on outcomes in people with stroke. Method: Three electronic databases, including PubMed, CINAHL, and PsycINFO, were searched to identify relevant studies published in peer-reviewed journals. The methodological quality of the included studies was assessed. Data were extracted and combined in a meta-analysis with a random-effect model to compute the size of the intervention effect. Results: A total of 11 studies met the eligibility criteria. Meta-analyses found a small-to-moderate effect of MABIs on depressive symptoms (standardized mean difference [SMD] = 0.39, 95% confidence interval [CI] = [0.12, 0.66]) and a large effect on mental fatigue (SMD = 1.22, 95% CI = [0.57, 1.87]). No statistically significant effect of MABIs on anxiety, quality of life, and mindfulness was found, but there was a trend in favor of MABIs overall. Conclusions: This meta-analysis found positive effects of MABIs on depressive symptoms and mental fatigue in stroke survivors, but future high-quality studies are needed to guarantee treatment effects of MABIs on varied outcomes in stroke survivors.


2011 ◽  
Vol 9 (3) ◽  
pp. 265-282 ◽  
Author(s):  
Diogo Diniz Gomes Bugano ◽  
Alexandre Biasi Cavalcanti ◽  
Anderson Roman Goncalves ◽  
Claudia Salvini de Almeida ◽  
Eliézer Silva

ABSTRACT Objective: To compare efficacy and safety of vancomycin versus teicoplanin in patients with proven or suspected infection. Methods: Data Sources: Cochrane Renal Group's Specialized Register, CENTRAL, MEDLINE, EMBASE, nephrology textbooks and review articles. Inclusion criteria: Randomized controlled trials in any language comparing teicoplanin to vancomycin for patients with proven or suspected infection. Data extraction: Two authors independently evaluated methodological quality and extracted data. Study investigators were contacted for unpublished information. A random effect model was used to estimate the pooled risk ratio (RR) with 95% confidence interval (CI). Results: A total of 24 studies (2,610 patients) were included. The drugs had similar rates of clinical cure (RR: 1.03; 95%CI: 0.98-1.08), microbiological cure (RR: 0.98; 95%CI: 0.93-1.03) and mortality (RR: 1.02; 95%CI: 0.79-1.30). Teicoplanin had lower rates of skin rash (RR: 0.57; 95%CI: 0.35-0.92), red man syndrome (RR: 0.21; 95%CI: 0.08-0.59) and total adverse events (RR: 0.73; 95%CI: 0.53-1.00). Teicoplanin reduced the risk of nephrotoxicity (RR: 0.66; 95%CI: 0.48-0.90). This effect was consistent for patients receiving aminoglycosides (RR: 0.51; 95%CI: 0.30-0.88) or having vancomycin doses corrected by serum levels (RR: 0.22; 95%CI: 0.10-0.52). There were no cases of acute kidney injury needing dialysis. Limitations: Studies lacked a standardized definition for nephrotoxicity. Conclusions: Teicoplanin and vancomycin are equally effective; however the incidence of nephrotoxicity and other adverse events was lower with teicoplanin. It may be reasonable to consider teicoplanin for patients at higher risk for acute kidney injury.


PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243897
Author(s):  
Junwei Gao ◽  
Ling Yang ◽  
Jinghui Zhao ◽  
Lian Wang ◽  
Jiao Zou ◽  
...  

Background PBL approach has been widely used in many Chinese universities over the past decade. However, the effects of PBL approach on medical psychology education in China are inconsistent. The purpose of this study was to ascertain whether the PBL approach was superior to the lecture-based teaching method in the context of the medical psychology curriculum in China. Methods A systematic review and meta-analysis was performed to confirm the effectiveness of PBL in Chinese medical psychology. Corresponding databases were searched for available studies, where data were extracted to calculated Hedges’ g and its 95% confidence interval in total and subgroup analyses. Subgroup analyses were also carried out. Results Nine studies with 551 cases and 496 controls were identified. The total examination scores of students in the PBL approach group were significantly higher compared with students in the traditional lecture-based teaching group under the random effect model (Hedges’ g = 1.510, 95%CI 0.792–2.227, p<0.001). Subgroup analyses based on major and school system exhibited similar results. Conclusions Our study supported the notion that the PBL approach may be applicable to Chinese medical psychology education.


10.2196/16695 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e16695 ◽  
Author(s):  
Praveen Indraratna ◽  
Daniel Tardo ◽  
Jennifer Yu ◽  
Kim Delbaere ◽  
Matthew Brodie ◽  
...  

Background Cardiovascular disease (CVD) remains the leading cause of death worldwide. Mobile phones have become ubiquitous in most developed societies. Smartphone apps, telemonitoring, and clinician-driven SMS allow for novel opportunities and methods in managing chronic CVD, such as ischemic heart disease, heart failure, and hypertension, and in the conduct and support of cardiac rehabilitation. Objective A systematic review was conducted using seven electronic databases, identifying all relevant randomized control trials (RCTs) featuring a mobile phone intervention (MPI) used in the management of chronic CVD. Outcomes assessed included mortality, hospitalizations, blood pressure (BP), and BMI. Methods Electronic data searches were performed using seven databases from January 2000 to June 2019. Relevant articles were reviewed and analyzed. Meta-analysis was performed using standard techniques. The odds ratio (OR) was used as a summary statistic for dichotomous variables. A random effect model was used. Results A total of 26 RCTs including 6713 patients were identified and are described in this review, and 12 RCTs were included in the meta-analysis. In patients with heart failure, MPIs were associated with a significantly lower rate of hospitalizations (244/792, 30.8% vs 287/803, 35.7%; n=1595; OR 0.77, 95% CI 0.62 to 0.97; P=.03; I2=0%). In patients with hypertension, patients exposed to MPIs had a significantly lower systolic BP (mean difference 4.3 mm Hg; 95% CI −7.8 to −0.78 mm Hg; n=2023; P=.02). Conclusions The available data suggest that MPIs may have a role as a valuable adjunct in the management of chronic CVD.


Author(s):  
Chanbeom Kwak ◽  
Woojae Han

To prevent intensive noise exposure in advance and be safely controlled during such exposure, hearing protection devices (HPDs) have been widely used by workers. The present study evaluates the effectiveness of these HPDs, partitioned into three different outcomes, such as sound attenuation, sound localization, and speech perception. Seven electronic journal databases were used to search for published articles from 2000 to 2021. Based on inclusion criteria, 20 articles were chosen and then analyzed. For a systematic review and meta-analysis, standardized mean differences (SMDs) and effect size were calculated using a random-effect model. The funnel plot and Egger’s regression analysis were conducted to assess the risk of bias. From the overall results of the included 20 articles, we found that the HPD function performed significantly well for their users (SMDs: 0.457, 95% confidence interval (CI): 0.034–0.881, p < 0.05). Specifically, a subgroup analysis showed a meaningful difference in sound attenuation (SMDs: 1.080, 95% CI: 0.167–1.993, p < 0.05) when to wear and not to wear HPDs, but indicated no significance between the groups for sound localization (SMDs: 0.177, 95% CI: 0.540–0.894, p = 0.628) and speech perception (SMDs: 0.366, 95% CI: −0.100–1.086, p = 0.103). The HPDs work well for their originally designated purposes without interfering to find the location of the sound sources and for talking between the workers. Taking into account various factors, such as the characteristics of the users, selection of appropriate types, and fitting methods for wearing in different circumstances, seems to be necessary for a reliable systematic analysis in terms of offering the most useful information to the workers.


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