Methodological Quality Of Observational Studies Research Articles

The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey.

An increasing number of observational studies have investigated the risk of using drugs during pregnancy on congenital malformations. However, the credibility of the causal relationships drawn from these studies remains uncertain. This study aims to evaluate the potential methodological issues in existing observational studies. We used a stepwise approach to investigate this issue. First, we identified observational studies published in 2020 that examined the risk of congenital malformations associated with medication use during pregnancy. We assessed the methodological characteristics for establishing causality, including study design, confounding control, and sensitivity analysis, and compared them between "core clinical journals" and "general journals." For studies reporting an increased risk of congenital malformations in core clinical journals, we searched for subsequent studies addressing the same research question published between January 2021 and May 2023 to assess the consistency of the literature. A total of 40 eligible studies were published in 2020, primarily focused on the safety of vitamin B12 and folic acid (n=4), antidepressants (n=4), and others (n=32). Our findings suggest that only two (5.00%) studies used causal models to guide the identification of confounding, and only eight (20.00%) studies assessed the potential dose-response relationship. In all, 15 (37.50%) studies used propensity score analysis strategy to achieve "mimic-randomization." In addition, 22 studies (55.00%) performed sensitivity analyses, while 10 (45.45%) showed inconsistency with the primary outcome. Furthermore, 5 studies reported positive outcomes, whereas only 1 out of 11 studies demonstrated a positive correlation between drug usage during pregnancy and major malformations in subsequent studies. A significant portion of the studies has failed to sufficiently consider the essential methodological characteristics required to improve the credibility of causal inferences. The increased risk of congenital malformations documented in core clinical journal was not adequately replicated in subsequent studies.

Recreational physical activity reduces breast cancer recurrence in female survivors of breast cancer: A meta-analysis.

The aim of this review was to systematically collect the published evidence to assess the effect of recreational physical activity (PA) in reducing breast cancer (BC) recurrence in female survivors. A bibliographic search was carried out in PubMed Medline, CINAHL Complete, Scopus and Lilacs until June 2021. We selected observational studies or clinical trials comprising women diagnosed with BC, in which the risk of recurrence of BC was measured before or after performing recreational PA. As a secondary outcome, we analyzed disease free survival for recurrence/disease-specific mortality. The methodological quality of observational studies was assessed with the Newcastle-Ottawa Scale and clinical trials with the PEDro scale. A random effects model was used to estimate the relative risks (RR) and their 95% confidence intervals (CI) to infer the results for any female survivor of BC. We performed separate meta-analyses for prediagnosis and postdiagnosis recreational PA. Eleven studies were included, providing data from 29,677 surviving women with BC with an age range of 18-79 years old. Postdiagnosis recreational PA reduced the risk of BC recurrence by 16% (RR, 0.84; 95% CI: 0.78 to 0.91) and the risk of recurrence/disease-specific mortality by 23% (RR, 0.77; 95% CI: 0.66 to 0.93). Prediagnosis PA reduced the risk of BC by 18% (RR, 0.82; 95% CI: 0.74 to 0.91). This systematic review with meta-analysis shows that recreational PA can be an interesting therapeutic tool to protect against recurrence of BC in female survivors.

Anti-epileptic drug exposure during pregnancy and neonatal birth weight outcomes: protocol for a systematic review and meta-analysis

BackgroundThe prevalence of epilepsy in pregnant women is estimated at 0.3-1%. Anti-epileptic drug (AED) exposure in-utero has been associated with various adverse health outcomes in neonates, including adverse birth weight outcomes.ObjectiveThis review aims to summarize the published evidence on the association between AED exposure in pregnancy and adverse birth weight outcomesMethodsStudies assessing AED exposure in pregnancy and neonatal birth weight outcomes, including small for gestational age (SGA), low birth weight (LBW), birth weight (BW), length, head circumference, and cephalization index will be identified in MEDLINE®, EMBASE, Cochrane Library, Scopus, Cumulative Index of Nursing and Allied Health Literature (CINAHL), International Pharmaceutical s (IPA), and Global Health. Open grey, Theses Canada, and ProQuest Dissertations will be used to locate gray literature. Eligible study designs will include both intervention and non-interventional studies. We will not impose any time limit in the review. We will use the Newcastle-Ottawa Scale to assess the methodological quality of observational studies and quasi-experimental studies included in the review. The risk of bias of experimental studies will be appraised using the Cochrane risk-of-bias tool for randomized trials (RoB 2). A meta-analysis will be conducted using a random-effects model.DiscussionThe results from this review could improve clinicians’ prescribing decisions by highlighting the safest AEDs for women who are pregnant or planning to conceive based on the evidence currently available.Systematic review registrationPROSPERO CRD42020192713

Prevalence of nosocomial infections in Iran: A systematic review and meta-analysis.

Background: Nosocomial infections represent a serious public health concern worldwide, and, especially, in developing countries where, due to financial constraints, it is difficult to control infections. This study aimed to review and assess the prevalence of nosocomial infections in Iran. Methods: Different databases were searched between January 2000 and December 2017. To determine the pooled prevalence, the stochastic DerSimonian-Laird model was used, computing the effect size with its 95% confidence interval. To examine the heterogeneity among studies, the I2 test were conducted. The reporting of observational studies in epidemiology (STROBE) checklist was used to assess the methodological quality of observational studies. To further investigate the source of heterogeneity, meta-regression analyses stratified by publication year, sample size and duration of hospitalization in the hospital were carried out. Results: 52 studies were included. Based on the random-effects model, the overall prevalence of nosocomial infection in Iran was 4.5% [95% CI: 3.5 to 5.7] with a high, statistically significant heterogeneity (I2=99.82%). A sensitivity analysis was performed to ensure the stability results. After removing each study, results did not change. A cumulative meta-analysis of the included studies was performed based on year of publication and the results did not change. In the present study, a high rate of infections caused by Klebsiella pneumoniae (urinary tract, respiratory tract, and bloodstream infections) was found. Conclusion: Preventing and reducing hospital infections can significantly impact on reducing mortality and health-related costs. Implementing ad hoc programs, such as training healthcare staff on admission to the hospital, may play an important role in reducing infections spreading.

Systematic review and meta-analysis of endovascular treatment for acute mesenteric ischaemia.

Introduction Acute mesenteric ischaemia is associated with a significant morbidity and mortality. Endovascular techniques have emerged as a viable alternative treatment option to conventional surgery. Our objective was to conduct a systematic review of the literature and perform a meta-analysis of reported outcomes. Methods Our review conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards and the protocol was registered in PROSPERO (CRD42016035667). We searched electronic information sources (MEDLINE, EMBASE, CINAHL, CENTRAL) and bibliographic lists of relevant articles to identify studies reporting outcomes of endovascular treatment for acute mesenteric ischaemia of embolic or thrombotic aetiology. We defined 30-day or in-hospital mortality and bowel resection as the primary outcome measures. We used the Newcastle-Ottawa scale to assess the methodological quality of observational studies. We calculated combined overall effect sizes using random effects models; results are reported as the odds ratio and 95% confidence interval. Results We identified 19 observational studies reporting on a total of 3362 patients undergoing endovascular treatment for acute mesenteric ischaemia. The pooled estimate of peri-interventional mortality was 0.245 (95% confidence interval 0.197-0.299), that of the requirement for bowel resection 0.326 (95% confidence interval 0.229-0.439), and the pooled estimate for acute kidney injury was 0.132 (95% confidence interval 0.082-0.204). Eight studies reported comparative outcomes of endovascular versus surgical treatment for acute mesenteric ischaemia (endovascular group, 3187 patients; surgical group, 4998 patients). Endovascular therapy was associated with a significantly lower risk of 30-day mortality (odds ratio 0.45, 95% confidence interval 0.30-0.67, P = 0.0001), bowel resection (odds ratio 0.45, 95% confidence interval 0.34-0.59, P < 0.00001) and acute renal failure (odds ratio 0.58, 95% confidence interval 0.49-0.68, P < 0.00001). No differences were identified in septic complications or the development of short bowel syndrome. Conclusion Endovascular treatment for acute mesenteric ischaemia is associated with a considerable mortality and requirement of bowel resection. However, endovascular therapy confers improved outcomes compared to conventional surgery, as indicated be reduced mortality, risk of bowel resection and acute renal failure. An endovascular-first approach should be considered in patients presenting with acute mesenteric ischaemia.

Blood Component Therapy and Coagulopathy in Trauma: A Systematic Review of the Literature from the Trauma Update Group.

BackgroundTraumatic coagulopathy is thought to increase mortality and its treatment to reduce preventable deaths. However, there is still uncertainty in this field, and available literature results may have been overestimated.MethodsWe searched the MEDLINE database using the PubMed platform. We formulated four queries investigating the prognostic weight of traumatic coagulopathy defined according to conventional laboratory testing, and the effectiveness in reducing mortality of three different treatments aimed at contrasting coagulopathy (high fresh frozen plasma/packed red blood cells ratios, fibrinogen, and tranexamic acid administration). Randomized controlled trials were selected along with observational studies that used a multivariable approach to adjust for confounding. Strict criteria were adopted for quality assessment based on a two-step approach. First, we rated quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. Then, this rating was downgraded if other three criteria were not met: high reporting quality according to shared standards, absence of internal methodological and statistical issues not detailed by the GRADE system, and absence of external validity issues.ResultsWith few exceptions, the GRADE rating, reporting and methodological quality of observational studies was “very low”, with frequent external validity issues. The only two randomized trials retrieved were, instead, of high quality. Only weak evidence was found for a relation between coagulopathy and mortality. Very weak evidence was found supporting the use of fibrinogen administration to reduce mortality in trauma. On the other hand, we found high evidence that the use of 1:1 vs. 1:2 high fresh frozen plasma/packed red blood cells ratios failed to obtain a 12% mortality reduction. This does not exclude lower mortality rates, which have not been investigated. The use of tranexamic acid in trauma was supported by “high” quality evidence according to the GRADE classification but was downgraded to “moderate” for external validity issues.ConclusionsTranexamic acid is effective in reducing mortality in trauma. The other transfusion practices we investigated have been inadequately studied in the literature, as well as the independent association between mortality and coagulopathy measured with traditional laboratory testing. Overall, in this field of research literature quality is poor.

Comparative safety of anti-epileptic drugs among infants and children exposed in utero or during breastfeeding: protocol for a systematic review and network meta-analysis.

BackgroundEpilepsy affects about 1% of the general population. Anti-epileptic drugs (AEDs) prevent or terminate seizures in individuals with epilepsy. Pregnant women with epilepsy may continue taking AEDs. Many of these agents cross the placenta and increase the risk of major congenital malformations, early cognitive and developmental delays, and infant mortality. We aim to evaluate the comparative safety of AEDs approved for chronic use in Canada when administered to pregnant and breastfeeding women and the effects on their infants and children through a systematic review and network meta-analysis.MethodsStudies examining the effects of AEDs administered to pregnant and breastfeeding women regardless of indication (e.g., epilepsy, migraine, pain, psychiatric disorders) on their infants and children will be included. We will include randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort, registry, and case-control studies. The main literature search will be executed in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. We will seek unpublished literature through searches of trial protocol registries and conference abstracts. The literature search results screening, data abstraction, and risk of bias appraisal will be performed by two individuals, independently. Conflicts will be resolved through discussion. The risk of bias of experimental and quasi-experimental studies will be appraised using the Cochrane Effective Practice and Organization of Care Risk-of-Bias tool, methodological quality of observational studies will be appraised using the Newcastle-Ottawa Scale, and quality of reporting of safety outcomes will be conducted using the McMaster Quality Assessment Scale of Harms (McHarm) tool. If feasible and appropriate, we will conduct random effects meta-analysis. Network meta-analysis will be considered for outcomes that fulfill network meta-analysis assumptions.The primary outcome is major congenital malformations (overall and by specific types), while secondary outcomes include fetal loss/miscarriage, minor congenital malformations (overall and by specific types), cognitive development, psychomotor development, small for gestational age, preterm delivery, and neonatal seizures.DiscussionOur systematic review will address safety concerns regarding the use of AEDs during pregnancy and breastfeeding. Our results will be useful to healthcare providers, policy-makers, and women of childbearing age who are taking anti-epileptic medications.Systematic review registrationPROSPERO CRD42014008925.

Uses and misuses of the STROBE statement: bibliographic study

ObjectivesAppropriate reporting is central to the application of findings from research to clinical practice. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations consist of a checklist of...

Dose–response meta-analysis of silica and lung cancer

To examine the association between occupational exposure to silica and lung cancer from a systematic review (and meta-analysis) of the epidemiologic literature, with special reference to the methodological quality of observational studies. We searched Medline, Toxline, BIOSIS, and Embase (1966-December 2007) for original articles published in any language. Observational studies (cohort and case-control studies) were selected if they reported the result of dose-response analyses relating lung cancer to occupational exposure to silica after appropriate adjustment for smoking. Ten studies (4 cohort studies and 6 case-control studies) met the inclusion criteria of the meta-analysis, nine of which contributing to the main analysis (dose-response analysis, no lag time). We found increasing risk of lung cancer with increasing cumulative exposure to silica, with heterogeneity across studies however. Posthoc analyses identified a set of seven more homogeneous studies. Their meta-analysis resulted in a dose-response curve that was not different from that obtained in the main analysis. Silica is a lung carcinogen. This increased risk is particularly apparent when the cumulative exposure to silica is well beyond that resulting from exposure to the recommended limit concentration for a prolonged period of time.