Expert Opinions on the Debate of Pericardial Reconstruction in Cardiovascular Surgery: To Close or Not to Close?

Background: As of 2019, pericardial closure was performed in only a small portion of the over 320,000 cardiac surgeries performed annually. However, evidence regarding the benefits of pericardial closure or reconstruction has been accruing, particularly with the publication of the RECON study in 2019. Methods: This group of authors convened to try to arrive at consensus expert opinion regarding pericardial reconstruction. Structured topic questions initially were used to stimulate discussion. Subsequently, a survey of proposed expert opinion statements was conducted among the authors. Based on that survey, consensus expert opinion statements and recommendations were compiled. Results: The expert opinions encompass various topics relating to pericardial reconstruction, including definitions, benefits/risks, and technique. Observed benefits include reductions in: (1) adhesions; (2) postoperative pericardial effusion, atrial fibrillation, and bleeding; and (3) readmissions and length of hospital stay. Expert opinion recommendations regarding surgical technique are compiled into a single chart. Complete pericardial reconstruction should be performed, using native pericardial tissue if available and viable; if not feasible, a patch may be used. Patches that stimulate the formation of site-specific tissue in situ (such as natural extracellular matrix) may have additional benefits (including bioregenerative properties and lack of inflammatory response). Closure should be taut, but tension-free. Adequate drainage of the closed pericardium must be ensured. Conclusions: Based on available data and collective surgical experience, we endorse pericardial reconstruction as standard approach in appropriately selected patients. We also endorse adoption of standardized pericardial reconstruction techniques to optimize patient outcomes and improve evidence quality in future studies.

Effectiveness of Dance-Based Interventions on Depression for Persons With MCI and Dementia: A Systematic Review and Meta-Analysis

Background: There is a growing need to offer appropriate services to persons with mild cognitive impairment (MCI) and dementia who are faced with depression and anxiety distresses beyond traditional pharmacological treatment. Dance-based interventions as multi-dimensional interventions address persons' physical, emotional, social, and spiritual aspects of well-being. However, no meta-analysis of randomized controlled treatment trials (RCTs) has examined the effectiveness of dance-based interventions on depression and anxiety among persons with MCI and dementia, and the results of RCTs are inconsistent. The study aimed to examine the effectiveness of dance-based interventions on depression (a primary outcome) and anxiety (a secondary outcome) among persons with MCI and dementia.Methods: A systematic review with meta-analysis was conducted. The inclusion criteria were: population: people of all ages with MCI and dementia; intervention: dance-based interventions; control group: no treatment, usual care, or waiting list group; outcome: depression and anxiety; study design: published or unpublished RCTs. Seven electronic databases (Cochrane, PsycINFO, Web of Science, PubMed, EBSCO, CNKI, WanFang) were searched from 1970 to March 2021. Grey literature and reference lists from relevant articles were also searched and reviewed. The Cochrane “Risk of Bias” tool was used to assess study quality. RevMan 5.4 was used for meta-analysis and heterogeneity was investigated by subgroup and sensitivity analysis. GRADE was applied to assess the evidence quality of depression and anxiety outcomes.Results: Five randomized controlled trials were identified. Sample sizes ranged from 21 to 204. The risk of bias was low, except for being rated as high or unclear for most included studies in two domains: allocation concealment, blinding participants and personnel. Meta-analysis of depression outcome showed no heterogeneity (I2 = 0%), indicating that the variation in study outcomes did not influence the interpretation of results. There were significant differences in decreasing depression in favor of dance-based interventions compared with controls [SMD = −0.42, 95% CI (−0.60, −0.23), p < 0.0001] with a small effect size (Cohen's d = 0.3669); Compared with the post-intervention data, the follow-up data indicated diminishing effects (Cohen's d = 0.1355). Dance-based interventions were more effective in reducing depression for persons with dementia than with those having MCI, and were more effective with the delivery frequency of 1 h twice a week than 35 min 2–3 times a week. Also, one included RCT study showed no significant benefit on anxiety rating scores, which demonstrated small effect sizes at 6 weeks and 12 weeks (Cohen's d = 0.1378, 0.1675, respectively). GRADE analysis indicated the evidence quality of depression was moderate, and the evidence quality of anxiety was low.Conclusions: Dance-based interventions are beneficial to alleviate depression among persons with MCI and dementia. More trials of high quality, large sample sizes are needed to gain more profound insight into dance-based interventions, such as their effects of alleviating anxiety, and the best approaches to perform dance-based interventions.

The Use of Evidence-Based Acupuncture: Current Evidence

Evidence-based medicine (EBM), which emphasizes that medical decisions must be based on the most recent best evidence, is gaining popularity. Individual clinical expertise is combined with the best available external clinical evidence derived from systematic research in the practice of EBM. The key and core of EBM is the hierarchical system for categorizing evidence. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system divides evidence quality into four categories: high, moderate, low, and very low. GRADE is based on the lowest quality of evidence for any of the outcomes that are critical to making a decision, reducing the risk of mislabeling the overall evidence quality, when evidence for a critical outcome is lacking. This principle is also used in acupuncture as a complementary and integrative treatment modality, but incorporating scientific evidence is more difficult due to a number of factors. The goal of this chapter is to discuss how to establish a clinical evidence system for acupuncture, with a focus on the current quality of evidence for a variety of conditions or diseases.

Migraine and Medical Ramifications: A Comprehensive Overview Based on Observational Study Meta-Analyses

Purpose: An umbrella review was conducted for comprehensively evaluating previous review-based literature together with meta-analysis of observational investigations probing correlations between migraine and medical end-point ramifications in patients. The breadth and validity of these associations were assessed.Methods: Multiple online scientific repositories (including PubMed, Medline, Embase, and Web of Science) were investigated (inception-August 2021) for related meta-analyses focusing on links between migraine and all possible health/medical ramification end-points. A summary effect size and 95% CIs were determined for each identified study with such links. Heterogeneity and small-study influence traces were also evaluated. The AMSTAR 2 platform was employed for evaluating standards of methodology, together with objective criteria, for assessing the standards of datasets from each medical end-point scrutinized in this study.Results: A total of 25 scientific reports comprising 10,237,230 participants for 49 meta-analyses of observational studies were selected. Among such 49 outcomes, 30 demonstrated statistical significance (P < 0.05). Significant associations were observed in multiple diseases, including cardiovascular/cerebrovascular, cerebral, pregnancy-related and metabolic disorders, other outcomes, and mortality.Conclusion: The results showed that migraine increased the risk of 29 health outcomes, though lowered the risk of breast cancer. However, evidence quality was graded as high only for angina. The evidence quality of ischaemic stroke, stroke, MACCE, WMAs, and asthma was graded as moderate. All remaining 24 outcomes had an evidence grade of “weak.”

Likeability and Expert Persuasion: Dislikeability Reduces the Perceived Persuasiveness of Expert Evidence

With the use of expert evidence increasing in civil and criminal trials, there is concern jurors' decisions are affected by factors that are irrelevant to the quality of the expert opinion. Past research suggests that the likeability of an expert significantly affects juror attributions of credibility and merit. However, we know little about the effects of expert likeability when detailed information about expertise is provided. Two studies examined the effect of an expert's likeability on the persuasiveness judgments and sentencing decisions of 456 jury-eligible respondents. Participants viewed and/or read an expert's testimony (lower vs. higher quality) before rating expert persuasiveness (via credibility, value, and weight), and making a sentencing decision in a Capitol murder case (death penalty vs. life in prison). Lower quality evidence was significantly less persuasive than higher quality evidence. Less likeable experts were also significantly less persuasive than either neutral or more likeable experts. This “penalty” for less likeable experts was observed irrespective of evidence quality. However, only perceptions of the foundational validity of the expert's discipline, the expert's trustworthiness and the clarity and conservativeness of the expert opinion significantly predicted sentencing decisions. Thus, the present study demonstrates that while likeability does influence persuasiveness, it does not necessarily affect sentencing outcomes.

Quality of Evidence Supporting the Role of Acupuncture for the Treatment of Irritable Bowel Syndrome

Objectives. To systematically collate, appraise, and synthesize the current evidence on acupuncture for irritable bowel syndrome (IBS). Methods. Systematic reviews (SRs)/meta-analyses (MAs) of acupuncture for IBS were searched in eight databases. For quality evaluation of the enrolled studies, Assessment of Multiple Systematic Reviews 2 (AMSTAR-2) was used for methodological quality, Preferred Reporting Item for Systematic Reviews and Meta-Analyses (PRISMA) for reporting quality, and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for evidence quality. Results. Ten studies were included in our review. According to AMSTAR-2, only one study met all the criteria and was rated as high methodological quality, and the rest were rated as low or very low methodological quality. According to the PRISMA checklist, most of the items were fully reported, with the exception of Q5 (protocol and registration), Q8 (search), and Q27 (funding). With the GRADE system, no outcome measure was rated as high quality. Conclusions. Acupuncture may be a promising therapy for IBS. However, this conclusion must be treated with caution since the quality of SRs/MAs providing evidence is generally low.

Activation and installation of orthodontic appliances temporarily impairs mastication: A systematic review with meta-analysis

ABSTRACT Objectives To investigate the masticatory (masticatory performance, bite force, swallowing threshold, muscle activity, and questionnaires) and nutritional (nutrient intake) impacts of the activation and/or installation of different orthodontic appliances (fixed labial, lingual appliances, and clear aligners). Materials and Methods Six electronic databases and gray literature were searched (up to May 2021) for relevant studies evaluating mastication and nutrition after activation/installation of orthodontic appliances. This review followed PRISMA guidelines and was registered at PROSPERO (CRD42020199510). The risk of bias (RoB 2 and ROBINS-I) and evidence quality Grading of Recommendations Assessment, Development, and Evaluation were analyzed. Results Of 4226 recorded and screened, 15 studies were finally included. Masticatory performance (standardized mean difference [SMD]: 1.069; 95% coefficient interval [CI]: 0.619 to 1.518) and bite force (SMD: -2.542; 95% CI: -4.867 to -0.217) reduced in the first 24 to 48 hours of fixed labial appliance installation/activation, but they were both normalized after 30 days (P > .05). The swallowing threshold remained constant (P > .05). Nutritional intake was rarely reported but showed copper (P = .002) and manganese (P = .016) reductions, with higher calorie and fat intake (P < .05). Lingual appliances impacted chewing more than labial, and clear aligner wearers reported fewer chewing problems (P < .001). Low to very low levels of evidence were found. Conclusions Based on low to very low levels of evidence, mastication was reduced during the first 24 to 48 hours of fixed labial appliance activation/installation, but it was transitory (up to 30 days). Due to insufficient data, the nutritional impact of orthodontic appliances was not conclusive.

The effects of quality of evidence communication on perception of public health information about COVID-19: Two randomised controlled trials

Background The quality of evidence about the effectiveness of non-pharmaceutical health interventions is often low, but little is known about the effects of communicating indications of evidence quality to the public. Methods In two blinded, randomised, controlled, online experiments, US participants (total n = 2140) were shown one of several versions of an infographic illustrating the effectiveness of eye protection in reducing COVID-19 transmission. Their trust in the information, understanding, feelings of effectiveness of eye protection, and the likelihood of them adopting it were measured. Findings Compared to those given no quality cues, participants who were told the quality of the evidence on eye protection was ‘low’, rated the evidence less trustworthy (p = .001, d = 0.25), and rated it as subjectively less effective (p = .018, d = 0.19). The same effects emerged compared to those who were told the quality of the evidence was ‘high’, and in one of the two studies, those shown ‘low’ quality of evidence said they were less likely to use eye protection (p = .005, d = 0.18). Participants who were told the quality of the evidence was ‘high’ showed no statistically significant differences on these measures compared to those given no information about evidence quality. Conclusions Without quality of evidence cues, participants responded to the evidence about the public health intervention as if it was high quality and this affected their subjective perceptions of its efficacy and trust in the provided information. This raises the ethical dilemma of weighing the importance of transparently stating when the evidence base is actually low quality against evidence that providing such information can decrease trust, perception of intervention efficacy, and likelihood of adopting it.

The effectiveness and safety of low-level laser therapy on breast cancer–related lymphedema: An overview and update of systematic reviews

The objective of our overview of systematic reviews was to critically analyze the evidence from existing systematic reviews investigating the effectiveness and safety of low-level laser therapy (LLLT) in patients with breast cancer–related lymphedema (BCRL). In addition, an updated and comprehensive systematic review was conducted, which aimed to provide updated evidence about this topic. PubMed, EMBASE, and Cochrane Library databases were systematically searched for systematic reviews and randomized controlled trials (RCTs) investigating the effectiveness and safety of LLLT in patients with BCRL. The methodological quality for each of included systematic reviews or RCTs was assessed using the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR 2) tool or Cochrane risk of bias tool, respectively. The updated systematic review separately compared the effectiveness of LLLT to each of active or negative interventions. Data were pooled with random-effects models for each outcome per comparison. The evidence quality of outcomes was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) or GRADE-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) for quantitative studies and qualitative studies, respectively. Seven systematic reviews and ten RCTs met the eligibility criteria. Conflicting results regarding the effectiveness of LLLT were presented by the overview of systematic reviews. The AMSTAR 2 showed that the methodological quality of included systematic reviews was low or critically low quality due to one or more critical weaknesses. The GRADE and GRADE-CERQual showed that the evidence quality was low to very low for most outcomes. The updated systematic review showed that LLLT may offer additional benefits as compared to compression therapies (pneumatic compression or compression bandage), placebo laser, or no treatment for patients with BCRL. However, when compared to other types of active interventions, LLLT did not improve outcomes significantly. None of the treatment-related adverse event was reported. Many trials had a high or unclear risk of bias for two or more items, and our updated systematic review showed low quality of evidence per outcome using GRADE approach. Due to insufficient data and poor quality of evidence, there is uncertain to reach these conclusions that LLLT is superior to another active or negative intervention and is safe. More RCTs of high methodological quality, with large sample sizes and long-term follow-up, are needed to inform clinical guidelines and routine practice.

Low vitamin D levels do not aggravate COVID-19 risk or death, and vitamin D supplementation does not improve outcomes in hospitalized patients with COVID-19: a meta-analysis and GRADE assessment of cohort studies and RCTs

Background The associations between vitamin D and coronavirus disease 2019 (COVID-19) infection and clinical outcomes are controversial. The efficacy of vitamin D supplementation in COVID-19 is also not clear. Methods We identified relevant cohort studies that assessed the relationship between vitamin D, COVID-19 infection and associated death and randomized controlled trials (RCTs) that reported vitamin D supplementation on the outcomes in patients with COVID-19 by searching the PubMed, EMBASE, and medRxiv databases up to June 5th, 2021. Evidence quality levels and recommendations were assessed using the GRADE system. Results Eleven cohort studies with 536,105 patients and two RCTs were identified. Vitamin D deficiency (< 20 ng/ml) or insufficiency (< 30 ng/ml) was not associated with an significant increased risk of COVID-19 infection (OR for < 20 ng/ml: 1.61, 95% CI: 0.92–2.80, I2 = 92%) or in-hospital death (OR for < 20 ng/ml: 2.18, 95% CI: 0.91–5.26, I2 = 72%; OR for < 30 ng/ml: 3.07, 95% CI: 0.64–14.78, I2 = 66%). Each 10 ng/ml increase in serum vitamin D was not associated with a significant decreased risk of COVID-19 infection (OR: 0.92, 95% CI: 0.79–1.08, I2 = 98%) or death (OR: 0.65, 95% CI: 0.40–1.06, I2 = 79%). The overall quality of evidence (GRADE) for COVID-19 infection and associated death was very low. Vitamin D supplements did not significantly decrease death (OR: 0.57, I2 = 64%) or ICU admission (OR: 0.14, I2 = 90%) in patients with COVID-19. The level of evidence as qualified using GRADE was low. Conclusions Current evidence suggested that vitamin D deficiency or insufficiency was not significantly linked to susceptibility to COVID-19 infection or its associated death. Vitamin D supplements did not significantly improve clinical outcomes in patients with COVID-19. The overall GRADE evidence quality was low, we suggest that vitamin D supplementation was not recommended for patients with COVID-19.