Grading Of Recommendations Assessment, Development And Evaluation Assessment Research Articles

Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.

This systematic review provides supporting evidence for the accompanying clinical practice guideline on the treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD). The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies that compared the use of pharmacological or nonpharmacological treatment to no treatment to improve patient-important outcomes. Statistical analyses were performed to determine the clinical significance of using various interventions to treat RLS and PLMD in adults and children. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence for making recommendations. The literature search resulted in 3631 studies out of which 148 studies provided data suitable for statistical analyses. The task force provided a detailed summary of the evidence along with the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations.

Effectiveness and safety of self-management interventions for improving glycemic control and health-related quality of life among adults with type 2 diabetes mellitus in sub-Saharan Africa: a systematic review and meta-analysis.

The objective of this review was to assess and synthesize evidence on the effectiveness and safety of self-management interventions for improving glycemic control and health-related quality of life among adults with type 2 diabetes mellitus (T2DM) in sub-Saharan Africa. There has been a rapid increase in the prevalence of T2DM in sub-Saharan Africa. Lifestyle-related risk factors require self-management strategies, and these must be tailored to the context. Several randomized controlled trials (RCTs) evaluating T2DM self-management interventions in sub-Saharan Africa have been conducted. This systematic review included RCTs assessing the effectiveness and safety of self-management interventions among adults with T2DM in sub-Saharan Africa, where the self-management intervention matched at least 1 category of the Practical Reviews in Self-Management Support (PRISMS) for long-term conditions taxonomy. The following databases were searched from inception until January 14, 2023: MEDLINE (Ovid), PubMed, Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), Directory of Open Access Journals, EThOS, and ProQuest Dissertations and Theses (ProQuest). Global Health (EBSCOhost) was searched from inception until June 8, 2021. OpenGrey was searched from inception until its archive date of December 1, 2020. Two independent reviewers conducted title and abstract screening, full-text screening, data extraction, and critical appraisal. Disagreements were resolved through discussion or with a third reviewer. Data synthesis was conducted narratively, followed by meta-analysis where feasible. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for assessing the certainty of evidence was applied. From 2699 records identified, 18 RCTs were included in the systematic review and 14 in the meta-analysis. Interventions included broad self-management education programs, peer support, exercise interventions with education, nutrition education, educational text messaging, and blood glucose self-monitoring support. Only 4 studies received a "yes" response for more than half of the criteria in the standardized JBI critical appraisal tool for RCTs. Compared to the control, self-management interventions did not significantly reduce glycated hemoglobin (HbA1c) levels at 3 months (302 participants, mean difference [MD] -6.0 mmol/mol, 95% CI -17.5, 5.4; very low certainty on GRADE assessment) or 12 months (1504 participants, MD -3.7 mmol/mol, 95% CI -8.2, 0.7; moderate certainty on GRADE assessment). HbA1c was significantly reduced at 6 months (671 participants, MD -8.1 mmol/mol, 95% CI -10.7, -5.4; low certainty on GRADE assessment). Four studies assessed health-related quality of life, but only 1 demonstrated an improvement (2205 participants). Three studies reported no adverse events in relation to the trial interventions (1217 participants), and adverse events were not reported in the remainder of studies. There did not appear to be clinically significant effects on body mass index, lipid profile, or systolic or diastolic blood pressure. The evidence was mixed for weight and waist circumference. Self-management interventions for adults living with T2DM in sub-Saharan Africa may produce a clinically significant improvement in glycemic control at 6 months, but this may wane in the long term. There was not convincing evidence to indicate a benefit of these interventions on health-related quality of life, but reporting on this outcome measure was limited. There were insufficient data on adverse events to be able to draw conclusions. PROSPERO CRD42021237506.

Effects of avoidance versus use of neuromuscular blocking agents for facilitation of tracheal intubation in children and infants: a protocol for a systematic review, meta-analysis and trial sequential analysis.

The European Society of Anesthesiology and Intensive Care recommends the use of neuromuscular blocking agents (NMBA) in adults, to facilitate tracheal intubation and reduce its associated complications. Children who undergo tracheal intubation may suffer some of the same complications, however, no consensus exists regarding the use of NMBA for tracheal intubation in the pediatric population. We will explore the existing evidence assessing the effects of avoidance versus the use of NMBA for the facilitation of tracheal intubation in children and infants. This protocol follows the preferred reporting items for systematic reviews and meta-analyses protocols recommendations. We will include all randomized controlled clinical trials assessing the effects of avoidance versus the use of NMBA for facilitation of tracheal intubation (oral or nasal) using direct laryngoscopy or video laryngoscopy in pediatric participants (<18 years). Our primary outcome is incidence of difficult tracheal intubation. Secondary outcomes include incidence of serious adverse events, failed intubation, events of upper airway discomfort or injury, and difficult laryngoscopy. We will conduct a thorough database search to identify relevant trials, including CENTRAL, MEDLINE, EMBASE, BIOSIS, Web of Science, CINAHL, and trial registries. Two review authors will independently handle the screening of literature and data extraction. Each trial will be evaluated for major sources of bias with the "classic risk of bias tool" used in the Cochrane Collaboration tool from 2011. We will use Review manager (RevMan) or R with the meta package to perform the meta-analysis. We will perform a trial sequential analysis on the meta-analysis of our primary outcome, providing an estimate of statistical reliability. Two review authors will independently assess the quality of the body of evidence using the grading of recommendations assessment, development, and evaluation (GRADE) approach. We will use GRADEpro software to conduct the GRADE assessments and to create "Summary of the findings" tables.

Efficacy and Safety of Acupuncture in Managing COPD: An Overview of Systematic Reviews.

Acupuncture has been used as an adjuvant therapy for Chronic obstructive pulmonary disease (COPD). However, systematic reviews (SRs) and meta-analyses (MAs) have reported inconsistent results and unknown quality. This overview aimed to summarize the current SRs/MAs to provide evidence for the effectiveness and safety of acupuncture in the treatment of COPD. SRs/MAs were searched via eight databases from their establishment to December 31, 2023. The methodological quality was assessed by A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). The risk of bias was assessed using the Risk of Bias in Systematic Review (ROBIS) tool. The Preferred Reporting Items for Systematic Reviews and Meta-analyses for Acupuncture (PRISMA-A) to evaluate the reporting quality. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to determine the strength of evidence. In addition, we also conducted an analysis of the acupuncture points used in the primary RCTs. Twenty-two SRs/MAs were included in this overview. Based on the assessment using AMSTAR 2, nineteen SRs/MAs were "critically low". Eight SRs/MAs had a low risk of bias. Based on PRISMA-A, the reporting completeness of eighteen SRs/MAs were more than 70%. As for GRADE assessment, only three outcome measures were of high quality. COPD patients can benefit from moxibustion, acupoint application, acupoint catgut embedding, manual acupuncture, and electroacupuncture, as indicated by effectiveness in measures including lung function, 6MWD, mMRC, CAT, and acute exacerbation. In addition, the efficacy of TENS needed to be further demonstrated. The commonly used acupuncture points in the RCTs include BL13, BL23, and EX-B1. Evidence from SRs showed that acupuncture is beneficial to lung function, acute exacerbation, 6MWD, mMRC and CAT. For SGRQ and brog scale, acupuncture should be used selectively, but this finding should still be taken with caution.

Oral Chinese patent medicines for diabetic kidney disease: An overview of systematic reviews

Diabetic kidney disease (DKD) has become a global public health problem with a significant disease burden. A number of Chinese patent medicines (CPMs) are widely used in the treatment of DKD in China. An overview of systematic reviews (SRs) can summarize the overall evidence of its effectiveness and safety for both practice and research. SRs and/or meta-analyses based on randomized controlled trials (RCTs) of oral CPMs for DKD were identified. Eight databases were searched from their inception to October 2021. The AMSTAR 2 tool was applied to appraise the methodological quality of the included SRs by two authors. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to summarize the certainty of evidence of the included reviews. A total of 88 SRs were included, of which three were published as abstracts only. The methodological quality using the AMSTAR 2 approach was assessed as "low" for five SRs and "critically low" for 80 SRs. Renal end-point events and quality of life were not reported in all SRs. Most of the reviews reported surrogate outcomes. Serum creatinine and 24-hour urinary total protein were the two most commonly reported indicators, and regrettably, no high-quality evidence with GRADE assessment was found. Regarding safety, except for Tripterygium glycosides tablet, other CPMs had mild adverse effects. Due to the lack of end-point outcomes and high-quality evidence, the effectiveness and safety of oral CPMs for DKD remain uncertain. Future studies with more critical methodological designs are needed to provide robust evidence. A core outcome set for adults with DKD could help improve the consistency and relevance of outcomes from clinical trials.

Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis

The evidence on prophylactic use of negative pressure wound therapy on primary closed incisional wounds (iNPWT) for the prevention of surgical site infections (SSI) is confusing and ambiguous. Implementation in daily practice is impaired by inconsistent recommendations in current international guidelines and published meta-analyses. More recently, multiple new randomised controlled trials (RCTs) have been published. We aimed to provide an overview of all meta-analyses and their characteristics; to conduct a new and up-to-date systematic review and meta-analysis and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment; and to explore the additive value of new RCTs with a trial sequential analysis (TSA). PubMed, Embase and Cochrane CENTRAL databases were searched from database inception to October 24, 2022. We identified existing meta-analyses covering all surgical specialties and RCTs studying the effect of iNPWT compared with standard dressings in all types of surgery on the incidence of SSI, wound dehiscence, reoperation, seroma, hematoma, mortality, readmission rate, skin blistering, skin necrosis, pain, and adverse effects of the intervention. We calculated relative risks (RR) with corresponding 95% confidence intervals (CI) using a Mantel-Haenszel random-effects model. We assessed publication bias with a comparison-adjusted funnel plot. TSA was used to assess the risk of random error. The certainty of evidence was evaluated using the Cochrane Risk of Bias-2 (RoB2) tool and GRADE approach. This study is registered with PROSPERO, CRD42022312995. We identified eight previously published general meta-analyses investigating iNPWT and compared their results to present meta-analysis. For the updated systematic review, 57 RCTs with 13,744 patients were included in the quantitative analysis for SSI, yielding a RR of 0.67 (95% CI: 0.59-0.76, I2=21%) for iNPWT compared with standard dressing. Certainty of evidence was high. Compared with previous meta-analyses, the RR stabilised, and the confidence interval narrowed. In the TSA, the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate from the meta-analysis. In this up-to-date meta-analysis, GRADE assessment shows high-certainty evidence that iNPWT is effective in reducing SSI, and uncertainty is less than in previous meta-analyses. TSA indicated that further trials are unlikely to change the effect estimate for the outcome SSI; therefore, if future research is to be conducted on iNPWT, it is crucial to consider what the findings will contribute to the existing robust evidence. Dutch Association for Quality Funds Medical Specialists.

Clinical efficacy and safety of compound Congrong Yizhi Capsules on Alzheimer's disease in mainland China: A systematic review with trial sequential analysis and GRADE assessment.

Alzheimer's disease (AD) is a degenerative disease of the central nervous system (CNS) with insidious onset. AD is also the most common cause of dementia. Compound Congrong Yizhi Capsules (CCYC), a traditional Chinese medicine compound developed by the team of Beijing University of Chinese Medicine, has been widely used to treat AD. To systematically evaluate the clinical efficacy and safety of CCYC for AD by meta-analysis, Trial Sequential Analysis (TSA) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. This study was registered at PROSPERO (CRD42022295496). Randomized controlled trials (RCTs) of CCYC as the treatment for AD published before December 1, 2021 were retrieved from 4 Chinses databases, 4 English databases and 2 clinical trials registration systems. RevMan 5.4 and STATA 17.0 was used to conduct the meta-analysis of the included studies, the quality of outcomes was rated by the GRADE system, the TSA was conducted by TSA 0.9.5.10 software. Seven studies were included, and the total sample size was 746. Meta-analysis showed that 6 months of treatment with CCYC plus conventional western medicine treatments (CTs) improved MMSE scores compared with CTs alone (WMD: 4.32, 95% CI: 3.23, 5.42), and TSA confirmed that more trials in the future will not reverse the result. Among which, CCYC combined with donepezil can significantly improve MMSE scores (WMD: 3.54, 95% CI: 2.86, 4.22). CCYC combined with olanzapine also showed good effect on both MMSE (WMD: 6.49, 95% CI: 5.54, 7.44) and ADL scores (WMD: 5.23, 95% CI: 4.63, 5.83). No serious adverse events were reported. The strengths of the evidences above are MODERATE. CCYC combined with cognition-modifying western medicine can improve cognitive function, mental behavioural symptoms, and activities of daily living in AD patients with good safety.

Sarcopenia and health-related quality of life: A systematic review and meta-analysis.

The decrease of physical abilities and functional decline that can be caused by musculoskeletal conditions such as sarcopenia, can lead to higher levels of dependency and disability. Therefore, it may influence patient reported outcome measures (PROM), such as the health-related quality of life (HRQoL). The purpose of this systematic review and meta-analysis is to provide a comprehensive overview of the relationship between sarcopenia and HRQoL. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were followed throughout the whole process of this work. A protocol was previously published on PROSPERO. The electronic databases MEDLINE, Scopus, Allied and Complementary Medicine (AMED), EMB Review - ACP Journal Club, EBM Review - Cochrane Central of Register of Controlled Trials and APA PsychInfo were searched until October 2022 for observational studies reporting a HRQoL assessment in both sarcopenic and non-sarcopenic individuals. Study selection and data extraction were carried out by two independent researchers. Meta-analysis was performed using a random effect model, reporting an overall standardized mean difference (SMD) and its 95% confidence interval (CI) between sarcopenic and non-sarcopenic individuals. Study quality was measured using the Newcastle-Ottawa Scale and the strength of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The search strategy identified 3725 references from which 43 observational studies were eligible and included in this meta-synthesis study. A significantly lower HRQoL was observed for sarcopenic individuals compared with non-sarcopenic ones (SMD -0.76; 95% CI -0.95; -0.57). Significant heterogeneity was associated with the model (I2 =93%, Q test P-value <0.01). Subgroup analysis showed a higher effect size when using the specific questionnaire SarQoL compared with generic questionnaires (SMD -1.09; 95% CI -1.44; -0.74 with the SarQoL versus -0.49; 95% CI -0.63; -0.36 with generic tools; P-value for interaction <0.01). A greater difference of HRQoL between sarcopenic and non-sarcopenic was found for individuals residing in care homes compared with community-dwelling individuals (P-value for interaction <0.001). No differences were found between age groups, diagnostic techniques, and continents/regions. The level of evidence was rated as moderate using the GRADE assessment. This systematic review and meta-analysis combining 43 observational studies shows that HRQoL is significantly reduced in sarcopenic patients. The use of disease-specific HRQoL instruments may better discriminate sarcopenic patients with respect to their quality of life.

High-Flow Nasal Cannula for Apneic Oxygenation in Obese Patients for Elective Surgery: A Systematic Review and Meta-Analysis.

Obese patients desaturate rapidly during the apneic period after induction of anesthesia for elective surgery. Administration of oxygen using high-flow nasal cannulae (HFNCs) may prevent desaturation in nonobese patients compared to facemask (FM) preoxygenation. The aim of this meta-analysis was to compare the effectiveness of HFNC to FM preoxygenation techniques in reducing preintubation desaturation in obese patients undergoing elective surgery. This study protocol was registered on PROSPERO (CRD42022309391). Adult studies that compared HFNC and FM preoxygenation in obese patients requiring general anesthesia for elective surgery were included. The primary outcome was desaturation resulting in oxygen saturation of <92% from induction of anesthesia until intubation. Secondary outcomes included the lowest arterial oxygen content before intubation expressed in mm Hg, safe apnea time expressed in seconds, the lowest oxygen saturation before intubation expressed as a percentage, patient-reported discomfort, the need for rescue ventilation, and the incidence of aspiration of gastric contents during intubation. Risk of bias was assessed using the Cochrane Collaboration tool. Certainty was assessed following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Six studies including 351 participants were eligible for analysis. There was no difference in odds of oxygen desaturation <92% between HFNC and FM (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.15-1.63; P = .24). The HFNC group had a significantly longer safe apnea time (mean difference [MD], -124.20 with 95% CI, -200.47 to -47.93; P = .001). There was no difference between HFNC and FM in the lowest arterial oxygen content (MD, -23.90; 95% CI, -88.64 to 40.85; P = .47) and the lowest peripheral oxygenation saturation (MD, -0.47 with 95% CI, -5.07 to 4.12; P = .84). HFNC had a lower odd of discomfort than FM (OR, 0.13; 95% CI, 0.03-0.52; P = .004). There was no difference in the odds of aspiration of gastric contents between HFNC and FM (OR, 0.33; 95% CI, 0.01-8.21; P = .50). The risk of bias for our primary and secondary outcomes was low. The GRADE assessment for our primary outcome indicated a low level of certainty. For secondary outcomes, the GRADE assessment indicated a very low certainty for all outcomes except for patient discomfort, which was indicated as a moderate level of certainty. There may be no difference between HFNC and FM preoxygenation in preventing oxygen desaturation <92% or the lowest oxygen saturation before intubation. Preparation remains important to prevent and manage desaturation during induction of obese patients.

The Effect and Safety of Xuefu Zhuoyue Prescription for Coronary Heart Disease: An Overview of Systematic Reviews and Meta-Analyses.

In China, the traditional Chinese medicine compound Xuefu Zhuoyue prescription (XFZY) has been widely used in the therapy of coronary heart disease (CHD). Currently, several systematic reviews (SRs)/meta-analyses (MAs) of XFZY for the treatment of CHD have been published. This overview aims to evaluate the existing SRs/MAs and provide a scientific basis for evaluating the efficacy and safety of XFZY for the therapy of CHD. The SRs/MAs of XFZY for the treatment of CHD were obtained from 7 electronic databases with the search date set at March 7, 2022. Two researchers independently assessed the methodological quality, reporting quality, and evidence quality of the included SRs/MAs using the following tools: the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. A total of 11 SRs/MAs were included in this overview. All SRs/MAs assessed by means of AMSTAR-2 had more than one critical defect, so all SRs/MAs were rated low. Regarding the assessment of reporting quality, the results of PRISMA 2020 showed that none of the SRs/MAs were fully reported. In addition, the results of the GRADE assessment of the quality of evidence indicated that only one outcome was rated as high quality across all SRs/MAs. Current evidence suggests that XFZY is effective and safe for the management of patients with CHD. However, the high risk of bias of the original clinical studies and the low quality of the SRs/MAs reduced the reliability of the results.

Clinical differences between menstrual migraine and nonmenstrual migraine: a systematic review and meta-analysis of observational studies.

Approximately 60% of female migraineurs experience menstrual migraine (MM). Whether MM is a distinct clinical entity with more severe migraine attacks and a worse prognosis than nonmenstrual migraine (nMM) is still under debate. We conducted a systematic review and meta-analysis to investigate clinical differences between MM and nMM patients. A systematic literature search was performed to identify observational studies comparing MM and nMM patients' clinical characteristics. Quality of evidence grades of the synthesized effect estimates for each outcome were determined following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Of 1837 identified studies, 16 were eligible for inclusion. MM patients had more migraine attacks per month (MD 0.65, 95% CI 0.05-1.24) than nMM patients; however, the quality of evidence was "low" according to the GRADE assessment. They also had more headache days (MD 0.86, 95% CI 0.12-1.60) per month, a higher rate of family history of migraine (OR 1.41 95% CI 1.12-1.78), migraine aggravation with physical activity (OR 1.60, 95% CI 1.35-1.89), a younger age at migraine onset (MD - 0.99, 95% CI - 1.78 to - 0.19), and a higher risk of accompanying symptoms (OR 2.31, 95% CI 1.72-3.10) than nMM patients; however, the quality of evidence was "very low". There were differences between MM and nMM, showing that MM patients have a worse profile than nMM patients, but the quality of evidence is too low to draw definite conclusions on the separation/unification of the two clinical entities.

Effectiveness of telenursing for people with lung cancer at home: A systematic review and meta-analysis.

To evaluate the effectiveness of telenursing involving nurses on the health outcomes of adults with lung cancer at home. We conducted literature searches on PubMed, CINAHL, EMBASE, CENTRAL, and the Japan Medical Abstracts Society up to December 2021. Articles eligible for inclusion were (i) reporting on randomized controlled trials involving telenursing, (ii) focusing on health consultations provided by healthcare providers involving nurses, and (iii) targeting adults with lung cancer at home. Two researchers independently screened eligible studies and assessed the risk of bias using the Cochrane risk-of-bias tool 2. We performed meta-analyses of symptom distress and quality of life. This study was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The quality of evidence was assessed applying the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Four studies with 508 participants were included, of which three were finally evaluated by meta-analysis. Telemonitoring and education by nursing professionals in collaboration with other healthcare professionals were confirmed. Symptom distress was significantly lower in the intervention group (mean difference=-0.54, 95% confidence interval: -1.06, -0.02). There was no significant effect on other outcomes. The GRADE assessment revealed serious risk of bias, inconsistency, and imprecision. The findings suggest that telenursing brought about low symptom distress in adults with lung cancer compared with the absence of telenursing. However, the certainty of the evidence was low owing to the high risk of bias. Further accumulation of high-quality studies is needed to establish definitive evidence.

Effectiveness of adjunct therapy for the treatment of apical periodontitis: A systematic review and meta-analysis.

Adjunct therapy refers to any intracanal procedure going beyond chemomechanical preparation with instruments and traditionally delivered irrigants (excluding interim dressings). It is not clear whether and which of these adjunct therapies have a significant impact on the outcome of root canal treatment [healing of apical periodontitis (AP) and other patient-related outcomes]. This systematic review aimed to analyse available evidence on the effectiveness of adjunct therapy for the treatment of AP in permanent teeth, according to a population, intervention, comparison, outcome, time and study design framework formulated a priori by the European Society of Endodontology. Five electronic databases (PubMed, Embase, Scopus, Cochrane and Web of Science) were searched up to October 2021 to identify clinical studies comparing adjunct therapy to no adjunct therapy in adult patients with AP. Animal studies, reviews, studies with less than 10 patients per arm and studies with a follow-up time of less than 1year, or less than 7 days for postoperative pain, were excluded. The quality of the included studies was appraised by the appropriate tools [Risk of Bias 2 (RoB2) for randomized clinical trials (RCTs) and Newcastle-Ottawa Scale for observational studies]. Meta-analysis was performed using a random-effects model. The certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Fourteen studies (13 RCTs and one retrospective cohort) fulfilled the inclusion criteria for this review. They evaluated different types of adjunct therapy: antimicrobial photodynamic therapy (aPDT; three studies), diode laser canal irradiation (3), Nd:YAG laser canal irradiation (2), Er;Cr:YSGG laser canal irradiation (1), ozone therapy (2) and ultrasonically activated irrigation (UAI) (4). Radiographical healing was reported in seven studies, but meta-analysis was only possible for UAI (two studies), showing no statistically significant difference in healing after 12 months. Pain after 7 days was reported in seven studies. Meta-analysis on three studies that used aPDT and on two studies using diode laser irradiation showed no significant difference in the prevalence of pain after 7 days between the control and adjunct therapy. According to RoB2 tool, six studies had a high risk of bias, five studies had some concerns, and two studies low risk of bias. The GRADE assessment revealed a very low strength of evidence for diode laser, and low strength of evidence for PDT, ozone and UAI studies. The included studies displayed significant heterogeneity in terms of type of adjunct therapy, technical details per adjunct therapy, outcome reporting and several combinations of these, limiting the potential for meta-analysis. There is insufficient evidence to recommend any adjunctive therapy for the treatment of apical periodontitis. Prospero CRD42021261869.

One-Third of Systematic Reviews in Rehabilitation Applied the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) System to Evaluate Certainty of Evidence: A Meta-Research Study

ObjectiveTo determine how many systematic reviews (SRs) of the literature in rehabilitation assess the certainty of evidence (CoE) and how many apply the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to do this. Data SourcesFor this meta-research study, we searched PubMed and Cochrane Database of Systematic Reviews databases for SRs on rehabilitation published in 2020. Study Selection and Data ExtractionTwo reviewers independently selected the SRs and extracted the data. Reporting characteristics and appropriate use of the GRADE system were assessed. Data SynthesisThe search retrieved 827 records: 29% (239/827) SRs evaluated CoE, 68% (163/239) of which applied the GRADE system. GRADE was used by SRs of randomized controlled trials (RCTs, 88%; 144/163), non-randomized intervention studies (NRIS, 2%; 3/163), and both RCT and NRIS (10%; 16/163). In the latter case, a separate GRADE assessment according to the study design was not provided in 75% (12/16). The reasons for GRADE judgment were reported in 82% (134/163) of SRs. ConclusionsOne-third of SRs in rehabilitation assessed CoE with the GRADE system. GRADE assessment was presented transparently by most SRs. Journal editors and funders should encourage the uptake of the GRADE system when considering SRs in rehabilitation for publication. The authors should pre-define GRADE assessment in a registered and/or published protocol.

Left atrial appendage flow velocity predicts recurrence of atrial fibrillation after catheter ablation: A systematic review and meta-analysis

PurposeThere is increasing evidence that left atrial appendage flow velocity (LAAFV) is linked to the recurrence of atrial fibrillation (AF) after catheter ablation (CA), suggesting the potential predictable significance of LAAFV in this setting. We performed a systematic review and meta-analysis to assess whether LAAFV is association with AF recurrence after CA.MethodsUp to May 1, 2022, six databases (PubMed, EMBASE, Web of Science, Cochrane Library, Scopus, and CINAHL) were searched for literature reporting the association between LAAFV and AF recurrence after CA. All statistical analyses were carried out using STATA version 16 software. Heterogeneity was determined by the Cochrane’s Q test and I2 statistics. The Newcastle-Ottawa Scale (NOS) was used to assess the methodological quality of each included study, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was adopted to evaluate the quality of evidence.ResultSixteen studies with 5,006 AF patients after CA (1,479 patients with AF recurrence, 3,527 without AF recurrence) were included in the meta-analysis. The meta-analysis of 15 studies (16 data sets) showed that patients with recurrence exhibited lower LAAFV values than those without recurrence [standardized mean difference (SMD): −0.65, 95% CI: −0.88 to −0.42, P < 0.01]. Moreover, we evaluated the association of LAAFV and the risk of AF recurrence after CA. Nine studies (11 data sets) defined LAAFV as continuous variables, and the pooled analysis suggested that for every 1 cm/s rise in LAAFV values, the risk of AF recurrence after CA decreased by 3% [Odds Ratio (OR): 0.97, 95% CI: 0.95 to 0.99, P < 0.01]. Seven studies defined LAAFV as categorical variables, and the pooled analysis showed that lower LAAFV were associated with an increased risk of AF recurrence after CA [OR: 2.28, 95% CI: 1.46 to 3.57, P < 0.01]. The subgroup analyses showed that the association between LAAFV and AF recurrence after CA was not significantly affected by the AF type and ablation procedure. The NOS indicated that included studies were moderate to high quality, while the GRADE assessment suggested a low certainty of the evidence.ConclusionLower LAAFV may be associated with an increased risk of AF recurrence after CA. Further studies with well designed and randomized studies for LAAFV should be conducted.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022333627].

Intestinal Barrier Permeability in Obese Individuals with or without Metabolic Syndrome: A Systematic Review.

Altered intestinal barrier permeability has been associated with obesity and its metabolic and inflammatory complications in animal models. The purpose of this systematic review is to assess the evidence regarding the association between obesity with or without Metabolic Syndrome (MetS) and alteration of the intestinal barrier permeability in humans. A systematic search of the studies published up until April 2022 in Latin America & Caribbean Health Sciences Literature (LILACS), PubMed, Scopus, Embase, and ScienceDirect databases was conducted. The methodological quality of the studies was assessed using the Newcastle–Ottawa scale (NOS) and the Agency for Healthcare Research and Quality (AHRQ) checklist. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to assess the quality of the evidence. Eight studies were included and classified as moderate to high quality. Alteration of intestinal barrier permeability was evaluated by zonulin, lactulose/mannitol, sucralose, sucrose, lactulose/L-rhamnose, and sucralose/erythritol. Impaired intestinal barrier permeability measured by serum and plasma zonulin concentration was positively associated with obesity with MetS. Nonetheless, the GRADE assessment indicated a very low to low level of evidence for the outcomes. Thus, clear evidence about the relationship between alteration of human intestinal barrier permeability, obesity, and MetS was not found.

Trazodone changed the polysomnographic sleep architecture in insomnia disorder: a systematic review and meta-analysis

Trazodone has been widely prescribed for off-label use as a sleep aid. Identifying how trazodone impacts the performance of polysomnographic sleep architecture in insomnia disorder will provide additional data that can be used to guide clinical application. To assess the efficacy of trazodone in altering the polysomnographic sleep architecture in insomnia disorder so that sleep can be facilitated. PubMed, EMBASE, Web of Science, PsycINFO, Cochrane Library, Chinese Biomedical Literature Database (SinoMed), China National Knowledge Infrastructure, Wanfang Database, and the China Science and Technology Journal Database were searched for articles published between inception and June 2022. RCTs in patients with insomnia disorder applying trazodone in one arm of interventions at least 1 week, and reporting PSG parameters in the outcomes were eligible. RoB 2 was used to evaluate the risk of bias. The results of quality of evidence assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. When I2 < 50%, the fixed effects model was used. When I2 ≥ 50%, the random effects model was used. The mean differences (MD) or standardized mean differences (SMD) and odds ratios (OR) with 95% confidence intervals (CIs) were estimated. Eleven randomized controlled trials were selected and participants were 466. Risk of bias was low in 5 trials (45.5%), and was moderate in 6 (54.5%). Compared with the control group, trazodone significantly increased total sleep time (TST, min) (MD = 39.88, 95% CI 14.44–65.32, P = 0.002) and non-rapid eye movement stage 3 (N3, mixed min and %) (SMD = 1.61, 95% CI 0.69–2.53, P = 0.0006); trazodone significantly decreased latency to onset of persistent sleep (LPS, min) (MD = − 19.30, 95% CI − 37.28 to − 1.32, P = 0.04), non-rapid eye movement stage 1 (N1, mixed min and %) (SMD = − 0.62, 95% CI − 1.13 to − 0.12, P = 0.02), the number of awakenings (NAs, including both arousal times and arousal index) (SMD = − 0.67, 95% CI − 0.91 to − 0.42, P < 0.00001), and waking time after persistent sleep onset (WASO, mixed min and %) (SMD = − 0.42, 95% CI − 0.81, − 0.03, P = 0.04), with no obvious effect on non-rapid eye movement stage 2 (N2, mixed min and %) (SMD = − 0.15, 95% CI − 0.41 to 0.11, P = 0.25), rapid eye movement (REM, mixed min and %) (SMD = 0.22, 95% CI − 0.26 to 0.70, P = 0.37), rapid eye movement latency (REML, min) (MD = 2.33, 95% CI − 27.56 to 32.22, P = 0.88), or apnea–hypopnea index (AHI) (MD = − 4.21, 95% CI − 14.02 to 5.59, P = 0.40). Daytime drowsiness (OR = 2.53, 95% CI 1.14–5.64, P = 0.02) and decreased appetite (OR = 2.81, 95% CI 1.14–6.92, P = 0.02) occurred with greater frequency in the trazodone group as compared to the control group, and the differences were significant. The results of quality of evidence were very low in TST, N3 and AHI, were low in LPS, WASO and REM, and were moderate in N1 and NAs. The sources of heterogeneity in TST and N3 were not found out from sensitive and subgroup analysis and there was no high quality of evidence in outcomes by GRADE Assessment. Trials with combination of other therapy could be a problem in this meta-analysis as the possibility of interactions were found from sungroup analysis. Trazodone could improve sleep by changing the sleep architecture in insomnia disorder, but it should be used with caution due to the adverse events that may occur.PROSPERO registration register name: The effect of trazodone on polysomnography sleep architecture in patients with insomnia: a systematic review and meta-analysis protocol; Registration Number CRD42020215332.

Comparative effectiveness of different acupuncture therapies for neck pain.

Background:Neck pain is a common musculoskeletal symptom that has negative effects on quality of life and work productivity. Acupuncture has been widely used for neck pain, and a number of randomized controlled trials (RCTs) and systematic reviews (SRs) have evaluated its effectiveness. However, previous studies have obtained inconsistent results regarding the effects of acupuncture for neck pain, and there is no SR for the comparative efficacy and safety of various types of acupuncture. Therefore, we herein conducted a SR and network meta-analysis to compare and rank different types of acupuncture with respect to their effectiveness in treating neck pain.Methods:We searched 9 electronic databases for relevant RCTs published from their inception to July 1, 2021. Pairwise meta-analyses and network meta-analysis were performed with R software using the frequentist framework. Change of pain intensity was assessed as the primary outcome, and change of pain-related disability and efficacy rate were assessed as secondary outcomes. The Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument were used to evaluate the quality of the included RCTs and the certainty of the evidence.Results:A total of 65 RCTs involving 5266 participants and 9 interventions were included. Three network meta-analyses were constructed for the following: pain intensity (42 RCTs, 3158 participants), pain-related disability (21 RCTs, 1581 participants), and efficacy rate (40 RCTs, 3512 participants). The results indicated that fire acupuncture, electroacupuncture, and warm acupuncture were more effective than manual acupuncture in terms of pain intensity reduction and efficacy rate, and that electroacupuncture decreased pain-related disability more effectively than manual acupuncture. Fire acupuncture ranked first among the 9 interventions. The overall q of evidence was very low according to the GRADE assessment. The reported adverse events were not serious.Conclusion:Fire acupuncture, warm acupuncture, acupoint catgut embedding, and electroacupuncture ranked higher than other interventions (usual care, sham acupuncture, no treatment) in reducing the pain and disability index scores and the efficacy rate. However, the included trials were evaluated as being of low quality; thus, we recommend additional well-designed RCTs with larger sample sizes to confirm these findings.Systematic review registration:PROSPERO, CRD42021235274.

Role of human papillomavirus (HPV) vaccination on HPV infection and recurrence of HPV related disease after local surgical treatment: systematic review and meta-analysis

ObjectiveTo explore the efficacy of human papillomavirus (HPV) vaccination on the risk of HPV infection and recurrent diseases related to HPV infection in individuals undergoing local surgical treatment.DesignSystematic review and...

Scientific Evidence of Traditional Chinese Exercise (Qigong) for Chronic Obstructive Pulmonary Disease: An Overview of Systematic Reviews and Meta-Analyses.

Background As a traditional Chinese exercise, Qigong has potential benefits for the management of chronic obstructive pulmonary disease (COPD). This overview is aimed at assessing the existing evidence for the intervention of Qigong in COPD so as to provide scientific guidance for clinical decision-making. Methods The systematic reviews (SRs)/meta-analyses (MAs) of Qigong for the treatment of COPD were obtained from 7 electronic databases with the search date set at April 5, 2022. Two researchers independently assessed the methodological quality, reporting quality, and evidence quality for the included SRs/MAs using the following tools: the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Results A total of 13 SRs/MAs were included in this overview. All SRs/MAs assessed by AMSTAR-2 had more than one critical defect, so all SR/MAs were rated very low. Regarding the assessment of reporting quality, the results of PRISMA 2020 showed that none of the SRs/MAs were fully reported. In addition, the results of the GRADE assessment of the quality of evidence indicated that only 3 outcomes were rated as high quality across all SRs/MAs. Conclusion Current evidence suggests that Qigong is effective and safe for the management of patients with COPD. However, the high risk of bias in the original clinical studies and the low quality of the SRs/MAs reduced the reliability of the results.