Poor Reliability between Cochrane Reviewers and Blinded External Reviewers When Applying the Cochrane Risk of Bias Tool in Physical Therapy Trials

Objectives

To test the inter-rater reliability of the RoB tool applied to Physical Therapy (PT) trials by comparing ratings from Cochrane review authors with those of blinded external reviewers.

Methods

Randomized controlled trials (RCTs) in PT were identified by searching the Cochrane Database of Systematic Reviews for meta-analysis of PT interventions. RoB assessments were conducted independently by 2 reviewers blinded to the RoB ratings reported in the Cochrane reviews. Data on RoB assessments from Cochrane reviews and other characteristics of reviews and trials were extracted. Consensus assessments between the two reviewers were then compared with the RoB ratings from the Cochrane reviews. Agreement between Cochrane and blinded external reviewers was assessed using weighted kappa (κ).

Results

In total, 109 trials included in 17 Cochrane reviews were assessed. Inter-rater reliability on the overall RoB assessment between Cochrane review authors and blinded external reviewers was poor (κ  =  0.02, 95%CI: −0.06, 0.06]). Inter-rater reliability on individual domains of the RoB tool was poor (median κ  = 0.19), ranging from κ  =  −0.04 (“Other bias”) to κ  =  0.62 (“Sequence generation”). There was also no agreement (κ  =  −0.29, 95%CI: −0.81, 0.35]) in the overall RoB assessment at the meta-analysis level.

Conclusions

Risk of bias assessments of RCTs using the RoB tool are not consistent across different research groups. Poor agreement was not only demonstrated at the trial level but also at the meta-analysis level. Results have implications for decision making since different recommendations can be reached depending on the group analyzing the evidence. Improved guidelines to consistently apply the RoB tool and revisions to the tool for different health areas are needed.     

Use of Kampo Diagnosis in Randomized Controlled Trials of Kampo Products in Japan: A Systematic Review

Background

The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is “How frequently is Kampo diagnosis used in RCTs of Kampo medicines?” The secondary research question is “When is Kampo diagnosis used in RCTs?”

Materials and Methods

The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process.

Results

Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs.

Conclusions

Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis.     

Reporting Quality of Systematic Reviews/Meta-Analyses of Acupuncture

Background

The QUOROM and PRISMA statements were published in 1999 and 2009, respectively, to improve the consistency of reporting systematic reviews (SRs)/meta-analyses (MAs) of clinical trials. However, not all SRs/MAs adhere completely to these important standards. In particular, it is not clear how well SRs/MAs of acupuncture studies adhere to reporting standards and which reporting criteria are generally ignored in these analyses.

Objectives

To evaluate reporting quality in SRs/MAs of acupuncture studies.

Methods

We performed a literature search for studies published prior to 2014 using the following public archives: PubMed, EMBASE, Web of Science, the Cochrane Database of Systematic Reviews (CDSR), the Chinese Biomedical Literature Database (CBM), the Traditional Chinese Medicine (TCM) database, the Chinese Journal Full-text Database (CJFD), the Chinese Scientific Journal Full-text Database (CSJD), and the Wanfang database. Data were extracted into pre-prepared Excel data-extraction forms. Reporting quality was assessed based on the PRISMA checklist (27 items).

Results

Of 476 appropriate SRs/MAs identified in our search, 203, 227, and 46 were published in Chinese journals, international journals, and the Cochrane Database, respectively. In 476 SRs/MAs, only 3 reported the information completely. By contrast, approximately 4.93% (1/203), 8.81% (2/227) and 0.00% (0/46) SRs/Mas reported less than 10 items in Chinese journals, international journals and CDSR, respectively. In general, the least frequently reported items (reported≤50%) in SRs/MAs were “protocol and registration”, “risk of bias across studies”, and “additional analyses” in both methods and results sections.

Conclusions

SRs/MAs of acupuncture studies have not comprehensively reported information recommended in the PRISMA statement. Our study underscores that, in addition to focusing on careful study design and performance, attention should be paid to comprehensive reporting standards in SRs/MAs on acupuncture studies.     

Analysis of 567,758 randomized controlled trials published over 30 years reveals trends in phrases used to discuss results that do not reach statistical significance

The power of language to modify the reader’s perception of interpreting biomedical results cannot be underestimated. Misreporting and misinterpretation are pressing problems in randomized controlled trials (RCT) output. This may be partially related to the statistical significance paradigm used in clinical trials centered around a P value below 0.05 cutoff. Strict use of this P value may lead to strategies of clinical researchers to describe their clinical results with P values approaching but not reaching the threshold to be “almost significant.” The question is how phrases expressing nonsignificant results have been reported in RCTs over the past 30 years. To this end, we conducted a quantitative analysis of English full texts containing 567,758 RCTs recorded in PubMed between 1990 and 2020 (81.5% of all published RCTs in PubMed). We determined the exact presence of 505 predefined phrases denoting results that approach but do not cross the line of formal statistical significance (P < 0.05). We modeled temporal trends in phrase data with Bayesian linear regression. Evidence for temporal change was obtained through Bayes factor (BF) analysis. In a randomly sampled subset, the associated P values were manually extracted. We identified 61,741 phrases in 49,134 RCTs indicating almost significant results (8.65%; 95% confidence interval (CI): 8.58% to 8.73%). The overall prevalence of these phrases remained stable over time, with the most prevalent phrases being “marginally significant” (in 7,735 RCTs), “all but significant” (7,015), “a nonsignificant trend” (3,442), “failed to reach statistical significance” (2,578), and “a strong trend” (1,700). The strongest evidence for an increased temporal prevalence was found for “a numerical trend,” “a positive trend,” “an increasing trend,” and “nominally significant.” In contrast, the phrases “all but significant,” “approaches statistical significance,” “did not quite reach statistical significance,” “difference was apparent,” “failed to reach statistical significance,” and “not quite significant” decreased over time. In a random sampled subset of 29,000 phrases, the manually identified and corresponding 11,926 P values, 68,1% ranged between 0.05 and 0.15 (CI: 67. to 69.0; median 0.06). Our results show that RCT reports regularly contain specific phrases describing marginally nonsignificant results to report P values close to but above the dominant 0.05 cutoff. The fact that the prevalence of the phrases remained stable over time indicates that this practice of broadly interpreting P values close to a predefined threshold remains prevalent. To enhance responsible and transparent interpretation of RCT results, researchers, clinicians, reviewers, and editors may reduce the focus on formal statistical significance thresholds and stimulate reporting of P values with corresponding effect sizes and CIs and focus on the clinical relevance of the statistical difference found in RCTs.

The power of language to modify the reader’s perception of interpreting biomedical results cannot be underestimated. An analysis of more than half a million randomized controlled trials reveals that researchers are using appealing phrases to describe non-significant findings as if they were below the p=0.05 significance threshold.     

The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. Analysis of 176,620 RCTs published between 1966 and 2018 reveals that the risk of bias in RCTs generally decreased. Nevertheless, relatively high probabilities of bias remain, showing that further improvement of RCT registration, conduct, and reporting is still urgently needed.     

Body composition adaptations to lower-body plyometric training: a systematic review and meta-analysis

The aim of this meta-analysis was to explore the effects of plyometric jump training (PJT) on body composition parameters among males. Relevant articles were searched in the electronic databases PubMed, MEDLINE, WOS, and SCOPUS, using the key words “ballistic”, “complex”, “explosive”, “force-velocity”, “plyometric”, “stretch-shortening cycle”, “jump”, “training”, and “body composition”. We included randomized controlled trials (RCTs) that investigating the effects of PJT in healthy male’s body composition (e.g., muscle mass; body fat), irrespective of age. From database searching 21 RCTs were included (separate experimental groups = 28; pooled number of participants = 594). Compared to control, PJT produced significant increases in total leg muscle volume (small ES = 0.55, p = 0.009), thigh muscle volume (small ES = 0.38, p = 0.043), thigh girth (large ES = 1.78, p = 0.011), calf girth (large ES = 1.89, p = 0.022), and muscle pennation angle (small ES = 0.53, p = 0.040). However, we did not find significant difference between PJT and control for muscle cross-sectional area, body fat, and skinfold thickness. Heterogeneity remained low-to-moderate for most analyses, and using the Egger’s test publication bias was not found in any of the analyses (p = 0.300–0.900). No injuries were reported among the included studies. PJT seems to be an effective and safe mode of exercise for increasing leg muscle volume, thigh muscle volume, thigh and calf girth, and muscle pennation angle. Therefore, PJT may be effective to improve muscle size and architecture, with potential implications in several clinical and sport-related contexts.     

Associated Factors and Consequences of Risk of Bias in Randomized Controlled Trials of Yoga: A Systematic Review

Background

Bias in randomized controlled trials (RCTs) of complementary therapy interventions seems to be associated with specific factors and to potentially distort the studies’ conclusions. This systematic review assessed associated factors of risk of bias and consequences for the studies’ conclusions in RCTs of yoga as one of the most commonly used complementary therapies.

Methods

Medline/PubMed, Scopus, IndMED and the Cochrane Library were searched through February 2014 for yoga RCTs. Risk of selection bias was assessed using the Cochrane tool and regressed to a) publication year; b) country of origin; c) journal type; and d) impact factor using multiple logistic regression analysis. Likewise, the authors’ conclusions were regressed to risk of bias.

Results

A total of 312 RCTs were included. Impact factor ranged from 0.0 to 39.2 (median = 1.3); 60 RCT (19.2%) had a low risk of selection bias, and 252 (80.8%) had a high or unclear risk of selection bias. Only publication year and impact factor significantly predicted low risk of bias; RCTs published after 2001 (adjusted odds ratio (OR) = 12.6; 95% confidence interval (CI) = 1.7, 94.0; p<0.001) and those published in journals with impact factor (adjusted OR = 2.6; 95%CI = 1.4, 4.9; p = 0.004) were more likely to have low risk of bias. The authors’ conclusions were not associated with risk of bias.

Conclusions

Risk of selection bias was generally high in RCTs of yoga; although the situation has improved since the publication of the revised CONSORT statement 2001. Pre-CONSORT RCTs and those published in journals without impact factor should be handled with increased care; although risk of bias is unlikely to distort the RCTs’ conclusions.     

Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

Background

Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.

Objective

To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.

Methods

We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.

Results

Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data). Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57–621.94 ml), 250.30 ml postoperatively (95% CI, 35.31–465.30), and 601.40 ml overall (95% CI, 306.64–896.16 ml). The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30–754.67 ml). The transfusion rate was 44.6% (108/242) in the patients with antifibrinolytic agents and 68.3% (142/208) in the patients with placebo. (OR 0.38; 95% CI; 0.25–0.58; P<0.00001, I² = 9%). All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group).

Conclusion

The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements in scoliosis surgery. There was no evidence that the use of antifibrinolytic agents was a risk factor for adverse events, especially thromboembolism, in scoliosis surgery.     

Evolution of Treatment Regimens in Multiple Myeloma: A Social Network Analysis

Background

Randomized controlled trials (RCTs) are considered the gold standard for assessing the efficacy of new treatments compared to standard treatments. However, the reasoning behind treatment selection in RCTs is often unclear. Here, we focus on a cohort of RCTs in multiple myeloma (MM) to understand the patterns of competing treatment selections.

Methods

We used social network analysis (SNA) to study relationships between treatment regimens in MM RCTs and to examine the topology of RCT treatment networks. All trials considering induction or autologous stem cell transplant among patients with MM were eligible for our analysis. Medline and abstracts from the annual proceedings of the American Society of Hematology and American Society for Clinical Oncology, as well as all references from relevant publications were searched. We extracted data on treatment regimens, year of publication, funding type, and number of patients enrolled. The SNA metrics used are related to node and network level centrality and to node positioning characterization.

Results

135 RCTs enrolling a total of 36,869 patients were included. The density of the RCT network was low indicating little cohesion among treatments. Network Betweenness was also low signifying that the network does not facilitate exchange of information. The maximum geodesic distance was equal to 4, indicating that all connected treatments could reach each other in four “steps” within the same pathway of development. The distance between many important treatment regimens was greater than 1, indicating that no RCTs have compared these regimens.

Conclusion

Our findings show that research programs in myeloma, which is a relatively small field, are surprisingly decentralized with a lack of connectivity among various research pathways. As a result there is much crucial research left unexplored. Using SNA to visually and analytically examine treatment networks prior to designing a clinical trial can lead to better designed studies.     

Prophylactic corticosteroid to prevent pain flare in bone metastases treated by radiotherapy

BackgroundThe aim of this study was to evaluate the effectiveness of prophylactic corticosteroids to prevent pain flare (PF) in bone metastases treated with radiotherapy performing a meta-analysis of randomized clinical trials (RCT).Materials and methodsRCTs were identified on Medline, Embase, the Cochrane Library, and the proceedings of annual meetings through June 2020. We followed the PRISMA and MOOSE guidelines. A meta-analysis was performed to assess if corticosteroids reduce the PF, pain progression, and the mean of days with PF compared with the placebo. A p-value < 0.05 was considered significant.ResultsThree RCTs with a total of 713 patients treated were included. The corticosteroids reduced the occurrence of early PF 20.5% (51/248) versus 32% (80/250) placebo, OR = 0.55 (95% CI: 0.36–0.82, p = 0.002). The mean days of PF were reduced to 1.6 days (95% CI: 1.3–1.9, p = 0.0001). Prophylactic corticosteroids had more patients with no PF and no pain progression, OR = 1.63 (95% CI: 1.14–2.32, p = 0.007). No significant corticosteroids effect was observed for pain progression (p = ns) and late PF occurrence (p = ns).ConclusionProphylactic corticosteroids reduced the incidence of early PF, the days with PF, resulting in a superior rate of patients with no PF and no pain progression, but with no significant benefit for reducing pain progression or late PF occurrence.     

体外与非体外循环冠状动脉旁路移植术再血管化率的系统评价

目的:系统评价采用体外循环与非体外循环下冠状动脉旁路移植术比较,治疗冠状动脉粥样硬化性心脏病的再血管化率。方法:计算机检索MEDLINE(1966～2010.3)、EMbase(1984～2010.3)、Cochrane临床对照试验资料库(2010年第2期)和中国生物医学文献数据库(1979～2010.3),同时手工检索所有纳入试验的参考文献,质量评价后用RevMan 5.0软件进行Meta分析。结果:共纳入2个随机对照试验,包括2276例患者。Meta分析结果显示:体外循环组的再血管化率高于单用非体外循环组,其差异有统计学意义P<0.00001[OR=1.78,95%C(I1.40,2.26)]。结论:当前的证据表明,体外循环下冠状动脉旁路移植术在治疗冠心病时,再血管化率比非体外循环高;评价患者长期预后有一定指导意义。由于纳入研究随访时间较短,上述结论尚需要高质量、大样本、长时间的随机双盲对照试验进一步证实。     

Comparison of Clinical Efficacy and Safety between Indacaterol and Tiotropium in COPD: Meta-Analysis of Randomized Controlled Trials

Two once-daily inhaled bronchodilators, indacaterol and tiotropium, are widely used as first-line therapy in stable COPD patients. This study was performed to compare the clinical efficacy and safety between indacaterol and tiotropium in patients with moderate-to-severe COPD. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched to identify all published randomized controlled trials (RCTs). The primary outcome was trough forced expiratory volume in 1 second (FEV₁) at week 12. Four RCTs were eligible for inclusion (three RCTs with moderate-to-severe COPD patients and one RCT with only severe COPD patients). Trough FEV₁ at weeks 12 and 26 were not significantly different between indacaterol and tiotropium by the standardized mean difference with 0.014 (95% CI, -0.036, 0.063, I²= 23.5%) and with 0.037 (95% CI, -0.059 to 0.133, I²= 0%) along with differences in means of 0.003L and 0.014L, respectively. Indacaterol and tiotropium also showed similar St. George`s Respiratory Questionnaire (SGRQ) total scores and percentages of patients with SGRQ improvement (≥ 4 units) at week 26. The incidences of nasopharyngitis, serious cardiovascular events, and serious adverse events were not different between indacaterol and tiotropium, while those of cough (OR = 1.68, P < 0.001, and RR = 1.63) and COPD worsening (OR = 1.18, P = 0.003, and RR = 1.12) were higher for indacaterol than tiotropium. However, when one study with only severe COPD patients was removed from the meta-analysis, the difference in the incidence of COPD worsening between indacaterol and tiotropium became non-significant (OR = 1.13, P = 0.204, and RR = 1.09). The clinical efficacy and serious adverse events between indacaterol and tiotropium were equivocal in patients with moderate-to-severe COPD. Cough is a common complaint associated with indacaterol, and COPD worsening needs to be carefully monitored in severe COPD patients when treated with indacaterol.     

Do Pediatric Hospitals Improve Operative Efficiency?

BackgroundIn recent years there has been a push towards developing free standing pediatric facilities to provide care specifically towards pediatric patients. The purpose of this study was to determine if moving pediatric cases from a general hospital to a dedicated pediatric facility improved the quality and efficiency of surgical procedures.MethodsA retrospective review of pediatric patients undergoing posterior spinal fusion (PSF) was performed. All procedures were performed by one orthopaedic surgeon (SLW) from 2015 to 2019. The procedures were performed at a general hospital (GH) the first two years, and at a pediatric hospital (PH) the subsequent years. Data extracted included patient sex, age, and procedure type as well as procedure duration, operative turnover time, hospital length of stay, transfusion requirements, and operative delay. Exclusively pediatric adolescent idiopathic scoliosis (AIS) patients undergoing PSF were included due to the high volume and consistent surgical procedures therefore limiting confounding variables.ResultsA total of five hundred PSF pediatric procedures were performed during the time period. After excluding non-adolescent idiopathic scoliosis cases, a total of 208 procedures were reviewed (105 at GH; 103 at PH). There was no statistical difference between the groups in regards to operative time (GH: 200 min, PH: 200 min; p=0.91), room turnover time (GH: 38 min, PH: 38 min; p=0.801), or rate of transfusion (GH: 20% PH: 30%; p=0.09). Length of stay was significantly shorter in the PH cohort compared to the GH cohort (4.35 vs. 3.84 days, p=0.0001). However, a smaller proportion of cases at the PH started on time compared to the GH (34% vs. 58%; p=0.0005).ConclusionOverall, this study demonstrated that AIS procedures at the PH did show a statistically significant reduction in hospital length of stay. However, timely start of the procedure was less likely at this particular facility. Level of Evidence: III     

Appraisal Tools for Clinical Practice Guidelines: A Systematic Review

Introduction

Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools.

Methods

Among others we searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from 1995 to May 2011 for relevant primary and secondary publications. We also handsearched the reference lists of relevant publications.On the basis of the available literature we firstly generated 34 items to be used in the comparison of appraisal tools and grouped them into thirteen quality dimensions. We then extracted formal characteristics as well as questions and statements of the appraisal tools and assigned them to the items.

Results

We identified 40 different appraisal tools. They covered between three and thirteen of the thirteen possible quality dimensions and between three and 29 of the possible 34 items. The main focus of the appraisal tools were the quality dimensions “evaluation of evidence” (mentioned in 35 tools; 88%), “presentation of guideline content” (34 tools; 85%), “transferability” (33 tools; 83%), “independence” (32 tools; 80%), “scope” (30 tools; 75%), and “information retrieval” (29 tools; 73%). The quality dimensions “consideration of different perspectives” and “dissemination, implementation and evaluation of the guideline” were covered by only twenty (50%) and eighteen tools (45%) respectively.

Conclusions

Most guideline appraisal tools assess whether the literature search and the evaluation, synthesis and presentation of the evidence in guidelines follow the principles of evidence-based medicine. Although conflicts of interest and norms and values of guideline developers, as well as patient involvement, affect the trustworthiness of guidelines, they are currently insufficiently considered. Greater focus should be placed on these issues in the further development of guideline appraisal tools.     

Minimally Invasive Midvastus versus Standard Parapatellar Approach in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials

Objective

Minimally invasive midvastus approach (mini-midvastus) has been widely used in total knee arthroplasty (TKA). However, the clinical effects still remains controversial. This meta-analysis was based on randomized controlled trials (RCTs) aiming to quantitatively analyze the clinical efficacy of mini-midvastus versus standard parapatellar approach in TKA.

Methods

This meta-analysis was performed according to the PRISMA guidelines. A literature search for the eligible RCTs was carried out in the databases of PubMed, the Cochrane library, EMBASE and Web of Science. Two independent reviewers independently completed the study selection, data extraction, and the assessment of methodological quality. Meta-analysis was conducted by the RevMan 5.2 software.

Results

A total of 18 RCTs (937 patients with 1093 TKAs) published from 2007 to 2013 were included. The meta-analysis suggested that the mini-midvastus approach significantly improved knee range of motion (ROM) and decreased visual analog score (VAS) at postoperative 1–2 weeks (p<0.05), and there were no statistical differences in terms of knee society score (KSS) (6 weeks to 1 year), VAS (6 weeks to 6 months), ROM (6 weeks to 6 months), lateral retinacular release, blood loss, straight leg raise, hospital stay and postoperative complications between the mini-midvastus and standard parapatellar approach (p>0.05). However, the operative time was significantly longer when performing the mini-midvastus group than the parapartellar approach (p<0.05).

Conclusion

This meta-analysis found that compared with the standard parapatellar approach, the mini-midvastus approach had early advantages in the VAS and ROM, but had the disadvantage in the operative time.

Level of Evidence

Therapeutic study Level I.     

Periodontal Therapy and Systemic Inflammation in Type 2 Diabetes Mellitus: A Meta-Analysis

Aim

The aim of this systematic review was to assess the effect of periodontal therapy (PT) on serum levels of inflammatory markers in people with type 2 diabetes mellitus (T2DM).

Methods of Study Selection

A literature search was carried out using MEDLINE via Pubmed, EMBASE, LILACS and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Randomized-controlled trials (RCTs) and controlled clinical trials (CCTs) evaluating the effect of PT on systemic inflammatory markers were deemed eligible. Case series (CS), reports and pilot trials were excluded. Study quality was assessed using the Cochrane Collaboration’s risk assessment tool. Meta-analysis was carried out using random effect methods.

Results

The search strategy identified 3,164 potential studies of which 61 were assessed for eligibility and 9 (6 RCTs and 3 CCTs) were included in this systematic review. Three RCTs were classified by the authors as being at low risk of bias and three were “unclear” and classified as uncertain risk of bias. All CCTs were considered to be at a high risk of bias. The meta-analysis showed a statistically significant mean difference (MD) for TNF- α (-1.33 pg/ml, 95% CI: -2.10; -0.56, p<0.001) and CRP (-1.28 mg/l, 95% CI: -2.07; - 0.48, p<0.001) favoring periodontal intervention versus control.

Conclusion

The results of this meta-analysis support the hypothesis that PT reduces serum levels of TNF- α and CRP in T2DM individuals. The decrease of inflammatory burden has important implications for metabolic control and can, in part, explain the mechanisms linking periodontitis and increased risk for complications in people with T2DM.     

Operative Time and Risk of Surgical Site Infection and Periprosthetic Joint Infection: A Systematic Review and Meta-Analysis

BackgroundThe purpose of this study was to perform a systematic review and meta-analysis on the association between operative time and peri-prosthetic joint infection (PJI) after primary total hip arthroplasty (THA) and total knee arthroplasty (TKA).MethodsPubMed, Embase, and Cochrane CENTRAL databases were searched for relevant articles dating 2000-2020. Relationship of operative time and PJI rate in primary total joint arthroplasty (TJA) was evaluated by pooled odds ratios (OR) and 95% confidence intervals.ResultsSix studies were identified for meta-analysis. TJA lasting greater than 120 minutes had greater odds of PJI (OR, 1.63 [1.00-2.66], p=0.048). Similarly, there were greater odds of PJI for TJA procedures lasting greater than 90 minutes (OR, 1.65 [1.27-2.14]; p<0.001). Separate analyses of TKA (OR, 2.01 [0.76-5.30]) and THA (OR, 1.06 [0.80-1.39]) demonstrated no difference in rates of PJI in cases of operative time ≥ 120 minutes versus cases < 120 minutes (p>0.05 for all). Using any surgical site infection (SSI) as an endpoint, both TJA (OR, 1.47 [1.181.83], p<0.001) and TKA (OR, 1.50 [1.08-2.08]; p=0.016) procedures lasting more versus less than 120 minutes demonstrated significantly higher odds of SSI.ConclusionFollowing TJA, rates of SSI and PJI are significantly greater in procedures ≥120 minutes in duration relative to those < 120 minutes. When analyzing TKA separately, higher rates of SSI were observed in procedures ≥ 120 minutes in duration relative to those <120 minutes. Rates of PJI in TKA or THA procedures alone were not significantly impacted by operative time. Level of Evidence: V