Non-Inferiority Trials: A Systematic Review on Methodological Quality and Reporting Standards.

BACKGROUND: Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior therapies in clinical practice. With the abundance of novel therapies, NI trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality. We conducted a systematic review without restriction to journal type, journal impact factor, disease state or intervention to evaluate the quality of NI trials, including a comprehensive risk of bias assessment and comparison of quality over time. METHODOLOGY: We searched PubMed and Cochrane Library databases for NI trials published in English in 2014 and 2019. They were assessed for: study design and NI margin characteristics, primary results, and risk of bias for blinding, concealment, analysis method and missing outcome data. RESULTS: We included 823 studies. Between 2014 and 2019, a shift from publication in specialty to general journals (15% vs 28%, p < 0.001) and from pharmacological to non-pharmacological interventions (25% vs 38%, p = 0.025) was observed. The NI margin was specified in most trials for both years (94% vs 95%). Rationale for the NI margin increased (36% vs 57%, p < 0.001), but remained low, with clinical judgement the most common rationale (30% vs 23%), but more 2019 articles incorporating patient values (0.3% vs 21%, p < 0.001). Over 50% of studies were open-label for both years. Gold standard method of analyses (both per protocol + (modified) intention to treat) declined over time (43% vs 36%, p < 0.001). DISCUSSION: The methodological quality and reporting of NI trials remains inadequate although improving in some areas. Improved methods for NI margin justification, blinding, and analysis method are warranted to facilitate clinical decision-making.

Transitivity, coherence, and reliability of network meta-analyses comparing proximal humerus fracture treatments: a meta-epidemiological study.

BACKGROUND: Network meta-analyses can be valuable for decision-makers in guiding clinical practice. However, for network meta-analysis results to be reliable, the assumptions of both transitivity and coherence must be met, and the methodology should adhere to current best practices. We aimed to assess whether network meta-analyses of randomized controlled trials (RCTs) comparing interventions for proximal humerus fractures provide reliable estimates of intervention effects. METHODS: We searched PubMed, EMBASE, The Cochrane Library, and Web of Science for network meta-analyses comparing interventions for proximal humerus fractures. We critically assessed the methodology regarding the development of a protocol, search strategy, trial inclusion, outcome extraction, and the methods used to conduct the network meta-analyses. We assessed the transitivity and coherence of the network graphs for the Constant score (CS), Disabilities of the Arm, Shoulder, and Hand score (DASH), and additional surgery. Transitivity was assessed by comparing probable effect modifiers (age, gender, fracture morphology, and comorbidities) across intervention comparisons. Coherence was assessed using Separating Indirect from Direct Evidence (SIDE) (Separating Indirect from Direct Evidence) and the design-by-treatment interaction test. We used CINeMA (Confidence in Network Meta-analyses) to assess the confidence in the results. RESULTS: None of the three included network meta-analyses had a publicly available protocol or data-analysis plan, and they all had methodological flaws that could threaten the validity of their results. Although we did not detect incoherence for most comparisons, the transitivity assumption was violated for CS, DASH, and additional surgery in all three network meta-analyses. Additionally, the confidence in the results was 'very low' primarily due to within-study bias, reporting bias, intransitivity, imprecision, and heterogeneity. CONCLUSIONS: Current network meta-analyses of RCTs comparing interventions for proximal humerus fractures do not provide reliable estimates of intervention effects. We advise caution in using these network meta-analyses to guide clinical practice. To improve the utility of network meta-analyses to guide clinical practice, journal editors should require that network meta-analyses are done according to a predefined analysis plan in a publicly available protocol and that both coherence and transitivity have been adequately assessed and reported.

Application of magnetic resonance imaging radiomics in endometrial cancer: a systematic review and meta-analysis.

PURPOSE: We aimed to systematically assess the methodological quality and clinical potential application of published magnetic resonance imaging (MRI)-based radiomics studies about endometrial cancer (EC). METHODS: Studies of EC radiomics analyses published between 1 January 2000 and 19 March 2023 were extracted, and their methodological quality was evaluated using the radiomics quality score (RQS) and Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Pairwise correlation analyses and separate meta-analyses of studies exploring differential diagnoses and risk prediction were also performed. RESULTS: Forty-five studies involving 3 aims were included. The mean RQS was 13.77 (range: 9-22.5); publication bias was observed in the areas of 'index test' and 'flow and timing'. A high RQS was significantly associated with therapy selection-aimed studies, low QUADAS-2 risk, recent publication year, and high-performance metrics. Raw data from 6 differential diagnosis and 34 risk prediction models were subjected to meta-analysis, revealing diagnostic odds ratios of 23.81 (95% confidence interval [CI] 8.48-66.83) and 18.23 (95% CI 13.68-24.29), respectively. CONCLUSION: The methodological quality of radiomics studies involving patients with EC is unsatisfactory. However, MRI-based radiomics analyses showed promising utility in terms of differential diagnosis and risk prediction.

Efficacy of stem cell therapy for diabetic foot: Clinical evidence from meta-analyses.

To assess the clinical data on the effectiveness of stem cell therapy for diabetic foot (DF) based on recent systematic reviews and meta-analyses (SRs/MAs). SRs/MAs that evaluate the clinical evidence on the efficacy of stem cell therapy for DF were identified through a systematic search in public databases. The methodological quality and evidence quality of the included SRs/MAs were assessed separately by two researchers. Eight SRs/MAs were included in this analysis. Since there were no registered protocol or exclusion criteria for the included SRs/MAs, the methodological quality was rated as critically low. There was no high-quality evidence available for the outcomes, and the evidence quality ranged from critically low to moderate. Evidence degradation was most commonly caused by the risk of bias, followed by imprecision, publication bias and inconsistency. In conclusion, stem cell therapy may be effective for DF. However, this conclusion should be approached with caution, considering the quality of the supporting SRs/MAs.

Metanalyses on metformin's role in pancreatic cancer suffer from severe bias and low data quality - An umbrella review.

AIMS: Discrepancies in the preclinical evidence, retrospective studies, and randomized trials evaluating metformin's role in pancreatic cancer are difficult to disentangle. We aimed to critically and systematically examine the quality and sources of heterogeneity between meta-analyses investigating the association between metformin intake and the prognosis of patients with pancreatic cancer. MATERIALS AND METHODS: We performed a literature search on PubMed, MEDLINE, Embase, and Scopus on October 31, 2021 to identify meta-analyses investigating the impact of metformin treatment on the prognosis of patients with pancreatic cancer. Meta-analyses quality was assessed using according to the AMSTAR 2 criteria. We assessed bias in individual studies included in the meta-analyses, with particular attention to immortal time bias and quality of reporting. RESULTS: Eleven meta-analyses describing 24 individual studies were included. All meta-analyses were rated low (n = 5) or critically low (n = 6) quality. Only 4 followed PRISMA reporting guidelines and only in 5 presented data were sufficient to replicate the analyses. Most meta-analyses combined results from clinical trials and retrospective studies (n = 6); patients with different cancer stages (resectable vs advanced) and from studies with different control group definitions. Immortal time bias was present and not accounted for in most (65.2%) of the individual retrospective studies; almost all (n = 9) meta-analyses failed to identify and correct for this source of bias. CONCLUSIONS: Meta-analyses describing the association of metformin use in patients with pancreatic cancer are plagued by various types of bias inherent in retrospective studies. The quality of evidence linking metformin to decreased pancreatic cancer mortality is generally low.

Methodological quality and reporting quality of COVID-19 living systematic review: a cross-sectional study.

OBJECTIVES: The main objective of this study is to evaluate the methodological quality and reporting quality of living systematic reviews (LSRs) on Coronavirus disease 2019 (COVID-19), while the secondary objective is to investigate potential factors that may influence the overall quality of COVID-19 LSRs. METHODS: Six representative databases, including Medline, Excerpta Medica Database (Embase), Cochrane Library, China national knowledge infrastructure (CNKI), Wanfang Database, and China Science, Technology Journal Database (VIP) were systematically searched for COVID-19 LSRs. Two authors independently screened articles, extracted data, and then assessed the methodological and reporting quality of COVID-19 LSRs using the "A Measurement Tool to Assess systematic Reviews-2" (AMSTAR-2) tool and "Preferred Reporting Items for Systematic reviews and Meta-Analyses" (PRISMA) 2020 statement, respectively. Univariate linear regression and multivariate linear regression were used to explore eight potential factors that might affect the methodological quality and reporting quality of COVID-19 LSRs. RESULTS: A total of 64 COVID-19 LSRs were included. The AMSTAR-2 evaluation results revealed that the number of "yes" responses for each COVID-19 LSR was 13 ± 2.68 (mean ± standard deviation). Among them, 21.9% COVID-19 LSRs were rated as "high", 4.7% as "moderate", 23.4% as "low", and 50% as "critically low". The evaluation results of the PRISMA 2020 statement showed that the sections with poor adherence were methods, results and other information. The number of "yes" responses for each COVID-19 LSR was 21 ± 4.18 (mean ± standard deviation). The number of included studies and registration are associated with better methodological quality; the number of included studies and funding are associated with better reporting quality. CONCLUSIONS: Improvement is needed in the methodological and reporting quality of COVID-19 LSRs. Researchers conducting COVID-19 LSRs should take note of the quality-related factors identified in this study to generate evidence-based evidence of higher quality.

Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study.

BACKGROUND: The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. METHODS: This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. RESULTS: We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). CONCLUSIONS: In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.

Quality of systematic reviews on timing of complementary feeding for early childhood allergy prevention.

BACKGROUND: Only rigorously prepared analyses can provide the highest level of evidence to inform decision-making. Several recent systematic reviews (SRs) examined the hypothesis that the early introduction of specific allergenic complementary foods (CFs) to infants may lead to a lower incidence of one or more allergic outcomes. However, the methodological rigour and quality of reporting of SRs in this area has not yet been systematically evaluated. METHODS: We comprehensively searched PubMed, Medline (Ovid), and Web of Science Core Collection on 13th January 2022, using a pre-specified and tested search syntax for SRs with RCT evidence on the early introduction of allergenic CFs as a means for allergy prevention in infants and children. We examined the quality and risk of bias (RoB) using AMSTAR-2 and ROBIS tools, examined adherence to the Preferred Reporting Items for SRs and Meta-Analyses (PRISMA), and checked whether certainty of the evidence was assessed. RESULTS: Twelve SRs were included. Application of both tools resulted in similar overall judgements in terms of direction and extent for nine of the 12 SRs. Nine SRs were found to be of critically low to low quality according to AMSTAR-2 and to be at high RoB according to ROBIS. One SR received a moderate quality rating (AMSTAR-2) and high RoB rating (ROBIS). However, for two SRs, judgements between AMSTAR-2 and ROBIS were at stark variance. Only two SRs fully adhered to the PRISMA checklist. Six SRs evaluated the certainty of the body of RCT evidence. Several SRs failed to consider unpublished studies either by an explicit a priori exclusion or by inadequate search strategies. CONCLUSIONS: Well-conducted SRs are important for decision-making and informing guideline development, the quality of their methodology should therefore be considered. The methodological rigour and the reporting quality of SRs on the timing of CF for allergy prevention must be improved. REGISTRATION: https://osf.io/7cs4b .

Evolution of appraisal tool usage preferences in PROSPERO records: a study of non-Cochrane systematic reviews.

OBJECTIVES: This research-on-research substudy uses a data-driven approach to investigate the range of appraisal tools in non-Cochrane systematic reviews and meta-analyses registered in the International Prospective Register of Systematic Reviews (PROSPERO). STUDY DESIGN AND SETTING: A comprehensive web scraping of all completed non-Cochrane registrations in PROSPERO from February 2011 to December 2017 was performed. The focus was classifying the appraisal tools based on study type, assessment aspects, and research topics. RESULTS: After analyzing 17,708 complete records, we found a predominant use of methodological quality assessment tools compared to those for reporting quality or risk of bias (RoB). This indicates a greater emphasis on methodological rigor in the studied protocols. Various tools for assessing methodological quality were observed, reflecting the complexity of such evaluations. Instruments designed for evaluating methodological or reporting quality were mainly intended for non-randomized clinical trials or observational studies, unlike RoB tools more commonly used in randomized clinical trials. No distinct trends in tool usage were observed in specific research conditions or domains, suggesting that tool choice is influenced more by study design than research topic. CONCLUSION: This study provides insights into the preferential use of various assessment tools in conducting non-Cochrane systematic reviews, as evidenced in PROSPERO records. The findings reveal various methodological assessment tools, underscoring their versatility across different study designs and research areas.

The methodological quality assessment of systematic reviews/meta-analyses of chronic prostatitis/chronic pelvic pain syndrome using AMSTAR2.

BACKGROUND: This study aimed to assess the methodological quality of the systematic reviews/meta-analyses (SRs/MAs) of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) using A Measurement Tool to Assess systematic Reviews (AMSTAR2) and to explore the potential influencing factors. METHODS: PubMed, EMBASE and Cochrane Library databases were searched for relevant studies. AMSTAR2 was used for evaluating the methodological quality of eligible SRs/MAs. Differences between methodological characteristics of SRs/MAs were compared using chi-square tests. The intra-class correlation coefficient (ICC) was used to assess reviewer agreement in the pre-experiment. Multivariate regression analysis was used to identify potential factors affecting methodological quality. RESULTS: A total of 45 SRs/MAs were included. After AMSTAR2 evaluation, only two (4.4%) of 45 SRs/MAs were moderate, three (6.7%) were rated as low quality, and the remainder 40 (88.9%) were rated as critically low quality. Among the 16 items of AMSTAR2, item 3 and item 10 had the poorest adherence. Item 4 received the most significant number of "Partial Yes" responses. Univariable analysis indicated that there were significant differences in methodological quality in SRs between different continents (P = 0.027) as well as between preregistered SRs and those that were not (P = 0.004). However, in multivariate analysis, there was no significant association between methodological quality and the following research characteristics: publication year, continent, whether reporting followed Preferred Reporting Items for Systematic Reviews (PRISMA), preregistration, funding support, randomized controlled trials (RCT) enrollment, whether SR was published in the Cochrane Database of Systematic Reviews (CDSR), and whether with meta-analysis. Additionally, subgroup analysis based on interventional SRs/MAs showed that continent was independently associated with the methodological quality of SRs/MAs of CP/CPPS via univariable and multivariate analysis. CONCLUSIONS: Our study demonstrates that the methodological quality of SRs/MAs of CP/CPPS was generally poor. SRs/MAs of CP/CPPS should adopt the AMSTAR2 to enhance their methodological quality.

Guidance to best tools and practices for systematic reviews.

Data continue to accumulate indicating that many systematic reviews are methodologically flawed, biased, redundant, or uninformative. Some improvements have occurred in recent years based on empirical methods research and standardization of appraisal tools; however, many authors do not routinely or consistently apply these updated methods. In addition, guideline developers, peer reviewers, and journal editors often disregard current methodological standards. Although extensively acknowledged and explored in the methodological literature, most clinicians seem unaware of these issues and may automatically accept evidence syntheses (and clinical practice guidelines based on their conclusions) as trustworthy.A plethora of methods and tools are recommended for the development and evaluation of evidence syntheses. It is important to understand what these are intended to do (and cannot do) and how they can be utilized. Our objective is to distill this sprawling information into a format that is understandable and readily accessible to authors, peer reviewers, and editors. In doing so, we aim to promote appreciation and understanding of the demanding science of evidence synthesis among stakeholders. We focus on well-documented deficiencies in key components of evidence syntheses to elucidate the rationale for current standards. The constructs underlying the tools developed to assess reporting, risk of bias, and methodological quality of evidence syntheses are distinguished from those involved in determining overall certainty of a body of evidence. Another important distinction is made between those tools used by authors to develop their syntheses as opposed to those used to ultimately judge their work.Exemplar methods and research practices are described, complemented by novel pragmatic strategies to improve evidence syntheses. The latter include preferred terminology and a scheme to characterize types of research evidence. We organize best practice resources in a Concise Guide that can be widely adopted and adapted for routine implementation by authors and journals. Appropriate, informed use of these is encouraged, but we caution against their superficial application and emphasize their endorsement does not substitute for in-depth methodological training. By highlighting best practices with their rationale, we hope this guidance will inspire further evolution of methods and tools that can advance the field.

Cost-effectiveness of left atrial appendage closure for stroke prevention in atrial fibrillation: a systematic review appraising the methodological quality.

BACKGROUND: The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prevention strategies can play a crucial role in maximising efficient allocation of resources. In this systematic review, we assessed the methodological quality of such economic evaluations. METHODS: We searched electronic databases of PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Econ Lit to identify model-based economic evaluations comparing the left atrial appendage closure procedure (LAAC) and oral anticoagulants published in English since 2000. Data on study characteristics, model-based details, and analyses were collected. The methodological quality was evaluated using the modified Economic Evaluations Bias (ECOBIAS) checklist. For each of the 22 biases listed in this checklist, studies were categorised into one of four groups: low risk, partial risk, high risk due to inadequate reporting, or high risk. To gauge the overall quality of each study, we computed a composite score by assigning + 2, 0, - 1 and - 2 to each risk category, respectively. RESULTS: In our analysis of 12 studies, majority adopted a healthcare provider or payer perspective and employed Markov Models with the number of health states varying from 6 to 16. Cost-effectiveness results varied across studies. LAAC displayed a probability exceeding 50% of being the cost-effective option in six out of nine evaluations compared to warfarin, six out of eight evaluations when compared to dabigatran, in three out of five evaluations against apixaban, and in two out of three studies compared to rivaroxaban. The methodological quality scores for individual studies ranged from 10 to - 12 out of a possible 24. Most high-risk ratings were due to inadequate reporting, which was prevalent across various biases, including those related to data identification, baseline data, treatment effects, and data incorporation. Cost measurement omission bias and inefficient comparator bias were also common. CONCLUSIONS: While most studies concluded LAAC to be the cost-effective strategy for stroke prevention in AF, shortcomings in methodological quality raise concerns about reliability and validity of results. Future evaluations, free of these shortcomings, can yield stronger policy evidence.

Guidance to best tools and practices for systematic reviews.

Data continue to accumulate indicating that many systematic reviews are methodologically flawed, biased, redundant, or uninformative. Some improvements have occurred in recent years based on empirical methods research and standardization of appraisal tools; however, many authors do not routinely or consistently apply these updated methods. In addition, guideline developers, peer reviewers, and journal editors often disregard current methodological standards. Although extensively acknowledged and explored in the methodological literature, most clinicians seem unaware of these issues and may automatically accept evidence syntheses (and clinical practice guidelines based on their conclusions) as trustworthy. A plethora of methods and tools are recommended for the development and evaluation of evidence syntheses. It is important to understand what these are intended to do (and cannot do) and how they can be utilized. Our objective is to distill this sprawling information into a format that is understandable and readily accessible to authors, peer reviewers, and editors. In doing so, we aim to promote appreciation and understanding of the demanding science of evidence synthesis among stakeholders. We focus on well-documented deficiencies in key components of evidence syntheses to elucidate the rationale for current standards. The constructs underlying the tools developed to assess reporting, risk of bias, and methodological quality of evidence syntheses are distinguished from those involved in determining overall certainty of a body of evidence. Another important distinction is made between those tools used by authors to develop their syntheses as opposed to those used to ultimately judge their work. Exemplar methods and research practices are described, complemented by novel pragmatic strategies to improve evidence syntheses. The latter include preferred terminology and a scheme to characterize types of research evidence. We organize best practice resources in a Concise Guide that can be widely adopted and adapted for routine implementation by authors and journals. Appropriate, informed use of these is encouraged, but we caution against their superficial application and emphasize their endorsement does not substitute for in-depth methodological training. By highlighting best practices with their rationale, we hope this guidance will inspire further evolution of methods and tools that can advance the field.

Methodological and reporting quality of systematic reviews on health effects of air pollutants were higher than extreme temperatures: a comparative study.

BACKGROUND: An increasing number of systematic reviews (SRs) in the environmental field have been published in recent years as a result of the global concern about the health impacts of air pollution and temperature. However, no study has assessed and compared the methodological and reporting quality of SRs on the health effects of air pollutants and extreme temperatures. This study aims to assess and compare the methodological and reporting quality of SRs on the health effects of ambient air pollutants and extreme temperatures. METHODS: PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, Web of Science, and Epistemonikos databases were searched. Two researchers screened the literature and extracted information independently. The methodological quality of the SRs was assessed through A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). The reporting quality was assessed through Preferred Reporting Items of Systematic reviews and Meta-Analyses (PRISMA). RESULTS: We identified 405 SRs (286 for air pollution, 108 for temperature, and 11 for the synergistic effects). The methodological and reporting quality of the included SRs were suboptimal, with major deficiencies in protocol registration. The methodological quality of SRs of air pollutants was better than that of temperature, especially in terms of satisfactory explanations for any heterogeneity (69.6% v. 45.4%). The reporting quality of SRs of air pollution was better than temperature, however, adherence to the reporting of the assessment results of risk of bias in all SRs (53.5% v. 34.3%) was inadequate. CONCLUSIONS: Methodological and reporting quality of SRs on the health effect of air pollutants were higher than those of temperatures. However, deficiencies in protocol registration and the assessment of risk of bias remain an issue for both pollutants and temperatures. In addition, developing a risk-of-bias assessment tool applicable to the temperature field may improve the quality of SRs.

Systematic review of the methodological quality of patient-reported outcome measure for patients with chronic ankle instability.

OBJETIVE: Chronic ankle instability is generally associated with ankle sprain. Its consequences can be measured by means of patient-reported outcome measures (PROMs). The aim of this review is to identify the PROMs specifically available for chronic ankle instability and to evaluate their methodological quality and that of the cross-cultural adaptations made. DATA SOURCES: Papers were retrieved from PubMed, Embase, Scopus and Google Scholar databases, with no time limit applied, based on the following inclusion criteria: (1) type of participants: patients with chronic ankle instability, over 18 years of age; (2)type of study: those specifically focused on this pathology, using PROMs specific to chronic ankle instability and published in English; (3) type of outcome: measurement properties based on COSMIN criteria in patient-reported outcomes associated with chronic ankle instability. METHODS: This systematic review, following the COSMIN checklist, was conducted to determine the methodological quality of PROMs specific to foot and ankle pathologies, for patients presenting chronic ankle instability. RESULTS: Of the 576 studies identified in the initial search, 34 were included in the final analysis of measurement properties. Four - the Ankle Instability Instrument, the Chronic Ankle Instability Scale, the Cumberland Ankle Instability Tool and the Identification of Functional Ankle Instability - were original questionnaires, and the remaining 30 were cross-cultural adaptations. CONCLUSION: The Cumberland Ankle Instability Tool and the Identification of Functional Ankle Instability questionnaires can be useful instruments for evaluating chronic ankle instability, both in patients with this condition and also in non-pathological patients.

A Modified Medical Education Research Study Quality Instrument (MMERSQI) developed by Delphi consensus.

BACKGROUND: The Medical Education Research Study Quality Instrument (MERSQI) is widely used to appraise the methodological quality of medical education studies. However, the MERSQI lacks some criteria which could facilitate better quality assessment. The objective of this study is to achieve consensus among experts on: (1) the MERSQI scoring system and the relative importance of each domain (2) modifications of the MERSQI. METHOD: A modified Delphi technique was used to achieve consensus among experts in the field of medical education. The initial item pool contained all items from MERSQI and items added in our previous published work. Each Delphi round comprised a questionnaire and, after the first iteration, an analysis and feedback report. We modified the quality instruments' domains, items and sub-items and re-scored items/domains based on the Delphi panel feedback. RESULTS: A total of 12 experts agreed to participate and were sent the first and second-round questionnaires. First round: 12 returned of which 11 contained analysable responses; second-round: 10 returned analysable responses. We started with seven domains with an initial item pool of 12 items and 38 sub-items. No change in the number of domains or items resulted from the Delphi process; however, the number of sub-items increased from 38 to 43 across the two Delphi rounds. In Delphi-2: eight respondents gave 'study design' the highest weighting while 'setting' was given the lowest weighting by all respondents. There was no change in the domains' average weighting score and ranks between rounds. CONCLUSIONS: The final criteria list and the new domain weighting score of the Modified MERSQI (MMERSQI) was satisfactory to all respondents. We suggest that the MMERSQI, in building on the success of the MERSQI, may help further establish a reference standard of quality measures for many medical education studies.

Methodological quality of evidence-based clinical practice guidelines in cariology.

OBJECTIVE: The present study aimed to appraise the methodological quality of evidence-based Clinical Practice Guidelines (CPGs) in the cariology field. MATERIALS AND METHODS: A systematic search on electronic databases (MEDLINE/Pubmed, EMBASE, DARE and Epistemonikos), websites, and guideline organizations were undertaken. Evidence-based CPGs including at least one recommendation for clinical prevention and/or management of dental caries, developed for any clinical setting, were included. The quality of each guideline was evaluated using the AGREE II tool. Descriptive analysis was performed and the average overall score for each domain was calculated. RESULTS: Thirty-two guidelines were included. Most of the CPGs achieved higher scores for the domains of clarity of presentation (66.7%, 95% IC 37.3-52.2) and scope and purpose (59.6%, 95% IC 53.7-65.5) domains; and lower scores for editorial independence (46.1%, 95% IC 37.8-55.7) and applicability domain (44.7%, 95% IC 37-55.3). The reviewers assessed 12 CPGs (37.5%) as recommended for use, 15 (46.9%) recommended with modifications, and 5 (15.6%) as not recommended. CONCLUSION: The overall methodological quality of evidence-based CPGs in the cariology field is moderate, and there is a need for improvements in reporting related to most domains. The poorest reporting was found in the description of the domains' applicability of its recommendations and editorial independence. CLINICAL RELEVANCE: Clinical Practice Guidelines provide guidance to patients, healthcare professionals, and stakeholders. The quality of these documents is essential for establishing trust in their recommendations.

Methodological quality of dignity-related patient reported outcome measures used in acute hospital settings: A systematic review using the COSMIN methodology.

AIMS AND OBJECTIVE: The aim of this systematic review was to examine the methodological quality of dignity-related patient reported outcome measures (PROMs) used to measure patients' dignity during acute hospitalisation using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology for systematic review of PROMs. BACKGROUND: Previous scoping review studies on the methodological quality of dignity-related PROMs lack specificity for dignity during acute hospital admission. They included PROMs that were developed to measure constructs of care other than patient dignity or designed to measure dignity in contexts outside of the acute hospital setting. STUDY DESIGN: A systematic review based on COSMIN methodology. METHODS: A systematic search was undertaken using five databases (CINAHL Complete, Medline Complete, EMBASE, PsycINFo and AgeLine) for articles published between 2000 and 2022. Relevant papers were identified using strict adherence to eligibility criteria, and studies that included development of dignity-related PROMs for use in acute hospital settings were selected. Two reviewers independently screened the identified papers, extracted data and examined the quality of studies. RESULTS: Six papers met the inclusion criteria. Two PROMs, the 25-item Patient Dignity Inventory and the 34-item Inpatient Dignity Scale, met the COSMIN quality criteria because of their sufficient quality of evidence for content validity and reliable internal consistency. None of the PROMs met the quality criteria for assessment of measurement error, criterion validity, cross-cultural validity and responsiveness. CONCLUSION: We recommend the Patient Dignity Inventory and the Inpatient Dignity Scale as the PROMs of choice for evaluating patients' dignity and/or dignified care during acute hospital admissions. These PROMs were developed using robust procedures with sufficient overall quality for content validity, internal consistency reliability and other measurement properties, and with moderate to high quality of evidence for these measurement properties. Researchers and clinicians who wish to use other dignity-related PROMs identified in this review should consider the methodological limitations of these PROMs, as highlighted in the present systematic review. RELEVANCE TO CLINICAL PRACTICE: The review findings will guide healthcare professionals about their choice of patient reported outcome measures for evaluating patients' dignity or dignified care during acute hospitalisation.

Methodological assessment and overall confidence in the results of systematic reviews with meta-analyses focusing on traumatic dental injuries: A cross-sectional study.

BACKGROUND/AIMS: High methodological quality is required to interpret results of systematic reviews (SRs) in a reliable and accurate manner. The primary aim of this study was to appraise the methodologic quality of SRs with meta-analysis within the field of traumatic dental injuries using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 tool and assess overall confidence in their results. A secondary aim was to identify potential predictive factors associated with methodological quality. MATERIALS AND METHODS: SRs with meta-analyses published in English in the field of traumatic dental injuries from inception to March 2023 were identified. The methodological quality of the included reviews was assessed using the AMSTAR 2 checklist. Two independent evaluators scored each AMSTAR 2 item as "yes" if it was adequately addressed, "partial yes" if it was partially addressed, and "no" if it was not addressed. The overall confidence in the results of each review was classified as "High," "Moderate," "Low," or "Critically low." Using multiple regression, the relationship between five predictor variables (journal impact factor, year of publication, number of authors, journal adherence to Preferred Reporting Items for Systematic reviews and Meta-analyses [PRISMA] guidelines and a priori protocol registration) and the total AMSTAR 2 scores was analyzed. The p-value was 5%. RESULTS: Forty-one SRs were included. The overall confidence in the results of 13 reviews was categorized as "Critically low," 18 as "Low," 3 as "Moderate" and 7 as "High." Among the five predictor variables analyzed statistically, impact factor of the journal and year of publication significantly influenced the total AMSTAR 2 scores. The number of authors, adherence to PRISMA guidelines, and a priori protocol registration had no significant impact on AMSTAR 2 scores. CONCLUSION: The overall confidence in the results of SRs with meta-analysis within the field of traumatic dental injuries was "Low" or "Critically Low" in the vast majority of studies (31 of 41). SRs with meta-analyses published in journals with higher impact factors and more recent publications had significantly higher methodological quality.

[Overview of systematic reviews of Chinese herbal injections for sepsis].

In this study, an overview of systematic reviews/Meta-analysis(SR/MA) of Chinese herbal injections for sepsis was performed to provide references for clinical practice and promote the quality improvement of clinical evidence. Eight Chinese and English databases such as CNKI, Medline, and EMbase were electronically searched for SR/MA of Chinese herbal injections for sepsis from database inception to June 2022. AMSTAR 2, PRISMA 2020, and GRADE system, combined with Recommendations for Clinical Evidence Grading on Traditional Chinese Medicine Based on Evidence Body, were applied to evaluate the methodological quality, reporting quality, and evidence quality of the included articles. Twenty-seven articles of SR/MA were included, containing four Chinese herbal injections(Xuebijing Injection, Shenfu Injection, Shenmai Injection, and Shengmai Injection). AMSTAR 2 checklist showed that the methodological quality of the SR/MA ranged from moderate to very low. Item 2(prior study design) was the critical item with poor scores, and the non-critical items with poor scores were items 3(explain the selection of the study designs), items 10(report on the sources of funding), and items 16(conflicts of interest stated). In terms of PRISMA 2020, items in eight topics with complete reporting of missing>50%, including search strategy, certainty assessment, results of syntheses, certainty of evidence, registration and protocol, support, competing interests, availability of data, code and other materials. The included SR/MA involved 30 outcome indicators. Evidence quality of mortality, APACHE Ⅱ, and safety, the top three outcome indicators, was evaluated, and all of them were graded as the medium level. The lack of random allocation sequence, allocation concealment mechanism, blinding, and trial sample size was the main reason for the reduction of the evidence level. The available evidence shows that Chinese herbal injections can serve as an effective and safe adjunctive treatment for sepsis, which can reduce mortality, inhibit inflammation, improve coagulation function, and regulate immune function, tissue perfusion, and oxygenation in patients with sepsis. However, the quality of SR/MA was suboptimal, and more high-quality SR/MA is needed to provide evidence to support the efficacy and safety of Chinese herbal injections in the treatment of sepsis.