Journal of Evidence‐Based Medicine最新文献

Aim

Utilizing external information in clinical trials enhances validity by including a wider population and expedites the implementation of adaptive designs, ultimately improving research efficiency. However, current research focused on scenarios in which only the control group benefited from the utilization of external information, while trials involving external information in both experimental and control arms were more complex and might pose challenges when applied in real-world settings.

Methods

To address these concerns, our study pioneered the application of test-then-pool, normalized power prior, calibrated power prior, and elastic prior to a two-arm information borrowing framework and systematically compared their operating characteristics through a series of simulation studies under most and least desirable scenarios.

Results

In the most desirable scenarios of information borrowing, all methods managed to control the mean of type I error rates within 5%, among which the normalized power prior, calibrated power prior and elastic prior approaches increased the mean of power from 85.94% to 95%. In the least desirable scenarios, the mean type I error rates for normalized power prior, calibrated power prior and elastic prior approaches exceeded 20%, while the mean power decreased to around 80%.

Conclusions

Our findings reveal that the normalized power prior, calibrated power prior and elastic prior approaches are suitable for situations with minimal heterogeneity between historical and current data, whereas the test-then-pool approach emerges as a more prudent choice when facing substantial discrepancies between historical and current information for trials consider information borrow in both arms.

Objective

This study compares the safety and efficacy of general anesthesia (GA) and nongeneral anesthesia (non-GA) on functional outcomes in patients receiving endovascular therapy for ischemic stroke.

Methods

All available studies on the anesthetic management of patients with acute ischemic stroke in PubMed, the Cochrane Central Register of Controlled Trials, and Embase were included. We also compared the clinical outcomes in the studies with subgroup analyses of the occlusion site (anterior vs. posterior circulation) and preretriever group versus retriever group. Functional independence, mortality, successful recanalization, hemodynamic instability, intracerebral hemorrhage, and respiratory complications were considered primary or secondary outcomes.

Results

A total of 24,606 patients in 60 studies were included. GA had a lower risk of 90-day functional independence (OR = 0.67, 95% CI 0.58 to 0.77), higher risk of 90-day mortality (OR = 1.29; 95% CI 1.15 to 1.45), and successful reperfusion (OR = 1.18; 95% CI 1.94 to 6.82). However, there were no differences in functional independence and mortality between GA and non-GA at 90 days after the procedure.

Conclusion

The study shows poorer results in the GA group, which may be due to the inclusion of nonrandomized studies. However, analysis of the RCTs suggested that the outcomes do not differ between the two groups (GA vs. non-GA). Thus, general anesthesia is as safe as nongeneral anesthesia under standardized management.

Aim

To formulate the guideline for the development of diagnostic criteria for Chinese medicine syndromes, which can contribute to standardization of development of Chinese medicine syndrome diagnostic standards.

Methods

We embark into account on the development of Guideline on Establishing Diagnostic Criteria for Chinese Medicine Syndromes through Delphi method with reference to the existing technical system of diagnostic criteria for Chinese medicine syndromes and relevant criteria.

Results

Our guideline specifies principles, methods, and procedures for the formulation of diagnostic criteria for Chinese medicine syndromes.

Conclusions

It is a comprehensive and systematic evidence-based guideline, and we hope this guideline can be applied as a reference in developing diagnostic criteria for Chinese medicine syndromes in other disciplines. It is also applicable to the formulation of diagnostic criteria for relevant clinical, educational, and scientific research by hospitals, institutes, and academies.

Chronic obstructive pulmonary disease (COPD), with high prevalence rate, mortality, disability rate, and heavy disease burden, has become a critical chronic disease seriously threatening public health worldwide. Traditional Chinese medicine and Western medicine both have shown advantages in diagnosing and treating COPD, which has been widely applied in the clinics. In order to improve the diagnostic and treatment level for COPD with integrated traditional Chinese and Western medicine, the Guidelines of Integrated Chinese and Western Medicine for Diagnosis and Treatment of COPD were developed by the Internal Medicine Committee of the World Federation of Chinese Medicine Societies. First, a multidisciplinary working group was established. Development methods and processes of international clinical practice guidelines were adopted in the whole research. In final, a total of 13 recommendations for the diagnosis and treatment of COPD were established based on available evidence with the best quality. Meanwhile, characteristics of integrated traditional Chinese and Western medicine in treating COPD were taken into account with pros and cons of each intervention. The guidelines could be used as a reference for physicians in respiratory medicine departments (traditional Chinese medicine, integrated traditional Chinese and Western medicine, and Western medicine) at various levels of medical institutions in their diagnosis and treatment.

Background

Time-varying drug treatments are common in studies using routinely collected health data (RCD) for assessing treatment effects. This study aimed to examine how these studies reported, handled, and interpreted time-varying drug treatments.

Methods

A systematic search was conducted on PubMed from 2018 to 2020. Eligible studies were those used RCD to explore drug treatment effects. We summarized the reporting characteristics and methods employed for handling time-varying treatments. Logistic regressions were performed to investigate the association between study characteristics and the reporting of time-varying treatments.

Results

Two hundred and fifty-six studies were included, and 225 (87.9%) studies involved time-varying treatments. Of these, 24 (10.7%) reported the proportion of time-varying treatments and 105 (46.7%) reported methods used to handle time-varying treatments. Multivariable logistic regression showed that medical studies, prespecified protocol, and involvement of methodologists were associated with a higher likelihood of reporting the methods applied to handle time-varying treatments. Among the 105 studies that reported methods, as-treated analyses were the most commonly used analysis sets, which were employed in 73.9%, 75.3% and 88.2% of studies that reported approaches for treatment discontinuation, treatment switching and treatment add-on. Among the 225 studies involved time-varying treatments, 27 (12.0%) acknowledged the potential bias introduced by treatment change, of which 14 (51.9%) suggested that potential biases may impact acceptance or rejection of the null hypothesis.

Conclusions

Among observational studies using RCD, the underreporting about the presence and methods for handling time-varying treatments was largely common. The potential biases due to time-varying treatments have frequently been disregarded. Collaborative endeavors are strongly needed to enhance the prevailing practices.

Objective

Observational studies had demonstrated a link between sleep disturbances and cognitive decline. Here, we aimed to investigate the causal association between genetically predicted sleep traits and cognitive impairment using Mendelian randomization (MR).

Methods

Using strict criteria, we selected genetic variants from European ancestry Genome-wide association studies (GWAS) from the Sleep Disorders Knowledge Portal and UK Biobank as instrumental variables for several sleep traits, including insomnia, sleep duration, daytime sleepiness, daytime napping, and chronotype. Summary statistics related to cognitive impairment were derived from five different GWAS, including the Social Science Genetic Association Consortium. The role of self-reported sleep trait phenotypes in the etiology of cognitive impairment was explored using inverse-variance weighted (IVW) tests, MR-Egger tests, and weighted medians, and sensitivity analyses were conducted to ensure robustness.

Results

In the main IVW analysis, sleep duration (reaction time: β = –0.05, 95% CI –0.07 to –0.04, p = 1.93×10⁻¹²), daytime sleepiness (average cortical thickness: β = –0.12, 95% CI –0.22 to –0.02, p = 0.023), and daytime napping (fluid intelligence: β = –0.47, 95% CI –0.87 to –0.07, p = 0.021; hippocampal volume in Alzheimer's disease: β = –0.99, 95% CI –1.64 to –0.35, p = 0.002) were significantly negatively correlated with cognitive performance. However, any effects of insomnia and chronotype on cognitive impairment were not determined.

Conclusions

Our findings highlighted that focusing on sleep behaviors or distinct sleep patterns-particularly sleep duration, daytime sleepiness, and daytime napping, was a promising approach for preventing cognitive impairment. This study also shed light on risk factors for and potential early markers of cognitive impairment risk factors.

Objective

To investigate the most effective and best-tolerated drugs for treating diseased smokers.

Methods

Eight databases were searched for randomized controlled trials (RCTs) involving different pharmacological interventions for smoking cessation in disease patients (January 2023). Network meta-analysis was performed using STATA 15.1 software. The Cochrane Risk of Bias Tool assessed the risk of bias, and confidence in evidence was assessed using CINeMA.

Results

A total of 60 RCTs involving 13,009 patients of 12 disease categories were included. All trials reported 13 interventions, resulting in 78 comparisons. Network meta-analysis showed that varenicline (OR = 2.30, 95% CI (1.77, 3.00)) and bupropion (OR = 1.65, 95% CI (1.29, 2.11)) showed favorable abstinence effects compared to placebo in the cardiovascular disease population. Nicotine replacement therapy (NRT) had better withdrawal advantages than placebo (OR = 11.18, 95% CI (2.25, 55.54)) in the chronic obstructive pulmonary disease (COPD) population. Some combination treatments showed better results than monotherapy, such as bupropion + NRT was superior to bupropion (OR = 8.45, 95% CI (1.84, 38.89)) and NRT (OR = 4.98, 95% CI (1.25, 19.78)) in mental illness population. The final surface under the cumulative ranking curve indicated that bupropion + NRT achieved the best smoking cessation effect. Overall confidence in the evidence was low. In a comparison of drugs, the results showed that bupropion + NRT had the best safety.

Conclusions

Most interventions show the benefit of quitting smoking compared with placebo, including monotherapy and combination therapy. Moreover, varenicline or bupropion combined with NRT is superior to some monotherapies.

Background

International guidelines recommend cyclin-dependent kinase 4/6 inhibitor (CDK4/6i)-based first-line therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). However, direct drug comparisons are lacking. We aimed to identify the most effective and safe therapy through network meta-analysis (NMA).

Methods

We searched PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and OpenGrey up to September 30, 2023. Eligible studies included randomized controlled trials (RCTs) assessing endocrine therapy alone or in combination with CDK4/6i as first-line endocrine treatment for HR+/HER2− ABC patients. The hazard ratios for progression-free survival (PFS) and overall survival (OS) and relative risks for objective response rate and adverse events (AEs) were available in selected trials. We performed a Bayesian NMA following PRISMA guidelines.

Results

Thirteen RCTs, involving 10 treatments, were included. Most studies were at low risk of bias. Regarding PFS, ribociclib+fulvestrant ranked first with a surface under the cumulative ranking curve (SUCRA) of 85.0%, followed by dalpiciclib+nonsteroidal aromatase inhibitor (NSAI) (SUCRA = 78.9%). Considering OS, the top three ranked treatments were ribociclib+fulvestrant (SUCRA = 94.1%), abemaciclib+NSAI (SUCRA = 69.9%), and ribociclib+NSAI (SUCRA = 68.5%). Out of four CDK4/6is, ribociclib minimized the grade 3/4 AEs, while dalpiciclib demonstrated the worst safety. Publication bias could not be ignored in our analyses, and the certainty of evidence was downgraded primarily due to imprecision.

Conclusions

Ribociclib+fulvestrant probably represents the best option in a first-line setting. When combined with NSAI, dalpiciclib likely showed the best efficacy but the worst safety. Abemaciclib+NSAI and ribociclib+NSAI could also be promising treatments, while palbociclib presented inferiority. (PROSPERO Registration No. CRD42022370271)