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Journal of General Internal Medicine Jul 2024Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior...
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.
PubMed: 38954320
DOI: 10.1007/s11606-024-08890-9 -
Journal of Nephrology Jul 2024Chronic kidney disease (CKD) is commonly associated with psychosocial problems, especially depression, contributing to poor overall outcomes. Depression has not been... (Review)
Review
BACKGROUND
Chronic kidney disease (CKD) is commonly associated with psychosocial problems, especially depression, contributing to poor overall outcomes. Depression has not been given adequate priority in the management of CKD patients despite its significant adverse impact on all major outcomes. This systematic review and meta-analysis determined the pooled prevalence of clinical depression in the global CKD population and sub-populations.
METHODS
PubMed, African Journals Online (AJOL), and EMBASE were systematically searched to identify published articles with relevant data. The pooled prevalence of clinical depression in the global CKD population was determined using random effects meta-analytic techniques. The study protocol was registered with PROSPERO (CRD42022382708).
RESULTS
Sixty-five articles were included in this review, comprising 80,932 individuals with CKD from 27 countries. The participants' mean age ranged from 11.0 to 76.3 years. Most (70.4%) of the studies had medium methodological quality. The overall pooled prevalence of depression was 26.5% (95% CI 23.1-30.1%). Studies using the Diagnostic Statistical Manual for Mental Diseases (DSM) and International Classification of Disease (ICD) returned a pooled prevalence of 25.5% and 39.6%, respectively, p = 0.03. There was a significant difference in the pooled prevalence across regions; p = 0.002.The prevalence of depression was higher among individuals on chronic hemodialysis compared to pre-dialysis patients (29.9% versus 18.5%; p = 0.01) and among those on hemodialysis compared to peritoneal dialysis (30.6% versus 20.4%; p = 0.04). There was no significant difference between adults and children (26.8% versus 15.9%, p = 0.21). There was an increasing temporal trend in depression prevalence, though this did not achieve statistical significance (p = 0.16).
CONCLUSION
Depression is common in patients with CKD. The findings of this study highlight the need for clinicians to make efforts to evaluate individuals with CKD for depression, especially those with advanced stages of the disease.
PubMed: 38954184
DOI: 10.1007/s40620-024-01998-5 -
Annals of Surgical Oncology Jul 2024Surgical management of head and neck cutaneous melanoma (HNCM) has evolved tremendously since sentinel lymph node biopsy (SLNB) has become the prominent tool of... (Review)
Review
BACKGROUND
Surgical management of head and neck cutaneous melanoma (HNCM) has evolved tremendously since sentinel lymph node biopsy (SLNB) has become the prominent tool of prognosis and staging. This meta-analysis aimed to evaluate the safety and efficiency of intraparotid SLNB compared with a more extensive surgery of superficial parotidectomy (SP).
METHODS
The electronic database of PubMed and Scopus were searched for publications until 10 March 2022. In addition, the study included data of patients from our institution who underwent cherry-picking procedures. Pooled estimates were calculated using the random-effects model. Heterogeneity was calculated using the I test.
RESULTS
The pooled result regarding the rate of SLNB excision success was 97 % (95 % confidence interval [CI], 0.95-0.99; p < 0.0001), and the pooled probability of a positive SLNB result was 16 % (95 % CI 0.12-0.20; p < 0.0001). Failure of SLNB had pooled results of 4 % (95 % CI 0.02-0.06; p < 0.0009). For SP, no study examining N0 HNCM patients has met the authors' inclusion criteria. Cherry-picking SLNB had temporary and permanent facial nerve paralysis relative risks (RRs) of 0.12 (95 % CI 0.06-0.27; p < 0.0001) and 0.46 (95 % CI 0.17-1.22; p < 0.0001), respectively, compared with historical data from four weighted meta-analyses of SP.
CONCLUSIONS
The data from this study suggest that intraparotid SLNB performed for N0 HNCM patients is a safe and reliable procedure, with very low complication rates. Failure of the procedure did not exceed 4 %. Therefore, intraparotid SLNB may be superior to an extensive surgery such as SP and should be examined in future prospective trials.
PubMed: 38954096
DOI: 10.1245/s10434-024-15668-0 -
Graefe's Archive For Clinical and... Jul 2024In the context of ophthalmologic practice, there has been a rapid increase in the amount of data collected using electronic health records (EHR). Artificial intelligence... (Review)
Review
Adherence of studies involving artificial intelligence in the analysis of ophthalmology electronic medical records to AI-specific items from the CONSORT-AI guideline: a systematic review.
PURPOSE
In the context of ophthalmologic practice, there has been a rapid increase in the amount of data collected using electronic health records (EHR). Artificial intelligence (AI) offers a promising means of centralizing data collection and analysis, but to date, most AI algorithms have only been applied to analyzing image data in ophthalmologic practice. In this review we aimed to characterize the use of AI in the analysis of EHR, and to critically appraise the adherence of each included study to the CONSORT-AI reporting guideline.
METHODS
A comprehensive search of three relevant databases (MEDLINE, EMBASE, and Cochrane Library) from January 2010 to February 2023 was conducted. The included studies were evaluated for reporting quality based on the AI-specific items from the CONSORT-AI reporting guideline.
RESULTS
Of the 4,968 articles identified by our search, 89 studies met all inclusion criteria and were included in this review. Most of the studies utilized AI for ocular disease prediction (n = 41, 46.1%), and diabetic retinopathy was the most studied ocular pathology (n = 19, 21.3%). The overall mean CONSORT-AI score across the 14 measured items was 12.1 (range 8-14, median 12). Categories with the lowest adherence rates were: describing handling of poor quality data (48.3%), specifying participant inclusion and exclusion criteria (56.2%), and detailing access to the AI intervention or its code, including any restrictions (62.9%).
CONCLUSIONS
In conclusion, we have identified that AI is prominently being used for disease prediction in ophthalmology clinics, however these algorithms are limited by their lack of generalizability and cross-center reproducibility. A standardized framework for AI reporting should be developed, to improve AI applications in the management of ocular disease and ophthalmology decision making.
PubMed: 38953984
DOI: 10.1007/s00417-024-06553-3 -
Sexual Medicine Jun 2024Cardiovascular diseases (CVDs) and erectile dysfunction (ED) frequently co-occur, significantly affecting the quality of life of individuals. (Review)
Review
BACKGROUND
Cardiovascular diseases (CVDs) and erectile dysfunction (ED) frequently co-occur, significantly affecting the quality of life of individuals.
AIM
To assess the impact of cardiac rehabilitation (CR) on ED in patients with CVD through a systematic review and meta-analysis.
METHODS
This study analyzed randomized controlled trials and other studies comparing CR with usual care for adult males (≥18 years) with any cardiac disease. Literature searches were extensive, and the risk of bias was evaluated by the Cochrane Collaboration tool. Data from 6 studies involving 668 participants were included in the meta-analysis.
OUTCOMES
The primary outcome was the improvement in ED, as measured with the International Index of Erectile Function.
RESULTS
A statistically significant improvement in erectile function was observed across 6 studies, with a Morris dppc2 effect size of 0.38 (95% CI, 0.17-0.59). Despite initial high heterogeneity ( = 95.7%), identification and correction for selective outcome reporting bias mitigated this issue.
CLINICAL TRANSLATION
CR has a modest but statistically significant impact on improving ED in patients with CVD, indicating its potential positive contribution to the quality of life of this group.
STRENGTHS AND LIMITATIONS
The study's strengths include a comprehensive literature search and a rigorous methodological approach. Limitations involve high heterogeneity among studies and a low level of evidence due to small sample sizes and study quality; however, the source of heterogeneity was identified and mitigated following risk-of-bias assessment.
CONCLUSION
The results suggest that CR has a statistically significant but modest impact on improving ED in patients with CVD. Clinicians should consider the integration of CR into the clinical management of these individuals. This study underscores the potential for CR to contribute positively to the quality of life for patients with CVD by addressing associated ED (PROSPERO: CRD42022374625).
PubMed: 38953013
DOI: 10.1093/sexmed/qfae043 -
Frontiers in Clinical Diabetes and... 2024With diabetes self-management continuing to become more complex for older adults, self-management programs have been shown to support this population in meeting their...
OBJECTIVES
With diabetes self-management continuing to become more complex for older adults, self-management programs have been shown to support this population in meeting their multifaceted medical needs. Building on our previous systematic review and meta-analysis, we aimed to update the literature on the effectiveness of diabetes self-management programs and investigate the impact of specific self-management interventions on clinical and patient-reported outcomes.
METHODS
We updated our literature search in the following databases: Medline, EMBASE, PsychINFO, CINAHL and Cochrane Database of Randomized Controlled Trials from November 2013 to July 2023 for studies that may fit our inclusion criteria. Two independent reviewers screened and extracted data from the included group of studies.
RESULTS
A total of 17 studies with 21 comparison arms met the inclusion criteria, totalling 5976 older adults (3510 individuals randomized to self-management programming and 2466 to usual care). The pooled effectiveness of diabetes self-management programs in older adults on glycemic control (hemoglobin A1C) was a reduction of -0.32 (95% CI -0.44, -0.19). Specifically, the most effective approach on glycemic control (A1C) was the use of feedback (-0.52%; 95% CI -0.68, -0.36). Overall, self-management programs improved behaviour change outcomes, with feedback interventions being most effective (standardized mean difference [SMD] 0.91; 95% CI 0.39, 1.43). The effect of self-management programs on body mass index, weight and lipids were statistically and clinically significant.
CONCLUSIONS
The evidence for diabetes self-management programs for older adults demonstrates a small but clinically meaningful reduction in A1C, improvement in patient-reported outcomes (behaviour, self-efficacy, knowledge), and other clinical outcomes (BMI, weight and lipids). The specific strategy used in diabetes self-management programs for older adults should be considered to achieve optimal results on outcomes.
PubMed: 38952998
DOI: 10.3389/fcdhc.2024.1348104 -
Pakistan Journal of Medical Sciences Jul 2024Several studies have investigated the effectiveness of preoperative or perioperative pulmonary rehabilitation in thoracic surgery patients, but the results are... (Review)
Review
Effectiveness of preoperative and perioperative pulmonary rehabilitation nursing program for the management of patients undergoing thoracic surgery: A systematic review and meta-analysis.
BACKGROUND & OBJECTIVE
Several studies have investigated the effectiveness of preoperative or perioperative pulmonary rehabilitation in thoracic surgery patients, but the results are inconsistent and inconclusive. This study attempts to summarize the existing data on the effect of the preoperative and perioperative pulmonary rehabilitation nursing program for the management of patients undergoing thoracic surgery.
METHODS
Systematic search was done in PubMed Central, SCOPUS, EMBASE, MEDLINE, Google Scholar, and ScienceDirect for papers published until December 2022 and reporting data of postoperative complications and pulmonary health status in patients undergoing thoracic surgery and receiving preoperative or perioperative pulmonary rehabilitation nursing intervention or standard care. Meta-analysis was done by random-effects model and pooled standardised mean differences (SMD) or odds ratios (OR) along with 95% confidence intervals (CIs) were reported.
RESULTS
Eighteen studies were included and analysed. Pooled SMD was 0.44 (95%CI: -0.21 to 1.08) for forced expiratory volume (FEV-1), -0.34 (95%CI: -0.94 to 0.26) for peak expiratory flow (PEF), 0.61 (95%CI: -0.60 to 1.81) for forced vital capacity (FVC), 0.42 (95%CI: -0.13 to 0.98) for diffusing capacity of carbon monoxide (DLCO). Pooled SMD for length of hospital stay was -0.64 (95%CI: -1.09 to -0.19). Pooled OR was 0.87 [95%CI: 0.32 to 2.37] for all-cause mortality, 0.35 [95%CI: 0.25 to 0.50] for postoperative pulmonary complications, 0.98 [95%CI: 0.45 to 2.12] for respiratory failure, 0.52 [95%CI: 0.38 to 0.78] for pneumonia and 0.50 [95%CI: 0.33 to 0.76] for atelectasis.
CONCLUSION
Perioperative pulmonary rehabilitation nursing program is effective in reducing the postoperative lung complications and shortening the length of hospital stay in patients undergoing thoracic surgery.
PubMed: 38952505
DOI: 10.12669/pjms.40.6.9259 -
Aging & Mental Health Jul 2024To determine a pooled prevalence of depression and its influencing factors among nursing home residents. (Review)
Review
OBJECTIVES
To determine a pooled prevalence of depression and its influencing factors among nursing home residents.
METHOD
PsycINFO, PubMed, Embase, and Web of Science were searched for studies investigating the prevalence and risk factors of late-life depression among nursing home residents between January 2012 and November 2022. Two reviewers independently completed the literature screening, data extraction and quality assessment. A random-effects model was utilized to pool the prevalence of depression and summarize the influencing factors.
RESULTS
This meta-analysis included 48 studies involving 28,501 participants. The pooled prevalence of depressive mood and major depressive disorder was 53% and 27%, respectively. The rate of depressive mood is higher in lower-middle-income countries (60.0%), compared with high- (53.0%) and upper-middle-income countries (44.0%). The rate of depressive mood (35.0%) is higher among females than male (19.0%). Depression was influenced by factors, including male ( = 0.28), insufficient income ( = 3.53), comorbidities ( = 2.66), pain ( = 2.67; = 0.31), functional disability ( = 0.33), loneliness ( = 0.43), number of chronic health problems ( = 0.18), social support ( = -0.28), activities of daily living ( = -0.43), subjective health ( = -0.28), autonomy ( = -0.41), environment ( = -0.50) and physical ( = -0.57) and psychological health ( = -0.65).
CONCLUSION
The prevalence of depressive mood is high among nursing home residents, especially in lower-middle-income countries. It is influenced by factors including gender, income, social support, daily activities, environment, physical and psychological health and autonomy. Understanding those factors can provide evidence-based recommendations for improved awareness, prevention and better management of late-life depression.
PubMed: 38952191
DOI: 10.1080/13607863.2024.2367044 -
American Journal of Clinical Oncology Jul 2024Trastuzumab deruxtecan (T-DXd) is a novel antibody-drug conjugate (ADC) promising in treating metastatic HER2+ and HER2-low breast cancer. This updated systematic review...
OBJECTIVES
Trastuzumab deruxtecan (T-DXd) is a novel antibody-drug conjugate (ADC) promising in treating metastatic HER2+ and HER2-low breast cancer. This updated systematic review and meta-analysis, integrating data from the latest clinical trials, aimed to evaluate the safety and efficacy of T-DXd in this patient population.
METHODS
We adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A comprehensive search was conducted across PubMed, Scopus, and Web of Science up to January 2024, focusing on clinical trials that assessed T-DXd's efficacy and safety. Eligibility criteria were based on the PICOS framework, and selected studies underwent rigorous quality assessment and data extraction. The primary outcomes were progression-free survival (PFS), overall survival (OS), and the incidence of adverse events. A random-effects meta-analysis was performed to synthesize the data.
RESULTS
Seven studies involving 2,201 patients met the inclusion criteria. The pooled analysis revealed that T-DXd significantly improved PFS (OR=0.37, 95% CI: 0.27-0.52), indicating a robust efficacy in slowing disease progression. However, treatment was associated with an increased risk of anemia (OR=2.10, 95% CI: 1.36-3.25), fatigue (OR=1.56, 95% CI: 1.21-2.02), nausea (OR=6.42, 95% CI: 4.37-9.42), vomiting (OR=6.21, 95% CI: 3.14-12.25), constipation (OR=2.26, 95% CI: 1.53-3.34), and notably, drug-related interstitial lung disease (OR=10.89, 95% CI: 3.81-31.12). The efficacy outcomes demonstrated significant heterogeneity, which was addressed through sensitivity analysis.
CONCLUSIONS
T-DXd shows significant efficacy in treating metastatic HER2+ and HER2-low breast cancer, offering a valuable therapeutic option for patients with advanced disease. However, the treatment is associated with notable adverse events, including a heightened risk of ILD. These findings underscore the need for careful patient selection, monitoring, and management strategies to mitigate risks. Future research should focus on optimizing treatment protocols and exploring methods to enhance safety profiles.
PubMed: 38951994
DOI: 10.1097/COC.0000000000001126 -
Journal of Cancer Research and Clinical... Jul 2024To conduct a systematic review and meta-analysis of case-control and cohort human studies evaluating metabolite markers identified using high-throughput metabolomics... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To conduct a systematic review and meta-analysis of case-control and cohort human studies evaluating metabolite markers identified using high-throughput metabolomics techniques on esophageal cancer (EC), cancer of the gastroesophageal junction (GEJ), and gastric cancer (GC) in blood and tissue.
BACKGROUND
Upper gastrointestinal cancers (UGC), predominantly EC, GEJ, and GC, are malignant tumour types with high morbidity and mortality rates. Numerous studies have focused on metabolomic profiling of UGC in recent years. In this systematic review and meta-analysis, we have provided a collective summary of previous findings on metabolites and metabolomic profiling associated with EC, GEJ and GC.
METHODS
Following the PRISMA procedure, a systematic search of four databases (Embase, PubMed, MEDLINE, and Web of Science) for molecular epidemiologic studies on the metabolomic profiles of EC, GEJ and GC was conducted and registered at PROSPERO (CRD42023486631). The Newcastle-Ottawa Scale (NOS) was used to benchmark the risk of bias for case-controlled and cohort studies. QUADOMICS, an adaptation of the QUADAS-2 (Quality Assessment of Diagnostic Accuracy) tool, was used to rate diagnostic accuracy studies. Original articles comparing metabolite patterns between patients with and without UGC were included. Two investigators independently completed title and abstract screening, data extraction, and quality evaluation. Meta-analysis was conducted whenever possible. We used a random effects model to investigate the association between metabolite levels and UGC.
RESULTS
A total of 66 original studies involving 7267 patients that met the required criteria were included for review. 169 metabolites were differentially distributed in patients with UGC compared to healthy patients among 44 GC, 9 GEJ, and 25 EC studies including metabolites involved in glycolysis, anaerobic respiration, tricarboxylic acid cycle, and lipid metabolism. Phosphatidylcholines, eicosanoids, and adenosine triphosphate were among the most frequently reported lipids and metabolites of cellular respiration, while BCAA, lysine, and asparagine were among the most commonly reported amino acids. Previously identified lipid metabolites included saturated and unsaturated free fatty acids and ketones. However, the key findings across studies have been inconsistent, possibly due to limited sample sizes and the majority being hospital-based case-control analyses lacking an independent replication group.
CONCLUSION
Thus far, metabolomic studies have provided new opportunities for screening, etiological factors, and biomarkers for UGC, supporting the potential of applying metabolomic profiling in early cancer diagnosis. According to the results of our meta-analysis especially BCAA and TMAO as well as certain phosphatidylcholines should be implicated into the diagnostic procedure of patients with UGC. We envision that metabolomics will significantly enhance our understanding of the carcinogenesis and progression process of UGC and may eventually facilitate precise oncological and patient-tailored management of UGC.
Topics: Humans; Metabolomics; Esophageal Neoplasms; Stomach Neoplasms; Biomarkers, Tumor; Gastrointestinal Neoplasms; Metabolome; Case-Control Studies; Esophagogastric Junction
PubMed: 38951269
DOI: 10.1007/s00432-024-05857-5