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BMJ Open Dec 2023The review aims to conduct the first network meta-analysis to comprehensively evaluate the application of multiple acupuncture techniques in patients with postmenopausal...
INTRODUCTION
The review aims to conduct the first network meta-analysis to comprehensively evaluate the application of multiple acupuncture techniques in patients with postmenopausal osteoporosis, ranking the best acupuncture treatment and providing a reference for clinical treatment extensively.
METHODS AND ANALYSIS
Randomised controlled trials of different acupuncturerelated therapies for postmenopausal osteoporosis will be searched in the following databases from 1 January 2002 to 31 December 2022, including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database and China Biomedical Literature Database. Overall, clinical efficacy rate, bone mineral density and a Visual Analogue Scale score are used as the primary outcome indicators. In addition, the secondary outcome indicator is adverse reactions. The entire screening process will be conducted by two independent investigators; meanwhile, Stata (V.14.0) and RevMan (V.5.4) will be used to conduct the network meta-analysis. If the data are permissible and feasible, we will also perform meta-regression and subgroup analyses to address the underlying causes of data inconsistency and heterogeneity in the statistical analyses. Besides, to improve the credibility of this network meta-analysis, we will evaluate the quality of evidence in this research according to the GRADE assessment.
ETHICS AND DISSEMINATION
Ethics approval is not required for network meta-analyses, which do not involve animals' or people's welfare. The results of this network meta-analysis will be submitted to a recognised journal for publication.
PROSPERO REGISTRATION NUMBER
CRD42023401003.
Topics: Female; Humans; Acupuncture Therapy; Bayes Theorem; Meta-Analysis as Topic; Network Meta-Analysis; Osteoporosis, Postmenopausal; Research Design; Systematic Reviews as Topic
PubMed: 38159952
DOI: 10.1136/bmjopen-2023-074740 -
JSLS : Journal of the Society of... 2023Percutaneous endoscopic gastrostomy (PEG) is a common procedure performed world-wide on patients with different comorbidities, with many indications and overall low...
INTRODUCTION
Percutaneous endoscopic gastrostomy (PEG) is a common procedure performed world-wide on patients with different comorbidities, with many indications and overall low morbidity. However, studies showed an elevated early mortality in patients undergoing PEG placement. In this systematic review, we review the factors associated with early mortality after PEG.
METHODS
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. The methodological index for nonrandomized studies (MINORS) score system was used to perform qualitative assessment of all included studies. Recommendations were summarized for predefined key items.
RESULTS
The search found 283 articles. A refined total of 21 studies were included; 20 studies cohort studies and 1 case-control study. For the cohort studies, MINORS score ranged from 7 to 12 out of 16. The single case-control study scored 17 out of 24. The number of study patients ranged from 272 to 181,196. Thirty-day mortality rate varied from 2.4% to 23.5%. Albumin, age, body mass index, C-reactive protein, diabetes mellitus, and dementia were the most frequently associated factors to early mortality in patients undergoing PEG placement. Five studies reported procedure related deaths. Infection was the most commonly reported complication of PEG placement.
CONCLUSIONS
PEG tube insertion is a fast, safe and effective procedure, but is not free of complications and can have a high early mortality rate as demonstrated in this review. Patient selection should be a key factor and the identification of factors associated with early mortality is important in the elaboration of a protocol to benefit patients.
Topics: Humans; Case-Control Studies; Gastrostomy; Body Mass Index; C-Reactive Protein; Patient Selection
PubMed: 37304929
DOI: 10.4293/JSLS.2023.00005 -
BioMed Research International 2023This systematic review was conducted to provide up-to-date evidence on the safety and effectiveness of task sharing in the delivery of modern contraceptives. . The... (Review)
Review
OBJECTIVE
This systematic review was conducted to provide up-to-date evidence on the safety and effectiveness of task sharing in the delivery of modern contraceptives. . The review followed the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines. We searched Medline, Embase, Cochrane CENTRAL, and Google Scholar for peer-reviewed studies that reported on effectiveness and/or safety outcomes of task sharing of any modern contraceptive method. Only Cochrane Effective Practice of Organizations of Care (EPOC) study designs were eligible, and quality assessment of the evidence was performed using the Cochrane risk of bias (RoB) tools. Meta-analyses, where possible, were carried out using Stata, and certainty of the evidence for outcomes was assessed using the Grading of Recommendations Assessment, Development, and Evaluation tool (GRADE).
RESULTS
Six studies met the inclusion criteria: five reported on self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) compared to administered by trained health providers; and one assessed tubal ligation performed by associate clinicians compared to advanced-level associate clinicians. Self-injection improved contraceptive continuation, with no increase in unintended pregnancy and no difference in side effects compared to provider administered. In tubal ligation, the rate of adverse events, time to complete procedure, and participant satisfaction were similar among associate clinicians and advanced clinicians.
CONCLUSION
The evidence suggests that self-injection of DMPA-SC and tubal ligation performed by associate clinicians are safe and effective. These findings should be complemented with the evidence on the feasibility and acceptability of task sharing of these methods. The review protocol was registered with PROSPERO CRD42021283336.
Topics: Pregnancy; Female; Humans; Family Planning Services; Contraception; Contraceptive Agents, Female; Subcutaneous Tissue; Research Design
PubMed: 36817856
DOI: 10.1155/2023/8735563 -
BMC Medical Research Methodology Aug 2021Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Randomization is the foundation of any clinical trial involving treatment comparison. It helps mitigate selection bias, promotes similarity of treatment groups with respect to important known and unknown confounders, and contributes to the validity of statistical tests. Various restricted randomization procedures with different probabilistic structures and different statistical properties are available. The goal of this paper is to present a systematic roadmap for the choice and application of a restricted randomization procedure in a clinical trial.
METHODS
We survey available restricted randomization procedures for sequential allocation of subjects in a randomized, comparative, parallel group clinical trial with equal (1:1) allocation. We explore statistical properties of these procedures, including balance/randomness tradeoff, type I error rate and power. We perform head-to-head comparisons of different procedures through simulation under various experimental scenarios, including cases when common model assumptions are violated. We also provide some real-life clinical trial examples to illustrate the thinking process for selecting a randomization procedure for implementation in practice.
RESULTS
Restricted randomization procedures targeting 1:1 allocation vary in the degree of balance/randomness they induce, and more importantly, they vary in terms of validity and efficiency of statistical inference when common model assumptions are violated (e.g. when outcomes are affected by a linear time trend; measurement error distribution is misspecified; or selection bias is introduced in the experiment). Some procedures are more robust than others. Covariate-adjusted analysis may be essential to ensure validity of the results. Special considerations are required when selecting a randomization procedure for a clinical trial with very small sample size.
CONCLUSIONS
The choice of randomization design, data analytic technique (parametric or nonparametric), and analysis strategy (randomization-based or population model-based) are all very important considerations. Randomization-based tests are robust and valid alternatives to likelihood-based tests and should be considered more frequently by clinical investigators.
Topics: Computer Simulation; Humans; Likelihood Functions; Random Allocation; Sample Size; Selection Bias
PubMed: 34399696
DOI: 10.1186/s12874-021-01303-z -
International Journal of Surgery... Jun 2022revisional bariatric surgery is gaining increasing interest as long term follow-up studies demonstrate an elevated failure rate of primary surgery due to insufficient... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
revisional bariatric surgery is gaining increasing interest as long term follow-up studies demonstrate an elevated failure rate of primary surgery due to insufficient weight loss, weight regain or complications. This particularly concerns restrictive bariatric surgery which has been widely adopted from the '80s till present through different procedures, notably vertical banded gastroplasty, laparoscopic adjusted gastric banding and sleeve gastrectomy. The aim of this study is to define which revisional bariatric procedure performs the best after failure of primary restrictive surgery.
METHODS
a systematic review and network meta-analysis of 39 studies was conducted following the PRISMA guidelines and the Cochrane protocol.
RESULTS
biliopancreatic diversion with duodenal switch guarantees the best results in terms of weight loss (1 and 3-years %TWL MD: 12.38 and 28.42) followed by single-anastomosis duodenoileal bypass (9.24 and 19.13), one-anastomosis gastric bypass (7.16 and 13.1), and Roux-en-Y gastric bypass (4.68 and 7.3) compared to re-sleeve gastrectomy. Duodenal switch and Roux-en-Y gastric bypass are associated to an increased risk of late major morbidity (OR: 3.07 and 2.11 respectively) compared to re-sleeve gastrectomy while no significant difference was highlighted for the other procedures. Re-sleeve gastrectomy is the revisional intervention most frequently burdened by weight recidivism; compared to it, patients undergoing single-anastomosis duodenoileal bypass have the lowest risk of weight regain (OR: 0.07).
CONCLUSION
considering the analyzed outcomes altogether, single-anastomosis duodenoileal bypass and one-anastomosis gastric bypass are the most performing revisional procedures after failure of restrictive surgery due to satisfying short and mid-term weight loss and low early and late morbidity. Moreover, single-anastomosis duodenoileal bypass has low risk of weight recidivism.
Topics: Bariatric Surgery; Gastrectomy; Gastric Bypass; Humans; Laparoscopy; Morbidity; Network Meta-Analysis; Obesity, Morbid; Reoperation; Retrospective Studies; Weight Gain; Weight Loss
PubMed: 35589051
DOI: 10.1016/j.ijsu.2022.106677 -
CPT: Pharmacometrics & Systems... Feb 2022The full random-effects model (FREM) is a method for determining covariate effects in mixed-effects models. Covariates are modeled as random variables, described by mean...
The full random-effects model (FREM) is a method for determining covariate effects in mixed-effects models. Covariates are modeled as random variables, described by mean and variance. The method captures the covariate effects in estimated covariances between individual parameters and covariates. This approach is robust against issues that may cause reduced performance in methods based on estimating fixed effects (e.g., correlated covariates where the effects cannot be simultaneously identified in fixed-effects methods). FREM covariate parameterization and transformation of covariate data records can be used to alter the covariate-parameter relation. Four relations (linear, log-linear, exponential, and power) were implemented and shown to provide estimates equivalent to their fixed-effects counterparts. Comparisons between FREM and mathematically equivalent full fixed-effects models (FFEMs) were performed in original and simulated data, in the presence and absence of non-normally distributed and highly correlated covariates. These comparisons show that both FREM and FFEM perform well in the examined cases, with a slightly better estimation accuracy of parameter interindividual variability (IIV) in FREM. In addition, FREM offers the unique advantage of letting a single estimation simultaneously provide covariate effect coefficient estimates and IIV estimates for any subset of the examined covariates, including the effect of each covariate in isolation. Such subsets can be used to apply the model across data sources with different sets of available covariates, or to communicate covariate effects in a way that is not conditional on other covariates.
Topics: Humans; Models, Statistical; Research Design
PubMed: 34984855
DOI: 10.1002/psp4.12741 -
Journal of Surgical Education 2021In the United States, the majority of colorectal procedures are performed primarily by nonfellowship trained general surgeons. Given that surgical technique and... (Observational Study)
Observational Study
OBJECTIVE
In the United States, the majority of colorectal procedures are performed primarily by nonfellowship trained general surgeons. Given that surgical technique and experience affect patient outcomes, it is important that general surgeons are well-trained to perform colorectal surgery operations. In this study, we evaluated how prepared general surgery residents were to perform colorectal procedures upon graduating residency.
DESIGN
This was a retrospective observational cohort study. Attending ratings of residents' intraoperative performance were collected with the System for Improving and Measuring Procedural Learning application from 9/2015 to 9/2018. Descriptive analyses and Bayesian mixed models were used to determine a resident's probability of being deemed competent upon graduating residency, controlling for core vs. advanced procedure, case complexity, and rater and resident effects.
SETTING
Faculty and residents within 30 teaching institutions within the Procedural Learning and Safety Collaborative (PLSC).
PATIENTS
We sampled colorectal procedures and categorized them as core or advanced based on American Board of Surgery designations.
RESULTS
A total of 564 residents were rated after 2102 operations (82% core, 18% advanced). A resident in their fifth year of clinical training had a 93% (95% CI 85-97%) adjusted probability of competent performance after a core procedure and 75% (95% CI 55-89%) after an advanced procedure.
CONCLUSIONS
General surgery residents were not universally deemed competent to perform colorectal procedures even at the end of residency. These gaps were more pronounced for advanced colorectal procedures. Current graduation requirements should be carefully reviewed to ensure residents are appropriately trained to meet the needs of their communities. Additionally, advanced training remains a critical resource for surgeons who will perform complex colorectal procedures in practice.
Topics: Bayes Theorem; Clinical Competence; Cohort Studies; Colorectal Neoplasms; Education, Medical, Graduate; General Surgery; Humans; Internship and Residency; United States
PubMed: 33431299
DOI: 10.1016/j.jsurg.2020.12.015 -
Statistics in Medicine Mar 2022In this study, we propose a two-stage procedure for hypothesis testing, where the first stage is conventional hypothesis testing and the second is an equivalence testing...
In this study, we propose a two-stage procedure for hypothesis testing, where the first stage is conventional hypothesis testing and the second is an equivalence testing procedure using an introduced empirical equivalence bound (EEB). In 2016, the American Statistical Association released a policy statement on P-values to clarify the proper use and interpretation in response to the criticism of reproducibility and replicability in scientific findings. A recent solution to improve reproducibility and transparency in statistical hypothesis testing is to integrate P-values (or confidence intervals) with practical or scientific significance. Similar ideas have been proposed via the equivalence test, where the goal is to infer equality under a presumption (null) of inequality of parameters. However, the definition of scientific significance/equivalence can sometimes be ill-justified and subjective. To circumvent this drawback, we introduce the B-value and the EEB, which are both estimated from the data. Performing a second-stage equivalence test, our procedure offers an opportunity to improve the reproducibility of findings across studies.
Topics: Humans; Reproducibility of Results; Research Design
PubMed: 35014082
DOI: 10.1002/sim.9298 -
BMJ Open Nov 2022The prevention of child abuse and neglect is an urgent matter given the serious effects persisting into adulthood, and the increased risk of the offspring of abused...
INTRODUCTION
The prevention of child abuse and neglect is an urgent matter given the serious effects persisting into adulthood, and the increased risk of the offspring of abused children being abusive themselves. Intervening as early as possible may prevent abuse that can begin in infancy. Although several systematic reviews have investigated the effects of interventions on populations who are at increased risk for perpetrating child abuse and neglect, few studies have focused on women or interventions that start during perinatal periods. This study aims to describe a systematic review to examine the effects of interventions to prevent child abuse and neglect that begin during pregnancy and immediately after childbirth (less than 1 year). The study will involve performing a systematic review and meta-analysis based on the latest research articles and a broader literature search.
METHODS AND ANALYSIS
The protocol was prepared using the 2015 statement of Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The literature search will be performed using the MEDLINE, PsycINFO, Embase and Cochrane Central Register of Controlled Trials databases from inception onward. Randomised controlled trials of interventions that begin during pregnancy or the first year postpartum, designed to prevent child abuse and neglect in families who are at increased risk for these issues, will be included. Data collection, quality assessment and statistical syntheses will be conducted by following the methods in the protocol that are predefined. Any index of child maltreatment will be included as a primary outcome. A meta-analysis and sub-group analyses will be considered based on the characteristics of interventions.
ETHICS AND DISSEMINATION
This study does not require ethical approval. The findings will be presented at conferences and will be submitted to a peer-reviewed journal.
PROSPERO REGISTRATION NUMBER
CRD42021266462.
Topics: Pregnancy; Child; Humans; Female; Adult; Research Design; Systematic Reviews as Topic; Meta-Analysis as Topic; Child Abuse; Parents
PubMed: 36410800
DOI: 10.1136/bmjopen-2022-064603 -
BMC Medical Research Methodology Aug 2022For the development of prognostic models, after multiple imputation, variable selection is advised to be applied from the pooled model. The aim of this study is to...
BACKGROUND
For the development of prognostic models, after multiple imputation, variable selection is advised to be applied from the pooled model. The aim of this study is to evaluate by using a simulation study and practical data example the performance of four different pooling methods for variable selection in multiple imputed datasets. These methods are the D1, D2, D3 and recently extended Median-P-Rule (MPR) for categorical, dichotomous, and continuous variables in logistic regression models.
METHODS
Four datasets (n = 200 and n = 500), with 9 variables and correlations of respectively 0.2 and 0.6 between these variables, were simulated. These datasets included 2 categorical and 2 continuous variables with 20% missing at random data. Multiple Imputation (m = 5) was applied, and the four methods were compared with selection from the full model (without missing data). The same analyzes were repeated in five multiply imputed real-world datasets (NHANES) (m = 5, p = 0.05, N = 250/300/400/500/1000).
RESULTS
In the simulated datasets, the differences between the pooling methods were most evident in the smaller datasets. The MPR performed equal to all other pooling methods for the selection frequency, as well as for the P-values of the continuous and dichotomous variables, however the MPR performed consistently better for pooling and selecting categorical variables in multiply imputed datasets and also regarding the stability of the selected prognostic models. Analyzes in the NHANES-dataset showed that all methods mostly selected the same models. Compared to each other however, the D2-method seemed to be the least sensitive and the MPR the most sensitive, most simple, and easy method to apply.
CONCLUSIONS
Considering that MPR is the most simple and easy pooling method to use for epidemiologists and applied researchers, we carefully recommend using the MPR-method to pool categorical variables with more than two levels after Multiple Imputation in combination with Backward Selection-procedures (BWS). Because MPR never performed worse than the other methods in continuous and dichotomous variables we also advice to use MPR in these types of variables.
Topics: Computer Simulation; Humans; Logistic Models; Models, Statistical; Nutrition Surveys; Research Design
PubMed: 35927610
DOI: 10.1186/s12874-022-01693-8