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BMJ Open Jul 2019Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for...
Worldwide, there are at least 230 million invasive procedures performed annually and most of us will undergo several in our lifetime. There is therefore a need for high-quality evidence to underpin this clinical area. Currently, however, there is no widely accepted definition of an invasive procedure and the terms 'surgery' and 'interventional procedure' are characterised inconsistently. We propose a definition for invasive procedures which addresses the limitations of those currently available. Our definition was developed from an analysis of the 3946 papers from the last decade. A preliminary definition was created based on existing definitions and applied to a variety of papers reporting all types of procedures. This definition was continuously updated and applied iteratively to all articles. The definition has three key components: (1) method of access to the body, (2) instrumentation and (3) requirement for operator skill. It therefore encapsulates all types of invasive procedure regardless of the method of access to the body (incision, natural orifice or percutaneous access), and is relevant whatever the clinical discipline (eg, obstetric, cardiac, dental, interventional cardiology or radiology). Crucially, the definition excludes medicinal products, except where their administration occurs within an invasive procedure (and thereby involves operator skill). The application of a universal definition of an invasive procedure will (1) inform the selection of relevant methods for study design, (2) streamline evidence synthesis and (3) improve research tracking, helping to identify evidence gaps and direct research funds.
Topics: Biomedical Research; Humans; Research Design; Surgical Procedures, Operative; Terminology as Topic
PubMed: 31366651
DOI: 10.1136/bmjopen-2018-028576 -
JMIR MHealth and UHealth Sep 2020Body weight variability (BWV) is common in the general population and may act as a risk factor for obesity or diseases. The correct identification of these patterns may...
BACKGROUND
Body weight variability (BWV) is common in the general population and may act as a risk factor for obesity or diseases. The correct identification of these patterns may have prognostic or predictive value in clinical and research settings. With advancements in technology allowing for the frequent collection of body weight data from electronic smart scales, new opportunities to analyze and identify patterns in body weight data are available.
OBJECTIVE
This study aims to compare multiple methods of data imputation and BWV calculation using linear and nonlinear approaches.
METHODS
In total, 50 participants from an ongoing weight loss maintenance study (the NoHoW study) were selected to develop the procedure. We addressed the following aspects of data analysis: cleaning, imputation, detrending, and calculation of total and local BWV. To test imputation, missing data were simulated at random and using real patterns of missingness. A total of 10 imputation strategies were tested. Next, BWV was calculated using linear and nonlinear approaches, and the effects of missing data and data imputation on these estimates were investigated.
RESULTS
Body weight imputation using structural modeling with Kalman smoothing or an exponentially weighted moving average provided the best agreement with observed values (root mean square error range 0.62%-0.64%). Imputation performance decreased with missingness and was similar between random and nonrandom simulations. Errors in BWV estimations from missing simulated data sets were low (2%-7% with 80% missing data or a mean of 67, SD 40.1 available body weights) compared with that of imputation strategies where errors were significantly greater, varying by imputation method.
CONCLUSIONS
The decision to impute body weight data depends on the purpose of the analysis. Directions for the best performing imputation methods are provided. For the purpose of estimating BWV, data imputation should not be conducted. Linear and nonlinear methods of estimating BWV provide reasonably accurate estimates under high proportions (80%) of missing data.
Topics: Computer Simulation; Female; Humans; Longitudinal Studies; Male; Research Design; Weight Loss
PubMed: 32915155
DOI: 10.2196/17977 -
BMC Medical Research Methodology Nov 2021Propensity score matching is a statistical method that is often used to make inferences on the treatment effects in observational studies. In recent years, there has... (Review)
Review
BACKGROUND
Propensity score matching is a statistical method that is often used to make inferences on the treatment effects in observational studies. In recent years, there has been widespread use of the technique in the cardiothoracic surgery literature to evaluate to potential benefits of new surgical therapies or procedures. However, the small sample size and the strong dependence of the treatment assignment on the baseline covariates that often characterize these studies make such an evaluation challenging from a statistical point of view. In such settings, the use of propensity score matching in combination with oversampling and replacement may provide a solution to these issues by increasing the initial sample size of the study and thus improving the statistical power that is needed to detect the effect of interest. In this study, we review the use of propensity score matching in combination with oversampling and replacement in small sample size settings.
METHODS
We performed a series of Monte Carlo simulations to evaluate how the sample size, the proportion of treated, and the assignment mechanism affect the performances of the proposed approaches. We assessed the performances with overall balance, relative bias, root mean squared error and nominal coverage. Moreover, we illustrate the methods using a real case study from the cardiac surgery literature.
RESULTS
Matching without replacement produced estimates with lower bias and better nominal coverage than matching with replacement when 1:1 matching was considered. In contrast to that, matching with replacement showed better balance, relative bias, and root mean squared error than matching without replacement for increasing levels of oversampling. The best nominal coverage was obtained by using the estimator that accounts for uncertainty in the matching procedure on sets of units obtained after matching with replacement.
CONCLUSIONS
The use of replacement provides the most reliable treatment effect estimates and that no more than 1 or 2 units from the control group should be matched to each treated observation. Moreover, the variance estimator that accounts for the uncertainty in the matching procedure should be used to estimate the treatment effect.
Topics: Bias; Humans; Monte Carlo Method; Propensity Score; Sample Size
PubMed: 34809559
DOI: 10.1186/s12874-021-01454-z -
Journal of Applied Physiology... Sep 2020Selecting the most appropriate performance test is critical in detecting the effect of an intervention. In this investigation we ) used time-trial (TT) performance data...
Selecting the most appropriate performance test is critical in detecting the effect of an intervention. In this investigation we ) used time-trial (TT) performance data to estimate sample size requirements for test selection and ) demonstrated the differences in statistical power between a repeated-measures ANOVA (RM-ANOVA) and analysis of covariance (ANCOVA) for detecting an effect in parallel group design. A retrospective analysis of six altitude studies was completed, totaling 105 volunteers. We quantified the test-retest reliability [i.e., intraclass correlation coefficient (ICC) and standard error of measurement (SEM)] and then calculated the standardized effect size for a 5-20% change in TT performance. With these outcomes, a power analysis was performed and required sample sizes were compared among performance tests. Relative to TT duration, the 11.2-km run had the lowest between-subject variance, and thus greatest statistical power (i.e., required smallest sample size) to detect a given percent change in performance. However, the 3.2-km run was the most reliable test (ICC: 0.89, SEM: 81 s) and thus better suited to detect the smallest absolute (i.e., seconds) change in performance. When TT durations were similar, a running modality (11.2-km run; ICC: 0.83, SEM: 422 s) was far more reliable than cycling (720-kJ cycle; ICC: 0.77, SEM: 480 s). In all scenarios, the ANCOVA provided greater statistical power than the RM-ANOVA. Our results suggest that running tests (3.2 km and 11.2 km) using ANCOVA analysis provide the greatest likelihood of detecting a significant change in performance response to an intervention, particularly in populations unaccustomed to cycling. This is the first investigation to utilize time-trial (TT) data from previous studies in simulations to estimate statistical power. We developed an easy-to-use decision aid detailing the required sample size needed to detect a given change in TT performance for the purpose of test selection. Furthermore, our detailed methods can be applied to any scenario in which there is an impact of a stressor and the desire to detect a treatment effect.
Topics: Exercise Test; Humans; Reproducibility of Results; Research Design; Retrospective Studies; Running; Sample Size
PubMed: 32730177
DOI: 10.1152/japplphysiol.00408.2020 -
Pain Physician Mar 2021Vertebroplasty and kyphoplasty are leading treatments for patients with vertebral body compression fractures. Although cement augmentation has been shown to help relieve...
BACKGROUND
Vertebroplasty and kyphoplasty are leading treatments for patients with vertebral body compression fractures. Although cement augmentation has been shown to help relieve pain and instability from fractures containing a cleft, there is some controversy in the literature regarding the procedure's efficacy in these cases. Additionally, some of the literature blurs the distinction between clefts and cement patterns (including cement nonunion and cement fill pattern). Both clefts and cement patterns have been mentioned in the literature as risks for poorer outcomes following cement augmentation, which can result in complications such as cement migration.
OBJECTIVES
This study aims to identify the prevalence of fracture clefts and cement nonunion, the relationship between them as well as to cement fill pattern, and their association with demographics and other variables related to technique and outcomes.
STUDY DESIGN
Retrospective cohort study.
SETTING
Interventional radiology department at a single site university hospital.
METHODS
This retrospective cohort study assessed 295 vertebroplasties/kyphoplasties performed at the University of Colorado Hospital from 2008 to 2018. Vertebral fracture cleft and cement nonunion were the main variables of interest. Presence and characterization of a fracture cleft was determined on pre-procedural imaging, defined as an air or fluid filled cavity within the fractured vertebral body on magnetic resonance or computed tomography. Cement nonunion was evaluated on post-procedural imaging, defined as air or fluid surrounding the cement bolus on magnetic resonance or computed tomography or imaging evidence of cement migration. Cement fill pattern was assessed on procedural and/or post-procedural imaging. Pain improvement scores were based on a visual analog score immediately prior to the procedure and during clinical visits in the short-term follow-up period. Additional patient demographics, medical history, and procedure details were obtained from electronic medical chart review.
RESULTS
Pre-procedural vertebral fracture clefts were demonstrated in 29.8% of our cases. Increasing age, secondary osteoporosis, and thoracolumbar junction location were associated with increased odds of clefts. There was no significant difference in pain improvement outcomes in patients following cement augmentation between clefted and non-clefted compression fractures. Clefts, especially large clefts, and cleft-only fill pattern were associated with increased odds of cement nonunion. Procedure techniques (vertebroplasty, curette, and balloon kyphoplasty) demonstrated similar proportion of cement nonunion and distribution of cement fill pattern.
LIMITATIONS
Cement nonunion was observed in only 6.8% of cases. Due to this low proportion, statistical inference tends to have low power. Multiple levels were treated in nearly half of the study's patients undergoing a single vertebroplasty/kyphoplasty session; in these cases, each level was treated as independent rather than spatially correlated within the same study patient.
CONCLUSIONS
Vertebral body fracture clefts are not uncommon and are related to (but distinct from) cement nonunion and cement fill patterns. Our study shows that, although patients with clefts will benefit from cement augmentation just as much as patients without a cleft, the performing provider should take note of cement fill and take extra steps to ensure optimal cement fill. These providers should also identify cement nonunion and associated complications (such as cement migration) on follow-up imaging.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Middle Aged; Retrospective Studies; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 33740359
DOI: No ID Found -
Journal of Occupational Medicine and... Jan 2024Mild traumatic brain injuries receive voluminous attention in the research literature, but this is confined almost entirely to sports and military contexts. As an...
BACKGROUND
Mild traumatic brain injuries receive voluminous attention in the research literature, but this is confined almost entirely to sports and military contexts. As an occupation, performing stunts in film, television, and entertainment places the head at high risk of repetitive impact and whiplash, but stunt performers do not enjoy the same level of healthcare supervision and access as that provided to sports participants. Therefore, the aim of this study was to evaluate stunt performers' qualitative perceptions of reporting and management of head trauma in their industry.
METHODS
After giving their informed consent, 87 motion picture and television stunt performers responded to a query about their views of ways to improve how stunt performers' occupational head trauma-specifically head impacts and head whips that could cause a concussion-are reported and managed. We analyzed their responses via content and thematic analyses. Two researchers independently marked and categorized key words, phrases, and texts to identify codes that described participants' comments. They then revised, discussed, and resolved coding discrepancies through consensus to establish inter-coder reliability. Next, we identified thematic patterns that described participants' understanding of the stunt performer industry and what must change to facilitate reporting of head trauma. We derived themes from data that occurred multiple times, both within and across short answer responses.
RESULTS
We identified three primary themes cited by the stunt performers as needs in their industry: (1) Need to Reduce the Stigma of Reporting a Stunt-Related Injury, (2) Need to Eliminate the "Cowboy Culture," and (3) Need to Improve the Quality of the Work Environment.
CONCLUSIONS
Stunt performers are crucial members of a global entertainment industry valued at approximately US$100 billion annually. A large segment of the world's population consumes their work in motion pictures, television, and live entertainment. When they are given an anonymous opportunity to speak, stunt performers offer insight into and recommendations for industry changes-primarily cultural and educational in nature-that could improve their physical and mental health, career longevity, and employability when they are confronted with head trauma.
PubMed: 38297318
DOI: 10.1186/s12995-024-00401-0 -
Medicine Aug 2019Several pharmacological treatments are beneficial for patients with irritable bowel syndrome (IBS), and there are numbers of systematic reviews evaluating the... (Review)
Review
INTRODUCTION
Several pharmacological treatments are beneficial for patients with irritable bowel syndrome (IBS), and there are numbers of systematic reviews evaluating the effectiveness of these treatments. However, the overall quality of the evidence has not been quantitatively assessed. The aim of this study is to evaluate the possible biases in the published systematic reviews and determine the treatments with reliable evidence.
METHODS AND ANALYSIS
We will perform an umbrella review to identify eligible systematic reviews. A comprehensive literature search will be conducted in MEDLINE, EMBASE, and the Cochrane library for systematic reviews. We will describe the general information such as participants, interventions, outcome measurements, and conclusion. Additionally, the heterogeneity and inconsistency between trials will be assessed by the I statistical test and Cochrane Q test. We will assess risk of bias, and summarize the strength evidence.
CONCLUSION
The umbrella reviews will assess the reliability of the evidence so that doctors and patients can make better medical choices.
PROSPERO REGISTRATION NUMBER
CRD42018109597.
Topics: Humans; Irritable Bowel Syndrome; Meta-Analysis as Topic; Research Design; Systematic Reviews as Topic
PubMed: 31393342
DOI: 10.1097/MD.0000000000015920 -
BMJ Open Oct 2023Low back pain (LBP) is a major global public health problem and the majority (nearly 90%) of patients with LBP suffer from non-specific LBP (NSLBP). Acupuncture has been...
Dose-response relationship between acupuncture time parameters and the effects on chronic non-specific low back pain: a systematic review and Bayesian model-based network meta-analysis protocol.
INTRODUCTION
Low back pain (LBP) is a major global public health problem and the majority (nearly 90%) of patients with LBP suffer from non-specific LBP (NSLBP). Acupuncture has been widely used for relieving pain and is recommended as a first-line treatment in LBP guidelines. However, the guidelines do not recommend a specific acupuncture temporal dosage. A Bayesian model-based network meta-analysis (MBNMA) will be conducted to optimise the dosages of time parameters (session, frequency and duration).
METHODS AND ANALYSIS
The following databases will be searched from their inception until 1 July 2023: MEDLINE (via PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Web of Science, Cumulative Index to Nursing & Allied Health Literature (CINAHL), alternative health research database (Alt HealthWatch), China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database for Chinese Technical Periodicals, ClinicalTrials.gov, the WHO's International Clinical Trial and Chinese Clinical Registry. RCTs assessing the effects of acupuncture on chronic NSLBP will be selected. The primary outcome measure will be the improvement in pain intensity at different acupuncture time points. The MBNMA will be performed using R V.4.2.1 with related R packages. Risk of Bias V.2.0 and Confidence in Network Meta-Analysis will be used to assess the evidence quality.
ETHICS AND DISSEMINATION
Ethical approval is not required for literature-based studies. The results will be published in peer-reviewed journals or conferences.
PROSPERO REGISTRATION NUMBER
CRD42022336056.
Topics: Humans; Low Back Pain; Bayes Theorem; Network Meta-Analysis; Acupuncture Therapy; China; Research Design; Systematic Reviews as Topic; Meta-Analysis as Topic
PubMed: 37813535
DOI: 10.1136/bmjopen-2023-071554 -
BMJ Open Apr 2023The type of extended adjuvant endocrine therapy is not clear, nor is the optimum duration of extended adjuvant endocrine therapy for patients with early breast cancer....
Optimum duration of extended adjuvant endocrine therapy in patients with hormone receptor-positive breast cancer: protocol for a network meta-analysis of randomised controlled trials.
INTRODUCTION
The type of extended adjuvant endocrine therapy is not clear, nor is the optimum duration of extended adjuvant endocrine therapy for patients with early breast cancer. Our study aims to satisfy the requirements for systematically identifying and synthesising the available evidence on the clinical safety and efficacy of extended adjuvant endocrine therapy for patients with hormone receptor-positive early breast cancer.
METHODS AND ANALYSIS
A comprehensive electronic literature database search will be performed using three electronic databases: PubMed, Cochrane Library and Embase (Ovid interface). Our main outcomes of interest were overall survival, disease-free survival, relapse-free survival, invasive contralateral breast cancer, acceptability and grades 3 and 4 non-haematological toxicities in this study. We will assess the risk of bias and overall quality of evidence using the Cochrane Collaboration's tool and Grades of Recommendation, Assessment, Development and Evaluation, respectively. We will perform subgroup and sensitivity analyses in the selected trials. We will assess the three key assumptions of network meta-analysis: transitivity, consistency and homogeneity.
ETHICS AND DISSEMINATION
The protocol was preregistered in the International Prospective Register of Systematic Reviews (PROSPERO) database. Ethics approval and patient consent are not required for the network meta-analysis. The final results of this network meta-analysis will be disseminated through national and international conferences and published in a peer-reviewed journal.
PROSPERO REGISTRATION NUMBER
CRD42021278271.
Topics: Female; Humans; Breast Neoplasms; Combined Modality Therapy; Meta-Analysis as Topic; Neoplasm Recurrence, Local; Network Meta-Analysis; Randomized Controlled Trials as Topic
PubMed: 37080619
DOI: 10.1136/bmjopen-2022-070972 -
The American Journal of Gastroenterology Oct 2020The American Neurogastroenterology and Motility Society Task Force recommends that gastrointestinal motility procedures should be performed in motility laboratories...
The American Neurogastroenterology and Motility Society Task Force recommends that gastrointestinal motility procedures should be performed in motility laboratories adhering to the strict recommendations and personal protective equipment (PPE) measures to protect patients, ancillary staff, and motility allied health professionals. When available and within constraints of institutional guidelines, it is preferable for patients scheduled for motility procedures to complete a coronavirus disease 2019 (COVID-19) test within 48 hours before their procedure, similar to the recommendations before endoscopy made by gastroenterology societies. COVID-19 test results must be documented before performing procedures. If procedures are to be performed without a COVID-19 test, full PPE use is recommended, along with all social distancing and infection control measures. Because patients with suspected motility disorders may require multiple procedures, sequential scheduling of procedures should be considered to minimize need for repeat COVID-19 testing. The strategies for and timing of procedure(s) should be adapted, taking into consideration local institutional standards, with the provision for screening without testing in low prevalence areas. If tested positive for COVID-19, subsequent negative testing may be required before scheduling a motility procedure (timing is variable). Specific recommendations for each motility procedure including triaging, indications, PPE use, and alternatives to motility procedures are detailed in the document. These recommendations may evolve as understanding of virus transmission and prevalence of COVID-19 infection in the community changes over the upcoming months.
Topics: Advisory Committees; Betacoronavirus; COVID-19; COVID-19 Testing; Clinical Laboratory Techniques; Coronavirus Infections; Gastroenterology; Gastrointestinal Diseases; Gastrointestinal Motility; Humans; Infection Control; Infectious Disease Transmission, Patient-to-Professional; Infectious Disease Transmission, Professional-to-Patient; Laboratories; Pandemics; Patient Selection; Personal Protective Equipment; Pneumonia, Viral; Prevalence; SARS-CoV-2; Societies, Medical; Triage; United States
PubMed: 32868631
DOI: 10.14309/ajg.0000000000000823