Median Sample Size Research Articles

A review of current practice in the design and analysis of extremely small stepped-wedge cluster randomized trials.

Stepped-wedge cluster randomized trials tend to require fewer clusters than standard parallel-arm designs due to the switches between control and intervention conditions, but there are no recommendations for the minimum number of clusters. Trials randomizing an extremely small number of clusters are not uncommon, but the justification for small numbers of clusters is often unclear and appropriate analysis is often lacking. In addition, stepped-wedge cluster randomized trials are methodologically more complex due to their longitudinal correlation structure, and ignoring the distinct within- and between-period intracluster correlations can underestimate the sample size in small stepped-wedge cluster randomized trials. We conducted a review of published small stepped-wedge cluster randomized trials to understand how and why they are used, and to characterize approaches used in their design and analysis. Electronic searches were used to identify primary reports of full-scale stepped-wedge cluster randomized trials published during the period 2016-2022; the subset that randomized two to six clusters was identified. Two reviewers independently extracted information from each report and any available protocol. Disagreements were resolved through discussion. We identified 61 stepped-wedge cluster randomized trials that randomized two to six clusters: median sample size (Q1-Q3) 1426 (420-7553) participants. Twelve (19.7%) gave some indication that the evaluation was considered a "preliminary" evaluation and 16 (26.2%) recognized the small number of clusters as a limitation. Sixteen (26.2%) provided an explanation for the limited number of clusters: the need to minimize contamination (e.g. by merging adjacent units), limited availability of clusters, and logistical considerations were common explanations. Majority (51, 83.6%) presented sample size or power calculations, but only one assumed distinct within- and between-period intracluster correlations. Few (10, 16.4%) utilized restricted randomization methods; more than half (34, 55.7%) identified baseline imbalances. The most common statistical method for analysis was the generalized linear mixed model (44, 72.1%). Only four trials (6.6%) reported statistical analyses considering small numbers of clusters: one used generalized estimating equations with small-sample correction, two used generalized linear mixed model with small-sample correction, and one used Bayesian analysis. Another eight (13.1%) used fixed-effects regression, the performance of which requires further evaluation under stepped-wedge cluster randomized trials with small numbers of clusters. None used permutation tests or cluster-period level analysis. Methods appropriate for the design and analysis of small stepped-wedge cluster randomized trials have not been widely adopted in practice. Greater awareness is required that the use of standard sample size calculation methods can provide spuriously low numbers of required clusters. Methods such as generalized estimating equations or generalized linear mixed models with small-sample corrections, Bayesian approaches, and permutation tests may be more appropriate for the analysis of small stepped-wedge cluster randomized trials. Future research is needed to establish best practices for stepped-wedge cluster randomized trials with a small number of clusters.

The association between maternal immune activation and brain structure and function in human offspring: a systematic review.

Maternal immune activation (MIA) during pregnancy, as a result of infectious or inflammatory stimuli, has gained increasing attention for its potential role in adverse child neurodevelopment, with studies focusing on associations in children born preterm. This systematic review summarizes research on the link between several types of prenatal MIA and subsequent child structural and/or functional brain development outcomes. We identified 111 neuroimaging studies in five MIA areas: inflammatory biomarkers (n = 13), chorioamnionitis (n = 18), other types of infections (n = 18), human immunodeficiency virus (HIV) (n = 42), and Zika virus (n = 20). Overall, there was large heterogeneity in the type of MIA exposure examined and in study methodology. Most studies had a prospective single cohort design and mainly focused on potential effects on the brain up to one year after birth. The median sample size was 53 participants. Severe infections, i.e., HIV and Zika virus, were associated with various types of cerebral lesions (e.g., microcephaly, atrophy, or periventricular leukomalacia) that were consistently identified across studies. For less severe infections and chronic inflammation, findings were generally inconsistent and mostly included deviations in white matter structure/function. Current findings have been mainly observed in the infants' brain, presenting an opportunity for future studies to investigate whether these associations persist throughout development. Additionally, the inconsistent findings, encompassing both regions of interest and null results, call into question whether prenatal exposure to less severe infections and chronic inflammation exerts a small effect or no effect on child brain development.

The Impact of Sedative Choice in the Management of Aneurysmal Subarachnoid Hemorrhage: A Scoping Review.

Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by high mortality and morbidity. This scoping review assesses the current evidence regarding the use of sedatives and analgesics in the acute intensive care unit management of aSAH. We conducted a systematic search of Ovid MEDLINE, Ovid Embase, Ovid EmCare, APA PsycInfo, CINAHL, and the Cochrane Database of Systematic Reviews from inception to June 2023. Studies were included if they enrolled intensive care unit patients aged 18 or older with a significant proportion (> 20%) who had aSAH and evaluated the impact of one or more commonly used analgosedatives on physiological parameters in the management of aSAH. The methodological quality of the studies was assessed using the Methodological Index for Nonrandomized Studies score. Of 2,583 articles, 11 met the inclusion criteria. The median sample size was 47 (interquartile range 10-127), and the median Methodological Index for Nonrandomized Studies score was 9.5 (interquartile range 8-11). The studies' publication years ranged from 1980 to 2023. Dexmedetomidine and ketamine showed potential benefits in reducing the incidence of cortical spreading depolarization and delayed cerebral ischemia. Propofol and opioids appeared safe but lacked robust evidence for efficacy. Benzodiazepines were associated with increased delayed cerebral ischemia-related cerebral infarctions and cortical spreading depolarization events. The evidence available to guide the use of analgosedative medications in aSAH is critically inadequate. Dexmedetomidine and ketamine warrant further exploration in large-scale prospective studies because of their potential benefits. Improved study designs with consistent definitions and a focus on patient-centered outcomes are necessary to inform clinical practice.

Comprehensive assessment of lumpy skin disease prevalence across Asia and African countries: A systematic review and meta-analysis

Lumpy Skin Disease (LSD) stands out as one of the economically significant ailments affecting both small-scale farmers and the broader livestock industry. To gauge its prevalence across Asia and Africa, this study employs a rigorous methodology combining systematic review, and meta-analysis, accounting for heterogeneity. Adhering to the guidelines set forth by the cochrane collaboration’s preferred reporting items for systematic reviews and meta-analysis, present initial search sifted through approximately 6,000 articles spanning from 1990 to 2022, using carefully crafted combinations of keywords; Boolean operators, asterisks, and quotation marks. After meticulous assessment for quality bias, employing inclusion and exclusion criteria, 52 publications were included in present study for analysis. The methodology involved in current study utilizing scientometric tools to determine LSD prevalence, with a median sample size of 293 across various studies, predominantly focusing on cattle and buffaloes. Meta-analysis outcomes were dissected based on parameters such as study period, sample size, tests employed, continents, and species, with samples stratified into two to three categories based on medians for heterogeneity assessment. Meta-analysis unveiled a pooled prevalence rate of 14% in Asia and Africa. The subgroup analysis found an 11% prevalence in Asia and Africa constituted 21%. Clinical observation showed a 19% prevalence followed by other tests and PCR with 12 and 13%, respectively. The results underscore the necessity for effective strategies to control and prevent LSD spread, mitigating its economic impact on the livestock industry. This collaborative and comprehensive assessment is crucial in combating the widespread dissemination of LSD and offers valuable insights for policymakers, veterinarians, and stakeholders in the livestock sector.

Total energy expenditure measured using doubly labeled water in adults with major chronic diseases: a systematic review

BackgroundEnergy requirement assessment is a cornerstone for nutrition practice. The extent to which total energy expenditure (TEE; indicator of energy requirements) has been measured in adults with chronic diseases has not been explored. ObjectivesThis systematic review aimed to characterize evidence on TEE among individuals with chronic diseases and describe TEE across chronic diseases and in comparison to controls without a chronic disease. MethodsA literature search using terms related to doubly labeled water and TEE was conducted in PubMed, MEDLINE, Web of Science, and Embase. Eligible articles included those that measured TEE using doubly labeled water in adults with a major chronic disease. Methodological quality was determined using the Academy of Nutrition and Dietetics quality criteria checklist. Sample size-weighted TEE was calculated in each chronic disease subgroup. ResultsFifty studies were included, of which 15 had a control group. Median sample size was 20 participants, and approximately half of studies were published over 10 y ago. Thirty-five (70%) studies reported resting energy expenditure, and approximately half (k = 26) reported physical activity level. Methodological quality was neutral (k = 25) or positive (k = 23) for most studies. TEE among individual studies ranged from 934 to 3274 kcal/d. Mean weighted TEE was lowest among gastrointestinal (1786 kcal/d) and neurologic (2104 kcal/d) subgroups and highest among cancer (2903 kcal/d), endocrine (2661 kcal/d), and autoimmune (2625 kcal/d) subgroups. Excluding 1 article in cancer survivors resulted in a low TEE in the cancer subgroup (2112 kcal/d). Most studies with a control group reported no differences in TEE between controls and patients; however, only 1 study was powered for between-group comparisons. ConclusionsEnergy requirements vary across chronic diseases, although there is insufficient evidence to suggest that TEE in patients with chronic disease is different than that among controls. Further research is needed to inform energy requirement recommendations that consider chronic disease.This review was registered at PROSPERO as CRD42022336500 (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=336500).

Assessment of LGBTQ+ Diversity, Equity, and Inclusion in Subspecialty Surgery Literature: A Scoping Review

ObjectiveTo identify LGBTQ+ DEI publications and contextualize the current frequency of the literature across subspecialty surgical fields. MethodsA PRISMA systematic review using PubMed, MEDLINE, and Web of Science was conducted in April 2024. Inclusion criteria required intra-field DEI content of defined subspecialties while foreign language literature, poor methodology, and duplicates were excluded. The primary endpoint was the number of publications across subspecialties. Secondary endpoints included publication dates, study design, and sample size. ResultsOf the 702 articles identified, 27 were included. Neurological surgery had 2 studies while plastic surgery, orthopedic surgery, otolaryngology, and thoracic surgery had 11, 7, 5, and 2 respectively. There was a statistically significant different frequency of publications across subspecialties (p = 0.031). Post-hoc residual analysis indicated neurosurgery and thoracic surgery had statistically fewer publications, while plastic surgery had statistically more (p = 0.04, 0.002, 0.21, 0.42, 0.04 for neurological Surgery, plastic surgery, orthopedic surgery, otolaryngology, and thoracic surgery, respectively). Secondary outcomes found a majority of publication dates between 2022 to 2024. Study methodologies involved cross-sectional studies, editorials, and retrospective reviews (14, 11, and 3 respectively) and contained a median sample size of 248.5. ConclusionsThis systematic review provides objective data to contextualize DEI literature across surgical subspecialties. Overall, this review highlights the lack of LGBTQ+ DEI literature within neurosurgery and advocates for correcting this gap for the benefit of both surgeons and patients. Understanding the current numbers and evaluating progress in other surgical fields might provide solutions.

Small-group originating model: Optimized individual-level GWAS simulation featured by SLiM and using open-access data

The development of analytical methods for Genome-wide Association Studies (GWAS) has outpaced the evolution of simulation techniques and pipelines. This disparity underscores the importance of innovative simulation methods that can keep pace with the rapidly increasing scale of GWAS. The median sample size of GWAS over the past ten years has exceeded 50,000 individuals, a trend that emphasizes the need for simulation tools capable of generating data on a similar or larger scale. This paper introduces a novel method, the small-group originating (SGO) model, utilizing the SLiM software for simulating individual-level GWAS data. Our standardized protocol facilitates the generation of tens of thousands of pseudo-individuals with millions of variants from small (30−90) open-access datasets.SGO stands out, especially when compared to the widely-used resampling method in HapGen, showcasing superior simulation efficiency for large sample sizes (> 13,000) of unrelated individuals. This capability is particularly relevant given the current trajectory towards larger GWAS, necessitating tools that can simulate datasets reflective of this growth. Additionally, SGO provides customization options and can model dynamic life cycles and mating across generations, positioning it as a highly promising alternative for GWAS simulations.In a case study, sensitivity analyses of chromosome-level principal component analysis and kinship coefficient estimation were conducted. The results highlighted the poor robustness of chromosome-level quality control (QC) indexes and the uneven distribution of population structure across chromosomes and ancestries, advocating for the caution against relying solely on chromosome-level QC statistics.With its flexible and efficient approach to generating pseudo GWAS data, our standardized SGO protocol emerges as a crucial asset for method development, power analysis, and benchmarking in GWAS research. It is especially vital in the context of accommodating the demands for large-scale simulations, aligning with the current and future scale of GWAS.

Primary outcomes and characteristics of clinical trial registries (up to October 2021) on COVID-19 vaccines.

To analyse the general and primary outcome-related characteristics of clinical trials protocols on COVID-19 vaccines. A meta-research study. A search for clinical trial protocols on COVID-19 vaccines was conducted on the ClinicalTrials.gov platform. We considered all protocols of comparative trials registered up to October 26, 2021. Two hundred and eighty-two trials were analysed. The median expected trial duration was 445 days (interquartile range [IQR] = 225), and the median target sample size was 420 participants (IQR = 1638). A retrospective registry (after the start date) was observed for 42.55% of the trials. Randomization procedures were planned by 84.75% and full-blinding procedures by 34.75% of the 282 trials. Most trials were labelled as active or still recruiting, and 14 trials (5%) were completed. None of the 14 trials labelled as completed on our search date had results available. Industry funding was reported by 198 trials (70.2%). Most studies declared more than one primary outcome, usually a safety or immunogenicity outcome, and 59 studies (20.9%) had at least one primary efficacy outcome. The description of the primary efficacy outcomes was limited in most cases, referred to as a non-specified 'efficacy' outcome (18.6%) or described as 'COVID-19 cases' (32.2%). the primary outcomes of clinical trials on COVID-19 vaccines are poorly described, and the registers provide insufficient information about them. The registry was retrospectively fulfilled for many trials, which may lead to bias and research waste. Outcomes were generically described and did not provide transparent information for replication in practice, further trials or meta-analyses.

A systematic review of fall prediction models for community-dwelling older adults: comparison between models based on research cohorts and models based on routinely collected data.

Prediction models can identify fall-prone individuals. Prediction models can be based on either data from research cohorts (cohort-based) or routinely collected data (RCD-based). We review and compare cohort-based and RCD-based studies describing the development and/or validation of fall prediction models for community-dwelling older adults. Medline and Embase were searched via Ovid until January 2023. We included studies describing the development or validation of multivariable prediction models of falls in older adults (60+). Both risk of bias and reporting quality were assessed using the PROBAST and TRIPOD, respectively. We included and reviewed 28 relevant studies, describing 30 prediction models (23 cohort-based and 7 RCD-based), and external validation of two existing models (one cohort-based and one RCD-based). The median sample sizes for cohort-based and RCD-based studies were 1365 [interquartile range (IQR) 426-2766] versus 90441 (IQR 56442-128157), and the ranges of fall rates were 5.4% to 60.4% versus 1.6% to 13.1%, respectively. Discrimination performance was comparable between cohort-based and RCD-based models, with the respective area under the receiver operating characteristic curves ranging from 0.65 to 0.88 versus 0.71 to 0.81. The median number of predictors in cohort-based final models was 6 (IQR 5-11); for RCD-based models, it was 16 (IQR 11-26). All but one cohort-based model had high bias risks, primarily due to deficiencies in statistical analysis and outcome determination. Cohort-based models to predict falls in older adults in the community are plentiful. RCD-based models are yet in their infancy but provide comparable predictive performance with no additional data collection efforts. Future studies should focus on methodological and reporting quality.

Bayesian Estimation Improves Prediction of Outcomes after Epilepsy Surgery.

Low power is a problem in many fields, as underpowered studies that find a statistically significant result will exaggerate the magnitude of the observed effect size. We quantified the statistical power and magnitude error of studies of epilepsy surgery outcomes. The median power across all studies was 14%. Studies with a median sample size or less (n<=56) and a statistically significant result exaggerated the true effect size by a factor of 5.4 (median odds ratio 9.3 vs. median true odds ratio 1.7), while the Bayesian estimate of the odds ratio only exaggerated the true effect size by a factor of 1.6 (2.7 vs. 1.7). We conclude that Bayesian estimation of odds ratio attenuates the exaggeration of significant effect sizes in underpowered studies. This approach could help improve patient counseling about the chance of seizure freedom after epilepsy surgery.

Systematic review: Patient-related, microbial, surgical, and histopathological risk factors for endoscopic post-operative recurrence in patients with Crohn's disease.

Risk stratification for endoscopic post-operative recurrence (ePOR) in Crohn's disease (CD) is required to identify patients who would benefit most from initiation of prophylactic medication and intensive monitoring of recurrence. To assess the current evidence on patient-related, microbial, surgical and histopathological risk factors for ePOR in patients with CD after ileocolic (re-)resection. Multiple online databases (Embase, MEDLINE, Web of Science and Cochrane Library) were searched up to March 2024. Studies with reported associations of patient-related, microbial, surgical and/or histopathological factors for ePOR (i.e., Rutgeerts' score ≥i2 or modified Rutgeerts' score ≥i2a) were included. The risk of bias was assessed with the Newcastle-Ottawa Scale for observational cohort studies and case-control studies. In total, 47 studies were included (four RCTs, 29 cohort studies, 12 case-control studies, one cross-sectional study and one individual participant data meta-analysis) including 6006 patients (median sample size 87 patients [interquartile range 46-170]). Risk of bias assessment revealed a poor quality in 41% of the studies. An association was reported in multiple studies of ePOR with active smoking at and post-surgery, male sex and prior bowel resection. A heterogeneous association with ePOR was reported for other risk factors included in the current guidelines (penetrating disease, perianal disease, younger age, extensive small bowel disease and presence of granulomas in the resection specimen or myenteric plexitis in the resection margin), and other patient-related, microbial, surgical and histopathological factors. Risk factors for ePOR in international guidelines are not consistently reported as risk factors in current literature except for active smoking and prior bowel resection. To develop evidence-based, personalised strategies, large prospective studies are warranted to identify risk factors for ePOR. Validation studies of promising (bio)markers are also required.

Exploring Sample Size Determination in Educational Research: A Comprehensive Review

Background By conducting an in-depth study of the publications, a review was conducted with the goal of evaluating the sample size in educational research. The sample size, represented by the letter “n,” is a key factor in this research because it specifies the number of participants who represent the target population. Although various studies have been published in the literature defining the processes for calculating sample sizes, there is still much uncertainty. It is vital to understand that there is no single all-encompassing method for determining sample sizes for different study designs. Instead, different study designs call for different approaches to determine sample numbers. Methods Information was retrieved from the databases in accordance with updated PRISMA recommendations. The keywords used for the retrieval of the relevant articles from two databases (Google Scholar and PubMed). The articles were selected by thorough scrutiny and application of inclusion and exclusion criteria. Results Seven articles were selected and the comparison was made among the studies in the relation to methods, objective, and outcome from the enrolled studies. Conclusions The evaluation of the seven studies as a whole concluded that the sample size for testing any novel approach essentially required 24.24 participants in each group. The median sample size for the simulation-based educational research was 30. Further research is required to determine the proper sample size based on a single universal formula for all types of designs.

Comparison of Obstetrical Randomized Controlled Trials in the United States and Abroad [ID 2683467

INTRODUCTION: Research priorities and governing regulations differ between the United States and other nations (non-United States). This study compared the characteristics of U.S. and non-U.S. obstetric randomized controlled trials (RCTs). METHODS: Original research articles published in seven journals (NEJM, JAMA, The Lancet, AJOG, AJOG-MFM, BJOG, and Obstetrics &amp; Gynecology) from 2017 to 2022 were examined, and all RCTs with an obstetric focus were analyzed. Studies were categorized based on whether they were conducted in the United States. RESULTS: Of 238 RCTs in this study, 110 (46.2%) occurred in the United States. Compared to non-U.S. studies, U.S. RCTs were more likely to be published in obstetrics and gynecology journals (90.9% versus 73.4%; P=.001) and to be multicenter studies (59.4% versus 29.9%; P&lt;.001). U.S. RCTs had a smaller median sample size (172 versus 335; P&lt;.001) and a shorter median study length (19.9 versus 28.9 months; P=.026). U.S. RCTs were less likely to study the antepartum period (P&lt;.001), to have a primary outcome examining the fetus/neonate (11.8% versus 37.8%; P&lt;.001), and to study preventative interventions (51.6% versus 68.9%; P=.011). There was no difference in intervention type (drug, behavior, procedure, or device; P=.96) or whether the trial had a positive result (6.0% versus 3.7%; P=.52) between U.S. and non-U.S. studies. CONCLUSION: U.S. RCTs had smaller sample sizes and shorter study lengths, perhaps because of multicenter recruitment. Despite being potentially more generalizable, U.S. studies are less likely to be published in general medical journals. Further research is warranted to pursue this discrepancy as broad dissemination of information is important for improving maternal and fetal outcomes.

Prevalence and factors associated with burnout syndrome in Peruvian health professionals before the COVID-19 pandemic: A systematic review

IntroductionBurnout syndrome (BS) is a prevalent occupational health problem in health professionals. To describe the prevalence and factors associated with BS in Peruvian health professionals. MethodA systematic review and meta-analysis were performed. The key terms “burnout” and “professional exhaustion” were used with words related to Peru. The databases consulted were LILACS/Virtual Health Library, Medline/PubMed, Science Direct, EBSCO, Scopus, SciELO, and RENATI-SUNEDU; articles published between January 2000 to December 2020 were considered for inclusion. Methodological quality was evaluated using the Newcastle–Ottawa scale. ResultsThirty studies were identified (8 scientific articles and 22 graduate theses). The median sample size was 78, with an interquartile range of 50–110. A meta-analysis was performed to calculate a dichotomic prevalence of burnout syndrome in health professionals of 25 % (95%CI: 9 %–45 %; I2 = 97.14 %; 5 studies). Also, our meta-analysis estimated the overall prevalence of mild burnout (27 %; 95%CI: 16%–41 %; I2 = 96.50 %), moderate burnout (48 %; 95%CI: 32%–65 %; I2 = 97.54 %), and severe burnout (17 %; 95%CI: 10%–24 %; I2 = 92.13 %; 18 studies). We present meta-analyses by region, profession, hospital area, and by dimension of the Maslach Burnout Inventory. Overall, the studies presented adequate levels of quality in 96.7 % of the included studies (n = 29). In addition, our narrative review of factors associated with BS and its three dimensions identified that different studies find associations with labor, socio-demographic, individual, and out-of-work factors. ConclusionsThere is a higher prevalence of moderate BS in Peruvian health professionals at MINSA and EsSalud hospitals in Peru, with severity differing by region of Peru, type of profession, work area, and dimensions of BS.

Psychometric properties and domains covered by patient-reported outcome measures used in trials assessing interventions for chronic pain

ObjectivesTo identify the patient-reported outcome measures (PROMs) used in clinical trials assessing interventions for chronic pain, describe their psychometric properties, and the clinical domains they cover. Study Design and SettingWe identified phase 3 or 4 interventional trials: on adult participants (aged >18 years), registered in clinicaltrials.gov between January 1, 2021 and December 31, 2022, and which provided “chronic pain” as a keyword condition. We excluded diagnostic studies and phase 1 or 2 trials. In each trial, one reviewer extracted all outcomes registered and identified those captured using PROMs. For each PROM used in more than 1% of identified trials, two reviewers assessed whether it covered the six important clinical domains from the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain, emotional functioning, physical functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition (eg, adherence to medication). Second, reviewers searched PubMed for both the initial publication and latest review reporting the psychometric properties of each PROM and assessed their content validity, structural validity, internal consistency, reliability, measurement error, hypotheses testing, criterion validity, and responsiveness using published criteria from the literature. ResultsIn total, 596 trials assessing 4843 outcomes were included in the study (median sample size 60, interquartile range 40–100). Trials evaluated behavioral (22%), device-based (21%), and drug-based (10%) interventions. Of 495 unique PROMs, 55 were used in more than 1% trials (16 were generic pain measures; 8 were pain measures for specific diseases; and 30 were measures of other symptoms or consequences of pain). About 50% PROMs had more than 50% of psychometric properties rated as sufficient. Scales often focused on a single clinical domain. Only 25% trials measured at least three clinical domains from IMMPACT. ConclusionHalf of PROMs used in trials assessing interventions for chronic pain had sufficient psychometric properties for more than 50% of criteria assessed. Few PROMs assessed more than one important clinical domain. Only 25% of trials measured more than 3/6 clinical domains considered important by IMMPACT.

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

ObjectiveInternational trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international...

Access to colorectal cancer screening in populations in China, 2020: A coverage-focused synthesis analysis.

In populations in China, colorectal cancer (CRC) screening can be mainly accessed through organized screening, opportunistic screening, and physical examination. This screening intervention is found to be effective but the exact coverage rate is difficult to measure. Based on data from published articles, official websites, and available program reports, the screening coverage rate and related indicators were quantified. A rapid review was then conducted to estimate the overall and the breakdown coverage rates of the sub-type screening services, by leveraging the numbers of articles and the by-type median sample sizes. Up to 2020, two central government-funded and four provincial/municipal-level organized CRC screening programs have been initiated and included in this analysis. For populations aged 40-74, the estimated coverage rate of organized programs in China was 2.7% in 2020, and the 2-year cumulative coverage rate in 2019-2020 was 5.3% and the 3-year cumulative coverage rate in 2018-2020 was 7.7%. The corresponding coverage rates of 50-74-year-olds were estimated to be 3.4%, 7.1%, and 10.3%, respectively. Based on the rapid review approach, the overall screening coverage rate for 40-74 years, considering organized screening programs, opportunistic screening, and physical examinations, was then estimated to be 3.0% in China in 2020. However, comparing the findings of this study with the number of health check-ups reported in the local national health statistics yearbooks suggeststhat the number of CRC physical examinations may be underestimated in this study. The findings suggest that further efforts are needed to improve population access to CRC screening in China. Furthermore, evidence for access to opportunistic CRC screening and physical examination is limited, and more quantitative investigation is needed.

O262: Evaluating the role and efficacy of virtual reality and simulation in teaching acute and trauma scenarios – a systematic review

Abstract Introduction Simulation allows trainees to practice skills safely and is the current gold standard method of teaching. More recently, novel methods such as virtual reality (VR) and augmented reality are being explored as possible methods of teaching. Aims To evaluate the current evidence pertaining to simulation and VR as methods of teaching in teaching acute and trauma management. Methods A systematic review was conducted using the PRISMA guidelines. Medline and Embase (via Ovid interface) were used to search for articles up to March 2023. The following MeSH terms were used: ‘(virtual reality OR VR) AND (acute surgical OR surgery OR trauma OR trauma management) AND (medical education OR education OR surgical training OR training) AND simulation’. Results A total of 3815 articles were identified. 2648 were screened upon de-duplication. 40 articles underwent full-text review; 14 were extracted. Prospective cohort studies were the most common, 43.8%. Experimental studies included a total of 436 participants, with a median sample size of 23 (IQR:14–32). 6 studies compared VR to simulation methods. Half of these articles indicated favourable conclusions towards VR training compared to standard training. A further 8 studies evaluated feasibility of VR training only – all had favourable outcomes for VR. Conclusion This review identified a range of evidence indicating that VR can be useful for training of acute surgical scenarios. VR was generally a well-received training modality although unlikely to replace simulation entirely. More robust statistical analysis in further studies is required, with investigation into the longer-term impact of VR training.

Compression for preventing recurrence of venous ulcers.

Up to 1% of adults will have a leg ulcer at some time. Most leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or damaged valves. Venous ulcer prevention and treatment typically involves the application of compression bandages/stockings to improve venous return and thus reduce pressure in the legs. Other treatment options involve removing or repairing veins. Most venous ulcers heal with compression therapy, but ulcer recurrence is common. For this reason, clinical guidelines recommend that people continue with compression treatment after their ulcer has healed. This is an update of a Cochrane review first published in 2000 and last updated in 2014. To assess the effects of compression (socks, stockings, tights, bandages) for preventing recurrence of venous leg ulcers. In August 2023, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, three other databases, and two ongoing trials registries. We also scanned the reference lists of included studies and relevant reviews and health technology reports. There were no restrictions on language, date of publication, or study setting. We included randomised controlled trials (RCTs) that evaluated compression bandages or hosiery for preventing the recurrence of venous ulcers. At least two review authors independently selected studies, assessed risk of bias, and extracted data. Our primary outcome was reulceration (ulcer recurrence anywhere on the treated leg). Our secondary outcomes included duration of reulceration episodes, proportion of follow-up without ulcers, ulceration on the contralateral leg, noncompliance with compression therapy, comfort, and adverse effects. We assessed the certainty of evidence using GRADE methodology. We included eight studies (1995 participants), which were published between 1995 and 2019. The median study sample size was 249 participants. The studies evaluated different classes of compression (UK class 2 or 3 and European (EU) class 1, 2, or 3). Duration of follow-up ranged from six months to 10 years. We downgraded the certainty of the evidence for risk of bias (lack of blinding), imprecision, and indirectness. EU class 3 compression stockings may reduce reulceration compared with no compression over six months (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.27 to 0.76; 1 study, 153 participants; low-certainty evidence). EU class 1 compression stockings compared with EU class 2 compression stockings may have little or no effect on reulceration over 12 months (RR 1.70, 95% CI 0.67 to 4.32; 1 study, 99 participants; low-certainty evidence). There may be little or no difference in rates of noncompliance over 12 months between people using EU class 1 stockings and people using EU class 2 stockings (RR 1.22, 95% CI 0.40 to 3.75; 1 study, 99 participants; low-certainty evidence). UK class 2 hosiery compared with UK class 3 hosiery may be associated with a higher risk of reulceration over 18 months to 10 years (RR 1.55, 95% CI 1.26 to 1.91; 5 studies, 1314 participants; low-certainty evidence). People who use UK class 2 hosiery may be more compliant with compression treatment than people who use UK class 3 hosiery over 18 months to 10 years (RR for noncompliance 0.69, 95% CI 0.49 to 0.99; 5 studies, 1372 participants; low-certainty evidence). There may be little or no difference between Scholl UK class 2 compression stockings and Medi UK class 2 compression stockings in terms of reulceration (RR 0.77, 95% CI 0.47 to 1.28; 1 study, 166 participants; low-certainty evidence) and noncompliance (RR 0.97, 95% CI 0.84.1 to 12; 1 study, 166 participants; low-certainty evidence) over 18 months. No studies compared different lengths of compression (e.g. below-knee versus above-knee), and no studies measured duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. Compression with EU class 3 compression stockings may reduce reulceration compared with no compression over six months. Use of EU class 1 compression stockings compared with EU class 2 compression stockings may result in little or no difference in reulceration and noncompliance over 12 months. UK class 3 compression hosiery may reduce reulceration compared with UK class 2 compression hosiery; however, higher compression may lead to lower compliance. There may be little to no difference between Scholl and Medi UK class 2 compression stockings in terms of reulceration and noncompliance. There was no information on duration of reulceration episodes, ulceration on the contralateral leg, proportion of follow-up without ulcers, comfort, or adverse effects. More research is needed to investigate acceptable modes of long-term compression therapy for people at risk of recurrent venous ulceration. Future trials should consider interventions to improve compliance with compression treatment, as higher compression may result in lower rates of reulceration.

Fragility index analysis for randomized controlled trials of approved biologicals and small molecule drugs in inflammatory bowel diseases

IntroductionBiologics and small molecules have been increasingly applied in Crohn’s disease (CD) and ulcerative colitis (UC). But the robustness of their trials has not been evaluated. MethodsWe initially collected all the approved biologics or small molecules for CD or UC up to December 1, 2022. Databases were then queried by keywords in chemical name and CD or UC. Randomized controlled trials (RCTs) in the two-arm, 1:1 design were included. Fragility index (FI) and fragility quotient (FQ) were subsequently calculated. ResultsWe included twenty-eight RCTs, including nine pivotal trials listed in approval labels, nineteen non-pivotal trials not included in the labels. The median sample size was 99 [IQR, 60–262] and the median number of loss-of-follow-up (LFU) was 14 [IQR, 8–43]. Pivotal trials in the labels had the median FI of 8 [IQR, 4–14, n = 6] that was marginally higher than non-pivotal trials (3 [IQR, 2–4], p = 0.08). The median FQ was 0.0330 [IQR, 0.1220–0.0466] and 0.0310 [IQR, 0.0129–0.0540] for pivotal and non-pivotal trials, respectively (p = 1.0). The sample size and FI were significantly correlated (Spearman correlation coefficient [r] = 0.56, 95 %CI 0.21–0.78, p = 0.003). The number of total events was also significantly correlated with FI (r = 0.53, 95 %CI 0.17–0.77, p = 0.006). Study p-values were significantly associated with FI (p = 0.01): trials with p-values < 0.001 had the highest median FI of 10 [IQR, 6–17]. No factor was found strongly correlated with FQ. ConclusionResults from trials assessing administration-approved biologics or small molecules for treating CD or UC were vulnerable to small changes by measuring FI or FQ. Pivotal studies contributing to regulatory approvals exhibited a relatively higher degree of resilience compared to non-pivotal trials.