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Background and Aim: Gastric cancer is an important malignancy worldwide due to high lethality, and it accounted for 20% of all cancers in 2017. Because the internet is increasingly used for health information, it is necessary to have tools that establish the quality of medical-related sites. Much of the information found on the Internet is non-compliant, posing a danger to patients and putting their lives at risk. The study aimed to evaluate the quality of the information about the treatment of gastric, hepatic, pancreatic, and colorectal cancer using the Brief Discern instrument and to test if the Brief Discern scores correlated with the websites’ credibility, completeness, and accuracy. Materials and Methods: This study included the first 25 websites listed on Google for each cancer, employing the most common search terms. Web sources were assessed using the Brief Discern, a six-question tool derived from the DISCERN instrument, which was developed to help patients to assess the quality of written information concerning treatment. Brief DISCERN scores can range from 5 for the poorest websites to 30. Credibility, completeness, and accuracy of information were graded on a scale from 0 to 10. Results: The mean Brief DISCERN score of the study sample was 19.0 (SD=5.7). The subsamples had the following mean Brief DISCERN scores: gastric cancer 21.7 (SD=5.0); colorectal cancer 16.4 (SD=6.4); hepatic cancer 18.7 (SD=5.4), and pancreatic cancer 19.0 (SD=5.0). The Kruskal-Wallis test showed a statistically significant difference (p=0.0137). The Brief DISCERN scores were correlated with the credibility (rho=0.3059, p=0.002) and completeness scores (rho=0.3952, p

Background and Aim: AI-powered chatbots are expected to revolutionize patients’ access to health information but their ability to provide comprehensive and scientifically accurate answers is insufficiently known. The study aimed to assess the completeness and accuracy of information regarding two cardiovascular and two oncological diseases of high interest to health information seekers. Materials and Methods: The completeness and accuracy of the information about acute myocardial infarction, peripheral artery disease, colorectal and gastric cancer provided by three AI chatbots (ChatGPT–Open AI, Gemini–Google, Llama–Meta) were evaluated against an evidence-based information quality benchmark on a scale ranging from 0 to 10. Chatbot prompting followed two basic scenarios, plausible for most users: (A) a single broad-scoped question; (B) a series of focused questions covering basic information about disease definition, causes, risk factors, symptoms, treatment and prevention. Responses were rated against evidence-based, disease-specific quality benchmarks following a predefined procedure. Data were collected between October 2023 and May 2024. Overall and chatbot-specific mean completeness, and accuracy scores were calculated. Results: Scenario A yielded an overall completeness score of 5.4, while bot-specific scores were 6.3 for ChatGPT, 5.1 for Gemini, and 5.0 for Llama. The overall accuracy score was 6.6, and bot-specific scores were 7.0 for ChatGPT, 6.1 for Gemini, and 6.5 for Llama. Scenario B showed an overall accuracy score of 8.1 with the following bot-specific accuracy scores: ChatGPT 8.6, Gemini 8.2, and Llama 7.6. The completeness score was not applicable within the second scenario. Conclusions: The overall completeness of the information provided by the three studied AI-powered chatbots about the four investigated diseases was moderate. The overall accuracy scores were high in case of the first scenario and very high in the second one. ChatGPT performed slightly better than the other two bots on both quality measures.

AimsTo assess the diagnostic accuracy and time impact of the 4AT scale in emergency department triage.MethodsA Prospective diagnostic accuracy study was carried out. People aged ≥65 years presenting to the emergency department from 1 November 2021 to 30 June 2022 were included. Nurses opportunistically screened eligible patients using the 4AT scale during triage according to the Manchester Triage System Francesc de Borja Hospital emergency department, Gandía (Spain). Accuracy was compared with medical diagnosis of delirium. Time (seconds) spent in triage with and without screening was assessed.ResultsThe study included 370 patients (55.1% men, mean age 81.8 years), of whom 58.4% (n = 216) were screened. A final diagnosis of delirium was made in 41.4% of those screened. The most frequently used presentational flow charts and discriminators were ‘behaving strangely’ (15%) and ‘rapid onset’ (33.3%). The highest accuracy was obtained for a score of 3 points or more (sensitivity 85.1%; specificity 66.9%; positive predictive value 52.8%; negative predictive value 71.7%). No significant differences were found in the time spent in triage according to the performance of screening.ConclusionA score of 3 points or more on the 4AT scale enables rapid detection of delirium in emergency department triage, without consuming more time than conventional triage.

Purpose: The aim of this study was accuracy assessment of placed implants in full-arch cases using specific software and hardware to perform static computer-assisted implantology and immediately loaded prostheses. The degree of deviation existing between planned and achieved implants was carried out by a new noninvasive measurement procedure of the implant position performed on stone casts. Materials and Methods: Fourteen stone casts retrieved from 14 full-arch fully guided implant treatments were selected to perform the study. Each cast, manufactured for the surgical treatment by using a specific laboratory kit, was obtained from the respective surgical guide. A sleeve for each implant was embedded into the guide, which helped the examiners to manufacture a stone cast per guide containing the implant analogs, which was used to recover the final position of the planned implants. A total sample of 60 implants were assessed. The postoperative casts, poured to produce the immediate prostheses, were then processed by a contact (or tactile) scanner, and the generated standard tessellation language (STL) files were overlapped (best-fit alignment) using engineering software that revealed all the measured discrepancies. In terms of accuracy, differences relating to arch, assessed bone quality, implant length, and drill length (prolongation short or long) were reported. Results: The use of a noninvasive tactile scanner revealed mean entry point horizontal deviations of 0.30 mm (SD: 0.39 mm), mean entry point vertical deviations of 0.20 mm (SD: 0.25 mm), mean apical horizontal deviations of 0.50 mm (SD: 0.73 mm), and mean apical vertical deviations of 0.24 mm (SD: 0.28 mm). The frontal and lateral angular deviations were investigated, and corresponding mean values of 1.99 degrees (SD: 2.30 degrees) and 1.80 degrees (SD: 2.44 degrees) were detected. Conclusion: The reported results demonstrate that the contact tactile scan is a viable and biologic way to assess implant deviations. [ABSTRACT FROM AUTHOR]

Abstract Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real world evidence are much less expensive than randomized clinical trials that do not rely on “real world evidence” such as contained in electronic health records (EHR). Consequently, we can expect an increase in the number of reports of these types of trials, which we identify here as ‘EHR-sourced trials.’ ‘In this selected literature review, we discuss the various designs and the ethical issues they raise. EHR-sourced trials have the potential to improve/increase common data elements and other aspects of the EHR and related systems. Caution is advised, however, in drawing causal inferences about the relationships among EHR variables. Nevertheless, we anticipate that EHR-CTs will play a central role in answering research and regulatory questions.

Objectives To build a data set capturing the whole breast cancer screening journey from individual breast cancer screening records to outcomes and assess data quality. Methods Routine screening records (invitation, attendance, test results) from all 79 English NHS breast screening centres between January 1, 1988 and March 31, 2018 were linked to cancer registry (cancer characteristics and treatment) and national mortality data. Data quality was assessed using comparability, validity, timeliness, and completeness. Results Screening records were extracted from 76/79 English breast screening centres, 3/79 were not possible due to software issues. Data linkage was successful from 1997 after introduction of a universal identifier for women (NHS number). Prior to 1997 outcome data are incomplete due to linkage issues, reducing validity. Between January 1, 1997 and March 31, 2018, a total of 11 262 730 women were offered screening of whom 9 371 973 attended at least one appointment, with 139 million person-years of follow-up (a median of 12.4 person years for each woman included) with 73 810 breast cancer deaths and 1 111 139 any-cause deaths. Comparability to reference data sets and internal validity were demonstrated. Data completeness was high for core screening variables (>99%) and main cancer outcomes (>95%). Conclusions The ATHENA-M project has created a large high-quality and representative data set of individual women's screening trajectories and outcomes in England from 1997 to 2018, data before 1997 are lower quality. Advances in knowledge This is the most complete data set of English breast screening records and outcomes constructed to date, which can be used to evaluate and optimize screening. [ABSTRACT FROM AUTHOR]

Background: The Manchester University National Health Service (NHS) Foundation Trust (MFT) is one of the largest NHS Trusts in England. Historically, the Trust has had very mixed clinical record keeping, including over 1000 individual information systems. None of these health information technology systems had the full functionality of an integrated electronic patient record (EPR). MFT evolved to its current size and complexity with a vision to improve patient care in Greater Manchester by adopting a Trust-wide EPR. The EPR "Go Live" occurred in September 2022. Aim: To describe the process of EPR integration as it reflected and impacted upon MFT's health information management (HIM) teams. Method: MFT worked through a 2-year readiness program of work. This included technical readiness, software development and migration planning. Migration of data from the approximately 1000 systems was a major undertaking, during which access to the clinical history and ongoing operational reporting needed to be maintained. Pre-implementation requirements were outlined, a change management program was implemented, and the overall implementation was managed to tight timelines. Discussion: "Go Live" was achieved for the EPIC EPR product (HIVE) within MFT. Legacy systems are still in the process of being decommissioned and staff are transacting within HIVE. Significant changes in processes and reporting continue to be made, despite some challenges. Conclusion: The Trust delivered the single largest EPIC European "Go live." Lessons learnt continue to be identified. The impact of what the EPR means for the HIM function is described. [ABSTRACT FROM AUTHOR]

The development of an information society that prefers quick and remote resolution of issues, including on the Internet, raises the issue of protecting information and data disseminated and provided by personal data subjects. People do not want to transmit personal information without a clear understanding that it will be protected and not used, or to transfer it unnecessarily to third parties, because most of this information is identifying and personal, and in some cases even «sensitive». In this case, persons who transfer, process, or store personal data must be guided by legal grounds that determine the course of such actions. The fundamental concepts that must be followed in any operations with personal data are the principles. Principles are the basic framework that everyone in this process must adhere to, and failure to do so entails legal liability. The institute of personal data protection is relatively new, therefore, with the development of this institute, legislation at various levels develops and improves the basic provisions and general principles of personal data protection. At present, the general principles of personal data processing and protection can be summarised as: transparency, fairness, lawfulness, purpose limitation, data minimisation, data accuracy, data retention period limitation, data security and the princ iple of accountability. Such principles are enshrined in the General Data Protection Regulation and meet the main goal, namely to define the standards on the basis of which personal data should be collected, processed, transferred, stored, and destroyed. The existence of such principles and, most importantly, their consolidation in regulatory legal acts that are binding for all and are primarily necessary to preserve and not restrict the right to privacy and the right to protection of personal data, the right to privacy. The general principles of legitimate operations with personal information provide for notification of the person who provides his/her personal data about the purpose of processing and all the details concerning future actions with the provided information and regulation, limitation and determination of liability for violation of the principles of processing and protection of personal data for the person who further carries out the specified operations. [ABSTRACT FROM AUTHOR]

Objectives: This systematic review and meta-analysis evaluated the diagnostic accuracy of CT and MRI for differentiating atypical lipomatous tumors and malignant liposarcomas from benign lipomatous lesions. Methods: MEDLINE, EMBASE, Scopus, the Cochrane Library, and the gray literature from inception to January 2022 were systematically evaluated. Original studies with > 5 patients evaluating the accuracy of CT and/or MRI for detecting liposarcomas with a histopathological reference standard were included. Meta-analysis was performed using a bivariate mixed-effects regression model. Risk of bias was evaluated using Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). This study is registered on PROSPERO, number CRD42022306479. Results: Twenty-six studies with a total of 2613 patients were included. Mean/median reported patient ages ranged between 50 and 63 years. The summary sensitivity and specificity of radiologist gestalt for detecting liposarcomas was 85% (79–90% 95% CI) and 63% (52–72%), respectively. Deep depth to fascia, thickened septations, enhancing components, and lesion size (≥ 10 cm) all demonstrated sensitivities ≥ 85%. Other imaging characteristics including heterogenous/amorphous signal intensity, irregular tumor margin, and nodules present demonstrated lower sensitivities ranging from 43 to 65%. Inter-reader reliability for radiologist gestalt within studies ranged from fair to substantial (k = 0.23–0.7). Risk of bias was predominantly mixed for patient selection, low for index test and reference standard, and unclear for flow and timing. Conclusion: Higher sensitivities for detecting liposarcomas were achieved with radiologist gestalt, deep depth to fascia, thickened septations, enhancing components, and large size. Combined clinical and imaging scoring and/or radiomics both show promise for optimal performance, though require further analysis with prospective study designs. Clinical relevance: This pooled analysis evaluates the accuracy of CT and MRI for detecting atypical lipomatous tumors and malignant liposarcomas. Radiologist gestalt, deep depth to fascia, thickened septations, enhancing components, and large size demonstrate the highest overall sensitivities. Key Points: • The summary sensitivity and specificity of radiologist gestalt for detecting liposarcomas was 85% (79–90% 95% CI) and 63% (52–72%), respectively. • Radiologist gestalt, deep depth to fascia, thickened septations, enhancing components, and large tumor size (≥ 10 cm) showed the highest sensitivities for detecting atypical lipomatous tumors/well-differentiated liposarcomas and malignant liposarcomas. • A combined clinical and imaging scoring system and/or radiomics is likely to provide the best overall diagnostic accuracy, although currently proposed scoring systems and radiomic feature analysis require further study with prospective study designs. [ABSTRACT FROM AUTHOR]

Background Cone-beam computed tomography (CBCT) has several applications in various fields of dental medicine such as diagnosis and treatment planning. When compared to computed tomography (CT), CBCT's radiation exposure dose is decreased by 3%–20%. However, CBCT produces more scattered signals and may present poorer image quality when compared to medical CT. Objectives To review the findings regarding the accuracy of multi-detector computed tomography (MDCT) and CBCT and to compare the different software programs that segment the upper airway. Search methods Three databases (PubMed, Medline, and Web of Science) were searched for articles and a manual search was performed. Selection criteria The inclusion criteria were defined following the PICO framework: P—any patient with a CBCT or CT; I—dimensional evaluation of the upper airway using MDCT or CBCT; C—phantoms; O—the primary outcome was MDCT and CBCT accuracy, the secondary outcome was the evaluation and comparison of software programs used to segment the upper airway. Data collection and analysis Articles that met eligibility criteria were assessed using the Critical Appraisal Skills Program Checklist. Results Among the 16 eligible studies, 6 articles referred to the accuracy of MDCTs or CBCTs and 10 to the accuracy of the software. Most articles were qualified as high quality. Conclusions MDCT and CBCT scans' accuracy in upper airway dimensional measurements depends on machine brand, parameters, and segmentation technique. Regarding the segmentation technique, 12 programs were studied. Most either underestimated or overestimated upper airway measurements. In particular, OnDemand3D and INVIVO showed poor accuracy. On the contrary, Invesalius, and MIMICS were accurate in assessing nasal cavities when using an interactive threshold. However, results varied due to methodological differences among the studies. Finally, fully automatic segmentation based on artificial intelligence may represent the future of airway segmentation because it is faster and seems to be accurate. However, further studies are necessary. Registration This study was registered in Prospero (International Prospective Register of Systematic Reviews) with the ID number CRD42022373998. [ABSTRACT FROM AUTHOR]

Brain-computer interfaces (BCI) are a channel that implements direct communication between the brain and some external unit. Developments of BCIs can provide new application opportunities in a large number of fields of use. In the development of BCI devices, the development of technology and digital technology represented a big change, as it provided the necessary computing power to implement and run the continuously developing signal processing algorithms that ensure processing and evaluation. The aim of this paper is to provide an overview of BCI research results which were published in the engineering field. In the present study, articles that had a greater impact, where the annual average number of citations is greater than 30, in the BCI field were reviewed and processed in a systematic way, in order to make individual research more comparable. The systematic processing was focused on the aims of application, used device/dataset, applied data process and achieved best accuracy. This systematic study summarizes the most effective methods used in the BCI processing and highlights the future trends. The results showed an accuracy of 85% thanks to increasingly reliable, accurate and cost-effective signal detection and processing devices, as well as algorithms. [ABSTRACT FROM AUTHOR]

Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real world evidence are much less expensive than randomized clinical trials that do not rely on "real world evidence" such as contained in electronic health records (EHR). Consequently, we can expect an increase in the number of reports of these types of trials, which we identify here as 'EHR-sourced trials.' 'In this selected literature review, we discuss the various designs and the ethical issues they raise. EHR-sourced trials have the potential to improve/increase common data elements and other aspects of the EHR and related systems. Caution is advised, however, in drawing causal inferences about the relationships among EHR variables. Nevertheless, we anticipate that EHR-CTs will play a central role in answering research and regulatory questions. [ABSTRACT FROM AUTHOR]

In order to improve the accuracy and reliability of the collected data, the weighted information fusion algorithm and the Kalman filtering fusion algorithm in multi-sensor data fusion technology are researched and improved. Firstly, the definition of multi-sensor data fusion and the basic working principle of multi-sensor data fusion are expounded. Structural models of multi-sensor data fusion are introduced, the existing problems of multi-sensor data fusion are analyzed, the development trend of data fusion is pointed out. Secondly, the multi-sensor data fusion algorithms are analyzed, the weighted information fusion fusion algorithm and Kalman filtering algorithm in multi-sensor data fusion technology are focused on. Aiming at the deficiency of the weighted information fusion algorithm, an information fusion algorithm combining the jackknife method and the adaptive weighted method is proposed, and the basic steps of the improved fusion algorithm are given. The algorithm makes full use of the observed values and the estimated values of each historical moment, Quenouille estimation on the estimated values is performed by constructing pseudo-values. On the basis of the traditional Kalman filtering algorithm, an improved filtering algorithm is proposed, and a new state estimation equation is derived, which both treats the field value to prevent the filtering divergence, and introduces the observed value at the next moment to the state estimate at the current moment. Finally, improved fusion algorithms are applied and simulated in intelligent monitoring systems. Application and simulation results show that improved fusion algorithms are effective and superior, they have high reliability and anti-interference performances, the accuracy of the data is greatly increased, and they play a positive role in promoting the wide application of multi-sensor data fusion technology. [ABSTRACT FROM AUTHOR]

This study evaluates the agreement of data on dental caries between electronic dental records and data retrieved from the national SKaPa-registry (Swedish Quality Registry for caries and periodontal disease), with special reference to e/M in deft/DMFT. In a random sample of 500 6- and 12-year-old children having received dental care in 2014 in the county region of Värmland, Sweden, the diagnostic accuracy of data in electronic dental records with corresponding data obtained from the SKaPa-registry was compared by using Cohen's Kappa and Intraclass correlation coefficient (ICC). For dft/DFT the Kappa was 0.95, and ICC 0.98 (total population). For deft/DMFT in the total population the Kappa was 0.80 and ICC 0.96. For 6-year-olds (deft) the Kappa was 0.89 and ICC 0.99 and for 12-year-olds (DMFT) the Kappa was 0.70, and ICC 0.83. The corresponding figures for Kappa and ICC when excluding individuals without caries (deft/DMFT = 0) were: Total population 0.63 and 0.94; 6-year-olds 0.79 and 0.99; 12-year-olds 0.42 and 0.68. Agreement between data in the dental records and SKaPa was very high for dft/DFT confirming that transfer from the dental records to the SKaPa-registry is safe and correct. As the accuracy of deft/DMFT was considerably lower than for dft/DFT we advise against using deft/DMFT data from SKaPa for research purposes at this point. [ABSTRACT FROM AUTHOR]

Spatio-temporal heterogeneous data is the database for decisionmaking in many fields, and checking its accuracy can provide data support for making decisions. Due to the randomness, complexity, global and local correlation of spatiotemporal heterogeneous data in the temporal and spatial dimensions, traditional detection methods can not guarantee both detection speed and accuracy. Therefore, this article proposes a method for detecting the accuracy of spatiotemporal heterogeneous data by fusing graph convolution and temporal convolution networks. Firstly, the geographic weighting function is introduced and improved to quantify the degree of association between nodes and calculate theweighted adjacency value to simplify the complex topology. Secondly, design spatiotemporal convolutional units based on graph convolutional neural networks and temporal convolutional networks to improve detection speed and accuracy. Finally, the proposed method is compared with three methods, ARIMA, T-GCN, and STGCN, in real scenarios to verify its effectiveness in terms of detection speed, detection accuracy and stability. The experimental results show that the RMSE, MAE, and MAPE of this method are the smallest in the cases of simple connectivity and complex connectivity degree, which are 13.82/12.08, 2.77/2.41, and 16.70/14.73, respectively. Also, it detects the shortest time of 672.31/887.36, respectively. In addition, the evaluation results are the same under different time periods of processing and complex topology environment, which indicates that the detection accuracy of this method is the highest and has good research value and application prospects. [ABSTRACT FROM AUTHOR]

ABSTRACT Objective: This study evaluated the accuracy and precision of digital models acquisition using a home-built, low-cost scanning system based on the structured light method. Methods: a plaster model (PM) was scanned using the experimental device (SL) and a dental desktop scanner (DS). The teeth dimensions of PM and SL models were measured in triplicate, with a caliper and digitally, respectively. The agreement of the measurements of each model was evaluated using the intraclass correlation coefficient, and the validity between the different measurement techniques was assessed using the Bland-Altman analysis. The accuracy and precision of the models were qualitatively investigated using the mesh superposition of the SL and DS models. Results: A high intraclass correlation coefficient was observed in all models (PM=0.964; SL1=0.998; SL2=0.995; SL3=0.998), and there was no statistical difference between the measurements of the SL models (p>0.05). PM and SL model measurements were found to be in good agreement, with only 3.57% of the observed differences between the same measurement being located outside 95% limits of agreement according to Bland and Altman (0.43 and -0.40 mm). In the superimpositions of SL-SL and SL-DS models, areas of discrepancy greater than 0.5 mm were observed mainly in interproximal, occlusal, and cervical sites. Conclusion: These results indicate that the home-built SL scanning system did not possess sufficient accuracy and precision for many clinical applications. However, the consistency in preserving the dental proportions suggests that the equipment can be used for planning, storage, and simple clinical purposes.

Abstract Repositioning guides are commonly employed in clinical studies to ensure consistent tooth color measurements. Yet, their influence on measured color remains uncertain. Objective This study evaluated the impact of repositioning guides’ color and usage on tooth color measurement using a clinical spectrophotometer. Methodology In total, 18 volunteers participated in this study, in which the color of their upper left central incisor and upper left canine was measured with or without repositioning guides (control). The guides were made from pink, blue, or translucent silicone, as well as an acetate-based bleaching tray. Tooth color was measured in triplicates using a clinical spectrophotometer based on the CIELAB system. The standard deviations of these readings were used to estimate reproducibility, and color differences (ΔE00) between the measurements with guides and the control were calculated. Results Repositioning guides had a minimal effect on L* values and no effect on b* values. The use of pink silicone increased a* values, whereas blue or translucent silicone reduced them. Irrespective of the evaluated tooth, the lowest ΔE00 values were observed for the translucent silicone and bleaching tray. The usage of guides only affected data variability for the L* color coordinate. Conclusion Using repositioning guides can significantly impact the precision of tooth color measurement with a clinical spectrophotometer.

Introduction There are two main data sources for perinatal data in Ontario, Canada: the BORN BIS and CIHI-DAD. Such databases are used for perinatal health surveillance and research, and to guide health care related decisions. Objectives Our primary objective was to examine the level of agreement between the BIS and CIHI-DAD. Our secondary objectives were to identify the differences between the data sources when identifying a low-risk birth (LRB) cohort and to understand their implications. Methods We conducted a population-based cohort study comparing characteristics and clinical outcomes of all linkable births in BIS and CIHI-DAD between 1$^{\rm st}$ April 2012 and 31$^{\rm st}$ March 2018. We excluded out-of-hospital births, those with invalid healthcare numbers, non-Ontario residents and gestational age < 20 weeks. We compared the portion of the cohort that met the criteria of a provincial definition of LRB based on each data source and compared clinical outcomes between the groups. Results During the study period, 779,979 eligible births were linkable between the two data sources. After applying the LRB exclusions, there were 129,908 cases in the BIS and 136,184 cases in CIHI-DAD. Most exclusion criteria had almost perfect, substantial or moderate agreement. The agreement for non-cephalic presentation and BMI ≥ 40 kg/m2 (kappa coefficients 0.409 and 0.256, respectively) was fair. Comparison between the two LRB cohorts identified differences in the prevalence of cesarean (14.3% BIS versus 12.0% CIHI-DAD) and NICU admission (8.7% BIS versus 7.5% CIHI-DAD) and only 0.01% difference in the prevalence of ICU admission. Conclusions Overall, we found high levels of agreement between the BIS and CIHI-DAD. Identifying a LRB cohort in either database may be appropriate, with the caveat of appropriate understanding of the collection, coding and definition of certain outcomes. The decision for selecting a database may depend on which variables are most important in a particular analysis.

ABSTRACT Objective: To build and validate an instrument to evaluate Lean Healthcare in healthcare institutions. Method: Methodological study conducted in three stages: 1) Instrument construction; 2) Content validity using the Delphi technique with 14 experts; and 3) Construct validation using Structural Equation Modeling with sample consisted of 113 professionals with experience in Lean Healthcare. Data collection carried out from October/2020 to January/2021 using a digital form. Data analysis performed with the SmartPLS2.0/M3 software. Results: Items were developed after an integrative review and divided into the dimensions Structure, Process and Outcome, according to Donabedian’s theoretical framework. Content validation in two rounds of the Delphi technique. Final instrument, after model adjustment, containing 16 items with Cronbach’s alpha of 0.77 in Structure, 0.71 in Process and 0.83 in Outcome. Conclusion: The instrument presented evidence of validity and reliability, enabling its use in healthcare institutions to evaluate Lean Healthcare.

Short-term probabilistic forecasts of the trajectory of the COVID-19 pandemic in the United States have served as a visible and important communication channel between the scientific modeling community and both the general public and decision-makers. Forecasting models provide specific, quantitative, and evaluable predictions that inform short-term decisions such as healthcare staffing needs, school closures, and allocation of medical supplies. Starting in April 2020, the US COVID-19 Forecast Hub (https://covid19forecasthub.org/) collected, disseminated, and synthesized tens of millions of specific predictions from more than 90 different academic, industry, and independent research groups. A multimodel ensemble forecast that combined predictions from dozens of groups every week provided the most consistently accurate probabilistic forecasts of incident deaths due to COVID-19 at the state and national level from April 2020 through October 2021. The performance of 27 individual models that submitted complete forecasts of COVID-19 deaths consistently throughout this year showed high variability in forecast skill across time, geospatial units, and forecast horizons. Two-thirds of the models evaluated showed better accuracy than a naïve baseline model. Forecast accuracy degraded as models made predictions further into the future, with probabilistic error at a 20-wk horizon three to five times larger than when predicting at a 1-wk horizon. This project underscores the role that collaboration and active coordination between governmental public-health agencies, academic modeling teams, and industry partners can play in developing modern modeling capabilities to support local, state, and federal response to outbreaks.

Abstract Background The Norwegian Trauma Registry (NTR) is designed to monitor and improve the quality and outcome of trauma care delivered by Norwegian trauma hospitals. Patient care is evaluated through specific quality indicators, which are constructed of variables reported to the registry by certified registrars. Having high-quality data recorded in the registry is essential for the validity, trust and use of data. This study aims to perform a data quality check of a subset of core data elements in the registry by assessing agreement between data in the NTR and corresponding data in electronic patient records (EPRs). Methods We validated 49 of the 118 variables registered in the NTR by comparing those with the corresponding ones in electronic patient records for 180 patients with a trauma diagnosis admitted in 2019 at eight public hospitals. Agreement was quantified by calculating observed agreement, Cohen’s Kappa and Gwet’s first agreement coefficient (AC1) with 95% confidence intervals (CIs) for 27 nominal variables, quadratic weighted Cohen’s Kappa and Gwet’s second agreement coefficient (AC2) for five ordinal variables. For nine continuous, one date and seven time variables, we calculated intraclass correlation coefficient (ICC). Results Almost perfect agreement (AC1 /AC2/ ICC > 0.80) was observed for all examined variables. Nominal and ordinal variables showed Gwet’s agreement coefficients ranging from 0.85 (95% CI: 0.79–0.91) to 1.00 (95% CI: 1.00–1.00). For continuous and time variables there were detected high values of intraclass correlation coefficients (ICC) between 0.88 (95% CI: 0.83–0.91) and 1.00 (CI 95%: 1.00–1.00). While missing values in both the NTR and EPRs were in general negligeable, we found a substantial amount of missing registrations for a continuous “Base excess” in the NTR. For some of the time variables missing values both in the NTR and EPRs were high. Conclusion All tested variables in the Norwegian Trauma Registry displayed excellent agreement with the corresponding variables in electronic patient records. Variables in the registry that showed missing data need further examination.

BackgroundThe World Health Organization (WHO) has endorsed the next-generation Xpert MTB/RIF Ultra (Ultra) cartridge, and Uganda is currently transitioning from the older generation Xpert MTB/RIF (Xpert) cartridge to Ultra as the initial diagnostic test for pulmonary tuberculosis (TB). We assessed the diagnostic accuracy of Ultra for pulmonary TB among adults in Kampala, Uganda.MethodsWe sampled adults referred for Xpert testing at two hospitals and a health center over a 12-month period. We enrolled adults with positive Xpert and a random 1:1 sample with negative Xpert results. Expectorated sputum was collected for Ultra, and for solid and liquid culture testing for Xpert-negative patients. We measured sensitivity and specificity of Ultra overall and by HIV status, prior history of TB, and hospitalization, in reference to Xpert and culture results. We also assessed how classification of results in the new "trace" category affects Ultra accuracy.ResultsAmong 698 participants included, 211 (30%) were HIV-positive and 336 (48%) had TB. The sensitivity of Ultra was 90.5% (95% CI 86.8-93.4) and specificity was 98.1% (95% CI 96.1-99.2). There were no significant differences in sensitivity and specificity by HIV status, prior history of TB or hospitalization. Xpert and Ultra results were concordant in 670 (96%) participants, with Ultra having a small reduction in specificity (difference 1.9, 95% CI 0.2 to 3.6, p=0.01). When "trace" results were considered positive for all patients, sensitivity increased by 2.1% (95% CI 0.3 to 3.9, p=0.01) without a significant reduction in specificity (- 0.8, 95% CI - 0.3 to 2.0, p=0.08).ConclusionsAfter 1 year of implementation, Ultra had similar performance to Xpert. Considering "trace" results to be positive in all patients increased case detection without significant loss of specificity. Longitudinal studies are needed to compare the benefit of greater diagnoses to the cost of overtreatment.

The application of next-generation sequencing extends from microbial identification to epidemiologic insight and antimicrobial resistance prediction. Despite this potential, the roadblock for clinical laboratories lies in implementation and validation of such complex technology and data analysis. Herein, a validation study used whole-genome sequencing (WGS) for pan-bacterial identification (ID) in a clinical laboratory, and assessed its clinical relevance. A diverse set of 125 bacterial isolates, including a subset without genus (25) and/or species (10) ID, were analyzed by de novo assembly and reference genome mapping. The 16S rRNA, rpoB, and groEL genes were used for ID. Using WGS, 100% (89 of 89) and 89% (79 of 89) of isolates were identified at the genus and species-levels, respectively. WGS also provided improved results for 71% (25/35) isolates originally reported with genus-only or descriptive IDs. Chart review identified cases in which improved genus and/or species-level ID by WGS may have had a positive impact on patient care. Reasons included the use of an ineffective antibiotic owing to unclear ID, use of antibiotics when not clinically indicated, and help with an outbreak investigation. The implementation of next-generation sequencing in a clinical microbiology setting is a challenging but necessary task. This study provides a model for the validation and implementation of bacterial ID by WGS in such a setting.

Objective We aimed to systematically characterize reporting missing quality of life (QoL) data in oncology randomized controlled trials (RCTs) and to estimate prevalence of adequate reporting according to existing guidelines. Study Design and Setting This cross-sectional analysis includes all articles on anti-cancer drugs tested in RCTs in six high impact medical/oncology journals, published between January 2015 and May 2020, that reported QoL outcomes. From 1942 identified articles, 215 (11%) met inclusion criteria. Data abstracted included whether compliance for QoL assessment were reported, whether results from a missing data statistical analysis were reported, whether articles met current recommendations for reporting missing data in QoL assessments. Results The results from a missing data statistical analysis were available in 22 trials (10.2%). Overall, 16 trials (7.4%) met current recommendations for reporting missing data in QoL assessments. Articles specifically reporting on QoL or patient reported outcomes were more likely to meet recommendations than other reports (P < 0.0001). Conclusion This systematic cross-sectional study found that most oncology RCTs reporting on QoL do not report adequately on missing data in QoL, with only 7.4% of trials meeting current reporting guidelines. The possibility of informative censoring, therefore, cannot be assessed in most of trials.

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The current review explores multiple definitions of school shootings used by myriad data collection platforms and by various scholars. Importantly, the impacts of definitional discrepancies on inclusion criteria, data divergence, research, policy, and public perception are discussed at length. The review concludes with a call to Criminologists and school gun violence scholars to better collaborate on what should be considered a “school shooting” and lists five benefits that may result from modifying school gun violence definitions and data collection methodologies.

Three-dimensional soft tissue simulation has become a popular tool in the process of virtual orthognathic surgery planning and patient–surgeon communication. To apply 3D soft tissue simulation software in routine clinical practice, both qualitative and quantitative validation of its accuracy are required. The objective of this study was to systematically review the literature on the accuracy of 3D soft tissue simulation in orthognathic surgery. The Web of Science, PubMed, Cochrane, and Embase databases were consulted for the literature search. The systematic review (SR) was conducted according to the PRISMA statement, and 40 articles fulfilled the inclusion and exclusion criteria. The Quadas-2 tool was used for the risk of bias assessment for selected studies. A mean error varying from 0.27 mm to 2.9 mm for 3D soft tissue simulations for the whole face was reported. In the studies evaluating 3D soft tissue simulation accuracy after a Le Fort I osteotomy only, the upper lip and paranasal regions were reported to have the largest error, while after an isolated bilateral sagittal split osteotomy, the largest error was reported for the lower lip and chin regions. In the studies evaluating simulation after bimaxillary osteotomy with or without genioplasty, the highest inaccuracy was reported at the level of the lips, predominantly the lower lip, chin, and, sometimes, the paranasal regions. Due to the variability in the study designs and analysis methods, a direct comparison was not possible. Therefore, based on the results of this SR, guidelines to systematize the workflow for evaluating the accuracy of 3D soft tissue simulations in orthognathic surgery in future studies are proposed.

Genomic data are being produced and archived at a prodigious rate, and current studies could become historical baselines for future global genetic diversity analyses and monitoring programs. However, when we evaluated the potential utility of genomic data from wild and domesticated eukaryote species in the world's largest genomic data repository, we found that most archived genomic datasets (86%) lacked the spatiotemporal metadata necessary for genetic biodiversity surveillance. Labor-intensive scouring of a subset of published papers yielded geospatial coordinates and collection years for only 33% (39% if place names were considered) of these genomic datasets. Streamlined data input processes, updated metadata deposition policies, and enhanced scientific community awareness are urgently needed to preserve these irreplaceable records of today's genetic biodiversity and to plug the growing metadata gap.

Objective:To compare and analyze the precision, accuracy, and reliability of commonly used cone-beam computed tomography (CBCT) software in predicting the mesiodistal diameter of impacted canines.Methods:This study was conducted on 11 patients (six males and five females, mean age: 17.5±5.5 years) with either unilateral or bilateral impacted canines in the maxilla or mandible. DICOM data sets of the patients obtained from CBCT scans were then loaded and visualized with four selected CBCT software to measure the widest mesiodistal diameter of the impacted teeth. Physical measurements using a digital vernier caliper, kept as a control, were also made on the extracted teeth and orthodontically erupted teeth. The collected data underwent statistical analysis, and the statistical significance level was set at p

Background/Aims Administrative databases provide valuable information for large-cohort studies. This study aimed to evaluate the diagnostic accuracy of an administrative database for resected gastric adenomas. Methods Data of patients who underwent endoscopic resection for benign gastric lesions were collected from three hospitals. Gastric adenoma cases were identified in the hospital database using International Classification of Diseases (ICD) 10-codes. The non-adenoma group included patients without gastric adenoma codes. The diagnostic accuracy for gastric adenoma was analyzed based on the pathological reports of the resected specimen. Results Among 5,095 endoscopic resections with codes for benign gastric lesions, 3,909 patients were included in the analysis. Among them, 2,831 and 1,078 patients were allocated to the adenoma and non-adenoma groups, respectively. Regarding the overall diagnosis of gastric adenoma with ICD-10 codes, the sensitivity, specificity, positive predictive value, and negative predictive value were 98.7%, 88.5%, 95.2%, and 96.8%, respectively. There were no significant differences in these parameters between the tertiary and secondary centers. Conclusions Administrative codes of gastric adenoma, according to ICD-10 codes, showed good accuracy and can serve as a useful tool to study prognosis of these patients in real-world data studies in the future.

Background and Objective: One of the primary challenges faced by telehealth systems is the accurate transmission of patient information to remote doctors. In this context, portable medical sensors deployed at the remote patients' end play a crucial role in measuring vital information. There are many sensors available in the market. However, the accuracy of the sensors has been always a concern. The objective of this study is to verify different sensors and create awareness for using accurate sensors to avoid misdiagnosis for the patients’ safety. Methods: This study considered the test result of a Japanese clinical pathology laboratory as the reference gold standard. The clinical pathology laboratory uses 1) Hexokinase UV method for blood glucose, 2) Enzymatic Determination method for cholesterol, 3) Automatic Analyzer (EDTA-2 K) of Hemoglobin, and 4) Uricase POD method for uric acid. To assess the performance of a medical sensor, its test results were compared to the gold standard test results obtained from the laboratory using the same sample. A Normalized Root Mean Square Error (NRMSE) threshold of less than 0.2 was established as the criterion for determining whether the medical sensor's performance fell within an acceptable range. Results: Among the eight most commonly used blood glucose devices in the Asian market, only one device was deemed acceptable with NRMSE less than 0.2. However, all four devices found in the Japanese market showed their acceptability. In the case of cholesterol, hemoglobin, and uric acid devices, only a limited number of items were available in Asian markets. Some of the hemoglobin and uric acid devices were found to be somewhat acceptable, while all the cholesterol sensors were found erroneous. Conclusions: This study has clearly shown the issues with the portable medical sensors and recommends the device approval authority of each country to approve sales of the quality sensors only for patients’ safety.

Resumen: Objetivo: Evaluar el sistema de información en salud (SIS) de México según la información reportada a la Organización para la Cooperación y el Desarrollo Económicos (OCDE). El fin último es evidenciar las mejoras que se deberían considerar. Método: Se analizan indicadores sobre salud publicados por la OCDE (2017 a 2021) según 11 grupos temáticos. Se valoraron cobertura (cantidad y tipo de indicadores reportados por grupo temático) y calidad de la información, según lineamientos de la OCDE. Resultados: México reportó anualmente 14 de 378 indicadores (3,7%) y de forma discontinua 204. En ningún grupo se reportaron anualmente todos los indicadores, excepto los dos sobre COVID-19. Se reportan anualmente tres de 88 sobre utilización de servicios y ninguno sobre estado de salud, calidad de la atención y mercado farmacéutico. Con calidad óptima y reporte anual fueron 12 indicadores (5,5% de los reportados por México, 3,2% del set completo OCDE). El 57,7% de los indicadores reportados tuvieron al menos un defecto de calidad. Conclusiones: En el marco de los estándares marcados por la OCDE, de la cual México es miembro, el SIS mexicano presenta déficits importantes de cobertura y de calidad de la información. Estos resultados deberían considerarse para implementar iniciativas de mejora. Abstract: Objective: To evaluate the health information system (HIS) of Mexico according to the information reported to the Organization for Economic Co-operation and Development (OECD). The ultimate goal is to identify the improvements that should be considered. Method: Health indicators published by the OECD (2017 to 2021) are analyzed according to 11 thematic groups. Coverage (quantity and type of indicators reported by thematic group) and quality of information were assessed, according to OECD guidelines. Results: Mexico reported annually 14 of 378 indicators (3.7%), and discontinuously 204. In no group were all indicators reported annually, except for the two on COVID-19. Three out of 88 were reported annually on use of services; and none on health status, quality of care and pharmaceutical market. Twelve indicators (5.5% of those reported by Mexico, 3.2% of the full OECD set) had optimal quality and annual reporting. 57.7% of the reported indicators had at least one quality defect. Conclusions: Within the framework of the standards set by the OECD, of which Mexico is a member, the Mexican HIS presents significant deficits in coverage and quality of information. These results should be considered to implement improvement initiatives.

Background Randomised controlled trials (‘trials’) are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures Number of host trials funded. Results Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information. Plain language summary Aims of the research A Study Within A Trial is a research study nested inside a larger ‘host trial’, promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. Background The best way to test health and social care treatments is to do a randomised controlled trial (‘trial’), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Methods Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. Results We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found ‘pre-notifying’ before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Conclusions Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future. Scientific summary Background Many delivery aspects of randomised controlled trials (RCTs) have not been subjected to rigorous evaluation. Strategies to enhance recruitment and retention often tend to not be based on evidence. However, there is an increasing interest in embedding RCTs of such strategies. The Medical Research Council (MRC) funded systematic techniques for assisting recruitment to trials (START), which found it feasible to test two strategies for recruitment and retention across a number of trials by performing randomised ‘Studies Within A Trial (SWATs)’. Aims The aim of the PROMoting THE USE of Studies Within A Trial (PROMETHEUS) programme was to build on the START initiative and make embedding SWATs standard practice across Clinical Trials Units (CTUs). We intended to pump prime and facilitate the start of at least 25 SWATs across multiple CTUs within 30 months. The ultimate aim was to make the inclusion of SWATs routine when conducting a trial in a CTU. We share our experience of delivering the PROMETHEUS programme, along with the lessons learnt for undertaking randomised SWATs of recruitment and retention methods. Methods A network of 10 CTUs and one primary care research centre committed to conducting randomised controlled SWATs of recruitment and/or retention interventions was established by the PROMETHEUS team. We identified promising recruitment and retention interventions from a variety of sources including Cochrane systematic reviews, the Northern Ireland Network for Trial Methodology Research SWAT Repository Store, and existing prioritisation exercises. Promising strategies were reviewed by our patient and public (PPI) members to create an initial priority list of seven recruitment and eight retention interventions. The programme allowed host trial teams to apply for funding of up to £5000 and receive support from the PROMETHEUS team to design, implement and report SWATs. We also tested the feasibility of undertaking co-ordinated SWATs, across multiple host trials simultaneously. Results The PROMETHEUS programme funded 42 SWATs, embedded within 31 host trials, across 12 CTUs. The mean cost of a funded SWAT was £3535. Of the 42 SWATs, 12 tested the same SWAT across multiple host trials using a co-ordinated SWAT design and four tested more than one strategy in a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. In the space of just 4 years, PROMETHEUS will add 18% more SWATs to the Cochrane review of global recruitment strategies, and 79% more SWATs to the Cochrane review of global retention strategies. The results from the SWATs reported to date found there was no evidence of a significant difference in recruitment for any of the strategies tested. For retention, pre-notifying participants by card prior to sending questionnaires was effective [risk difference 3.3%, 95% confidence interval (CI) −3.0% to 9.6%]; as was pre-notifying participants by letter or e-mail (risk difference 3.8%, 95% CI −6.1% to 13.6%). Sending personalised text messages was more effective for improving the return of postal questionnaires compared to non-personalised text messages (risk ratio 1.16, 95% CI 1.00 to 1.33); and resulted in fewer completions via telephone compared with a non-personalised text [adjusted odds ratio (OR) 0.44, 95% CI 0.22 to 0.87]. Including a pen with a questionnaire probably increases retention and response rate (pooled OR 1.21, 95% CI 1.09 to 1.35). We highlight key lessons learnt below (see Recommendations section). Conclusions The PROMETHEUS programme significantly increased the international evidence base for both recruitment and retention strategies within RCTs. The funded SWATs evaluated a wide range of recruitment and retention strategies; however, the COVID-19 pandemic negatively impacted five funded SWATs, with two being delayed and three prematurely terminated. Through this project, we identified that when provided with both funding and practical support, host trial teams successfully implemented SWATs. PROMETHEUS led to an overall increase in the evidence base; however, ongoing ‘routine’ application of SWATs across RCTs employing the lessons learnt is required to ensure that efficient trial conduct strategies are identified. Recommendations Recommendations for funders All trial funders should contribute to the effort to improve the efficiency of trials. Funders should encourage the teams that they fund to undertake SWATs. Funding streams specifically designed to support SWATs must be made available to trial teams to continue building the trial process evidence base, for recruitment and retention as well as for other stages of the trial design and delivery process. This includes funding streams for undertaking specific SWATs, as well as infrastructure funding to support CTUs and other centres to undertake co-ordination activities that will support the design, conduct, reporting, and implementation of SWATs and their findings to inform the work of the National Institute for Health and Care Research (NIHR), the MRC, and other funders. PROMETHEUS has demonstrated that co-ordination of activity remains crucial to the delivery of SWATs. A central, national co-ordination point that provides hands-on support needs to continue and funding should be allocated for this. Additionally, CTUs should identify a lead for SWATs, to support SWAT activities and evidence-based trial conduct within the CTU, as well as links with others undertaking SWATs elsewhere to share best practice. The funding for both central and CTU-based support should be ongoing. SWAT priorities need to be identified and communicated clearly to funders, and funders should use these priorities to inform their funding decisions. Funders should develop a mechanism to promote SWAT questions that have been identified as a priority during the funding application process. The mean cost of funding requested for a standalone SWAT within PROMETHEUS was £3535 (range £500–5000). The co-ordinated SWATs cost was £10,668 (training SWAT) and £1306.40 (Christmas cards); however, these did not include costs for central co-ordination, data preparation and sharing by the host trial teams, data cleaning, analysis and write-up. These costs suggest that the £10,000 being offered by the NIHR for trial teams to include a SWAT should be sufficient for most planned SWATs. However, there may be occasions where trial teams may wish to test strategies that may be more expensive. When applying for SWAT funding, trial teams should be asked to indicate whether the question they are addressing is a priority SWAT question, and to provide a clear rationale for selecting that particular question. If teams are unable to undertake a SWAT, funders should ask that recruitment and retention methods are clearly reported to support the evidence base. Recommendations for Sponsors Our experience suggests that there is a need for clear, easily accessible information about the nature of SWATs, as well as the role of the funder in supporting SWATs. Any future changes proposed by the Health Research Authority (HRA) to the approvals process need to be communicated clearly and applied consistently to each SWAT. Recommendations for involving patient and public involvement partners in Studies Within A Trial research PPI should be considered when undertaking a SWAT, in the same way PPI is expected to be undertaken in the main trial. PPI partners should be involved to develop novel and untested recruitment and retention strategies, as well as to adapt existing strategies to the context of their specific host trial and the population being enrolled. Recommendations for oversight committees Our experience suggests that Trial Management Groups (TMGs) play a key role in decisions about whether a SWAT is undertaken and continued in the host trial or not. TMG members should encourage the uptake of SWATs in their trials. While the findings of SWATs may not always directly inform their host trial, the findings of SWATs undertaken during the early, or internal pilot, phase of the trial may inform the decisions about which strategies should be used at a later stage, such as in the main trial. Trial Steering Committees should review the SWAT activity and progress, in the same way that they review substudies in a trial. Data Monitoring Committee review is dependent on the specific host trial and SWAT strategy being evaluated. Recommendations for journals and reviewers Journal peer reviewer profiles should be updated to include methodological interests and expertise, to support evidence of suitability to undertake a peer review for a SWAT. When selecting peer reviewers, the SWAT and methodology interests as registered by reviewers should be used where possible. SWATs are a niche area and so to increase the pool of reviewers, journals should consider being more flexible when assessing reviewer credentials to review a SWAT, such as allowing relevant experience in place of a PhD. Reviewers should be advised that in many instances informed consent from participants need not be obtained when undertaking a SWAT, due to the low risk associated with the intervention and in the case of retention SWATs due to existing consent for further research being in place. This may depend on the jurisdiction. In the UK, this approach is supported by HRA guidance in relation to grading for SWAT interventions and approvals. Robust and transparent reporting is necessary, that is compliant with CONsolidated Standards Of Reporting Trials (CONSORT). Recommendations for trial teams and methodologists undertaking SWAT research There remains a need for continually updated research priorities to allow researchers to address the questions relevant at that time. When SWAT priorities are set, methodologists need to provide enough information to enable teams to make informed decisions about evaluating the priorities set. Further work is needed to help teams identify suitable SWAT strategies for their host trials. SWAT priorities need to be communicated clearly and consistently to trial teams. Recommendation for trial conduct and using SWAT evidence As the evidence base develops for effective and cost-effective recruitment and retention strategies, it will become increasingly important for trial teams to use this evidence base to inform their recruitment and retention activities. Trial teams need to actively engage with the evidence base to inform their practice. Funders will need to actively support the trials they fund to use evidence-informed recruitment and retention strategies. Recommendations for future research There remains a substantial need for more high-quality SWAT evidence and so Chief Investigators should be encouraged to consider the embedding of a SWAT at the funding stage. Further work is therefore needed to increase the awareness of the methodological importance of SWAT research with research teams, and to develop engagement strategies to increase SWAT activity. Future research needs to focus on identifying whether further replications are needed for existing evidence. If so, the gaps in the evidence base should be targeted. More co-ordination and replication of SWAT evaluations are encouraged. A ‘real-time’ and dynamic communication strategy including a clear cost and resource breakdown for each suggested SWAT should be developed. This will alleviate the burden on trials teams to begin costing exercises and enable them to make an informed decision more quickly as to whether they can embed a given SWAT. There is a need to aid teams to identify and select a suitable SWAT for their host trial populations. Pragmatic decisions on which SWAT may be appropriate and feasible to include should be taken as required. A mechanism to communicate SWAT research priorities is needed, and this information needs to be readily accessible for all trialists to refer to. Our findings demonstrate that within an individual host trial, there is often a capacity to address more than one SWAT question, either separately, or simultaneously using a factorial design. This suggests that there is a capacity to significantly speed up and strengthen the evidence base through teams undertaking more than one SWAT in their trials where relevant. For certain strategies, co-ordinated SWATs should be encouraged. This method could be used to rapidly replicate SWAT evaluations to plug the evidence gap, as well as to evaluate more complex recruitment and retention strategies that may be more challenging to undertake using individual SWATs. Materials should be developed to advise teams on how to undertake co-ordinated SWATs, as well as a method of networking to enable teams to promote their co-ordinated SWAT and collaborate. As the evidence base develops, it will become increasingly important for trialists to utilise the evidence base in a systematic way to identify both effective and ineffective strategies to inform their practice. Future work should therefore consider issues around the dissemination and implementation of SWATs and develop guidance to enable the wider trials community to undertake, report and adopt the findings of SWATs. Implementation science, the study of methods to promote the uptake of evidence-based practice, could be used to inform any such future work. Funders can also help by questioning strategies proposed by trial teams that are known to be either ineffective or not cost-effective. Improving the knowledge of the potential ‘harms’ from implementing interventions that have no evidence of benefit is an important next step to help improve uptake. While establishing the effectiveness of recruitment or retention strategies is important, the high costs of research waste and limited public finance mean that cost considerations around SWATs are just as important. With only one retention strategy having high Grading of Recommendations, Assessment, Development and Evaluations (GRADE) certainty of cost effectiveness, we encourage trial teams to undertake streamlined economic evaluations alongside all their SWATs in the future, for strategies shown to be effective, as well as those that are ineffective. For cost effectiveness, trial teams should look to report the cost per additional participant recruited or retained (i.e. the incremental cost-effectiveness ratio). Value of information analyses can help determine the need for further SWAT evidence where several SWATs already exist. Many trial teams wish to contribute to developing the evidence base by undertaking non-randomised SWATs. Future work that informs the development of guidance for undertaking non-randomised SWATs would be helpful. Working with trial teams to develop engagement strategies and training to undertake SWATs would be beneficial. Audience specific guidance should be developed to support SWAT research. Trial teams have expressed they want to undertake SWATs that are important and necessary to increase the evidence base. Collaboration with funders, working groups involved in priority setting, and trial teams is needed to develop a mechanism to communicate this dynamic and evolving information once priority SWATs have been identified. Work is needed to identify the barriers that teams have when undertaking a SWAT, and strategies and solutions for addressing these barriers should be identified and implemented. Continued and proactive collaboration is needed with working groups to enable networking, and collaboration with teams undertaking SWAT research. Reporting guidance is needed to support teams when writing publications to ensure sufficient information is included to GRADE evaluation can be undertaken. Study registration All SWATs in the PROMETHEUS programme had to be registered with the Northern Ireland Network for Trials Methodology Research SWAT Repository. Funding details This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

Objective: The aim of this study was to validate the content accuracy of the PCFD classification. Methods: A survey-based study distributed through international foot and ankle programs among surgeons with vast experience in practice to analyze the terminology and interpretations used in the PCFD classification. A returned survey with completion of all questions filled out was considered a valid record. Descriptive statistical analysis was applied using SAS version 9.4 for data processing, statistical analysis, and visualization. Results: Eighty-two valid returned surveys from surgeons in 22 countries with a mean of 16 years in clinical practice were included. Among them, 80.5% of the participants considered the PCFD classification helpful in guiding decision-making, 79.3% thought it helped facilitate diagnosis and documentation, 58.5% found it easy to use, 30.5% were unlikely to use the classification, and 29.3% noted that the interpretation of the classification was not clear. Regarding the accuracy, clarity, and clinical relevance of terminology, 42.7% had difficulty in using increased foot and ankle offset, 35.4% had difficulty in using increased hindfoot moment arm, 19.5% found peritalar subluxation not clear, 13.4% found the term sinus tarsi impingement an unclear description, and 8.5% found forefoot varus difficult to diagnose. Conclusions: This international survey-based study provides readers with insights into the content of the PCFD classification. The findings indicate that some terminologies used in the PCFD classification are not universally understood. The authors recommend that modifications may be beneficial to enhance the accuracy and user-friendliness of the PCFD classification. Level of Evidence II; Retrospective study.

ABSTRACT Parkinson’s disease (PD) is a common neurodegenerative disease associated with cognitive impairment. The Montreal Cognitive Assessment (MoCA) has been used as a recommended global cognition scale for patients with PD, but there are some concerns about its application, partially due to the floor and ceiling effects. Objective: To explore the floor and ceiling effects on the MoCA in patients with PD in Brazil. Methods: Cross-sectional study with data from patients with PD from five Brazilian Movement Disorders Clinics, excluding individuals with a possible diagnosis of dementia. We analyzed the total score of the MoCA, as well as its seven cognitive domains. The floor and ceiling effects were evaluated for the total MoCA score and domains. Multivariate analyses were performed to detect factors associated with floor and ceiling effects. Results: We evaluated data from 366 patients with PD and approximately 19% of individuals had less than five years of education. For the total MoCA score, there was no floor or ceiling effect. There was a floor effect in the abstraction and delayed memory recall domains in 20% of our sample. The ceiling effect was demonstrated in all domains (80.8% more common in naming and 89% orientation), except delayed recall. Education was the main factor associated with the floor and ceiling effects, independent of region, sex, age at evaluation, and disease duration. Conclusion: The floor and ceiling effects are present in specific domains of the MoCA in Brazil, with a strong impact on education. Further adaptations of the MoCA structure for underrepresented populations may reduce these negative effects.

Background: Records from occupations of workers in information systems mean much more than just sociodemographic data. In Occupational Medicine and Occupational Health Epidemiology, they are especially relevant as they indicate possible occupational risk factors. Objective: To estimate quality indicators of the record of occupation of asbestos-related diseases in the Mortality Information System (SIM), Brazil. Method: Cross-sectional study, conducted with death records of people over 16 years of age, registered in SIM, from 2000 to 2016, with diagnoses of asbestos-related diseases (ARD): mesothelioma, asbestosis, and pleural plaques. The “occupation” field was analyzed for completeness and consistency. Results: From a total of 3,764 death records, for which 60.3% (n=2,268) of missed/inconsistent occupation records were observed. Invalid occupation data accounted for 40.1% (n=1,508), mainly filled with “retired” or “housewives”, not recognized as formal job titles. The poor occupancy record quality among ARD records was over 50.0% in all regions of the country. Conclusions: The quality of the occupation records in SIM was poor for both ARD and other diagnoses, especially regarding the completeness and consistency of the data, in relation to the Brazilian Classification of Occupations. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate the readability and quality of current online information on Bell's palsy. Method: A Google search using the terms 'Bell's palsy' and 'facial palsy' was performed separately. The first three pages of results were analysed. Readability was assessed using Flesch Reading Ease Score, Flesch–Kincaid Grade Level, the Gunning-Fog Index and the Simple Measure of Gobbledygook. Quality was assessed using the Discern tool. Spearman's correlation between quality and readability was calculated. Results: A total of 31 websites met the inclusion criteria. The mean Flesch Reading Ease Score, Flesch–Kincaid Grade Level, the Gunning Fox Index and the Simple Measure of Gobbledygook scores were 52.45 (95 per cent confidence interval = 47.01–57.86), 10.50 (95 per cent confidence interval = 9.42–11.58), 12.76 (95 per cent confidence interval = 11.68–13.85) and 9.36 (95 per cent confidence interval = 8.52–10.20), respectively. The average Discern score was 44 (95 per cent confidence interval = 40.88–47.12). A negligible correlation was noted between the Discern and Flesch Reading Ease Score (rs = −0.05, p = 0.80). Conclusion: Online information on Bell's palsy is generally of fair quality but is written above the recommended reading age guidance in the UK. [ABSTRACT FROM AUTHOR]

Aim: This study aims to evaluate and compare the scanning accuracy of various intraoral scanners when taking digital impressions of single-implantsupported prostheses. Methodology: A partially edentulous model with a single implant was produced, and a scan body was fixed on the model. The control model was created by scanning the model using Ineos X5 (CM). The model was also scanned (n = 3) using three different intraoral scanners (IOS) [(Helios (H), TRIOS 3 (T3), Medit (M)]. GOM Inspect software was used for comparison. The data were analyzed with a Shapiro–Wilk test, resulting in a nonnormal distribution, and Kruskal–Wallis test was employed for intergroup parameter comparisons. Results: There were significant differences in the devices’ accuracy values (p < 0.05). Accuracy [M (19.1 μm), T3 (25.3 μm), H (33.9 μm)] and sensitivity values [M (10 μm), T3 (19.05 μm), H (25 μm)] are similarly listed from high to low as M, T3, and H. Conclusion: IOS can be used to create digital impressions for single-unit implant crowns. Clinicians should be cautious and selective when choosing IOS for more successful and accurate impressions. More comprehensive and clinical studies using different brands are needed on this subject. [ABSTRACT FROM AUTHOR]

Background: The Norwegian Trauma Registry (NTR) is designed to monitor and improve the quality and outcome of trauma care delivered by Norwegian trauma hospitals. Patient care is evaluated through specific quality indicators, which are constructed of variables reported to the registry by certified registrars. Having high-quality data recorded in the registry is essential for the validity, trust and use of data. This study aims to perform a data quality check of a subset of core data elements in the registry by assessing agreement between data in the NTR and corresponding data in electronic patient records (EPRs). Methods: We validated 49 of the 118 variables registered in the NTR by comparing those with the corresponding ones in electronic patient records for 180 patients with a trauma diagnosis admitted in 2019 at eight public hospitals. Agreement was quantified by calculating observed agreement, Cohen's Kappa and Gwet's first agreement coefficient (AC1) with 95% confidence intervals (CIs) for 27 nominal variables, quadratic weighted Cohen's Kappa and Gwet's second agreement coefficient (AC2) for five ordinal variables. For nine continuous, one date and seven time variables, we calculated intraclass correlation coefficient (ICC). Results: Almost perfect agreement (AC1 /AC2/ ICC > 0.80) was observed for all examined variables. Nominal and ordinal variables showed Gwet's agreement coefficients ranging from 0.85 (95% CI: 0.79–0.91) to 1.00 (95% CI: 1.00–1.00). For continuous and time variables there were detected high values of intraclass correlation coefficients (ICC) between 0.88 (95% CI: 0.83–0.91) and 1.00 (CI 95%: 1.00–1.00). While missing values in both the NTR and EPRs were in general negligeable, we found a substantial amount of missing registrations for a continuous "Base excess" in the NTR. For some of the time variables missing values both in the NTR and EPRs were high. Conclusion: All tested variables in the Norwegian Trauma Registry displayed excellent agreement with the corresponding variables in electronic patient records. Variables in the registry that showed missing data need further examination. [ABSTRACT FROM AUTHOR]

The article provides stability and parenteral compatibility study guidelines for authors applying manuscript submissions to the journal. It describes the stability study design which covers assay validation and sample preparation. It discusses requirements in stability study including physical assays, storage and sampling, statistical considerations, stability and beyond-use-date definition, reporting results and stability of biologic drugs. An overview of compatibility study design is given.

Aim: To understand how nurses talk about documentation audit in relation to their professional role. Background: Nursing documentation in health services is often audited as an indicator of nursing care and patient outcomes. There are few studies exploring the nurses' perspectives on this common process. Design: Secondary qualitative thematic analysis. Methods: Qualitative focus groups (n = 94 nurses) were conducted in nine diverse clinical areas of an Australian metropolitan health service for a service evaluation focussed on comprehensive care planning in 2020. Secondary qualitative analysis of the large data set using reflexive thematic analysis focussed specifically on the nurse experience of audit, as there was the significant emphasis by participants and was outside the scope of the primary study. Results: Nurses': (1) value quality improvement but need to feel involved in the cycle of change, (2) highlight that 'failed audit' does not equal failed care, (3) describe the tension between audited documentation being just bureaucratic and building constructive nursing workflows, (4) value building rapport (with nurses, patients) but this often contrasted with requirements (organizational, legal and audit) and additionally, (5) describe that the focus on completion of documentation for audit creates unintended and undesirable consequences. Conclusion: Documentation audit, while well‐intended and historically useful, has unintended negative consequences on patients, nurses and workflows. Impact: Accreditation systems rely on care being auditable, but when individual legal, organizational and professional standards are implemented via documentation forms and systems, the nursing burden is impacted at the point of care for patients, and risks both incomplete cares for patients and incomplete documentation. No Patient or Public Contribution: Patients participated in the primary study on comprehensive care assessment by nurses but did not make any comments about documentation audit. [ABSTRACT FROM AUTHOR]

Aim: To determine the reporting accuracy of pressure injury categorisation by bedside clinicians, compared with nurse experts. Background: Pressure injuries are an enduring complication of hospitalisation. The categorisation of pressure injury affects treatment and management decision‐making and use of resources, and severe hospital‐acquired pressure injury incidence is used to benchmark quality of care. However, it is unclear how accurately pressure injuries are categorised by clinicians in practice. Design: Secondary analysis of hospital pressure injury incident and validation data. Methods: All pressure injuries reported in adults between 2016 and 2019 that were subsequently validated by nurse experts were analysed. Absolute agreement is reported using percentages, with inter‐rater agreement reported using Kappa measure of agreement. The GRRAS reporting guideline was followed. Results: Of 6186 pressure injuries that were analysed, the category was reported correctly in 67.3% (n = 4163), with an overall moderate level of inter‐rater agreement by category (Κ =.567, p <.001). Of those found to be non‐pressure injuries when validated (18.3%, n = 1129), most were reported originally as stage II (41.2%, n = 465) or stage I (30.5%, n = 344), and 13.4% (n = 151) were categorised initially as unstageable. The majority reported initially as stage I, stage II, suspected deep tissue injury or mucosal pressure injury were validated, whereas half of those reported initially as stage III or IV were validated and less than a third of those reported initially as unstageable pressure injuries were validated. Conclusions: This study provides important insight into the accuracy of pressure injury categorisation. Whilst moderate agreement of categorisation was found between reporting clinicians and nurse experts, pressure injury differential diagnosis and categorisation of severe injuries were inadequate. Relevance to Clinical Practice: These results may be used for benchmarking and provide a focal point for future education and practice improvement efforts. Patient or Public Contribution: Neither patients nor the public were directly involved in the project. [ABSTRACT FROM AUTHOR]

Background: Clinical quality registries provide rich and useful data for clinical quality monitoring and research purposes but are susceptible to data quality issues that can impact their usage. Objective : This study assessed the concordance between comorbidities recorded in the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry and those in state-based hospital admission datasets. Method: All patients in New South Wales, South Australia, Tasmania, Victoria and Western Australia recorded in ANZDATA as requiring chronic kidney replacement therapy (KRT) between 01/07/2000 and 31/12/2015 were linked with state-based hospital admission datasets. Coronary artery disease, diabetes mellitus, cerebrovascular disease, chronic lung disease and peripheral vascular disease recorded in ANZDATA at each annual census date were compared overall, over time and between different KRT modalities to comorbidities recorded in hospital admission datasets, as defined by the International Classification of Diseases (ICD-10-AM), using both the kappa statistic and logistic regression analysis. Results: 29, 334 patients with 207,369 hospital admissions were identified. Comparison was made at census date for every patient comparison. Overall agreement was "very good" for diabetes mellitus (92%, k = 0.84) and "poor" to "fair" (21–61%, k = 0.02–0.22) for others. Diabetes mellitus recording had the highest accuracy (sensitivity 93% (±SE 0.2) and specificity 93% (±SE 0.2)), and cerebrovascular disease had the lowest (sensitivity 54% (±SE 0.2) and specificity 21% (±SE 0.3)). The false positive rates for cerebrovascular disease, peripheral vascular disease and chronic airway disease ranged between 18 and 33%. The probability of a false positive was lowest for kidney transplant patients for all comorbidities and highest for patients on haemodialysis. Conclusions and Implications: Agreement between the clinical quality registry and hospital admission datasets was variable, with the prevalence of comorbidities being higher in ANZDATA. [ABSTRACT FROM AUTHOR]