OBJECTIVE: High quality data entry in clinical trial databases is crucial to the usefulness, validity, and replicability of research findings, as it influences evidence-based medical practice and future research. Our aim is to assess the quality of self-reported data in trial registries and present practical and systematic methods for identifying and evaluating data quality.
METHODS: We searched ClinicalTrials.Gov for interventional total knee arthroplasty(TKA) trials between 2000-2015. We extracted required and optional trial information elements and used the CTG\'s variables\' definitions. We performed a literature review on data quality reporting on frameworks, checklists, and overviews of irregularities in healthcare databases. We identified and assessed data quality attributes: consistency, accuracy, completeness, and timeliness.
RESULTS: We included 816 interventional TKA trials. Data irregularities varied widely: 0% to 100%. Inconsistency ranged from 0% to 36%, most often non-randomized labeled allocation were combined with a \"single group\" assignment trial design. Inaccuracy ranged from 0% to 100%. Incompleteness ranged from 0% to 61%: 61% finished TKA trials did not report their outcome. As regard to irregularities in timeliness: 49% of the trials were registered more than 3 months after the start date.
CONCLUSIONS: We found significant variations in the data quality of registered clinical TKA trials. Trial sponsors should be committed to ensuring that the information they provide is reliable, consistent, up-to-date, transparent and accurate. CTG\'s users need to be critical when drawing conclusions based on the registered data. We believe this awareness will increase well-informed decisions about published articles and treatment protocols, including replicating and improving trial designs.

Rapid climate change or climate crisis is one of the most serious emergencies of the 21st century, accounting for highly impactful and irreversible changes worldwide. Climate crisis can also affect the epidemiology and disease burden of gastrointestinal diseases because they have a connection with environmental factors and nutrition. Gastrointestinal endoscopy is a highly intensive procedure with a significant contribution to greenhouse gas (GHG) emissions. Moreover, endoscopy is the third highest generator of waste in healthcare facilities with significant contributions to carbon footprint. The main sources of direct carbon emission in endoscopy are use of high-powered consumption devices (e.g. computers, anesthesia machines, wash machines for reprocessing, scope processors, and lighting) and waste production derived mainly from use of disposable devices. Indirect sources of emissions are those derived from heating and cooling of facilities, processing of histological samples, and transportation of patients and materials. Consequently, sustainable endoscopy and climate change have been the focus of discussions between endoscopy providers and professional societies with the aim of taking action to reduce environmental impact. The term \"green endoscopy\" refers to the practice of gastroenterology that aims to raise awareness, assess, and reduce endoscopy´s environmental impact. Nevertheless, while awareness has been growing, guidance about practical interventions to reduce the carbon footprint of gastrointestinal endoscopy are lacking. This review aims to summarize current data regarding the impact of endoscopy on GHG emissions and possible strategies to mitigate this phenomenon. Further, we aim to promote the evolution of a more sustainable \"green endoscopy\".

For quality management of healthcare, various ISO-standards are important such as ISO 9001 (quality management systems), ISO 13940 (concepts of continuity of care) and ISO 21298 (functional and structural roles). For concurrent, integrated use of the standards, this paper proposes a unifying conceptual model that integrates essential elements of the standards. The model may be useful to clarify basic concepts such as collaboration, systems-and-structures and realization, as well as the interrelations between these concepts.

UNASSIGNED: Thyroid-stimulating hormone (TSH) is a glycoprotein secreted by the anterior pituitary gland and is regulated by negative feedback from the serum free thyroid hormones. In this study we aimed to quantitate the relative bias caused by calibration drifting as seen in our TSH Levey-Jennings quality control (QC) charts and assess the magnitude of bias on patients\' samples.
UNASSIGNED: In the period from October 2021 to August 2022 we looked at the QC results of ten 28-days\' calibration time intervals and calculated relative bias compared to the mean. For each time interval the mean from three QC points before and after calibration was calculated. The average from 10 pre- and post-calibration means was calculated and the relative bias, pre- and post-calibration, was then calculated. We used 5 patient samples with low, normal and high TSH concentrations and calculated relative bias pre- and post-calibration. The allowed relative bias for TSH is ± 6.7%.
UNASSIGNED: At both QC levels, with the respective means of 5.14 mIU/L (coefficient of variation, CV% = 3.1%) and 27.80 mIU/L (CV% = 3.2%) had their respective relative bias - 8.2% and - 7.9%. The patient samples with low (0.586 mIU/L), normal (2.89 mIU/L and 5.19 mIU/L) and high (20.5 mIU/L and 39.8 mIU/L) TSH had - 4.1%, - 4.0%, - 3.5%, - 5.1% and - 4.1%, respectively.
UNASSIGNED: Even though the relative bias exceeded allowable criteria for the QC samples, this was not manifested on the patients\' samples.

Background and study aims Low-quality colonoscopy increases cancer risk but measuring quality remains challenging. We developed an automated, interactive assessment of colonoscopy quality (AI-CQ) using machine learning (ML). Methods Based on quality guidelines, metrics selected for AI development included insertion time (IT), withdrawal time (WT), polyp detection rate (PDR), and polyps per colonoscopy (PPC). Two novel metrics were also developed: HQ-WT (time during withdrawal with clear image) and WT-PT (withdrawal time subtracting polypectomy time). The model was pre-trained using a self-supervised vision transformer on unlabeled colonoscopy images and then finetuned for multi-label classification on another mutually exclusive colonoscopy image dataset. A timeline of video predictions and metric calculations were presented to clinicians in addition to the raw video using a web-based application. The model was externally validated using 50 colonoscopies at a second hospital. Results The AI-CQ accuracy to identify cecal intubation was 88%. IT ( P = 0.99) and WT ( P = 0.99) were highly correlated between manual and AI-CQ measurements with a median difference of 1.5 seconds and 4.5 seconds, respectively. AI-CQ PDR did not significantly differ from manual PDR (47.6% versus 45.5%, P = 0.66). Retroflexion was correctly identified in 95.2% and number of right colon evaluations in 100% of colonoscopies. HQ-WT was 45.9% of, and significantly correlated with ( P = 0.85) WT time. Conclusions An interactive AI assessment of colonoscopy skill can automatically assess quality. We propose that this tool can be utilized to rapidly identify and train providers in need of remediation.

Background and study aims International guidelines recommend real-time viewing (RTV) in capsule endoscopy for gastric emptying monitoring, yet it is often overlooked in clinical practice. We aimed to assess risk factors for incomplete small bowel capsule endoscopy (SBCE) and evaluate the clinical relevance and cost-effectiveness of RTV implementation. Methods We included consecutive SBCEs from 2013 to 2020. RTV was not applied per local protocol. We used multivariate logistic regression to identify risk factors for incomplete SBCE, including prolonged gastric transit time (GTT) and prolonged small bowel transit time (SBTT). Results Analyzing 858 SBCEs, we observed a completion rate of 94.6%. Prolonged GTT and SBTT were present in 4.9% and 18.2% of complete SBCEs, and in 13% ( P =0.03) and 10.8% ( P =0.24) of incomplete SBCEs, respectively. Only 0.7% (6 of 858) had incomplete SBCE with prolonged GTT. In both univariate and multivariate analysis, a modifiable (prolonged GTT odds ratio [OR] 2.9; 95% confidence interval [CI] 1.1-7.5) and two unmodifiable risk factors (inpatient status OR 2.3; 95% CI 1.1-4.5) and history of incomplete SBCE (OR 4.2; 95% CI 1.3-13.7) were independently linked to higher incomplete SBCE rates. The pretest completion probability was 90.5% and 95.8% in patients with and without unmodifiable risk factors, respectively ( P <0.01). The direct cost of systematic RTV adoption and prokinetics administration would be €5059, aiming to identify and treat each case of prolonged GTT associated with incomplete SBCE. Conclusions Modern devices make incomplete SBCE rare, usually not tied to prolonged GTT. In a low-incidence scenario, widespread RTV use brings high costs and uncertain effectiveness.

UNASSIGNED: The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016-02 and HOKLAS 021).
UNASSIGNED: The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016-02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process-based quality management system model was also performed to elicit further coverage information.
UNASSIGNED: HOKLAS 016-02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process-based quality management system model.
UNASSIGNED: The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016-02 and HOKLAS 021.

Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a consequence, many documents, forms and reports are generated. The retention time for each of these has to be specified. In addition to medical laboratory reports as part of the patient\'s medical record, the medical laboratory has to retain many documents and specimens according to national legislation or guidance from professional organizations, if these exist. If not, the laboratory management needs to define a retention schedule, which shall define the storage conditions and period of storage, according to ISO 15189:2022 requirements for retention of general quality management documents and records. The EFLM Working Group on Accreditation and ISO/CEN standards provides here a proposal on retention periods of documentation and specimens based on a failure-mode-effects-analysis (FMEA) risk-based approach, a concept of risk reduction that has become an integral part of modern standards.

This research addresses a gap in the literature by conducting a comprehensive analysis of patients\' level of satisfaction with dental care.
METHODS: By combining quantitative and qualitative survey methods with a PSQ, this study aims to augment ongoing initiatives to enhance dental patients\' experiences by painting a more comprehensive depiction of patients\' level of satisfaction.
RESULTS: When asked about their overall level of satisfaction 77.1% of the patients said that they received excellent services from office personnel and 72.2% said they trust their doctors.
CONCLUSIONS: Assessing patient satisfaction in the realm of dental service quality is crucial for enhancing service quality and accuracy, which would benefit both patients and dentists and, ultimately, improve public health.

BACKGROUND: Immunocytochemistry (ICC) is a widely available and extensively used ancillary method in diagnostic cytopathology with great variability in all test phases and a low level of adequate quality management. The non-standardized ICC landscape is now challenged with the introduction of the new European (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). According to this regulation, ICC on cytological slides falls under the category of Laboratory-Developed Tests (LDT), which requires rigorous standardization, validation, and thorough quality management.
CONCLUSIONS: Complete standardization of pre-analytical and analytical steps in ICC is impossible due to the complexity of the method and the constantly evolving antibodies, detection systems, and platforms. However, similar to the approach in immunohistochemistry, improving and standardizing \"best practices\" in quality management will result in high-quality, correct, accurate, and reliable ICC results. In this review, the current challenges of ICC in diagnostic cytopathology will be discussed, along with practical insights into ICC standardization and validation.
CONCLUSIONS: Control slides prepared in the same manner as the patient samples, optimized ICC protocols, and participation in external quality control for ICC are the pillars of good quality management and essential to ensure safe and reliable patient diagnostics.