Standard Evaluation Research Articles

A retrospective comparative study of robot-assisted unilateral biportal endoscopic lumbar decompression and fusion surgery versus percutaneous endoscopic lumbar decompression and fusion surgery.

The objective of this study is to illustrate the advantages of robot-assisted unilateral biportal endoscopy in lumbar decompression fusion and internal fixation surgery. According to the different surgical methods, we divided the 26 patients into 2 groups, robot-assisted unilateral biportal endoscopy for lumbar interbody fusion (R-ULIF) group and percutaneous endoscopic lumbar decompression and interbody fusion (Endo-LIF) group, with a 1:1 ratio. Gender, disease course, lesion site, fluoroscopy times, operative time, blood loss, postoperative hospital stay, screw placement success rate, fusion rate, complications rate, postoperative pain visual analog scale (VAS) (The VAS score is used only to evaluate pain in the lower back and legs.) Oswestry Disability Index (ODI) (The ODI score can serve as a reference indicator for evaluating the effectiveness of treatment for patients with low back pain, and has good responsiveness in assessing patients with chronic low back pain), and MacNab (The MacNab standard is divided into 4 levels: excellent, good, fair, and poor, which can be used to evaluate the therapeutic efficacy of certain spinal surgeries) standard efficacy evaluation were analyzed and compared between the 2 groups. All patients successfully completed the surgery. Compared with the Endo-LIF group, the R-ULIF group had fewer fluoroscopy procedures, less intraoperative blood loss, and shorter postoperative hospital stay (P < .05). The VAS scores and ODI scores of both groups significantly decreased at all-time points (P < .05). The ODI scores of the R-ULIF group were better than the Endo-LIF group at 1 month and 3 months after surgery (P = .017/P = .047), but there was no statistically significant difference between the groups before surgery and 1 week after surgery (P > .05). The efficacy was evaluated using the MacNab criteria at 6 months after surgery. The R-ULIF group has an excellent and good rate of 84.6%, while the Endo-LIF group has an excellent and good rate of 76.9% (P = 1.000). Robot-assisted unilateral biportal endoscopy for lumbar interbody and fusion surgery has shown short-term clinical efficacy in the treatment of lumbar disc herniation combined with lumbar instability, surpassing endoscopic lumbar interbody fusion surgery. Robot-assisted unilateral biportal endoscopy for lumbar interbody and fusion surgery has demonstrated high success rate in screw placement, minimal radiation exposure, less intraoperative blood loss, shorter hospital stay, and thus deserves further clinical promotion.

Research on the Design of Academic Evaluation Standards of E-commerce Professional Group in Secondary Vocational Schools based on the Integration of Post-course Competition Certificate: Taking Short Video Courses as an Example

Given the subjective and one-sided problems existing in the current evaluation system of e-commerce courses in secondary vocational schools, this paper puts forward the implementation path of “four in one.” Through the integration of big data technology, knowledge graph technology and the PGSD ability analysis model, the evaluation graph is constructed, aiming at achieving comprehensiveness, adaptability, professionalism, scientific and objectivity of the evaluation. The evaluation graph includes a three-tier structure of evaluation system, knowledge domain and skill dimension, and systematically distributes weights to realize the development of multi-dimensional evaluation and personalized learning path.

CDC Program Evaluation Framework, 2024.

Program evaluation is a critical tool for understanding and improving organizational activities and systems. This report updates the 1999 CDC Framework for Program Evaluation in Public Health (CDC. Framework for program evaluation in public health. MMWR Recomm Rep 1999;48[No. RR-11];1-40) by integrating major advancements in the fields of evaluation and public health, lessons learned from practical applications of the original framework, and current Federal agency policies and practices. A practical, nonprescriptive tool, the updated 2024 framework is designed to summarize and organize essential elements of program evaluation, and can be applied at any level from individual programs to broader systems by novices and experts for planning and implementing an evaluation. Although many of the key aspects from the 1999 framework remain, certain key differences exist. For example, this updated framework also includes six steps that describe the general process of evaluation planning and implementation, but some content and step names have changed (e.g., the first step has been renamed Assess context). The standards for high-quality evaluation remain central to the framework, although they have been updated to the five Federal evaluation standards. The most substantial change from the 1999 framework is the addition of three cross-cutting actions that are core tenets to incorporate within each evaluation step: engage collaboratively, advance equity, and learn from and use insights. The 2024 framework provides a guide for designing and conducting evaluation across many topics within and outside of public health that anyone involved in program evaluation efforts can use alone or in conjunction with other evaluation approaches, tools, or methods to build evidence, understand programs, and refine evidence-based decision-making to improve all program outcomes.

Tolerability of Diquas LX on tear film and meibomian glands findings in a real clinical scenario.

Long-acting diquafosol ophthalmic solution (DQS-LX) has significant advantages regarding patient adherence owing to the reduced frequency of required eye drops; however, some patients prefer conventional diquafosol ophthalmic solution (DQS) over DQS-LX. Herein, to clarify the characteristics of patients according to their preference for ophthalmic solutions, dry eye (DE) and meibomian gland (MG) findings were retrospectively investigated. This study enrolled 341 patients with DE (mean age, 62.1 ± 11.7 years) treated at the Itoh Clinic between November 8, 2022, and July 31, 2023, who switched from DQS to DQS-LX. Patients were divided into two groups: those who continued DQS-LX administration (DQS-LX group) and those who wished to revert to conventional DQS (DQS group). Data regarding subjective symptoms assessed using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film breakup time (BUT), tear meniscus height (TMH), corneal and conjunctival fluorescein staining (CFS), conjunctival hyperemia/papilla, meiboscore, plugging, vascularity, meibum grade, and Schirmer's score at the time of DQS-LX switch were evaluated. Of the 341 patients, 31 (9.1%) wished to revert to conventional DQS. In total, 16 eyes of 16 patients in the DQS group and 32 eyes of 32 patients in the DQS-LX group-for whom complete data were available-were included in the analysis. The DQS-LX group had higher SPEED scores, lower TMHs (P < 0.001, respectively), shorter FBUTs, greater CFS findings, larger meibum grades, lower Schirmer scores, and more pluggings compared with the DQS group (P = 0.005, 0.001, 0.001, 0.046, 0.003, respectively). Meiboscores and vascularity did not differ significantly between the two groups (P = 0.73 and 0.39, respectively). In conclusion, patients with low tear film volume and DE complicated by moderate or severe meibomian gland dysfunction (MGD) preferred DQS-LX, while those with allergic findings preferred conventional DQS.

Revolucionando el aprendizaje de idiomas: el impacto transformador de las aplicaciones móviles

This study investigated the impact of mobile apps on language learning, focusing on the improvement of linguistic competencies and student motivation. Five popular applications (Duolingo, Babbel, Rosetta Stone, Memrise, and Busuu) were analyzed in an experimental group through standardized tests and qualitative evaluations, before and after a study period. The results showed that students who used these apps experienced significant improvements in their language skills compared to a control group. Interactivity, personalization and gamification were identified as the main contributions to these positive outcomes, with gamification highlighted as a crucial driver of motivation. Nonetheless, the study also emphasized the need for a more robust pedagogical design in the apps to equitably address all language areas.

Minimum Risk Quantification Method for Error Threshold of Wind Farm Equivalent Model Based on Bayes Discriminant Criterion

The error threshold is the cornerstone to balance the mathematical complexity and simulation speed of wind farm (WF) equivalent models, and can promote the standardization process of equivalent methodology. Due to differences in power system conditions and model evaluation standards in different countries, the form and indexes of error thresholds of WF equivalent models have not been unified yet. This paper proposes a theoretical method for quantifying the minimum risk of error threshold of WF equivalent models based on the Bayes discriminant criterion. Firstly, the Euclidean errors of WF equivalent models in different periods are quantified, and the probability density distributions of the errors are fitted by kernel density estimation. Secondly, the real-time weighted prior probability algorithm is used to obtain the prior probability of a valid WF equivalent model, and the different losses caused by the missed judgment and misjudgment of the model validity to power systems are taken into account. Thirdly, the minimum risk quantification model of error threshold is established based on the Bayes discriminant criterion, and the feasibility of the proposed method is verified by an actual WF with numerical examples. Compared with the existing error thresholds, the proposed error threshold can more quickly and accurately determine the validity of WF equivalent models.

Magnification calibration of X-ray 3D microscopy using micro-line structures.

X-ray microscopy using computed tomography (CT) is an excellent three-dimensional imaging instrument. Three-dimensional X-ray microscopy (3DXRM) is a nondestructive imaging technique used to inspect internal and external structures in units of submicrometers or less. The 3DXRM, although attractive, is mostly used as an observation instrument and is limited as a measurement system in quantitative evaluation and quality control. Calibration is required for use in measurement systems such as coordinate measurement systems, and specific standard samples and evaluation procedures are needed. The certified values of the standard samples must ideally be traceable to the International System of Units (SI). In the 3DXRM measurement system, line structures (LSs) are fabricated as prototype standard samples to conduct magnification calibration. In this study, we evaluated the LS intervals using calibrated cross-sectional scanning electron microscopy (SEM). A comparison of the evaluation results between SEM and 3DXRM for the LS intervals provided the magnification calibration factor for 3DXRM and validated the LSs, whereby the interval methods and feasibility of constructing an SI traceability system were evaluated using the calibrated SEM. Consequently, a magnification calibration factor of 1.01 was obtained for 3DXRM based on the intervals of the LSs evaluated by SEM. A possible route for realizing SI-traceable magnification calibration of 3DXRM has been presented.

Can you mitigate gender bias in student evaluations of teaching? Evaluating alternative methods of soliciting feedback

Student evaluations of teaching can be unreliable indicators of effective teaching and affected by implicit bias. We conduct a randomized experiment at a selective U.S. liberal arts college in which we vary both the instrument and timing at which we solicit student feedback to assess whether either intervention can mitigate gender disparities in qualitative evaluation comments. External evaluators with expertise in teaching evaluation scored the positivity, specificity, and constructiveness of student comments in control and treatment groups. We find neither intervention is successful in mitigating gender disparities. Students that receive an alternate prompt which highlights the potential for implicit bias and asks them to articulate and apply their own criteria for effective teaching penalize female faculty at similar rates as those receiving a more standard evaluation prompt. We also find no evidence that delaying solicitation of student feedback until the start of the next semester, when students face less stress and fatigue, reduces the gender gap in the positivity of feedback. Instead, we find substantial evidence that the positivity of qualitative student evaluations is affected by student, instructor, and course characteristics across all study conditions. The results suggest that bias in student evaluations may be difficult to mitigate.

Tracking Community Outreach and Engagement Activities among National Cancer Institute-Designated Cancer Centers.

The National Cancer Institute's (NCI) Cancer Center Support Grant mandates that NCI-Designated Cancer Centers establish a Community Outreach and Engagement (COE) component to help direct efforts at reducing cancer burden within their catchment areas. Despite the critical role of COE offices, little is known about how they track and evaluate outreach activities and outcomes. We gathered information on current practices from representatives of 40 out of 65 COE offices using an online survey. While nearly all responding centers (97.5%) tracked COE activities, no consensus existed on resources used and satisfaction with current solutions was mixed (51.0% not satisfied). Respondents expressed need for a centralized, standardized, and comprehensive tracking solution to capture outreach events and external partnerships, automate report generation, and ensure alignment with COE aims. This study highlights challenges COE offices face with resource limitations and a heterogeneity of activities to track, and the need for a standard evaluation framework.

Numerical modelling of CMAS infiltration and dimensionless numbers of anti-infiltration designs of thermal barrier coatings

Resistance to calcium–magnesium–alumina–silicate (CMAS) infiltration and corrosion is a crucial problem for safely applying thermal barrier coatings (TBCs) in advanced aero engines. This work proposes a CMAS infiltration model based on the phase-field method to simulate the CMAS infiltration process in TBCs and analyse the influence factor. Further, a key dimensionless number called relative driving force K=rσcos(θc)tsμϛ2hTC2 was found to determine the CMAS infiltration depth using dimensional analysis. A criterion of K<2 was derived and was considered to be the evaluation standard of TBCs with excellent CMAS infiltration resistance. Based on K minimization, novelty TBCs with microstructure of S-shaped intercolumnar gaps and spherical pores are expected to significantly improve the resistance to CMAS infiltration and corrosion.

Leveraging foundation and large language models in medical artificial intelligence.

Recent advancements in the field of medical artificial intelligence (AI) have led to the widespread adoption of foundational and large language models. This review paper explores their applications within medical AI, introducing a novel classification framework that categorizes them as disease-specific, general-domain, and multi-modal models. The paper also addresses key challenges such as data acquisition and augmentation, including issues related to data volume, annotation, multi-modal fusion, and privacy concerns. Additionally, it discusses the evaluation, validation, limitations, and regulation of medical AI models, emphasizing their transformative potential in healthcare. The importance of continuous improvement, data security, standardized evaluations, and collaborative approaches is highlighted to ensure the responsible and effective integration of AI into clinical applications.

Development and Validation of a Tool for VBOI (Virtual Body Ownership Illusion) Level Assessment

Virtual Body Ownership Illusion (Virtual BOI) refers to the perceptual, cognitive, and behavioral changes that occur due to the illusion that a virtual body is one’s own actual body. Recent research has focused on inducing Virtual Body Ownership Illusion (Virtual BOI) using various physical conditions of VR environments such as haptic feedback and 360-degree immersion, among others. The level of Virtual BOI has been recognized as an important factor in VR-based clinical therapy programs where patient immersion is crucial. However, a common issue is the lack of standardized evaluation tools for Virtual BOI, with most experiments relying on ad hoc tools based on experimental conditions or lacking consideration for the physical design elements of VR. This measurement tool was designed to consider the characteristics of recent VR devices, such as haptics and hand tracking, in the design of experiments and questionnaires. The tool is composed of sub-attributes related to VR technology, including Embodiment, Presence, Visuo-tactile, Visuo-proprioceptive, and Visuo-Motor. Based on a review of the existing literature, we hypothesized that the Virtual BOI scores would vary depending on manipulation methods, viewpoints, and haptic conditions. An experiment was conducted with 39 participants, who performed the same task under four different conditions using a virtual hand. Virtual BOI scores were assessed using the evaluation tool developed for this study. The questionnaire underwent CFA, and three items with factor loadings below 0.5 were removed, resulting in a total of 14 items. Each subscale demonstrated high reliability, with Cronbach’s alpha values greater than 0.60. When developing experiments, clinical programs, or VR content related to Virtual BOI, the evaluation tool presented in this study can be used to assess the level of Virtual BOI. Additionally, by considering technological elements such as haptics and hand tracking, VR environments can be designed to enhance the level of Virtual BOI.

Research on Comprehensive Evaluation Indicators and Methods of World-Class Open-Pit Coal Mines

Since the 20th century, with the rapid development of the global economy, human demand for fossil energy such as coal has been increasing. In the face of fierce competition, the state and various ministries and commissions have put forward the goals and requirements of building a world-class enterprise, and how to become a world-class open-pit coal mine and establish the corresponding evaluation standards has become an urgent scientific problem to be solved. According to the characteristics of open-pit coal mine production and operation, from the perspective of benchmarking world class, the key factors affecting the construction of world-class open-pit coal mines are extracted by using the fuzzy DEMATEL method, and the comprehensive evaluation index system, evaluation standards, and methods of open-pit coal mines are established, which provides benchmarks and guidelines for the construction of world-class open-pit coal mines and improves the construction level of world-class open-pit coal mines.

Carbon Sequestration Capacity after Ecological Restoration of Open-Pit Mines: A Case Study in Yangtze River Basin, Jurong City, Jiangsu Province

Open-pit mining seriously damages the original vegetation community and soil layer and disturbs the carbon cycle of vegetation and soil, causing instability in the mining ecosystem and decrease in the carbon sequestration capacity of the mining area. With the deepening of environmental awareness and the influence of related policies, the ecological restoration of open-pit mines has been promoted. The mining ecosystem is distinct owing to the disperse distribution of mines and small scale of single mines. However, the carbon sequestration capability of mines after ecological restoration has not been clearly evaluated. Therefore, this study evaluated the carbon sequestration capacity of restoration mines, taking the mines of the Yangtze River Basin in Jurong City, Jiangsu Province as the research objects. Firstly, the visual effects of the vegetation and soil in their current status were determined through field investigation, the methods for sampling and data collection for the vegetation and soil were selected, and the specific laboratory tests such as the vegetation carbon content and soil organic carbon were clarified. Meanwhile, the evaluation system consisting of three aspects and nine evaluation indexes was established by using the analytic hierarchy process (AHP) and fuzzy comprehensive evaluation (FCE). The process of evaluation included the following: the establishment of the judgment matrix, calculation of the index weight, determination of the membership function, and establishment of the fuzzy membership matrix. Finally, the evaluation results of the restoration mines were determined with the ‘excellent, good, normal and poor’ grade classification according to the evaluation standards for each index proposed considering the data of the field investigation and laboratory tests. The results indicated that (1) the evaluation results of the mines’ carbon sequestration capacity were of excellent and good grade at a proportion of 62.5% and 37.5%, which was in line with the field investigation results and demonstrated the carbon sequestration capacity of all the restored mines was effectively improved; and (2) the weights of the criterion layer were ranked as system stability &gt; vegetation &gt; soil with the largest value of 0.547, indicating the stability of the system is the main factor in the carbon sequestration capacity of the mines and the sustainability of the vegetation community and the stability of soil fixation on the slope. The proposed evaluation system effectively evaluates the short-term carbon sequestration capability of the restoration mining system according to the visual effects and the laboratory testing results, objectively reflecting the carbon sequestration capacity via qualitative assessment and quantitative analysis. The evaluation method is relatively applicable and reliable for restoration mines and can provide a reference for similar ecological restoration engineering.

German mHealth App Usability Questionnaire (G-MAUQ) and short version (G-MAUQ-S): Translation and validation study

BackgroundThe use of mobile health applications is increasingly common among the general public and in healthcare systems. With such apps percolating into the classic healthcare sector, the necessity of sound and standardized evaluation grows. The mHealth App Usability Questionnaire (MAUQ) provides a novel and custom-tailored psychometrically validated instrument to capture users’ perception of the usefulness and usability of an mHealth application. So far, this questionnaire is only available in English, Malay and Chinese. The aim of this study was to translate and validate a German version of the MAUQ (G-MAUQ). Further, we developed a short scale with 6 items (G-MAUQ-S) in German. MethodsWe used the Translation, Review, Adjudication, Pretest and Documentation (TRAPD) method to translate the MAUQ. Subsequently, we assessed content validity with 15 expert ratings and face validity with 15 German speaking mHealth users. To further validate the questionnaire, we used data from 148 participants of an RCT examining symptom checkers in the Emergency Department to assess convergent validity by correlating the G-MAUQ with the German version of the System Usability Scale and discriminant validity by correlating the G-MAUQ with other unrelated questionnaires. Lastly, we developed a short version by assessing item discrimination, factor loadings, correlation with the full scale and construct validity. ResultsAll but one item showed sufficient content validity with item-level content validity index values between CVI-I = 0.8 and 1.0. Face validity was excellent with item-level face validity index values ranging from FVI-I = 0.87 to 1. Convergent validity was sufficient with r = 0.769, and discriminant validity was sufficient with values between r = −0.014 and r = 0.220. An internal consistency of Cronbach's α = 0.93 demonstrated high reliability. The short scale showed sufficient convergent validity (r = 0.762) and discriminant validity (r between −0.012 and 0.201). ConclusionsA validated and reliable G-MAUQ can be used by researchers and practitioners to assess the usability of mHealth interventions. We also provide the German mHealth App Usability Questionnaire – Short Version (G-MAUQ-S) with six questions to quickly assess the usability of an intervention.

Comparative Effectiveness of Teledermatology Versus In-person Consultations: A Systematic Review of Diagnostic Information Elements

Context: Teledermatology is delivered through two primary methods: Live video conferencing, which enables real-time interaction between patients and doctors, and the store-and-forward technique, where images of skin lesions are sent over the internet for later examination. Objectives: This systematic review evaluates the concordance between in-person and telemedicine follow-up methods in dermatology. Methods: In February 2024, a comprehensive literature search was conducted across PubMed, Medline, ISI Web of Science, and the ACM Digital Library. Keywords such as "teledermatology," "telemedicine," and "mobile health" were used, following the PICOS criteria. Results: Initially, 716 articles were identified from the databases, along with four studies from the gray literature search. After removing duplicates, screening studies, and applying the inclusion and exclusion criteria, 21 studies were selected for the final review. These studies detailed follow-up procedures and assessed both direct and indirect costs and effectiveness. The consensus indicates that teledermatology reduces costs and satisfies both patients and healthcare professionals. Conclusions: Teledermatology has been shown to potentially increase the efficiency of follow-up care compared to traditional methods. However, further research is needed to develop standardized evaluation protocols and to more accurately measure and validate key variables. Publications suggest that teledermatology is cost-effective, reduces patient wait times, extends access to dermatological care in remote areas, and enhances satisfaction among patients, doctors, and nurses.

Exploring the impact of microfluidic chip structure on the efficacy of three-dimensional tumor microspheres cultivation.

Three-dimensional (3D) tumor microspheres can simulate the interaction and growth dynamics of tumor cells, and have been used as a new in vitro model for drug screening and tumor biology related research. The scaffold-free culture of 3D tumor microspheres on microfluidic chips has many advantages, including low cost, high throughput, convenience and flexibility. However, it is still unclear how various factors, such as chip structure, influence the culture effect of tumor microspheres. The lack of standardized evaluation and characterization of the culture effect hinders the further optimization and development of chip function. This study presents numerical simulations of multiple parts or processes of the proposed 3D culture chips with two different structural parameters based on computational fluid dynamics (CFD) methods. An evaluation system for tumor microspheres was established. The prediction of the CFD simulation was consistent with the culture results of the chips, reflecting the important role of the structural parameters of the microtrap in the formation of uniform tumor microspheres. Furthermore, the velocity of cell suspension also had a significant impact on the retention of tumor cells. Additionally, the drug screening results of tumor microspheres indicated that tumor microspheres exhibit greater drug resistance, which may be attributed to their size. These results offer valuable insights into the factors that influence the characteristics of tumor microspheres. This research provides a reference and direction for the optimal design and functional evaluation of scaffold-free 3D culture chips, and holds promise for promoting the development of novel drug research platforms.

Fibrosis, biomarkers and liver biopsy in AAT deficiency and relation to liver Z protein polymer accumulation.

The course of adults with ZZ alpha-1-antitrypsin deficiency (AATD) liver disease is unpredictable. The utility of markers, including liver biopsy, is undefined. A prospective cohort, including protocol liver biopsies, was enrolled to address these questions. We enrolled 96 homozygous ZZ AATD adults prospectively at three US sites with standardized clinical evaluations, and protocol liver biopsies. Fibrosis was scored using Ishak (stages 0-6). Also, 51% of the 96 subjects had Ishak score >1 fibrosis (49% Ishak 0-1, 36% Ishak 2-3 and 15% ≥4). Elevated aspartate aminotransferase (AST) more than alanine aminotransferase (ALT), high body mass index (BMI), obesity, AST platelet ratio index and elevated serum Z alpha 1 antitrypsin (AAT) polymer levels were associated with increased fibrosis. Steatosis did not correlate to fibrosis. Increased fibrosis was associated with increased mutant Z polymer globular inclusions (p = .002) and increased diffuse cytoplasmic Z polymer on biopsy (p = .0029) in a direct relationship. Increased globule Z polymer was associated with increased serum AST (p = .007) and increased periportal inflammation on histopathology (p = .004), but there was no relationship of Z polymer hepatocellular accumulation with ALT, gamma glutamine transferase, inflammation in other parts of the lobule, necrosis or steatosis. Serum Z polymer levels were directly correlated to hepatic Z protein polymer content. Lung function, smoking and alcohol consumption patterns were not associated with fibrosis. In AATD high BMI, obesity and elevated AST are associated with increased fibrosis. Liver biopsy features are correlated to some serum tests. Serum Z AAT polymer levels could be a future biomarker to detect fibrosis early and is directly correlated to liver Z content.

SATURN: assessing the feasibility of utilising existing registries for real-world evidence data collection to meet patients, regulatory, health technology assessment and payer requirements

BackgroundSATURN (Systematic Accumulation of Treatment practices and Utilisation, Real world evidence, and Natural history data) for the rare condition osteogenesis imperfecta (OI) has the objective to create a common core dataset by utilising existing, well-established data sources to meet the needs of the various stakeholders (physicians, registry/dataset owners, patients and patient associations, OI community leaders, European [EU] policymakers, regulators, health technology assessments [HTA]s, and healthcare systems including payers). This paper describes the steps taken to assess the feasibility of one existing OI registry (i.e., the Registry of OI [ROI]) as a candidate for SATURN. The same methodology will be applied to other existing OI registries in the future and this same concept could be utilised for other rare disease registries.MethodsThe approach to assessing the feasibility of the ROI registry consisted of three steps: (1) an assessment of the registry characteristics using the Registry Evaluation and Quality Standards Tool (REQueST); (2) a gap analysis comparing SATURN required Core Variables to those being captured in the registry’s Case Report Form (CRF); and (3) a compliance check on the data exchange process following the Title 21 of Code of Federal Regulations (CFR) Part 11/EudraLex Annex 11 Compliance Checklist. The first registry that SATURN has assessed is the ROI database at the Istituto Ortopedico Rizzoli (IOR) in Italy.ResultsThe results from the ROI REQueST have demonstrated satisfactory complete responses in terms of methodology, essential standards, interpretability, and interoperability—readiness for data linkage, data sources, and ethics to meet the needs of data customers. However, the ROI data is from a tertiary referral centre which may limit the ability to understand the full patient journey. The gap analysis has revealed that an exact or logical match between SATURN requested variables and the ROI current variables exists for the following items: patient characteristics, treatment of OI (medical and surgical) and treatment of pain (with the exception of frequency of treatment and reasons for discontinuation), fracture history and bone density. However, data on safety was missing. The compliance check has implied that the ROI implemented appropriate controls for the web-based platform (i.e., Genotype–phenotype Data Integration Platform [GeDI]) that is involved in processing the electronic patient data, and GeDI is a validated/compliant application that follows relevant 21 CFR Part 11/EudraLex Annex 11 regulations.ConclusionsThis robust feasibility process highlights potential limitations and opportunities to develop and to refine the collaboration with the ROI as the SATURN programme moves forward. It also ensures that the existing datasets in the rare condition OI are being maximised to respond to the needs of patients, data customers and decision-makers. This feasibility process has allowed SATURN to build a compliant methodology that aligns with the requirements from the European Medicines Agency (EMA) and HTAs. More data variables will continue to be developed and refined along the way with more registries participating in SATURN. As a result, SATURN will become a meaningful and truly collaborative core dataset, which will also contribute to advancing understanding of OI diagnosis, treatment, and care.

A surgical preadmission pharmacist service in a tertiary paediatric hospital: a pilot study

AbstractBackgroundPharmacist surgical preadmission review is common in adult healthcare settings, however there is little evidence of this practice in the paediatric setting. This research describes a pilot surgical preadmission pharmacist service in a paediatric hospital.AimTo evaluate the impact of a surgical preadmission pharmacist service on patient flow and the quality of medication management.MethodA retrospective review (2 months) was conducted to compare an intervention group (1 May 2019–30 June 2019) to historical baseline (1 October 2018–30 November 2018). Children and adolescents (aged 0–18 years) presenting for elective surgery and overnight admission were included. Relevant clinical data and timestamps were extracted from the electronic medical record. Multiple linear regression models were built to examine the difference in outcomes between the control and intervention groups. This project was exempt due to the local policy requirements that constitute research by the Queensland Children's Hospital Human Research Ethics Committee (Reference no: LNR/19/QCHQ/53406). The justification for this exemption was as follows: the study presented no foreseeable risk of patient harm as it involved evaluation of an established standard of clinical care and involved the use of existing collections of records that contain only non‐identifiable patient data.ResultsIn total, 135 patients were included in the baseline and 96 patients were included in the intervention group. The intervention group had statistically significant lower time to best possible medication history (BPMH) by 47.57 h (95% confidence interval [CI] −53.25 to −41.89, p &lt; 0.001). Time to prescription of home medications was significantly reduced in the intervention group by 5.26 h (95% CI −10.45 to −0.08, p = 0.05). There was no difference in proportion of patients with home medications omitted (71–62%, p = 0.38) or requiring modification (14–12%, p = 0.58) between the two groups.ConclusionImplementation of a surgical preadmission pharmacist service in our paediatric hospital demonstrated earlier BPMH documentation and prescription of home medications, without negative effects on perioperative patient flow.