[Increased report completeness and satisfaction with structured neurotological reporting in the interdisciplinary assessment of vertigo]. / Erhöhte Befundvollständigkeit und gesteigerte Zuweiserzufriedenheit bei strukturierter neurootologischer Befunderhebung in der interdisziplinären Schwindelabklärung.

BACKGROUND: Results of neurotological function diagnostics in the context of interdisciplinary vertigo assessment are usually formulated as free-text reports (FTR). These are often subject to high variability, which may lead to loss of information. The aim of the present study was to evaluate the completeness of structured reports (SR) and referrer satisfaction in the neurotological assessment of vertigo. MATERIALS AND METHODS: Neurotological function diagnostics performed as referrals (n = 88) were evaluated retrospectively. On the basis of the available raw data, SRs corresponding to FTRs from clinical routine were created by means of a specific SR template for neurotological function diagnostics. FTRs and SRs were evaluated for completeness and referring physician satisfaction (n = 8) using a visual analog scale (VAS) questionnaire. RESULTS: Compared to FTRs, SRs showed significantly increased overall completeness (73.7% vs. 51.7%, p < 0.001), especially in terms of patient history (92.5% vs. 66.7%, p < 0.001), description of previous findings (87.5% vs. 38%, p < 0.001), and neurotological (33.5% vs. 26.7%, p < 0.001) and audiometric function diagnostics (58% vs. 32.3%, p < 0.001). In addition, SR showed significantly increased referring physician satisfaction (VAS 8.8 vs. 4.9, p < 0.001). CONCLUSION: Neurotological SRs enable a significantly increased report completeness with higher referrer satisfaction in the context of interdisciplinary assessment of vertigo. Furthermore, SRs are particularly suitable for scientific data analysis, especially in the context of big data analyses.

Postoperative complications after surgery for lumbar spinal stenosis, assessment using two different data sources.

PURPOSE: Lumbar spinal stenosis (LSS) is a prevalent disorder, and surgery for LSS is a common procedure. Postoperative complications occur after any surgery and impose costs for society and costs and additional morbidity for patients. Since complications are relatively rare, medical registries of large populations may provide valuable knowledge. However, recording of complications in registries can be incomplete. To better estimate the true prevalence of complications after LSS surgery, we reviewed two different sources of data and recorded complications for a sample of Norwegian LSS patients. METHODS: 474 patients treated surgically for LSS during 2015 and 2016 at four hospitals reported to a national spine registry (NORspine). Postoperative complications were recorded by patients in NORspine, and we cross-referenced complications documented in NORspine with the patients´ electronic patient records (EPR) to re-test the complication rates. We performed descriptive statistics of complication rates using the two different data sources above, and analyzed the association between postoperative complications and clinical outcome with logistic regression. RESULTS: The mean (95%CI) patient age was 66.3 (65.3-67.2) years, and 254 (53.6%) were females. All patients were treated with decompression, and 51 (10.7%) received an additional fusion during the index surgery. Combining the two data sources, we found a total rate for postoperative complications of 22.4%, the NORspine registry reported a complication rate of 15.6%, and the EPR review resulted in a complication rate of 16.0%. However, the types of complications were inconsistent across the two data sources. According to NORspine, the frequency of reoperation within 90 days was 0.9% and according to EPR 3.4%. The rates of wound infection were for NORspine 3.1% and EPR review 2.1%. There was no association between postoperative complication and patient reported outcome. CONCLUSION: Postoperative complications occurred in 22% of LSS patients. The frequency of different postoperative complications differed between the two data sources.

Efforts to improve the billing accuracy of robotic-assisted thoracic surgery through education, updated procedure cards, and electronic medical record system changes.

Precise medical billing is essential for decreasing hospital liability, upholding environmental stewardship and ensuring fair costs for patients. We instituted a multifaceted approach to improve the billing accuracy of our robotic-assisted thoracic surgery programme by including an educational component, updating procedure cards and removing the auto-populating function of our electronic medical record. Overall, we saw significant improvements in both the number of inaccurate billing cases and, specifically, the number of cases that overcharged patients.

Accuracy of dental implants positioning in computer-assisted surgeries: In vitro study.

OBJECTIVES: The aim of this study is to presents an experimental method for surgical guide confection using an intraoral scanner to obtain a 3D model of the patient's complete denture and compare its accuracy with the conventional methodology using computed tomography. STUDY DESIGN: This prospective in-vitro study used 30 polyurethane pre-manufactured mandibles which were divided into two groups, conventional technique (group I) and a new method using intraoral scanner (group II), establishing the virtually planned position of the dental implants as a control group, considered as the gold standard for postoperative comparison. RESULTS: The difference between these methods is close to zero and not statistically significant (p > 0.05), being heigh deviation (Xh) with p:0.130 and angulation difference of dental implants between the groups (Ang) with p:0.396. CONCLUSION: The acquisition of stereolithography image of the prosthesis using an intraoral scanner has a clinically acceptable accuracy, being in agreement with the conventional method.

Defining a low-risk birth cohort: a cohort study comparing two perinatal data sets in Ontario, Canada.

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 1st April 2012 and 31st 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.

Augmented-reality-assisted intraoral scanning: A proof-of-concept study.

PURPOSE: The aims of the present study were (a) to compare the scanning time and image count to complete optical scans of a typodont between augmented-reality-assisted intraoral scanning (ARIOS) and intraoral scanning (IOS); (b) to compare the accuracy of the digital casts derived from ARIOS and IOS; (c) to compare participant-related outcomes between ARIOS and IOS. MATERIALS AND METHODS: A multi-session within-subject experiment was conducted to compare ARIOS and IOS. Thirty-one dental students participated in the study. Following a trial session, each participant obtained optical scans under ARIOS and IOS conditions. The time required to complete the scan, and the number of images taken were recorded. Participant feedback was collected using entry, exit, and NASA-Task Load Index (TLX) surveys. The accuracy of the digital casts derived from the optical scans was measured in root mean square error (RMSE). RESULTS: The present study found a 6.8% increase in preference for ARIOS from entry to exit survey. Slightly more participants favored the ARIOS setup compared to IOS; 54.8% of participants favored ARIOS, 9.7% were indifferent, and 35.5% favored IOS. NASA-TLX subscale ratings were higher for IOS in general apart from mental demand. The accuracy of the digital casts between ARIOS and IOS was comparable in RMSE. CONCLUSION: ARIOS was advantageous compared to IOS in ergonomics, improved scanner tracking, and ease of scanner orientation. However additional trials, increased field of view, and better superimposition of scanning status to the target site were improvements desired by the study participants.

[Quality of health information in Mexico in the OECD context: 2017-2021]. / Calidad de la información en salud de México en el contexto de la OCDE: 2017-2021.

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.

Data quality review of the Brazilian nosocomial infections surveillance system.

BACKGROUND: Surveillance of healthcare-associated infections (HAIs) is an essential component of hospital infection prevention and control systems. We aimed to assess the quality of the data compiled by the Brazilian HAI Surveillance System from pediatric (PICUs) and neonatal intensive care units (NICUs), between 2012 and 2021. METHODS: Data Quality Review, including adherence, completeness, internal consistency, consistency over time, and consistency of population trend, were computed at both national and state levels based on quality metrics from World Health Organization Toolkit. Incidence rates (or incidence density) of ventilator-associated pneumonia (VAP) and central line-associated bloodstream infection (CLABSI) were obtained from the Brazilian National Nosocomial Infections Surveillance (NNIS) system. Data on sepsis-related mortality, spanning the period from 2012 to 2021, were extracted from the Brazilian National Health Service database (DATASUS). Additionally, correlations between sepsis-related mortality and incidence rates of VAP or CLABSI were calculated. RESULTS: Throughout the majority of the study period, adherence to VAP reporting remained below 75%, exhibiting a positive trend post-2016. Widespread outliers, as well as inconsistencies over time and in population trends, were evident across all 27 states. Only four states maintained consistent adherence levels above 75% for more than 8 years regarding HAI incidence rates. Notably, CLABSI in NICUs boasted the highest reporting adherence among all HAIs, with 148 periods out of 270 (54.8%) exhibiting reporting adherence surpassing 75%. Three states achieved commendable metrics for CLABSI in PICUs, while five states demonstrated favorable results for CLABSI in NICUs. CONCLUSIONS: While adherence to HAI report is improving among Brazilian states, an important room for improvement in the Brazilian NNIS exists. Additional efforts should be made by the Brazilian government to improve the reliability of HAI data, which could serve as valuable guidance for hospital infection prevention and control policies.

Opportunities, challenges, and future directions of large language models, including ChatGPT in medical education: a systematic scoping review

BACKGROUND: ChatGPT is a large language model (LLM) based on artificial intelligence (AI) capable of responding in multiple languages and generating nuanced and highly complex responses. While ChatGPT holds promising applications in medical education, its limitations and potential risks cannot be ignored. METHODS: A scoping review was conducted for English articles discussing ChatGPT in the context of medical education published after 2022. A literature search was performed using PubMed/MEDLINE, Embase, and Web of Science databases, and information was extracted from the relevant studies that were ultimately included. RESULTS: ChatGPT exhibits various potential applications in medical education, such as providing personalized learning plans and materials, creating clinical practice simulation scenarios, and assisting in writing articles. However, challenges associated with academic integrity, data accuracy, and potential harm to learning were also highlighted in the literature. The paper emphasizes certain recommendations for using ChatGPT, including the establishment of guidelines. Based on the review, 3 key research areas were proposed: cultivating the ability of medical students to use ChatGPT correctly, integrating ChatGPT into teaching activities and processes, and proposing standards for the use of AI by medical students. CONCLUSION: ChatGPT has the potential to transform medical education, but careful consideration is required for its full integration. To harness the full potential of ChatGPT in medical education, attention should not only be given to the capabilities of AI but also to its impact on students and teachers.

Monitorización de la glucemia en el paciente crítico adulto: tipo de muestra y método de análisis. Revisión sistemática y metanálisis / Blood glucose monitoring in critically ill adult patients: Type of sample and method of analysis. Systematic review and meta-analysis

IntroducciónLa guía clínica para el manejo de la sepsis recomienda usar muestras de sangre arterial para el control glucémico. Un estudio multicéntrico en 86 unidades de cuidados intensivos españolas reveló que el 85,4% de estas utilizaban punción capilar.ObjetivoAnalizar la fiabilidad de la glucemia comparando diferentes muestras sanguíneas (arterial, venosa, capilar) e instrumentos (glucómetros, gasómetros, laboratorio central). Secundariamente, estimar el efecto de variables confusoras y el rendimiento de los instrumentos de medición determinados por las diferentes normas de calidad.MetodologíaRevisión sistemática y metanálisis con búsqueda en las bases de datos PubMed, CINAHL y Embase en septiembre-2021 y septiembre-2022, sin límites temporales ni idiomáticos. Fuentes de literatura gris: DART-Europe, OpenGrey y Google Académico. Resultados resumidos mediante síntesis cualitativa (descripción de resultados, características de los estudios) y cuantitativa (metanálisis para evaluar la diferencia de medias estandarizadas). Calidad metodológica de artículos evaluada con Quality Assessment of Diagnostic Accuracy Studies-2. Protocolo: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultadosSe incluyeron un total de 32 artículos y 5.451 pacientes. No se obtuvieron discrepancias entre muestras arteriales con glucómetro vs. laboratorio (sesgo [IC95%]: 0,01 [−0,12 a 0,14] mg/dL). En cambio, muestras arteriales con gasómetro sí sobreestimaron de forma significativa (sesgo [IC95%]: 0,12 [0,01 a 0,24] mg/dL). La misma tendencia presentan capilares con glucómetro, aunque no de forma significativa (sesgo [IC95%]: 0,07 [−0,02 a 0,15] mg/dL). Hay discrepancia entre los estudios sobre el efecto del hematocrito y el equilibrio ácido-base. El mayor consenso se da en la poca concordancia del glucómetro con muestras capilares vs. laboratorio en presencia de shock y soporte vasopresor, situación de fallo renal o durante el tratamiento con vitamina C.Conclusiones... (AU)

IntroductionThe clinical guideline for the management of sepsis recommends using arterial blood samples for glycaemic control. A multicentre study in 86 Spanish intensive care units revealed that 85.4% of these used capillary puncture.ObjectiveTo analyse the reliability of glycaemia by comparing different blood samples (arterial, venous, capillary) and instruments (glucometers, gasometers, central laboratory). Secondarily, to estimate the effect of confounding variables and the performance of measuring instruments as determined by different quality standards.MethodologySystematic review and meta-analysis with search in PubMed, CINAHL and Embase databases in September-2021 and September-2022, with no time or language limits. Grey literature sources: DART-Europe, OpenGrey and Google Scholar. Results summarised by qualitative (description of results, study characteristics) and quantitative (meta-analysis to assess standardised mean difference) synthesis. Methodological quality of articles assessed with Quality Assessment of Diagnostic Accuracy Studies-2. Protocol: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultsA total of 32 articles and 5451 patients were included. No discrepancies were obtained between arterial glucometer vs. laboratory samples (bias [95%CI]: 0.01 [−0.12 to 0.14] mg/dL). In contrast, arterial samples with a gasometer did significantly overestimate (bias [95%CI]: 0.12 [0.01 to 0.24] mg/dL). The same trend is seen in capillaries with a glucometer, although not significantly (bias [95%CI]: 0.07 [−0.02 to 0.15] mg/dL). There is discrepancy between studies on the effect of haematocrit and acid-base balance. The greatest consensus is on the poor agreement of glucometer with capillary vs. laboratory samples in the presence of shock and vasopressor support, renal failure or during vitamin C treatment.Conclusions... (AU)

Validation of primary and outcome data quality in a Swedish population-based breast cancer quality registry.

BACKGROUND: Population-based cancer quality registries are of great importance for the improvement of cancer care. However, little is known about the quality of recurrence data in cancer quality registries. The aim of this study was to evaluate data quality in the regional Breast Cancer Quality Registry of Central Sweden, with emphasis on the validity of recorded information on recurrence. METHODS: Validation by re-abstraction was performed on a random sample of 800 women with primary invasive breast cancer stage I-III diagnosed between 1993 and 2010, of which 400 had at least one registered recurrence and 400 had no registered recurrence. Registry data were compared with data from medical records. Exact agreement, correlation and kappa values, sensitivity and specificity were calculated. RESULTS: Seven hundred forty-seven women (93%) were available for analysis. Exact agreement was high for diagnostics, tumor characteristics, surgery, and adjuvant oncological treatment (90% or more for most variables). The registry's sensitivity was low for regional recurrence (47%), but higher for local and distant recurrence (80% and 75%), whereas specificity was overall high (≥ 95%). Combining all recurrence categories irrespective of localization improved sensitivity to 90% with a specificity of 91%. In 87% of women, the date of first recurrence according to medical records fell within ± 90 days of the date recorded in the registry. CONCLUSIONS: While the quality of data in the regional Breast Cancer Quality Registry was generally high, data accuracy on recurrences was lower. The overall precision of identifying any recurrence, irrespective of localization, was high. However, the accuracy of classification of recurrences (local, regional or distant) was lower, with evidence of underreporting for each of the recurrence categories. Given the importance of recurrence-related outcomes in the assessment of quality of care, efforts should be made to improve the reporting of recurrences.

Monitorización de la glucemia en el paciente crítico adulto: tipo de muestra y método de análisis. Revisión sistemática y metanálisis / Blood glucose monitoring in critically ill adult patients: Type of sample and method of analysis. Systematic review and meta-analysis

IntroducciónLa guía clínica para el manejo de la sepsis recomienda usar muestras de sangre arterial para el control glucémico. Un estudio multicéntrico en 86 unidades de cuidados intensivos españolas reveló que el 85,4% de estas utilizaban punción capilar.ObjetivoAnalizar la fiabilidad de la glucemia comparando diferentes muestras sanguíneas (arterial, venosa, capilar) e instrumentos (glucómetros, gasómetros, laboratorio central). Secundariamente, estimar el efecto de variables confusoras y el rendimiento de los instrumentos de medición determinados por las diferentes normas de calidad.MetodologíaRevisión sistemática y metanálisis con búsqueda en las bases de datos PubMed, CINAHL y Embase en septiembre-2021 y septiembre-2022, sin límites temporales ni idiomáticos. Fuentes de literatura gris: DART-Europe, OpenGrey y Google Académico. Resultados resumidos mediante síntesis cualitativa (descripción de resultados, características de los estudios) y cuantitativa (metanálisis para evaluar la diferencia de medias estandarizadas). Calidad metodológica de artículos evaluada con Quality Assessment of Diagnostic Accuracy Studies-2. Protocolo: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultadosSe incluyeron un total de 32 artículos y 5.451 pacientes. No se obtuvieron discrepancias entre muestras arteriales con glucómetro vs. laboratorio (sesgo [IC95%]: 0,01 [−0,12 a 0,14] mg/dL). En cambio, muestras arteriales con gasómetro sí sobreestimaron de forma significativa (sesgo [IC95%]: 0,12 [0,01 a 0,24] mg/dL). La misma tendencia presentan capilares con glucómetro, aunque no de forma significativa (sesgo [IC95%]: 0,07 [−0,02 a 0,15] mg/dL). Hay discrepancia entre los estudios sobre el efecto del hematocrito y el equilibrio ácido-base. El mayor consenso se da en la poca concordancia del glucómetro con muestras capilares vs. laboratorio en presencia de shock y soporte vasopresor, situación de fallo renal o durante el tratamiento con vitamina C.Conclusiones... (AU)

IntroductionThe clinical guideline for the management of sepsis recommends using arterial blood samples for glycaemic control. A multicentre study in 86 Spanish intensive care units revealed that 85.4% of these used capillary puncture.ObjectiveTo analyse the reliability of glycaemia by comparing different blood samples (arterial, venous, capillary) and instruments (glucometers, gasometers, central laboratory). Secondarily, to estimate the effect of confounding variables and the performance of measuring instruments as determined by different quality standards.MethodologySystematic review and meta-analysis with search in PubMed, CINAHL and Embase databases in September-2021 and September-2022, with no time or language limits. Grey literature sources: DART-Europe, OpenGrey and Google Scholar. Results summarised by qualitative (description of results, study characteristics) and quantitative (meta-analysis to assess standardised mean difference) synthesis. Methodological quality of articles assessed with Quality Assessment of Diagnostic Accuracy Studies-2. Protocol: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultsA total of 32 articles and 5451 patients were included. No discrepancies were obtained between arterial glucometer vs. laboratory samples (bias [95%CI]: 0.01 [−0.12 to 0.14] mg/dL). In contrast, arterial samples with a gasometer did significantly overestimate (bias [95%CI]: 0.12 [0.01 to 0.24] mg/dL). The same trend is seen in capillaries with a glucometer, although not significantly (bias [95%CI]: 0.07 [−0.02 to 0.15] mg/dL). There is discrepancy between studies on the effect of haematocrit and acid-base balance. The greatest consensus is on the poor agreement of glucometer with capillary vs. laboratory samples in the presence of shock and vasopressor support, renal failure or during vitamin C treatment.Conclusions... (AU)

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

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.

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. 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. 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. 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. 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.

Comparative Analysis of META and SALT Disaster Triage in an Adult Trauma Population: A Retrospective Observational Study.

BACKGROUND: Medical professionals can use mass-casualty triage systems to assist them in prioritizing patients from mass-casualty incidents (MCIs). Correct triaging of victims will increase their chances of survival. Determining the triage system that has the best performance has proven to be a difficult question to answer. The Advanced Prehospital Triage Model (Modelo Extrahospitalario de Triaje Avanzado; META) and Sort, Assess, Lifesaving Interventions, Treatment/Transport (SALT) algorithms are the most recent triage techniques to be published. The present study aimed to evaluate the META and SALT algorithms' performance and statistical agreement with various standards. The secondary objective was to determine whether these two MCI triage systems predicted patient outcomes, such as mortality, length-of-stay, and intensive care unit (ICU) admission. METHODS: This retrospective study used patient data from the trauma registry of an American College of Surgeons Level 1 trauma center, from January 1, 2018 through December 31, 2020. The sensitivity, specificity, and statistical agreement of the META and SALT triage systems to various standards (Revised Trauma Score [RTS]/Sort Triage, Injury Severity Score [ISS], and Lerner criteria) when applied using trauma patients. Statistical analysis was used to assess the relationship between each triage category and the secondary outcomes. RESULTS: A total of 3,097 cases were included in the study. Using Sort triage as the standard, SALT and META showed much higher sensitivity and specificity in the Immediate category than for Delayed (Immediate sensitivity META 91.5%, SALT 94.9%; specificity 60.8%, 72.7% versus Delayed sensitivity 28.9%, 1.3%; specificity 42.4%, 28.9%). With the Lerner criteria, in the Immediate category, META had higher sensitivity (77.1%, SALT 68.6%) but lower specificity (61.1%) than SALT (71.8%). For the Delayed category, SALT showed higher sensitivity (META 61.4%, SALT 72.2%), but lower specificity (META 75.1%, SALT 67.2%). Both systems showed a positive, though modest, correlation with ISS. For SALT and META, triaged Immediate patients tended to have higher mortality and longer ICU and hospital lengths-of-stay. CONCLUSION: Both META and SALT triage appear to be more accurate with Immediate category patients, as opposed to Delayed category patients. With both systems, patients triaged as Immediate have higher mortality and longer lengths-of-stay when compared to Delayed patients. Further research can help refine MCI triage systems and improve accuracy.

Territorial gaps on quality of causes of death statistics over the last forty years in Spain.

BACKGROUND: The quality of the statistics on causes of death (CoD) does not present consolidated indicators in literature further than the coding group of ill-defined conditions of the International Classification of Diseases. Our objective was to assess the territorial quality of CoD by reliability of the official mortality statistics in Spain over the years 1980-2019. METHODS: A descriptive epidemiological design of four decades (1980-, 1990-, 2000-, and 2010-2019) by region (18) and sex was implemented. The CoD cases, age-adjusted rates and ratios (to all-cause) were assigned by reliability to unspecific and ill-defined quality categories. The regional mortality rates were contrasted to the Spanish median by decade and sex by the Comparative Mortality Ratio (CMR) in a Bayesian perspective. Statistical significance was considered when the CMR did not contain the value 1 in the 95% credible intervals. RESULTS: Unspecific, ill-defined, and all-cause rates by region and sex decreased over 1980-2019, although they scored higher in men than in women. The ratio of ill-defined CoD decreased in both sexes over these decades, but was still prominent in 4 regions. CMR of ill-defined CoD in both sexes exceeded the Spanish median in 3 regions in all decades. In the last decade, women's CMR significantly exceeded in 5 regions for ill-defined and in 6 regions for unspecific CoD, while men's CMR exceeded in 4 and 2 of the 18 regions, respectively on quality categories. CONCLUSIONS: The quality of mortality statistics of causes of death has increased over the 40 years in Spain in both sexes. Quality gaps still remain mostly in Southern regions. Authorities involved might consider to take action and upgrading regional and national death statistics, and developing a systematic medical post-grade training on death certification.

Diagnostic accuracy of non-contrast MRI in frozen shoulder.

INTRODUCTION: Despite being the most used exam today, few studies have evaluated the accuracy of findings on non-contrast magnetic resonance imaging (MRI). The primary objective of the study was to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of non-contrast MRI findings in frozen shoulder, isolated and in combination. The secondary objectives were to define the interobserver and intraobserver agreement of the assessments and the odds ratio for frozen shoulder because of the various findings of MRI. METHODS: A retrospective diagnostic accuracy study comparing non-contrast MRI findings between the frozen shoulder group and the control group. Sensitivity, specificity, positive and negative predictive value, accuracy, odds ratio, interobserver and intraobserver agreement were calculated for each finding and their possible associations. RESULTS: The hyperintensity on capsule in the axillary recess presented 84% sensitivity, 94% specificity, and 89% accuracy. The obliteration of the subcoracoid fat triangle in the rotator interval had sensitivity 34%, specificity 82% and accuracy 58%. For coracohumeral ligament thickness ≥ 2 mm had specificity 66%, 48% specificity and 57% accuracy. Capsule thickness in the axillary recess ≥ 4 mm resulted in 54% sensitivity, 82% specificity, and 68% accuracy. Regarding interobserver agreement, only the posteroinferior and posterosuperior quadrants showed moderate results, and all the others showed strong reliability. The odds ratio for hyperintensity in the axillary recess was 82.3 for frozen shoulder. The association of these findings increased specificity (95%). CONCLUSION: The accuracy of non-contrast magnetic resonance imaging is high for diagnosing frozen shoulder, especially when evaluating the hyperintensity of the axillary recess. The exam has high reliability and reproducibility. The presence of an association of signs increases the specificity of the test. LEVEL OF EVIDENCE: Level III, study of diagnostic test.

Measurement of the retinal venous pressure with a new instrument in patients with primary open angle glaucoma.

PURPOSE: To compare the results of retinal venous pressure (RVP) measurement performed with contact lens dynamometry (CLD) and with the new IOPstim. METHODS: In this cross-sectional study, we included 36 patients with primary open angle glaucoma with a median age (Q25; Q75) of 74 (64; 77) years (m/f = 18/18), baseline intraocular pressure (IOP): 13.9 (12.2; 15.1) mmHg. Median mean defect: - 5.8 (- 11.9; - 2.6) db. Principle of the IOPstim: an empty balloon with a diameter of 8 mm is positioned on the eye, laterally of the limbus. Under observation of the central retinal vein (CRV), the examiner inflates the balloon. As soon as the CRV starts pulsation, the inflation is stopped and the IOP is measured, equaling the RVP at this moment. In the CLD, the pulsation of the CRV is observed with a contact lens. The RVP is calculated from the attachment force applied when pulsation appears. COURSE OF EXAMINATIONS: Three single measurements of RVP in quick succession with both methods. The sequence of the two methods was randomized. The means of the three RVP measurements were compared. RESULTS: Pressures in mmHg. RVP: IOPstim: 19.4 ± 5.4 (mean ± SD), CLD: 20.3 ± 5.9. Range of three single measurements: IOPstim: 2.9 ± 1.5, CLD: 2.2 ± 1.1. The differences were RVPIOPstim - RVPCLD = - 0.94 ± 1.15, and approximately normally distributed. Bland-Altman analysis: only one data point was 0.5 mmHg higher than the upper line of agreement. The confidence interval of this line was 0.65 mmHg. Concordance correlation coefficient according to Lin (CCC): 0.96. Intraclass correlation coefficient: both methods, 0.94. CONCLUSION: In both methods, the range of the single measurements may be taken as a sign of good reliability, the CCC of 0.96 as a sign of a very good agreement. At the mean, the IOPstim RVP values were 1 mmHg lower than those obtained with the CLD. This difference may be due to the different directions of the prevailing force vectors induced by the instruments. The IOPstim seems applicable in glaucoma diagnostics.

Development and quality appraisal of a new English breast screening linked data set as part of the age, test threshold, and frequency of mammography screening (ATHENA-M) study.

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.

The diagnosis of cerebral palsy in two Danish national registries: a validation study.

AIMS: To determine the quality of prospectively collected data from the highly specialized Danish Cerebral Palsy Follow-up Program (CPOP), and to establish the validity of a reported cerebral palsy (CP) diagnosis in the Danish National Patient Registry (NPR), regularly used as a proxy for neurodevelopmental disorders in epidemiological research. METHODS: We compared data from the two registries on children with registered CP, born in Denmark between 2008 and 2009, with information from medical records verified by two experienced physicians specializing in pediatric neurology. Data accuracy was estimated by completeness, correctness, and reliability. Completeness was calculated as the number of cases with correctly registered CP diagnoses divided by the total number of true CP diagnoses (similar to sensitivity). Correctness was calculated as the number of cases with correct registrations divided by the total number of cases (similar to positive predictive value). Reliability was estimated using kappa statistics. RESULTS: Registered CP diagnoses in the CPOP had high accuracy, with 94% correctness and 91% completeness. Furthermore, most key variables in the CPOP showed excellent reliability, especially variables defining the severity of the condition. In the Danish NPR, only 225 of 348 children with a noted CP diagnosis fulfilled the diagnostic criteria for CP, resulting in 65% correctness. CONCLUSIONS: Danish CPOP data are a valid source for epidemiological research. Conversely, a noted CP diagnosis in the Danish NPR was, at best, correct in only two out of three patients.