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Background: Multiple diseases, such as Adolescent Idiopathic Scoliosis (AIS), present at adolescent age and the impact on quality of life (QoL) prolongs into adulthood. For the EQ-5D, a commonly used instrument to measure QoL, the current guideline is ambiguous whether the youth or adult version is to be preferred at adolescent age. To assess which is most suitable, this study tested for equivalence along predefined criteria of the youth (EQ-5D-5L) and adult (EQ-5D-Y-5L) version in an adolescent population receiving bracing therapy for AIS. Methodology: 107 adolescents were recruited from 4 scoliosis centers in the Netherlands between March 2022 and January 2023; they completed both EQ-5D's and the SRS-22r (scoliosis-specific questionnaire). The following criteria were evaluated using the individual and sum of domains (level-sum-score (LSS)). Our primary criterion for non-equivalence of the EQ-5D's was less than excellent (≤ 0.9) intra-individual agreement using Intraclass Correlation Coefficient (ICC) analysis for LSS and weighted (quadratic) kappa for domains. Secondary criteria were differences in ceiling using McNemar test; a different number of quantified hypotheses for construct validity achieved using the SRS-22r as comparator; differences in test-retest reliability by comparing ICC/kappa values using a Z-test. Results: Adolescents had a mean age of 14 years (range 12–18), and 78% were female. Ceiling was mostly comparable between EQ-5D's, ranging from 78 to 81% for mobility and self-care, 52–54% for usual activities, and 31–36% for pain/discomfort. The EQ-5D-5L showed more ceiling (57%) compared to the EQ-5D-Y-5L (41%) on anxiety/depression (p = 0.006). Agreement between the EQ-5D's did not meet our criterion for the LSS (ICC 0.79 (95% confidence interval 0.70–0.85)), and decreased further at the domain-level. Both EQ-5D's achieved 5/7 validity hypotheses. Test-retest reliability was slightly better for EQ-5D-5L LSS (ICC 0.76 (0.64–0.84)) compared to EQ-5D-Y-5L LSS (ICC 0.69 (0.55–0.79)), although this was statistically insignificant (p = 0.284). This pattern was similar for most domains. Conclusions: The EQ-5D versions showed insufficient agreement, and cannot be considered fully equivalent. While they were similar in terms of validity and test-retest reliability, differences in score distribution were present. Taken together, we advise using the EQ-5D-5L to monitor the QoL in adolescent patients with AIS, as it avoids switching instruments and thus data discontinuities. Future studies should verify these findings in different patient groups and the general population. [ABSTRACT FROM AUTHOR]

Introduction: Anticoagulation is essential for treating thromboembolic diseases and preventing complications associated with pathologies such as atrial fibrillation. However, it carries a significant risk of bleeding, which highlights the importance of reversal agents use. In Colombia, scientific evidence on these therapies is limited. Objective: To implement the Colombian Registry of Anticoagulation Clinics (RECCANT) and the Colombian Registry of Anticoagulation Clinics and and the Use of Reversal Agents (RECCANT-AR), which aim to fill this information gap by providing robust and representative data on these patients. Method: RECCANT is an observational, analytical, prospective, and multicenter study that includes patients over 18 years of age with an indication for anticoagulant management for at least 3 months. RECCANT-AR is an observational, analytical, ambispective, and multicenter study that includes patients over 18 years of age requiring reversal agents due to significant bleeding or the need for urgent or priority invasive procedures. Sociodemographic, clinical, and therapeutic data are collected using he electronic platform REDCap (Research Electronic Data Capture) to ensure information security and confidentiality. Results: RECCANT and RECCANT-AR are established as the first national registries focused on characterizing anticoagulated patients and those requiring reversal agents. Conclusions: RECCANT and RECCANT-AR are essential for addressing the knowledge gap regarding anticoagulation and the use of reversal agents in Colombia. By providing precise and detailed information, these registries will improve understanding of patient profiles, identify national patterns, and support the development of standardized strategies to enhance care and clinical outcomes in the country. [ABSTRACT FROM AUTHOR]

ABSTRACT On May 26, 2021, the European Medical Device Regulation (EU-MDR) entered into effect resulting in a major shift in the requirements for assessment of medical devices in Europe. The EU-MDR Cardiovascular Collaboratory (EU-MCVC) was founded to contribute to the development of faster, more efficient, and more effective pathways for innovation of cardiac medical devices. A registry is an organized system that collects uniform data and evaluates specified outcomes in a population defined by a disease, condition, or exposure. Most registries have been created to improve the quality of care and provide feedback to physicians, hospitals, and health providers. Clinical registries represent an ideal construct for scientific, clinical, and policy-making collaboration. We describe diverse experiences from 5 European countries and address the traditional quality components in clinical trials. Continued collaboration is expected among academics, clinical trialists, patient representatives, regulatory experts, research organizations, registry platforms, regulatory bodies, and industry partners. Data quality is a primary concern and registry leaders need to optimize data quality to become regulatory compliant. A collaborative approach among medical device stakeholders may improve quality of care, reduce costs, and provide faster access to innovative technologies, with the common objective of improving cardiovascular care and outcomes.

Background: Multiple diseases, such as Adolescent Idiopathic Scoliosis (AIS), present at adolescent age and the impact on quality of life (QoL) prolongs into adulthood. For the EQ-5D, a commonly used instrument to measure QoL, the current guideline is ambiguous whether the youth or adult version is to be preferred at adolescent age. To assess which is most suitable, this study tested for equivalence along predefined criteria of the youth (EQ-5D-5L) and adult (EQ-5D-Y-5L) version in an adolescent population receiving bracing therapy for AIS. Methodology: 107 adolescents were recruited from 4 scoliosis centers in the Netherlands between March 2022 and January 2023; they completed both EQ-5D's and the SRS-22r (scoliosis-specific questionnaire). The following criteria were evaluated using the individual and sum of domains (level-sum-score (LSS)). Our primary criterion for non-equivalence of the EQ-5D's was less than excellent (≤ 0.9) intra-individual agreement using Intraclass Correlation Coefficient (ICC) analysis for LSS and weighted (quadratic) kappa for domains. Secondary criteria were differences in ceiling using McNemar test; a different number of quantified hypotheses for construct validity achieved using the SRS-22r as comparator; differences in test-retest reliability by comparing ICC/kappa values using a Z-test. Results: Adolescents had a mean age of 14 years (range 12–18), and 78% were female. Ceiling was mostly comparable between EQ-5D's, ranging from 78 to 81% for mobility and self-care, 52–54% for usual activities, and 31–36% for pain/discomfort. The EQ-5D-5L showed more ceiling (57%) compared to the EQ-5D-Y-5L (41%) on anxiety/depression (p = 0.006). Agreement between the EQ-5D's did not meet our criterion for the LSS (ICC 0.79 (95% confidence interval 0.70–0.85)), and decreased further at the domain-level. Both EQ-5D's achieved 5/7 validity hypotheses. Test-retest reliability was slightly better for EQ-5D-5L LSS (ICC 0.76 (0.64–0.84)) compared to EQ-5D-Y-5L LSS (ICC 0.69 (0.55–0.79)), although this was statistically insignificant (p = 0.284). This pattern was similar for most domains. Conclusions: The EQ-5D versions showed insufficient agreement, and cannot be considered fully equivalent. While they were similar in terms of validity and test-retest reliability, differences in score distribution were present. Taken together, we advise using the EQ-5D-5L to monitor the QoL in adolescent patients with AIS, as it avoids switching instruments and thus data discontinuities. Future studies should verify these findings in different patient groups and the general population. [ABSTRACT FROM AUTHOR]

Abstract Physicians’ letters are the optimal source of diagnoses for registries. However, most registries demand for diagnosis codes such as ICD-10. We herein describe an algorithm that infers ICD-10 codes from German ophthalmologic physicians’ letters. We assess the method in three German eye hospitals. Our algorithm is based on the nearest-neighbor method as well as on a large thesaurus for ICD-10 codes. This thesaurus was embedded into a Word2Vec space created from anonymized physicians’ reports of the first hospital. For evaluation, each of the three hospitals sent all diagnoses taken from 100 letters. The inferred ICD-10 codes were evaluated for correctness by the senders. A total of 3332 natural language terms had been sent in (812 hospital one, 1473 hospital two, 1047 hospital three). A total of 526 non-diagnoses were excluded upfront. 2806 ICD-10 codes were inferred (771 hospital one, 1226 hospital two, 809 hospital three). In the first hospital, 98% were fully correct and 99% correct at the level of the superordinate disease concept. The percentages in hospital two were 69% and 86%. The respective numbers for hospital three were 69% and 91%. Our simple method is capable of inferring ICD-10 codes for German natural language diagnoses, especially when the embedding space has been built with physicians’ letters from the same hospital. The method may yield sufficient accuracy for many tasks in the multi-centric setting and can easily be adapted to other languages/specialities.

Background: Historically, national programs for collecting stroke data in Australia required the use of multiple online tools. Clinicians were required to enter overlapping variables for the same patient in the different databases. From 2013 to 2016, the Australian Stroke Data Tool (AuSDaT) was built as an integrated data management solution. Objective: In this article, we have described the development, implementation, and evaluation phases of establishing the AuSDaT. Method: In the development phase, a governance structure with representatives from different data collection programs was established. Harmonisation of data variables, drawn from six programs used in hospitals for monitoring stroke care, was facilitated through creating a National Stroke Data Dictionary. The implementation phase involved a staged deployment for two national programs over 12 months. The evaluation included an online survey of people who had used the AuSDaT between March 2018 and May 2018. Results: By July 2016, data entered for an individual patient was, for the first time, shared between national programs. Overall, 119/422 users (90% female, 61% aged 30–49 years, 57% nurses) completed the online evaluation survey. The two most positive features reported about the AuSDaT were (i) accessibility of the system (including simultaneous user access), and (ii) the ability to download reports to benchmark local data against peer hospitals or national performance. More than three quarters of respondents (n = 92, 77%) reported overall satisfaction with the data collection tool. Conclusion: The AuSDaT reduces duplication and enables users from different national programs for stroke to enter standardised data into a single system. Implications: This example may assist others who seek to establish a harmonised data management solution for different disease areas where multiple programs of data collection exist. The importance of undertaking continuous evaluation of end-users to identify preferences and aspects of the tool that are not meeting current requirements were illustrated. We also highlighted the opportunities to increase interoperability, utility, and facilitate the exchange of accurate and meaningful data. [ABSTRACT FROM AUTHOR]

This comparative study examines the transition from isolated registries to a consolidated data-centric approach at University Hospital Schleswig-Holstein, focusing on migrating the Atrioventricular Valve Intervention Registry (AVIR) from REDCap to a Medical Data Integration Center based openEHR registry. Through qualitative analysis, we identify key disparities and strategic decisions guiding this transition. While REDCap has historical utility, its limitations in automated data integration and traceability highlight the advantages of a data-centric approach, which include streamlined data (integration) management at a singlepoint-of-truth based on e.g., centralized consent management. Our findings lay the groundwork for the AVIR project and a proof-of-concept data-centric registry, reflecting a broader industry trend towards data-centric healthcare initiatives. [ABSTRACT FROM AUTHOR]

Physicians' letters are the optimal source of diagnoses for registries. However, most registries demand for diagnosis codes such as ICD-10. We herein describe an algorithm that infers ICD-10 codes from German ophthalmologic physicians' letters. We assess the method in three German eye hospitals. Our algorithm is based on the nearest-neighbor method as well as on a large thesaurus for ICD-10 codes. This thesaurus was embedded into a Word2Vec space created from anonymized physicians' reports of the first hospital. For evaluation, each of the three hospitals sent all diagnoses taken from 100 letters. The inferred ICD-10 codes were evaluated for correctness by the senders. A total of 3332 natural language terms had been sent in (812 hospital one, 1473 hospital two, 1047 hospital three). A total of 526 non-diagnoses were excluded upfront. 2806 ICD-10 codes were inferred (771 hospital one, 1226 hospital two, 809 hospital three). In the first hospital, 98% were fully correct and 99% correct at the level of the superordinate disease concept. The percentages in hospital two were 69% and 86%. The respective numbers for hospital three were 69% and 91%. Our simple method is capable of inferring ICD-10 codes for German natural language diagnoses, especially when the embedding space has been built with physicians' letters from the same hospital. The method may yield sufficient accuracy for many tasks in the multi-centric setting and can easily be adapted to other languages/specialities. [ABSTRACT FROM AUTHOR]

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Rare or orphan diseases belong to one of the most severe groups of diseases. At the same time, early and accurate diagnosis of such diseases is a serious problem for general practitioners, pediatricians and therapists. The article discusses the possibilities of using machine learning methods, including artificial intelligence, to improve the diagnosis of rare diseases. Information is provided on various models developed by both international experts and Russian researchers.

Heart failure (HF) is a growing, global public health issue. Despite advances in HF care, many challenges remain and HF outcomes are poor. Some of the major reasons for this are the lack of understanding and treatment for certain HF sub-types as well as the lack of implementation of treatment in areas where effective treatment exists. HF registries provide the opportunity to transform clinical research and patient care. Recently the registry-based randomized clinical trial has emerged as a pragmatic and inexpensive alternative to the gold standard in clinical trial design, the randomized controlled trial. Registries may also provide platforms for strategy trials, implementation trials, and screening. Using examples from the Swedish Heart Failure Registry and others, the present review provides insights into how registry-based research can address many of the unmet needs in HF. [Display omitted] • Registries can help address many of the unmet needs in heart failure. • Registries facilitate implementation, provide patient insights, and generate hypotheses. • Registry-based randomized clinical trial can effectively address and mitigate limitations of traditional trials. • Future registry designs could improve and simplify clinical research further. [ABSTRACT FROM AUTHOR]

Abstract Background Patient Reported Outcome Measures (PROMs) are being increasingly introduced in clinical registries, providing a personal perspective on the expectations and impact of treatment. The aim of this study was to describe response rates (RR) to PROMs in clinical registries and databases and to examine the trends over time, and how they change with the registry type, region and disease or condition captured. Methods We conducted a scoping literature review of MEDLINE and EMBASE databases, in addition to Google Scholar and grey literature. All English studies on clinical registries capturing PROMs at one or more time points were included. Follow up time points were defined as follows: baseline (if available),

Background: Patient Reported Outcome Measures (PROMs) are being increasingly introduced in clinical registries, providing a personal perspective on the expectations and impact of treatment. The aim of this study was to describe response rates (RR) to PROMs in clinical registries and databases and to examine the trends over time, and how they change with the registry type, region and disease or condition captured. Methods: We conducted a scoping literature review of MEDLINE and EMBASE databases, in addition to Google Scholar and grey literature. All English studies on clinical registries capturing PROMs at one or more time points were included. Follow up time points were defined as follows: baseline (if available), < 1 year, 1 to < 2 years, 2 to < 5 years, 5 to < 10 years and 10 + years. Registries were grouped according to regions of the world and health conditions. Subgroup analyses were conducted to identify trends in RRs over time. These included calculating average RRs, standard deviation and change in RRs according to total follow up time. Results: The search strategy yielded 1,767 publications. Combined with 20 reports and four websites, a total of 141 sources were used in the data extraction and analysis process. Following the data extraction, 121 registries capturing PROMs were identified. The overall average RR at baseline started at 71% and decreased to 56% at 10 + year at follow up. The highest average baseline RR of 99% was observed in Asian registries and in registries capturing data on chronic conditions (85%). Overall, the average RR declined as follow up time increased. Conclusion: A large variation and downward trend in PROMs RRs was observed in most of the registries identified in our review. Formal recommendations are required for consistent collection, follow up and reporting of PROMs data in a registry setting to improve patient care and clinical practice. Further research studies are needed to determine acceptable RRs for PROMs captured in clinical registries. [ABSTRACT FROM AUTHOR]

Purpose: Bariatric and metabolic surgery is an effective treatment for severe and complex obesity; however, robust long-term data comparing operations is lacking. Clinical registries complement clinical trials in contributing to this evidence base. Agreement on standard data for bariatric registries is needed to facilitate comparisons. This study developed a Core Registry Set (CRS) — core data to include in bariatric surgery registries globally. Materials and Methods: Relevant items were identified from a bariatric surgery research core outcome set, a registry data dictionary project, systematic literature searches, and a patient advisory group. This comprehensive list informed a questionnaire for a two-round Delphi survey with international health professionals. Participants rated each item's importance and received anonymized feedback in round 2. Using pre-defined criteria, items were then categorized for voting at a consensus meeting to agree the CRS. Results: Items identified from all sources were grouped into 97 questionnaire items. Professionals (n = 272) from 56 countries participated in the round 1 survey of which 45% responded to round 2. Twenty-four professionals from 13 countries participated in the consensus meeting. Twelve items were voted into the CRS including demographic and bariatric procedure information, effectiveness, and safety outcomes. Conclusion: This CRS is the first step towards unifying bariatric surgery registries internationally. We recommend the CRS is included as a minimum dataset in all bariatric registries worldwide. Adoption of the CRS will enable meaningful international comparisons of bariatric operations. Future work will agree definitions and measures for the CRS including incorporating quality-of-life measures defined in a parallel project. [ABSTRACT FROM AUTHOR]

• The AO-Trauma Italy council has encouraged the development of a national fracture registry in Italy (RIFra). • Thirteen AO-Trauma Italy members, chairmen of Level-I orthopaedic and trauma centres, diffused throughout Italy, were involved in the RIFra project. • The RIFra form, developed between November 2019 and March 2020, consists of 5 main sections, namely: epidemiologic data, previous surgical procedure (if any), patient and fracture features, surgical procedure, surgical implant details. • This study constitutes the first step to start, the bureaucratic procedure leading to the final establishment of a national fracture registry in Italy. In recent years, there has been an increasing interest in the development of arthroplasty registries, therefore, in our country, the Italian Arthroplasty Registry (RIAP), was issued by the National Law No. 221/2012. In the last decade, however, some European countries -namely Sweden, Denmark, Norway, and Germany (in development)- have introduced another nationwide orthopaedic registry than arthroplasty registers: the fracture registry. The development of this new tool aims to improve quality and safety in fracture management, thus trying to provide a better postoperative quality of life in trauma patients. Based on these findings, the AO-Trauma Italy Council encouraged the development of a national fracture registry in Italy. The present study aims to (1) provide an overview of the fracture registries in Europe and (2) to develop, for the first time, a pilot Italian Fracture Registry (RIFra). Thirteen AO-Trauma Italy members, chairmen of Level-I orthopaedic and trauma centres, diffused throughout Italy, were involved in the RIFra project. The RIFra form, developed between November 2019 and March 2020, consists of 5 main sections, namely: epidemiologic data, previous surgical procedure (if any), patient and fracture features, surgical procedure, surgical implant details. This study constitutes the first step to start, in future years, the bureaucratic procedure leading to the final establishment of a RIAP-like fracture registry in Italy. [ABSTRACT FROM AUTHOR]

National clinical registries offer the benefits of a comprehensive dataset, particularly when linked with patient-reported outcome (PRO) data. This aim of this study was to utilise UK registry data to assess cross-sectional differences in health-related quality of life (HrQoL) in patients with primary rectal (PRC) and locally recurrent rectal cancer (LRRC). Data were extracted from the COloRECTal cancer Repository (CORECT-R) and the Locally Recurrent Rectal Cancer – Quality of Life (LRRC-QoL) datasets. Propensity score matching was undertaken in a 1:1 ratio using two covariates: age and sex. The primary outcome was the FACT-C Colorectal Cancer Subscale (CCS). Statistical significance was determined using p < 0.05 and clinical significance using effect size (ES) and minimally important clinical difference (MCID). A matched cohort with 72 patients in each group was identified. Overall FACT-C CCS scores were worse in patients with LRRC from a statistical (11.80 vs 18.03, p < 0.001) and clinically meaningful perspective (ES 1.63, MCID 6.23). Patients with PRC reported better digestion (p < 0.001, ES 0.85), better control over their bowels (p < 0.001, ES 1.03) and increased appetite (p < 0.001, ES 1.74, MCID 2.08). Patients with LRRC reported worse stomach swelling (p < 0,001, ES 0.97) and more diarrhoea (p < 0.001, ES 0.92), however they reported better body image (p < 0.001, ES 0.80). Patients with LRRC reported significantly worse overall scores in the FACT-C CCS from both a statistical and clinical perspective, demonstrating the ability of the FACT-C to distinguish between these patient groups and the benefits of the inclusion of PROs within colorectal cancer registries, specifically including patients with advanced/recurrent disease. [ABSTRACT FROM AUTHOR]

Visualization of research results based on data from real clinical practice (RWD) is mandatory when conducting presentations and publishing reports. One of the additional tools that allow you to customize complex reports is the business intelligence service from Microsoft Power BI. The article discusses various ways of loading, processing and visualizing data from clinical registers using the specified software.

The concept of registry-based medical research goes back to the mid of 18th century where data was collected in actual physical registers and analyzed using manual counts in a very primitive way until computing technologies took over to digitize information, to change the process all the way from data collection to data analysis. This digital age of technology can be hypothetically classified in 3 eras; the Digitization Era, the Integration Era, and finally the Futuristic, Smart Intelligence Era. This study would highlight the changes in the fundamental aspects of a medical registry under each of these digital eras. [ABSTRACT FROM AUTHOR]

Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain. [ABSTRACT FROM AUTHOR]

ObjectivesTo compare management of patients with acute non-ST segment elevation myocardial infarction (NSTEMI) in three developed countries with national ongoing registries.BackgroundResults from clinical trials suggest significant variation in care across the world. However, international comparisons in "real world" registries are limited.MethodsWe compared the use of in-hospital procedures and discharge medications for patients admitted with NSTEMI from 2007 to 2010 using the unselective MINAP/NICOR [England and Wales (UK); n=137,009], the unselective SWEDEHEART/RIKS-HIA (Sweden; n=45,069), and the selective ACTION Registry-GWTG/NCDR [United States (US); n=147,438] clinical registries.ResultsPatients enrolled among the three registries were generally similar except those in the US who were younger but had higher rates of smoking, diabetes, hypertension, prior heart failure, and prior MI than in Sweden or in UK. Angiography and percutaneous coronary intervention (PCI) were performed more often in the US (76% and 44%) and Sweden (65% and 42%) relative to the UK (32% and 22%). Discharge betablockers were also prescribed more often in the US (89%) and Sweden (89%) than in the UK (76%). In contrast, discharge statins, angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), and dual antiplatelet agents (among those not receiving PCI) were higher in the UK (92%, 79%, and 71%) than in the US (85%, 65%, 41%) and Sweden (81%, 69%, and 49%).ConclusionsThe care for patients with NSTEMI differed substantially among the three countries. These differences in care among countries provide an opportunity for future comparative effectiveness research as well as identify opportunities for global quality improvement.

In resource-constrained settings, where inequalities in access to and quality of surgical care results in excess mortality, peri-operative care registries are uncommon. A south-south collaboration supported the implementation of a context specific, clinician-led, multicentre real-time peri-operative registry in Ethiopia. Peri-operative information, including the Ethiopian Ministry of Health's national 'Saving Lives through Safe Surgery initiative', was linked to real-time dashboards, providing clinicians and administrators with information on service utilisation, surgical access, national surgical key performance indicators and measures of quality of care. We recruited four hospitals representing 285 in-patient beds from the Amhara and Southern Nations Nationalities and Peoples regions and Addis Ababa city, and reported on 1748 consecutive surgical cases from April 2019 to April 2020. Key performance indicators included: compliance with the World Health Organization's Surgical Safety Checklist in 1595 (92.1%) surgical cases; adverse events during anaesthesia in 33 (3.1%) cases; and surgical site infections in 21 (2.0%) patients. This collaboration has successfully implemented a multicentre digital surgical registry that can enable measurement of key performance indicators for surgery and evaluation of peri-operative outcomes. The peri-operative registry is currently being rolled out across the Amhara region and Addis Ababa city administration. It will provide continuous granular healthcare information necessary to empower clinicians to drive context-specific priorities for service improvement and research, in collaboration with national stakeholders and international research consortiums. [ABSTRACT FROM AUTHOR]

Objective: Surgical registries play a crucial role in clinical knowledge discovery, hospital quality assurance, and quality improvement. However, maintaining a surgical registry requires significant monetary and human resources given the wide gamut of information abstracted from medical records ranging from patient co-morbidities to procedural details to post-operative outcomes. Although natural language processing (NLP) methods such as pretrained language models (PLMs) have promised automation of this process, there are yet substantial barriers to implementation. In particular, constant shifts in both underlying data and required registry content are hurdles to the application of NLP technologies., Materials and Methods: In our work, we evaluate the application of PLMs for automating the population of the Society of Thoracic Surgeons (STSs) adult cardiac surgery registry (ACS) procedural elements, for which we term Cardiovascular Surgery Bidirectional Encoder Representations from Transformers (CS-BERT). CS-BERT was validated across multiple satellite sites and versions of the STS-ACS registry., Results: CS-BERT performed well (F1 score of 0.8417 ± 0.1838) in common cardiac surgery procedures compared to models based on diagnosis codes (F1 score of 0.6130 ± 0.0010). The model also generalized well to satellite sites and across different versions of the STS-ACS registry., Discussion and Conclusions: This study provides evidence that PLMs can be used to extract the more common cardiac surgery procedure variables in the STS-ACS registry, potentially reducing need for expensive human annotation and wide scale dissemination. Further research is needed for rare procedural variables which suffer from both lack of data and variable documentation quality., Competing Interests: MG is a consultant to Edwards Lifesciences, Medtronic, Abbott, Artivion, ClearFlow, AtriCure, Johnson and Johnson, Corcym., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Abstract Background Using outcome measures to advance healthcare continues to be of widespread interest. The goal is to summarize the results of studies which use outcome measures from clinical registries to implement and monitor QI initiatives. The second objective is to identify a) facilitators and/or barriers that contribute to the realization of QI efforts, and b) how outcomes are being used as a catalyst to change outcomes over time. Methods We searched the PubMed, EMBASE and Cochrane databases for relevant articles published between January 1995 and March 2017. We used a standardized data abstraction form. Studies were included when the following three criteria were fulfilled: 1) they relied on structural data collection, 2) when a structural and comprehensive QI intervention had been implemented and evaluated, and 3) impact on improving clinical and/or patient-reported outcomes was described. Data on QI strategies, QI initiatives and the impact on outcomes was extracted using standardized assessment tools. Results We included 21 articles, of which eight showed statistically significant improvements on outcomes using data from clinical registries. Out of these eight studies, the Chronic Care Model, IT application as feedback, benchmarking and the Collaborative Care Model were used as QI methods. Encouraging trends in realizing improved outcomes through QI initiatives were observed, ranging from improving teamwork, implementation of clinical guidelines, implementation of physician alerts and development of a decision support system. Facilitators for implementing QI initiatives included a high quality database, audits, frequent reporting and feedback, patient involvement, communication, standardization, engagement, and leadership. Conclusion This review suggests that outcomes collected in clinical registries are supportive to realize QI initiatives. Organizational readiness and an active approach are key in achieving improved outcomes.

Abstract Background Despite much research effort, there is a paucity of conclusive evidence in the field of preterm birth prediction and prevention. The methods of monitoring and prevention strategies offered to women at risk vary considerably around the UK and depend on local maternity care provision. It is becoming increasingly recognised that this experience and knowledge, if captured on a larger scale, could be a utilized as a valuable source of evidence for others. The UK Preterm Clinical Network (UKPCN) was established with the aim of improving care and outcomes for women at risk of preterm birth through the sharing of a wealth of experience and knowledge, as well as the building of clinical and research collaboration. The design and development of a bespoke internet-based database was fundamental to achieving this aim. Method Following consultation with UKPCN members and agreement on a minimal dataset, the Preterm Clinical Network (PCN) Database was constructed to collect data from women at risk of preterm birth and their children. Information Governance and research ethics committee approval was given for the storage of historical as well as prospectively collected data. Collaborating centres have instant access to their own records, while use of pooled data is governed by the PCN Database Access Committee. Applications are welcomed from UKPCN members and other established research groups. The results of investigations using the data are expected to provide insights into the effectiveness of current surveillance practices and preterm birth interventions on a national and international scale, as well as the generation of ideas for innovation and research. To date, 31 sites are registered as Data Collection Centres, four of which are outside the UK. Conclusion This paper outlines the aims of the PCN Database along with the development process undertaken from the initial idea to live launch.

A National registry program is a resource intensive initiative involving multiple stakeholders, multi-institutional/multi-role/multi-users collaborative effort, where various aspects starting from work culture, research culture, registry conceptualization, resource availability, data format, data storage/retrieval techniques, data sharing protocols, data/dataset standards, data quality etc. vary drastically between different institutions. The biggest challenge for a national program will be to map these aspects under a common umbrella to establish standards for operations/execution, policies and procedures, which means aligning the registry operations with the operative process of each institution at first, due to this only a handful initiatives are implemented with limited success, hence it is advisable to study such implementations in great details as a guideline to build a solid foundation for future national initiatives[1][2].The idea goes around building a solid database for holding all clinical registries under a single repository, along with streamlining and generalizing the policies and procedures for any disease or medical device registry, in order to save infrastructure spending, streamlining, saving on management and operational costs and overheads. [ABSTRACT FROM AUTHOR]

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Clinical registries are increasingly used as national performance measurement platforms. In 2018, nearly 70 percent of the more than 50 specialty society registries in the United States were used by the Centers for Medicare & Medicaid Services (CMS) to measure the quality of clinical care. Private payers and evaluating organizations also use or desire to use registry information to inform quality improvement programs and value-based payment models. The requirements for an entity to become a CMS Qualified Clinical Data Registry (QCDR) constitute a minimum set of standards for the purpose of reporting to the CMS Quality Payment Program. Models and frameworks exist that can help classify registries by purpose and use, and maturity models are available for evaluating health IT systems generally. However, there is currently no framework that describes the capability that should be expected from a registry at different phases of its development and maturity. In response, the National Quality Registry Network (NQRN) has developed a registry maturational framework. The framework models early, intermediate and mature development phases, the capabilities anticipated during these phases and 17 domains across which registry programs support those capabilities. The framework was developed and refined by NQRN registry stewards, users and other stakeholders between 2013--2018. It is intended to be used as a developmental guide or for registry evaluation. The successful use of registry information to execute value-based payment models is a critical need in U.S. health care. The NQRN framework can help ensure that our national system of registries is rising to the occasion. [ABSTRACT FROM AUTHOR]

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Clinical registries provide a valuable opportunity to study specific diagnoses or conditions with a broader scope than possible using individual center-based series and with more clinical detail than typically available in administrative data sources. These registries amass structured data with uniform definitions, thus facilitating reliable adoption and consistent use across contributing sites. By compiling granular data from a multitude of geographically diverse sites, clinical registries allow investigation of rare outcomes, comparison of practice and cost variation, and benchmarking across institutions. Registries may track cohorts of patients over time, providing unique longitudinal follow-up that cannot be obtained from many alternate data sources. As clinical registries become more prevalent, research conducted using these registries is increasing and helping to expand knowledge boundaries in children's surgery. The purpose of this review is to provide an overview of several of the most common clinical registries used in children's surgery and explore the strengths and limits of these tools in the conduct of meaningful health services research. [ABSTRACT FROM AUTHOR]

Background: Denmark has national clinical indicator programs for adult patients diagnosed with depression and schizophrenia, respectively. Within each program, the responsible steering group (SG) decided to add some indicators based upon patient-reported outcome measures (PROMs). Aims: The primary aim was to describe the process of selecting PROMs and defining a national measurement concept for use in clinical practice and for indicator monitoring and the secondary aim s to collect patient recommendations for implementation. Methods: An interdisciplinary SG of healthcare professionals and a Patient Peer Board (PPB) representing both patient groups co-created the output in an iterative process. The work included literature search, PPB workshops, SG meetings, ratings of PROM topics and items, and a pilot. The PPB discussed the following: item relevance, mode of data collection, graphical format of the online PROMs, and display of results. Finally, requirements for PROM patient information were identified. Based upon input from the PPB, the SG selected the items and specified the measurement concept. Results: The PPB prioritized 20 of 53 suitable items and suggested alternative wording and answer categories. A pilot was performed and 19 items covering well-being, lack of well-being, impairment of functioning, and overall health were selected for clinical testing. The patients recommended concrete, unambiguous, easily understandable information and procedures for data collection and display of results. Conclusions: The iterative co-creation process based upon a high degree of patient involvement resulted in a set of PROMs, a national measurement concept, and patient recommendations for implementation. The cooperation between patients and professionals was successful. [ABSTRACT FROM AUTHOR]

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Randomised controlled clinical trials are the best source of evidence for assessing the efficacy of drugs. Observational studies provide critical descriptive data and information on long-term efficacy and safety that clinical trials cannot provide, at generally much less expense. Observational studies include case reports and case series, ecological studies, cross-sectional studies, case-control studies and cohort studies. New and ongoing developments in data and analytical technology, such as data linkage and propensity score matching, offer a promising future for observational studies. However, no study design or statistical method can account for confounders and bias in the way that randomised controlled trials can. Clinical registries are gaining importance as a method to monitor and improve the quality of care in Australia. Although registries are a form of cohort study, clinical trials can be incorporated into them to exploit the routine follow-up of patients to capture relevant outcomes. [ABSTRACT FROM AUTHOR]

When registries collect accurate clinical data over time, they can act as fundamental support structures for patients and their families and powerful cost-effective instruments to support clinical trials and translational research to improve quality of care, quality of life and survival. Registries are critical for rare diseases ( RD) with low prevalence and propensity for variation in treatment and outcomes. Rare Voices Australia is leading a call for action to the research and clinical community to prioritise RD data collection and develop an integrated RD Registry strategy for Australia. Financial, operational and governance challenges exist for establishing and maintaining RD registries. As a multidisciplinary team whose interests converge on RD, we highlight the need for the establishment of an Australian RD Registry Alliance. This 'umbrella' organisation will: (i) bring together existing RD registries across Australia; (ii) establish National RD Registry Standards to support interoperability and cohesion across registries; (iii) develop strategies to attract sustainable funding from government and other sources to maximise the utility of existing RD registries and support the development of new RD registries. The most important role for the Alliance would be to use the RD registries for translational research to address current knowledge gaps about RD and to improve the care for the over 1.4 million Australians estimated to live with RD. [ABSTRACT FROM AUTHOR]

Clinical Registries are established to provide a clinically credible means for monitoring and benchmarking healthcare processes and outcomes, to identify areas for improvement, and drive strategies for improving patient care. Clinical Registries are used to assess changes in clinical practice, appropriateness of care and health outcomes over time. The American Heart Association Policy Statement in April 2011 called for expanding the application for existing and future Clinical Registries, with well-designed Clinical Registry programs. Concurrently, in Australia, and similarly within the United States and United Kingdom, there has been an increased focus on performance measurement for quality and patient safety. Within Victoria, the Victorian Clinical Governance Policy Framework outlines clinical effectiveness as one of the four domains of Clinical Governance As Clinical Registries evaluate effectiveness and safety of patient care by measuring patient outcomes compared with peers, the use of Clinical Registries data to improve a health service’s quality of care seems intuitive. A mixed methods approach was utilised, involving (1) semi-structured interviews and (2) documentation audit in this study conducted at Austin Health, a major tertiary teaching hospital in North-Eastern metropolitan Melbourne, affiliated with the University of Melbourne and various research institutes within Austin LifeSciences. Although many studies have highlighted the benefits of data collected via individual Clinical Registries, [5,6] the level of voluntary medical staff participation in Clinical Registries at a health service level is yet to be established. The aim of this study was to document the level of medical staff involvement for Clinical Registries within a major tertiary teaching hospital, and the level of reporting into Quality Committees within the organisation. This study demonstrates that along with a very high level of medical staff participation in Clinical Registries, there is a lack of systematic reporting of Registries data into quality committees beyond unit level, and utilisation of such data to reflect upon practice and drive quality improvement. Abbreviations: CREPS – Centre for Excellence in Patient Safety; CSU – Clinical Services Unit; HOU – Heads of Unit; VASM – Victorian Audit of Surgical Mortality.

Summary All scientific data should be presented with sufficient accuracy and precision so that they can be both analyzed properly and reproduced. Visual data are the foundation upon which plastic surgeons advance knowledge. We use visual data to achieve reproducible results by discerning details of procedures and differences between pre- and post-surgery images. This review highlights how the presentation of visual data evolved from 1816, when Joseph Carpue published his book on nasal reconstruction to 1916, when Captain Harold Gillies began to treat over 2000 casualties from the Battle of the Somme. It shows the frailties of human nature that led some authors such as Carl von Graefe, Joseph Pancoast and Thomas Mutter to record inaccurate methods or results that could not be reproduced, and what measures other authors such as Eduard Zeis, Johann Dieffenbach, and Gurdon Buck took to affirm the accuracy of their results. It shows how photography gradually supplanted illustration as a reference standard. Finally, it shows the efforts that some authors and originators took to authenticate and preserve their visual data in what can be considered the forerunners of clinical registries. [ABSTRACT FROM AUTHOR]

Clinical registries are a powerful method to observe the clinical practice and natural disease history. In contrast to clinical trials, where guidelines and standardized methods exist and are mandatory, only a few initiatives have published methodological guidelines for clinical registries. The objective of this paper was to review these guidelines and systematically assess their completeness, usability and feasibility according to a SWOT analysis. The results show that each guideline has its own strengths and weaknesses. While one supports the systematic planning process, the other discusses clinical registries in great detail. However, the feasibility was mostly limited and the special requirements of clinical registries, their flexible, expandable and adaptable technological structure was not addressed consistently. [ABSTRACT FROM AUTHOR]

Clinical Registries are established to provide a clinically credible means for monitoring and benchmarking healthcare processes and outcomes, to identify areas for improvement, and drive strategies for improving patient care. Clinical Registries are used to assess changes in clinical practice, appropriateness of care and health outcomes over time. The American Heart Association Policy Statement in April 2011 called for expanding the application for existing and future Clinical Registries, with well-designed Clinical Registry programs. Concurrently, in Australia, and similarly within the United States and United Kingdom, there has been an increased focus on performance measurement for quality and patient safety. Within Victoria, the Victorian Clinical Governance Policy Framework outlines clinical effectiveness as one of the four domains of Clinical Governance As Clinical Registries evaluate effectiveness and safety of patient care by measuring patient outcomes compared with peers, the use of Clinical Registries data to improve a health service's quality of care seems intuitive. A mixed methods approach was utilised, involving (1) semi-structured interviews and (2) documentation audit in this study conducted at Austin Health, a major tertiary teaching hospital in NorthEastern metropolitan Melbourne, affiliated with the University of Melbourne and various research institutes within Austin LifeSciences. Although many studies have highlighted the benefits of data collected via individual Clinical Registries, [5,6] the level of voluntary medical staff participation in Clinical Registries at a health service level is yet to be established. The aim of this study was to document the level of medical staff involvement for Clinical Registries within a major tertiary teaching hospital, and the level of reporting into Quality Committees within the organisation. This study demonstrates that along with a very high level of medical staff participation in Clinical Registries, there is a lack of systematic reporting of Registries data into quality committees beyond unit level, and utilisation of such data to reflect upon practice and drive quality improvement. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective review of clinical data registry.Objective: In the current era of quality reporting and pay for performance, neurosurgeons must develop models to identify patients at high risk of complications. We sought to identify risk factors for complications in spine surgery and to develop a score predictive of complications.Summary Of Background Data: We examined spinal surgeries from the American College of Surgeons National Surgical Quality Improvement Project (ACS-NSQIP) database. 22,430 cases were identified based on common procedural terminology.Methods: Univariate analysis followed by multivariate regression was used to identify significant factors.Results: The overall complication rate for the cohort was 9.9%. The most common complications were postoperative bleeding requiring transfusion (4.1%), nonwound infections (3.1%), and wound-related infections (2.2%). Multivariate regression analysis identified 20 factors associated with complications. Assigning 1 point for the presence of each factor a risk model was developed. The range of scores for the cohort was 0 to 13 with a median score of 4. Complication rates for a risk score of 0 to 4 was 3.7% and for scores 5 to 13 was 18.5%. The risk model robustly predicted complication rates, with complication rate of 1.2% for score of 0 (n = 412, 1.8% of total) and 63.6% and 100% for scores of 12 and 13 (n = 22 patients, 0.1% of total cohort) respectively (P < 0.001). The risk score also correlated strongly with total length of stay, mortality, and total work relative value units for the case.Conclusion: Patient-specific risk factors including comorbidities are strongly associated with surgical complications, length of stay, cost of care, and mortality in spine surgery and can be used to develop risk models that are highly predictive of complications.Level Of Evidence: 3. [ABSTRACT FROM AUTHOR]

In the application of marginal structural models to compare time-varying treatments, it is rare that the hierarchical structure of a data set is accounted for or that the impact of unmeasured confounding on estimates is assessed. These issues often arise when analyzing data sets drawn from clinical registries, where patients may be clustered within health-care providers, and the amount of data collected from each patient may be limited by design (e.g., to reduce costs or encourage provider participation).We compared the survival of patients undergoing treatment with various dialysis types, where some patients switched dialysis modality during the course of their treatment, by estimating a marginal structural model using data from the Australia and New Zealand Dialysis and Transplant Registry, 2003-2011. The number of variables recorded by the registry is limited, and patients are clustered within the dialysis centers responsible for their treatment, sowe assessed the impact of accounting for unmeasured confounding or clustering on estimated treatment effects. Accounting for clustering had limited impact, and only unreasonable levels of unmeasured confounding would have changed conclusions about treatment comparisons. Our analysis serves as a case study in assessing the impact of unmeasured confounding and clustering in the application of marginal structural models. [ABSTRACT FROM AUTHOR]

Clinical registries are established as tools for auditing clinical standards and benchmarking quality improvement initiatives. They also have an emerging role (as electronic health records) in cardiovascular research and, in particular, the conduct of RCTs. While the RCT is accepted as the most robust experimental design, observational data from clinical registries has become increasingly valuable for RCTs. Data from clinical registries may be used to augment results from RCTs, identify patients for recruitment and as an alternative when randomization is not practically possible or ethically desirable. Here the authors appraise the advantages and disadvantages of both methodologies, with the aim of clarifying when their joint use may be successful. [ABSTRACT FROM AUTHOR]