Clinical Quality Registries Research Articles

Danish and Swedish National Data Collections for Cancer – Solutions for Radiotherapy

Collecting large amounts of radiotherapy (RT) data from clinical systems is known to be a challenging task. Still, data collections outside the original RT systems are needed to follow-up on the quality of cancer care and to improve RT. This paper aims to describe how RT data is collected nationally in Denmark and Sweden for this purpose and gives an overview of the stored information in both countries' national data sources.Although both countries have clinical national quality registries with broad coverage and completeness for many cancer diagnoses, some were initiated already in the seventies, and less than one in ten includes quantitative information on RT to a level of detail useful for more than basic descriptive statistics. Detailed RT data can, however, be found in Denmark's DICOM Collaboration (DcmCollab) database, initiated in 2009 and in Sweden's quality registry for RT launched in 2023 (SKvaRT). Denmark has collected raw DICOM data for all patients enrolled in clinical trials, with files being directly and automatically transferred to DcmCollab from the original data sources at each RT centre. Sweden collects aggregated RT data into SKvaRT for all patients undergoing RT in Sweden, with DICOM files being transferred and selected alpha-numeric variables forwarded via a local intermediate storage database (MIQA) at each hospital. In designing their respective solutions, both countries have faced similar challenges regarding which RT variables to collect and how to technically link clinical systems to their data repositories. General lessons about how flexibility currently is balanced with storage requirements and data standards are presented here together with future plans to harvest real-world RT data.

Incidence of seropositive and seronegative rheumatoid arthritis in Denmark: a nationwide population-based study

Objective To investigate and compare trends in incidence rates (IRs) of seropositive and seronegative rheumatoid arthritis (RA) in Denmark using various data sources for serostatus definition. Method This nationwide population-based cohort study was based on data from Danish healthcare and clinical quality registries between 2000 and 2018. Information on anti-cyclic citrullinated peptide and immunoglobulin M rheumatoid factor was obtained, and definitions of seropositivity according to the number of applied data sources were prespecified. Annual age- and sex-standardized IRs were calculated as the number of incident seropositive and seronegative cases, divided by the number of person-years (PY) in the general population in that given year. Results An increasing temporal trend in IR of seropositive RA and a decreasing trend in seronegative RA were observed. The IRs were higher for seropositive RA than for seronegative RA from 2009 onwards, with a widening of the IR gap between 2009 and 2016 regardless of the definition of seropositivity. When combining laboratory- and physician-reported autoantibody information and ICD-10 codes, the IR of seropositive RA in 2018 was approximately twice that of seronegative RA, at 19.0 and 9.0 per 100 000 PY, respectively. The level of antibody testing increased significantly during the study period. Conclusions The IR of seropositive RA increased over time, whereas the IR of seronegative RA decreased. Temporal IR changes may be caused by a real change in the RA serology subtypes, an increase in autoantibody testing and availability, changes in registration practice over time, or a combination of these factors.

Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review.

Implementing patient-reported outcome measures (PROMs) to measure and evaluate health outcomes is increasing worldwide. Along with this emerging trend, it is important to identify which guidelines, frameworks, checklists, and recommendations exist, and if and how they have been used in implementing PROMs, especially in clinical quality registries (CQRs). This review aims to identify existing publications, as well as publications that discuss the application of actual guidelines, frameworks, checklists, and recommendations on PROMs' implementation for various purposes such as clinical trials, clinical practice, and CQRs. In addition, the identified publications will be used to guide the development of a new guideline for PROMs' implementation in CQRs, which is the aim of the broader project. A literature search of the databases MEDLINE, Embase, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials will be conducted since the inception of the databases, in addition to using Google Scholar and gray literature to identify literature for the scoping review. Predefined inclusion and exclusion criteria will be used for all phases of screening. Existing publications of guidelines, frameworks, checklists, recommendations, and publications discussing the application of those methodologies for implementing PROMs in clinical trials, clinical practice, and CQRs will be included in the final review. Data relating to bibliographic information, aim, the purpose of PROMs use (clinical trial, practice, or registries), name of guideline, framework, checklist and recommendations, the rationale for development, and their purpose and implications will be extracted. Additionally, for publications of actual methodologies, aspects or domains of PROMs' implementation will be extracted. A narrative synthesis of included publications will be conducted. The electronic database searches were completed in March 2024. Title and abstract screening, full-text screening, and data extraction will be completed in May 2024. The review is expected to be completed by the end of August 2024. The findings of this scoping review will provide evidence on any existing methodologies and tools for PROMs' implementation in clinical trials, clinical practice, and CQRs. It is anticipated that the publications will help us guide the development of a new guideline for PROMs' implementation in CQRs. PROSPERO CRD42022366085; https://tinyurl.com/bdesk98x. DERR1-10.2196/52572.

The Tasmanian Emergency Care Outcomes Registry (TECOR) Protocol

Emergency Departments (ED) play a vital role within the health system, representing the ‘front door’ to hospitals, the first point of hospital contact for patients who are undifferentiated and may be critically ill. They also serve as a safety net for the healthcare system. Together with ED overcrowding, this patient care environment is highly vulnerable to the provision of suboptimal care and breaches in patient safety. Government agencies in Australia currently collect data that are broad and administratively focused and are limited in capacity to identifying clinical quality. Clinical quality registries (CQR) help fill this gap but are often funded by not-for-profit organisations or research grants. There is no emergency care CQR in Tasmania, Australia. We propose the establishment of the Tasmanian Emergency Care Outcomes Registry (TECOR) to monitor emergency care processes and outcomes. The primary objective of TECOR is to monitor the unexpected 30-day mortality of patients who are cared for in the ED as well as 30-day safety events where emergency care was the primary contributor. The TECOR is expected to provide ongoing data on other important processes of emergency care in Tasmania such as length of stay in EDs, 28-day representation to EDs and hospital length of stay. The registry was designed to national standards and will meet the needs of the clinical community and have a positive impact on the communities it serves.

Bloodstream infections and multidrug resistant bacteria acquisition among burns patients in Australia and New Zealand: A registry-based study

IntroductionThis study interrogates infection related data in the Burns Registry of Australia and New Zealand (BRANZ), to examine associations of multi-drug resistant organisms (MDROs) and blood stream infection (BSI). MethodsData between July 2016 and June 2021 were analysed to determine prevalence, risk factors and outcomes associated with BSIs and MDROs: Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), carbapenem-resistant Pseudomonas spp. (CRP), and carbapenem-resistant Enterobacter (CRE). Data completeness and value for quality improvement activity were assessed. ResultsWe found a low incidence (3.4%) of the resistant organisms of interest, and no change over the study period. Fequency varied between services and increased with age and size of burn. MRSA was the commonest organism in all age groups. A positive BSI result occurred in 1.6% of patients (12.1% of cultures taken) at a median time of 10.2 days post injury. Free text identification of organisms was inconsistently documented. ConclusionsThe low rate and patterns of acquisition of MDROs of interest and BSIs is comparable with reports from countries with low incidence of massive burns. Wider adoption of a standardized laboratory reporting framework would help realise the potential of clinical quality registries to provide data which supports evidence based infection prevention initiatives.

Development of clinically meaningful quality indicators for contemporary lung cancer care, and piloting and evaluation in a retrospective cohort; experiences of the Embedding Research (and Evidence) in Cancer Healthcare (EnRICH) Program

ObjectivesLung cancer continues to be the most common cause of cancer-related death and the leading cause of morbidity and burden of disease across Australia. There is an ongoing need to...

International Atherosclerosis Society Roadmap for Familial Hypercholesterolaemia.

Familial hypercholesterolaemia (FH), a common monogenic disorder, is a preventable cause of premature coronary artery disease and death. Up to 35 million people worldwide have FH, but most remain undetected and undertreated. Several clinical guidelines have addressed the gaps in care of FH, but little focus has been given to implementation science and practice. The International Atherosclerosis Society (IAS) has developed an evidence-informed guidance for the detection and management of patients with FH, supplemented with implementation strategies to optimize contextual models of care. The guidance is partitioned into detection, management and implementation sections. Detection deals with screening, diagnosis, genetic testing and counselling. Management includes risk stratification, treatment of adults and children with heterozygous and homozygous FH, management of FH during pregnancy, and use of lipoprotein apheresis. Specific and general implementation strategies, guided by processes specified by the Expert Recommendations for Implementing Change taxonomy, are provided. Core generic implementation strategies are given for improving care. Nation-specific cholesterol awareness campaigns should be utilized to promote better detection of FH. Integrated models of care should be underpinned by health policy and adapted to meet local, regional and national needs. Clinical centres of excellence are important for taking referrals from the community. General practitioners should work seamlessly with multidisciplinary teams. All health-care providers must receive training in essential skills for caring for patients and families with FH. Management should be supported by shared decision-making and service improvement driven by patient-reported outcomes. Improvements in services require sharing of existing resources that can support care. Advocacy should be utilized to ensure sustainable funding. Digital health technologies and clinical quality registries have special value. Finally, academic-service partnerships need to be developed to identify gaps in care and set priorities for research. This new IAS guidance on FH complements the recent World Heart Federation Cholesterol Roadmap.

Improvements in Quality, Safety and Costs Associated with Use of Implant Registries Within a Health System

Clinical quality registries (CQRs) are intended to enhance quality, safety, and cost reduction using real-world data for a self-improving health system. Starting in 2001, Kaiser Permanente established several medical device CQRs as a quality improvement initiative. This report examines the contributions of these CQRs on improvement in health outcomes, changes in clinical practice, and cost-effectiveness over the past 20 years. Eight implant registries were instituted with standardized collection from the electronic health record and other institutional data sources of patient characteristics, medical comorbidities, implant attributes, procedure details, surgical techniques, and outcomes (including complications, revisions, reoperations, hospital readmissions, and other utilization measures). A rigorous quality control system is in place to improve and maintain the quality of data. Data from the Implant Registries form the basis for multiple quality improvement and patient safety initiatives to minimize variation in care, promote clinical best practices, facilitate recalls, perform benchmarking, identify patients at risk, and construct reports about individual surgeons. Following the inception of the Implant Registries, there was an observed (1) reduction in opioid utilization following orthopedic procedures, (2) reduction in use of bone morphogenic protein during lumbar fusion allowing for cost savings, (3) reduction in allograft for anterior cruciate ligament reconstruction and subsequent decrease in organizationwide revision rates, (4) cost savings through expansion of same-day discharge programs for joint arthroplasty, (5) increase in the use of cement fixation in the hemiarthroplasty treatment of hip fracture, and (6) organizationwide discontinuation of an endograft device associated with a higher risk for adverse outcomes following endovascular aortic aneurysm repair. The use of Implant Registries within our health system, along with clinical leadership and organizational commitment to a learning health system, was associated with improved quality and safety outcomes and reduced costs. The exact mechanisms by which such registries affect health outcomes and costs require further study.

Non-COVID-19 intensive care admissions during the pandemic: a multinational registry-based study

BackgroundThe COVID-19 pandemic resulted in a large number of critical care admissions. While national reports have described the outcomes of patients with COVID-19, there is limited international data of the...

Registry randomized controlled trials: the future of surgical trials?

Registry randomized controlled trials: the future of surgical trials?

Estimating the cost-effectiveness and return on investment of the Victorian Cardiac Outcomes Registry in Australia: a minimum threshold analysis

ObjectivesWe sought to establish the minimum level of clinical benefit attributable to the Victorian Cardiac Outcomes Registry (VCOR) for the registry to be cost-effective.DesignA modelled cost-effectiveness study of VCOR was...

The utility of clinical registries for guiding clinical practice in upper tract urothelial cancer: a narrative review.

Upper tract urothelial cancer (UTUC) lacks high-quality evidence to appraise current patterns of presentation, diagnosis, treatment and outcomes as a result of disease rarity and patient heterogeneity. Registries may overcome many of the challenges making clinical trials challenging in UTUC and provide answers to many of the clinical questions that afflict UTUC management. In this narrative review we aim to summarise the design of registries that have contributed to the UTUC literature, discuss their strengths and limitations and the future directions of registries in UTUC. Two independent reviewers conducted a search of the OVID MEDLINE database from July 2002-July 2022. Included articles were required to be published in peer reviewed journals and use registry-based methodology to report on UTUC. Search was limited by MeSH and key words and was limited to the English language. One hundred and forty-four articles were identified and included as reporting on UTUC from a registry-based methodology. Articles utilising registry-based data have substantially increased over the study period with the majority of articles arising from large generalised cancer databases in North America. There has been an increase in UTUC-specific registries in the previous five years that have offered the most granular, complete analysis and these will continue to report in the coming years. The majority of published data assessed epidemiological factors and compared outcomes of treatment modalities with a small proportion of articles focusing on prognostic nomograms and quality of life. Larger cancer registries that contribute the majority of the published analysis are likely subject to significant selection bias when comparing cohorts for treatment analysis and the need for prospective UTUC specific registries is apparent. Future directions include the potential for registry-based randomised controlled trials (RCTs) and clinical quality registries (CQR) that have the ability to change practice and improve care. The utilisation of registry-based methodology for analysis in UTUC has increased substantially over the last 20 years. In addition to the utilisation of large cancer registries, the creation of UTUC specific registries is likely to contribute the most granular, translatable data in diagnosis and management.

Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

The science of clinical quality registries.

Clinical quality registries can be a transformational tool to improve healthcare delivery. Clinical registries with an incorporated quality emphasis identify evidence-practice gaps, inform quality improvement, and provide foundational research data to examine and improve health-related outcomes. For registries to create an impact it is essential that clinicians and researchers understand historical context, importance, advantages, and key criticisms. This methodological paper highlights the skills and capabilities required to build and maintain a robust clinical quality registry. This includes key measures to ensure data security, quality control, ongoing operational components, and benchmarking of care outcomes.

Which strategies support the effective use of clinical practice guidelines and clinical quality registry data to inform health service delivery? A systematic review

BackgroundEmpirical evidence suggests data and insights from the clinical practice guidelines and clinical quality registries are not being fully utilised, leaving health service managers, clinicians and providers without clear guidance on how best to improve healthcare delivery. This lack of uptake of existing research knowledge represents low value to the healthcare system and needs to change.MethodsFive electronic databases (MEDLINE, Embase, CINAHL, Cochrane Central and Cochrane Database of Systematic Reviews) were systematically searched. Included studies were published between 2000 and 2020 reporting on the attributes, evidence usage and impact of clinical practice guidelines and clinical quality registries on health service delivery.ResultsTwenty-six articles including one randomised controlled trial, eight before-and-after studies, eight case studies/reviews, five surveys and four interview studies, covering a wide range of medical conditions and conducted in the USA, Australia and Europe, were identified. Five complementary strategies were derived to maximise the likelihood of best practice health service delivery: (1) feedback and transparency, (2) intervention sustainability, (3) clinical practice guideline adherence, (4) productive partnerships and (5) whole-of-team approach.ConclusionThese five strategies, used in context-relevant combinations, are most likely to support the application of existing high-quality data, adding value to health service delivery. The review highlighted the limitations of study design in opportunistic registry studies that do not produce clear, usable evidence to guide changes to health service implementation practices. Recommendations include exploration of innovative methodologies, improved coordination of national registries and the use of incentives to encourage guideline adherence and wider dissemination of strategies used by successful registries.

Improving outcomes for patients with lymphoma: design and development of the Australian and New Zealand Lymphoma and Related Diseases Registry

BackgroundLymphoma is a malignancy of lymphocytes and lymphoid tissues comprising a heterogeneous group of diseases, with up to 80 entities now described. Lymphoma is the 6th most common cancer in Australia, affecting patients of all ages, with rising incidence rates. With the proliferation of efficacious novel agents, therapeutic strategies are increasingly diverse and survival is improving. There is a clear need for contemporary robust and detailed data on diagnostic, investigational and management strategies for this disease in Australia, New Zealand and worldwide, to inform and benchmark local and international standards of care. Clinical quality registries can provide these data, and support development of strategies to address variations in management, including serving as platforms for clinical trials and other research activities. The Lymphoma and Related Diseases Registry (LaRDR) was developed to capture details of patient demographics, disease characteristics, and management throughout their disease course and therapy and to develop outcome benchmarks nationally and internationally for lymphoma. This report describes the aims, development and implementation of the LaRDR, as well as challenges addressed in the process.MethodsThe LaRDR was established in 2016 as a multicentre, collaborative project at sites across Australia with a secure online database which collects prospective data on patients with a new diagnosis of lymphoma or chronic lymphocytic leukaemia (CLL). LaRDR development required multidisciplinary participation including specialist haematology, information technology, and biostatistical support, as well as secure funding. Here we describe the database development, data entry, ethics approval process, registry governance and support for participating sites and the coordinating centre.ResultsTo date more than 5,300 patients have been enrolled from 28 sites in Australia and New Zealand. Multiple challenges arose during the development, which we describe, along with approaches used to overcome them. Several confirmed international collaborations are now in place, and the registry is providing valuable data for clinicians, researchers, industry and government, including through presentations of results at major national and international conferences.ConclusionChallenges in establishing the LaRDR have been successfully overcome and the registry is now a valuable resource for lymphoma clinicians, researchers, health economists and others in Australia, New Zealand and globally.

EP04.01-021 Cancer Clinical Quality Registries: A Systematic Review of the Utilisation and Effectiveness of Knowledge Translation Interventions

Clinical quality registries (CQRs) are essential to support quality improvement in cancer, leading to interventions that improve outcomes. Knowledge translation (KT) strategies bridge the gap between clinical evidence and implementation of solutions. This study is a systematic review of KT strategies utilised, and the effectiveness of them, in the context of cancer CQRs.

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper

IntroductionAustralia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care...

Classifying outcomes in secondary and tertiary care clinical quality registries—an organizational case study with the COMET taxonomy

BackgroundThe choice of what patient outcomes are included in clinical quality registries is crucial for comparable and relevant data collection. Ideally, a uniform outcome framework could be used to classify the outcomes included in registries, steer the development of outcome measurement, and ultimately enable better patient care through benchmarking and registry research. The aim of this study was to compare clinical quality registry outcomes against the COMET taxonomy to assess its suitability in the registry context.MethodsWe conducted an organizational case study that included outcomes from 63 somatic clinical quality registries in use at HUS Helsinki University Hospital, Finland. Outcomes were extracted and classified according to the COMET taxonomy and the suitability of the taxonomy was assessed.ResultsHUS clinical quality registries showed great variation in outcome domains and in number of measures. Physiological outcomes were present in 98%, resource use in all, and functioning domains in 62% of the registries. Patient-reported outcome measures were found in 48% of the registries.ConclusionsThe COMET taxonomy was found to be mostly suitable for classifying the choice of outcomes in clinical quality registries, but improvements are suggested. HUS Helsinki University Hospital clinical quality registries exist at different maturity levels, showing room for improvement in life impact outcomes and in outcome prioritization. This article offers an example of classifying the choice of outcomes included in clinical quality registries and a comparison point for other registry evaluators.

Evaluating data quality in the Australian and New Zealand dialysis and transplant registry using administrative hospital admission datasets and data-linkage.

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