Second generation registry framework

Background

Information management systems are essential to capture data be it for public health and human disease, sustainable agriculture, or plant and animal biosecurity. In public health, the term patient registry is often used to describe information management systems that are used to record and track phenotypic data of patients. Appropriate design, implementation and deployment of patient registries enables rapid decision making and ongoing data mining ultimately leading to improved patient outcomes. A major bottleneck encountered is the static nature of these registries. That is, software developers are required to work with stakeholders to determine requirements, design the system, implement the required data fields and functionality for each patient registry. Additionally, software developer time is required for ongoing maintenance and customisation. It is desirable to deploy a sophisticated registry framework that can allow scientists and registry curators possessing standard computing skills to dynamically construct a complete patient registry from scratch and customise it for their specific needs with little or no need to engage a software developer at any stage.

Results

This paper introduces our second generation open source registry framework which builds on our previous rare disease registry framework (RDRF). This second generation RDRF is a new approach as it empowers registry administrators to construct one or more patient registries without software developer effort. New data elements for a diverse range of phenotypic and genotypic measurements can be defined at any time. Defined data elements can then be utilised in any of the created registries. Fine grained, multi-level user and workgroup access can be applied to each data element to ensure appropriate access and data privacy. We introduce the concept of derived data elements to assist the data element standards communities on how they might be best categorised.

Conclusions

We introduce the second generation RDRF that enables the user-driven dynamic creation of patient registries. We believe this second generation RDRF is a novel approach to patient registry design, implementation and deployment and a significant advance on existing registry systems.

     

Striated acto-myosin fibers can reorganize and register in response to elastic interactions with the matrix

The remarkable striation of muscle has fascinated many for centuries. In developing muscle cells, as well as in many adherent, nonmuscle cell types, striated, stress fiberlike structures with sarcomere-periodicity tend to register: Based on several studies, neighboring, parallel fibers at the basal membrane of cultured cells establish registry of their respective periodic sarcomeric architecture, but, to our knowledge, the mechanism has not yet been identified. Here, we propose for cells plated on an elastic substrate or adhered to a neighboring cell, that acto-myosin contractility in striated fibers close to the basal membrane induces substrate strain that gives rise to an elastic interaction between neighboring striated fibers, which in turn favors interfiber registry. Our physical theory predicts a dependence of interfiber registry on externally controllable elastic properties of the substrate. In developing muscle cells, registry of striated fibers (premyofibrils and nascent myofibrils) has been suggested as one major pathway of myofibrillogenesis, where it precedes the fusion of neighboring fibers. This suggests a mechanical basis for the optimal myofibrillogenesis on muscle-mimetic elastic substrates that was recently observed by several groups in cultures of mouse-, human-, and chick-derived muscle cells.     

Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study

Background

The ability to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access data sets from legacy formats and platforms to advanced standard formats and operating systems are crucial for both clinical healthcare and biomedical research settings.

Purpose

Our study describes a reproducible, highly scalable, standard framework for a device registry implementation addressing both local data quality components and global linking problems.

Methods and Results

We developed a device registry framework involving the following steps: (1) Data standards definition and representation of the research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according to the clinical research workflow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and linked open data collections, (5) Data quality control and (6) Data dissemination through the registry Web site. Our registry adopted all applicable standardized data elements proposed by American College Cardiology / American Heart Association Clinical Data Standards, as well as variables derived from cardiac devices randomized trials and Clinical Data Interchange Standards Consortium. Local interoperability was performed between REDCap and data derived from Electronic Health Record system. The original data set was also augmented by incorporating the reimbursed values paid by the Brazilian government during a hospitalization for pacemaker implantation. By linking our registry to the open data collection repository Linked Clinical Trials (LinkedCT) we found 130 clinical trials which are potentially correlated with our pacemaker registry.

Conclusion

This study demonstrates how standard and reproducible solutions can be applied in the implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries.     

Inter-rater reliability of data elements from a prototype of the Paul Coverdell National Acute Stroke Registry

Background  

The Paul Coverdell National Acute Stroke Registry (PCNASR) is a U.S. based national registry designed to monitor and improve the quality of acute stroke care delivered by hospitals. The registry monitors care through specific performance measures, the accuracy of which depends in part on the reliability of the individual data elements used to construct them. This study describes the inter-rater reliability of data elements collected in Michigan's state-based prototype of the PCNASR.     

Bias in survival estimates created by a requirement for consent to enter a clinical breast cancer registry

BackgroundA requirement for consent for inclusion may bias the results from a clinical registry. This study gives a direct measure of this bias, based on a population-based clinical breast cancer registry where the requirement for consent was removed after further ethical review and data could be re-analysed.MethodsIn Auckland, New Zealand, the population-based clinical breast cancer registry required written patient consent for inclusion from 2000-2012. A subsequent ethical review removed this requirement and allowed an analysis of consented and non-consented patients. Kaplan-Meier survival to 10 years (mean follow-up 5.1 years, maximum 13.9 years), demographic and clinical characteristics were compared. Of 9244 women with invasive cancer, 926 (10.4%) were not consented, and of 1642 women with ductal carcinoma in situ, 245 (14.9%) were not consented.ResultsSurvival was much higher for consenting patients; invasive cancer, 5 year survival 83.2% (95% confidence limits 82.2–84.1%) for consenting patients, 57.1% (53.0–60.9%) for non-consenting, and 80.8% in all patients. Analyses based only on consenting patients overestimate survival in all patients by around 2% at 2, 5, and 10 years. Non-consented patients were older, more often of Pacific ethnicity, had fewer screen-detected cancers, and more often had metastatic disease; they less frequently had primary surgery or systemic treatments.ConclusionData from a registry requiring active consent gives an upward bias in survival results, as non-consenting patients have more extensive disease, less treatment, and lower survival. To give unbiased results active consent should be not required in a clinical cancer registry.     

Adoption of prasugrel into routine practice: rationale and design of the Rijnmond Collective Cardiology Research (CCR) study in percutaneous coronary intervention for acute coronary syndromes

Background

Platelet inhibition is crucial in reducing both short- and long-term atherothrombotic risks in patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI). Based on randomised trials, recent recommendations in the current guidelines include the endorsement of prasugrel as a first-choice adenosine diphosphate receptor inhibitor. Yet, there is limited experience with the use of prasugrel in routine practice.

Methods

The Rijnmond Collective Cardiology Research (CCR) registry is a prospective, observational study that will follow-up 4000 PCI-treated ACS patients in the larger region of Rotterdam, the Netherlands. Based on recently implemented hospital protocols, all patients will receive prasugrel as first-choice antiplatelet agent, unless contraindicated, in accordance with European guidelines, and will be followed for up to 1 year post-discharge for longitudinal assessment of outcomes and bleeding events. This registry exemplifies a collaborative study design that employs a regional PCI registry platform and provides feedback to participating sites regarding their practice patterns, thereby supporting and promoting improvement of quality of care.

Conclusion

The CCR registry will evaluate the adoption of prasugrel into routine clinical practice and thus, will provide important evidence with regard to the benefits and risks of real-world utilisation of prasugrel as antiplatelet therapy in PCI-treated ACS patients.     

Pittsburgh Registry of Infant Multiplets (PRIM).

This paper describes the Pittsburgh Registry of Infant Multiplets (PRIM; Pittsburgh, Pennsylvania), the results of pilot research conducted in this registry, and the plans for future studies. The main focus of the registry is on psychological development and the risk for behavioral disorders. Particularly, characteristics associated with antisociality and the risk for substance use disorders (e.g., aggressivity, hyperactivity/impulsivity), as well as language development and other traits (e.g., dental health) are among the research targets.     

The first fifty years of the Connecticut Tumor Registry: reminiscences and prospects

The first fifty years of the Connecticut Tumor Registry (1935-1985) have seen unprecedented progress in the collection of standardized data on cancer patients and in the processing of these data, from paper documents to punch cards and magnetic tapes. The need for collecting such information was first recognized, in the early 1930s, by a group of physicians, health professionals, and laymen in New Haven who observed alarming increases in cancer rates and poor survival of cancer patients in this city. This paper recalls the growth and development of the registry and the role played by the Connecticut legislature, the State Medical Society, the Connecticut Department of Health, and the National Cancer Institute in this process. For half a century, the registry has provided assistance to practitioners, hospitals, and research scientists, not only in Connecticut but across the country and around the world. By making available reliable data on incidence and survival, the registry has played a key role in patient management, clinical trials, and etiologic studies. It has also demonstrated the value and served as an exemplary model of a population-based registry. At this juncture in its history, prospects for the future of the Connecticut Tumor Registry appear bright. Its data base will be an essential resource for the recently established Cancer Control Research Unit (CCRU) in the state and for new intervention studies by investigators at Yale, the University of Connecticut, and the State Health Department.     

Peripartum cardiomyopathy: Euro Observational Research Program

Peripartum cardiomyopathy is a rare but potentially life-threatening form of heart failure affecting women late in pregnancy or in the first months after delivery. Peripartum cardiomyopathy is difficult to diagnose and its onset and progression are variable between individuals. The pathophysiology remains poorly understood, hence treatment options are limited and possibly harmful to the foetus. Furthermore, geographical incidence varies greatly and little is known about the incidence in Western countries. To gain further understanding of the pathophysiology and incidence of peripartum cardiomyopathy, the European Society of Cardiology initiated a study group to implement a registry. This review provides an overview of current insights into peripartum cardiomyopathy, highlights the need for such a registry and provides information about this Euro Observational Research Program.     

Introduced annual grass increases regional fire activity across the arid western USA (1980–2009)

Non‐native, invasive grasses have been linked to altered grass‐fire cycles worldwide. Although a few studies have quantified resulting changes in fire activity at local scales, and many have speculated about larger scales, regional alterations to fire regimes remain poorly documented. We assessed the influence of large‐scale Bromus tectorum (hereafter cheatgrass) invasion on fire size, duration, spread rate, and interannual variability in comparison to other prominent land cover classes across the Great Basin, USA. We compared regional land cover maps to burned area measured using the Moderate Resolution Imaging Spectroradiometer (MODIS) for 2000–2009 and to fire extents recorded by the USGS registry of fires from 1980 to 2009. Cheatgrass dominates at least 6% of the central Great Basin (650 000 km²). MODIS records show that 13% of these cheatgrass‐dominated lands burned, resulting in a fire return interval of 78 years for any given location within cheatgrass. This proportion was more than double the amount burned across all other vegetation types (range: 0.5–6% burned). During the 1990s, this difference was even more extreme, with cheatgrass burning nearly four times more frequently than any native vegetation type (16% of cheatgrass burned compared to 1–5% of native vegetation). Cheatgrass was also disproportionately represented in the largest fires, comprising 24% of the land area of the 50 largest fires recorded by MODIS during the 2000s. Furthermore, multi‐date fires that burned across multiple vegetation types were significantly more likely to have started in cheatgrass. Finally, cheatgrass fires showed a strong interannual response to wet years, a trend only weakly observed in native vegetation types. These results demonstrate that cheatgrass invasion has substantially altered the regional fire regime. Although this result has been suspected by managers for decades, this study is the first to document recent cheatgrass‐driven fire regimes at a regional scale.     

Survival from five common cancers in Georgia, 2015–2019 (CONCORD)

BackgroundPopulation-based cancer survival is a key metric of the effectiveness of health systems in managing cancer. Data from population-based cancer registries are essential for producing reliable and robust cancer survival estimates. Georgia established a national population-based cancer registry on 1 January 2015. This is the first analysis of population-based cancer survival from Georgia.MethodsData were available from the national cancer registry for 16,359 adults who were diagnosed with a cancer of the stomach, colon, rectum, breast (women) or cervix during 2015–2019. We estimated age-specific and age-standardised net survival at one, two and three years after diagnosis for each cancer, by sex.ResultsThe data were of extremely high quality, with less than 2% of data excluded from each dataset. For the patients included in analyses, at least 80% of the tumours were microscopically verified.Age-standardised three-year survival from stomach cancer was 30.6%, similar in men and women. For colon cancer, three-year survival was 60.1%, with survival 4% higher for men than for women. Three-year survival from rectal cancer was similar for men and women, at 54.7%. For women diagnosed with breast cancer, three-year survival was 84.4%, but three-year survival from cervical cancer was only 67.2%.ConclusionEstablishment of a national cancer registry with obligatory cancer registration has enabled the first examination of population-based cancer survival in Georgia. Maintenance of the registry will facilitate continued surveillance of both cancer incidence and survival in the country.     

Potential bias regarding birth weight in historical and contemporary twin data bases.

In this study we examine the hypothesis that monozygotic (MZ) twins in historical databases are less discordant for birth weight due to negative selection of severely discordant MZ twins. Furthermore, we test the hypothesis that MZ twins are less discordant for birth weight when comparing a volunteer based twin registry with a population based twin registry, due to selective registration. Data were available on 3927 twin pairs from the volunteer Australian Twin Registry born before 1964, 3059 volunteer twin pairs from the Netherlands Twin Register born 1987-1989 and 454 Belgian twin pairs from The East Flanders Prospective Twin Survey born 1987-1989. Intrapair relative birth weight differences (RBWD) were computed for MZ and dizygotic (DZ) twins from each twin registry. Comparing birth weight differences between MZ and DZ twins provides support for the hypothesis that MZ twins are subject to a negative selection in historical databases. Furthermore, Australian MZ twins have a lower RBWD compared to Dutch MZ twins when corrected for the RBWD of Australian and Dutch DZ twins, indicating circumstances which only affect MZ twins. Our hypothesis that MZ twins are less discordant for birth weight in a volunteer based twin registry compared to a population based twin registry had to be rejected. We suggest that investigators using historical databases to test the fetal origins hypothesis should be aware of this increased likelihood of selective exclusion of individuals with extreme morphometric parameters at time of birth.     

Amount of Food Group Variety Consumed in the Diet and Long‐Term Weight Loss Maintenance

Objective: Decreases in variety of foods consumed within high‐fat‐dense food groups and increases in variety of foods consumed within low‐fat‐dense food groups are associated with lower energy intake and greater weight loss during obesity treatment and may assist with weight loss maintenance. This study examined food group variety in 2237 weight loss maintainers in the National Weight Control Registry, who had lost 32.2 ± 18.0 kg (70.9 ± 39.5 lbs) and maintained a weight loss of at least 13.6 kg (30 lbs) for 6.1 ± 7.7 years. Research Methods and Procedures: At entry into the registry, registry members completed a food frequency questionnaire from which amount of variety consumed from different food groups was assessed. To provide a context for interpreting the level of variety occurring in the diet of registry participants, food group variety was compared between registry participants and 96 individuals who had recently participated in a behavioral weight loss program and had lost at least 7% of initial body weight. Results: Registry members reported consuming a diet with very low variety in all food groups, especially in those food groups higher in fat density. Registry participants consumed significantly (p < 0.001) less variety within all food groups, except fruit and combination foods, than recent weight losers after 6 months of weight loss treatment. Discussion: These results suggest that successful weight loss maintainers consume a diet with limited variety in all food groups. Restricting variety within all food groups may help with consuming a low‐energy diet and maintaining long‐term weight loss.     

Measurements of birth defect prevalence: Which is most useful as a comparator group for pharmaceutical pregnancy registries?

Pharmaceutical pregnancy registries document birth defects and other complications reported in pregnancies exposed to specific medications or diseases. A baseline estimate of birth defect prevalence is necessary for comparison. To identify potential teratogenic signals, the pregnancy registry must have a comparator that most closely matches the exposed population and data collection methodology, which are characteristics that vary among the multiplicity of birth defect surveillance systems. The system that yields the most accurate prevalence data may be different from that most closely matching the pregnancy registry methods. State public health programs have highly accurate and precise statistics, but their populations are broader than those of a pharmaceutical pregnancy registry. Large collaborative databases may have a more useful covered population, but there are secondary problems related to data precision. Health care databases enroll large numbers of patients and have good information about exposures and health problems, but the data can be difficult to access and lack useful detail. Exposure‐related databases are closer in population definition and collection methods, though the presence of different diseases and exposures can be problematic. Internal comparators are likely to be most useful in formal statistical analysis, but added cost and management burden and may require significantly increased registry enrollment. There is no ideal comparator, and this must be taken into account when planning a single‐exposure or single‐disease pregnancy registry. Birth Defects Research (Part A), 2009. © 2009 Wiley‐Liss, Inc.     

我国心血管专科临床科研数据中心的建设与思考

中国是心血管疾病的数据大国,但是从数据质量和临床科研上讲,并非强国。为了提高心血管数据在临床质量评估和科研中的应用,我院心内科开始了心血管专科临床科研数据中心的尝试和建设。通过借鉴美国相关经验,以及对我国心血管临床质量评估以及科研需求的深入调研,我们建设了以心血管专科临床数据仓库以及心血管注册数据中心为核心的心血管专科临床科研数据中心。在此基础上,进一步探索并建设了自定义科研表单,多维度组合筛选,基于随访策略的心血管随访管理,基于个性化诊疗计划的心血管病人院后管理,相关性分析及不良心血管事件模式发现等应用和工具,有助于提升心血管专科的临床流程效率,临床质量评估和科研水平,同时为建立全国性的心血管疾病注册数据库打下了基础。     

BioMOBY: an open source biological web services proposal

BioMOBY is an Open Source research project which aims to generate an architecture for the discovery and distribution of biological data through web services; data and services are decentralised, but the availability of these resources, and the instructions for interacting with them, are registered in a central location called MOBY Central. BioMOBY adds to the web services paradigm, as exemplified by Universal Data Discovery and Integration (UDDI), by having an object-driven registry query system with object and service ontologies. This allows users to traverse expansive and disparate data sets where each possible next step is presented based on the data object currently in-hand. Moreover, a path from the current data object to a desired final data object could be automatically discovered using the registry. Native BioMOBY objects are lightweight XML, and make up both the query and the response of a simple object access protocol (SOAP) transaction.     

Under-diagnosis and under-ascertainment of cases may be the reasons for low childhood cancer incidence in rural India

Cancer statistics from India revealed that childhood cancer incidence is lesser in rural than urban India. This might be due to under-diagnosis or under-ascertainment of cases or could even be true. With registries able to explicitly measure and appropriately streamline the ascertainment of cases to comply with acceptable standards, it is under-diagnosis that is variable and highly influenced by development of or accessibility to specialized centres in or around the registry area. This is reflected implicitly by marked variation in incidence between different populations in India: weighted age standardized rates of all childhood cancers together was the highest (108 per million) in metropolitan areas, followed by other urban (86) and rural (53) areas in that order. A childhood cancer registry focusing on pertinent data collection and specific epidemiological studies is desirable to explain the variations in incidence and outcome of childhood cancers in India.     

The Human Oocyte Preservation Experience (HOPE) a phase IV, prospective, multicenter, observational oocyte cryopreservation registry

Background  

It has been recommended by the American Society of Clinical Oncology and the American Society of Reproductive Medicine that options to preserve fertility be presented at the outset of treatment for cancer. This recommendation may have arisen, in part, to the increasing survival of patients with cancer and the realization that certain forms of cancer treatment can lead to infertility. One option for these patients, particularly those with ethical or religious objections to freezing embryos is oocyte cryopreservation. However universal acceptance of these procedures has yet to be established, most likely due to a poor history of success and concerns that there has yet to be a comprehensive approach to evaluating these techniques. In light of this, a registry of patients undergoing oocyte cryopreservation, called the HOPE registry, is being implemented.