None listed
Conditions
Brief summary
Within cardiovascular medicine, the process of diagnosis and risk assessment is no longer heavily reliant on clinical intuition alone, but rather increasingly dependent on objectively assessable and electronically recorded information. By harnessing the organ-system and social phenotypes already captured within existing health information systems, this data repository will establish a real-time clinical and health service laboratory that can explore and evaluate the organic biology of the healthcare process model and the people for which it provides care. PHOCQUS aims to develop digital phenotypes of cardiovascular diseases and care, patient comorbidities and social determinants of health, health service characteristics, and measure outcomes through an automated data retrieval and collation by linking currently collected routine clinical health service use and demographic data from various electronic health information systems for all patients under the custodianship of the Cardiology department at Flinders Medical Centre. This study will provide the groundwork for evaluating impacts of health policy and service redesign. Such a repository will also feed back into routinely collected data increasing data integrity, reducing “missingness”, improving interfaces and further standardizing data definitions and workflows. The overall aim of this project is the development of validated data specifications that will enable the implementation of low cost, yet high fidelity, routine clinical quality registries in cardiovascular care.
Interventions
No patient level clinical interventions will be undertaken within the scope of this project. Clinical phenotyping and monitoring of outcome will be conducted parallel to clinical care, but clinicians will not have visibility of the phenotyping process so as not to influence clinical care. The department will continue to provide standard care as per normal practice. Information regarding performance of the system and the clinical cardiology unit will be reported to the Department of Cardiology le
No patient level clinical interventions will be undertaken within the scope of this project. Clinical phenotyping and monitoring of outcome will be conducted parallel to clinical care, but clinicians will not have visibility of the phenotyping process so as not to influence clinical care. The department will continue to provide standard care as per normal practice. Information regarding performance of the system and the clinical cardiology unit will be reported to the Department of Cardiology leadership and governance. Any changes from standard care would come under the aegis of either normal changes in clinical care, or a separate research study with separate HREC approval sought, and any consequent conditions abided by including full informed consent Phase/stage 1 will use retrospective data only to define and validate electronic phenotypes for arrhythmia (i.e. atrial fibrillation), heart failure (i.e. systolic and diastolic heart failure) and acute coronary syndromes (i.e. myocardial infarction). It will also establish the processes for routine ongoing data-linkage based on unique identifiers held within health datasets and will refine processes for de-identification. No re-identification of data and direct patient contact will be required. No intervention will be conducted for these retrospective patients, and a full waiver of consent has been requested. Only the patient record initially comprising of data from databases that are local to FMC and those that produce aggregate data of a minimum standard, from 2006 onwards, will be used within this retrospective component and no additional patient contact will be sought. Data collection will include information pertinent to patient admissions, discharges, diagnosis, investigations, interventions, procedures, management, pharmacological therapy, outcomes, risk factors and stratification, demographics, social determinants of health and any associated relevant clinical or administrative data. Phase/stage 2 will build on the data-linkage and de-identification processes of Phase/stage 1 but, using prospective participant data, will incorporate the phenotypic templates into prospective clinical quality registries of acute coronary syndromes, heart failure and arrhythmia. Prospective participant hospital presentation records will be utilised to further refine and validate the phenotypes to ensure the fidelity of the phenotype templates in an ongoing manner. Departmental care will be at the discretion of the treating clinical teams. All clinical assessments shall occur as per standard clinician discretion, both in method, timing, frequency, and scope, given the observational nature of this study. Clinical data is to be recorded either as per standard care or directly into the PHOCQUS database as determined by data variable.
Sponsors
Flinders University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult participants who have been admitted to FMC from 2006, regardless of diagnosis and cardiac investigations, noting that the study methodology requires the sampling of patients with and without clinical suspicion of the cardiovascular diseases under question within the retrospective audit as these patients contribute the true negative/false positive patient cohort for sensitivity/specificity analysis. 2. Prospective participants or their legally authorised representatives are capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the opt-out consent form (ICF) and in the study protocol.
Exclusion criteria
Prospective participants are excluded from the study if they notify Flinders Cardiology Research that they choose to either withdraw or opt-out of consent. Prior enrolment/participation in this study in not exclusionary.
Outcome results
None listed