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Table 4 Characteristics of clinical registries (N = 13)

From: Defining key design elements of registry-based randomised controlled trials: a scoping review

Studies Type Name Purpose Time-period
coverage
Population coverage Consent Funding Variables Validity/reliability
Alexander et al. 2011 [35] Disease registry The National Cardiovascular Data Registry (NCDR) ACTION Registry® – GWTGTM Platform for hospitals to measure and improve their myocardial infarction
care and to advance quality improvement efforts
Not reported Detailed clinical information on > 150,000 existing
patients with either ST-elevation or non-ST-elevation myocardial infarction (STEMI and NSTEMI)
Not reported Initiative of the American College of Cardiology Foundation and the American Heart Association, with partnering support from The Society of Chest Pain Centres, The Society of Hospital Medicine and The American College of Emergency Physicians. The registry is sponsored by Bristol-Myers Squibb/Sanofi Pharmaceuticals Patient demographics, presenting features, pre-hospital and in-hospital therapies,
timing of care delivery, laboratory tests, procedure use, and in-hospital patient outcomes
Data entered via a secure password-protected, web-based server system with programmed frontend
logic and range checks to optimise data quality at the time of data entry
Barbanti et al. 2015 [33] Procedure registry Registry of Percutaneous Aortic Valve Replacement (the REPLACE registry) Created to monitor the institutional procedural,
acute and long-term outcomes of transcatheter aortic valve replacement
Not reported Ferrarotto Hospital in Catania, Italy Yes Not reported Patient demographics, medical history, concomitant medications, procedure details, and in-hospital clinical outcomes are routinely entered in the registry’s electronic data collection system using standardised case report forms Not reported
Daley et al. 2002 [26] Procedure registry Immunisation registry Administered vaccines are entered into the registry daily, and it operates in accordance with nationally recommended
standards for immunisation registries
Began in May 1998 The Children’s Hospital, Denver, Colorado, USA Not reported Not reported Age of child, immunisation status and uptake of new vaccines (such as PCV7) Validation of registry immunisation data by performing a chart review of 40 randomly selected records. The registry error rate was 8%, calculated as the percentage of immunisations documented in the medical records but not in the registry. The registry duplicate record rate was less than 1%
Kempe et al. 2005 [29] Procedure registry Immunisation registry Immunisation records for all children < 72 months of age in the participating practices were entered into an existing regional immunisation registry 15–24 months before the present study Not reported 47% of children 0 to 6 years of age in Colorado Not reported Not reported Immunisation data from medical records and billing data Quality assessment data for the 5 practices, demonstrated an overall completeness rate of 97.4% (children in the practice who were in the registry) and an error rate of 7.2% (immunisation not in the registry or incorrect date)
Dombkowski et al. 2012 [27]; Dombkowski et al. 2014 [28] Procedure registry Michigan Care Improvement Registry (MCIR) MCIR is used widely by
public and private providers throughout Michigan; state law requires that all vaccination doses administered to children aged less than 20 years be entered into MCIR
Not reported Children aged less than 20 years in Michigan Not reported CDC Cooperative Agreement In addition to tracking individual vaccination
doses, MCIR has extensive assessment, reporting, and reminder/recall notification capabilities based on recommendations of the National Vaccine Advisory Committee
2012 Validation of addresses conducted retrospectively using US Postal Services
2014 Not reported on; Data validation/reliability
Frobert et al. 2013 [16]; Lagerqvist et al. 2014 [24]; Erlinge et al. 2017 [6]; Hofmann et al. 2017a [36] Disease registry Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated According to Recommended Therapy
(SWEDEHEART registry)
Merging of the national registry of acute cardiac care (RIKSHIA),
the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), the Swedish
heart surgery registry and the national registry of secondary prevention (SEPHIA). The main purpose of the registry is to support the improvement of care and evidence-based
development of therapy of coronary artery disease by providing continuous information on
care needs, therapy and results of therapy and changes within a hospital as well as in
comparison to other hospitals
Began in December 2009 Patients admitted to hospital because of symptoms suggestive of an acute coronary syndrome (ACS), and patients undergoing coronary angiography/angioplasty or heart surgery from all 29 Swedish and 1 Icelandic coronary intervention
centres
Yes for all 4 studies The Swedish
Association of Local Authorities and Regions (the public health care provider), and is
supported by the Swedish Heart Association, the National Board of Health and Welfare and the Swedish Heart and Lung Foundation. Participating hospitals are not reimbursed by the
registry and costs of local data entry are borne by their internal budget
106 variables and include patient demographics,
admission logistics, risk factors, past medical history, medical treatment prior to admission,
electrocardiographic changes, biochemical markers, other clinical features and investigations, medical treatment in hospital, interventions, hospital outcome, discharge diagnoses and
discharge-medications
Uppsala Clinical Research Centre provides manuals, education and technical advice, including a telephone help desk for all users of the registry. The system has error-checking routines for range and consistency. Definitions are easily available when data are entered. To ensure the correctness of the data entered a monitor visits about 20 hospitals each year and compares data entered into the SWEDEHEART with the information in the patients’ records
from 30 to 40 randomly chosen patients in each hospital
Hall et al. 2013 [32] Disease registry Australian state-based cancer registry It is a legal requirement that all cancer diagnoses are notified to the relevant cancer registry. Not reported 1 Australian state No consent required Not reported Age, gender, cancer type, year of diagnosis, postcode and other demographic and disease characteristics were collected from the cancer registry Not reported
Irigoyen et al. 2006 [31] Procedure registry EzVac To consolidate immunisation records for a hospital health care system Began in 2000 All children born or receiving care at the hospital or affiliated practices Not reported Funding provided by U66/CCU 212961 National Immunisation Program Immunisation Internal validity of EzVac assessed by comparing immunisation in EzVac with paper medical records. External validity of EzVac assessed by comparing immunisations from EzVac with CIR
Jensen et al. 2016b [23] Disease registry The Western Denmark Heart Registry (WDHR) To monitor and improve the quality of cardiac intervention in Western Denmark and to allow for clinical and health-service research Began in 1999 All adult (≥ 15 years) patients in Western Denmark referred for cardiac intervention, i.e. invasive procedures (coronary angiography or percutaneous coronary intervention), cardiac surgery (predominantly valve surgery and coronary artery bypass grafting), and from 2008 also computed tomography coronary angiography Yes Collaborative effort by Western Denmark’s 3 major cardiac centres (Aarhus University Hospital-Skejby, Odense University Hospital and Aarhus University Hospital-Aalborg). The participating centres own the WDHR and finance its operation through annual membership fees set according to hospital size For each procedure, physicians report administrative data, including dates of referral, admission, operation and discharge; and clinical data, including medical history, procedure data, lesion-data, complications, and research study enrolments. Depending on the procedure type, 50 to 150 variables are registered for each procedure The data quality is ensured by automatic validation rules at data entry combined with systematic validation procedures and random spot-checks after entry
Kristensen et al. 1996c [25] Disease registry The Danish Breast Cancer Cooperative Group Registry To improve the prognosis in breast cancer Began in 1977 90% of all women with breast cancer in Denmark Not reported Until 1982, financed from private sources: The Danish Health and Medicines Authority and the Finsen Institute. Thereafter, financed from counties and from 2007 Danish regions Characteristics of the primary tumour, of surgery, radiotherapy and systemic therapies, and of follow-up reported on specific forms from the departments Queries are sent to the departments if reporting is missing according to the guidelines indicated on the forms, or if the database receives forms from 1 discipline (for instance, pathology), but not from the corresponding discipline (for instance, surgery or oncology). The completeness has improved to more than 95%
LeBaron et al. 2004 [30] Procedure registry Metro Atlanta Team for Child Health (MATCH) immunisation registry To improve immunisation rates (providing provider measurement and feedback) Began in 1993 Atlanta metropolitan area: the public health clinics of DeKalb County (the other county that includes part of Atlanta), the area’s federally qualified community health centres, the 2 major private paediatric hospitals with their outpatient and satellite centres, the 2 major academic medical facilities, the major Roman Catholic hospital with its outpatient and outreach facilities, and a number of large private practices Not reported Not reported Vaccination doses, race and sex Not reported
Rao et al. 2014d [17] Disease registry The National Cardiovascular Data Registry (CathPCI) To assist health care providers and institutions in documenting their processes and outcomes of care in the cardiac catheterisation laboratory Began in 1997 85% of the cardiac catheterisation laboratories in the United States Yes Co-sponsored by the American College of Cardiology and the Society for
Cardiovascular Angiography and Intervention
Demographics, medical history, concomitant medications, procedure details, in-hospital clinical outcomes ‘Formally validated’ – no further information provided
Van der Veer et al. 2013 [34] Health services registry The Dutch National Intensive Care Evaluation (NICE) registry To systematically and continuously monitor and improve ICU performance by reporting and benchmarking quality indicators Began in 1996 86% of all Dutch ICUs Yes Not reported 11 structure, process and outcome indicators Data collected through the NICE registry which has its own inbuilt infrastructure validation systems
  1. aAdditional information extracted from supplementary file [36]
  2. bAdditional information extracted from cited paper [42]
  3. cAdditional information extracted from Christiansen, Ejlertsen [43]
  4. dAdditional information extracted from Dehmer, Weaver [44]