Article

Patient Registries of Acute Coronary Syndrome Assessing or Biasing the Clinical Real World Data?

Vall d'Hebron Hospital, Barcelona, Spain.
Circulation Cardiovascular Quality and Outcomes (Impact Factor: 5.04). 11/2009; 2(6):540-7. DOI: 10.1161/CIRCOUTCOMES.108.844399
Source: PubMed

ABSTRACT The risk of selection bias in registries and its consequences are relatively unexplored. We sought to assess selection bias in a recent registry about acute coronary syndrome and to explore the way of conducting and reporting patient registries of acute coronary syndrome.
We analyzed data from patients of a national acute coronary syndrome registry undergoing an audit about the comprehensiveness of the recruitment/inclusion. Patients initially included by hospital investigators (n=3265) were compared to eligible nonincluded (missed) patients (n=1439). We assessed, for 25 exposure variables, the deviation of the in-hospital mortality relative risks calculated in the initial sample from the actual relative risks. Missed patients were of higher risk and received less recommended therapies than the included patients. In-hospital mortality was almost 3 times higher in the missed population (9.34% [95% CI, 7.84 to 10.85] versus 3.9% [95% CI, 2.89 to 4.92]). Initial relative risks diverged from the actual relative risks more than expected by chance (P<0.05) in 21 variables, being higher than 10% in 17 variables. This deviation persisted on a smaller degree on multivariable analysis. Additionally, we reviewed a sample of 129 patient registries focused on acute coronary syndrome published in thirteen journals, collecting information on good registry performance items. Only in 38 (29.4%) and 48 (37.2%) registries was any audit of recruitment/inclusion and data abstraction, respectively, mentioned. Only 4 (3.1%) authors acknowledged potential selection bias because of incomplete recruitment.
Irregular inclusion can introduce substantial systematic bias in registries. This problem has not been explicitly addressed in a substantial number of them.

Full-text

Available from: Héctor Bueno, Feb 28, 2014
0 Followers
 · 
150 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background-Accurate case ascertainment is essential for clinical registries to be valid and representative. We assessed case ascertainment in the Michigan Stroke Registry by linking to a statewide hospital discharge database (Michigan Inpatient Database [MIDB]). Methods and Results-In 2009, all ischemic stroke cases submitted by 30 registry hospitals were linked to ischemic stroke discharges (International Classification of Diseases, Ninth Revision code 433.x1, 434.x1, or 436) in the MIDB. Databases were linked using hospital, age, sex, and admission date. The MIDB was regarded as the gold standard. To assess completeness, we calculated the percent difference between the number of cases entered in the registry relative to the MIDB. To quantify accuracy, we defined sensitivity as the proportion of cases identified in the MIDB that were matched to the registry and positive predictive value as the proportion of cases identified in the registry that were matched to the MIDB. Before data linkage, 4 hospitals were known to be using a case sampling approach. The remaining 26 registry hospitals submitted 21% fewer cases (n=3403) than were found in the MIDB (n=4340). The overall sensitivity was 68.8% (95% confidence interval, 76.4%-79.3%), and positive predictive value was 87.7% (95% confidence interval, 87.4%-89.8%). The sensitivity of case ascertainment was significantly lower in teaching hospitals and primary stroke centers but was higher in the sites that used prospective case ascertainment methods. Conclusions-Among registry hospitals, these results revealed relatively high levels of completeness and accuracy. Matching registry data to hospital discharge data identified hospitals that changed their case ascertainment method to a case sampling approach. This study illustrates the value of monitoring case ascertainment in stroke registries using external data sources.
    Circulation Cardiovascular Quality and Outcomes 08/2014; 7(5). DOI:10.1161/CIRCOUTCOMES.113.000706 · 5.66 Impact Factor
  • Stroke 10/2014; 45(11). DOI:10.1161/STROKEAHA.114.007436 · 6.02 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Utstein-style guidelines contribute to improved public health internationally by providing a structured framework with which to compare emergency medical services systems. Advances in resuscitation science, new insights into important predictors of outcome from out-of-hospital cardiac arrest, and lessons learned from methodological research prompted this review and update of the 2004 Utstein guidelines. Representatives of the International Liaison Committee on Resuscitation developed an updated Utstein reporting framework iteratively by meeting face to face, by teleconference, and by Web survey during 2012 through 2014. Herein are recommendations for reporting out-of-hospital cardiac arrest. Data elements were grouped by system factors, dispatch/recognition, patient variables, resuscitation/postresuscitation processes, and outcomes. Elements were classified as core or supplemental using a modified Delphi process primarily based on respondents' assessment of the evidence-based importance of capturing those elements, tempered by the challenges to collect them. New or modified elements reflected consensus on the need to account for emergency medical services system factors, increasing availability of automated external defibrillators, data collection processes, epidemiology trends, increasing use of dispatcher-assisted cardiopulmonary resuscitation, emerging field treatments, postresuscitation care, prognostication tools, and trends in organ recovery. A standard reporting template is recommended to promote standardized reporting. This template facilitates reporting of the bystander-witnessed, shockable rhythm as a measure of emergency medical services system efficacy and all emergency medical services system - treated arrests as a measure of system effectiveness. Several additional important subgroups are identified that enable an estimate of the specific contribution of rhythm and bystander actions that are key determinants of outcome. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.
    Resuscitation 11/2014; DOI:10.1016/j.resuscitation.2014.11.002 · 3.96 Impact Factor