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: 5.66). 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.

0 0
  • Source
    [show abstract] [hide abstract]
    ABSTRACT: From 2006, the Stroke Code system operates throughout Catalonia with full coverage. The objective of this study was to determine safety and effectiveness of intravenous thrombolysis in routine practice through a monitored study (Catalan Stroke Code and Thrombolysis [Cat-SCT]) and to assess outcomes according to hospitals' previous experience. We conducted a prospective, multicenter, observational, monitored study of recombinant tissue plasminogen activator-treated patients declared to the Cat-SCT by all treating hospitals in Catalonia (n=13, of which 6 were newly designated) over a 12-month period. Consecutive recruitment and quality of data were assured through comprehensive quality control. We estimated rates of outcome measures for the potential final sample (after inclusion of undeclared cases) and compared them with those reported for the actual sample. Symptomatic intracranial hemorrhage, mortality, and favorable outcome (modified Rankin Scale score 0 to 1) at 3 months were also evaluated according to hospitals' previous experience using multilevel logistic regression. We analyzed 488 patients with a median age of 72 years (interquartile range: 63, 77), 57.2% males, with a baseline National Institutes of Health Stroke Scale score of 13 (interquartile range: 8, 19), and stroke to treatment time of 150 minutes (interquartile range: 120, 180 minutes). Symptomatic intracranial hemorrhage (Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy definition) was observed in 3.3% patients. Ninety-day mortality was 16.6% and 38.5% showed a favorable outcome at 3 months. External monitoring set inclusion losses at <5%. A sensitivity analysis including undeclared cases did not show significant changes in main outcomes. Inexperienced hospitals achieved similar outcomes, except for a higher rate of favorable outcome at 3 months. Health planning applied to acute stroke care and based on dissemination of the Stroke Code system and designation of new referral hospitals showed intravenous thrombolysis safe and effective in routine practice, even among inexperienced hospitals.
    Stroke 05/2011; 42(7):2001-6. · 6.16 Impact Factor
  • [show abstract] [hide abstract]
    ABSTRACT: The national observational study of diagnostic and interventional cardiac catheterization (ONACI) is a prospective multicenter registry of the French Society of Cardiology including all interventional cardiology procedures performed from 2004. We aimed to evaluate "real-world" management of patients with coronary artery disease in France from this registry. The present study was focused on data collected from 2004 to 2008. Patient demographics and co-morbidities, invasive parameters, treatment options, and procedural techniques were prospectively collected. Patients were recruited from 99 hospitals (55% of patients were hospitalized in private clinics and 45% in public institutions). During a 5-year period, a total of 298,105 patients underwent coronary angiography and 176,166 patients underwent percutaneous coronary intervention. Diagnosis was acute coronary syndrome in 22%, stable angina or silent ischemia in 23%, and atypical chest pain in 9% of cases. Normal coronary arteries or nonsignificant coronary narrowing were found in 26% of patients. Radial access was increasingly used over the years regardless of the indication. The average number of percutaneous coronary interventions per procedure was 1.5 ± 0.7 (range, 1.3 ± 0.7 to 1.5 ± 0.7) and that of stents per procedure was 1.5 ± 0.8 (range, 1.5 ± 0.8 to 1.6 ± 0.8). Drug-eluting stents were used in 45% (range, 34% to 62%), increasing from 2004 to 2006, and then decreasing after the 2006 controversy. In conclusion, ONACI is one of the largest catheterization registries during this period, providing a detailed and comprehensive global description of the spectrum and management of patients with suspected coronary artery disease undergoing cardiac catheterization.
    The American journal of cardiology 05/2013; · 3.58 Impact Factor
  • [show abstract] [hide abstract]
    ABSTRACT: OBJECTIVE: To assess the transparency of assisted reproductive technology (ART) surveillance reports published by the Centers for Disease Control and Prevention (CDC) and by the Society for Assisted Reproductive Technologies (SART). DESIGN: Retrospective analysis. SETTING: Private clinical ART and research center. PATIENT(S): We analyzed ART data for the years 2005-2010, which were reported under federal mandate to the CDC (818,927 completed cycles) and voluntarily to SART (812,400 initiated cycles). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Initiated cycles excluded from final outcome reporting were used to evaluate transparency. RESULT(S): Only SART, but not CDC, reported initiated cycles, allowing analysis of excluded cycles. Excluded cycles increased significantly from 3.3% to 7.4% between 2005 and 2010. By 2010, 13/341 (3.8%) ART centers accounted for 50% of excluded cycles, representing an average of 37.3% of their cycles. These 13 clinics reported significantly better pregnancy and cancellations rates than national averages and collectively increased by 19.9% their share of U.S. ART cycles. CONCLUSION(S): Our data indicate decreasing transparency in public ART reporting in the United States, likely due to changes in practice and reporting patterns. A few clinics accounted for the majority of excluded cycles, leading to improved reported clinical outcomes and increasing market share. CDC and SART should ensure that all ART clinics publicly report the outcomes of all initiated cycles including embryo-banking cycles. ART surveillance and quality of care may be improved by prospectively tracking the total reproductive potential of each initiated cycle.
    Fertility and sterility 06/2013; · 3.97 Impact Factor

Full-text (2 Sources)

1 Download
Available from
Mar 1, 2014