Dataset Information

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

ABSTRACT:

Background

ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata.

Methods

The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query) and "dirty" (any incomplete, inconsistent or illegible data). The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent) and time delay (in days) between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India) and "Developed" (Italy, UK, Austria and Australia).

Results

There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month). The time interval for the receipt of data was longer for "Developing" countries (median:37 days) compared to "Developed" ones (median:11 days) (p < 0.001). The median number of data queries was 23% in "Developed" countries compared to 19% in "Developing" ones (p = ns).

Conclusions

In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality.

Trial registration

ISRCTN46552265.

SUBMITTER: Krzych LJ

PROVIDER: S-EPMC3205027 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

Krzych Lukasz J LJ Lees Belinda B Nugara Fiona F Banya Winston W Bochenek Andrzej A Cook Jo J Taggart David D Flather Marcus D MD

Trials 20110926

<h4>Background</h4>ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata.<h4>Methods</h4>The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edi ...[more]

PMID: 21943128

Similar Datasets

Project description:BackgroundThe DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function.MethodsThis international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747).Findings445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority < 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p < 0.001).InterpretationThis is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function.FundingThe study was funded by Elixir Medical.

Project description:BACKGROUND:To date, studies evaluating outcome improvements associated with participation in physician-led collaboratives have been limited by the absence of a contemporaneous control group. We examined post cardiac surgery pneumonia rates associated with participation in a statewide, quality improvement collaborative relative to a national physician reporting program. METHODS AND RESULTS:We evaluated 911 754 coronary artery bypass operations (July 1, 2011, to June 30, 2017) performed across 1198 hospitals participating in a voluntary national physician reporting program (Society of Thoracic Surgeons [STS]), including 33 that participated in a Michigan-based collaborative (MI-Collaborative). Unlike STS hospitals not participating in the MI-Collaborative (i.e., STSnonMI) that solely received blinded reports, MI-Collaborative hospitals received a multi-faceted intervention starting November 2012 (quarterly in-person meetings showcasing unblinded data, webinars, site visits). Eighteen of the MI-Collaborative hospitals received additional support to implement recommended pneumonia prevention practices ("MI-CollaborativePlus"), whereas 15 did not ("MI-CollaborativeOnly"). We evaluated rates of postoperative pneumonia, adjusting for patient mix and hospital effects. Baseline patient characteristics were qualitatively similar between groups and time. During the preintervention period (Q3/2011 through Q3/2012), there was no statistically significant difference in the adjusted odds of pneumonia for STS hospitals participating in the MI-Collaborative compared to the STS non-MI hospitals. However, during the intervention period (Q4/2012 through Q2/2017), there was a significant 2% reduction per quarter in the adjusted odds of pneumonia for MI-Collaborative hospitals (n=33) relative to the STS-nonMI hospitals. There was a significant 3% per quarter reduction in the adjusted odds of pneumonia for the MI-CollaborativeOnly (n=15) hospitals relative to the STS-nonMI hospitals. Over the course of the overall study period, the STS-nonMI hospitals had a 1.96% reduction in risk-adjusted pneumonia (pre- vs. intervention periods), which was less than the MI-Collaborative (3.23%, P=0.011). Over the same time period, the MI-CollaborativePlus (n=18) reduced adjusted pneumonia rates by 10.29%, P=0.001. CONCLUSIONS:Participation in a physician-led collaborative was associated with significant reductions in pneumonia relative to a national quality reporting program. Interventions including collaborative learning may yield superior outcomes relative to solely using physician feedback reporting. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02068716.

Dataset Information

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

Background

Methods

Results

Conclusions

Trial registration

Publications

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets