Key result
Data from developing countries was received with a significantly longer median delay (37 days) compared to developed countries (11 days), though data quality measured by query rates was comparable.
Why the study?
Does the socio-economic status of a country affect data quality and timeliness in an international multi-centre randomised trial?
Observational (n=3,102)
Yes
Does the socio-economic status of a country affect data quality and timeliness in an international multi-centre randomised trial?
Absolute Event Rate: 37% vs 11%
p-value: p=<0.001
Data quality in a large international surgical trial was comparable between developed and developing countries, although data submission was slower from developing countries.
May delay global trial timelines; leaves open whether targeted support can accelerate submission from developing countries without compromising quality.
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.
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Krzych et al. (2011) conducted an observational in Coronary artery disease (n=3,102). Developing countries vs. Developed countries was evaluated on Time elapsed between 6-week visit and receipt of data (days) (p=<0.001). Data from developing countries was received with a significantly longer median delay (37 days) compared to developed countries (11 days), though data quality measured by query rates was comparable.
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