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http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry).

BackgroundElectronic Case Report Forms (eCRFs) are increasingly chosen by investigators and sponsors of clinical research instead of the traditional pen-and-paper data collection (pCRFs). Previous studies suggested that eCRFs avoided mistakes, shortened the duration of clinical studies and reduced data collection costs.MethodsOur objectives were to describe and contrast both objective and subjective efficiency of pCRF and eCRF use in clinical studies. A total of 27 studies (11 eCRF, 16 pCRF) sponsored by the Paris hospital consortium, conducted and completed between 2001 and 2011 were included. Questionnaires were emailed to investigators of those studies, as well as clinical research associates and data managers working in Paris hospitals, soliciting their level of satisfaction and preferences for eCRFs and pCRFs. Mean costs and timeframes were compared using bootstrap methods, linear and logistic regression.ResultsThe total cost per patient was 374€ ±351 with eCRFs vs. 1,135€ ±1,234 with pCRFs. Time between the opening of the first center and the database lock was 31.7 months Q1 = 24.6; Q3 = 42.8 using eCRFs, vs. 39.8 months Q1 = 31.7; Q3 = 52.2 with pCRFs (p = 0.11). Electronic CRFs were globally preferred by all (31/72 vs. 15/72 for paper) for easier monitoring and improved data quality.ConclusionsThis study found that eCRFs and pCRFs are used in studies with different patient numbers, center numbers and risk. The first ones are more advantageous in large, low–risk studies and gain support from a majority of stakeholders.

f/b EVAR in high risk patients offers similar 2 year mortality to OSR performed in lower risk patients but at a higher cost. The cost is mainly driven by the cost of the stent graft, which is not compensated for by lower healthcare resource consumption. Further studies are necessary to evaluate the cost-effectiveness in low risk f/b EVAR patients who may experience fewer complications.

Unsuccessful patients should not lose hope, because nearly half may subsequently succeed in having a child.

Among adult and pediatric patients in the UK, CLB is more often prescribed for epilepsy than CZP. The median CLB dosage used by both adults and children remained stable over the 16-year study period, while the median CZP dosage increased in both adults and children.

A strategy of CTCA triage in the intermediate-risk group, no imaging test in the low-risk group, and CA in the high-risk group, has good diagnostic accuracy and could significantly cut costs. Medium-term and long-term outcomes need to be evaluated in patients with coronary stenosis potentially misclassified by CTCA due to false negative examinations.

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