Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer

Purpose To provide empirical evidence on the impact of on-site initiation visits on the following outcomes: patient recruitment, quantity and quality of data submitted to the trial coordinating office, and patients' follow-up time. Patients and methods This methodological study was performed as...

Full description

Saved in:

Bibliographic Details
Published in:	Clinical trials (London, England) Vol. 3; no. 5; pp. 486 - 492
Main Authors:	Liénard, J-L, Quinaux, E, Fabre-Guillevin, E, Piedbois, P, Jouhaud, A, Decoster, G, Buyse, M, on behalf of the European Association for Research in Oncology (AERO)
Format:	Journal Article
Language:	English
Published:	Thousand Oaks, CA Sage Publications 01-01-2006 Sage Publications Ltd SAGE Publications
Subjects:	Antineoplastic Agents, Phytogenic - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bioinformatics Breast cancer Breast Neoplasms - drug therapy Cell Behavior Cellular Biology Chemotherapy Chemotherapy, Adjuvant Clinical trials Cognitive science Computer science Computer Science and Game Theory Cyclophosphamide - therapeutic use Epirubicin - therapeutic use Female Fluorouracil - therapeutic use Human health and pathology Humans Life Sciences Medical Oncology - standards Modeling and Simulation Outcome Assessment (Health Care) Paclitaxel - therapeutic use Patient Selection Quantitative Methods Randomized Controlled Trials as Topic - standards Research Design Research methodology Tissues and Organs Urology and Nephrology
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	Purpose To provide empirical evidence on the impact of on-site initiation visits on the following outcomes: patient recruitment, quantity and quality of data submitted to the trial coordinating office, and patients' follow-up time. Patients and methods This methodological study was performed as part of a randomized trial comparing two combination chemotherapies for adjuvant treatment of breast cancer. Centers participating to the trial were randomized to either receive systematic on-site visits (Visited group), or not (Non-visited group). Results The study was terminated after two years, while the main randomized trial continued. Of the 135 centers that had expressed an interest in the trial, only 69 randomized at least one patient (35/68 in the Visited group, 34/67 in the Nonvisited group). Almost two-thirds of the patients were entered by 17 centers (10 in the Visited group, seven in the Non-visited group) that accrued more than 10 patients each. None of the prespecified outcomes favored the group of centers submitted to on-site initiation visits (ie, mean number of queries par patient: 6.1 ± 9.7 versus 5.4 ± 6.4, respectively for the Visited and Non-visited groups). Spontaneous transmittal of case report forms, although required by protocol, was low in both randomized groups (mean number of pages per patient: 1.5 ± 2.0 versus 2.1 ± 2.3, respectively), with investigators submitting about one-third of the expected forms on time (29% and 39%, respectively). Limitations This study could not evaluate the impact of repeated on-site visits on clinical outcomes. Conclusion Systematic on-site initiation visits did not contribute significantly to this clinical trial.
ISSN:	1740-7745 1740-7753
DOI:	10.1177/1740774506070807