This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Quality of Care, Other  • Academic Medical Centers  • Randomized Controlled Trial  • Alert me on articles by topic

SST Report No. 2

Submacular Surgery Trials Research Group^*

Arch Ophthalmol. 2004;122:857-863.

Objective  To compare the performance of community- vs university-based clinical centers in 3 multicenter randomized clinical trials of intraocular surgery.

Methods  Each Submacular Surgery Trials clinical center was classified as a university-based center, if the contract to perform as a center was signed by a university official, or as a community-based center. The 2 groups of centers were compared on performance, assessed cumulatively by the Submacular Surgery Trials Quality Assurance and Monitoring Subcommittee.

Outcome Measures  Patient accrual, completion of scheduled examinations, completion of masked vision examinations 2 years after enrollment (the designated primary study end point evaluation time), timeliness of submission of retinal photographs required by protocol to the Photograph Reading Center, completion of health- and vision-related quality-of-life interviews, and timeliness of submission of the primary outcome data to the Coordinating Center after completion of the examination.

Results  Almost all centers performed at a very high (good) level, although there was a trend for some community-based centers to be at the lower end of most distributions.

Conclusions  Most community- and university-based centers performed well in these multicenter clinical trials. Monitoring performance and periodically providing feedback to clinical center investigators may encourage excellent performance in areas critical to the success of clinical trials, regardless of whether the center is community or university based.

^*The Writing Committee members for the Submacular Surgery Trials Report No. 2 who had complete access to the raw data needed for this report and who also bear authorship responsibility for this report are Neil M. Bressler, MD, chairperson; Barbara S. Hawkins, PhD; Susan B. Bressler, MD; Päivi H. Miskala, PhD; and Marta J. Marsh, MS. The authors have no relevant financial interest in this article.