Non-publication of large randomized clinical trials: cross sectional analysis.

OBJECTIVE: To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public. DESIGN: Cross sectional analysis SETTING: Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. DATA SOURCES: PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database. MAIN OUTCOME MEASURES: The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database. RESULTS: Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299,763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov. CONCLUSIONS: Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.

A study of personal digital assistants to enhance undergraduate clinical nursing education.

This study reports on personal digital assistants (PDAs) as a means to prepare nurse professionals who value and seek current information. An interdisciplinary team of nursing and library faculty, information technology and bookstore staff, students, and educational consultants developed this project. A pre-post and comparative group design of second-degree students in the accelerated and traditional baccalaureate nursing degree (BSN) options was used to examine students' information-seeking behaviors, and the effectiveness and cost of innovation strategies associated with incorporation of PDAs into students' clinical practice. Results of this study support PDAs as an effective student learning resource, especially for reference materials. The student group with PDAs had increasing numbers of questions associated with clinical situations and a greater recognition of the need to use current resources. Students made substantial use of their PDAs and health team members, while decreasing reliance on textbooks and clinical faculty. Students' use of and satisfaction with this technology is linked to access speed and readability. Providing faculty with PDAs is recommended to enhance their comfort with and incorporation of PDAs into clinical teaching.