From registration to publication: A study on Dutch academic randomized controlled trials.

INTRODUCTION: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch investigator-initiated randomized controlled clinical trials (RCTs). METHODS: All Dutch investigator-initiated RCTs with a completion date between December 31, 2010, and January 1, 2012, and registered in the Trial Register of The Netherlands database were included. PubMed was searched for the publication of these RCT results until September 2016, and the time to the publication date was calculated. Consistency in hypothesis, sample size, and primary endpoint compared with the registry data were assessed. RESULTS: The search resulted in a total of 168 Dutch investigator-initiated RCTs. In September 2016, the results of 129 (77%) trials had been published, of which 50 (39%) within 2 years after completion of accrual. Consistency in hypothesis with the original protocol was observed in 108 (84%) RCTs; in 71 trials (55%), the planned sample size was reached; and 103 trials (80%) presented the original primary endpoint. Consistency in all three parameters was observed in 50 studies (39%). CONCLUSION: This study shows that approximately one out of four Dutch investigator-initiated RCTs remains unpublished 5 years after initiation. The observed low overall consistency with the initial study outline is a matter of concern and warrants improvements in trial design and assessment of trial feasibility.

Keeping track of all ongoing colorectal cancer trials using a mobile application: Usability and satisfaction results of the Dutch Colorectal Cancer Group Trials application.

BACKGROUND AND AIM: Both the number and complexity of medical trials are increasing vastly. To facilitate easy access to concise trial information, a freely available mobile application including all ongoing clinical trials of the Dutch Colorectal Cancer Group (DCCG) was developed. The aim of this study was to investigate the use and user satisfaction over the first 2 years. METHODS: The application was launched in January 2015 on iOS and Android platforms. Google Analytics was used to monitor anonymous user data up to February 2017. In addition, an online survey regarding the use and satisfaction among health-care professionals and research affiliates active in the field of colorectal cancer in the Netherlands was conducted. RESULTS: A total of 6173 unique users were identified, of which 1822 (30%) were from the Netherlands, representing a total of 16,065 and 10,987 (68%) sessions, respectively. The median session duration per day was 01:47 min (IQR 0:51-03:03). The mobile application was mostly used on Monday, Tuesday, and Thursday, and the number of sessions was highest during the following time frames: 12-13 pm (9%), 17-18 pm (9%), and 13-14 pm (8%). Of 121 survey responses, most were medical doctors (47%), nurses (25%), or researchers (9%), working either in a teaching (40%), academic hospital (32%), or general hospital (19%). 83% of all respondents rated the application 4 or higher for satisfaction on a 5-point scale. Highest reported reasons of the use were urgent trial inquiry (57%) and usage during multi-disciplinary meetings (49%). CONCLUSION: The DCCG Trials application is frequently used, and the majority of users is highly satisfied. RELEVANCE FOR PATIENTS: Clustering trial information into one platform, such as DCCG trials app, has shown to be useful for medical professionals treating patients with colorectal carcinoma in the Netherlands.