RESUMEN
Randomized controlled trials (RCT) are the driver of therapeutic innovations. However, it has been frequently shown that less than 5% of adult cancer patients enroll in clinical trials, although 70% of patients are considered as being willing to participate. Barriers to trial participation have been extensively studied. Although there is evidence that trial participation correlates with improved survival and reduced mortality, the rate of participation has not changed substantially. We provide retrospective data from a single-center analysis of 411 patients with multiple myeloma (MM) who were treated at the University Hospital Duesseldorf in Germany between January 2014 and December 2016. Each patient was analyzed for the real-world possibility of participating in a clinical study, based on the inclusion and exclusion (I/E) criteria and the recruiting period of open studies. The overall rate of study participation was 19%. A total of 53% of NDMM patients were eligible for first-line studies (GMMG-HD6, LenaMain). Of these, 80% consented to enrolment (42% of all). In contrast, only 38% of the RRMM population was eligible (GMMG-Relapse, Castor, Tourmaline, Admyre). Of these, only 22% (7% of all) consented. This was confirmed by virtual analysis, showing that only 29% of all RRMM patients would have been eligible for six internationally recruiting trials leading to later drug approval. The majority of cases were rendered ineligible by only one I/E criterion. The most common criteria were study-specific (prior therapies or refractory disease to a specific drug), kidney disease, and previous malignancy, followed by internal, neurologic, and infectious disease. In summary, this single-center analysis showed that I/E criteria permit study participation for most NNDM patients, with a dramatic decrease in the RRMM population. This is aggravated by the fact that the willingness for study participation also significantly declines in RRMM. Thus, addressing patient expectations and priorities seems to be the most promising approach to increasing patient enrollment in clinical trials.
RESUMEN
BACKGROUND: Skills trainings are increasing in popularity in undergraduate medical education enhancing clinical competencies and motivation for clinical practice. A suprapubic aspiration (SPA) is the gold standard to obtain urine from toddlers and young infants with fever and unclear focus to prove an urinary tract infection. METHODS: In a blended-learning scenario with virtual patients and skills lab training students were trained for a SPA. Currently, no toddler simulation manikin for SPA is available on the market so we constructed one with simple means. Students' acceptance and their view on relevant aspects of the manikin for learning effectiveness were assessed. RESULTS: With an expenditure regarding work of 3½ h and material costs of 188.12 Euro we were able to construct a paediatric manikin for suprapubic bladder punction using a cheap basic life support manikin. N = 56 students rated their learning success with the manikin as high (77.2 ± 21.6; mean and standard deviation; visual analogue scales from 100 = totally agree to 0 = don't agree at all). The model was rated as useful for training (84.2 ± 17.2) and realistic (62.1 ± 23.5). Important factors for students' learning success were (in descending order) that "urine" could be aspirated (81.4 ± 19.5), the feel of the needle inserted in the manikin (71.5 ± 23.2), and--notably less important--the outer appearance in general (40.3 ± 24.6). CONCLUSIONS: We present a construction of a paediatric manikin for suprapubic aspiration with simple means for a realistic learning scenario with high learning success.
