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Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

Overview of attention for article published in BMC Medical Research Methodology, February 2017
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Title
Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned
Published in
BMC Medical Research Methodology, February 2017
DOI 10.1186/s12874-017-0308-6
Pubmed ID
Authors

Belinda von Niederhäusern, Annette Orleth, Sabine Schädelin, Nawal Rawi, Martin Velkopolszky, Claudia Becherer, Pascal Benkert, Priya Satalkar, Matthias Briel, Christiane Pauli-Magnus

Abstract

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution. We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01.01.2012 and 31.12.2014. We extracted study characteristics and monitoring information from the CTU Enterprise Resource Management system and from monitoring reports of all selected studies. We summarized the data descriptively. Additionally, we conducted semi-structured interviews with the three current CTU monitors. During the observation period, a total of 214 monitoring visits were conducted in 43 studies resulting in 2961 documented monitoring findings. Our risk-based approach predominantly identified administrative (46.2%) and patient right findings (49.1%). We identified observational study design, high ADAMON risk category, industry sponsorship, the presence of an electronic database, experienced site staff, and inclusion of vulnerable study population to be factors associated with lower numbers of findings. The monitors understand the positive aspects of a risk-based approach but fear missing systematic errors due to the low frequency of visits. We show that the factors mostly increasing the risk for on-site monitoring findings are underrepresented in the current risk analysis scheme. Our risk-based on-site approach should further be complemented by centralized data checks, allowing monitors to transform their role towards partners for overall trial quality, and success.

Twitter Demographics

The data shown below were collected from the profiles of 2 tweeters who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 52 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 52 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 10 19%
Student > Master 10 19%
Other 8 15%
Student > Doctoral Student 5 10%
Student > Bachelor 4 8%
Other 8 15%
Unknown 7 13%
Readers by discipline Count As %
Medicine and Dentistry 10 19%
Pharmacology, Toxicology and Pharmaceutical Science 7 13%
Business, Management and Accounting 5 10%
Nursing and Health Professions 4 8%
Biochemistry, Genetics and Molecular Biology 2 4%
Other 10 19%
Unknown 14 27%

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 March 2017.
All research outputs
#13,850,190
of 22,958,253 outputs
Outputs from BMC Medical Research Methodology
#1,340
of 2,026 outputs
Outputs of similar age
#221,744
of 428,400 outputs
Outputs of similar age from BMC Medical Research Methodology
#24
of 35 outputs
Altmetric has tracked 22,958,253 research outputs across all sources so far. This one is in the 38th percentile – i.e., 38% of other outputs scored the same or lower than it.
So far Altmetric has tracked 2,026 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 10.2. This one is in the 32nd percentile – i.e., 32% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 428,400 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 47th percentile – i.e., 47% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 35 others from the same source and published within six weeks on either side of this one. This one is in the 28th percentile – i.e., 28% of its contemporaries scored the same or lower than it.