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View article: Nonregistration, Discontinuation, and Nonpublication of Randomized Trials
Nonregistration, Discontinuation, and Nonpublication of Randomized Trials Open
Importance Previous work found that 25% to 30% of randomized clinical trials (RCTs) with protocols approved in 2012 or between 2000 and 2003 were discontinued prematurely, most commonly due to inadequate participant recruitment. To minimiz…
View article: Public availability of randomized clinical trial protocols: a repeated meta-research study
Public availability of randomized clinical trial protocols: a repeated meta-research study Open
The availability of protocols increased in RCTs approved in 2016 compared to RCTs from 2012. This was mainly driven by industry sponsored trials. Efforts to further improve protocol availability should be continued, especially in nonindust…
View article: Metaresearch on patient-reported outcomes in trial protocols and results publications suggested large outcome reporting bias
Metaresearch on patient-reported outcomes in trial protocols and results publications suggested large outcome reporting bias Open
Less than half of RCT protocols with planned PROs reported them as specified in corresponding published results, suggesting outcome reporting bias, and PRO reporting quality was often deficient. These limitations complicate informed decisi…
View article: A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study Open
View article: A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols
A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols Open
RCT protocols should be made available at an early stage of the trial.
View article: Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)
Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE) Open
Objectives Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Int…
View article: Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis
Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis Open
Background We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade la…
View article: Reliability of Trial Information Across Registries for Trials With Multiple Registrations
Reliability of Trial Information Across Registries for Trials With Multiple Registrations Open
In this systematic review, for a substantial proportion of registered RCTs, information about key trial characteristics was inconsistent across trial registries, raising concerns about the reliability of the information provided in these r…
View article: Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials
Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials Open
This cross-sectional study compares randomized clinical trial protocols to assess the prevalence and reporting quality of planned subgroup analyses over time.
View article: Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study
Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study Open
View article: Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects Open
View article: Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation
Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation Open
Based on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information am…
View article: Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE)
Academic response to improving value and reducing waste: A comprehensive framework for INcreasing QUality In patient-oriented academic clinical REsearch (INQUIRE) Open
We present a framework based on a consensus of different stakeholder groups guiding the practical assessment of clinical research quality at all stages of a research project. Operationalization of this common structure will support the inc…
View article: The impact of clinical trial units on the value of clinical research in Switzerland
The impact of clinical trial units on the value of clinical research in Switzerland Open
A prominent 2014 series by The Lancet on “Increasing value, reducing waste in biomedical research” provided recommendations on how to optimise precious resources, including in clinical research. Despite being ideally placed to lead the mov…
View article: De novo fatty acid synthesis by Schwann cells is essential for peripheral nervous system myelination
De novo fatty acid synthesis by Schwann cells is essential for peripheral nervous system myelination Open
Myelination calls for a remarkable surge in cell metabolism to facilitate lipid and membrane production. Endogenous fatty acid (FA) synthesis represents a potentially critical process in myelinating glia. Using genetically modified mice, w…
View article: Funding characteristics of randomised clinical trials supported by the Swiss National Science Foundation: a retrospective cohort study
Funding characteristics of randomised clinical trials supported by the Swiss National Science Foundation: a retrospective cohort study Open
A third of the total SNSF grant sum spent on healthcare RCTs between 1986 and 2015 did not result in peer-reviewed scientific publications. New SNSF grant schemes might improve publication outcomes but their effectiveness needs to be evalu…
View article: How to Conceptualize and Implement a PhD Program in Health Sciences—The Basel Approach
How to Conceptualize and Implement a PhD Program in Health Sciences—The Basel Approach Open
Objectives: Over the past decade, several excellent guidelines have been published on how to enhance the quality of PhD education in Europe. Aimed primarily at preparing students for innovative roles in their fields, they include variously…
View article: Validity of mobile electronic data capture in clinical studies: a pilot study in a pediatric population
Validity of mobile electronic data capture in clinical studies: a pilot study in a pediatric population Open
View article: Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality
Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality Open
Clinical research quality is often discussed but rarely defined. A framework defining clinical research quality across stakeholders' individual perspectives is desirable to facilitate discussion, assessment, and improvement of quality at a…
View article: Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study
Discontinuation and non-publication of randomised clinical trials supported by the main public funding body in Switzerland: a retrospective cohort study Open
Objective The Swiss National Science Foundation (SNSF) promotes academic excellence through competitive selection of study proposals and rigorous evaluation of feasibility, but completion status and publication history of SNSF-supported ra…
View article: The quality of clinical research is often discussed but rarely defined – a systematic survey and proposal for a comprehensive framework of clinical research quality
The quality of clinical research is often discussed but rarely defined – a systematic survey and proposal for a comprehensive framework of clinical research quality Open
Background: While the quality of clinical research is often criticized, there is no underlying consensus on a definition of the term “quality” yet. Objectives: (1) To systematically survey definitions of quality in clinical research; and (…
View article: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned
Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned Open
View article: Improving value of clinical research - an evidence-based approach
Improving value of clinical research - an evidence-based approach Open
Evidence suggests that 85% of biomedical research spending, i.e. 200 billion US dollars every year, goes to waste. In 2014, The Lancet published a series of five reviews showing how dividends from the investment in research might be increa…