Abstract
Title: UK Researcher views on Blinding in Complex Intervention Randomised Controlled Trials: A Survey of UKCRC and TMRP Researchers
Background:
Blinding, the practice of concealing treatment allocation, plays a crucial role in randomized controlled trials (RCTs). However, in the context of complex interventions, its feasibility and impact on study quality have been subjects of debate. This survey aims to capture the perceptions of researchers affiliated with the UK Clinical Research Collaboration (UKCRC) and the Trial Methodology Research Partnership (TMRP) in the United Kingdom regarding blinding in complex intervention RCTs.
Methods:
This cross-sectional study employed an online survey comprising 30 questions. Utilizing a structured questionnaire, we targeted the population of UKCRC and TMRP researchers. The Likert scale was employed to assess respondents' views, ranging from "Strongly Disagree" to "Strongly Agree." In addition to quantitative responses, a free-text box allowed for qualitative input. The survey collected data from a substantial sample size of UKCRC and TMRP researchers and employed descriptive statistical analyses.
Results:
Our findings indicate a diverse spectrum of perceptions among UKCRC and TMRP researchers regarding blinding in complex intervention RCTs. While many respondents acknowledged the challenges inherent in blinding within this context, responses varied in terms of its perceived importance, influence on securing funding, and alignment with critical appraisal tools. Notably, the recent NIHR-MRC Framework (2021) emerged as a focal point in shaping attitudes toward blinding.
Conclusion:
This survey presents interesting researchers' perceptions regarding blinding in complex intervention RCTs. The results emphasise the necessity for continued dialogue within the research community to address methodological challenges and adapt guidelines to better suit the complex intervention context. A comprehensive understanding of these perceptions has the potential to enhance the quality and relevance of clinical research in this evolving field.
Aim
The aim of this study is to investigate and capture the perceptions of researchers affiliated with the UK Clinical Research Collaboration (UKCRC) and the Trial Methodology Research Partnership (TMRP) in the United Kingdom regarding the practice of blinding in the context of complex intervention Randomized Controlled Trials (RCTs). The study seeks to understand how these researchers perceive the feasibility, importance, and impact of blinding in complex intervention RCTs, as well as its alignment with guidelines and appraisal tools. Additionally, the study aims to explore how the recent NIHR-MRC Framework (2021) has influenced researchers' views on blinding in this specific context.
Intended Impact of the Study
Impact:
The impact of the dissemination activities related to this survey is multi-fold. Firstly, by presenting the preliminary findings at conferences, it allowed for constructive feedback from experts and researchers, enriching the study with diverse perspectives and insights.
Secondly, the forthcoming publication of the survey results will contribute significantly to the existing body of knowledge in the field of complex intervention Randomized Controlled Trials (RCTs). This dissemination will ensure that the research outcomes are accessible to a wider academic community, enabling other researchers to benefit from the insights and potentially leading to advancements in the methodology of complex intervention RCTs.
Furthermore, the survey results will be shared with members of the UK Clinical Research Collaboration (UKCRC) and the Trial Methodology Research Partnership (TMRP), which includes professionals actively involved in complex intervention research. By sharing the findings with this specific audience, it has the potential to inform their research practices and influence discussions surrounding blinding in complex intervention RCTs, ultimately contributing to more robust and methodologically sound research in this area.
In summary, the dissemination activities and the anticipated impact of this survey are essential steps in ensuring that the research contributes to the academic community's knowledge base and positively influences research practices in the field of complex intervention RCTs
Project Lead
Project Collaborators
Fiona C Warren Institute of Health Research, College of Medicine and Health, University of Exeter, Exeter, UK
Rod Taylor Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
Contact Project Author
Keywords
Research Area(s)
Other Areas: Clinical Trial Methodology, Clinical Research Methodology and Practice"
Study Design(s)
Other Designs: A cross-sectional, web-based survey was conducted using Microsoft Form in the year 2020
Data Collection Method(s)
Participant(s)
Other Participants: The population for this survey consists of researchers affiliated with the UK Clinical Research Collaboration (UKCRC) and Trial Methodology Research Partnership (TMRP) in the United Kingdom. These individuals were selected as they possess expertise in the field of complex intervention Randomized Controlled Trials (RCTs) and are actively involved in research related to these trials.
Status
Stage
Study Funding/Support
Dissemination Activity/Activities
Other(s): Dissemination Activities: The survey conducted as part of my PhD research project has been actively disseminated through various channels. Initially, the research findings were presented at two prestigious conferences: the International Clinical Trials Methodology Conference (ICTMC) in 2022 in Harrogate, where it was presented as a poster, and the Research Meeting at the University of Exeter, Falmouth, UK, in June 2023. These conferences provided an excellent platform to share the preliminary results and engage with fellow researchers and experts in the field of clinical trials and complex interventions. Additionally, the survey results are currently being prepared for publication. The publication process is underway, which involves a rigorous peer-review procedure to ensure the quality and academic rigor of the research. This publication will further contribute to disseminating the survey findings to a broader academic audience.