Article type
Abstract
Background
Randomised controlled trials (RCTs), the cornerstone of evidence-based intervention recommendations, are inherently susceptible to some degree of bias. RCTs conduction may be funded by governments, non-profit organisations, industry, or may have no funding source. However, it is ethically imperative for a publicly funded RCT to have a high quality, due to the societal implication of taxpayers' resources expenditure. In this sense, it is crucial to estimate the quality of research across funding sources, to identify possible flaws in current publicly-funded research, especially in resource-limited contexts.
Objectives
To assess the risk of bias (RoB) of Chilean RCTs over time, comparing it across funding sources.
Methods
As part of a broader project, we identified all Chilean RCTs published between 2017 and 2022. We considered a RCT as Chilean if it had at least one author with a Chilean affiliation, or if it was conducted in Chilean population. Two independent reviewers evaluated a random sample, stratified by year of publication. We assessed the RoB with the Cochrane Collaboration RoB1 tool, and explored differences across funding groups (public; private; funded but unclear, not funded and not reported) over time.
Results
So far, we have analysed a random sample of 62 RCTs. 30 (48.4%) received public funding, 26 (41.9%) private funding, 6 (9.7%) received no funding, and 5 (8.1%) did not report their funding source.
A higher proportion of publicly funded RCTs had a high RoB in all domains of the tool: random sequence generation and allocation concealment (selection bias), selective reporting (reporting bias), blinding of participants and personnel (performance bias), blinding of outcome assessors (detection bias) and incomplete outcome data (attrition bias). The attached figure details the assessment for each domain.
Conclusions
Publicly-funded RCTs consistently had a higher RoB than those with private funding across all domains of the RoB1 tool. There is a need for improvement in the quality of local research, which could be achieved by developing a minimum set of quality-related requirements, especially when applying for public funding. Further inquiries will be presented at the summit.
The public and/or consumers were not involved in this study.
Randomised controlled trials (RCTs), the cornerstone of evidence-based intervention recommendations, are inherently susceptible to some degree of bias. RCTs conduction may be funded by governments, non-profit organisations, industry, or may have no funding source. However, it is ethically imperative for a publicly funded RCT to have a high quality, due to the societal implication of taxpayers' resources expenditure. In this sense, it is crucial to estimate the quality of research across funding sources, to identify possible flaws in current publicly-funded research, especially in resource-limited contexts.
Objectives
To assess the risk of bias (RoB) of Chilean RCTs over time, comparing it across funding sources.
Methods
As part of a broader project, we identified all Chilean RCTs published between 2017 and 2022. We considered a RCT as Chilean if it had at least one author with a Chilean affiliation, or if it was conducted in Chilean population. Two independent reviewers evaluated a random sample, stratified by year of publication. We assessed the RoB with the Cochrane Collaboration RoB1 tool, and explored differences across funding groups (public; private; funded but unclear, not funded and not reported) over time.
Results
So far, we have analysed a random sample of 62 RCTs. 30 (48.4%) received public funding, 26 (41.9%) private funding, 6 (9.7%) received no funding, and 5 (8.1%) did not report their funding source.
A higher proportion of publicly funded RCTs had a high RoB in all domains of the tool: random sequence generation and allocation concealment (selection bias), selective reporting (reporting bias), blinding of participants and personnel (performance bias), blinding of outcome assessors (detection bias) and incomplete outcome data (attrition bias). The attached figure details the assessment for each domain.
Conclusions
Publicly-funded RCTs consistently had a higher RoB than those with private funding across all domains of the RoB1 tool. There is a need for improvement in the quality of local research, which could be achieved by developing a minimum set of quality-related requirements, especially when applying for public funding. Further inquiries will be presented at the summit.
The public and/or consumers were not involved in this study.