This article discusses the arguments for using the Consolidated Standards of Reporting Trials (CONSORT) procedures in political science field experiments, with the aim of improving the clarity and transparency of research work and reducing the possibility of bias. The article reviews the background to CONSORT, which is increasingly required for carrying out and reporting trials in healthcare and other disciplines. It sets out the main elements of the scheme and then applies its criteria to evaluate a published Get Out the Vote (GOTV) study by John and Brannan (2008). The CONSORT checklist shows the methods in this article to be clear and transparent but that CONSORT could improve the reporting of turnout experiments, such as details of the numbers going through the trial at each stage. The article argues that applying CONSORT to reports of trials in political science journals is a feasible and desirable objective.
Objective To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results.
OBJECTIVE: To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. DESIGN: Qualitative interview study. PARTICIPANTS: Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed. SETTING: Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest. RESULTS: The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage. CONCLUSION: This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers' understanding of what conflicts of interest are and when they should be reported.
In: Østengaard , L , Lundh , A , Tjørnhøj-Thomsen , T , Abdi , S , Gelle , M H A , Stewart , L A , Boutron , I & Hróbjartsson , A 2020 , ' Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study ' , B M J , vol. 371 , m3764 . https://doi.org/10.1136/bmj.m3764
Objective: To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. Design: Qualitative interview study. Participants: Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed. Setting: Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest. Results: The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage. Conclusion: This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers' understanding of what conflicts of interest are and when they should be reported.
AbstractIntroductionAn important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating reporting guidelines, it may be helpful to construct a supportive topic‐specific bibliographic database.MethodsIn support of updating the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the CONsolidated Standards Of Reporting Trials (CONSORT) 2010, we developed the SPIRIT‐CONSORT Evidence Bibliographic database (SCEBdb): a freely available topic‐specific bibliographic database of publications providing an evidence foundation for the updates. We searched multiple sources of potential publications and tagged included ones with database‐specific keywords. For context, we also formulated 10 core considerations for constructing topic‐specific bibliographic databases and identified and described 5 illustrative other databases.ResultsAs of April 2024, the SCEBdb included 846 publications. The database proved useful as a supplementary information source for our scoping review of published comments on SPIRIT 2013 and CONSORT 2010, for a supplementary Delphi process, and in the writing phase of the guidance documents. We expect that the database will be useful for future projects within the fields of clinical research methodology, bias, evidence synthesis, and randomized trials.ConclusionThe methods involved in constructing the SCEBdb, and our suggested core considerations for topic‐specific bibliographic databases, could be helpful for researchers reflecting on whether, and how, to develop a topic‐specific bibliographic database.