Enhancing the transparency and reporting of randomised trials: update of the SPIRIT 2013 and CONSORT 2010 Statements

Randomised trials provide the best evidence of the effectiveness (and harms) of health care interventions and are a crucially important part of evidence-based health care. If randomised trials are not well reported it is difficult for clinicians and policymakers to use best evidence to inform best practice. Similarly, patients using the reports of randomised trials to help inform their decision making rely on complete and transparent reporting.

The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed in 1996 to try to improve the reporting of randomised trials. In the form of a checklist and flow diagram, CONSORT offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. Originally published in 1996, the CONSORT Statement was updated in 2001 and then in 2010. Similar problems related to lack of clear and transparent reporting of trial protocols led to development of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement in 2013. Extensions to SPIRIT and CONSORT have been also developed to tackle the methodological issues associated with reporting different types of trial designs, data and reporting different types of interventions.

There is now a large and increasing body of evidence that SPIRIT and CONSORT have had a beneficial impact on the quality of published articles. CONSORT and SPIRIT are used and endorsed of by hundreds of medical journals and organisations worldwide. The CONSORT website is viewed nearly a quarter of a million times, annually. It is important that SPIRIT and CONSORT are kept up to date to reflect new evidence and changing opinion. It has been more than 10 years since CONSORT was updated and 8 years since publication of SPIRIT. In addition, a number of extensions to SPIRIT and CONSORT have been developed for specific types of randomised trials. The aim of this research study is to update the SPIRIT 2013 and CONSORT 2010 Statements, including integration of key extensions, and to develop web-based resources to promote their adherence. We will use established methods for development of health research reporting guidelines.

First, we will conduct a scoping review of the literature to identify new evidence and guidance of relevance to the reporting of protocols and results of randomised trials. Second, we will conduct an online Delphi survey to decide: (1) changes to existing SPIRIT-CONSORT checklist items; (2) adding of new checklist items (identified from the scoping review or suggested by the Delphi survey participants). Survey participants will include experienced clinical trial researchers, knowledge users and representatives from funding bodies, ethics committees, medical journals, regulatory agencies and patient and public involvement groups. Third, we will organise a meeting of a broad range of stakeholders (represented in the survey) to establish consensus on items to be included in the updated SPIRIT and CONSORT checklists. Finally, we will develop and publish the updated SPIRIT and CONSORT guidance Statements and accompanying Explanation and Elaboration documents, which explain and illustrate the principles underlying the updated Statements.

We will also create a new joint SPIRIT-CONSORT website and add new resources. We will produce an online training course aimed at researchers, journal editors and peer reviewers explaining the main changes to the SPIRIT and CONSORT guidance and now it should be used. We will also create a separate new portal to the SPIRIT-CONSORT website specifically aimed at patients and the public explaining the importance of clear and transparent reporting of randomised trials and their importance in the delivery of evidence based healthcare.

Well-designed and properly executed randomised trials provide the most reliable evidence on the efficacy of healthcare interventions; however, there is overwhelming evidence that the quality of trial reporting is not always optimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (CONsolidated Standards Of Reporting Trials) Statements are widely adopted standards for reporting protocols and results of randomised trials. They provide authors with a standard reporting structure, facilitating completeness and transparency, and aiding in their critical appraisal and interpretation and are endorsed of by hundreds of medical journals and organisations worldwide. It is important SPIRIT and CONSORT are kept up-to-date and relevant to the end user(s); reflecting new evidence and emerging perspectives. It has been over 10 years since CONSORT was last updated in 2010 and 8 since publication of SPIRIT in 2013.

The aim of this study is to enhance the transparency and reporting of randomised trials by updating the SPIRIT 2013 and CONSORT 2010 Statements, including integration of key extensions, and through development of implementation strategies to promote adherence. We will use established methods for development of health research reporting guidelines. We will: (1) conduct a scoping review of the literature; (2) conduct a Delphi survey to identify changes to existing SPIRIT and CONSORT checklist items and adding of new items; (3) organise a meeting of key stakeholders to establish consensus on items included in the updated SPIRIT and CONSORT checklists; (4) develop the SPIRIT and CONSORT guidance Statements and accompanying Explanation and Elaboration documents; (5) disseminate and implement the updated SPIRIT and CONSORT Statements, including a new joint SPIRIT-CONSORT website, online training modules and new patient-facing trial portal.