Reporting guidelines under development for clinical trials protocols
Clinical trial protocols and SPIRIT extensions
(year of registration in brackets)
An official extension of the SPIRIT 2013 Statement defining standard protocol items for clinical trials in children is currently under development. A Delphi process to generate possible reporting standards for the guideline has taken place in Q2-3 2014. A Consensus meeting was held on 15 September 2014. The group informs that the evidence synthesis, Delphi survey and international consensus have been completed. The checklists have been finalised (available on request).
In February 2022, the group updated their website, saying that SPIRIT-C Statement and Explanation and Elaboration document will be published in Q2 2022.
- Website: http://www.sickkids.ca/Research/EnRICH/Research-Projects-and-Initiatives/SPIRIT-C/index.html
- Contact: Dr Martin Offringa, email@example.com
PLOT (Protocol Lab for Online Trials) (registered 5 December 2019)
The PLOT consortium aims to build a research reporting checklist for protocols of randomised controlled trials involving the online participation of patients and citizens. PLOT is designed as an extension of the SPIRIT reporting guideline but focussed on the reporting of patient and public involvement (PPI) in trials conducted through the internet. The checklist will apply to clinical trials and also to mixed methods study protocols.
The group has reviewed the literature on patient and public involvement in the design of clinical trials, about the engagement of citizens in clinical trials through online sources and about dissemination practices about PPI. They are also identifying uncertainties around informed consent.
An online Delphi process will be used to develop the reporting guideline to be used in writing protocols for clinical trials involving self-recruitment. This process involves a wide range of stakeholders: researchers, clinicians, patient and public representatives, guideline developers, publishers, epidemiologists, methodologists, ethicists, content experts, funders, journal editors. The PLOT research reporting guideline will be piloted with student groups, new career researchers, contributors for English as a second language, and members of the public (planned for mid-2020). The group plans to publish the PLOT reporting guideline as an open-access document in the last quarter of 2021.
There is a dissemination plan for PLOT involving a dedicated website, the inclusion in the EQUATOR database, publishing editorials, lobbying with journals, academic institutions and funders, presentations in conferences, posting in social media, and online training.
- Contact: Dr Amy Price, Stanford University School of Medicine. E-mail: firstname.lastname@example.org
The SPIRIT authors plan to update the SPIRIT 2013 Statement, which contains a 33-item checklist. The update, SPIRIT 2022, applies to the content of a clinical trial protocol, including its appendices, and provides guidance for minimum protocol content.
The SPIRIT 2022 Statement will primarily relate to the content of the protocol rather than its format, which is often subject to local regulations, traditions, or standard operating procedures. Nevertheless, adherence to certain formatting conventions will facilitate protocol review.
The intent of SPIRIT 2022 will be to promote transparency and a full description of what is planned—not to prescribe how a trial should be designed or conducted. The checklist should not be used to judge trial quality because the protocol of a poorly designed trial may address all checklist items by fully describing its inadequate design features. With an updated evidence base, the authors also plan to produce the SPIRIT 2022 Explanation and Elaboration article.
The CONSORT and SPIRIT groups have merged, and the resulting combined group will update both guidelines simultaneously. The individuals in SPIRIT-CONSORT are An-Wen Chan, Kenneth Schulz, David Moher, Asbjørn Hróbjartsson, Isabelle Boutron, and Sally Hopewell.
They started development in 2019 and are currently conducting a comprehensive literature search for evidence. As part of the development process, they will organise an international face-to-face consensus meeting. With the COVID-19 pandemic, they do not believe they can hold that meeting until late 2021. Thus, at present, they plan to publish the materials in 2022 as open access documents.
- Dr An-Wen Chan. E-mail: email@example.com
SPIRIT-DEFINE – Extension for Dose-finding Trials (registered 27 November 2020, updated May 2022)
This extension of the SPIRIT reporting guidelines focused on the reporting of clinical trials protocols will address early phase clinical trials that investigate dosage. The extension will incorporate adaptive designs and PROs (patient-reported outcomes) in any disease. The same Executive Group involved with the CONSORT extension will develop this SPIRIT extension beginning with a literature review, a Delphi survey, consensus meetings and concluding with the open-access publication of statement and explanation and elaboration documents.
- The guideline development protocol (PDF) was updated in May 2022.
- Contact: Christina Yap. Institute of Cancer Research. E-mail: firstname.lastname@example.org
SPIRIT-iNeurostim – Reporting guidelines for clinical trial protocols of implantable neurostimulation devices (registered 23 February 2021)
This project aims to develop an extension to the SPIRIT 2013 statement for clinical trial protocols for implantable neurostimulation devices. Implantable neurostimulation devices include, for example, deep brain stimulation, occipital nerve stimulation, sacral nerve stimulation and spinal cord stimulation (SCS) and can be used for the management of several clinical indications. Recent systematic reviews show that methodological and reporting deficiencies in trials of SCS were common.
The SPIRIT-iNeurostim extension will be developed through a funded staged consensus process involving a literature review for the generation of candidate items, a two-stage Delphi survey and a two-day face-to-face (or videoconference) consensus meeting. The group plans to publish the reporting guideline as an open-access document around February 2022. The Working Group is also involved in another reporting guideline under development on the same topic but focused on clinical trials reports, an extension to the CONSORT reporting guideline.
- Contact: Rui Duarte, Liverpool Reviews and Implementation Group, University of Liverpool. email@example.com
SPIRIT-ROUTINE – for protocols of trials using cohorts and routinely collected data (registered 5 May 2021)
The reporting guideline SPIRIT guides the reporting of protocols of clinical trials. This project aims to systematically develop, test and effectively disseminate an extension of SPIRIT specifically for studies conducted using cohorts and routinely collected data (RCD): the SPIRIT-ROUTINE.
The project comprises five stages:
1- project launch, steering group gathering and definition of the scope of the extension;
2 – rapid literature review including other key reporting guidelines;
3 – two-round Delphi exercise;
4 – virtual consensus meeting that will finalise the items to include in the extension;
5 – publication preparation and dissemination of the final checklist.
The group plans to publish the project protocol soon. The final publication of the reporting guideline is planned as an open-access document.
- Contact: Megan McCarthy, University College Cork. E-mail: firstname.lastname@example.org
This is an extension to the SPIRIT reporting guideline, focusing on the protocols of trials with factorial design, i.e., where participants are simultaneously randomised to more than one research question. The RAFT (Reporting Factorial Trials) group is developing, at the same time, the extensions for SPIRIT and CONSORT (the reporting guideline for randomised clinical trials). The four-stage process of development are:
- Synthesising results from a scoping review to generate an initially long list of concepts for consideration for inclusion in the CONSORT and SPIRIT extensions;
- Evaluating the concepts identified in the scoping review through an online Delphi survey with expert stakeholders to develop a shorter list of concepts;
- Hosting a consensus meeting to finalise the concepts to be included in the extension documents;
- Developing SPIRIT and CONSORT extensions items for factorial trials, including an Explanation and Elaboration document, and disseminating these documents widely.
A protocol has been prepared for this project, available as a PDF document: RAFT Study Protocol. The group plans to publish complete the project by 2023 and then publish the reporting guideline as an open-access document.
This reporting guideline, an extension of SPIRIT, will focus on the protocols of studies whose primary (or primary composite) endpoint is a surrogate endpoint. Surrogate endpoints are physical measurements made objectively that are considered valid, representative or predictors of patient-relevant outcomes, i.e., variables that reflect how patients feel, function, or survive.
A Project Management Group (PMG) and Advisory Executive Committee have been set up and started working in November 2021. The group will review the literature and conduct a Delphi study and a consensus meeting. This project, funded by UK MRC, is developed together with the development of the CONSORT-SURROGATE reporting guideline. The group plans to publish the guideline, as an open-access document, in 2023.
- Read the protocol for the development of this reporting guideline
- Read a commentary in the journal Trials
- Contact: Anthony Manyara, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow. E-mail: Anthony.Manyara@glasgow.ac.uk or email@example.com
Multicentre trials are increasingly common, but writing protocols for such studies can be challenging. This project aims to find solutions to help reduce heterogeneity between study centres and avoid excessive centre effects on treatments. This will be an extension of the SPIRIT reporting guideline for multicentre trials.
The project, funded by Health and Medical Research Fund (Hong Kong), is led by the Chinese EQUATOR Centre and includes a multidisciplinary team of clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians and editors. Using SPIRIT as a starting point, the group leading the project is reviewing the literature, and they plan to conduct a Delphi survey and a consensus meeting to agree on the final items of the checklist. They also plan a pilot study to test the applicability of the checklist.
The group plans to publish the reporting guideline as an open-access document in 2023.
SPIRIT-Nut – SPIRIT Extension for Interventional Trials of NUTritional interventions (registered 14 June 2022)
This evidence-based and consensus-driven reporting guideline is being developed for protocols of randomised controlled trials (RCTs) of nutritional interventions. Although almost all of the elements in the SPIRIT statement apply equally to the reporting protocols of RCT of nutritional interventions, some elements might need to be adapted, tailored or extended. The “Standard Protocol Items: Recommendations for Interventional Trials of NUTritional interventions” is an official SPIRIT development aiming at consolidating existing and potentially new guidance for reporting such protocols. It will provide examples of good reporting for each item in the final consolidated checklist, with explanations for each adaptation or additional item.
Interested stakeholders should contact the project team to get involved in the development and dissemination of this reporting guideline.
The project is also registered in the Open Science Framework platform and the detailed project can be found here.
- Contact: Michael Schlüssel. E-mail: firstname.lastname@example.org
RECONSIDER – Reporting extension of CONSORT and SPIRIT for Inclusion, Diversity, Ethnicity and Race (registered 18 November 2022) – Access this registration details here.
Page last updated on 19 December 2022