SPIRIT|CONSORT-SURROGATE summary
How might we improve the research methods we use to measure certain outcomes in health research?
This question lies at the core of this study. It is being carried out by a team of people who are interested in trial methodology and involves patients and the public.
The study is intended to improve the guidance that is offered when substitutes (surrogate) outcomes (endpoints) are used.
We are also keen to explore the way in which Patient and Public Involvement (PPI) can be effective with trial methodology and of mutual value.
Randomised controlled trials (RCTs) are studies that randomly assign a number of similar people to two or more groups to test the benefits of an intervention, drug or treatment. Although these studies provide the most reliable scientific evidence for practice and decision making, they are cost and time consuming. To make them more time and cost efficient, trials sometimes use surrogate endpoints so it is the public’s interest that we get this right.
Surrogate endpoints are measurements of a specific outcome that are used in RCTs in place of the real outcome (often referred to as patient relevant outcome or clinical endpoint). For example, blood pressure is used as a surrogate endpoint for cardiovascular events such as stroke and heart attacks.
Despite their benefits in reducing trial time and cost, there are risks associated with surrogate endpoints. For instance, they may be poor substitutes of real outcomes by failing to predict the true health benefits of interventions. This may lead to approval of interventions which have no benefit or are harmful. To avoid such occurrences, it is important to develop guidelines (checklist of items) which scientists can use to transparently and consistently report findings of trials that use surrogate endpoints. This is where we believe Patient and Public Involvement can make a difference in terms of relevance, appropriacy and grounding the work in reality of patient experience.
There are two common guidelines used in reporting of trials: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) a checklist used to report trial protocols (detailed plan of the trial); and CONSORT (Consolidated Standards of Reporting Trials) a checklist used to report completed trials. This project aims to develop extensions to these guidelines (SPIRIT-SURROGATE and CONSORT-SURROGATE), that is, modify items or add new items in the original SPIRIT and CONSORT guidelines to enable better reporting of trial protocols and reports that use surrogate endpoints.
To develop these extensions, published guidance on developing health research reporting guidelines will be followed. Based on this guidance, the project will have four phases as shown in the roadmap below:
- Phase 1 (Literature reviews) to identify items to be included in extensions and participants for a Delphi study;
- Phase 2 (Delphi study) to rate the items identified in Phase 1;
- Phase 3 (Consensus meeting) to agree on final items for inclusion in extensions; and
- Phase 4 (Knowledge translation) to share knowledge from the project such as through publications, presentations, video tutorials, and social media posts.
