Duration: 30 minutes

Chair: Karen Matvienko-Sikar, PhD

Participants: Lynda Powell, PhD, Kate Guastaferro, PhD and Evan Mayo-Wilson, PhD

Moderated by Marie Johnston, PhD and Vera Araujo-Soares, PhD

View the Q&A session

Speakers have kindly provided responses to questions submitted by conference participants during the Discussion session that did not get an opportunity to be discussed.

1. Question from Kim Lavoie – Behavioral researchers have ‘RCT impatience’ – they tend to slap together an intervention package and completely gloss over conducting small POC studies – how can we get the message across? Do we need to focus on convincing researchers to do this (address researcher barriers, which might include lack of knowledge or wanting the prestige associated with big trials) OR does this reflect a systemic problem with funding, publishability, etc?

I agree. Please repeat this (loudly) when reviewing grant applications, during study sections, and when reviewing papers!

2. Question from Simon Bacon – How much should we systematically assess harms during the development phases and how should we do this and code this?

During intervention development, I would suggest that researchers look for suspected harms (e.g., those known to be associated with similar interventions), which might be done by systematically assessing AEs, and for any signals of new harms, which might be assessed non-systematically. As with potential benefits, a goal of early stage research is to determine which harms to assess and how to assess them in larger studies, so it would be sensible to conduct pilot and feasibility studies about systematic harms just like we conduct pilot and feasibility studies about potential benefits.

3. How a minimal set of outcome measures can work for RCTs in a specific disorder if it is necessary to design an RCT based on the resources we have? – that can be heterogeneous around the world.

Core outcome set development should consider the burden on researchers and participants. Core outcome sets are the minimum outcomes to assess for a health condition. Some studies with greater resources will include additional outcomes.

Guidance of development for core outcome sets outlines importance of engaging international stakeholders from a range of contexts and locations to ensure that the minimum outcome set is feasible for all RCTs. This is not always possible and/or done however. In situations where it is not possible to measure all outcomes within a core outcome set, current guidance is to measure all those possible and note those that are not feasible- this ensures increased standardisation with regard to the outcomes that can be measures, and can provide useful information in refining core outcome sets in the future.