Table 3 Examples of advice given by the committee, for each of the seven main topics

1) Methodology

• “What are your selection criteria? What is your target group and when does a patient belong to this group?”

• “A possible problem might be that the excretion of urine cannot be measured properly, as patients usually do not have a catheter.”

• “Comatose patients cannot give their consent to participate. How will you inform the family or do they have to give their consent?”

2) Communication

• “Results of the study will be shared in several ways. Don’t forget the general practitioner in this, as that’s where the first signalling [of risks for disease] occurs.”

• “It’s unclear if and how patients are informed about treatment options, and if they’re offered the chance to reject the treatment”

• “It’s unclear how the research results will be shared afterwards with the patients who participated. Will they ever know in which group they were placed?”

3) Safety

• “Where will the data be stored?”

• “Description of possible risks is lacking. If there are any risks, patients should be informed about it before they decide to participate in the study”

• “The risks of undergoing several MRI scans in a short period of time is unclearly described. Also, it’s unclear to me how many MRI scans will be needed.”

4) Understandability

• “It’s a pity that the summary is in English [rather than Dutch]. It’s doable, but I had to google some abbreviations.”

• “Too much medical terminology, e.g. renal, vasodilatation, diuresis etc. [...] more empathy is needed when you ask a lay man to think along.”

5) Patients’ role

• “How are patients exactly involved? It says that they are involved, but not how.”

• “Collaboration with Harteraad is described, but it is unclear how they can influence the proposal. In other words: we can say a lot, but are you able to do something with it as well?”

6) Background

• “I miss information on the benefits of Shared Decision Making (SDM) and what currently goes wrong. [...] How many lives could be saved with SDM and how will it improve the Quality of Life of patients?”

• “I miss the expected results and benefits [of the study] for patients. Also, I miss literature and numbers on the successes for existing interventions and how integration of these existing interventions with those in this study will lead to better results.”

7) Applicability

• “What will happen when risk factors can be recognized earlier, and who is going to do something with that information? Does the general practitioner have time to use such a diagnostic system? For patients it’s only useful if it involves risk factors you can do something about yourself”

• “You assume that all Dutch hospitals will implement your findings, provided that the results of the study are positive. However, you’re not anticipating on a situation in which hospitals don’t want to follow your implementation plans.”