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Table 3 Numerical aspects selected to be discussed at the priority setting meeting (stage 2)

From: Patient and public involvement in numerical aspects of trials (PoINT): exploring patient and public partners experiences and identifying stakeholder priorities

Aspects Meaning
Target differences (clinically meaningful difference, non-inferiority margins) This is the difference that will make researchers and clinicians conclude a treatment is better or good enough compared with a control
Risk/benefit trade-off In a clinical trial, we usually test to find out whether a treatment gives more benefit than another. However, there could be risks or burdens to the patient there are different depending on the treatment.
Expected contamination People in the control group unintentionally take the treatment or people in the treatment group unintentionally do not.
Clinical equipoise A state of uncertainty in terms of what treatment option is best.
Randomisation allocation ratio Ratio in which patients are allocated to receive a treatment compared with a control. It is usually done on a 1:1 basis which means the same number of people will get randomised to the treatment and the control.
Discussions about representativeness of sample Discussion about the characteristics of people included in research studies and whether they are representative of the population of interest
Recruitment and retention projections Recruitment is the process through which an individual is recruited as a study participant. Participant retention is the engagement of the participant in the research study.
Stop/go criteria Often trials include specific criteria to decide on whether they should move forward, i.e. collect all data as planned or stop due to unfeasibility of recruitment, treatment delivery or due to treatment harm.
Data monitoring committee data discussions A committee that may be established by the trial sponsor to assess at intervals, the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. (INVOLVE; webpage consulted in 09/11/2020)
Missing data When a participant outcome is unavailable, due to a missing questionnaire or non-attendance to a trial related clinical appointment
Cost-effectiveness (value for money) Economic analysis that views effects in terms of overall health specific to the problem, and describes the costs for some additional health gain (e.g. cost per additional stroke prevented).
Interpretation of trial results and their dissemination Discussion about trial results (presented as numbers, for example, treatment effects) and how to present them to patients and the public