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. 2019 Mar 29;21(3):e12374. doi: 10.2196/12374

Table 1.

Summary of progression criteria.

Progression criteriaa Measures used Assessment of whether criteria have been met
PC1. Feasibility to recruit a sufficient proportion of new NERS patients to participate in the trial, with appropriate retention to 12-month follow-up (T2) Percentage of eligible patients recruited; Percentage of participants retained at T2; Regression models used to identify predictors of loss to follow-up If >20% of new patients recruited=proceed (green); if <5%=full-scale trial unlikely to be feasible (red). If 5%-20% (amber) of the trial steering committee (TSC) will consider the feasibility of proceeding to a full-scale trial bearing in mind the data presented, representativeness of the sample, and possible steps to increase recruitment; If >80% retained at T2=proceed (green), if <60%=full-scale trial unlikely to be feasible (red). If 60%-80% (amber) of the TSC will consider the feasibility of proceeding based on available data and possible steps to increase retention
PC2a. Trial methodology delivered as intended PC2b. Intervention delivered as intended Summary statistics for intervention fidelity measures overall and by area; Compliance with study invite processes; Compliance with randomization processes The TSC will consider the data presented and make a judgement about whether the intervention and trial methodology were delivered as intended
PC3. At least 1 of the 2 intervention components is acceptable to participants Percentages of participants reporting acceptability of intervention components on self-report questions; Issues regarding acceptability of the intervention components explored in qualitative interviews The TSC will consider the quantitative and qualitative data and make an overall judgement on whether the intervention is acceptable
PC4. Recruitment and randomization processes acceptable to >50% of recruited participants Percentages of participants reporting acceptability of recruitment and randomization processes on patient questionnaires; Exploration of understanding and acceptability of recruitment and randomization processes in qualitative interviews >50% of recruited participants report agree or strongly agree about the acceptability of recruitment and randomization processes; The TSC will apply discretion in judging whether this criterion has been met or could be addressed to improve acceptability in a full-scale trial
PC5. <20% of control group exposed to the intervention components Percentage of participants in intervention and control groups who report that they were provided with an MWKb device or accessed the MWC Web platform <20% of control participants report they have used an MWK device during the study period; <20% of control participants report that they have accessed MWC during study period

aPC: progression criteria.

bMWK: MyWellnessKey.