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Table 2 Feasibility outcomes and definitions

From: Design, analysis, and reporting of pilot studies in HIV: a systematic review and methodological study

Outcomea (n/%) Definition
Acceptance (180/72.6%) a) Participant satisfaction with the intervention and study procedures (165/91.7%)
b) Participant recruitment or enrolment rate (10/5.6%)
c) Intervention completion (16/8.9%)
d) Participant retention (11/6.1%)
e) Participant feedback (4/2.2%)
f) Intervention usability (2/1.1%)
Contamination (2/0.8%) The proportion of participants that deviated from their allocated intervention and partook in the alternative intervention
Complianceb (131/52.8%) a) Participant attendance of any intervention sessions or simply adherence to assigned intervention (27/20.1%)
b) The number of sessions attended and engagement with the intervention (110/82.1%)
Data completion (9/5%) The proportion of data expected to be collected which was not
Enrolment (106/42.7%) a) The proportion of eligible participants who consented to join the study (95/90.5%)
b) The proportion of participants which were recruited and randomized (9/8.5%)
c) The proportion of participants recruited, consented and were randomized (2/1.9%)
Feedback (90/36.3%) What participants and study staff thought of the intervention, study procedures and their time in the trial
Fidelity (37/14.9%) The ability of the trialists to adhere to study protocol
Randomization (11/4.4%) The ability to successfully randomly allocate participants to the different arms in a trial
Retention (135/54.4%) The proportion of participants which remained in the study till the primary endpoint (either end of the intervention or a set follow-up period)
Resources (16/6.5%) An evaluation of the resources required to conduct the study
Timeliness of intervention (2/0.8%) Assessment of the ability to administer the intervention in the prespecified time
Other (34/13.7%) a) Implementation—the ability to deliver the intervention to participants (17/65.38%)
b) Initiation—the proportion of eligible participants which were recruited, consented to join the study and actually began using or were administered the intervention (6/23.07%)
c) Consent rate—the proportion of eligible patients which consented to joining the study (1/3.8%)
  1. aStudies may possess several feasibility outcomes
  2. bParticipant acceptance was often defined and assessed in multiple ways in the same study