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Table 3 Variables to assess the feasibility of the intervention and the research methods

From: Feasibility of a tapering opioids prescription program for trauma patients at high risk of chronic consumption (TOPP-trauma): protocol for a pilot randomized controlled trial

Variables

Indicators

Intervention feasibility

 1- The possibility to deliver the intervention as planned

 2- Participants adhering to the intervention

- Provision of ≥80% of planned components of each in-presence session and of the overall intervention [59].

- Session duration (sessions 1 to 6: 15 min).

- Challenges faced during session delivery.

- Attendance to ≥80% of sessions by participants [59].

- Involvement in intervention activities and implementation of recommended self-management ≥80% behaviors by participants [59].

Research methods feasibility

 1- Adequacy of the sampling pool and recruitment time

 2- Ease of screening

 3- The possibility of applying randomization procedures as planned

 4- Attrition rate in experimental and control groups

 5- Ease of data collection procedures

- Obtaining consent from ≥80% of patients approached to participate in the study.

- Percentage of eligible patients who were included in the study.

- Patient’s reasons for refusal to participate in the study.

- Difficulties in obtaining patients’ consent.

- Recruiting study sample (i.e., 50 participants) in ≤9 months [31].

- The time required to screen participants relative to recruitment.

- The time required to obtain consent and baseline data relative to recruitment.

- Eligibility criteria not limiting the pool of participants by ≥50% [32].

- Reasons for ineligibility.

- Difficulties when applying the randomization procedures.

- Patient acceptance to randomization, either to the treatment or control group ≥80% of the time [32].

- Attrition rate in experimental and control groups, i.e., ≤ 20% [60].

- Percentage of questionnaires completed in full.

- Pattern and rates of non-answered questions at each time measure.

- Mean time required to complete the outcome questionnaires.

- Mean time period between expected dates for questionnaire completion and actual completion.

- Recall rates (telephone calls or emails) for questionnaire completion.