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Table 2 Summary of findings against 14 methodological issues for feasibility research

From: A feasibility study of a randomised controlled trial to examine the impact of the ABCDE bundle on quality of life in ICU survivors

Methodological items

Findings

Evidence

1. What factors influenced eligibility and what proportion of those approached were eligible?

Ineligibility for inclusion was mainly due to not expected to survive, having a neuromuscular illness, or having an advanced health directive or acute care plan.

30 out of 37 eligible patients (81.1%) agreed to participate in the trial.

2. Was recruitment successful?

Yes. Recruiting success was defined as 80% of eligible participants agreeing to participate and were enrolled in the study.

Review of inclusion and exclusion criteria will facilitate more timely recruitment.

81.1% of eligible participants agreed to participate and were enrolled in the study.

3. Did eligible participants consent?

Yes. There was high conversion to consent.

30 out of 37 (81.1%) eligible patients or their substitute decision maker consented to participate.

4. Were participants successfully randomised?

Yes. Randomisation procedures worked well.

Table 1 shows variation between the intervention and control group as may occur with small sample size

5. Were blinding procedures adequate?

Yes. Assessors of the FIM and PFIT-s remained blinded to participant assignment throughout the trial.

Participant treatment group information was not provided to assessors. Assessors did not work in ICU.

6. Did participants adhere to the intervention?

Yes. Successful adherence to the Intervention was defined as participants receiving at least 80% of the components of the intervention on each ventilated day.

Awakening and Breathing Coordination: A daily SAT and a SBT was provided on 105 of a total of 131 ventilated days (80.2%). Delirium monitoring and management: RASS score was completed on 100% of ventilated days, CAM–ICU was completed on 97.4% of ventilated days. Early exercise and mobility: The intervention group participated in a total of 432 exercise sessions out of a total of 479 prescribed sessions (90.2%).

7. Was the intervention acceptable to the participants?

Both participants and their families were keen for the patient to receive the intervention. Acceptability was measured by participant refusal to comply with therapy.

1 out of 47 exercise sessions (2.1%) not delivered was related to patient refusal.

8. Was it possible to calculate intervention costs and duration?

An economic evaluation was not conducted as part of this study

 

9. Were outcome assessments completed?

Reasons for non-completion of the assessment included mortality, transfer to other facilities, refusal of the assessment at hospital discharge and one patient remained an in-patient at the time of writing this report.

A total of 25 (83.3%) FIMs were performed at ICU discharge and 24 (80%) at hospital discharge.

24 patients (80%) completed the PFIT-s assessment at ICU discharge.

29 (96.7%) HRQOL assessments were completed during the initial ICU admission. 23 (76.7%) assessments were completed at 90 days post discharge.

10. Were outcomes measured those that were the most appropriate outcomes?

All outcomes were deemed appropriate and valid.

The PFIT-s has a small floor and ceiling effect that may exclude functional assessments in some ICU patients [45].

11. Was retention to the study good?

Successful retention in the study was defined by less than 10% attrition rate for those patients who had survived to the 90 days post discharge assessment.

Five (16.7%) of the 30 participants had died within 90 days following hospital discharge.

Twenty three (92.0%) of the remaining 25 participants, were successfully followed up.

Two participants were lost to follow up due to non-contactability (n = 1) and withdrawal of consent (n = 1).

12. Were the logistics of running a multi-centre trial assessed?

No. This was not assessed as this is a single-centre trial.

 

13. Did all components of the protocol work together?

The components of both the study itself and the complex intervention worked well together.

Study processes were completed and met all pre-determined criteria at the end of the study.

14. Did the feasibility/pilot study allow a sample size calculation for the main trial?

No. A sample size calculation for a future RCT was not calculated.

Our feasibility study did not provide a meaningful effect size estimate for planning a subsequent RCT. This is due to the imprecision inherent in data from small sample sizes [46].