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 | Â |
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. | Â |
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]. |