Recommendation | Rationale |
---|---|
Future interventional trial | |
Evidence Focus on NMES interventions delivered in the ICU or physical rehabilitation interventions delivered after ICU discharge | The current evidence for these specific areas is currently low and/or insufficient. Focusing on these topics would address gaps in the existing evidence base |
Population Define target population to benefit from interventions | Stratification of patient cohorts that would benefit from rehabilitation interventions would streamline the rehabilitation pathway, greater efficiency of resource utilisation and cost-effectiveness as well as delivering personalised care |
Intervention Full and accurate reporting of intervention detail using Template for Intervention Description and Replication checklist and guide44 | Increase transparency of intervention delivered within the trial, improve reporting of interventions in a systematic and structured manner, enhance interpretation of findings |
Comparison Accurate and detailed description of usual care or the comparative intervention arm should be documented | Facilitate understanding of the clinical context in which the intervention was trialled, and assist in interpretation of findings and determining generalisability |
Outcomes When available, use one or more relevant COS, for example, Connolly et al.45 In addition, ensure inclusion of a patient-reported outcome, long-term outcomes to fully evaluate effect of physical rehabilitation interventions and report adverse events or harms associated with the intervention | COS facilitate greater comparison across studies, pooling of datasets for meta-analyses and clinical applicability of results. Patient-reported outcomes were not evident from the current overview, and long-term follow-up was limited. Adverse event rates are valuable for considering clinical efficacy of an intervention even if statistically significant differences are observed |
Timepoint Up-to-date literature search to underpin research question; further updated at the time of trial publication | Ensure trial findings are reported in context of most current existing data |
Publication of a priori trial protocol developed in line with Standard Protocol Items: Recommendations for Interventional Trials guidance | Enhances credibility of final publication of trial findings by supplementing clinical trial registration; streamlines final publication text; comprehensive reporting of key trial components facilitates transparency |
Include a process evaluation framework into trial design of complex interventions46 | To distinguish true intervention effect from factors related to delivery of intervention and trial conduct; explain contextual influences and provide insight into wider implementation |
COS, core outcome sets; ICU, intensive care unit; NMES, neuromuscular electrical stimulation.