Objectives:
Critically ill adults requiring artificial airways experience profound communication deficits. Studies of interventions supporting communication report disparate outcomes, creating subsequent challenges in the interpretation of their effectiveness. Therefore, we aimed to develop international consensus for a communication core outcome set (Comm-COS) for future trials of communication interventions in this population.
Design:
1) Systematic review, 2) patient/family interviews, 3) two-round modified Delphi, and 4) virtual consensus meetings with a final voting round. A multidisciplinary expert steering committee oversaw all stages.
Setting:
Interviews and consensus meetings were conducted via videoconferencing. Digital methods were used for Delphi and final Comm-COS voting.
Subjects:
Three stakeholder groups: 1) patient and family members with lived experience within 3 years, 2) clinicians with experience working in critical care, and 3) researchers publishing in the field.
Intervention:
None.
Measurements and Main Results:
We identified 59 outcomes via our systematic review, 3 unique outcomes from qualitative interviews, and 2 outcomes from our steering committee. Following item reduction, 32 outcomes were presented in Delphi round 1; 134 participants voted; 15 patient/family (11%), 91 clinicians (68%), and 28 researchers (21%). Nine additional outcomes were generated and added to round 2; 106 (81%) participants voted. Following completion of the consensus processes, the Comm-COS includes seven outcomes: 1) changes in emotions and wellbeing associated with ability to communicate, 2) physical impact of communication aid use, 3) time to functional communication, 4) ability to communicate healthcare needs (comfort/care/safety/decisions), 5) conversation agency, 6) ability to establish a communication connection to develop and maintain relationships, and 7) acceptability of the communication intervention.
Conclusions:
This is the first COS to specifically focus on communication for critically ill adults. Limitations for operationalization include selection of measures to use with these outcomes. Identification of suitable measures and adoption of the Comm-COS in future trials will help establish effective interventions to ameliorate the highly prevalent and negative experience of communicative incapacity.
Louise Rose (co-PI) King's College London
Amy Freeman-Sanderson (co-PI) University of Technology Sydney
Anna- Liisa Sutt,
Martin B. Brodsky, Johns Hopkins University
Nick Hart, Guy's and St Thomas' NHS Foundation Trust, London,
Peter Spronk, Gelre Ziehenhuis, Apeldorn
Craig Dale, University of Toronto
Kimberley Haines, Western Health (Melbourne)
Mary Beth Happ, The Ohio State University College of Nursing
Disease Category: Consumer & communication strategies
Disease Name: Artificial airways
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Device
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- Service providers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Nominal group technique (NGT)
- Systematic review
Item generation
1 Systematic Review: we will extract data on primary and secondary outcomes reported, measures used and measurement time-points from studies included in our ongoing Cochrane systematic review.
2. Interviews with key stakeholders and end users including patients and family members: we will conduct qualitative interviews with patients, family members and other relevant stakeholders as to outcomes they consider important to measure in future studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilator support.
Consensus Building
1. We will conduct a modified Delphi study to establish consensus on outcomes for inclusion in a core outcome set. We will recruit an international expert panel representing key stakeholders and end users including former patients and family members.
2. If consensus on a core outcome set is not achieved via the Delphi process, we will host a virtual consensus meeting using nominal group technique and voting to establish the core outcomes.
3. We will hold a second virtual consensus meeting using nominal group technique and voting to establish appropriate measures for the core outcomes.