Aims and Objectives
1. Choose which adjunctive therapies, at what dose, and for how long 2. Choose the dose(s) of IV furosemide to be used as the comparator 3. Choose primary and secondary outcomes 4. Estimate recruitment and engage sites for a future trial
Work package 2a methods overview
1. An online survey of clinicians (doctors, nurses and pharmacists) assessing potential ability to recruit and the acceptability of each adjunct and willingness to support a trial. 2. Evidence generated (survey and reviews) will be considered by an expert panel (N=20-25) including expert clinicians and allied health professionals who care for people with HF using a modified Delphi approach. The panel will make recommendations on all aspects of the trial design. 3. A patient and carer panel of people with a recent hospitalisation (\<6 months) for HF will provide recommendations on trial endpoints. The patient-and-carer advisory group (PCAG) will also input into these discussions.
Recent hospitalisation with heart failure (<6 months) or carer for a person with a recent hospitalisation with heart failure.
Able to participate in online group discussions in English
None
See inclusion / exclusions
Other
Prospective
Patient and carer panel using nominal group approach and thematic analysis
Other interventionPatient and carer panel using nominal group approach and thematic analysis
Thematic Analysis of Nominal Group Discussions on Appropriate Endpoints for a Proposed Clinical Trial
This qualitative study will use a nominal group technique to gather input from key stakeholders-including clinicians, researchers, and patient representatives-on appropriate endpoints for a proposed clinical trial. Participants will engage in structured group discussions guided by a topic guide with open-ended questions designed to prompt reflection on what makes an outcome meaningful, measurable, and feasible. Discussions will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. This process will involve inductive coding of the transcripts to identify recurring themes related to clinical relevance, patient-centeredness, feasibility, and scientific validity. After the discussions, participants will individually rank their preferred endpoints, supporting a structured consensus-building process. The combination of qualitative insights and ranked preferences will help prioritize outcomes that are both methodologically sound and aligned with stakeholder values.
Thematic Analysis of Nominal Group Discussions on which adjunctive therapies, at what dose, and for how long
This qualitative outcome measure will be based on structured discussions using the nominal group technique to identify stakeholder perspectives on which adjunctive therapies should be used alongside the main intervention in a proposed clinical trial, including appropriate types, doses, and treatment durations. Participants-including clinicians, researchers, and patient representatives-will take part in guided sessions using a topic guide with open-ended questions. The discussions will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis, which involves coding the data to identify key patterns and shared views. Themes will be developed around what therapies are considered beneficial, how dosing decisions should be made (e.g., based on weight, age, or clinical response), and what duration balances effectiveness with safety and feasibility. Participants will also rank their preferences after the discussion, enabling a consensus-driven prioritization of adjunctiv
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Hull University Teaching Hospitals NHS Trust
Lead sponsor
Hull York Medical School
Collaborator
University of Birmingham
Collaborator
Robertson Centre for Biostatistics University of Glasgow Glasgow G12 8QQ
Collaborator
