Preparatory Work for a Multi-arm, Multi-stage Trial of Adjunctive Treatments in Patients Hospitalised With Heart Failure (Pre-MAMMOTH-HF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Thematic Analysis of Nominal Group Discussions on Appropriate Endpoints for a Proposed Clinical Trial
研究概览
简要总结
Aims and Objectives
- Choose which adjunctive therapies, at what dose, and for how long
- Choose the dose(s) of IV furosemide to be used as the comparator
- Choose primary and secondary outcomes
- Estimate recruitment and engage sites for a future trial
Work package 2a methods overview
- 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.
- 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.
- 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.
详细描述
Online Survey 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. The survey will also engage the clinical community and gain wider input into the acceptability of each adjunctive therapy to inform trial decision making (aims 1,2, 4).
Through the British Society for Heart Failure and its Research Network, the Royal College of Physicians, and through professional networks we will identify sites interested in participating in the survey and engaging with this research project.
We will present the trial's concept and rationale. Interested sites will then be asked to complete an online survey designed using the findings of the above reviews and hosted on the Qualtrics secure online survey platform.
We will seek input from potential trial sites (n~30) about the acceptability of each intervention (for different doses/durations), with the opportunity to provide reasons for acceptability (or lack thereof). Closed questions will assess willingness to randomise and open questions to understand reasons for or against randomisation. The survey will assess interest in participation and give a realistic estimate of the ability of a trial to recruit patients, and hence estimate the time required for any trial. Results will be analysed using descriptive statistics and qualitative content analysis.56
Ethical approval will be obtained from the University of Hull Research Ethics Committee. The questionnaire will be piloted amongst 5-10 healthcare workers who care for patients with HF and oral or written feedback provided. Once amendments have been agreed by the research team the survey will be circulated via the BSH, British Cardiovascular Society, Royal College of Physicians, and professional networks.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1. Unable to participate in online group discussions in English
结局指标
主要结局
Thematic Analysis of Nominal Group Discussions on Appropriate Endpoints for a Proposed Clinical Trial
时间窗: From enrollment to end of third online monthly meeting (enrollment to 3 months)
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
时间窗: From enrollment to end of third online monthly meeting (Enrolment to month 3)
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
次要结局
未报告次要终点