Diaphragmatic dysfunction is an umbrella term for several positional and movement pathologies of the diaphragm, which may be unilateral or bilateral, transient or permanent. The underlying cause is often unclear, although multiple aetiologies are known. Diaphragmatic dysfunction is likely grossly underdiagnosed and may often be asymptomatic. Some patients, particularly those with comorbid cardiovascular conditions and/or obesity, suffer severe symptoms and resultant functional limitation - including an inability to exercise, lie flat, bend or swim.
Symptomatic patients are often offered surgical management for their diaphragmatic dysfunction. Surgery almost always takes the form of ‘plication’ (the conventional, established approach, in which there is much surgical variation), but newer approaches include nerve reconstructive surgery and pacing. There are no direct pharmacological options (although there may be a role in targeting an underlying or contributing cause); however, ‘conservative’ management, including weight loss and exercise, may be of benefit.
There is deep uncertainty as to the optimal treatment options, combinations and timings. The current evidence base is limited, and further compounded by significant heterogeneity in outcome measurement and reporting. This raises concerns about the degree to which they are all meaningful to the key stakeholders, risk outcome reporting bias, and is problematic for the synthesis of data for systematic reviews and meta-analyses. The results of clinical studies must be documented and reported in a consistent, replicable and comparable manner. This improves interpretability and reduces research waste, whilst facilitating timely change to clinical practice
Primary researcher:
Mr Swapnil Sahoo, 5th Year Intercalating Medical Student (Medical Research MSc)
Affiliations:
University of Leicester, UK
Principal Investigator and Supervisor:
Mr Edward J Caruana, Consultant Thoracic Surgeon
Affiliations:
Department of Thoracic Surgery, Glenfield Hospital, Leicester, UK
Institute for Lung Health, NIHR Leicester Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester, UK
Disease Category: Lungs & airways
Disease Name: Diaphragm dysfunction
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Systematic review
Stage 1: A systematic review of the existing literature will be undertaken to identify outcomes currently reported in studies of diaphragmatic dysfunction. This will include a variety of study types to establish the range and variability of outcome measures used.
Stage 2: Qualitative focus groups will be conducted with patients, carers and clinicians to explore outcomes that matter most. These will be facilitated with support from dedicated Patient and Public Involvement (PPI) researchers.
Stage 3: Outcomes identified from Stages 1 and 2 will be collated into a comprehensive list and prioritised through an electronic Delphi survey involving key stakeholder groups, including patients, carers, clinicians, and researchers. Participants will be asked to rate the importance of each outcome using predefined consensus criteria.
Stage 4: A final consensus meeting involving representatives from all stakeholder groups will be convened to review the Delphi results and agree on the final core outcome set for diaphragmatic dysfunction.