Improving our understanding of factors influencing patient outcomes in pleural disease

Severn Pleural Disease Outcomes: Long Term Insights Study

Registry ID
ISRCTN17535598
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
North Bristol NHS Trust
Enrollment
1000
Start date
2023-05-02
Completion date
2029-03-01
Last update
2026-08-17

Conditions

Summary

Respiratory

Detailed description

Patients presenting with radiologically confirmed pleural disease including (but not limited to) pneumothorax, pleural effusion, pleural thickening or pleural cancer (mesothelioma) to North Bristol NHS Trust will be screened and invited to participate by a member of the study team. The team will collect data on the patient’s demographics, past medical history and history of current illness, smoking status including cannabis, asbestos and other inhalational exposures, clinical frailty score (CFS) and performance status (PS). The team will also collect data related to their condition and its management, for example, radiological and thoracic ultrasound appearances, the number and type of interventions undertaken and digital measurements of air leaks in the case of pneumothorax. For patients with pleural effusions, if blood or pleural fluid samples are collected as part of their routine care, additional research samples will also be collected for use in current or future studies. For patients who undergo a pleural biopsy procedure following enrolment, additional tissue samples may be obtained and retained for research purposes if felt appropriate by the operator. These data and sample collections are not study-specific procedures but are performed as part of the participants’ routine clinical care. At enrolment and 4- and 12-months post-enrolment, patients will be asked to complete 2 routine questionnaires to provide patient-reported outcome measures. These are study-specific, not part of the patient’s routine care. Where necessary, additional PROMS relevant to a specific sub-study the patient may be eligible for may also be collected during the baseline assessment. These will be undertaken at the initial assessment, and either remotely, or during the routine clinical review at 4 and 12 months. Further data will be collected from the patient’s medical records at 4 months and 12 months post enrolment, to encompass the patient’s length of stay, number and type of inte

Interventions

Inclusion criteria

1. Confirmed presence (radiologically) of either: 1.1. Pleural effusion/pleural thickening OR 1.2. Spontaneous primary or secondary pneumothorax 2. Patient normally lives within the catchment area of the Bristol hospitals and is unlikely to relocate within 12 months 3. Aged 16 years old and over 4. Has access to telephone and/or internet

Exclusion criteria

To be eligible to participate in the cohort, none of the following criteria should apply: 1. Previously enrolled in SPOTLight 2. Patient (or appropriate proxy) is not able to provide written informed consent 3. Patient is in the final stages of life or sufficiently frail to make study involvement inappropriate

Locations

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