Title: “CONservative versus Standard carE for primary spontaneous PneumoThorax” (CONSEPT)
Funder: Department of Health and Social Care

Abstract: Aim_x000D_ We aim to understand whether treating people with a lung collapse (pneumothorax) without inserting a needle into the chest is safe and effective._x000D_ _x000D_ Background_x000D_ Primary spontaneous pneumothorax (PSP) is an abnormal collection of air in the space between the lung and the chest wall, causing collapse of the lung. This type of pneumothorax is called primary, as it happens in patients with no underlying lung disease, and spontaneous, as it occurs without injury. Previous work by our group shows that 3,000 patients/year need admission to hospital. Currently, patients with symptoms are treated by draining the air through a needle or tube put into the chest, as it is thought to reduce symptoms of pain and breathlessness and speed recovery. This treatment means patients often stay in hospital for 1 week and puts patients at risk of complications from treatment (for example, infection)._x000D_ Patients whose lung has only partially collapsed (small PSP) or who have fewer symptoms can be managed “conservatively”, this means not draining the air, and being observed instead. However, it is not clear whether it is safe to do this in patients with symptoms and a larger collapse (large PSP). Research published in 2020 from Australasia compared usual care (drainage) to conservative treatment in patients with large symptomatic PSP. However, there were problems with this research and although these results are promising, they have not changed how doctors treat patients. We will therefore conduct a study to investigate whether conservative care in symptomatic PSP is safe and effective using outcomes that are important to patients, such as the need for invasive treatments and length of hospital stay. _x000D_ _x000D_ Design and methods_x000D_ We will study 638 patients with PSP who are admitted to hospital. Patients will be put into one of two groups by chance. The first group will not have a needle or drain but will be monitored for a few hours, and if comfortable and stable, discharged from hospital. The second group will be treated in the usual way (by evacuating air with a needle or drain). We will collect information to see if patients need to have subsequent invasive treatment in the first month after the pneumothorax, and measure symptoms and general health. We will also monitor how often the pneumothorax recurs over a year._x000D_ _x000D_ Patient and public involvement_x000D_ We conducted a survey of sixteen patients to find out what was most important to them, and this feedback informed the design of the trial. The survey showed that patients wanted a treatment that reduced the number of procedures and risk of future recurrence. A patient is a co-applicant on this application and will represent the patient group and provide patient input throughout the trial. _x000D_ _x000D_ Dissemination_x000D_ If we find that treating lung collapse without drainage is safe, effective and acceptable to patients, this will lead to changes in patient care by reducing the need for invasive treatment. Results will be written up in scientific journals, presented at conferences and we will publicise using mainstream and social media channels to let doctors know the findings. Our patient groups will help us decide the best ways to let patients know about the results. These will include newsletters, social and traditional media, a YouTube video, and through charities. Throughout the trial the research team and patient group will work together to identify and engage key stakeholders and patient advocacy groups.

Lay abstract: Research Question _x000D_ Is initial conservative care of large symptomatic primary spontaneous pneumothorax (PSP) superior to initial usual invasive care in reducing risk of requiring a subsequent pleural intervention? _x000D_ _x000D_ Background _x000D_ Primary spontaneous Pneumothorax (PSP) typically affects young people, causing 3,000 admissions/year in the UK. Contemporary guidelines focus on treating a PSP either with short-term drainage (needle aspiration) or if this fails, with insertion of an intercostal chest drain (ICD), which typically requires admission. We have also shown that ambulatory treatment with a pleural vent is an effective treatment. _x000D_ There is evidence that not using an invasive pleural procedure may be a valid strategy. A recent Australasian trial compared conservative care to ICD insertion. The trial found that conservative care is effective in improving radiological outcomes and may reduce recurrence rates. Despite this evidence, optimal initial treatment remains contentious and conservative care is not routine within the NHS._x000D_ _x000D_ Aims and objectives _x000D_ Aim: To evaluate whether conservative care for large symptomatic PSPs is superior to usual care._x000D_ Objectives: _x000D_ a) To test whether conservative care is superior to usual care with respect to the need for a subsequent pleural procedure over the first 30 days._x000D_ b) To estimate the difference between groups with respect to a range of patient-reported and clinical secondary outcomes over the first 30 days._x000D_ c) To estimate the difference in recurrence rates between groups over 12 months follow-up._x000D_ d) To estimate the cost-effectiveness of conservative care compared to usual care._x000D_ _x000D_ Methods_x000D_ A multicentre, parallel, individually randomised controlled superiority trial in 35 hospitals in England, Scotland and Wales. 638 adult patients with PSP of sufficient size and symptoms causing the treating physician to consider intervention will be randomised between conservative care (intervention) or usual care (comparator). Usual care will consist of either needle aspiration, ICD or pleural vent. The primary outcome is any pleural procedure administered at any time after randomisation and after completion of initial care up to 30 days after randomisation (ICD insertion, needle aspiration, pleural vent, video-assisted thoracoscopy for persistent air-leak). Secondary outcomes are length of hospitalisation, pain and breathlessness scores, patient-related health status, radiological resolution, overall number of pleural procedures, PSP recurrence, acceptability, healthcare utilisation and costs, and cost-effectiveness. _x000D_ _x000D_ Timeline (months)_x000D_ 64-month project: Set-up (8 months); pilot recruitment (14 months); further recruitment (28 months); follow-up (minimum 6 months follow-up); study close-down analysis and reporting (8 months) _x000D_ _x000D_ Anticipated impact and dissemination _x000D_ The findings from this trial will impact on current care for PSP by determining the role of conservative care and will influence emergency and respiratory clinicians in managing a common respiratory presentation. Results will be submitted to major international meetings and for publication in a high impact medical journal. We anticipate rapid translation of results into clinical practice and incorporation in national and international guidelines. A plain English summary will be prepared and disseminated with the help of our PPI group and we will work with lung charities to generate other social media and internet summaries of the finding

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY