Evidence map›Paper›PMID 39725415›Full record

ArticleBMJ open2024

Pragmatic non-inferiority Randomised trial Investigating Needle aspiration versus ChEst drain for Secondary Spontaneous Pneumothorax (the PRINCE-SSP study): study protocol for a randomised non-inferiority trial.

Steven Walker, Ellie Taylor, Amy McAndrew, Edward Carlton, Ella Chaudhuri, Pooja Ghorpade, Charlotte Goodwin, James Connors, Heather Cook, Ramon Luengo-Fernandez and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. New strategies in the management of pneumothorax.Breathe (Sheffield, England) · 2025
    Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Steven WalkerAcademic Respiratory Unit, University of Bristol, Bristol, UK steven.walker@bristol.ac.uk.ORCID http://orcid.org/0000-0002-1713-5484
Ellie TaylorExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Amy McAndrewExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Edward CarltonNorth Bristol NHS Trust, Westbury on Trym, Bristol, UK.
Ella ChaudhuriNorth Bristol NHS Trust, Westbury on Trym, Bristol, UK.
Pooja GhorpadeExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Charlotte GoodwinExeter Clinical Trials Unit, University of Exeter, Exeter, UK.ORCID http://orcid.org/0009-0008-4880-8419
James ConnorsExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Heather CookExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Ramon Luengo-FernandezHealth Economics Research Centre, University of Oxford, Oxford, UK.
Siobhan CreanorExeter Clinical Trials Unit, University of Exeter, Exeter, UK.
Nick A MaskellAcademic Respiratory Unit, University of Bristol, Bristol, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSecondary spontaneous pneumothorax (SSP) is a medical emergency where the lung collapses in the presence of underlying chronic lung disease. Current international clinical guidelines advise intercostal drain (ICD) insertion for SSP. However, in a previous small study needle aspiration (NA) has been shown to reduce length of hospital stay (LOHS) and reduce complications. We are evaluating the clinical and cost-effectiveness of an initial NA approach to the management of patients with SSP in the United Kingdom. METHODS AND ANALYSIS: The PRINCE-SSP (Pragmatic non-inferiority Randomised trial Investigating Needle aspiration vs ChEst drain for Secondary Spontaneous Pneumothorax) trial is a pragmatic, multicentre, open-label, parallel, two-group, randomised, non-inferiority trial to establish whether NA for SSP is non-inferior in terms of LOHS compared with ICD. We aim to recruit 110 patients from at least 15 UK NHS hospitals, over 18 months. Participants allocated to the intervention (NA) group will have an NA inserted at the presentation. Those allocated to the comparator (usual care) group will have an ICD inserted. Participants are followed up for 30 days. The primary outcome measure is initial LOHS, up to day 30 postrandomisation. Secondary outcomes include (but are not limited to) total LOHS including readmissions, complications, cost-effectiveness and patient-reported quality of life. ETHICS AND DISSEMINATION: This trial received Health Research Authority (HRA) approval from Wales Research Ethics Committee seven ethics committee (23/WA/0085). Results will be submitted for publication in a peer-reviewed journal. A plain English summary of the trial results will be prepared and disseminated with the help of our patient advisory group, including via social media, and provided to trial participants via post or email according to their preference. TRIAL REGISTRATION NUMBER: ISRCTN12644940.

Indexed as

Chest TubesDrainagePneumothoraxPragmatic Clinical Trials as TopicCost-Benefit AnalysisEquivalence Trials as TopicHumansLength of StayMulticenter Studies as TopicQuality of LifeUnited KingdomACCIDENT & EMERGENCY MEDICINEAdult thoracic medicineRandomized Controlled Trial

Identifiers

PMID39725415
PMCPMC11683926

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.