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20/75 Conservative management of primary spontaneous pneumothorax

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

Can conservative management be used to treat medium and large unilateral primary spontaneous pneumothorax?

  1. Intervention: Conservative (watch and wait) management (applicants to define and justify) in addition to standard care with analgesia and/or oxygen supplementation as required.
  2. Patient group: Patients with a medium/large unilateral primary spontaneous pneumothorax (applicants to define and justify).
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Emergency department or acute care unit.
  4. Control: Simple needle aspiration, chest drain or alternative procedure (applicants to define and justify) in addition to standard care with analgesia and/or oxygen supplementation as required.
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Need for further intervention; pain; resolution of pneumothorax (applicants to define and justify); recurrence (short and long term, applicants to define and justify; length of hospital stay; patient acceptability.
    Other outcomes: Quality of life; cost-effectiveness; return to work.
    Where established Core Outcomes exist, they should be included amongst the list of outcomes unless there is good reason to do otherwise. 
  7. Minimum duration of follow-up: Applicants to define and justify.

Rationale

A pneumothorax refers to a collection of air in the pleural cavity (between the lung and the chest wall) resulting in collapse of the lung on the affected side. The extent of the collapse of the lung is dependent upon the amount of air that is present.

This brief is concerned with primary spontaneous pneumothorax (PSP) which are those that occur in otherwise healthy people (i.e. no underlying lung condition).

Removing the trapped air in the pleural cavity which allows reinflation of the whole lung on the affected side is key to management of the condition, but how best to do this, and for whom, remains a matter of considerable debate.

While small and mostly asymptomatic PSPs have been successfully treated conservatively with observation, those larger and more symptomatic PSPs which are not indicated for surgery have traditionally been managed by needle aspiration or insertion of a chest drain. There is growing indication however that conservative management could also be a safe and effective treatment option for some or indeed many of these larger PSPs. An adequately powered randomised trial within the NHS is however still required in order to provide the high-quality evidence needed to influence guidelines and change practice in the UK.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us

Email:

htacommissioning@nihr.ac.uk