Community Acquired Pneumonia PSP protocol

Published: 31 October 2024
Version: V1.9.2 - October 2024
13 min read

Purpose of the PSP and background

The purpose of this protocol is to clearly set out the aims, objectives, and commitments of the Community Acquired Pneumonia Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSP’s page of the JLA website. The Steering Group will review the Protocol regularly and any updated version will be sent to the JLA.

The JLA is a non-profit making initiative, established in 2004. It brings patients, carers, and clinicians together in PSPs. These PSPs identify and prioritise the evidence uncertainties, or ‘unanswered questions’, that they agree are the most important for research in their topic area. Traditionally PSPs have focused on uncertainties about the effects of treatments, but some PSPs have chosen to broaden their scope beyond that. The aim of a PSP is to help ensure that those who fund health research are aware of what really matters to patients, carers, and clinicians. The National Institute for Health and Care Research (NIHR) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Coordinating Centre (NIHRCC), University of Southampton.

The proposal for the Community Acquired Community Acquired PSP was developed by Fergus Hamilton (Wellcome Doctoral Fellow in Infectious Diseases) and David Arnold (NIHR Consultant Senior Lecturer in Respiratory Medicine), North Bristol NHS Trust and University of Bristol. It is financially supported by the Southmead Hospital Charity, North Bristol NHS Trust.

Pneumonia is the commonest cause for unplanned hospital admission in the United Kingdom (UK), with over 220,000 people diagnosed every year. The burden on patients and healthcare systems extends beyond the acute episode. Pneumonia survivors have long-term mortality rates three times higher than the general population, with cancer the cause of death in over a quarter.

Aims, objectives, and scope of the PSP

The aim of the Community Acquired Pneumonia PSP is to identify the unanswered questions about community acquired pneumonia from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.

The objectives of the PSP are to:

work with patients, carers, and clinicians to identify uncertainties about the diagnosis, complications, and management of community acquired pneumonia,
to agree by consensus a prioritised list of those uncertainties, for future research to address,
to publicise the results of the PSP and process; and
to take the results to research commissioning bodies to be considered for funding.

The scope of the Community Acquired Pneumonia PSP will include the diagnosis and management of community acquired pneumonia in the UK, along with longer term follow up and recovery. It is a very common condition that ranges from mild pneumonia managed in primary care to severe pneumonia managed in critical care.

The scope of the project will be based on two sets of NICE Guidance:

Specifically, this means that it will encompass the following key areas:

Diagnosis of the pathogen: Accurate and timely diagnosis of the pathogen causing pneumonia is important for appropriate treatment. Approaches such as rapid diagnostic tests and molecular methods may help improve diagnostic accuracy and speed up treatment. There is uncertainty about many aspects of this process at present, including who to test, pathogens to include, cost-effectiveness, etc.
Diagnosis of clinical syndrome: The clinical presentation of pneumonia can vary widely, and it can be challenging to distinguish pneumonia from a) other respiratory infections, and/or b) from other acute respiratory conditions that do not respond to antimicrobial therapy but require some other treatment for optimal management. Older patients may present with non-specific symptoms leading to a delay or missed diagnosis of pneumonia. Improving the accuracy of clinical diagnosis can help ensure appropriate and timely treatment. Many GPs diagnose pneumonia without radiological imaging. The scope of the PSP will include the role of radiology including chest x-ray and computed topography scanning.
Development of acute complications: Patients with pneumonia are vulnerable to developing local (e.g., pleural infection or pulmonary embolism) or systemic (e.g., cardiovascular) complications. A better understanding of these complications would be beneficial to patients and clinicians.
Management of ambulatory cases: Many cases of pneumonia can be managed in an outpatient setting including in primary care. Identifying optimal treatment strategies for ambulatory cases can help reduce hospitalisations and associated costs.
Management of severe cases and critical cases: Some cases of pneumonia can be severe or even life-threatening. Improving management strategies for severe and critical cases can help reduce mortality and improve outcomes.
Antimicrobial choice and duration: Identifying optimal antimicrobial choices and durations can help improve treatment outcomes. Appropriate step-down of antimicrobials to more targeted regimens (either pathogen-directed or clinical response-related) can reduce potential harms from over-exposure to antimicrobials a) to individuals - adverse effects or b) more widely - antibiotic resistance.
Host-directed therapy / adjunctive therapy: Host-directed therapy and adjunctive therapy are approaches that target the host (or person’s) response to infection rather than the pathogen itself. Identifying optimal host-directed and adjunctive therapies may help improve treatment outcomes.
Physiotherapy and nutrition: Although physiotherapy (general and chest-specific) has been widely used to support patients recovering from pneumonia. Strong evidence of treatment effect is still lacking. Which forms of physiotherapy and the intensity of treatment are unknown. Older patients with pneumonia often have nutritional deficiencies. How supplementation improves recovery is not known.
Delivery of care: There is increasing use of non-traditional care models for pneumonia (e.g. virtual wards; hospital at home; same-day emergency care). Evidence around whether these approaches improve outcomes in pneumonia is still lacking and is a key question for the modern NHS.
Diagnosis of underlying conditions: There is limited evidence on how patients with pneumonia should be optimally followed-up to diagnose underlying conditions, such and lung diseases or cancers, that might have been masked by and / or precipitated the initial infection.
Long-term complications, follow-up and recovery: More patients survive than die following hospitalisation for pneumonia. Pneumonia can have long-term complications such as lung scarring and impaired lung function. Understanding the long-term complications of pneumonia and identifying optimal strategies for recovery can help improve outcomes for patients. The scope of the PSP will include follow up for patients who have had community acquired pneumonia. There is poor understanding regarding the mechanisms underlying the pace of recovery and currently no evidence-based management strategies for post-pneumonia rehabilitation.

The NHS Long Term Plan specifically recognises that a significant burden of pneumonia is borne by “disadvantaged groups and areas of social deprivation, where there is often higher smoking incidence, exposure to higher levels of air pollution, and poor housing conditions.” We will take care to ensure that the PSP considers the needs of people in these disadvantaged groups.

The PSP will exclude from its scope questions about:

Hospital-acquired pneumonia.
The diagnosis, management, or follow-up of COVID-19 infection specifically.
The incidence, prevalence and distribution of community acquired pneumonia
The epidemiology of pneumonia or particular pathogens that cause pneumonia
Community Acquired pneumonia in children (<16 years of age).
Vaccines and other preventative measures
The management of community acquired pneumonia outside the UK, although evidence from around the world will be reviewed and considered during the evidence-checking phase of the PSP.

The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. Resources and expertise will be put in place to undertake this evidence checking.

The Steering Group

The Steering Group includes membership of patients, carers, and clinicians, as individuals or representatives from a relevant group.

The Community Acquired Pneumonia PSP will be led and managed by a Steering Group involving the following:

Patient and carer representative/s:

Rose Barkley - Lived experience of CAP
Julie Dunphy - Lived experience of CAP
Sally Grier - Carer
Jerry Kalidou - Lived experience of CAP
Carole Pitkeathley - Carer

Clinical Representatives:

Dr Haroon Ahmed - GP, Senior Clinical Lecturer in Epidemiology, Cardiff University School of Medicine
Jacqueline Jeff-Watts - Respiratory Physiotherapist in Critical Care, Aintree University Hospital
Prof Wei Shen Lim - Consultant Respiratory Physician, Honorary Professor of Medicine, Nottingham and University Hospitals NHS Trust
Katie Lowe - Advanced Clinical Practitioner, Liverpool Community Respiratory Team,Liverpool Acute Respiratory Virtual Ward
Dr Leon Peto - Senior Clinical Research Fellow in Population Health and honorary consultant in Infectious Diseases and Microbiology, Senior Clinical Research Fellow in Population Health and honorary consultant in Infectious Diseases and Microbiology
Prof Charlotte Summers - Professor of Intensive Care Medicine, University of Cambridge
Dr Dan Wootton - NIHR Advanced Fellow, Senior Clinical Lecturer and Honorary Consultant Respiratory Physician, University of Liverpool

Project Leads:

Fergus Hamilton - Wellcome Doctoral Fellow in Infectious Diseases, North Bristol NHS Trust and University of Bristol
David Arnold - NIHR Consultant Senior Lecturer in Respiratory Medicine, North Bristol NHS Trust and University of Bristol

Project Coordinator:

Julie Gibbs - North Bristol NHS Trust

Information Specialist:

Amerikos Argyriou - Specialised Foundation Doctor, University Hospitals Bristol and Weston NHS Foundation Trust

James Lind Alliance Adviser and Chair of the Steering Group:

Jo Watson - James Lind Alliance

The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process, with input and advice from the JLA.

Partners

Organisations and individuals will be invited to be involved with the PSP as partners. Partners are organisations or groups who will commit to supporting the PSP, promoting the process, and encouraging their represented groups or members to participate. Organisations which can reach and advocate for these groups will be invited to become involved in the PSP. Partners represent the following groups:

adults who have been diagnosed with community acquired pneumonia,
carers of adults who have been diagnosed with community acquired pneumonia, and
healthcare professionals with experience of supporting adults diagnosed with community acquired pneumonia.

Partner organisations will include Royal Colleges and healthcare charities.

Exclusion criteria

Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to potentially cause unacceptable bias as a member of the Steering Group. As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.

The methods the PSP will use

This section describes a schedule of proposed steps through which the PSP aims to meet its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods used in any step will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details of the method are in the Guidebook section of the JLA website where examples of the work of other JLA PSPs can be seen.

Step 1: Identification and invitation of potential partners

Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the Community Acquired Pneumonia PSP.

Step 2: Awareness raising

Members of the Community Acquired Pneumonia PSP Steering Group will need to raise awareness of its proposed activity among patient, carer, and clinician communities, to secure their support and participation. Depending on budget, this may be done by a face-to-face meeting, or there may be other ways in which the process can be launched, e.g., via social media. It may be conducted as part of steps 1 and/or 3. The Steering Group should advise on when to do this. Awareness raising has several key objectives:

to present the proposed plan for the PSP,
to generate support for the process,
to encourage participation in the process, and
to initiate discussion, answer questions and address concerns.

Step 3: Identifying evidence uncertainties

The Community Acquired Pneumonia PSP will conduct a consultation to gather uncertainties from patients, carers, and clinicians. A period of 3 months will be given to complete this exercise (which may be revised by the Steering Group if required).

The Community Acquired Pneumonia PSP recognises that the following groups may require additional consideration:

Adults from disadvantaged groups and areas of social deprivation who have been diagnosed with community acquired pneumonia,
Carers of adults from disadvantaged groups and areas of social deprivation who have been diagnosed with community acquired pneumonia; and
People living in residential and nursing homes who have been diagnosed with community acquired pneumonia.

The Steering Group will use the following methods to reach the target groups:

Online surveys
Paper copies of surveys
Facilitated individual survey completion, virtual and in person.
Facilitated discussion group, virtual and in person.

Existing sources of evidence uncertainties may also be searched. These may include:

A range of treatment guidelines from European, American, British, and other guideline bodies and specialist societies.
Cochrane reviews of specific questions (e.g., the role adjunctive corticosteroids).
Systematic reviews, consensus statements
Evidence sources relevant to medicine, nursing, allied health professional, pharmacy, and psychology.

Step 4: Refining questions and uncertainties

The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’, and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by Amerikos Argyriou into summary questions which are clear, addressable by research, and understandable to all. Similar or duplicate questions will be combined where appropriate. Out-of-scope and ‘answered’ submissions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data is being interpreted appropriately and that the summary questions are being worded in a way that is understandable to all audiences. The JLA Adviser will observe to ensure accountability and transparency.

This will result in a lengthy list of in-scope summary questions. These are not research questions and to try and word them as such may make them too technical for a non-research audience. They will be framed as researchable questions that capture the themes and topics that people have suggested.

The summary questions will then be checked against evidence to determine whether they have already been answered by research. This will be done by Amerikos Argyriou. The PSP will complete the JLA Question Verification Form, which clearly describes the process used to verify the uncertainty of the questions, before starting prioritisation. The Question Verification Form includes details of the types and sources of evidence used to check uncertainty. The Question Verification Form should be published on the JLA website as soon as it has been agreed, to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.

Questions that are not adequately addressed by previous research will be collated and recorded on a standard JLA template by Amerikos Argyriou. This will show the checking undertaken to make sure that the uncertainties have not already been answered. The data should be submitted to the JLA for publication on its website on completion of the priority setting exercise, considering any changes made at the final workshop, to ensure that PSP results are publicly available.

The Steering Group will also consider how it will deal with submitted questions that have been answered, and questions that are out of scope.

Step 5: Prioritisation – initial and final stages.

The aim of the final stage of the priority setting process is to prioritise, through consensus, the identified uncertainties about community acquired pneumonia. This will involve input from patients, carers, and clinicians. The PSP will encourage engagement from as wide a range of people as possible, including those who did and did not contribute to the first consultation. There will be two stages of prioritisation:

Initial prioritisation is the stage where the long list of summary questions is reduced to a shorter list that can be taken to the final priority setting workshop. This stage of the process will be aimed at a wide audience and will involve similar approaches to those used in the initial consultation survey, taking account of learning from that phase of the process. With the JLA’s guidance, the Steering Group will consider how best to reach and engage patients, carers, and clinicians in the process. The most highly ranked summary questions (around 25) will be taken to a final priority setting workshop. If the initial prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forwards to the final prioritisation.

The final priority setting stage is a one-day workshop facilitated by the JLA. With guidance from the JLA and input from the Steering Group, up to thirty patients, carers and clinicians will be recruited to participate in a day of discussion and ranking, to determine the top ten questions for research. All participants will declare their interests. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible.

Dissemination of results

The Steering Group will identify audiences with which it wants to engage when disseminating the results of the priority setting process, such as researchers, funders, and the patient and clinical communities. They will need to determine how best to communicate the results and who will take responsibility for this. Previous PSPs’ outputs have included academic papers, lay reports, infographics, conference presentations and videos for social media.

It should be noted that the priorities are not worded as research questions. The Steering Group will need to discuss how they will work with researchers and funders to establish how to address the priorities and to clarify the research questions are that will address the issues that people have prioritised. The dissemination of the results of the PSP will be led by Fergus Hamilton and David Arnold.

The PSP will report back to the JLA about any activities that have come about because of the PSP, including funded research, by sending details to jla@soton.ac.uk.

Agreement of the Steering Group

The Community Acquired Pneumonia PSP Steering Group agreed the content and direction of this Protocol on 3^rd October 2024.