Development and implementation of the LVR-PR tool to identify eligibility for lung volume reduction in people with COPD during pulmonary rehabilitation.

doi:10.21203/rs.3.rs-3092323/v1

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Development and implementation of the LVR-PR tool to identify eligibility for lung volume reduction in people with COPD during pulmonary rehabilitation.

https://doi.org/10.21203/rs.3.rs-3092323/v1

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Background: Completion of pulmonary rehabilitation is recognised in clinical guidelines as a key point in the management of people with COPD to systematically consider whether a lung volume reduction(LVR) procedure might be appropriate. We aimed to develop a decision-support tool (the LVR-PR tool) to allow PR programmes to operationalise this.

Methods: The development process involved an iterative mixed methods approach, utilising a consensus-based survey, focus groups and an observational study cohort at multiple pulmonary rehabilitation centres. External validity was evaluated using the content validity index (CVI), assessed by clinicians working in specialist LVR centres across the UK who were not otherwise involved in the development process.

Results: Diagnosis, exercise capacity, breathlessness and co-morbidities were acknowledged to be essential items for assessing basic LVR eligibility. Prior investigations and patient preference were considered useful but not essential. Clinician focus group findings revealed the following prominent themes; streamlining the tool; access to clinical information and investigations; and issues around introducing LVR therapies to patients in a PR setting. Access to clearer information about LVR procedures, the clinician’s role in considering eligibility and how educational resources should be delivered were identified as important themes from patient group input. The LVR-PR tool was considered to be feasible and valid for implementation in a variety of PR services across the UK.

Interpretation: The LVR-PR tool allows PR teams to identify and communicate back to referrers about people with COPD, who should have further respiratory review to establish whether they may benefit from a lung volume reduction procedure.

Physical Medicine & Rehab

Lung volume reduction

Pulmonary rehabilitation

COPD

patient pathway

Lung volume reduction procedures have been shown in clinical trials to produce substantial benefits for people with COPD, improving lung function, breathlessness, exercise capacity, quality of life and prognosis (1, 2). However current LVR patient pathways are fragmented and unsystematic(3). Referrals are often made too late and patients report having to ‘fight for a referral’, while clinicians describe a lack of clarity about who, when and how to refer(4).

To address this, the UK National Institute for Health Research and Care (NICE) recommends a three step process; (i) systematically identifying people with COPD who have severe airflow obstruction and limiting breathlessness, but whose exercise capacity is not so limited that LVR cannot be undertaken safely, where the possibility of an LVR procedure should be raised (ii) a respiratory review of these individuals to establish the presence of hyperinflation and emphysema as well as the absence of comorbidities, together with a discussion about patient preferences. This should lead, where appropriate, to (iii) LVR MDT referral to assess technical suitability for lung volume reduction surgery and/or endobronchial valve placement (Fig. 1)(5).

To achieve step one of this process, NICE guidance focusses on the point where people with COPD complete a pulmonary rehabilitation programme(5). At this stage, both medical care and management should have been optimised, and so if patients continue to experience limiting breathlessness other possibilities need to be considered systematically. Depending on the breathlessness and exercise capacity criteria used, between 4.9% and 18.7% of COPD patients completing a PR programme could be considered eligible for onward referral for a respiratory review(6).

In order to operationalise this guidance, we aimed to develop a decision-support LVR-PR tool reflecting NICE recommendations, that could be adopted by PR services across the UK to facilitate the routine and systematic consideration of all COPD patients accessing a programme, for respiratory review, and address the mismatch between the number who may be eligible and those who are actually referred in a timely way, or at all, for consideration of LVR.

The tool would include collection of necessary information to support a recommendation that a respiratory review for LVR should be considered, as well as the necessary standard text to communicate this, while being usable by PR practitioners who do not have an expert knowledge of LVR.

An iterative mixed-methods approach was employed to develop the scoring system for the decision-making tool, utilising a ‘modified Delphi’ methodology(7) as used in other clinical tool development studies(8–10). This methodology uses elements of a nominal group technique (NGT) for consensus development. The steps involved included the following: step 1: initial tool development via individual surveys; step 2: stakeholder consultation group interviews and analysis; Step 3: assessing external and content validity; Step 4: piloting the tool.

Patient and Public Involvement statement

Patients who had volunteered to be members of a PPIE group were involved in a consultation group to discuss the development of an LVR-PR decision-making tool. This is discussed further in the methodology.

Step 1: Expert survey

We conducted an online survey (appendix 1) of clinical stakeholders from across the UK, including respiratory physicians, thoracic surgeons, interventionists, specialist respiratory physiotherapists, specialist nurses and exercise practitioners. Recipients of the survey were recruited based on if they had been involved in the CELEB study, were part of a clinical service participating in the KHP transformation project, or if they were known to the research team as a clinical stakeholder in either an LVR or PR service. The survey was designed based on a scoping review of the literature and guidelines that exist around lung volume reduction pathways. The survey asked about professional identity, current confidence in identifying patients for LVR, involvement in an MDT and/or PR, and their view on the necessity of certain measures being included in this decision-making tool.

The results of the survey were used to develop a preliminary working outline of the LVR-PR tool which would then be presented to clinicians, asking those that would be using the tool for further feedback on feasibility and usability, as well as to identify any barriers or extra training that they felt might be required.

Step 2: Stakeholder consultation

We conducted two stakeholder consultations; The first, clinical group, included people who would either be responsible for completing the tool at the end of a course of PR or would at least need to be familiar with it. The aim of this focus group was to develop the information gathered from the survey responses and discuss in more detail issues raised, in addition to gaining more insight into the feasibility of implementing the tool and collecting the necessary data, within busy PR programmes.

The second group was a patient and public involvement and engagement (PPIE) event consisting of people with COPD. Discussion in this group included examining issues raised in the clinical focus group, particularly relating to how to introduce and educate patients about LVR procedures, and within what environment. Participants were shown the online video resources that have been developed by Asthma + Lung UK, with a formal process involving clinical experts and patient reviewers and are subject to review every two years and asked for comment.

The development process for this tool was done as part of a service development programme and the patient consultees were part of an already existing Pulmonary Rehabilitation Public Involvement Group. We asked for individuals' opinions about the questionnaire, not for their own experiences and as such ethical approval was not required(11).

Participants in both groups were briefed on the purpose of the group and topics that would be discussed, prior to the meetings, and were sent a copy of the proposed LVR-PR tool to review to allow time to formulate relevant questions or thoughts. All participants agreed on ground rules for the running of the meetings and verbally consented to participate. Reimbursement for time was available for individuals taking part in the PPIE event. The meetings were chaired by SB and paraphrased transcription was carried out by PW. Focus group one was moderated by NSH, an expert clinician in this field and during the PPIE group this role was fulfilled by LB, an expert in PPIE. The outline and questions used for discussion in consultation group 1 and 2 are presented as online supplementary material (appendix 2) and online educational resources which are updated regularly can be accessed here (https://www.blf.org.uk/support-for-you/copd/treatment/surgery ).

Step 3: Assessing validity

This step involved two strategies to test validity (face and content). First, the tool was sent to members of four PR services within London. Clinicians involved in these services were asked for further comment on the tool, which had been updated based on focus group feedback. The second part involved presenting the tool to PR teams across the UK at 2 specially set up meetings, to gain qualitative feedback. Finally, discussion at a regional specialist LVR meeting was used for further feedback. These steps were intended to ensure the external validity and utility of the tool within variable settings. A list of PR centres that were consulted during this process can be found in the online supplement (appendix 4). Finally, two clinicians from each centre who had been involved in using the tool but were not involved in the focus groups or development of the tool were asked to rate the tool’s content validity using the CVI questionnaire. This tool has been previously used in the development of a clinical tool by Corner et al(8) and is the most widely used index when evaluating a tool using a quantitative method (12). Raters were asked to score each individual item using a four point scale (not relevant, item needs some revision, relevant, very relevant) and scoring was to be done individually without group deliberation or discussion. The scores would be used to calculate an I-CVI score (validity of each individual item included in the tool) and an S-CVI score (an overall scale validity score). An I-CIV score of ≥ 0.78 is considered indicative of agreement that the individual item is valid for inclusion and a S-CVI of ≥ 0.80 suggests that the tool under assessment can be deemed valid and all items are relevant for inclusion (13).

Step 4: Pilot implementation of the LVR-PR tool

Step 4 involved piloting the tool between June 2021 and June 2022 at the 4 hospitals in London that were involved in the development process to review its feasibility. We asked the PR programme lead at these centres to consider every patient at discharge from PR, against the basic criteria on the LVR tool. No data were collected during this step only comments on the clinician’s opinion and experience of using the tool as well as suggestions for further changes. Educational resources that had been developed in line with the consultation group findings, for both practitioners and patients were also sent out to the piloting sites.

37 of 40 clinicians (92.5%) responded to the online survey; 13 consultant physicians, 9 consultant surgeons, 1 speciality trainee, 12 specialist physiotherapists and 2 specialist nurses. 51.4% of respondents were female and 73% within the 35–54 years age bracket. 60% reported being involved in an LVR MDT, 51.4% were directly involved in a PR programme, and 37.8% were involved in the PR referral process. When asked how confident responders felt in identifying patients who might be suitable for LVR (0 = not confident at all. 10 = very confident) the mean response was 6.2. Figure 2 shows the perceived importance of six key components suggested by literature/guidelines in LVR assessment rated by the survey respondents. All components were voted ‘essential’ by between 54.1% and 97.3% of respondents with only prior investigations and patient preference being voted ‘unnecessary’ by 40.5% and 24.3% respectively. The comments collected from the initial survey are summarised and presented in Table 1.

Stakeholder consultation groups

Focus group one was attended by 12 clinical stakeholders in PR programmes and the King’s Health Partners Transformation programme. These included 5 band 8 and 2 band 7 physiotherapists, 2 exercise practitioners, 1 band 7 clinical nurse specialist, 1 reader in rehabilitation and 1 professor of respiratory medicine). The main take away points for further development of the tool and in preparing for the second, patient focus group were; streamlining the tool; access to clinical information, investigations and issues around introducing LVR therapies to patients in a PR setting (Table S1 (Appendix 3).

Consultation group two was attended by 10 patients (5 female/5 male)), all members of a Pulmonary Rehabilitation Public Involvement Group. All participants were retired and had been through at least one course of PR with two attendees completing more than one course. Two of the participants had been considered for an LVR procedure and one had undergone it. The key points that arouse from this meeting were; the need for clearer information on LVR procedures for patients, the clinician’s role in considering eligibility and how educational resources should be delivered. Comments from this group were used in conjunction with focus group one to understand the importance of how information is delivered and will be used to further develop current educational resources.

Assessing external and content validity

Of the 14 centres that were asked for comment on the tool, all felt that it could feasibly be implemented into their service and the information that was needed to complete the tool was already routinely collected as part of their assessment process. Consensus was gained on the prior investigations component of the tool, but it was agreed that more clarification was needed around which investigations and what timelines. Professionals generally felt comfortable to introduce the tool to patients as part of their educational programme and signpost them to additional educational online resources or provide them with an Asthma + Lung UK leaflet. Clinician educational resources from Asthma + Lung UK were also welcomed by those who lacked confidence in their baseline LVR knowledge.

The LVR decision making tool was found to have an S-CVI score of 0.95 and each individual item achieved a score of 0.78 or greater suggesting that the tool can be considered valid and no items need deleting or revising (appendix 5).

Piloting of the tool and assessment of content validity

The tool (Table2) was piloted at 4 centres across London who were all part of a King’s Health Partners transformation project (Royal Brompton Hospital, Harefield Hospital, Kings College Hospital and Guys and St Thomas’ Hospital), over a period of 12 months. Alongside the tool a summary output for clinicians to add to their discharge summaries was provided (Table 3). Qualitative comments suggested that the tool appeared to be simple to use and feasible to implement into a PR setting. Most suggestions were focussed on the clarity of individual domains of the tool, largely the interpretation of defining significant comorbidities, reliability of patient reported investigations, and when outcomes should be collected/recorded. Changes were made to the final tool to reflect these suggestions (online supplement appendix 6).

The LVR-PR tool described in this paper provides a means to operationalise the pathway for LVR assessment in people with COPD that has been outlined in NICE guidance. The mixed-methods approach used in its development with wide stakeholder input should ensure that it will be straightforward to implement into routine clinical practice, providing consistency of patient care and identifying LVR eligible people with COPD in a timely manner.

We found a broad consensus on which items should be included in a decision-support tool – diagnosis, exercise capacity, airflow obstruction and breathlessness. For the LVR-PR tool to be useful it would need to be not too burdensome given oversubscribed and time-constrained services (14). Prior investigations and patient preference were initially identified as useful but not essential. This was explored further in focus group discussion which revealed that clinicians felt patients were unlikely to be able to provide accurate history of prior investigations and that searching for such records could be time-consuming, making the tool more burdensome. The need for clarity around how comorbidity might be considered, and eligibility criteria based on exercise capacity led to small changes to the final tool to make these domains clearer. It was decided that both comorbidity and prior investigations domains would be categorised as desirable rather than essential to ensure the feasibility of PR services adopting the tool.

Patient preference as a domain in this context was considered of less relevance. Clinicians felt that this should not be explored as part of the initial post-PR eligibility assessment, but once a respiratory review had identified whether LVR options might actually be available. This would allow patient preferences to be meaningful, representing informed choice. There is limited literature on patient preference in the context of LVR, but this has been researched in a lung cancer setting (15, 16). Findings suggest that patient preferences were only selectively taken into consideration and while recommendations were made for more joint decision making, some patients preferred a more directed approach from a professional with in depth knowledge to help weigh up the risks and benefits involved. However, this work largely focusses on different types of treatments rather than if a patient chose to undergo a treatment or not. Studies such as the CELEB trial, comparing the efficacy of LVRS to endobronchial valves(17) will help to facilitate these discussions and assist joint decision making. For the purpose of this tool it was settled that the clinician should briefly introduce LVR and crucially, provide educational resources, but discussion around patient preference should be addressed further down the line.

Overall, clinicians who used the LVR-PR tool found it to be feasible to implement in their service. Potential barriers to implementation were raised early in the consensus process which included concerns over professional knowledge in delivering LVR information/education to potential candidates and answering difficult questions, as well as sensitivity around introducing therapies to individuals who may later discover that they are ineligible. However, clinicians would be happy to provide a very brief introduction to LVR therapies and signpost patients to additional educational resources, such as those that have been developed as part of this work package.

Of note, in the patient PPIE group, which involved presenting the LVR decision making tool and educational resources to people with COPD, there seemed to be less concern among the patient group over the sensitivity of introducing these therapies to those who may not be suitable. Instead, participants were more concerned in improving the volume, quality and accessibility of educational resources that are available to them. Comments from participants suggested that they would prefer to be introduced to all existing therapies early in the disease process, to feel educated and allow them to explore all options potentially available to them. This attitude aligns with the self-management and patient empowerment concept that is well documented in COPD care(18, 19). It was suggested that information presented in a group PR setting should provide a broad overview that then signposts patients to more specific educational resources detailing individual therapies, that can be accessed by those who are interested, or are identified as potential candidates. Figure 1 highlights that the LVR referral pathway is a stepwise process and the review of basic criteria within the PR setting is just one step in this process, to identify people who should have a respiratory review as the second step on the LVR eligibility pathway.

A modified Delphi method was used in this study to gain consensus around the use of a decision- making tool within a PR setting, for identifying patients who may be suitable for onward referral for LVR consideration. Consensus methods have been recognised as an important practice for identifying and addressing uncertainly in healthcare settings as well as evaluating validity (10, 12, 20). Collecting the views of many stakeholders, including service providers and users through many stages of consensus, enhances the credibility of the development process for this tool

Difficulties in collecting outcomes were apparent at some centres due to the pandemic, with one centre being unable to assess against the exercise capacity criteria due to no walk test having been carried out as part of the assessment process. A future research question remains whether alternative tests of exercise capacity, such as a sit to stand test could be used to identify people in whom LVR may be unacceptably risky. The development of a digital version of the LVR-PR tool may also help to streamline pathways.

The LVR-PR tool provides a simple mechanism to facilitate the consideration of people with COPD for LVR referral in a systematic manner, within busy PR services. This tool appears to be valid and feasible to implement but continuing work will be needed to ensure that educational resources are up to date and fit for purpose, to ensure clinicians feel supported in delivering LVR information in a group setting.

Conflict of interest declaration; RAL reports unpaid advisory positions on the British Thoracic Society Specialist Advisory Group, Sheffield Respiratory Specialist Advisory Group, SYB Respiratory clinical network and is a Yorkshire and Humber Clinical Senate Council Member. All authors report no conflicts.

Funding statement; This project was funded as part of the CELEB trial by a grant provided by the National Institute for Health Research under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014-35051).

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Table 1; Comments from open-ended survey questions

Domain	Responder feedback
Further suggestions for inclusion in an LVR decision making tool	Exacerbation frequency/sputum; optimisation of management; smoking history/ smoking status/smoking cessation; BMI; substance misuse; lung volumes; previous interventions; patient motivation; oxygen saturations/ ABG’s; up to date CT scan.
Agreement on need for a tool	‘If there are clear criteria it seems like a sensible approach’ ‘Should be routine part of discharge assessment’ ‘This is how we initially wanted to target patients when starting our MDT.’
Concern over increased referrals to secondary care	‘need to be clear pathways to a specialist clinic for investigation, discussion and selection. A good tool I think therefore would be expected to screen out those clearly unsuitable, and the screening out should be reliable. Those screened in will include a significant number of people ultimately not suitable for LVRS after further testing.’ ‘Need to ensure that the capacity for timely review in secondary care exists right from the initiation of any tool, otherwise engagement in the process will be low’ ‘It may well create unprecedented demand!’
Concern over increased workload for PR services	‘The work needs to be easy for the rehab team itself and easy to encompass as part of final assessment process, but is likely to create workload for selection clinics, in excess of the increased procedures’
Concern over raising sensitive topics with patients	‘Advanced procedures are emotive for patients- potential for a quick and potentially life changing 'fix'. However, as we know benefit depends on accurate patient selection. The initial conversation is key to manage expectations and to be clear that teams do procedures that are likely to benefit patients’ ‘Change of focus, from self-management to interventions’
Need for further training/educational resources	‘Never had any training or information on this so would need some!’ ‘little plain English summaries of available LVR procedures exist for HCPs and/or patients’ ‘ If the tool was virtual, perhaps a video explanation may be of great value.’

Table 2; The Lung Volume Reduction Pulmonary Rehabilitation tool

	Referral consideration	When	notes
Diagnosis:	Do they have COPD?
	Is FEV₁ ≤50% predicted	Assess at beginning or obtain data.	FEV₁(l): FEV₁ % pred:
	Smoking status	Assess at beginning (and end)
Breathlessness	MRC dyspnoea score	Assess at end*Consider criteria to flag as possible at baseline? MRC 4 or 5	MRC score:
Exercise capacity	Walking distance	Assess at end *Consider criteria to flag as possible at baseline <300m?	ISWT: 6MWT:
Patient	Has the patient been introduced to LVR? □ Asthma+Lung UK resource/leaflet provided	Ask at baseline *Consider criteria to flag as possible at baseline?
Comorbidities	Do they have a condition that limits survival or ability to benefit from LVR?	Assess at beginning or during programme	Malignancy Frailty Severe heart failure
Prior investigations (only if available)	Have they had a CT scan? (ask patient)	When and where was it performed?
	Have they had detailed lung function? (ask patient)	When and where was it performed?
	Have they had an echo? (ask patient)	When and where was it performed?

Please tick or copy and paste one statement from below into your discharge summary and attach any relevant notes.

Green = essential consideration criteria, Red = desirable consideration criteria

Table 3; The Lung Volume Reduction Pulmonary Rehabilitation (LVR-PR) text

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Development and implementation of the LVR-PR tool to identify eligibility for lung volume reduction in people with COPD during pulmonary rehabilitation.

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Abstract

Figures

INTRODUCTION

METHODS

Step 1: Expert survey

Step 2: Stakeholder consultation

Step 3: Assessing validity

Step 4: Pilot implementation of the LVR-PR tool

RESULTS

Stakeholder consultation groups

Assessing external and content validity

Piloting of the tool and assessment of content validity

DISCUSSION

Conclusion

Declarations

References

Tables

Supplementary Files

Status:

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