Abstract
Introduction
The purpose of the quality standards document is to provide healthcare professionals, commissioners, service providers and patients with a guide to standards of care that should be met for the investigation and management of pulmonary nodules in the UK, together with measurable markers of good practice.
Methods
Development of British Thoracic Society (BTS) Quality Standards follows the BTS process of quality standard production based on the National Institute for Health and Care Excellence process manual for the development of quality standards.
Results
7 quality statements have been developed, each describing a key marker of high-quality, cost-effective care for the investigation and management of pulmonary nodules, and each statement is supported by quality measures that aim to improve the structure, process and outcomes of healthcare.
Discussion
BTS Quality Standards for the investigation and management of pulmonary nodules form a key part of the range of supporting materials that the Society produces to assist in the dissemination and implementation of guideline recommendations.
Keywords: lung cancer
Introduction
The British Thoracic Society (BTS) has been at the forefront of the production of guidelines for best clinical practice in respiratory medicine since the Society was established over 30 years ago. The Society’s guideline production process is accredited by National Institute for Health and Care Excellence (NICE) Accreditation (November 2011, renewed in 2017), and the Society’s Guideline Production Manual1 setting out the detailed methodology and policy for the production of guidelines is reviewed annually by the BTS Standards of Care Committee (SOCC).
A statement on quality standards based on each BTS guideline is a key part of the range of supporting materials that the Society produces to assist in the dissemination and implementation of a guideline’s recommendations.
The purpose of the quality standards document is to provide commissioners, healthcare professionals, planners and patients with a guide to standards of care that should be met for pulmonary nodule investigation and management in the UK, together with measurable markers of good practice.
BTS quality standards are intended for:
healthcare professionals to allow decisions to be made about care based on the latest evidence and best practice
people with pulmonary nodules undergoing investigation and treatment to enable understanding of what services they should expect from their healthcare provider
service providers to be able to quickly and easily examine the clinical performance of their organisation and assess the standards of care they provide
commissioners so that they can be confident that the services they are purchasing are high quality and cost-effective.
NICE Quality Standards and the NICE Quality Standards Process Guide2 were used as a model for the development of BTS Quality Standards.
A quality standard is a set of specific, concise statements that:
act as markers of high-quality, cost-effective patient care across a pathway or clinical area, covering treatment or prevention
are derived from the best available evidence.
The rationale for these quality standards is drawn from evidence and recommendations summarised in the BTS Guidelines for the Investigation and Management of Pulmonary Nodules.3
Each quality standard includes the following:
A quality statement, which describes a key marker of high-quality, cost-effective care for this condition.
Quality measures, which aim to improve the structure, process and outcomes of healthcare.
The quality measures are not intended to be new sets of targets or mandatory indicators for performance management that need to be collected. The quality measures are specified in the form of a numerator and a denominator, which define a proportion or ratio (numerator/denominator). It is assumed that the numerator is a subset of the denominator population. The suggested numerator and denominator are provided to allow healthcare professionals and service providers to examine their clinical performance in relation to each quality standard. It is recognised that no national quality indicators will be available for this condition, and institutions will need to agree locally what information is required for the denominator to be used in each case, and what the expected level of achievement should be, given local circumstances. A brief description about the quality standard in relation to each audience is given.
The main source references for these quality standards are:
BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 2015.3
NICE Clinical Guideline Lung Cancer: diagnosis and management, 2011.4
There is no specific order of priority associated with the list of quality standards.
Method of working
A Quality Standards Working Group was convened in February 2016 and met in May 2016. Membership is given in table 1.
Table 1.
Quality Standards Working Group members
| Name | To represent: | Location |
| Professor David Baldwin | Co-chair | Respiratory medicine, Nottingham |
| Dr Matthew Callister | Co-chair | Respiratory medicine, Leeds |
| Dr Ian Woolhouse | RCP London representative | Respiratory medicine, Birmingham |
| Professor Fergus Gleeson | RCR representative | Radiology, Oxford |
| Dr Kevin Franks | Clinical oncology, Leeds | |
| Dr Paul Cane | Pathology, London | |
| Jeanette Draffan | National Lung Cancer Forum for Nurses representative | Macmillan Lung Cancer Nurse Specialist, North Tees & Hartlepool |
| Mr David Waller | SCTS representative | Surgery, London |
| Dr Richard Graham | BNMS representative | Radiology, Bath |
| Dr Ahsan Akram | Respiratory medicine, Edinburgh | |
| Dr Puneet Malhotra | Respiratory medicine, St Helens and Knowsley | |
| Dr Manil Subesinghe | Radiology, London | |
| Dr Philip Pearson | BTS Quality Improvement Committee representative | Respiratory medicine, Northampton |
BNMS, British Nuclear Medicine Society; BTS, British Thoracic Society; RCP, Royal College of Physicians; RCR, Royal College of Radiologists; SCTS, Society of Cardiothoracic Surgeons.
Members of the Quality Standards Working Group submitted Declaration of Interest forms in line with the BTS Policy, and copies of forms are available on request from BTS head office.
The draft document was considered in detail by the BTS Standards of Care Committee initially in October 2016 and the BTS Quality Improvement Committee in March 2017.
The document was made available on the BTS website for public consultation for the period from 13 March to 10 April 2017.
Following further revision, the document was submitted for approval to the BTS Standards of Care Committee in October 2017.
The Quality Standards document will be reviewed in 5 years from the date of publication or following the publication of a revised Guideline whichever is sooner.
List of quality statements
| 1. People with non-calcified pulmonary nodules confirmed on CT have their nodule(s) assessed for risk of malignancy. |
| 2. People with solid pulmonary nodules have their nodules assessed by semi-automated volumetry in preference to manual diameter measurements where possible and appropriate (eg, for smaller nodules and for measuring doubling time, when growth not obvious). |
| 3. Positron emission tomography (PET)-CT examinations undertaken for assessment of solid pulmonary nodules are reported using qualitative assessment with an ordinal scale to define fluorodeoxyglucose (FDG) uptake as absent, faint, moderate or intense, in relation to background lung tissue and mediastinal blood pool, to facilitate use of the Herder risk prediction model. |
| 4. People with pulmonary nodules confirmed on CT are offered discharge, further surveillance, further work up or treatment according to BTS guidelines (see for specific recommendations). |
| 5. People with pulmonary nodules considered for definitive treatment and suitable for surgical intervention are offered lobectomy with pathological confirmation of malignancy by frozen section, if not previously confirmed, or anatomical segmentectomy if unfit for lobectomy. |
| 6. People with pulmonary nodules considered for definitive treatment but who decline or who are unsuitable for surgery are offered ablative non-surgical treatment where safe. |
| 7. People with pulmonary nodules confirmed on CT are offered verbal and written information that allows them to make an informed choice about their management. |
| Quality statement 1 | People with non-calcified pulmonary nodules confirmed on CT have their nodule(s) assessed for risk of malignancy. |
| Rationale | To ensure patients with non-calcified pulmonary nodules on CT have their nodule(s) assessed for risk of malignancy to guide appropriate use of interval imaging and recommendation for further workup. |
| Quality measure |
Structure:
|
| Description of what the quality statement means for each audience |
Service providers:
|
| Relevant existing indicators | Local multidisciplinary team (MDT) minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114 |
| Other information |
|
| Quality statement 2 | People with solid pulmonary nodules have their nodules assessed by semi-automated volumetry in preference to manual diameter measurements where possible and appropriate (eg, for smaller nodules and for measuring doubling time, when growth not obvious). |
| Rationale | To ensure patients with solid pulmonary nodules on CT have their nodule(s) assessed by the most accurate method, where possible to guide appropriate use of interval imaging and recommendation for further workup. |
| Quality measure |
Structure:
|
Process:
|
|
| Description of what the quality statement means for each audience |
Service providers:
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry. |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114
Note: To ensure accuracy of comparative measurements, serial volumetry should be measured using the same CT settings, same software and release version. |
| Other information |
|
|
Quality statement 3
Rationale |
PET-CT examinations undertaken for assessment of solid pulmonary nodules are reported using qualitative assessment with an ordinal scale to define FDG uptake as absent, faint, moderate or intense, in relation to background lung tissue and mediastinal blood pool, to facilitate use of the Herder risk prediction model.
The Herder risk prediction model is the most accurate at predicting malignancy in solid pulmonary nodules and has been validated in a UK population. It uses clinical and radiological factors in conjunction with FDG uptake within the pulmonary nodule to determine the risk of malignancy. The incorporation of FDG uptake has a synergistic effect on the predictive accuracy of clinicoradiological prediction models but is dependent on the accurate classification of FDG uptake within solid pulmonary nodules using qualitative assessment with an ordinal scale. The standardisation of reporting of FDG uptake within solid pulmonary nodules on PET-CT facilitates reliable reproducibility of the Herder risk prediction model in clinical practice. |
| Quality measure |
Structure:
|
| Description of what the quality statement means for each audience |
Service providers:
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114; RCP/RCR Evidence-based indications for the use of PET-CT in the United Kingdom, 20165 |
| Other information |
|
| Definitions |
BTS qualitative ordinal scale for classification of solid pulmonary nodules with FDG PET-CT
Absent: uptake indiscernible from background lung tissue. Faint: uptake less than or equal to mediastinal blood pool. Moderate: uptake greater than mediastinal blood pool. Intense: uptake markedly greater than mediastinal blood pool. |
|
Quality statement 4
Rationale |
People with pulmonary nodules confirmed on CT are offered discharge, further surveillance, further workup or treatment according to BTS Guidelines (see Box 1 for specific recommendations) To ensure that patients are not followed up inappropriately where the risk of follow-up is likely to outweigh the benefit. To ensure that patients with larger nodules are managed according to assessment of risk of malignancy by further surveillance, further workup or treatment. |
| Quality measure |
Structure:
|
Process:
|
|
| Description of what the quality statement means for each audience |
Service providers:
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114; Walter, J E et al. Occurrence and lung cancer probability of new solid nodules at incidence screening with low-dose CT: analysis of data from the randomised, controlled NELSON trial, 20166 |
Box 1. Specific guideline recommendations in relation to quality statement 4.
Solid Pulmonary nodules
Offer discharge if:
the largest nodule is <80 mm3 or 5 mm diameter, except where there is a history of previous malignancy or the nodule was not seen on a previous CT within 2 years.
there are obvious benign features (diffuse central laminated or popcorn pattern of calcification or macroscopic fat) or typical perifissural or sub-pleural nodules.
people with solid pulmonary nodules who are stable by semi-automated volumetry at one year, or at 2 years if by diameter measurement.
Offer imaging follow-up with low radiation dose CT (LDCT) and semi-automated volumetric analysis if:
nodule(s) are <300mm3 or 8mm diameter, or have a calculated risk of malignancy of <10% Offer PET-CT to further assess risk of malignancy
nodule(s) that are ≥300mm3 or ≥8mm diameter and have a >10% risk of malignancy. Offer biopsy (may also elect to have surveillance imaging or definitive treatment)
nodules that have a risk of malignancy of 10 to 70% after PET-CT.
Offer definitive treatment with or without prior biopsy
if nodule(s) have a risk of malignancy of >70% after PET-CT.
Sub-solid pulmonary nodules (SSN)
offer interval thin section LDCT at 3 months to people with sub-solid pulmonary nodules ≥5 mm diameter and subsequently manage them according to risk of malignancy with follow-up of persistent SSN for 4 years
Source references BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114; Walter, J. E et al. Occurrence and lung cancer probability of new solid nodules at incidence screening with low-dose CT: analysis of data from the randomised, controlled NELSON trial, 20166.
Other information BTS Pulmonary Nodule Risk Prediction Calculator https://www.brit-thoracic.org.uk/standards-of-care/guidelines/bts-guidelines-for-the-investigation-and-management-of-pulmonary-nodules/bts-pulmonary-nodule-risk-prediction-calculator/ (to be read in conjunction with the relevant sections of the above Guideline).
NHS England Service Specification for Thoracic Surgical Services https://www.england.nhs.uk/publication/thoracic-surgery-adults/
NHS England Commissioning Guidance for The Whole Lung Cancer Pathway https://www.brit-thoracic.org.uk/media/396232/Clinical-Advice-for-the-Provision-of-Lung-Cancer-Services-Aug-2017.pdf, https://www.brit-thoracic.org.uk/media/382380/National-Optimal-LUNG-Pathway-Aug-2017.pdf
NLCFN Patient Information: https://www.nlcfn.org.uk/patient-information
Note: Integration of nodule volumetry software with other radiology systems used for image management and reporting is important to reduce reporting times and ensure images are stored appropriately for future reference.
| Quality statement 5 | People with pulmonary nodules considered for definitive treatment and suitable for surgical intervention are offered lobectomy with pathological confirmation of malignancy by frozen section, if not previously confirmed, or anatomical segmentectomy if unfit for lobectomy. |
| Rationale | To maximise the surgical resection rate for early stage lung cancer and to allow geographical and temporal comparison of resection rates to instruct service development. To ensure an appropriate surgical strategy for resection that minimises lobectomy for benign disease, ensures anatomical resection for all pulmonary nodules confirmed as lung cancer and that, where appropriate, a completion lobectomy occurs during the same anaesthetic. |
| Quality measure |
Structure:
|
Numerator 1:
|
|
Denominator 1:
Numerator 3:
|
|
Denominator 3:
|
|
| Description of what the quality statement means for each audience |
Service providers:
|
Healthcare professionals
|
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114; BTS Guidelines on the Radical Management of Patients with Lung Cancer, 20107 |
| Other information |
|
| Quality statement 6 | People with pulmonary nodules considered for definitive treatment but who decline or who are unsuitable for surgery are offered ablative* non-surgical treatment where safe. |
| Rationale | People who are unfit or decline surgery still stand to gain a lot from having early-stage lung cancer treated with curative intent. Such patients should therefore be offered alternative treatment with curative intent. The outcome of treatment is similar whether in biopsy confirmed malignancy or where unconfirmed. |
Structure:
|
|
| Quality measure |
Process:
|
| Description of what the quality statement means for each audience |
Service providers:
|
Healthcare professionals:
|
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114; BTS Guidelines on the Radical Management of Patients with Lung Cancer, 20107 |
| Other information | *Ablative treatment refers to stereotactic ablative body radiotherapy, radiofrequency ablation or microwave ablation.
|
| Quality statement 7 | People with pulmonary nodules confirmed on CT are offered verbal and written information that allows them to make an informed choice about their management. |
| Rationale | People with pulmonary nodules confirmed on CT should be provided with verbal and written information that allows them to make an informed choice about their management. |
| Quality measure |
Structure:
|
Process:
|
|
| Description of what the quality statement means for each audience |
Service providers:
|
People with pulmonary nodules confirmed on CT
|
|
| Relevant existing indicators | Local MDT minutes/database/audit |
| National data sources | National Lung Cancer Audit, Society for Cardiothoracic Surgery Thoracic Registry |
| Source references | BTS Guidelines for the Investigation and Management of Pulmonary Nodules, 20153; NICE Lung Cancer: Diagnosis and Management Guideline, 20114 |
| Other information |
|
Glossary of terms
Definitive treatment: removal or ablation of the nodule with curative intent.
Ablative treatment: stereotactic ablative body radiotherapy, radiofrequency ablation or microwave ablation.
Footnotes
BTS Quality Standards for the investigation and management of pulmonary nodules are endorsed by:Royal College of Physicians (RCP), Royal College of Radiologists (RCR), National Lung Cancer Forum for Nurses (NLCFN), Society for Cardiothoracic Surgery (SCTS), British Nuclear Medicine Society (BNMS).
Contributors: DB and MC were the lead authors responsible for the overall editing and production of the document. All authors were responsible for the final approval of the document.
Competing interests: All authors completed declarations of interest in line with the BTS Policy for Declarations of Interest, and forms are available on request from BTS Head Office.
Provenance and peer review: Commissioned; internally peer reviewed.
References
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