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Endoscopy
Original research
Quality indicators for Barrett’s endotherapy (QBET): UK consensus statements for patients undergoing endoscopic therapy for Barrett’s neoplasia
  1. Durayd Alzoubaidi1,
  2. Krish Ragunath2,
  3. Sachin Wani3,
  4. Ian D Penman4,
  5. Nigel John Trudgill5,
  6. Marnix Jansen6,
  7. Matthew Banks7,
  8. Pradeep Bhandari8,
  9. Allan John Morris9,
  10. Robert Willert10,
  11. Phil Boger11,
  12. Howard L Smart12,
  13. Narayanasamy Ravi13,
  14. Jason Dunn14,
  15. Charles Gordon15,
  16. Jayan Mannath16,
  17. Inder Mainie17,
  18. Massi di Pietro18,
  19. Andrew M Veitch19,
  20. Sally Thorpe20,
  21. Cormac Magee21,22,
  22. Martin Everson20,
  23. Sarmed Sami20,
  24. Paul Bassett23,
  25. David Graham20,
  26. Stephen Attwood24,
  27. Oliver Pech25,
  28. Prateek Sharma26,
  29. Laurence B Lovat27,
  30. Rehan Haidry28
  1. 1 Division of Surgery and Interventional Science, University College London (UCL), London, UK
  2. 2 Department of Gastroenterology, Queens Medical Centre, University Hospital Nottingham, Nottingham, UK
  3. 3 Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
  4. 4 Gastrointestinal Unit, Western General Hospital, Edinburgh, UK
  5. 5 Gastroenterology, Sandwell General Hospital, West Bromwich, UK
  6. 6 Department of Histopathology, University College London Hospital, London, UK
  7. 7 Department of Gastroenterology, University College London Hospital, London, UK
  8. 8 Department of Gastroenterology, Queen Alexandra Hospital Portsmouth, Portsmouth, UK
  9. 9 Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK
  10. 10 Department of Gastroenterology, Manchester Royal Infirmary, Manchester, UK
  11. 11 Department of Gastroenterology, University Hospital Southampton, Southampton, UK
  12. 12 Department of Gastroenterology, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, Merseyside, UK
  13. 13 Division of Surgery, St James’s Hospital, Dublin, Ireland
  14. 14 Department of Gastroenterology, Guy's and St Thomas' Hospital, London, UK
  15. 15 Department of Gastroenterology, Royal Bournemouth Hospital, Bournemouth, UK
  16. 16 Department of Gastroenterology, Coventry and Warwickshire NHS Trust, Coventry, UK
  17. 17 Department of Gastroenterology, Belfast City Hospital, Belfast, UK
  18. 18 MRC Cancer Unit, University of Cambridge, Cambridge, UK
  19. 19 Department of Gastroenterology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK
  20. 20 Department of Gastroenterology, University Colleg London Hospital, London, UK
  21. 21 Department of Gastroenterology, University College London Hospital, Londons, UK
  22. 22 Metabolism and Experimental Therapeutic, University College London Division of Biosciences, London, UK
  23. 23 Statsconsultancy, Amersham, UK
  24. 24 Department of Health Services Research, Durham University, Durham, UK
  25. 25 Department of Medicine, HSK Wiesbaden, Wiesbaden, Germany
  26. 26 Department of Gastroenterology, University of Kansas, Kansas City, Kansas, USA
  27. 27 Division of Surgery and Interventional Science, University College London (UCL), Londons, UK
  28. 28 Department of Gastroenterology and Division of Surgery and Interventional Science, University College London Hospitals NHS Foundation Trust, London, UK
  1. Correspondence to Dr Durayd Alzoubaidi, Division of Surgery and Interventional Science, University College London, London W1W 7TS, UK; d.alzoubaidi{at}ucl.ac.uk

Abstract

Introduction Endoscopic therapy for the management of patients with Barrett’s oesophagus (BE) neoplasia has significantly developed in the past decade; however, significant variation in clinical practice exists. The aim of this project was to develop expert physician-lead quality indicators (QIs) for Barrett’s endoscopic therapy.

Methods The RAND/UCLA Appropriateness Method was used to combine the best available scientific evidence with the collective judgement of experts to develop quality indicators for Barrett’s endotherapy in four subgroups: pre-endoscopy, intraprocedure (resection and ablation) and postendoscopy. International experts, including gastroenterologists, surgeons, BE pathologist, clinical nurse specialist and patient representative, participated in a three-round process to develop 15 QIs that fulfilled the RAND/UCLA definition of appropriateness.

Results 17 experts participated in round 1 and 20 in round 2. Of the 24 proposed QIs in round 1, 20 were ranked as appropriate (put through to round 2) and 4 as uncertain (discarded). At the end of round 2, a final list of 15 QIs were scored as appropriate.

Conclusions This UK national consensus project has successfully developed QIs for patients undergoing Barrett’s endotherapy. These QIs can be used by service providers to ensure that all patients with BE neoplasia receive uniform and high-quality care.

  • Barrett’s Oesophagus
  • endoscopy
  • Endoscopic Mucosal Resection (EMR)
  • Endoscopic Submucosal Dissection (ESD)
  • Radio Frequency Ablation (RFA)

https://doi.org/10.1136/flgastro-2019-101247

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    Significance of this study

    What is already known on this topic

    • Endoscopic eradication therapy for Barrett’s neoplasia has revolutionised the management of patients with Barrett’s neoplasia; however, despite various societal guidelines, there still exists a great variation in clinical practice that results in variable patient outcomes.

    What this study adds and how might it impact on clinical practice in the foreseeable future

    • Quality indicators for Barrett’s endotherapy have been published recently in the USA.

    • Adherence to these quality indicators has shown improvement in dysplasia detection rate; however, quality indicators for Barrett’s endotherapy in the UK and Europe are lacking.

    • These quality indicators identify important steps for providing a unified high-quality care based on the best available evidence and expert opinion.

    • These quality indicators may also be used for the training of the new generation of advanced endoscopists, and adherence to these measures would ultimately result in improving patient outcomes.

    Introduction

    The past decade has seen significant advancement in minimally invasive endoscopic treatment modalities for Barrett’s oesophagus (BE) neoplasia. Short-term and long-term data report high eradication rates, acceptable disease durability and good safety profile that are comparable with the outcomes of surgical treatment.1 There has been great emphasis on targeting patients at earlier disease stages amenable to endoscopic eradication therapy (EET). EET for early neoplastic BE has been recommended by various major international guidelines.2

    EET for BE neoplasia has revolutionised the management of patients with BE neoplasia and is increasingly used at high-volume tertiary referral centres and smaller district general hospitals. Adherence to quality indicators (QIs) introduced by the American Gastroenterological Association for the endoscopic management of patients with BE has been shown to improve dysplasia detection rate. Despite various societal guidelines,2 there still exists a great variation in clinical practice that results in variable patient outcomes.

    It is important to note that the management of patients with BE neoplasia is confined not just to the endoscopic procedure. It requires case discussion in a dedicated multidisciplinary team (MDT) meeting with careful explanations to patients of their disease status and available therapies prior to and after endotherapy.

    The current endoscopic management of BE neoplasia consists of endoscopic resection (ER) of visible lesions for accurate staging and risk stratification of patients, followed by field ablation of the remaining areas of flat BE to prevent the development of metachronous neoplasia. It is therefore important that cases are carefully selected for endoscopic therapy following discussion in MDTs with appropriate choice of therapy (after discussion with the patient), with strict follow-up of these cases to ensure high-quality service provision and better patient outcomes.

    It is essential that medical resources are used appropriately and that health provision is shaped and maintained at the highest standard in order to ensure the best possible patient outcomes. Healthcare systems and providers will therefore need to be aligned to ensure a streamlined, efficient and high-quality service provision to all patients. QIs for Barrett’s endotherapy (BET) in the UK and Europe are lacking and have led to variable outcomes in the past.3

    The aim of this project was to develop physician-led quality indicators for Barrett’s endotherapy (QBET) to define standardised clinical practice and achieve optimal clinical outcomes for all patients with BE neoplasia.

    The aim from this project is not to replace existing guidelines but to create an adjunct so that clinicians can measure performance in a systematic way.

    Methods

    This project was not a clinical trial and there was no search conducted on humans.

    The RAND/UCLA Appropriateness Method

    The RAND/University of California, Los Angeles Appropriateness Methodology (RAND/UCLA Appropriateness Method (RAM)) was developed in the 1980s as part of the RAND Corporation/UCLA Health Services Utilisation Study. It is a tool used to measure the overuse and underuse of resources. In RAM an appropriate measure refers to one in which the expected health benefit exceeds the expected negative consequences by a wide margin, such that the procedure is worth performing without considering the cost.4 This methodology is used in situations where there is no adequate high-quality research (eg, randomised controlled trials) to guide clinical practice, and therefore the best available evidence is combined with expert opinion, in order to develop QIs. RAM is a modified Delphi method that gives experts the opportunity to have a face-to-face discussion. RAM has been used in various clinical specialties including gastroenterology.5 This methodology was successfully used in establishing similar quality measures in EET in the USA endorsed by the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG).5

    We used RAM to combine the best available scientific evidence with the collective judgement of experts to develop QBET in four subgroups that are integral to patient selection, treatment and follow-up in BET (figure 1). The expert panel was selected based on membership in the UK radiofrequency ablation registry and publication history in the field of BE and BET. In addition, geographical variation was considered to ensure expert representation from all regions in the UK, which could be representative of the European variation in practice. The experts consisted of gastroenterologists and therapeutic endoscopists (n=20), including two surgeons performing surgery for advanced oesophageal adenocarcinoma (OAC) and providing BET, and one BE expert pathologist. We also had participation from a BE clinical nurse specialist, a medical statistician and a patient representative. We developed QIs in four subgroups, as follows:

    Figure 1
    Figure 1

    RAND/UCLA Appropriateness Method (RAM): summary. EET, endoscopic eradication therapy.

    • Pre-endoscopy.

    • Intraprocedure (resection).

    • Intraprocedure (ablation).

    • Postendoscopy.

    Round 0

    RAND/UCLA uses three rounds as shown in figure 1. In round 0, experts were introduced to the project methodology and objectives (via teleconference on 18 September 2017 by RH, DA and KR) and familiarised with the RAM process. In addition, one expert was allocated as lead for each subgroup to facilitate the discussions during the face-to-face meeting (round 2). After round 0, the core group leading the project (RH, DA, KR, PS, OP) met to collate a list of potential QIs. These were then reviewed with the project leads, and the project leads (consisting of national and international experts) then proposed potential QIs for each of the four subgroups, which were put forward for ranking at round 1 (24 QIs in total).

    Round 1

    In round 1, 17 experts had the opportunity to rank each of the 24 QIs electronically in an independent fashion. This was done without interaction with other colleagues. The proposed QIs were sent to all the participating experts via a REDCap (Research Electronic Data Capture) database.

    Study data were collected and managed using REDCap electronic data capture tools hosted at University College London Hospital.6 7 REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources.

    Instructions were also sent to the panel indicating that each QI should be scored by each expert based on their current expertise and knowledge on the topic. The experts were advised to score each QI as it would be applied to an average patient presenting to an average medical facility and to an average physician without the consideration for cost or feasibility of applying the QI in clinical practice. Each QI was ranked from 1 to 9 as per the RAM protocol.

    • Score of 1, 2, 3: inappropriate QI.

    • Score of 4, 5, 6: uncertain QI.

    • Score of 7, 8, 9: appropriate QI.

    Following round 1 voting, all the scores were collected and analysed using four statistical methods by an expert statistician with knowledge of the RAM process.

    In addition, an extensive literature search on PubMed on the topic of BE and BET was performed around the proposed QIs. The literature search was limited to publications from 1 January 1990 to 23 January 2018.

    Prior to the round 2 face-to-face interaction and voting, the following were sent to all the investigators:

    • A summary copy of the literature search for each QI.

    • A document showing the distribution of all the responses from round 1, including the investigator’s personal response.

    Round 2

    Only QIs that were deemed appropriate at round 1 (based on round 1 voting and statistical analysis) were put forward for discussion at round 2. The round 2 meeting (face-to-face meeting) took place on 14 March 2018 in London. At this meeting 20 investigators were provided with individual iPads containing all the overall results of the round 1 voting, a summary of all the literature searches around the QIs, and full text copies of all manuscripts and references for reference and discussion. The lead for each subgroup led the discussion for each QI in that subgroup during this meeting. Each QI was discussed in detail taking into account the opinion from all those present and the available scientific literature. QIs were reworded, deleted and new QIs were developed (where necessary) for each of the four subgroups.

    At the end of round 2 meeting, a set of 15 QIs were finalised and scored by each investigator (pre-endoscopy 2 QIs; intraprocedure (resection) 5 QIs; intraprocedure (ablation) 6 QIs; and postprocedure 2 QIs). The experts also agreed on setting performance thresholds for each QI (if indicated) in order to set aspirational targets for all service providers. The median score (and range) of suggested performance thresholds is included with each QI. There were no set aspirational targets for QIs with predefined performance target in the text (eg, intraprocedural (ablation) QI number 4). The expert panel recognised that some performance targets had to be set cautiously in order to avoid undermining established efficient practices, and therefore aspirational targets were set to encourage centres to work towards enhancing their practice and performance.

    There were no attempts to force the expert panel to reach a consensus, and each expert had the opportunity to score the finalised QIs independently.

    Statistical method

    First, summaries of the number of responses in three categories were produced. Each response was categorised into one of the following categories:

    • Inappropriate: score 1–3.

    • Uncertain: score 4–6.

    • Appropriate: score 7–9.

    In addition to the categorisation, the median score for each QI was calculated and summarised.

    The deviation in the responses between the panel members was assessed using a number of different methods. First, deviation was assessed by the MAD-M statistics. This is the mean absolute deviation from the median (MAD-M). Higher values of MAD-M indicate more spread in responses between the panel. A second measure was based on the BIOMED Concerted Action on Appropriateness definition. This method calculates the number of raters outside of the response category (ie, inappropriate, uncertain, appropriate) containing the median response. Disagreement was assumed if the number of raters outside this category meets a predefined threshold. In the RAND/UCLA handbook guidance is given for panel sizes up to 16 raters, but none is provided for 20 raters, as per this panel. Although there were no set guidelines for this number of raters, the decision was based on the same criteria as for a 16-rater panel (agreement if ≤4 raters outside the category). The third measure used the RAND method that tests hypotheses about the distribution of ratings in a hypothetical population of repeated ratings. It is hypothesised that 90% of the hypothetical population of repeated ratings are within one of two extra wide regions (1–6 or 4–9). The binomial test was used to calculate the probability (p value) that that ‘true’ value is below 90%. If the calculated probability is below the predetermined level of 0.10, the conclusion will be reached that there is disagreement among raters. The final measure of deviation uses the interpercentile range adjusted for symmetry (IPRAS) method. This method is based on the interpercentile range (IPR) between the 30th and 70th percentiles. The IPRAS is a statistics based on the IPR which is adjusted for symmetry. Disagreement was assumed if the IPRAS was larger than the IPR.

    An additional set of analyses examined the threshold values for questions where these were appropriate. Median values and ranges were calculated for the thresholds.

    The measures of spread included the following:

    • The count of responses in each three-point region (1, 2, 3 – 4, 5, 6 – 7, 8, 9).

    • MAD-M.

    Appropriateness was measured using the following:

    • Median rating.

    • BIOMED Concerted Action on Appropriateness definition.

    • P value.

    • IPRAS.

    A QI was deemed appropriate if it met the definition of appropriateness, using all defined statistical methods.

    Results

    The summary of responses from round 2 for each individual QI is shown in table 1. At round 2, 20 investigators ranked 15 QIs that were all deemed appropriate and are shown in tables 2–5 with corresponding aspirational performance target (if indicated) and evidence summary. During round 1, 17 investigators ranked 24 QIs, of which 20 were deemed appropriate and 4 uncertain (table 6).

    View this table:
    Table 1

    Summary of responses from round 2 to individual QI

    View this table:
    Table 2

    Appropriate pre-endoscopy QIs after round 2 voting with the median score, MAD-M, BIOMED analysis, p value, IPRAS analysis and the performance threshold

    View this table:
    Table 3

    Appropriate intraprocedure (resection) QIs after round 2 voting with the median score, MAD-M, BIOMED analysis, p value, IPRAS analysis and the performance threshold

    View this table:
    Table 4

    Appropriate intraprocedure (ablation) QIs after round 2 voting with the median score, MAD-M, BIOMED analysis, p value, IPRAS analysis and the performance threshold

    View this table:
    Table 5

    Appropriate postprocedure QIs after round 2 voting with the median score, MAD-M, BIOMED analysis, p value, IPRAS analysis and the performance threshold

    View this table:
    Table 6

    Quality indicators ranked as uncertain after round 1 voting with the median score, MAD-M, BIOMED analysis, p value and IPRAS analysis

    Discussion

    Endoscopic treatment for dysplastic BE and early OAC has been recommended by various major societal guidelines; however, QIs for the management of patients with BE neoplasia have been lacking. This piece of work delivers a UK-based collection of QIs that will allow streamlined and accountable delivery of best clinical practice to patients undergoing BET.

    This nationwide project combined the best available evidence with the collective judgement of national and international experts in order to develop a set of formally validated QIs for the management of patients with BE neoplasia using a rigorous and validated methodology (RAM). RAM, unlike the original Delphi, provides the expert panel with the opportunity to have a face-to-face discussion in round 2. Unlike guidelines which use a consensus methodology, RAM reduces the possibility of results being influenced by the opinion of the most senior or most vocal member of the panel.

    These UK-based QIs reflect those recently published QIs in BET in the USA5; we were able to develop QIs for the intraprocedure component of patient care and for the management of patients at the pre-endoscopy and postendoscopy stages. In addition this UK-based project covered various aspects of patient care, including the importance of formal training of endoscopists prior to service provision, the use of high-quality endoscopic imaging modalities for lesion recognition in BE surveillance and the need for individual patient discussion at dedicated MDTs.

    Adherence to Prague classification is known to result in improved dysplasia detection in patients with BE. This may be influenced by data from tertiary centres where diagnosis was obtained by expert BE endoscopists that are more likely to adhere to Prague classification with access to better endoscopic equipment, including high-definition endoscopy and virtual chromoendoscopy.

    Our expert panel acknowledged the importance of ER modalities (endoscopic mucosal resection and endoscopic submucosal dissection (ESD)) for the management of visible lesions in BE neoplasia. ESD is a feasible treatment option that allows en-bloc resection for histological staging and treatment of patients with early BE neoplasia. ESD is likely to expand in the near future, and these QIs may need to evolve in order to cater for that in due course.

    It is important that the clinical community recognises the balance between performing BET and the rate of success and stenosis. Therefore the expert group emphasised the importance of minimising stricture rates (not exceeding 10%–15%) post-BET and the need for discussion of patients’ care in MDTs prior to BET and when BET fails to achieve successful outcomes.

    The current published evidence in BET3 provides data that are confined to a limited time period (less than 10 years); however, BET is expanding rapidly and therefore we need to continue long-term follow-up in these patients and monitor outcomes, which will provide us with essential information that will shape our future practice.

    In this project we were also able to set aspirational performance thresholds to ensure that patient care is of highest standard. Regulatory and accrediting agencies as well as hospitals and clinicians may use these QIs to measure performance and highlight areas for improvement. The regular audit of outcomes and adverse events will ensure the efficacy and safety of endoscopic therapy for patients with early BE neoplasia. Auditing results may be used to implement changes in routine practice nationally, allowing comparison of local practices with national standards. These QIs may also be used for teaching, service development and standardisation of care at all hospitals performing BET. Future studies will need to investigate the positive and the negative impact of these QIs on patient outcomes.

    There were some limitations to this study. First, high-quality evidence such as randomised controlled trials in the literature was not available for some QIs; however, this situation is common in many aspects of healthcare, and it was the very reason that the expert panel methodology such as RAM was developed.4 Second, some healthcare centres in the country may not be equipped with high-quality endoscopic modalities, and therefore these QIs may have a negative impact on their practice. Third, there was lack of validation of these QIs by an external committee and our expert panel voted on QIs that they developed themselves; hence, all the QIs in round 2 voting performed very well. Finally, the expert panel failed to determine the number of procedures needed to be performed by a centre to qualify as high-volume centre and also failed to determine the adequate number of procedures needed by an endoscopist prior to performing independent BET.

    In conclusion, this is the first UK national consensus project that has used a validated methodology to successfully develop process-based QIs for patients undergoing endoscopic treatment for early BE neoplasia. These indicators identify meaningful and important steps for providing a unified high-quality care based on the best available evidence and expert opinion. These QIs may also be used for the training of the new generation of advanced endoscopists, and adherence to these measures would ultimately result in improving patient outcomes.

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    Footnotes

    • Presented at This study was previously presented as an abstract at UEGW 2018.

    • Contributors DA is the first author, and has written and submitted the manuscript, and was directly involved with the planning, analysis, data search and critique of this paper. KR, SW, IDP, NJT, MJ, MB, PrB, AJM, RW, PhB, HLS, NR, JD, CG, JM, IM, MdP, AMV, ST, CM, ME, SS, DG, SA, OP, PS and LBL were directly involved with the planning and critique of this paper and provided intellectual input to this paper. PaB significantly contributed to the statistical analysis and critique of this paper. RH was directly involved in the planning, analysis, data search and critique of this paper, and is the senior author. All authors contributed to the refinement of the paper and approved the final manuscript.

    • Funding This project received funding from the BSG to cover travel expenses endured by the investigators in order to attend the face-to-face meeting in London for round 2 voting.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.