Frequently Asked Questions

1. What is the index endoscopy?
2. What is the process for the root cause analysis?
3. How will my unit be notified of the root cause analysis project?
4. Do I need to seek approval from Information Governance (IG) or Caldicott Guardian?
5. My Information Governance team has requested further detail on the project and need responses to several questions in order to approve our involvement. Where can I find further information?
6. Do endoscopists need to be concerned about the project?
7. Is the purpose of the project to find fault?
8. What if there are several endoscopy units in my Trust?
9. Why is there a combination of trusts and hospitals in the participating organisations?
10. Will endoscopies performed in the independent sector for the NHS be included in the project?
11. How many users can each organisation have?
12. How can users be added to the portal?
13. How are PEUGICs identified?
14. Why is the time period up to 3-years after endoscopy?
15. What happens when the diagnosis and index endoscopy occur at different trusts?
16. Are these all the cases identified or only some? If only some, could I have all of them, otherwise I have no way to interpret what looks like a serious problem at one of my endoscopy units?
17. We have been told there is a limit of 25 cases/organisation. Why has my organsation got more cases than this?
18. What is reallocation of cases?
19. Some cases go as far back as 6 years ago, do we need to do all of them?
20. We have identified some PEUGICs that are not on the list. Why is this?
21. Will the root cause analysis be time consuming?
22. Why can there be data quality issues?
23. Why are there cases without a cancer diagnosis hospital/index endoscopy hospital?
24. Why does the root cause analysis form require the GMC/NMC number of the person who did the index endoscopy?
25. What if I have queries about how to enter the data or categorise a case?
26. Why are patient names unintelligible?
27. Do you have a guide for calculating harm?
28. Will my data be used?
29. Why is aggregated data so important?
30. Is it possible to calculate our PEUGIC rate using the data in the portal?
31. We already assess PEUGICs monthly and have robust processes & checks in place which then feedback into our endoscopy user group. It feels like this national project is duplicating work.
32. Does the project replace the recommendation of the JAG, BSG and AUGIS to identify and review PEUGICs?
33. We already have a process in place to meet the JAG, BSG and AUGIS recommendation, why do we have to participate in this project?
34. How do I provide evidence to the JAG that we are participating in this project?
35. What is the process for more cases being added into the portal in the future?
36. How many PEUGIC cases can we expect to be uploaded every four months?
37. Can I review cases where I performed the endoscopy?

If you have any questions not answered by the material below please use the ‘Contact us’ form or email us on england.peugic.project@nhs.net.

What is the index endoscopy?

The index endoscopy is the most recent non-diagnostic endoscopy performed 3-36 months prior to an upper GI cancer diagnosis.

What is the process for the root cause analysis?

In the root cause analysis portal, there will be a list of patients who have had PEUGIC that were diagnosed at your organisation and/or had their index endoscopy in your organisation. Selecting one of these cases will launch the root cause analysis form. The root cause analysis form has been designed to be self-explanatory with explanation texts and links to a glossary page where necessary. In addition, there will be a variety of supporting documents in the portal to aid communication and implementation. These documents have been informed by experiences in thirteen pilot sites and the national post-colonoscopy colorectal cancer project. They will include explanatory documents, draft emails and presentations to share with colleagues and your organisation information governance team.

How will my unit be notified of the root cause analysis project?

The nominated organisation leads will be given detailed information about the project, and sign-up instructions. They will also receive suggested letters to send to information governance departments to register participation in this quality improvement project and relevant documentation about duty of candour and information governance.

Do I need to seek approval from Information Governance (IG) or Caldicott Guardian?

No. All the necessary approvals have been obtained from the National Disease Registration Service (NDRS) including the NDRS Caldicott Guardian. However, we recommend you inform your trust IG team of the root cause analysis project and suggested letters have been given to the organisation lead for this purpose. The project may identify cases that require discharge of the duty of candour and for this reason, we recommend you also inform and work with your organisation patient safety team from the outset of the project.

My Information Governance team has requested further detail on the project and need responses to several questions in order to approve our involvement. Where can I find further information?

Information governance guidance has been produced for this project. A Data Protection Impact Assessment (DPIA) has also been produced for the project to identify and minimise the data protection risks. If there are further IG questions, please contact us through the Contact Us form on the root cause analysis form or email england.peugic.project@nhs.net.

Do endoscopists need to be concerned about the project?

Virtually all endoscopists, even the very best, will have PEUGICs if they do enough endoscopy, especially if they scope patients at high risk of PEUGICs. In many instances, the PEUGIC will be considered unavoidable and in others it will not be clear whether the PEUGIC arose from poor quality endoscopy (largely because we don’t know the natural history of upper GI cancer). Inevitably, there will be some cases where it will be evident that the procedure was suboptimal and questions might be raised about the competence of individual endoscopists. However, the sample size will be far too small to make any judgements about competence, and as such, individual endoscopists should not be concerned that their competence is being questioned. The case will need to be reviewed in the context of other endoscopy performance data. Individuals should regard the PEUGIC root cause analysis project as an additional source of information about performance.

Is the purpose of the project to find fault?

No. The purpose of the root cause analysis project is to be more systematic about finding cases and reviewing them against a structured template to identify and prevent causes of PEUGIC. The dataset in the project portal will not be available to anyone outside the trust. However, data from the project will be aggregated (anonymously) to build an evidence base of why PEUGICs occur in England.

What if there are several endoscopy units in my Trust?

PEUGIC cases are identified on an organisation, not unit basis, but each hospital site will be identified on the portal. Up to four users can be registered for each organisation. Very large trusts with multiple large hospitals have been split into individual participating organisations to facilitate root cause analysis. However, the results, organisational learning and clinical governance issues should be under the auspices of the whole organisation.

Why is there a combination of trusts and hospitals in the participating organisations?

Very large trusts with multiple large hospitals have been split into individual participating organisations to facilitate root cause analysis.

Will endoscopies performed in the independent sector for the NHS be included in the project?

We know that 3% of NHS funded index endoscopies are performed by the independent sector. Unfortunately, we are unable to identify the NHS trust responsible for those index endoscopies. Therefore, cases with index endoscopies performed in the independent sector are not included in the PEUGIC project.

How many users can each organisation have?

The organisation lead can nominate up to three other individuals to also have access to the root cause analysis portal to assist with PEUGIC case review.

How can users be added to the portal?

Users can be added and removed in the ‘Manage portal users’ portal page which is only available to organisation leads. To add a user, insert their nhs.net or NHS accredited email into ‘Add a new user’ under ‘Manage portal users’. An email will be sent to that user to sign up to the Clinical Audit System and following admin checks an account will be created for them. The organisation lead will then be able to approve them within the ‘Manage portal users’ page under the ‘Action required’ tab.

How are PEUGICs identified?

For this project, PEUGICs are defined as when a patient underwent an endoscopy 3-36 months prior to an upper gastrointestinal cancer (squamous cell carcinoma or adenocarcinoma and variants) diagnosis. PEUGICs are identified following linkage of the cancer registry for cancer diagnosis records with HES (Hospital Episode Statistics) for endoscopy records. To find the most recent PEUGICs, we are identifying cancers in the provisional cancer registry prior to sign off where they become part of the final cancer registry. This may affect data quality in some cases.

Why is the time period up to 3-years after endoscopy?

For PEUGIC rate calculations the time period is 3 months to 3 years before cancer diagnosis to give an overview of the scale of the issue, track performance over time, and compare jurisdictions using the same metric. This root cause analysis delves deeper to find the exact causes for missed or delayed diagnoses.

An additional consideration is capturing PEUGICs in surveillance patients. Because surveillance patients are at higher risk of cancer, it is very important they are captured in the project. In recent years most services have had to delay surveillance procedures beyond recommended intervals because of pressures on waiting lists.

What happens when the diagnosis and index endoscopy occur at different trusts?

Approximately 23% of cases have a different cancer diagnosis trust and index endoscopy trust which is one of the huge benefits of national case identification. When it occurs, the case will be allocated to the organisation where the PEUGIC cancer was diagnosed to complete the questions regarding the cancer and its diagnosis. Once these have been completed the case will appear on the list of patients on the index endoscopy organisation site.

Are these all the cases identified or only some? If only some, could I have all of them, otherwise I have no way to interpret what looks like a serious problem at one of my endoscopy units?

We have restricted the root cause analysis form to a maximum of 25 cases because we did not want to overwhelm services. The intention is to get everyone started with the process and then regularly upload all newly identified cases. We can understand why you would wish for a complete set of cases to identify all serious problems. However, we can guarantee that while you will quickly discover the main issues, some will be so infrequent that even a complete set of cases will not identify all the shortcomings in a service. One of the main aims of the root cause analysis project is to acquire aggregated data which will provide strong evidence of all the possible problems that lead to PEUGICs. The idea being that services can implement change to prevent PEUGICs, even when they have not identified a problem. The airlines work on this principle: rare adverse events are shared, and future airline disasters are prevented by applying lessons learned from those rare events.

We have been told there is a limit of 25 cases/organisation. Why has my organsation got more cases than this?

Each organisation will receive up to 25 cases to review where the index endoscopy was performed at their trust. These includes cases where the cancer was diagnosed and the index endoscopy was performed at your organisation or where only the index endoscopy was performed at your organisation. When the cancer diagnosis and index endoscopy occur at different organisations, cases are allocated initially to the organisation of diagnosis regardless of the 25 case limit.

What is reallocation of cases?

You will notice that if the index endoscopy occurred in a different organisation from the cancer diagnosis, and your organisation is the site of cancer diagnosis, we are asking you for the cancer details of these patients. In this instance, once you have completed the cancer details section, the case will be reallocated to the organisation of the index endoscopy. The cancer details section is quite quick to complete so we encourage all trusts to check to see how many of their allocated cases are in this category and enter the data as soon as possible, to help the index endoscopy trust have sufficient time to complete their data entry too.

Some cases go as far back as 6 years ago, do we need to do all of them?

Up to 25 patients diagnosed with cancer at your organisation are uploaded onto the portal every four months. The process was to select the most recently diagnosed PEUGICs that fit the criteria. The registry is a few months behind the actual cancer diagnosis so the most recent cancers are likely to have been diagnosed a few months before each of the latest uploads. It is likely that some of the 25 PEUGICs will be diagnosed up to 3 years prior to the latest upload and if so, some will have had their endoscopy as far back as 6 years prior to the latest upload.

We have identified some PEUGICs that are not on the list. Why is this?

If PEUGICs are identified that are not on the list it is likely that these have fallen outside the window of the most recent 25 PEUGICs diagnosed at your organisation. Alternatively the patient data may have been incorrectly coded (more frequent in more recent cases which have a provisional case registration status before becoming finalised) which cause them not to be picked up during case selection.

Will the root cause analysis be time consuming?

The time required to review a case depends on your organisation information systems and whether you have electronic capture of endoscopic images. If you have to review large sets of case notes, and search for Polaroid images, it will take some time to answer all the root cause analysis form questions. However, once you have all the relevant information, completing the template is quick. The benefit of identifying areas in need of improvement will hugely outweigh the time it takes to review cases. Some of these will be quick wins, but other areas of improvement such as optimising Barrett’s surveillance may be more challenging.

Why can there be data quality issues?

We derive our data - the index endoscopy and the nature and date of diagnosis of the cancer - from national datasets. Data issues arise (largely) from two sources:

1. Incorrect cancer data. To make the cases as contemporaneous as possible we include the most recent additions to the cancer registry. The cancer registry can only act on the information it is given and normally goes through a validation process before sign off that takes up to 12 months. There is therefore a possibility that either the nature of the cancer, or the date of diagnosis is wrong. Providing cases that do not fit the project criteria is the small price we pay for having the most recent cases.
2. Incorrect coding of procedures in HES. Unfortunately, this is quite common. Some trusts coding of endoscopies is better than others. This project will be able to quantitate the size of this problem and prompt trusts to code more accurately. If you find a lot of miscoded endoscopy dates, we urge you to speak to your coders.

If the patient data, cancer data, cancer diagnosis or index endoscopy information are incorrect, you are able to provide details in the initial questions of the root cause analysis form. This will not affect the eligibility of the patient for the PEUGIC root cause analysis for many of the patients. The root cause analysis form will guide you as to whether the patient is still eligible for the project, following your correction of any data that were incorrect.

We anticipated there may be data quality issues and this is why we have provided an opportunity to point out erroneous data in the root cause analysis form. Please do not exclude a case if it was unavoidable - it is still definitely a PEUGIC. A hugely important output from the project is the proportion of PEUGICs that are unavoidable. We will then be able to put benchmarking data into context, and set targets for how much scope there is for preventing PEUGICs.

Why are there cases without a cancer diagnosis hospital/index endoscopy hospital?

Sometimes the hospital code for the cancer diagnosis event in the Cancer Registry or the index endoscopy event in the HES (Hospital Episode Statistics) dataset is the trust code. If your organisation is one of the hospitals from the very large trusts, cases where we do not have a hospital code are allocated to all hospitals. It is up to the hospitals to pick up cases that belong to their hospital. As soon as a user starts to complete the case it will be blocked to any other users to avoid more than one user completing the same case.

Why does the root cause analysis form require the GMC/NMC number of the person who did the index endoscopy?

The GMC/NMC number is not a mandatory field. It is possible to complete the dataset without entering a GMC/NMC because there is a ‘Not known’ option for this field but we would prefer you to enter these data if at all possible. The sample size required to assess individuals using their PEUGIC rate is huge so we will never be able to make judgments on individual competence or find fault with individuals. However, it will be possible using the GMC/NMC number to link the PEUGIC dataset to the National Endoscopy Database. This linkage will allow important multivariate analysis of the relationship of PEUGICs to performance metrics of endoscopy to improve endoscopy quality in future.

Doctor’s GMC numbers can be found in the medical register by providing their name. Nurse’s pin number/NMC number can be verified at the nmc register but it is not possible to use the register to obtain an NMC number using a name. Please ask your nurse colleagues for their NMC numbers at the start of the project and keep these to hand.

What if I have queries about how to enter the data or categorise a case?

We have set up a dedicated email address which members of the team will monitor on a weekly basis at the outset of the root cause analysis project. We will try and address any concerns within a week of submission. We have created some mock cases in the duty of candour guidance which outlines some of the common scenarios but inevitably there will be new problems that arise, and we are keen to help with the decision-making processes.

Why are patient names unintelligible?

To protect patient identity we have used the method used by the National Disease Registry Service whereby letters in a patient’s name are replaced with others. To reveal patient names, click the Reveal names tab found at the top of the page. This will expose patient names for 30 seconds.

Do you have a guide for calculating harm?

The issue of harm is difficult to be too prescriptive about. However, we consider death, potentially unnecessary surgical (rather than endoscopic resection if feasible) or palliative rather than potentially curative treatment as major harm. If there is doubt, please consult your risk management team. It’s also useful to discuss anonymised cases in a forum (e.g. an endoscopy user’s group) and ask the group what level of harm has been caused by delay in diagnosis. If you want us to review an anonymous case summary, we can provide an impartial opinion but please appreciate that judgement is not always straightforward.

Will my data be used?

The organisers of the project have permission from the National Disease Registration Service to collect and present aggregated data. The intention here is to develop a robust evidence base of factors that lead to PEUGICs. At the moment, there are very small samples of PEUGIC reviews that may not represent the ‘real world’. It is anticipated that a large sample from a national root cause analysis project will provide a high level of confidence of factors that lead to PEUGIC, at least in systems like the NHS. As the project progresses, the outputs will be shared with all organisations. It is expected they will be of use to other jurisdictions that are not able to collect such data. It is expected that during the process of assessment for the purposes of achieving or maintaining accreditation, the JAG may request sight of key issues arising from the project and importantly evidence they are being addressed. There will be no sharing of patient or endoscopist level data.

Why is aggregated data so important?

Aggregated data from the project will provide strong evidence of the causes of PEUGIC, justifying interventions based on the findings to reduce PEUGICs. Unfortunately, individual case series, however well conducted, are too small to justify such interventions. With such evidence it will be possible for professional bodies to make recommendations, and possibly even stipulate requirements designed to reduce the occurrence of PEUGICs. Another bonus of aggregated data will be to provide a reliable estimate of what proportion of PEUGICs are unavoidable and what proportion are falsely attributable to individual trusts because of coding or other data errors. This will help clinicians, patients, the wider public and the media understand that even with perfect processes and perfect endoscopy there will always be PEUGICs. The flip side of this is that we will also be able to predict with more certainty how many PEUGICs are avoidable and be able to set targets for the future. Widespread participation in the project will send a strong message to the country, and indeed the rest of the world, that England is very serious about improving the quality of endoscopy services. Finally, we expect other countries to benefit from what we learn from aggregated data.

Is it possible to calculate our PEUGIC rate using the data in the portal?

We have selected the latest 25 PEUGICs for each site. It is not possible to derive PEUGIC rates from this sample, or indeed any locally derived sample, or future PEUGICs we give you, as the number of upper GI cancers that are not PEUGIC is not included. To derive PEUGIC rates that are meaningful and can be compared between organisations, we have to integrate national cancer registry and HES data to perform the calculation. We do not yet have full access to up to date data to perform the calculation, so we are having to use older cancer data, and this means we can only currently provide rates for cancers diagnosed up to 2018. Please contact us if you wish to have this data, including adjusting it for factors associated with PEUGIC at trust level.

We already assess PEUGICs monthly and have robust processes & checks in place which then feedback into our endoscopy user group. It feels like this national project is duplicating work.

If you have discussed a case identified by the project previously then all the work may have been done, assuming you have addressed all the relevant questions, and you will only need to enter the responses. The advantage of the root cause analysis template is that it ensures all the relevant questions are considered and it is possible you may need to review some of your cases to answer the additional questions. This project is not a one off. The intention is to move from the current ad hoc review of PEUGICs (which will vary from nothing to a monthly review across trusts) to a consistent, and we hope gold standard approach using the portal. Using the portal should not interfere with your regular review of cases. It should enhance it with richer information about the case. It is very likely there will be cases you have missed in the portal who were diagnosed at another trust.

Does the project replace the recommendation of the JAG, BSG and AUGIS to identify and review PEUGICs?

The recommendation has not changed. The root cause analysis tool is helping endoscopy teams meet the recommendation by finding all the cases and providing a structured template to review cases. Having a structured template means that a possible reason for the PEUGIC is less likely to be overlooked.

We already have a process in place to meet the JAG, BSG and AUGIS recommendation, why do we have to participate in this project?

Participating in the PEUGIC root cause analysis project is not mandatory, but it will provide evidence to the JAG and Care Quality Commission (CQC) that a process to review PEUGICs is in place at individual trust level, and that the review is being conducted against recommended criteria. Increasingly, the CQC will be using proxy evidence to rate trusts and failure to participate in service improvement projects, particularly ones like this, will be viewed unfavourably. Furthermore, it will be possible to aggregate data which will provide substantial benefits. It is hoped that endoscopy teams will appreciate the clear benefit to patients of participation in the project and that this will be the prime motivation to take part.

How do I provide evidence to the JAG that we are participating in this project?

The national PEUGIC project process replaces whatever endoscopy teams were doing previously. The PEUGIC project team shall be providing the JAG with a report of which trusts are taking part in this project and this should be enough to meet the recommendation for those that are. We are working on producing an output from the portal that might be used to support governance meetings. Meanwhile we encourage all teams to bring a summary of the project cases and learning to the wider endoscopy team and this could be in the form of a presentation.

What is the process for more cases being added into the portal in the future?

We are aiming to update the portal every four months. Updates will take place at the end of January, May and September and will include all newly registered cancers in the cancer registry database that had an endoscopy in the previous 3-36 months. Depending on the size of your endoscopy service, and the rate of cancer diagnosis by endoscopy, we expect 95% of sites to have 1-7 PEUGICs per upload.

How many PEUGIC cases can we expect to be uploaded every four months?

The number of cases for each organisation is directly proportional to the number of cases of upper gastrointestinal cancer detected by endoscopy (not the total number of upper gastrointestinal cancers diagnosed) and the PEUGIC rate for that organisation. We expect up to 10 PEUGICs diagnosed within three years of an endoscopy to be diagnosed for every 100 cancers detected by endoscopy. For small, medium and large trusts we are looking at respectively approximately 50, 100 and 200 upper GI cancers diagnosed by endoscopy each year. This would mean there were, respectively 5, 10 and 20 PEUGICs each year, or 1-2, 3-4 or 6-7 cases uploaded every four months.

Can I review cases where I performed the endoscopy?

Yes.