Knowledge Bank

Within Concentric a clinician can review the state of any episode by searching for the patient.

Currently we do not provide functionality for clinicians to receive automated notifications when consent has been given. There are some situations where we believe this may be valuable to users - for example where a clinician does a small number of large cases, or sometimes in private practice - but for many this would just create notification noise either in-app or via email.

Planned development work in this area:

Improved episode filtering

Filtering by episodes is being introduced so that lists can be viewed based on different things such as episode status (awaiting remote consent, consent confirmed etc), episodes that the individual has interacted with, and by responsible clinician (and any combination of these).

Patient reminder to complete remote consent

The majority of patients complete remote consent within 48 hours of it being enabled. We plan to introduce a single reminder to patients (via the same comms route as initially used) at 48 hours if remote consent is not complete.

Clinician opt-in to status updates

At point of enabling remote consent (the only action that may need to be completed asynchronously by patients) an opt-in checkbox is planned for the clinician to state that they would like email notification that remote consent has been completed.

Consent can be revoked for any episode where consent has been given (either first stage consent or following confirmation of consent).

Revocation can only be done on a clinician login, not via the patient application. This is analogous to how it would be managed historically with paper consent, and is appropriate for 2 reasons:

- Revocation of consent is not usually an end point - it is usually a trigger for a conversation around alternative approaches. Managing revocation of consent via the clinician application ensures that no revocation events are missed.

- There is a risk that revocation could be completed at the last minute by the patient if it were available via the patient application. This could lead to a situation where the clinical team are not aware that revocation has occurred (for example an updated ‘revoked’ consent form may not have arrived into the EHR), leading to medico-legal complications should the procedure proceed.

Yes, Concentric is used across all specialties, including across both radiotherapy and chemotherapy.

The consent process is very similar for oncology as it is for surgical procedures, with a few small tweaks:

- appropriate wording is used, so for example ‘your treatment’ is used instead of ‘your surgery’,

- things that are irrelevant - such as consent statements around discussing anaesthetic plan are removed.

Consent templates

We use the CRUK (Cancer Research UK) and RCR (Royal College of Radiologists) templates as the basis of our oncology consent templates, and work with both organisations.

RCR - We were the partner organisation with the RCR for the national standardised radiotherapy templates project.

CRUK - We were named as a supplier in CRUK’s econsent guidance (see page 24-25).

Both organisations have mechanisms in place to inform the Concentric team of the release of new templates or updates to templates.

As with all other content, these templates can be modified locally should you wish.

Addition of remaining CRUK templates

There are a large number of CRUK templates and the clinical team have been adding these as templates in Concentric based on their volume of use. There are some that do not have their own template within Concentric as of yet, and a generic SACT template is used in this example.

A getting started guide should be shared with each new user - this is embedded as a link within the account activation email.

In some circumstances the getting started guide is managed by the healthcare organisation within a training portal, and in others the onboarding information is hosted by Concentric.

The getting started guide usually covers the rationale for moving to digital consent, stepwise guide including test patient details, information about local integration, and local support processes.

The project manager for digital consent within your healthcare organisation will be able to direct you to your local onboarding information. You can also view a generic version.

Yes, Concentric is used for all consent to treatment scenarios. Depending on the scenario different consent options will be presented - for example for an adult patient consent form 1 (adult with capacity) and consent form 4 (adult without capacity) options will be presented, and depending on the selection different information will be required.

Our consent form 4 guide describes how a best interest decision / consent form 4 is completed, including video walk through.

Concentric is also used for consent on behalf of a child or young person (consent form 2). Our consent form 2 guide walks through this process and the differences between a consent form 1 and 2 in Concentric.

No, in the unlikely event that someone is editing that consent episode at the same time an error message will show to warn that the consent information you are seeing has been further edited elsewhere and will block further edits until you refresh the page two bring all versions back into sync.

Currently Concentric focuses on the surgical consent / treatment consent element rather than the documented anaesthetic consent which has traditionally ran in parallel, often on the anaesthetic record without a patient signature.

Some anaesthetic information is shared within Concentric - such as likely anaesthetic approach - with this information selected by the surgical team as part of the consent process. This information includes links out to trusted resources such as the RCOA (Royal College of Anaesthetists) patient information.

A separate consent episode can however be done for the anaesthetic technique - e.g spinal anaesthesia - if wished.

No, the communication to the patient comes from Concentric, with the healthcare organisation’s branding, rather than from any clinician's email or mobile number, and so clinicians email addresses and mobile numbers are not made visible to patients. Read more about patient communications in Concentric.

If there seems to be an issue with Concentric or how it is communicating with other systems within your healthcare organisation these should be reported to the project manager for digital consent within your healthcare organisation (contact details are within your onboarding information) who will co-ordinate investigation and any alerting to other clinical users.

Where there is an issue with Concentric itself (rather than any local integrations) this status page will reflect the status and share any status updates.

Each organisation should have a business continuity plan in the rare circumstance that Concentric cannot be used for consent.

Additional consents are the final element within clinician view and are used for consents that are linked but are separate to the treatment consent. What we mean by separate here is that the treatment can continue, and its consent be valid, regardless of whether consent is given to the additional consent elements.

Examples of additional consents include:

- consent to blood transfusion if required intra-operatively

- sharing of treatment details with registries (e.g. National Joint Registry)

- consent for additional samples to be taken for research purposes

- consent for recording and use of images/videos in medical record / teaching / publications

What they are not used for

We sometimes get asked whether it’s appropriate for things like “+/- urinary catheter” or “+/- drain insertion” to be added as additional consents.

Within Concentric these are included within the risks section. This is based on user research with patients which showed that many were confused by the distinction between some things that were listed as complications and some things that were listed as additional procedures. It made more sense to patients to understand them together - i.e this could happen, and therefore we might need to do x/y/z.

The second reason for this model is that these sort of small +/- additional procedures are often not separate to the treatment consent, they are intra-operative decisions made based on the context at the time in terms of giving the best patient outcome.

Once a treatment is selected in Concentric the default position is that quick-select template options for each of the different elements (indications, risks etc.) are presented for that treatment. The clinician then selects the relevant options for the individual patient, either from the template options or custom additions, including consideration of any material risks. This approach is taken as the default approach in order to support best practice and the medico-legal demonstration that the individual patient has been considered by the clinician.

We know however that there are some scenarios where the same information is selected almost every time, and in these scenarios the balance of benefit (especially as in many of these cases there is very limited time with patients due to system pressures) is towards the selection of the standard options with one click. There is still the ability to personalise to the individual on top of this should it be appropriate.

The other scenario to consider is where generic information is shared by a non-clinician, often with remote consent enabled, prior to being seen by a clinician for the first time on the day of treatment. Whilst there is some ambiguity in terms of whether this represents best practice, we know that it is common practice particularly for diagnostic pathways such as endoscopy. If Concentric makes it difficult to share generic information easily it risks reducing the treatment information that is shared with patients prior to the day of treatment, which clearly is not the aim.

The path towards meeting these two use cases, and the rationale for the ordering is outlined below.

Planned development work in this area:

Ability to edit episodes where consent has been given

The reason this is required is that for the scenario where a non-clinician is sharing generic information with remote consent enabled there needs to be a mechanism (regardless of how often it is used in practice) where the clinician seeing the patient on the day of treatment can modify and personalise the information for the patient, and thereby meet the requirements set out in the Montgomery judgement.

Single-click population of agreed template

This work will take place following the completion of the ‘Ability to edit episodes’ functionality.

Based on user research with patients we made the decision to present risks according to both timing (when in the patient journey they may happen), and likelihood. 3 groups are generally a good approach for these sort of thing - giving enough granularity to differentiate, without presenting a confusing and difficult to digest number of options. Hence we landed on 3 categories for timing (immediate, early, late) and 3 for likelihood (common, less common, rare) - you can see the definitions for each in Concentric.

A challenge here is that there has never been an agreed standard in terms of how risks are presented, which means that each team / company / association / Royal College who have prepared consent forms or patient information have come up with their own approach and definitions.

This presents complexity for patients who have to work out the context for how a risk is being described, which may be quite different to how things were described when they had a previous procedure by a different specialty.

For this reason we are attempting to introduce some standardisation - we see no good reason for why risks should be described differently depending on the specialty - and are in a good place to drive standardisation as a platform that is used across all specialties and across many healthcare organisations.

Planned development work in this area:

Flexible risk likelihood categories to align with external sources

Whilst the above is true in terms of our general approach, we equally are of the view that digital technologies shouldn’t get in the way, and should nudge rather than force behaviour change. We plan to introduce the flexibility to be able to opt in (at a departmental level) to using different risk likelihood categories in order to align with those used by a relevant Royal College or national association. There is some complexity here around managing this for procedures which cross single specialty borders, and where combined procedures cause cross-specialty conflict in terms of categories…but that’s for us to solve!

Consent form 3’s are not used within Concentric as this is simply another version of ‘adult with capacity consent’ - i.e the same as a Consent Form 1. Adult with capacity consent is labelled as a Consent Form 1 within Concentric simply as this is what it is usually known as by clinicians.

For paper consent forms where no dynamic logic can be applied Consent Form 1 and Consent Form 3 options were required to differentiate between procedures where general anaesthesia / sedation were used and those where a consciousness would not be impaired - this logic and the sharing of appropriate anaesthetic information is managed within Concentric depending on clinician selections in clinician view.

Concentric makes it easy to collect patient and clinician feedback without any manual input, through two mechanisms.

Patient feedback

There is an automated mechanism that can be used to send a survey link out to patients 1-2 weeks post consent. This is sent via either email or SMS and includes a link to a survey. This can be a Concentric hosted survey or one that the organisation prepares (sometimes we see organisations like to use the same survey platform for all their surveys). If you’d like to use a survey you’ve prepared just send us the URL and we’ll get it linked in.

View our sample patient feedback survey.

There is also the option to add a Shared Decision Making (SDM-Q-9) questionnaire to the survey.

Patients also have the option to add free-text feedback at any point within the Concentric patient application. Any such patient feedback for patients from your organisation are visible within the Concentric admin application.

Clinician feedback

By default we conduct a quarterly feedback to all clinicians using Concentric. This is designed to be quick so that we get decent response rates, and is generally a 0-10 net promoter score questions and an optional free-text box for anything the user thinks we could be doing better. These results can be shared with you.

In addition it is straightforward to send an additional survey out to all clinicians from your organisation with a specific questionnaire that you have developed. We sometimes see healthcare organisations doing so during the initial phases of a deployment to get deeper feedback around any challenges being faced etc.

Currently, when consent is given it enters a locked state where only certain actions can occur, such as confirming or revoking consent. Therefore, to make changes such as changing the procedure name or risk profile – anything requiring more than a note at point of confirmation of consent – a new consent episode is needed.

In our early 2022 clinician feedback survey this came out as one of the key areas where Concentric could be improved. We are currently working on functionality to make it possible to return to an ‘editable’ state post-consent, alongside the other required logic around re-signing etc.

Yes, content updates are generally requested via the project manager for digital consent within your healthcare organisation and are managed by the clinical team at Concentric. Further details regarding this process for project managers are detailed on our process for content template updates page.

Informal requests for change which are not linked to any Service Level Agreements can be made directly by clinicians.

At an individual patient level templates can be modified by the clinician to ensure that the information is appropriate for the individual. If no template is available, a blank template can be used.

Concentric is, at least currently, a digital consent to treatment application - i.e. consent to any procedure, treatment, or operation (Concentric’s current model can also be used for most invasive investigations).

There are research consents that are done as part of Concentric, but these are all related to the core treatment consent - they are an additional consent in parallel to the treatment consent.

Currently, we do not offer the functionality for research protocols that are not associated with a treatment consent to be completed within Concentric and would advise using a different platform for this. (We do get asked about research consent commonly, and therefore it should be of no surprise that we expect to expand into this area, but do not have a set timeframe for this work currently).

Within Concentric, every episode is assigned a Responsible Clinician. This is based on some of the recommendations from the Francis Report (2014), and the subsequent guidance from the GMC and Academy of Medical Royal Colleges (AoMRC).

The guidance outlined that each episode of care should be under the care of a named individual - and introduced the 2 terms, ‘Responsible Consultant’ and ‘Responsible Clinicians’ - with either acceptable to use as the terminology.

Objective two was that patients should know who the responsible clinician is.

For these reasons, a responsible clinician must be assigned in Concentric.

Who can be the responsible clinician?

Again following the guidance from the AoMRC:

“In most circumstances the Responsible Consultant/Clinician will be the consultant doctor. However, in some cases it may be another senior doctor (e.g. a Specialty Doctor) with the right level of competence or another clinical healthcare professional.”

This is the reason that a clinician can assign themselves as the responsible clinician within Concentric, where appropriate, even if they are not of consultant grade.

Yes, the Concentric clinician and patient applications are both compatible with standard browser translation tools - such as in Chrome and Safari. Depending on the browser this enables automated translation to up to 108 languages and includes translation of both the Concentric Ontology information and any custom elements or notes added by the clinician. This is supported through the application, including both the treatment information and the steps for patients to go through to give their consent.

There are some details here in terms of how to change the language on a web page:

- For Google Chrome

- For Apple Safari

It is important to note that a translation does not replace the need for an interpreter as part of having a ‘meaningful dialogue’ consent conversation - as is required by GMC guidance and medico-legally. Details of the interpretation (interpreter details and notes regarding the conversation and/or interpretation) can be documented within Concentric as part of the consent flow.

Planned/possible development work in this area

Human translation of some languages

Automated translation has come a long way in recent years with a vast amount of investment in its quality by some of the big technology companies - notably Google and Apple, including in its ability to translate medical information (this work was prioritised by these companies in response to COVID-19 to support the spread of accurate medical information regarding coronavirus globally). Automated translations are now commonly offered on NHS Trust and Health Board websites, including for treatment information leaflets/pages on these websites.

However, there are still currently times when automated translation doesn’t quite get things right - although these are becoming increasingly rare. We are continuing to assess whether there is a role for Concentric (human)-trained automated translation for common languages. So that we don’t lose the benefits of automated translation - such as the translation of custom elements and notes added by clinicians, we would still use a model where a custom machine learning model used, but would be trained by human translators with the aim of improving the accuracy (and allows us to ensure better consistency with our English language tone of voice etc.) over time.

We don't have native applications, iOS or Android, but many clinicians add Concentric as a homescreen shortcut. Concentric is a web application, and clinicians access it on a wide range of devices, running various operating systems. As a web application, there is nothing for users to download before they can use Concentric – whether they are patients or clinicians, and users are able to easily switch between devices to access Concentric without it impacting their experience.

From a develoment perspective, being a web application means we only need to maintain a single application, supporting us to regularly deploy improvements to Concentric (take a look at our product updates) whilst not requiring users to install updates. It also means that we can utilise browser-based accessibility functionality, such as translation of consent information into multiple languages, and the use of screenreaders, without additional development effort.

Homescreen shortcuts are easily added. For example:

• On iOS Safari, whilst on Concentric, click 'Add to Home Screen' in the browser's 'Share' menu.
• On Android Chrome, whilst on Concentric, go to the browser's menu (three-dot icon) and click 'Add to Home Screen'.

No, we do not believe the consent form is the correct place to document this information.

Whilst deploying Concentric we have seen that a minority of organisations have had a pregnancy status section within their paper consent forms. These are sometimes a question regarding whether the patient may be pregnant, and sometimes the documentation of a pregnancy test.

Our experience is that each time this has been explored, the organisation has reflected that the consent form, given recent context, is not the correct place for documentation of pregnancy status.

With a move away from consent on the day of treatment – as per best practice, there may be a long period of time (including longer than 9 months) between the first-stage consent documentation and the treatment. Pregnancy status is only relevant, in this context, at the point of treatment.

Following UK NatSSIPs 2 national guidance, pregnancy status should be elicited as part of the pre-assessment checks for all major procedures, and minor procedures where radiology is required or anticipated during the treatment. This forms part of the pre-operative assessment process (which happens more consistently in the days or short number of weeks prior to treatment than the consent process), with confirmation of status as part of the ‘Sign-In’ check.

A digital patient record provides the opportunity to ensure that information recording is not duplicated, both to increase efficiency but also to remove the risk of conflicting information and subsequent error. Pregnancy status has broader applicability that simply on the consent form, and therefore should be documented in the single most appropriate place.

Where treatment is being undertaken during confirmed or possible pregnancy this should form a part of the consent record. The addition and modification of information within the consent information to reflect the context – for example risks to the fetus or increased maternal perioperative risks – should be ensured, and can be managed within Concentric.