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- PMC11138170
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Frontline Gastroenterol. 2023 Jul; 14(4): 273–281.
Published online 2023 Feb 7. doi:10.1136/flgastro-2022-102353
PMCID: PMC11138170
PMID: 37409330
Nicholas Ewin Burr,1,2 Ian D Penman,3 Helen Griffiths,4 Andrew Axon,5 and Simon M Everett
6
Author information Copyright and License information PMC Disclaimer
See "UpFront" in volume 14 onpage269.
Abstract
In 2016, the British Society of Gastroenterology (BSG) published comprehensive guidelinesfor obtaining consent for endoscopic procedures. In November 2020, the General MedicalCouncil (GMC) introduced updated guidelines on shared decision making and consent. Theseguidelines followed the Montgomery ruling in 2015, which changed the legal doctrinedetermining what information should be given to a patient before a medical intervention.The GMC guidance and Montgomery ruling expand on the role of shared decision makingbetween the clinician and patient, explicitly highlighting the importance of understandingthe values of the patient. In November 2021, the BSG President’s Bulletinhighlighted the 2020 GMC guidance and the need to incorporate patient -related factorsinto decision making.
Here, we make formal recommendations in support of this communication, and update the2016 BSG endoscopy consent guidelines. The BSG guideline refers to the Montgomerylegislation, but this document expands on the findings and gives proposals for how toincorporate it into the consent process. The document is to accompany, not replace therecent GMC and BSG guidelines.
The recommendations are made in the understanding that there is not a single solution tothe consent process, but that medical practitioners and services must work together toensure that the principles and recommendations laid out below are deliverable at a locallevel. The 2020 GMC and 2016 BSG guidance had patient representatives involved throughoutthe process. Further patient involvement was not sought here as this update is to givepractical advice on how to incorporate these guidelines into clinical practice and theconsent process. This document should be read by endoscopists and referrers from primaryand secondary care.
Keywords: ENDOSCOPY, ENDOSCOPIC PROCEDURES, SURGICAL COMPLICATIONS, MEDICO-LEGAL MATTERS
Summary of Recommendations
KQ1 - When seeking informed consent for an endoscopic procedure, how do we obtainindividualised consent?
Recommendation
Individualised consent for endoscopy requires that specific patient-related risk factorsand personal values are incorporated into the decision about whether to proceed with agiven endoscopic procedure. These can only be determined through knowledge of theprocedure and its alternatives as well as dialogue with the patient and, if necessary,family, friends or carers.
KQ2 - When seeking informed individualised consent for an endoscopic procedure, whichpatient related factors need to be taken into consideration?
Recommendation
Individualised consent for endoscopy requires that clinical factors related to thepatient’s symptoms, past medical history and specific patient related riskfactors related to the proposed procedure, as well as the patient’s personalpreferences and expectations, should be explored.
KQ3 - In broad terms, which procedure related factors need to be considered inindividualised consent?
Recommendation
The risks and alternatives to endoscopic procedures vary considerably. Patientinformation platforms such as leaflets or online resources represent a minimum and whererisk is greater or treatment options vary, steps must be taken to ensure that thepatient is aware of this ahead of the procedure.
KQ 4 - When considering individualising risk and patient/procedural factors, do weneed to re-define who can complete the consent process?
Recommendation
The person completing the consent form needs to have adequate knowledge of theprocedure, range of individual risks and alternatives to that procedure. This willdepend on the specific procedure but for high-risk procedures will require eitherconsiderable personal experience in the procedure or dedicated training that should beformally approved through local governance procedures.
Recommendation
The location in which consent is confirmed on the day of the procedure should beconfidential, in a different location to the endoscopy treatment room and offersufficient privacy and dignity to allow the patient to consider their decision.
KQ5 - For lower-risk procedures that are frequently referred “straight totest” how do we ensure that there is the opportunity to offer individual choice(without introducing unnecessary delay to the pathway)?
Recommendation
For low-risk procedures the endoscopy service should receive adequatepatient-specific information from the referrer to allow safe triage. The patient shouldreceive standardised information and have an opportunity for further discussion ifrequired ahead of the procedure. The person completing the consent process must verifythat this has occurred before the procedure occurs.
KQ6 - For high-risk/low-volume procedures what additional steps may be required toensure individualised consent in the elective or out-patient setting?
Recommendation
In the case of complex or higher-risk endoscopic interventions, careful vettingfor appropriateness is required and MDT discussion is encouraged. Referral centresshould adopt systems to ensure that the patient has access to appropriate informationabout risks and alternatives and an opportunity to discuss this with an appropriatelytrained individual ahead of the procedure.
KQ7 - For high-risk procedures what additional steps may be required to ensureindividualised consent in the urgent/emergency setting?
Recommendation
For high-risk urgent procedures patients should have access to an appropriatelytrained individual who can discuss the risks and alternatives to the patient on anindividualised basis before they attend the endoscopy department for theprocedure.
KQ8 - In considering all of the above, what recommendations should be made in respectof patient selection (vetting for appropriateness) ahead of the procedure?
Recommendation
Information on endoscopy requests must be sufficient to determine whether anendoscopy is appropriate. Vetting for appropriateness should be performed for all casesbut is particularly central to case selection for high-risk interventions.
Background
Historically, consent for medical intervention was a ‘paternalistic’ modelwhere the clinician would determine the entire clinical episode from assessment,investigation and treatment. Appropriately, this has now changed to a patient-centred modelwhere risks, benefits and alternatives including not undergoing procedures are discussedbetween the patient and clinician. The legal basis for this follows the Montgomery ruling in2015 (Montgomery v Lanarkshire Health Board (2015) A.C. 1430). Here, information as to therisk of shoulder dystocia associated with vagin*l delivery was not given to an expectantmother with diabetes. The consultant withheld information as she estimated the risk ofserious injury to be very small and, that if the condition were mentioned, most women wouldask for a Caesarean section, which was not in their interest. The delivery was complicatedby dystocia and subsequent hypoxic brain injury for the child.
The Supreme Court held that the clinician has a duty of care to ensure that the patient isaware of any material risk of an intervention and of any reasonable alternative or varianttreatments. A material risk is defined as whether a reasonable person in thepatient’s position would be likely to attach significance to the risk, or the doctoris or should reasonably be aware that the particular patient would be likely to attachsignificance to it.1
The court observed social and legal developments point away from the model of therelationship between doctor and patient based on medical paternalism, adopting an approachto the law which:
… instead of treating patients as placing themselves in the hands of the doctors(and then being prone to sue their doctors in the event of a disappointing outcome),treats them so far as possible as adults who are capable of understanding that medicaltreatment is uncertain of success and may involve risks, accepting responsibility for thetaking of risks affecting their own lives, and living with the consequences of theirchoices… (Paragraph 81. Montgomery v Lanarkshire Health Board [2015] A.C.1430).
If a patient is to accept responsibility for the consequences of their choices, it is theduty of a doctor to make them aware of any material risk they might consider significant aswell as the alternatives to the proposed procedure, adopting the seven principles ofdecision making set out below.
In practice, this means that the clinician must be satisfied that they understand thevalues of the patient before proceeding. Consent must be individualised, consideringclinical and patient-related factors and assumptions should not be made. For example, therisk of perforation during endoscopy may be more significant to someone with prior bowelsurgery than those without. As such, a tailored discussion with the patient outlining thepertinent facts relevant to that individual is preferred rather than merely a list ofpotential complications.
Updated General Medical Council guidance on consent
The updated General Medical Council (GMC) guidance on how to consent for medicalprocedures incorporated the Montgomery ruling and included seven principles to inform theprocess (table 1).
Table 1
The seven principles of decision making and consent
| Principle 1 | All patients have the right to be involved indecisions about their treatment and care and be supported to make informeddecisions if they are able |
| Principle 2 | Decision making is an ongoing process focused onmeaningful dialogue: the exchange of relevant information specific to theindividual patient |
| Principle 3 | All patients have the right to be listened to, and tobe given the information they need to make a decision and the time and supportthey need to understand it |
| Principle 4 | Doctors must try to find out what matters to patientsso they can share relevant information about the benefits and harms of proposedoptions and reasonable alternatives, including the option to take no action |
| Principle 5 | Doctors must start from the presumption that all adultpatients have capacity to make decisions about their treatment and care. A patientcan only be judged to lack capacity to make a specific decision at a specifictime, and only after assessment in line with legal requirements |
| Principle 6 | The choice of treatment or care for patients who lackcapacity must be of overall benefit to them, and decisions should be made inconsultation with those who are close to them or advocating for them |
| Principle 7 | Patients whose right to consent is affected by lawshould be supported to be involved in the decision-making process, and to exercisechoice if possible |
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Principle 4 is key when considering individualised consent. When completing consent forendoscopy, the burden is ultimately on the professional performing the procedure to ensurethat these principles are upheld, and this is explicit in the GMC guideline, whichstates:
You must use your professional judgement to apply this and our other guidance to yourpractice. If you do this, act in good faith and in the interests of patients, you willbe able to explain and justify your decisions and actions.2
Methods
The authors reviewed the 2020 GMC Guidance in detail and produced a list of areas in the2016 British Society of Gastroenterology (BSG) guideline that required development to complywith the principles laid out in that document. Key questions (KQs) were drafted that soughtto divide procedures into high and low volume and high and low complexity or risk. While itwas understood that this would not cover all procedures, and significant overlap wouldexist, it was felt that this would provide a useful lexicon on which to frame furtherdiscussion. The draft KQs were refined following circulation to all authors and specificallyfollowing input from legal counsel (AA).
After confirmation of the KQs, recommendations were drawn up and discussed by all authors.Full consensus for each recommendation was achieved. Once full agreement was achieved amongall authors, the document was reviewed by the BSG Endoscopy Committee and Clinical Servicesand Standards Committee before final approval.
These recommendations refer to the consent process in patients with capacity. It isassumed, unless otherwise stated, that a full capacity assessment has occurred as outlinedin the 2016 guideline.3 Recommendations in relation topatients without capacity are made in that guideline and are not repeated here.
Terminology around consent is important. The process of consent relates to the provision ofinformation and all of the discussions that occur ahead of and occasionally during theprocedure. The patient gives informed consent based on their understanding of the risks,benefits and alternatives that come out of this dialogue. Evidence that this process hasoccurred satisfactorily is provided by a signature from a suitably trained clinician andpatient on the consent form.
Thus, throughout this document we have avoided the term ‘taking’ consent;instead, we refer to either obtaining or seeking consent through a process that concludeswith the patient giving consent voluntarily. The term ‘completing’ is used torefer to the process of signing and finalising the consent form. Confirmation of consent canoccur at any point in the pathway after the patient has given their consent (as canwithdrawal), but does not refer to the signature or consent form per se.
KQs and recommendations
KQ1: when seeking informed consent for an endoscopic procedure, how do we obtainindividualised consent?
It is not possible to be prescriptive about how to obtain consent for endoscopicprocedures due to the number of procedural and patient-related factors involved. Whetherthe GMC principles of consent have been applied will always come to the professionaljudgement of the person performing the endoscopy. The principle message is to ensurethat individual patient values and clinical factors have been incorporated in theconsent process. Patients should have the opportunity for open dialogue with theclinical team proposing the endoscopic procedure to discuss the risks, benefits andalternatives, including the risks of not undergoing an endoscopy or the options of lessinvasive procedures. Where there are reasonable alternative investigations to anendoscopy such as faecal calprotectin, faecal immunochemical test (FIT), CT colonography(CTC), capsule endoscopy for lower GI investigations, or automated cell collectiondevice (eg, Cytosponge) for Barrett’s screening and surveillance, for example,they should be discussed with the patient in advance.
This relies on enough information being provided to all interested parties. The GMCrecommend that the following information is included2:
Recognised risks of harm that you believe anyone in the patient’s positionwould want to know. You’ll know these already from your professionalknowledge and experience.
The effect of the patient’s individual clinical circ*mstances on theprobability of a benefit or harm occurring. If you know the patient’s medicalhistory, you’ll know some of what you need to share already, but the dialoguecould reveal more.
Risks of harm and potential benefits that the patient would consider significantfor any reason. These will be revealed during your discussion with the patient aboutwhat matters to them.
Any risk of serious harm, however unlikely it is to occur.
Expected harms, including common side effects and what to do if they occur.
In order to satisfy these criteria, the patient must have had information about theprocedure and the endoscopist must have details from the referral pathway on theirmedical history and, where relevant, views of the patient. How and when that informationis given to the patient and discussed with them will depend in part on the procedurebeing recommended. For higher-risk procedures or more complex patients, more time willneed to be allocated to this discussion and for the patient to reflect on the options.This may require the input of family, friends or carers and be best in an electiveout-patient setting. For diagnostic tests in low-risk patients, it may be appropriatefor some of the process and completion of the form to occur on the day of the procedure,so long as adequate information has been provided and the patient given the opportunityto express their wishes or concerns in advance of this.
Recommendation
Individualised consent for endoscopy requires that specific patient-related riskfactors and personal values are incorporated into the decision about whether to proceedwith a given endoscopic procedure. These can only be determined through knowledge of theprocedure and its alternatives as well as dialogue with the patient and, if necessary,family, friends or carers.
KQ2: when seeking informed individualised consent for an endoscopic procedure,which patient-related factors need to be taken into consideration?
Individualised consent requires that the circ*mstances specific to that patient aretaken into consideration. This includes both clinical and personal factors (table 2).
Table 2
Factors to consider when discussing informed consent for an endoscopic procedure ina patient with capacity
| Risk evaluation (The risk of acomplication occurring and the consequences if a complication should occur) | Procedure | Patient |
| General | General risks of the underlying endoscopic procedure(eg, colonoscopy) | Fitness for endoscopy, including comorbidities andmedication use |
| Individualised | Factors that increase (or decrease) the risk of thespecific proposed procedure (eg, polypectomy) | Patient-related risk factors for this specificprocedure (eg, prior surgery) |
| Patient-related preferences or concerns in relationto the procedure and outcomes |
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Clinical factors can be divided into general risk factors for endoscopy and risks thatare specific to the procedure. General risk factors include comorbidities such ascardiovascular risk and medications. Individual risk factors for a given procedureinclude patient demographics, current symptoms (such as a history of dysphagia for upperGI procedures) and medical history (such as prior surgery, patient anatomy, prioradverse events). Often there is not a robust body of evidence to individualise risk butthere should be a discussion of overall risk and whether somebody is at greater orlesser risk compared with the general population. In some circ*mstances, there areuseful guides such as the European Society of Gastrointestinal Endoscopy (ESGE)guidelines for adverse events associated with endoscopic retrogradecholangiopancreatography (ERCP), which can highlight those at greater risk ofcomplications, and these should be incorporated into discussions where possible.4
Patient-specific clinical risk factors relate to the risk of a given complicationoccurring and the consequences if such a complication was to occur. A patient withsignificant comorbidities may be less likely to survive a given complication, such as aperforation, and this should be incorporated into an individualised consentdiscussion.
Personal factors will include a patient’s individual preferences and fears,prior experiences and expectations or hopes in terms of clinical outcomes. An obviousexample would be to differentiate the expectations of a young healthy adult comparedwith an elderly patient with limited life expectancy, but there will be many others,such as a greater desire to avoid surgical scars in some individuals. These should notbe taken for granted and must be explored prior to recommending a given invasiveprocedure.
Recommendation
Individualised consent for endoscopy requires that clinical factors related to thepatient’s symptoms, medical history and specific patient-related risk factorsrelated to the proposed procedure, as well as the patient’s personal preferencesand expectations, should be explored.
KQ3: in broad terms, which procedure-related factors need to be considered inindividualised consent?
Providing information about procedure-related risk is germane to the consent process.Often this is provided in a standardised platform such as information leaflets or onlineresources. However, the complexity and variation of endoscopic procedures has progressedso much in recent years, and will continue to do so, such that practitioners mustrecognise that these platforms can only function as a general guide. The risk ofcolonoscopy will vary considerably depending on the clinical indication—rangingfrom a low-risk diagnostic test to a high-risk large polypectomy. Examples of riskvariation can be found across all endoscopic procedures and need to be taken intoconsideration. As outlined in the 2016 BSG guideline, the consent process should includeall possible outcomes and additional procedures that might be required to fulfil theprimary objective of the endoscopy.3 This mayinclude scenarios such as resection of complex polyps found on screening or surveillanceprocedures where removal is appropriate. The 2016 guideline also deals with unexpectedfindings with explicit recommendation that the scope of the consent should not beexceeded unless failure to intervene would cause immediate harm.
Thus, while the use of standard patient information platforms is not discouraged, wherethe risk of a procedure exceeds that, this information must be provided in some otherformat, either verbally or written. Similarly, the alternatives to a given procedurewill vary considerably. For example, the treatment options for a patient with commonbile duct stones are very different to the treatment options for a patient with amalignant biliary stricture. These options cannot be comprehensively discussed in asingle leaflet so organisations and practitioners must find a way to allow this to bediscussed with a patient prior to the procedure.
Recommendation
The risks and alternatives to endoscopic procedures vary considerably. Patientinformation platforms such as leaflets or online resources represent a minimum and whererisk is greater or treatment options vary, steps must be taken to ensure that thepatient is aware of this ahead of the procedure.
KQ 4: when considering individualising risk and patient/procedural factors, do weneed to redefine who can complete the consent process?
The person discussing consent and completing the consent form with the patient musthave a detailed understanding of all aspects of the procedure including the risks,benefits and alternatives. This discussion may be short and simple for many low-riskdiagnostic procedures, to long and complex for high-risk interventional or therapeuticprocedures. Such discussions should be tailored to the specific procedure and thepatient. While, in many high-volume cases, this can be via standardised processes, everyopportunity must be taken to ensure that patient autonomy is preserved.
Any healthcare professional can, and should be, encouraged to have a conversation witha patient about a procedure up to the limit of their professional knowledge. However,the person signing the consent form is doing so to confirm that they are satisfied thatthe patient has received the relevant information and options and had time to considerthem. This person must have a clear knowledge of the factors as laid out in table 2. For low-risk procedures, a person who doesnot perform the procedure can be trained in a way that will facilitate such adiscussion. However, for complex or higher-risk procedures, it is anticipated that onlya person with considerable knowledge of this specific procedure will have such anunderstanding. Usually such a person will perform the procedure themselves. Wheredelegated to a non-endoscopist, the person completing the consent form with the patientmust be able to satisfy that they have clear knowledge of the factors as laid out intable 2, achieved through successful completionof validated training for that procedure that includes direct observation of practice.Whatever arrangements are adopted locally should be recorded within the Trust ConsentPolicy and be formally approved under local governance procedures.
Whoever is completing the consent process with the patient, this should occur in aconfidential and non-threatening environment that offers sufficient privacy and dignityto the patient. It should be comfortable and physically separate from the endoscopytreatment room and the patient should have the option of having relatives, friends orcarers present if desired. Ideally this should occur prior to the patient beingcannulated and changed for the procedure. This should reduce the possibility of coercionand allow space and time for the patient to consider the test before confirmingagreement to proceed.
Recommendation
The person completing the consent form needs to have adequate knowledge of theprocedure, range of individual risks and alternatives to that procedure. This willdepend on the specific procedure but for high-risk procedures will require eitherconsiderable personal experience in the procedure or dedicated training that should beformally approved through local governance procedures.
Recommendation
The location in which consent is confirmed on the day of the procedure should beconfidential, in a different location to the endoscopy treatment room and offersufficient privacy and dignity to allow the patient to consider their decision.
KQ5: for lower-risk procedures that are frequently referred ‘straight totest’ how do we ensure that there is the opportunity to offer individual choice(without introducing unnecessary delay to the pathway)?
An important consideration for the consent process is that it is proportionate andtakes into account the complexity of the decision, how quickly the decision needs to bemade, the impact of the potential outcome and what is already known about thepatient.2 The majority of endoscopic proceduresare low-risk tests and would not mandate a lengthy and complicated consent process. Forexample, upper gastrointestinal (GI) endoscopy in a relatively healthy person wouldcarry extremely low risk but is important to be performed in a timely manner. Theseupdated guidelines are not intended to introduce delay and constraints where they arenot necessary.
At a population-level harm would occur by delaying low-risk tests for suspectedmalignancy because of an overly burdensome consent process. Thus, each unit should finda solution for its service and population that can satisfy the requirements of theserecommendations and the GMC guideline without unnecessarily impacting on servicedelivery.
Where systems do not employ a consultation with an endoscopist prior to the day of theprocedure, the referral should contain sufficient patient-specific information, asoutlined in table 2, for appropriate triage andto determine if a consultation is required. This should include confirmation that thepatient has capacity to consent. Consultation should be available for patients whoseindication is borderline, may lack capacity, have personal risk factors or concerns, orsimply desire further discussion (accepting that such discussion may delay theirprocedure).
Accordingly, it may be advisable that where a referral is ‘straight totest’, there is confirmation that the patient has agreed to this approach anddoes not wish further dialogue with an endoscopist before attending on the day. Suchsystems require robust processes to ensure patients receive adequate information beforethe procedure in the form of information leaflets or online resources. Previously, thisprocess was termed ‘postal consent’. Although we endorse the provision ofinformation to patients by post, we no longer recommend the use of this term as itimplies that the consent process has been completed before the patient attends for theprocedure. Further, this requires that the patient has the opportunity to access furtherinformation prior to the procedure if they wish it, for example via a preassessment teamor helpline, and on the day of the procedure the endoscopist must verify that thepatient is satisfied with the information already received and is happy to proceed.
Electronic consent (eConsent)
Electronic methods for seeking informed consent and ‘eConsent’ refer tothe use of any electronic media (such as text, graphics, audio, video, podcasts orwebsites) to convey information related to the procedure and to seek and/or documentinformed consent via an electronic device such as a smartphone, tablet or computer. Suchsystems have become popular in clinical research trials and there are now emergingplatforms for consenting for clinical procedures.
eConsent for use in clinical trials has been approved in a Joint Statement from the UKNational Health Service (NHS) Health Research Authority in 2018.5 The principles in this statement, in broad regard, are similar tothose that should be adopted in clinical practice.
Electronic signatures can vary in complexity and are classified as‘simple,’ ‘advanced’ or ‘qualified’. Inresearch practice, it is recommended that the choice will depend on study type andcomplexity. In clinical practice, it is essential to be sure that the person signing theform is the same person that is potentially undergoing the procedure (and being able todemonstrate this if required). It is also important to understand that such methods mayunintentionally discriminate against people who are not comfortable with or who cannotuse such technology. Accordingly, alternative methods for the provision of informationand/or documentation of consent should be available for those unable or unwilling to useelectronic methods.
The Joint Statement stresses that ‘while a consent form provides an importantaudit trail and assurance that the consent process was conducted appropriately; asignature on a consent form (regardless of whether it is wet-ink or electronic) does notdetermine that the consent given has been sufficiently informed and is legallyvalid’. Further, eConsent does not absolve those engaged in studies of theresponsibility to communicate adequately with participants. The statement concludes thatin Clinical Trials of Investigational Medicinal Products, an interview (howeverconducted) is mandatory. This must be facilitated through an interactive communicationthat allows participants to ask questions and receive answers. A similar approach shouldbe adopted for clinical practice.
It should be noted that while eConsent is subject to a Joint Statement and is inwidespread use in clinical research, such platforms have not been validated or approvedfor clinical practice and we recommend caution until such time as they are. WhileeConsent platforms may offer advantages for low-risk high volume procedures, werecommend against their use in high-risk or complex procedures. Further, any service orindividual considering using such platforms should ensure that they meet all of thecriteria for individualised informed consent laid out in this section and the remainderof this document and we would advise that they be checked by organisational legal teamsbefore implementation.
Recommendation
For low-risk procedures, the endoscopy service should receive adequate patient-specificinformation from the referrer to allow safe triage. The patient should receivestandardised information and have an opportunity for further discussion if requiredahead of the procedure. The person completing the consent process must verify that thishas occurred before the procedure occurs.
KQ6: for high-risk/low-volume procedures what additional steps may be required toensure individualised consent in the elective or outpatient setting?
For higher-risk cases such as ERCP, percutaneous endoscopic gastrostomy (PEG), complexendoscopic resections and enteroscopies, the endoscopy service needs to have a robustsystem to ensure the consent process is completed in line with the GMC principles. Thiswas emphasised in the 2016 guideline:
However, where such a process is implemented for higher-risk or more complexprocedures, an opportunity to discuss the procedure either by telephone or face toface should be made available in advance of the day as a minimum standard3
Such cases are more likely to lead to complications, might have a number ofalternatives and risk evaluation may well be complex. Such issues recently emerged in aCoroner’s enquiry into post-ERCP deaths. (https://www.judiciary.uk/publications/william-doleman-anita-burkey-peter-sellars-and-carol-cole-prevention-of-future-deaths-report/).These cases are often referred from other specialties within the same hospital and,increasingly, from referral hospitals separate to the treating Trust. In manysituations, the referrers do not have the necessary expertise to fully counsel theirpatients as to risks and alternatives. Accordingly, it is essential that the receivingteam implement robust systems to review appropriateness for the procedure (vetting)ahead of the appointment so that inappropriate referrals can be intercepted, ornecessary additional information obtained well in advance of the procedure. Theinvolvement of multidisciplinary teams (MDTs), with appropriate administrative support,is encouraged for complex cases.6
Such ‘vetting for appropriateness’ is an important element of informedconsent in so far as it prevents the need for complex discussions about appropriatenesson the day of the procedure when the patient has attended and is expecting the procedureto go ahead. Every attempt must be made to prevent this from occurring. However, shoulda patient attend for a procedure that the endoscopist feels may not be indicated, orthat the indication or appropriateness has changed since referral, the endoscopist isresponsible for informing the patient and cancelling or deferring the procedure.
Further, while it is beholden on the referrer to initiate counselling of the patientabout the procedure, the receiving organisation cannot entirely rely on this. Thus,although this may create logistical difficulties, it is essential that solutions arefound to facilitate access for the patient to detailed discussion with an individual whois familiar with the risks and options and to allow individualised consent according tothe principles laid out above. Video and telephone consultations may be an appropriatesolution in this circ*mstance, but units should develop their own models.
Recommendation
In the case of complex or higher-risk endoscopic interventions, careful vetting forappropriateness is required and MDT discussion is encouraged. Referral centres shouldadopt systems to ensure that the patient has access to appropriate information aboutrisks and alternatives and an opportunity to discuss this with an appropriately trainedindividual ahead of the procedure.
KQ7: for high-risk procedures what additional steps may be required to ensureindividualised consent in the urgent/emergency setting?
Requests for acute interventions are often for patients admitted to hospital withemergency medical problems such as GI bleeding or cholangitis. These referralsfrequently come from specialties that lack complete knowledge of the availableendoscopic procedures. These are often higher-risk procedures and high-risk patients andthe consequences of intervention (or not) need to be adequately explained to satisfy therequirements for informed consent. While these cases are usually urgent, with rareexceptions, this does not reduce the need to fulfil the principles of assessment ofappropriateness and fully informed and individualised consent ahead of the procedure.Thus, with the exception of clinical emergencies where detailed discussion is notpossible, all inpatients referred for urgent procedures should have the same access toindividualised risk evaluation and discussion about alternatives as patients in theelective setting. This may require in-reach to the ward by an appropriately trainedindividual ahead of the procedure but, again, Trusts must find their own solutions tosatisfy these requirements. In the case of emergencies this may not be practical andclinical care should not be harmed by delay; nonetheless every attempt should be made tosatisfy these principles within the constraints of the emergency setting.
Recommendation
For high-risk urgent procedures, patients should have access to an appropriatelytrained individual who can discuss the risks and alternatives to the patient on anindividualised basis before they attend the endoscopy department for the procedure.
KQ8: in considering all of the above, what recommendations should be made inrespect of patient selection (vetting for appropriateness) ahead of theprocedure?
Endoscopy remains a service for which the majority of cases are performed onindividuals referred in from outside specialties, different hospitals or Trusts orprimary care. It is evident that a discussion about consent is invalid if the procedureper se is not required or inappropriate for the clinical indication. Increasingly triageand/or risk stratification tools are available to facilitate patient selection forinterventions, such as FIT or faecal calprotectin tests prior to colonoscopy, andalternative tests may be available for the same indication (eg, CTC or colon capsuleendoscopy). It is essential that such tools are used within the limits of availableevidence and patients can understand the relevance of such results and the alternativesavailable to them. Further, the opportunity for an individualised discussion must not belost, where required, even in high-volume low-risk referrals. Organisations must,therefore, implement systems that ensure the test is appropriate for the indication,that there is sufficient information for safe and individualised triage and, wherenecessary, the patient has access to discussion.
For higher-risk interventions, this need is even greater and careful vetting forappropriateness, with all of the relevant information available, ahead of the procedureby an appropriately trained individual is an essential prerequisite for a subsequentinformed consent discussion. Online systems are available to facilitate vettingprocesses and are encouraged.
Recommendation
Information on endoscopy requests must be sufficient to determine whether an endoscopyis appropriate. Vetting for appropriateness should be performed for all cases but isparticularly central to case selection for high-risk interventions.
Conclusions
Even high-volume, diagnostic endoscopic procedures are not without risk and in recent yearsmore alternatives to endoscopy and robust triage tools have become available. In addition,there are increasingly complex endoscopic interventions that that have higher risk but offernovel therapy or may offer alternatives to more conventional surgical approaches. All ofthese issues place greater demand on endoscopy services and individual endoscopists toensure that the consent process is robust, timely and patients are involved in the decisionprocess. Here, we have provided recommendations and guidance aiming to help endoscopyservices comply with recent updated GMC guidance on the consent process. It is recognisedthat these recommendations may place increased demands on already stretched units and it isintended that they be incorporated in a manner suited to individual units and in a way thatis proportionate to the indication and procedure. Nonetheless, it is essential to adoptthese in order to meet current legislation and, if implemented thoughtfully, they willimprove the quality of the patient journey and may reduce the number of inappropriateprocedures performed.
Footnotes
Twitter: @GastronautIan
Correction notice: This article has been corrected since it published Online First. The formatting of table1 has been updated.
Contributors: SME: conceptualisation, methodology, writing—original draft, writing—review and editing. NEB: conceptualisation, methodology, writing—original draft,writing—review and editing. IDP: methodology, writing—original draft,writing—review and editing. HG: methodology, writing—original draft,writing—review and editing. AA: methodology, writing—original draft,writing—review and editing.
Funding: The authors have not declared a specific grant for this research from any funding agencyin the public, commercial or not-for-profit sectors.
Competing interests: None declared.
Provenance and peer review: Not commissioned; externally peer reviewed.
Ethics statements
Patient consent for publication
Not applicable.
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